Prealize Health, an artificial intelligence (AI)-enabled predictive analytics company, announced a new partnership with VirtualHealth, provider of HELIOS, a software-as-a-service (SaaS) care management platform. The two companies will incorporate Prealize’s healthcare insights into VirtualHealth’s HELIOS program.
HELIOS, according to VirtualHealth, connects the end-to-end healthcare ecosystem, gathering medical, behavioral, social and service data to deliver a 360° view of each member. The platform’s proprietary clinical decision rule engines and automated workflows aim to guide clinicians and care managers toward proper communication, assessment, care planning and educational activities for every person in their care.
Prealize’s AI-enabled predictive analytics help payers and providers proactively address individuals’ health. The company says that its predictions have shown to be twice as accurate as that of other leading companies, enabling payers and providers to act as early as 12 months before a diagnosis hits a claim.
Pelican BioThermal, creators of the “School of Cool” online learning platform, has formed a partnership with South Korea-based Asiana Airlines, which helps expand the packaging company’s growing global network of locations and sector alliances.
In the ongoing rapid response to support the fight against Covid-19, the new partnership provides Asiana Airlines access to Pelican BioThermal’s Crēdo on Demand rental program when shipping temperature-sensitive pharma and pandemic payloads worldwide.
This newly formed deal also provides Asiana Airlines customers with Pelican BioThermal’s shipper solutions, including the company’s recently expanded range of temperature-controlled packaging to cover both deep frozen and frozen applications, which consist of dry ice and PCM coolants, covering parcel and bulk sizes for single or multi use/reusable, including rental through the Crēdo on Demand program.
Thermo Fisher Scientific Inc. has entered into a definitive agreement to acquire Mesa Biotech, Inc., a molecular diagnostic company, for approximately $450 million in cash. Per the deal, Thermo Fisher will pay up to an additional $100 million in cash if certain milestones are completed, following the close of the transaction.
The deal is expected to be completed in the first quarter, subject to customary closing conditions, including regulatory approval. Mesa Biotech will become part of Thermo Fisher’s Life Sciences Solutions sector, once the deal is final.
Mesa Biotech has developed and commercialized a polymerase chain reaction (PCR)-based rapid point-of-care testing platform available for detecting infectious diseases, including SARS-CoV-2, Influenza A and B, respiratory syncytial virus (RSV) and Strep A. Mesa Biotech’s patented technology furthers the availability of nucleic acid PCR amplification to point-of-care diagnostics.
The company’s Accula Flu A/Flu B, RSV and Strep A tests have obtained 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waivers from the FDA. Additionally, the Accula System has received Emergency Use Authorization (EUA) from the agency for SARS-CoV-2 in vitro diagnostic testing, and is now available for use in patient care settings, providing results in 30 minutes.
This deal comes on the heels of Thermo Fisher’s acquisition of Novasep’s viral vector manufacturing business last week, via an $876 million transaction.
Cure Genetics will collaborate with pharma company Boehringer Ingelheim to form novel adeno-associated virus (AAV) vectors, which will use Cure Genetics’ branded VELP platform to develop gene therapies. The new partnership combines Boehringer Ingelheim’s disease biology and gene therapy development experience with Cure Genetics’ AAV knowledge in library construction and in vivo AAV screening.
The aim is to potentially uncover new AAV serotypes for patients, as Cure Genetics notes that the clinical applications of current AAV serotypes could offer limitations, such as low transduction efficiency, low tissue specificity and immunogenicity.
VELP features various modes of innovation, including a strategy of building a plasmid library with high complexity and an effective ratio. The AAV production protocol allows for high genome-capsid correspondence and quality production capacity. It also allows for a shorter process to find the proper AAV vectors with nearly all possibilities effectively covered, Cure Genetics states.
Fujifilm Corporation and The Massachusetts Center for Advanced Biological Innovation and Manufacturing (CABIM), whose goal is to ensure new therapeutics, medicines and technologies reach patients quicker, have secured $76 million in financing, signing a lease for a 40,000 square-foot site in Watertown, MA, at The Arsenal on the Charles. The center, which will debut in early 2022, will help advance R&D in cell and gene therapy, gene editing, immunotherapy and biotechnology, while also looking to develop talent in the field of biopharma manufacturing in the greater Boston area.
Fujifilm recently invested over $2 billion in an unnamed US contract development and manufacturing organization (CDMO) site that is scheduled to begin operations in spring 2025.
Fujifilm Diosynth Biotechnologies, a Fujifilm subsidiary, will provide GMP (good manufacturing practice) contract process development and manufacturing services as part of its role in the new center. The initial $76 million fundraising round will be used toward construction, the payment of 40 full-time employees, and toward maintaining the center’s day-to-day operations.
The manufacturing facility is expecting to feature eight cleanrooms, containing a layout that will produce both cell and viral vector products within the physical area. The location will provide quality control, lab, office and meeting space to enable collaboration between the area’s academia, industries and hospitals.
etectRx, Inc., a digital health company, has entered into an agreement with Pear Therapeutics, Inc., a prescription digital therapeutics (PDTs) provider.
The objective: develop up to two product candidates in the central nervous system (CNS) sector that combine PDTs and adherence sensors. The companies say that this partnership is the first to explore the use of digital pill solutions with PDTs.
etectRx’s ingestible sensor, the ID-Cap System
etectRx’s FDA-cleared ID-Cap System, a digital pill system that the company says is accurate and flexible, enhances adherence to oral medication and helps to improve patient outcomes. Specifically, FDA cleared ID-Cap System as an ingestible event marker, which has the ability to guide digital and non-digital therapeutic interventions. Once swallowed, its ID-Tag uses etectRx’s proprietary communications technology to transmit a very low power digital message from within the patient’s stomach.
Thermo Fisher Scientific Inc. and Groupe Novasep SAS, a services and technologies supplier for the life sciences industry, announced that Thermo Fisher has acquired Henogen S.A., Novasep’s viral vector manufacturing business in Belgium, for approximately €725 million (about $876 million) in cash.
Henogen S.A. will be part of Thermo Fisher’s pharma services business within the laboratory products and services segment.
Between its two locations in Seneffe and Gosselies, Belgium, the business offers contract manufacturing services for both vaccines and therapies to biotech companies and large biopharma customers via approximately 75,347 square feet of capacity. The business’ estimated 2020 revenue was €80 million (approximately $97 million).
Amalgam Rx, Inc., which specializes in digital therapeutics and patient support, has acquired Avhana Health, a clinical decision support (CDS) company with tools that are directly integrated into the electronic health record (EHR) workflow, for an undisclosed amount. The software as a service (SaaS)-based CDS tool allows for two-way interactions within the EHR and can help enhance provider workflow. Amalgam Rx says that it will expand Avhana’s CDS features to various therapeutic areas, with the goal of making doctors’ daily processes a bit smoother.
Doctors use Avhana Health’s services in an effort to support adherence to clinical quality guidelines—the aforementioned tool has been implemented in more than 150 provider groups and reportedly recognizes over $120 million a year in cost savings.
CareMetx, a technology-enabled hub services company whose goal is to improve patient access to specialty medications; General Atlantic, a global growth equity firm; and The Vistria Group, a private investment firm, have formed a strategic partnership.
Although terms of the deal were not disclosed, General Atlantic will become the majority owner of CareMetx. The Vistria Group, an existing majority shareholder in CareMetx since 2017, will keep its significant position in the company by reinvesting through Vistria Fund III, LP. Further, Marty Nesbitt, co-CEO of The Vistria Group, will be CareMetx’s chairman.
CareMetx represents pharma and biotech companies, and looks to assist patients and providers with piloting reimbursement challenges. The plan is to continue designing solutions that can help lower the financial cost of patients’ therapy.
EVOQ Therapeutics has signed a license and collaboration contract with Amgen around the discovery and development of novel drugs for autoimmune disorders.
Under the terms of the agreement, Amgen and EVOQ will team up when it comes to preclinical development, while Amgen will be responsible for clinical development and commercialization. In exchange for exclusive rights to certain autoimmune programs, Amgen will make upfront and milestone payments potentially totaling more than $240 million, as well as pay royalties on sales of resulting therapies.
Amgen specializes in treating autoimmune disorders, with a résumé featuring Otezla and Enbrel, along with biosimilar products, such as AMGEVITA (a biosimilar to Humira) and AVSOLA (a biosimilar to Remicade). Michigan-based EVOQ Therapeutics is developing technology focused on the activation of dendritic cells. The two companies will work together to use dendritic cells to develop immune tolerance.
Sanofi has acquired Kymab, a biopharma immunotherapy company. Under the deal’s terms, the drug manufacturer will purchase Kymab for an upfront payment of approximately $1.1 billion and up to an additional $350 million for completion of specific milestones.
Sanofi will have full global rights to KY1005, a fully human monoclonal antibody that has a novel mechanism of action. KY1005 binds to OX40-ligand and has the potential to combat various immune-mediated diseases and inflammatory disorders.
Paul Hudson, Sanofi’s CEO, notes that this addition further establishes the company’s interest in fighting immune-related illnesses.
“The Kymab acquisition adds KY1005 to our dynamic pipeline, a potential first-in-class treatment for a range of immune and inflammatory diseases. The novel mechanism of action may provide treatment for patients with suboptimal responses to available therapies,” he said. “We understand from our ongoing work in debilitating immunological diseases how critical it is to find the right treatment for each patient. We look forward to rapidly developing this investigational medicine.”
Liveo Research and Plásticos DISE SA have entered into a strategic partnership to provide Argentinian pharmaceutical manufacturers and contract packagers with Liveo’s blister film portfolio. DISE’s local pharma business unit in Córdoba, Argentina, provides access to Liveo’s blister films while maintaining Liveo’s standards. As a result of the collaboration, Argentinian customers will be able to shorten the supply cycle and expedite the import process, the companies say.
Grand View Research notes that global pharmaceutical packaging market revenue is projected to grow to $188.8 billion, with a compound annual growth rate (CAGR) of 10.8%, from 2020-2027. More specifically, within the Argentinian pharma blister packaging sector, Research and Markets anticipate a 7.5% CAGR, from 2019-2024.
SK Capital Partners LP, a private equity firm that focuses on the specialty materials, chemicals and pharma sectors, has signed an agreement to acquire the Blow-Fill-Seal (BFS) sterile contract development and manufacturing business from Catalent Pharma Solutions, LLC.
The deal is expected to close in April 2021, which is when the contract development and manufacturing organization (CDMO) will function as an independent company.
The BFS business’ primary focus is clinical to commercial stage formulation and manufacturing. It is catered toward an international, blue-chip customer base with products that use its BFS sterile manufacturing capabilities and formulation know-how in small molecule, biologics, macromolecules and potent compounds.
Bayer has signed an agreement with CureVac N.V., a biopharma company that manufactures medication based on messenger ribonucleic acid (mRNA). Per the deal, Bayer will help with development, supply and territory operations of CureVac’s Covid-19 vaccine candidate, CVnCoV.
As of Dec. 14, the vaccine has been in Phase IIb/III.
Bayer will offer its perspective in areas including clinical operations, regulatory affairs, pharmacovigilance, medical information and supply chain performance.
CureVac will be the marketing authorization (MA) holder for the product, while Bayer will support CureVac with country operations in the EU and other markets. Bayer also holds options to become MA holder in markets outside of Europe. The companies plan to work together on enabling CureVac to supply hundreds of millions of CVnCoV doses internationally, if approvals are granted.
In November 2020, CureVac announced that it would expand up its European manufacturing network, working with Wacker and Fareva, among others.
In an effort to speed up the growth of its biopharma contract development and manufacturing organization (CDMO), Fujifilm Corporation will invest over $2 billion to build a new large-scale cell culture production site in the US. This news comes only two days after the company announced a $40 million investment toward the construction of a Boston-area, advanced therapy facility that will manufacture viral vectors.
Fujifilm Diosynth Biotechnologies, a Fujifilm subsidiary with locations in the US, UK and Denmark, will be in charge of the new facility. The new location, which has not been named yet, is scheduled to begin operations in the spring of 2025, and will be constructed near a current Fujifilm site.
It is expected to offer large-scale cell culture manufacturing of bulk drug substances with 8 x 20,000L bioreactors (physical volume), with the potential to expand and add further 24 x 20,000L bioreactors based on market demand. Besides manufacturing drug substances, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services.
Fujifilm has been actively seek investment opportunities to further develop its offerings across its Bio CDMO sites—most recently, in June 2020, the company put $928 million towards Fujifilm Diosynth Biotechnologies’ Hillerød, Denmark site, as part of its initiative to double large-scale cell culture manufacturing capacity and add commercial scale drug production capabilities.
Nearly three years after Pharmaceutical Commercebegan reporting on what was only a rumor at the time (albeit details were reversed), drug wholesaler AmerisourceBergen Corp. (ABC) will be purchasing the majority of Walgreens Boots Alliance (WBA)’s Alliance Healthcare businesses for approximately $6.5 billion, consisting of $6.275 billion in cash and 2 million shares of ABC common stock.
ABC’s acquisition of Alliance Healthcare, Walgreens said in a release, will provide even stronger support for pharmacies and pharmacists on an international level, while also providing integrated solutions for drug manufacturers. WBA will be able to increase its effort toward growing its retail pharmacy businesses by bringing more healthcare offerings to patients and customers.
The two companies are also extending and expanding their commercial agreements—their US distribution agreement will be extended by three years until 2029, while their partnership will now include a commitment to pursue more sourcing and distribution leads. Alliance Healthcare UK will remain WBA’s distribution partner until 2031.
Angelini Pharma, an international pharma company that is part of the Angelini Group, has acquired Swiss-based biopharma Arvelle Therapeutics, which focuses on advancing treatments for patients suffering from CNS disorders. The deal is valued at up to $960 million, in an all-cash transaction. Per the agreement, $610 million will be initially paid out. Later on, once Arvelle’s cenobamate—an FDA-approved anti-seizure drug for the treatment of partial-onset (focal-onset) seizures in adults, which is available under the brand name XCOPRI CV—reaches revenue targets, the remaining $350 million will be paid.
Angelini Pharma, headquartered in Rome, will own the exclusive license to commercialize cenobamate in not only the EU but other countries in the European Economic Area (EEA) as well. Angelini plans to launch cenobamate after it receives approval from the European Medicines Agency (EMA), which is expected to come later this year.
It should also be noted that SK Biopharmaceuticals, a pharma company that is listed on the Korea Stock Exchange, has agreed to sell its 12% stake in Arvelle to Angelini Pharma. SK Biopharmaceuticals will still be eligible to receive all payments that were referenced by the license agreement signed between Arvelle and SK in February 2019. Revenue share payments due to Arvelle shareholders will be assumed by Angelini Pharma.
Taysha Gene Therapies, Inc., which focused on developing adeno-associated virus (AAV)-based gene therapies for the treatment of monogenic diseases, has entered into a lease agreement for an approximately 187,000-sq.-ft. current Good Manufacturing Practices (cGMP) manufacturing facility in Durham, NC. The company will invest $75 million and create an estimated 200 jobs over two and a half years.
Multiple production suites are expected to be completed by 2023, and will allow production that is compliant with FDA guidelines. The facility will feature 2,000 liters of capacity—additional reinforcements aside from Taysha’s existing manufacturing agreements with UT Southwestern’s gene therapy program and Catalent—and will be designed to support all aspects of scalable manufacturing of gene therapy material to meet both clinical and commercial demand.
The company plans on having four open investigational new drug (IND) applications in 2021.
Technology giant Honeywell has agreed to acquire Sparta Systems for $1.3 billion in an all-cash deal, which is expected to close by the end of Q1 2021. Sparta Systems is a provider of enterprise quality management software (QMS)—including its own software as a service (SaaS) platform—for the life sciences industry.
Honeywell plans to leverage the Sparta portfolio to introduce new, integrated products, such as QMS offerings, for life sciences and other segments, particularly through the company’s TrackWise Digital and QualityWise.ai software. In turn, executives say, this will increase access for Honeywell’s pharma and biologics customers to higher-quality products in the form of new therapies, faster time to market, better business and patient outcomes, and regulatory compliance.
Honeywell says it will continue to develop TrackWise Digital QMS by implementing artificial intelligence and machine-learning features that augment human decision-making.
LSBio, a supplier of antibodies and life science research reagents, has acquired Absolute Antibody, Ltd. and its sister company Kerafast. Terms of the deal were not disclosed.
Specifically, LSBio provides immunohistochemistry (IHC)-validated reagent antibodies and offerings to academic, pharma and biotech researchers. With more than 750,000 reagent antibodies, assay kits, proteins and biochemicals, the company’s purchase of Absolute Antibody and Kerafast further expands its product portfolio by adding an assortment of additional reagents and antibody services.
Absolute Antibody specializes in recombinant antibody technology, offering antibody sequencing, engineering and recombinant production as custom services, along with recombinant antibodies and Fc-fusion proteins, designed into new formats. In 2018, it merged with Kerafast Inc., a company that enables access to unique laboratory-made reagents, to extend the availability of recombinant antibodies.
Aceto, a virtual manufacturer of specialty materials for the life sciences and advanced technology end markets, has acquired New York-based IsleChem. The latter’s specializations include chemical manufacturing, contract research and development, analytical services, and technical and support services. Founded in 1947, Aceto distributes over 1,100 chemical compounds used principally by the pharmaceutical, nutraceutical, agricultural, and specialty chemical industries.
The company says its deal with IsleChem is a part of its strategy for long-term growth. By adding manufacturing expertise in the US, Aceto boosts its global supply network that is mainly focused in India and China. Agreements like these, CEO Gilles Cottier said, have become increasingly important amid the coronavirus crisis.
“The Covid pandemic has reinforced that access to a diverse, secure supply chain and dependable manufacturing is essential to business continuity,” he said. “This acquisition adds manufacturing and R&D capabilities to enhance Aceto’s already robust supply network. IsleChem is poised for facility expansion to service growing market demand, allowing the combined company to support more of our customers’ needs, from development through to commercialization and full-scale production.”
Syneos Health, a biopharma solutions organization, has acquired Illingworth Research Group, a clinical research home health services provider.
Illingworth’s specialization is in-home and on-site research nursing services (including mobile research nursing) for clinical trials. The company works with biopharma and medical device companies supporting studies in more than 46 countries. The current pandemic has further accelerated the demand for these types of offerings. Illingworth also provides complementary patient-focused contract research organization (CRO) services aimed at decreasing patient and site burden, and has experience across Phase I–IV studies in therapeutic segments such as oncology, respiratory, rare disease and pediatrics. The deal adds additional capabilities to Syneos’s decentralized clinical trial solutions.
Illingworth will maintain its brand name, but will operate as a part of Syneos Health.
Eversana and Experic, a contract manufacturing organization (CMO) and pharmaceutical supply service company, announced a partnership to enhance clinical development, manufacturing, launch planning and commercialization efforts for life sciences companies.
Per the deal, Experic’s clinical and commercial scale manufacturing and packaging services will be available within Eversana’s platform, which is currently under contract to manage multiple product launches across various therapeutic fields. In 2021, the services will assist in the commercialization of new products or to revitalize the market position and performance of existing branded therapies.
According to the companies, clients will have greater access to end-to-end outsourced services and contracting to improve patient experiences. Eversana’s integrated or stand-alone pharma services intersect multiple areas, ranging from global pricing to patient support.
Experic supports every phase of a product’s life cycle from clinical to commercial scale, across multiple dosing and packaging formats, including capsule filling, powder and pellet dosing (including dry powder inhalation, or DPI), autoinjectors and pen assemblies.
The FDA identifies more than 20,000 prescription drug products as approved for marketing, and there are approximately 900,000 active physicians in the US who can prescribe those drugs. Accounting for all of the pharmaceutical products that ultimately reach patients requires a massive effort, and this complexity directly impacts pharmaceutical manufacturers who contract with, and sell to, middlemen and prescriber organizations.
The key to untangling the web of complexity between drug companies, wholesalers and prescribers is effective master data management (MDM). For pharmaceutical companies, “master data” goes well beyond clean and up-to-date records of products, prices and customers. In order to effectively and profitably contract with prescribers, pharmaceutical manufacturers must maintain complicated sets of master data, including ever-changing group membership rosters. They must track group purchasing organizations (GPOs), integrated delivery networks (IDNs) and health systems and ascertain their eligibility across highly regulated government health insurance programs such as the 340B drug pricing program, Department of Defense (Tricare) and the Veteran’s Administration (VA).
Mismanaging master data can mean lost revenue for companies, incorrectly calculated rebates and government prices and even legal non-compliance. In other words, the consequences are significant and can directly affect the success of an organization.
Complexity drives the need for master data management
For the purposes of this article, master data management (MDM) means a true understanding of the parties a company is doing business with, what it sells and what price is charged. This “master data” information is also sometimes referred to as the “material master,” and there are also associated “masters” for identifying and tracking related data, including customer and pricing masters.
However, for pharmaceutical manufacturers, things are much more complicated, because basic customer or product information reflects only “ground-level,” or baseline, information required to manage complex prescriber and payment data.
This complexity is driven by the numerous different entities that purchase drugs, including independent and community pharmacies, large chains, hospitals, independent doctor’s offices and clinics, VA facilities, long-term care facilities and even military bases. And given the regulations that govern pharma companies, the way each of these discrete customers purchases drugs can be very different. As for government customers, regulations are even more strict and, therefore, complex.
Today’s drug sales environment
When it comes to drug purchasing, larger entities obviously have more power, and, for that reason, many medical practices will join with others to obtain group and volume discounts. A common example is GPOs, which leverage the buying power of multiple entities to obtain better pricing, as well as relevant and legally-appropriate discounts. However, keeping track of which purchasers are eligible for what discounts, as well as ensuring they’re correctly enrolled in various discount programs, requires an incredible amount of tracking and management. Many pharma companies try— and fail—to manage their master data using manual methods like spreadsheets, and this critical business function often gets deprioritized.
In addition, manufacturers must keep track of wholesalers and their relationships with various provider organizations. For example, a long-term care facility might be working with a wholesaler that is unaware of the discounts that the facility is entitled to, or that wholesaler might be giving the facility an excessive and/or incorrect discount based on incorrect data.
Unfortunately, the onus is on the manufacturer to manage customer data and appropriate discounts, because there is little financial incentive for wholesalers to carefully track class of trade and other master data; their prime motivation is to make sales. Their lack of concern for the financial consequences that manufacturers face is because, in cases where manufacturers do not have strong MDM, these middlemen are made financially whole, whether they sell a given drug at full price or discount it and recover costs via chargeback.
Ultimately, pharma companies must deal more effectively with MDM. This is because mismanaging master data can lead to unhappy customers, as well as lost revenue, a result of incorrectly calculated rebates and government prices. In addition, failure to manage master data creates compliance risk and potential legal liability. What’s more, drug pricing has become a politically-charged issue, and the need for highly-scrutinized pharma companies to “get it right” has never been more important from a public relations standpoint.
Best practices and technology: Taming master data
Effective management of master data is critical to mitigating business risk, and, most important to manufacturers, to capturing maximum revenue. Given the complexity of the overall system of prescribers and payers, the most effective way to handle MDM and capture all of a company’s rightfully-earned revenue is by leveraging best practices and technology.
Comprehensive master data is far more than basic customer names, addresses and billing information. Proper master data is built on accurate and up-to-date visibility into products and what pricing and discount terms a provider organization should receive, taking into account factors such as relevant memberships and government regulations. Beyond a basic grasp of “what pills we sell,” firms must have visibility into the solutions they offer, as well as the critical details associated with those products, such as their size, shape, dimensions and weight. Comprehensive master data must also capture which regulatory processes those products have gone through, including their availability or lack thereof.
While it might sound counterintuitive, one of the most important best practices around MDM is to “start at the end.” What this means is that companies should establish a solid understanding of their customer base and then leverage technology to create a program of extremely solid data management built around the right pricing and privileges that each customer enjoys.
Systems should understand, for example, what providers and facilities are eligible for which pricing and discounts, based on specific criteria such as membership in a given GPO, as well as geography and other factors. Digital tools that manage this information also empower pharma companies to make discounting decisions using software that enhances speed and accuracy. These better-informed decisions, based on shared information, can then be used to drive wholesaler compliance while ensuring that customers get the right pricing and that sales are reported properly, ultimately reducing revenue leakage.
Effective oversight of master data can trigger early warnings that prevent losses. Technology solutions can provide manufacturers with an early warning system that can help ensure contract compliance. For example, a manufacturer might observe a transaction with a new or unknown customer who claims eligibility for VA or 340B pricing or one who might be attempting to incorrectly use a GPO discount. This transaction would then be automatically flagged in the system, giving the company the opportunity to adjust pricing, notify the impacted parties, and possibly reject an inappropriate chargeback request. The benefit of today’s revenue management solutions that integrate master data is that these pricing interventions can be done at scale, and in near real time, given the capabilities of cloud computing and data analysis.
Tech can facilitate proactive management of pricing and discounts through tight integration with membership organizations such as GPOs and wholesalers.
Driven by technology, more accurate reporting means that pharmas can leverage master data for increased sales. For example, if a company is reviewing a “heat map” of its sales and subsequently learns that a given geography is falling behind when compared to other regions of similar populations, it can rapidly implement new sales incentives and direct account management teams to extend special pricing that can lead to market share gains.
Manufacturers may have strong customer categorization and discount strategy, but if they are not in lockstep with their wholesalers regarding which entities should receive which pricing, they aren’t reaping the benefits. Data exchange with wholesalers and membership organizations is another area where systems and processes can drive increased contract compliance, while potentially recapturing lost or missed revenue opportunities. Optimizing data exchange with wholesalers means ensuring its absolute accuracy.
In addition, technology can improve support for membership practices, enabling companies to not only manage their membership but also to manage offices, subgroups and classes of trade. Tight synchronization gives companies better visibility into what providers they are reaching and serve as an effective roadmap for sales management efforts—enabling master data to become a tool not only for reducing revenue leakage but also for driving incremental revenue.
In the end, it is understandable that drug purchasers wish to gain every possible discount, and it is similarly understandable that pharma companies want to collect as much money as possible for their products. And through effective management of master data that integrates accurate and timely information, companies can ensure that their industry trading partners receive the pricing and compensation that they deserve in a fair, ethical and legally-compliant manner, ultimately mitigating business risk for all parties.
Private equity firm EQT AB has made an offer to acquire Recipharm AB, a contract development and manufacturing organization (CDMO), for $2.1 billion, EQT announced. The offer is expected to be made public on or around Dec. 17.
As Bloomberg reported, Sweden-based EQT has already secured ownership of about 25.7% of the shares and 74.3% of the votes in Recipharm via its chairman, Lars Backsell, and Thomas Eldered, its CEO.
The firm will be offering shareholders $26.24 in cash per share, the report stated.
Other reports noted that Recipharm recently signed a preliminary deal with Moderna Inc to fill and seal the packaging for the biotech’s mRNA Covid-19 vaccine.
Recipharm signed a letter of intent with Moderna to help “formulate, fill and finish” its Covid-19 vaccine, as an FDA advisory board prepares to meet on Thursday to discuss Moderna’s request for emergency use authorization (EUA).
Real Endpoints (RE), an advisory and analytics firm focused on market access within the pharma industry, has launched RE Marketplace, a platform the company says will boost the efficiency and reach of value-based contracting for drugs for rare and orphan disease, providing significant benefits for patients, payers and manufacturers.
The founding members consist of four regional health plans, representing nearly 2.5 million beneficiaries. More plans are expected to join in the coming months.
Through value-based contracts, the platform accelerates the availability of rare-disease drugs to millions of members in mid-sized and smaller health plans who otherwise may not normally have access to these products.
Further, RE Marketplace provides each plan access to value-based agreements through a single contract for all participating biotech drugs, while biopharma manufacturers have contracted access to previously hard-to-reach plan members.
Using the medical and pharmacy claims data from the RE Marketplace member health plans, Real Endpoints and its academic partner, the University of Colorado Anschutz Medical Campus, will be responsible for performing all of the analytics and financial reconciliation, using a secure, HIPAA-compliant system that has already been tried and used in various deals.
Tjoapack, a contract packaging organization (CPO) for the pharma industry, has invested $12.1 million into its packaging and supply chain facility in Etten-Leur, Netherlands over the next two years.
The location will expand from approximately 90,417 sq. ft. to about 123,785 sq. ft. in size, adding eight new production lines to double capacity for primary packaging for oral solids to over four billion tablets per year. Further, the company’s team is expected to double with the hiring of 100 employees.
Other than the growth in production capacity, Tjoapack said it will be “investing heavily” in both its warehousing and cold chain capabilities to meet the increased customer demand for the company’s logistics services.
DoKaSch Temperature Solutions and Air Europa have signed a master rental agreement for the use of DoKaScho’s temperature-controlled Opticooler packaging solution. The partnership opens up new direct routes between Europe and Latin America, giving forwarders and pharma producers additional transport options.
DoKaSch’s Opticooler RAP container. Credit: DoKaSch Temperature Solutions
DoKaSch’s airfreight container comes in two sizes: there is the RKN version that holds 1.5 Euro pallets (one CP1 pallet), while the RAP version—which United Cargo utilized last April—offers space for up to five Euro pallets (four CP1 pallets). The Opticooler is capable of keeping the desired temperature level between 2 and 8 ºC (35.6 and 46.4 ºF) at all times, regardless of the surrounding climate. It is equipped with batteries and only requires a power socket for charging.
Air Europa, an airline based in Spain’s capital city of Madrid, offers flights within Europe, to Africa and the Americas. At the moment, it is providing direct flights with wide-body aircrafts from Madrid to 21 destinations in Latin America.
Eversana, a provider of global commercial services to the life sciences industry, and ArisGlobal, a drug development software company, have officially reached a partnership that Eversana says will “digitally transform end-to-end pharmacovigilance services, leading to safer, more effective healthcare for patients worldwide.”
Per the agreement, Eversana will use ArisGlobal’s LifeSphere cloud platform for clinical and commercial product safety management, which includes intelligent automation and machine-learning-enhanced adverse event case processing—the commercial services company began onboarding clients to the platform last month and plans to continuing doing so into next year.
The technology adds real-time predictive intelligence to Eversana’s drug safety repertoire, including the capability to process and analyze data to recommend appropriate products to patients. It will also help clients determine safe options when it comes to therapeutics.
This latest announcement comes after Eversana reached data deals with both Symphony Health and Compile back in November.
Bora Pharmaceuticals Co., Ltd has officially acquired GlaxoSmithKline’s Mississauga, Ontario (Canada) facility in a minimum five-year supply agreement. The deal is part of a long-term growth strategy that has seen Bora, a contract development and manufacturing organization (CDMO), complete three M&As in the past five years.
Bora Pharmaceuticals’ Mississauga facility. Credit: Bora Pharmaceuticals
Originally announced in March, the Canadian location is the company’s first manufacturing facility in North America, which will now be home to its North American headquarters. This also marks the Bora’s second site on the continent, after opening a US office in Delaware in 2019.
With this deal, Bora is able to diversify its range of dosage forms—the new flagship location provides the company with greater production capabilities, which, executives say, will not only help strengthen Canada’s medicines supply chain, but will allow Bora to make 50 different products to 100 international markets. It also plans to bring additional employees aboard its technical and operational team.
CarepathRx, a pharmacy management company, has partnered with the University of Pittsburgh Medical Center (UPMC)’s Chartwell subsidiary in a deal that executives say will expand patient access to specialty pharmacy and home infusion capabilities. Per the $400 million agreement, CarepathRx will acquire the management services organization responsible for the operational and strategic management of Chartwell, while UPMC becomes a strategic investor in CarepathRx. The deal is expected to close within the next 30 days.
By prioritizing the most vulnerable patients—many of which are undergoing specialty and infusion therapies—CarepathRx’s goal is to overcome the hurdles that may come with traditional pharmacy care and medication management. CarepathRx works closely with an array of members within the healthcare field, such as health systems, community physicians, home health agencies and payers, providing services to more than 600 hospitals nationwide.
The deal is a positive for all parties involved, says Leslie Davis, senior vice president of UPMC, and executive vice president and COO of its health services division, noting that the center is continually searching for ways to get involved with new care delivery models, including in the pharmacy sector.
“Health systems nationwide are looking for new ways of delivering care beyond the walls of the hospital to drive better clinical outcomes at lower costs,” she mentioned. “Chartwell’s agreement with CarepathRx will allow other health systems to benefit from the pharmacy model that UPMC has created, while delivering even better care and service for our patients and health plan members.”
DHL Global Forwarding is growing its 72,000 sq.-ft. certified life science station in San Juan, Puerto Rico by investing over $650,000 in further cold storage space and technology for the life sciences and healthcare sector. This comes after previously announcing its $70 million US life sciences investment earlier this year, and the completion of a $1.6 million Indianapolis facility.
When it comes to working with Puerto Rico—which has been looking to fill a US supply chain gap—relations date back to 2016, when DHL funded over $1 million to reaching a tenfold upsurge in its temperature control area capacity. The latest announcement expands on that goal.
Among the various highlights, the mail service’s new project will consist of:
Construction of a new deep-frozen cool room with a temperature range of -18.0 to -30.0 °C, which allows for pre-conditioning of passive containers, blankets, boxes and PCM units, while still providing full ability to provide product delivery.
Additional 2-8 °C storage, a temperature controlled cross docking area and ample space for the control of RAP containers, which can each fit four US-size pallets.
Supplementary loading and unloading services for containers under the controlled ambient temperature (15-25°C & 2-8°C).
It is probable that Amazon’s Nov. 16 announcement of the long-awaited Amazon Pharmacy has had a bigger impact on Wall Street than in drug distribution, at least for now. The day of the announcement, the prices of the leading chain pharmacies dropped by 6-10%, and the Big 3 wholesalers by 1-2.5%. Amazon’s entry into pharmacy services has been a fixation of market analysts for over two years—ever since it acquired PillPack, a mail-order pharmacy that packages multiple drugs in pouches for polypharmacy patients, for $700 million—and back then chain pharmacies and major wholesalers also took a financial hit. Market watchers expect Amazon Pharmacy to be an e-commerce disrupter, as it has been for so many other retail industries.
The initial assessment of the Amazon announcement, however, is less dramatic. For one thing, retail pharmacies have by and large already adopted one of Amazon’s basic consumer benefits—home delivery in one or two days. At the same time, mail-order pharmacy has been a longstanding component of the pharmacy business, representing over a quarter of the market by sales. In its announcement, Amazon noted that it will be working with InsideRx, a business unit of Cigna (which is also the owner of the pharmacy benefit manager Express Scripts) to provide drug discounts that are potentially better than an insurer’s price (for those consumers on commercial insurance), as well as offering lower prices to the uninsured (cash) drug purchaser.
These discount programs are already available to consumers via other marketing programs—so, in the end, it will become the same sort of comparison shopping that consumers perform with many of their other purchasing decisions. Amazon noted that it will not share protected health information of its customers with others (without customer permission); however, this opens up the intriguing question of whether customers whose non-prescription purchases (of, say, glucose test strips used by diabetics) will be exposed to pharmaceutical marketing by the company.
There has been a buzz around Amazon for its potential in providing a range of health and wellness services, a trend that retail pharmacies, health systems, and a host of Silicon Valley startups have been looking at for the past few years. With a built-out pharmacy offering, Amazon takes a step closer to being a major player in healthcare. (One analyst even speculated that Amazon could co-locate a brick-and-mortar pharmacy in its Whole Foods stores, just as other supermarket chains have done.) But this big-picture view will take years to play out.
What effect does Amazon Pharmacy have on the pharma industry? For now, not much, beyond adding another retailer to the retail pharmacy channel. If it chooses to continue to go after the healthcare business, though, more changes might be coming from the company.
Pharma Logistics, a service provider operating out of its new Illinois-based reverse-distribution center, and ConsortiEX, a health care pharmacy IT company in Wisconsin, launched a strategic collaboration program, whose aim is to improve inventory efficiency and patient safety, reduce cost, manage cash flow and compliance for their customers.
Highlights of the program include:
ConsortiEX’s Drug Supply Chain Security Act (DSCSA) compliance takes responsibility for a majority of the work necessary, helping provide a lower cost.
Pharma Logistics’ reverse distribution service not only speeds up the process of returning generated credits—it also keeps labor costs for managing those returns at a minimum.
ConsortiEX’s services look to provide the most effective way of detecting suspicious drugs, so that these products do not reach the patients.
If saleable, unsaleable and recalled drugs need to be returned, Pharma Logistics works to simplify the credit recovery process.
Customers working with both companies will be able to use funds from Pharma Logistics to pay for ConsortiEX resources. And down the road, the organizations plan on assisting their mutual clients by managing drug recalls, optimizing inventory levels and limiting waste by keeping track of items that are close to expiring.
Conduent Incorporated, a patient support company, has reached a commercial agreement with Experian Health, a data aggregator that provides revenue cycle management products involving patient engagement, access and collections.
The deal allows Conduent’s IntelliHealth program to connect with Experian’s consumer data and electronic income verification tool. The combination, companies say, can help speed up prescription drug assistance approvals and shorten prescription fulfillment and time to therapy.
With Conduent’s experience with patient assistance programs (PAPs) and Experian’s Patient Financial Clearance tool, the alliance is projected to simplify access to free Rx drug assistance that could benefit up 28 million Americans with no or limited healthcare coverage, and more than 12.6 million that are reported to be jobless by the Bureau of Labor Statistics.
Eli Lilly’s investigational monoclonal antibody (mAb) bamlanivimab, which recently was issued emergency use authorization (EUA) by the FDA for Covid-19, is unlikely to face payer pushback, despite its broad label, GlobalData reports.
The data and analytics company notes that drug prices have been closely examined during the Covid-19 pandemic, but, citing feedback from EUA experts, given bamlanivimab’s potential benefit in curtailing hospitalizations, it and other mAbs under FDA review may offer pricing value. Manasi Vaidya of GlobalData said, “If bamlanivimab and other similar monoclonal antibodies can reduce hospitalization risk, they could be prevent [ing] anxiety and loss of income that would have resulted otherwise, and thus be cost-effective.”
Earlier this month, FDA granted bamlanivimab EUA to treat mild-to-moderate Covid-19 patients who are at high risk for progressing to severe infection and/or hospitalization. Specifically, this includes adults 65 years or older, and/or those with certain chronic medical conditions. Lilly will be supplying 300,000 vials of 700 mg bamlanivimab at a cost of $1,250 per vial.
Vaidya points out that distribution channels are different today from pre-pandemic times and uncertainty on demand coupled with specialized manufacturing requirements for mAbs could create their own barriers to access.
“Unlike situations where payers may require additional documentation or restrict use to a narrower patient population for a newly approved biologic, with COVID-19, a physician determination for bamlanivimab’s need may be adequate for coverage,” she said.
According to a recent report by Polaris Market Research, the worldwide active pharmaceutical ingredient (API) market valuation is projected to reach $306.1 billion by 2027. An increase in occurrences of chronic ailments such as cardiovascular diseases (CVDs), arthritis and diabetes, along with growing prevalence of infectious diseases such as influenza, hepatitis and Covid-19, are boosting the demand for drugs and medications across the globe. The growing elderly segment is also a contributor.
The global API market includes monoclonal antibodies (mAbs), cytokines, immunoglobulin, insulin, blood factors, peptide hormones, peptide antibiotics, small molecule antibiotics, vaccines and highly potent active APIs, among other areas.
Experts note as well that factors such drug side-effects, high capital investment requirements, along with government regulations and policies, could potentially hinder the growth of the API market between now and 2027.
In its biggest move yet in the tech giant’s steadily building but aggressive entrance into healthcare and the lucrative pharmacy market, Amazon today officially launched two new ways to help customers purchase their prescription medications. One is the unveiling of Amazon Pharmacy, which allows customers to complete an entire pharmacy transaction on their desktop or mobile device; all that’s required is the Amazon app and a prescription from a licensed healthcare provider. With a secure pharmacy profile, customers can add insurance information, manage prescriptions and choose payment options, all before checking out. Prime members, Amazon says, will receive unlimited, free two-day delivery on Rx orders included with their membership.
The other new offering involves savings for those without healthcare insurance. Prime members will have access to deals on medications at Amazon Pharmacy if choosing to purchase without coverage, as well as at over 50,000 other participating pharmacies nationwide. The Amazon Prime prescription savings benefit can reportedly save members up to 80% off generic drugs and 40% off brand-name medications when paying without insurance. Prime members will have access to their Rx savings at checkout.
Today’s moves follow other notable pharmacy plays by Amazon in the last couple years. In 2018, the company acquired mail-order pharmacy PillPack, now part of Amazon Pharmacy. It will continue to assist customers with chronic health conditions who are taking multiple daily medications. PillPack service provides pre-sorted dose packaging for everyday dispensing, In August, Horizon Healthcare Services and its pharmacy benefit manager, Prime Therapeutics, partnered with Amazon on offering Horizon members an integrated pharmacy experience with PillPack.
Following an agreement Pharmaceutical Commerce originally reported being reached in late October, Catalent Pharma Solutions, Inc. has officially completed its acquisition of Bone Therapeutics’ manufacturing subsidiary, Skeletal Cell Therapy Support SA (SCTS), for $14.2 million USD ($12 million EUR). With the transaction closing, SCTS’ manufacturing infrastructure and production operating teams are now part of Catalent’s Cell & Gene Therapy division.
Alongside this deal, Bone Therapeutics and Catalent also entered into associated supply agreements, which state that the purchased manufacturing entity will continue to service the production of ALLOB, Bone Therapeutics’ allogeneic cell therapy product, for Bone Therapeutics and its partners. This will grant the company access to Catalent’s network of clinical and commercial manufacturing facilities.
The partnership will allow Bone Therapeutics to focus its strategy on product development from its MSC (mesenchymal stromal cell) platform of cell and gene therapeutic targets for orthopedics, among other indications.
Italian multinational Antares Vision, which offers customized inspection and track-and-trace systems, has been selected by the French judicial authority as the winner of the tender for the purchase—directly or indirectly through its subsidiaries—of the assets of the French company Adents High Tech International, which is in liquidation. The closing will occur within two months for $1.8 million USD (1.5 million EUR), paid in cash.
Mainly focused on the pharmaceutical sector, Adents offers traceability and serialization software that can be used for the data management and exchange between companies and regulatory authorities (level 5). It also offers single-tenant and multi-tenant cloud services.
The deal lets Antares Vision multiply its software capabilities that are able to track and trace the end-to-end supply chain, which will allow for greater transparency among members across the industry. Both companies have verification router service (VRS) offerings.
Envision Pharma Group, a UK-based scientific communications company, has acquired Two Labs, a strategic consulting and commercialization provider with a footprint in the US pharma domestic market. Two Labs is known for helping pharma companies develop and execute customized launch strategies for products, a process that may include selecting a third-party logistics provider (3PL).
Howard Miller, CEO, Two Labs, noted, “We are delighted to be joining the Envision family and taking Two Labs to the next logical step in its successful journey to date. With Envision’s global footprint and Two Labs’ market-leading US footprint, we have a unique opportunity to enrich our client partnerships with more connected services across the launch continuum.”
He pointed as well to a “compelling” cultural fit between the two organizations.
Envision’s acquisition of Two Labs follows the recent announcement of GHO Capital’s increased investment in the company and management support for its continued expansion. Since its inception in 2001, Envision has produced solid organic growth, while also providing medical affairs strategy, medical communications, and its iEnvision technology.
J. Knipper and Company, Inc., a supplier of pharma healthcare marketing services, and its affiliates (including its three-year-old specialty pharmacy, KnippeRx), have finalized the acquisition of Eagle Pharmacy, LLC, a full-service, direct-to-patient (DTP) pharmacy. KnippeRx and Eagle Pharmacy are approved to ship and dispense prescription medications throughout the US, the District of Columbia and US territories.
Florida-based Eagle Pharmacy adds operational automation and scalability to KnippeRx’s résumé, while simultaneously offering clients separation of customer pharmacy solutions under one partner. According to J. Knipper, over 90% of enrollments completed by Eagle result in a shipment, while clean orders are processed and shipped in less than one business day. Operations are currently at 25% capacity, but Eagle Pharmacy reaches approximately 200,000 patients a month, supporting more than 50 customized drug programs.
KnippeRx, a provider of patient assistance program (PAP) services, has seen rapid expansion, adding brand name, DTP programs to its pharma client offerings, among pursuing other avenues for evolution.
Descartes Systems Group, a supply chain software firm that offers its technology to the pharmaceutical space, has purchased ShipTrack, a Canada-based provider of e-commerce final-mile (last-mile) solutions for $19 million.
ShipTrack offers cloud-based mobile resource management and shipment tracking solutions. These tools are able to assist users with automating dispatch, updates on shipment status and estimated time of arrival (ETA); they also remove the need for paper-based delivery. ShipTrack notes that its platform is a fit for the medical courier market—one component of the growing last-mile delivery market, which reports estimate to reach about $6.2 billion by 2025.
Shawn Winter, co-founder of ShipTrack and now the vice president of mobility solutions at Descartes, alluded to the obstacles surrounding high demand that are often faced by last-mile delivery services, saying that “The challenge for today’s final-mile carriers is how to handle increasing volumes alongside rising consumer expectations for delivery choice and real-time information. Our platform helps final-mile carriers meet that challenge head-on with powerful workflows across delivery processes and the ability to expose information to consumers in real-time.”
He says the deal merges ShipTrack’s final mile know-how with Descartes’ ability to improve routes.
Eversana, a provider of global commercial services to the life sciences industry, has solidified partnerships with a pair of comprehensive data and infrastructure companies, Symphony Health and Compile. The deals establish what Eversana calls the industry’s “first single, streamlined claims, formulary and physician dataset.”
Eversana and Symphony Health, a PRA Health Sciences company, reached a multi-year agreement that will provide access to claims and electronic medical records data for more than 300 million patients.
The company’s partnership with Compile, Eversana says, will help continue to incorporate physician information to drive market access and healthcare professional (HCP) participation. By combining public and government figures with privately licensed medical and pharmacy claims, Compile forms a record database on every practitioner, facility, health system and event that takes place in the US healthcare market.
The datasets from Symphony and Compile will feed into ACTICS by Eversana, a data-mastering platform and cloud-based infrastructure. In the coming month, Eversana plans to announce a third partnership to include formulary content.
The novel coronavirus has challenged the notion that our US supply chains were prepared, exposing limited logistics models, shuttering manufacturing lines, and causing personal protection and medical equipment shortages worldwide. Reliance on other global powers has become a national security concern and prompted a push to reshore life-critical manufacturing.
Puerto Rico is at the front and center of this movement. With a wealth of industry expertise, talent, and R&D prowess, the island is well-positioned to continue building on these strengths and affirm its spot as a global contributor. Puerto Rico can be a solution to filling critical supply chain and emerging gaps in the medical fields.
The island’s swift response to the initial wave of COVID-19 in March came instinctively, given past experiences with natural disasters, and it prompted industry to continue its manufacturing output. When Puerto Rico faced back-to-back hurricanes in September 2017, it still reportedly outperformed mainland states in total pharmaceutical exports. This year, several manufacturers claimed zero downtime in shift operations during the January earthquake.
With federal agencies eyeing domestic supply chain support for critical drug manufacturing, Puerto Rico is working with companies seeking financial incentives and loan opportunities so that they clearly understand the“why us?” The five reasons driving that message are:
Site-ready. With 50+ bioscience site-ready facilities and properties at all stages of development ready for occupation, the lead time on getting production going in Puerto Rico is faster than any other location.
Local supply and distribution chain. Dedicated Puerto Rico-based businesses and industry organizations are equipped with the background and skills necessary to support the bioscience industry’s needs.
Expertise and workforce. From mapping out the first continuous manufacturing model in the world to supporting other countries (Ireland and Singapore) in building their own bases, Puerto Rico shares the wealth and knowledge with other pharma markets.
Resources. Puerto Rico is working in close collaboration with the Development Finance Corporation and other federal agencies, in addition to the private sector, on creating competitive tax incentives and financing packages best suited for prospects seeking to reshore.
Continuously innovating. Aside from the biosciences industry, the island is investing in renewable energy solutions, advanced connectivity, and transportation, among other entrepreneurial initiatives.
This is a historic moment for Puerto to solidify its place in the US medical supply chain and serve as a base for key drug and medical device manufacturing, while creating new opportunities for its workforce and the larger biopharma industry.
About the author
Gail T. Nolan is chief strategy officer of Invest Puerto Rico.
Proposed moves aimed at gaining ‘most-favored nation’ drug pricing so that Medicare pays the same drug prices as other developed countries would face significant barriers to implementation, according to results of a survey released this week by Model N, Inc., a technology provider for many large pharma companies.
Model N fielded its survey to more than 100 pharmaceutical and medtech professionals in July 2020 in order to understand more about key financial concerns, public-facing issues associated with drug pricing, attitudes around technology, and to gauge the industry’s response to the global coronavirus pandemic.
Results indicated that a program requiring an overhaul of today’s complex system of incentives and rebates, as well as initiatives designed to address the technological and regulatory constraints under which the industry currently operates, would face an uphill battle.
Some 86 percent of the respondents believe there is a disconnect between pharmaceutical companies and the general public when it comes to the perception of drug pricing. The top reason cited (76 percent) was a lack of understanding of the complexity behind how a drug is paid for and how it gets to patients.
Other reasons cited by survey respondents include pricing disparity and international pricing differences (46 percent) and government regulations (46 percent).
Pharmaceutical and medtech executives also have concerns over revenue issues, with the survey showing that government regulations, as well as pricing and rebates, are the top concerns for solving revenue problems, at 41 percent each. While only 9 percent said Covid-19 has not impacted their revenue this year, 46 percent reported that it has impacted their revenue by delaying the process of bringing new products to market.
There is awareness that technology is key to solving the issues, as some 67 percent believe their companies need to invest more in technology to solve their financial and revenue management challenges.
In addition, the executives seem open to exploring new approaches to resolving revenue concerns, while at the same time addressing public concerns about drug prices. They cite better management of government regulations (26 percent), as well as pricing and contract compliance (25 percent), as two key opportunities for fixing pricing issues and avoiding ‘leaving money on the table.’ Assistance with value-based pricing is another area where industry professionals think technology can offer a useful assist, at 44 percent.
When polled about a broader, post-pandemic recovery, 76 percent of respondents report they have been satisfied with the industry’s response to Covid-19. Some 49 percent emphasized recovering from Covid-19 as their top priority, while 45 percent said eliminating system or process inefficiencies was their biggest priority for the remainder of 2020.
Overall, 40 percent said technology will be a key enabler in helping their firms recover from Covid-19. In terms of corporate planning, 55 percent of respondents report that current or new product launches are the top priority for the remainder of this year.
Model N offers visibility, insight and control for complex commercial operations and compliance, along with cloud revenue management technology in order to automate pricing, incentive and contract decisions. It serves such major pharmaceutical, medical technology, semiconductor and high-tech companies as Johnson & Johnson, AstraZeneca, Stryker, Seagate Technology, Broadcom and Microchip Technology.
Stevanato Group has expanded its collaboration with Catalent to include delivery of advanced visual inspection systems to help with potential Covid-19 pandemic programs, biologics and sterile injectable products.
Under the expanded arrangement, Catalent has ordered Plus 400 LKD automatic and PWL semi-automatic visual inspection machines from Stevanato and will install the equipment at its sites in Bloomington, IN and Anagni, Italy.
Plus 400 LKD inspection machine. (Images courtesy of Stevanato Group)
The move is intended to support various customer and quality assurance programs through the use of advanced technologies to inspect biologics and sterile injectables, maximizing the detection rate while keeping false rejections low.
Privately held Stevanato Group said it plans to speed delivery of the high precision and high throughput equipment to the Catalent manufacturing operations.
Catalent has signed an agreement with Bone Therapeutics to acquire its cell therapy manufacturing subsidiary, Skeletal Cell Therapy Support SA, including all of its assets located in Gosselies, Belgium. The transaction is expected to close in November.
The Skeletal Cell Therapy Support manufacturing facility in Gosselies, Belgium. (Image courtesy of Catalent)
Under the terms of the agreement, Catalent will purchase the shares of Skeletal Cell Therapy Support, currently held by Bone Therapeutics, which owns and operates a purpose-built CGxP facility of approximately 41,000 square feet, including its related quality control and product development laboratories, warehouse, grade C and B cleanrooms and equipment, as well as land for further development.
Catalent will undertake the manufacturing of clinical material for Bone Therapeutics’ drug, ALLOB, an allogeneic osteoblastic cell therapy product, derived fromex vivocultured bone marrow cells.
The Bone Therapeutics subsidiary and its facility, which is next to Catalent’s existing cell therapy site, will allow Catalent to expand its cell therapy capabilities and advanced clinical and commercial supply. Catalent is continuing work on a 60,000-square-foot commercial-scale production and fill-finish facility in Gosselies, which is scheduled to be completed by the end of 2021.
As part of the acquisition, manufacturing employees located in Gosselies and employed by Skeletal Cell Therapy Support are expected to remain with that entity and become part of the Catalent workforce, and Bone Therapeutics will continue to focus on its pipeline of products for orthopedics and bone diseases.
In addition to the expansion in Gosselies, validation of Catalent’s new 32,000-square-foot cell therapy development facility in Houston, TX is underway and scheduled to be completed by the end of this year.
Bone Therapeutics has a diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.
Catalent, based in Somerset, NJ, provides delivery technologies,development, and manufacturingservices for drugs, biologics, cell and gene therapies,and consumer health products. Catalent employsapproximately14,000 workers, includingroughly 2,400 scientistsand technicians, at more than45facilities, and in fiscalyear 2020generatedmore than$3billion in annual revenue.
Trebor Rx, a new venture in Canada, is launching PRO+ Dual Respirator masks, a patent-pending mask made of thermoplastic elastomer (TPE) that can provide more than 300 hours of usage and replace hundreds of disposable masks, according to the company.
The respirator body is 95 percent recyclable, washable and sterilizable. It is designed to be used across various sectors, including healthcare, dental, mining, construction and military.
This breather technology uses disposable N95 filters, and the company claims it can filter both inhaled and exhaled air, providing protection against the spread of contaminated particles for both the user and the surrounding environment.
The PRO+ Dual Respirator claims a 98 percent effectiveness protecting against Covid-19, other viruses and bacteria, and was tested and certified under EU-GMP, the EN1827, EN149, EN142 respiratory protection standards, and BFE ASTM F2101-19 protocols to evaluate bacterial filtration efficiency.
Production is slated to begin in Collingwood, Ontario with expansion to a larger facility planned for a late 2020 opening. The company forecasts Canadian domestic production capacity of more than 500,000 masks per week.
Rapid Reshore & Development (RR&D), an alliance of three specialized firms working together to provide professional services for the life sciences and biopharmaceutical industries, has formed to address logistical challenges facing companies developing drugs, vaccines and medical devices.
The three firms—Facility Logix, EwingCole and Biggins Lacy Shapiro & Co.—intend to maximize efficiency, minimize risk and facilitate speed-to-market. The alliance represents a shift from transaction-driven service models to a holistic focus on client needs, integrating an interdisciplinary team customized for a variety of individual projects.
“Our rapidly changing world created a multitude of challenges and opportunities across all industries,” said Jared Loos, PE, AIA, EwingCole’s CEO. “However, few face logistical obstacles like the life sciences and manufacturing sectors, including biopharmaceuticals, medical devices, medical equipment and their respective supply chains. Our goal was to create an alliance that can collaboratively and succinctly support their needs from start to finish.”
Life sciences and biopharmaceutical companies are pivoting to increase efficiency and capacity in record time, which requires quicker decision-making, identifying talent, retooling facilities, increasing capacity and shoring up resources.
According to its launch announcement, RR&D is approaching the speed-to-market process by aligning and accelerating all steps, including: Up-front planning and programming; scenario development and analysis; due diligence of talent market; new facility consideration and comparative costs; early conceptual designs; competitive real estate procurement, and full design/engineering and project management.
In related news, RR&D was selected this week by BrainStorm Cell Therapeutics Inc., a developer of autologous adult stem cell therapeutics, to expedite site selection and design services for a new manufacturing facility for NurOwn, a potential treatment for neurodegenerative diseases such as amyotrophic lateral sclerosis and multiple sclerosis. RR&D will provide project management services throughout the project’s lifecycle.
BrainStorm, which recently signed an agreement with Catalent Pharma Solutions to manufacture NurOwn at a scale large enough to meet potential commercial needs, intends to use the proposed 50,000-square-foot facility primarily for cell therapy production.
The facility is expected to contain manufacturing suites, complementary support and infrastructure, and the ability to expand the facility to 100,000 square feet to anticipate future programmatic needs.
Facility Logix, which specializes in the biotech industry, delivers new building solutions, enabling biotech companies to produce or house healthcare products. The company provides owners’ representation, facilities planning, move and transition, as well as project and operational management implementation.
EwingCole, in practice for nearly 60 years, is a fully integrated architecture, engineering, interior design and planning firm with more than 400 professionals located in several US cities.
Biggins Lacy Shapiro & Co. features a multi-disciplinary team—attorneys, project finance and tax professionals, planners and engineers—for complex projects and portfolios through site selection, incentives and customized energy needs. Over the years, the firm has advised numerous pharmaceutical, gene therapy, biotechnology and consumer health companies.
Strategikon Pharma is expanding its Clinical Maestro business operations platform for biopharmaceutical participants with two new offerings, a full-service model and an operator model. The company provides a Software as a Service (SaaS) product license for clinical trial RFP planning and budgeting, which includes implementation and training.
The Clinical Maestro cloud-based platform enables participants in clinical trials—sponsor companies, vendors and service providers—to plan studies, model and manage clinical contracts and outsourcing in a systematic way.
Clinical trial pipelines have been disrupted by delays and changes to trial designs due to the pandemic, increasing the use of remote technologies and tasks, according to the company. Sponsors may find themselves swamped with budgeting and planning, while short on time or resources.
A new ‘operator’ model consists of assigning trained experts to assist, or directly operate Clinical Maestro to expedite the output delivery. The model is geared towards biopharmaceutical sponsors who operate at high speed and may not have the trained staff available or the time to run clinical plans, budgets or RFPs in the cloud-based platform. In such cases, Strategikon will work remotely to deliver the outputs required.
The ‘full service’ model, optimized for small biotechnology companies with limited resources and a small pipeline, performs the analysis on Strategikon’s internal system and provides the sponsor with a baseline budget and alternative scenarios, depending upon the sponsor’s requirement. The option allows the sponsor to develop a budget and scenarios without investing in software licensing and personnel training.
Strategikon Pharma, developer of the Clinical Maestro service, is headquartered in San Rafael, CA.
Endo International plc will acquire BioSpecifics Technologies Corp. in an all cash transaction totaling an estimated $658 million in equity value. The transaction was unanimously approved by the boards of both companies and is expected to close during the current quarter.
Under the terms of the agreement, Endo, through a wholly owned subsidiary, will commence an all-cash tender offer for all outstanding shares of BioSpecifics common stock at a price of $88.50 per share.
The closing of the tender offer will be subject to a number of conditions, including that a majority of BioSpecifics’ shares are tendered in the tender offer, the expiration of the waiting period under antitrust laws and other customary closing conditions.
Following completion of the tender offer, Endo’s acquisition subsidiary will be merged into BioSpecifics, with any remaining shares of BioSpecifics common stock to be cancelled and converted into the right to receive consideration of $88.50. The merger agreement includes a remedy of specific performance and is not subject to a financing condition.
BioSpecifics Technologies Corp., based in Wilmington, DE, is a commercial-stage biopharmaceutical company. Endo International plc is a specialty pharmaceutical company with global headquarters in Dublin, Ireland and US headquarters in Malvern, PA.
Centerview Partners LLC acted as the exclusive financial advisor to BioSpecifics and Morgan, Lewis & Bockius LLP is serving as legal counsel.
The Accreditation Commission for Health Care (ACHC) and Healthcare Facilities Accreditation Program (HFAP) are joining to form a single company providing accreditation and certification services to providers.
Under the October 19 merger agreement between ACHC and Accreditation Association for Hospitals/Health Systems (AAHHS)—HFAP’s parent company—HFAP will operate as a brand within ACHC.
Formally approved by the Centers for Medicare & Medicaid Services (CMS), the move streamlines services for existing customers and organizations and marks the first time that two accrediting operations with deeming authority from CMS have merged.
“Together, the combined services of ACHC and HFAP open possibilities for healthcare providers, affording them more choices and greater ease in meeting the accreditation and certification needs of their organizations,” said José Domingos, president and CEO of ACHC, in a statement following the merger announcement.
ACHC has CMS deeming authority for home health, hospice, renal dialysis, home infusion therapy and DMEPOS—durable medical equipment, prosthetics, orthotics and supplies. It also is a deeming authority for specialty pharmacies.
The expanded ACHC now adds HFAP programs with CMS deeming authority for hospitals, ambulatory surgery centers, clinical laboratories and critical access hospitals. The merged group broadens the routes to certification for pharmacies, as HFAP overlaps to some degree in the case of compounding pharmacies.
Part of that overlap has to do with a number of the HFAP-accredited hospitals that operate their own compounding pharmacies, thus making it a logical step for HFAP to offer the additional service, Marci Ramahi, CAE, director of Accreditation/Certification Operations, explained a couple of years ago. Ramahi noted at the time that freestanding compounding pharmacies were also candidates, with certification consisting of a review of documentation, interviews and site visits by surveyors.
Additional HFAP offerings—such as accreditation programs for ambulatory specialty care (office-based surgery), non-deemed accreditation and specialty certification for four levels of stroke care, laser and lithotripsy services, inpatient and outpatient joint replacement and wound care—will expand and complement the ACHC portfolio, which also includes programs for ambulatory care, behavioral health, pharmacy, private duty and sleep.
The transition is expected to be seamless, the organizations say, adding the merger does not affect accreditation cycles for either ACHC or HFAP customers. Current accreditation and/or certification status, account managers and processes also are not expected to change. In addition, the merger does not require current HFAP customers to undergo an initial survey.
Still separate following the merger of the two big accreditation services is URAC, a nonprofit organization based in Washington, DC, which was founded in 1990 as a third-party quality validator, including for specialty pharmacies. Payers and manufacturers look for URAC accreditation as part of choosing which pharmacies to work with in specialty pharmaceutical distribution and dispensing.
URAC’s accreditation standards look closely at how pharmacies document their internal practices, and there is an emphasis on proper cold chain practices to ensure that temperature-sensitive specialty pharmaceuticals are being handled safely.
ACHC, a nonprofit organization, was formed in 1986. Its staff members are expected to remain in Cary, NC. HFAP, founded in 1945, is a not-for-profit accreditation program with staff located in both Cary and Chicago.
AGC Biologics, a biopharmaceutical contract development and manufacturing organization (CDMO), has announced leadership changes atits US and Copenhagen, Denmark operations. The changes became effectiveOctober 15.
Jeffrey D. Mowery, formerly general manager of the Copenhagen site, joins the global executive team at the company’s headquarters in Seattle as senior vice president of US operations.
Mowery, with more than 20 years of experience in small molecule, biologic and cell and gene therapy production and technology transfer, will oversee AGC’s newBoulder, COfacility rollout and progress at its expandingSeattlesite.
Andrea C. Porchia was promoted to succeed Mowery in the Denmark facility as general manager and site head for Copenhagen. She previously served in a variety of roles ranging from project director and business development representative to global head of project management.
She has more than two decades of research and process experience and will have a critical focus on project management and customer service, according to AGC.
AGC Biologics, with more than 1,400 employees worldwide, focuses on all phases of development through to commercialization, with expertise in process development, formulation, and analytical testing. Its global service network maintains US locations inSeattle andBoulder, as well as operations inDenmark,Italy, Germany and Japan.
Many businesses trading abroad ‘are in the dark’ about what they should be doing to prepare financially for the Brexit January 1, 2021 deadline, according to feedback received by Hamilton Court FX, a UK-based consulting firm that provides foreign exchange (FX) transactional advice and delivery.
Importers and exporters, including those in pharmaceuticals, shipping, logistics, insurance and other businesses are worried about the government’s failure to provide clear detail sooner to guide them through UK and European Union bureaucracy.
With eight out of 10 businesses still ‘sitting-on-the-fence’ and waiting for detailed government advice on the changes to the way they import/export goods and pay for them, the consulting group warns that it is imperative that they act now with proactive methods of hedging their currency needs so market fluctuations don’t eat into their profits.
“We have been receiving feedback from our clients for a year or more on their frustration with government over Brexit advice,” Mark Palmer, chief operating officer of Hamilton Court FX, said. “There is little available and no one to speak to. There is no one-size-fits-all answer here, which is why businesses need to speak to someone. All their issues are different and there are less than 80 days to go.”
Last week the British government sent an email to businesses with links to its website that purport to offer advice on dealing with the changes brought on by operating outside of the UK post-Brexit, the consultancy noted.
“The portal offers us no tangible advice that hasn’t already been covered externally and by comparison misses a lot of key elements of consideration,” Palmer said, adding that the firm is countering ‘Brexit fatigue’ by offering the following advice to help companies implement active strategies to ensure that they’ll know where they stand with foreign exchange, including:
What implications a large delay in receipt or delivery of inventory will have on cashflows and any underlying foreign exchange contracts allocated to them.
Whether a 10 percent move up or down in the value of the British pound will leave them having to pay extra collateral against hedging contracts.
The types of hedges being used: Are there more suitable methods?
Whether businesses in their supply chain are protecting themselves against financial exchange risk and if they would suffer as a result of any adverse effects they experience.
The small print.
A non-responsive banking relationship.
Terms with suppliers – are they able to get some payment flexibility if required, rather than breach any strict terms that don’t make a Brexit
Speak to people in the industry. What are they doing?
Act on the information they’ve got and avoid procrastination.
Get on top of the variables that they are in control of to reduce other distractions.
The firm also offered some alternative FX strategies instead of waiting:
Start small, hedge 50 percent of what they would regularly. This lowers the potential risk, while only giving up some of the potential upside.
Change the product mix. Something that is happening at scale already.
Hamilton Court FX added suggestions that businesses should consider with their FX product mix: A lower potential obligation; structures that allow for upside flexibility or that can deliver a level of outperformance vs. vanilla products if their risk tolerance allows for it; trades with low or zero chance of margin call, and working with an expert to tailor a trade that aligns with the company’s market view, while still delivering the level of protection required.
Over the last few decades, many scientific and technological advancements have helped the healthcare landscape to flourish and change—and no more so than in the area of patient engagement.
With the advent of digital communication platforms, patients are now able to engage more closely with the work of the pharma industry, and subsequently take more active roles in their treatment decisions. This has been encouraged by the availability and proliferation of information sharing between patient communities as they actively drive their own healthcare agendas.
Businesses throughout the entire supply chain are now facing a culture shift as a result of the rise of the patient voice and the increased acceptance of remote engagement catalyzed by the COVID-19 pandemic. This is a shift away from traditional scientific endpoints as the key driver in drug development, to a more holistic approach to the patient outcomes that really matter to patients’ lives.
HIV as an example
From a clinical perspective, HIV treatment is all about CD4 T-cell counts and viral loads. Throughout treatment, healthcare providers (HCPs) will monitor a patient’s blood levels and prescribe a carefully balanced regimen of drugs that aim to prevent the virus from reproducing—this allows the patient’s CD4 count to rise and their immune system to recover. The virus can become resistant to these drugs so the HCPs must work diligently to monitor viral concentrations and keep the upper hand by prescribing new drug combinations.
This approach shows how the scientific community has traditionally looked at the efficacy of treatment, with a focus on clinical outputs. While it has undoubtedly delivered incredible results—in only a few decades, HIV has become treatable with a daily single tablet combination regimen—it doesn’t factor in more holistic considerations of the patient’s well-being and day-to-day experience.
With a shift in focus from “outputs” to “outcomes,” a value-based approach might investigate how to modify antiretroviral medicines to reduce side effects and improve how convenient it is to take medication. It may also seek improved or faster ways for a patient to achieve an undetectable viral load, which will allow them to feel more confident in everyday life.
This example only shows a selection of the issues facing patients for one specific disease—and indeed one of the key questions facing our industry now is how healthcare models can be developed universally to meet diverse, complex, and individual patient needs across all therapy areas. As a result, healthcare industries are starting to view key performance indicators differently, taking a step away from scientific outputs as a primary focus, to a more inclusive approach toward outcomes that really make a difference to patients’ lives.
The move toward value-based healthcare, where patient needs and concerns are at the heart of drug development, is increasingly recognized as a sustainable business model for the pharmaceutical industry. Patient preference data is already starting to be requested at submission or approval stages and has even been included in product labeling in some instances, such as with Genentech’s hamato-oncology product Rituxan Hycela1, where patient preference survey results are included around administration methods.
In the US, the American College of Surgeons (ACS) and Harvard Business School’s (HBS) Institute for Strategy and Competitiveness is developing a program to help hospitals and surgical practices improve surgical patient outcomes while lowering the cost of delivering care. Appropriately named THRIVE (Transforming Health care Resources to Increase Value and Efficiency), the program is piloting the measurement of the full cycle of care—including key surgical, medical, behavioural, and social elements—for three surgical conditions.2
It is clear then that the trend toward patient outcomes is gaining momentum and this has implications throughout the lifecycle of healthcare—not just at the point of primary care.
Accelerating the route to digital
While there has been a historical reluctance in the industry to accept the use of digital communications technology in some aspects of patient dialogue, mainly resulting from compliance limits, through necessity the pandemic has done a lot to address these reservations. In response to the pandemic, care providers and their partners had to build services for patients that enable them to be supported at home. Service areas such as remote patient monitoring, self-management training, and home-administration have all increased significantly, enabling patients in many cases to commence or continue treatment at home. Patient Solutions teams at Ashfield, for instance, are now running a number of remote programs and delivering virtual support to patients that was previously delivered face-to-face.
Digital platforms are enabling patients to openly communicate preferences around their own treatment and have driven patient preference information (PPI) to become an increasingly important part of the wider healthcare conversation.
Technological advancements are allowing pharma businesses to explore this area more effectively, and as the digital revolution continues to unfold, so do the ways in which technology can potentially support patient needs. Implementation and interpretation of electronic health record (EHR) systems, big data, and health analytics offer a huge potential for driving toward true value-based healthcare.
The industry is investing in this burgeoning area and working to understand the many ways it can possibly connect global healthcare systems and translate the hidden value in their data. Unlocking data could lead to more informed healthcare decisions, reduced costs, and widespread improvements in treatment.
There is a lot of buzz around this theme, as technology and healthcare experts try to unpick this incredibly diverse and complex landscape. Although data are becoming increasingly available, the processes and tools for capturing, sharing, and understanding them are still behind. A further concern is around how regulation and patient privacy can be maintained, especially in an era where GDPR is high on the agenda for anyone managing or accessing patient data.
The “people factor” is explored in another way by the International Consortium for Health Outcomes Measurement (ICHOM).3 The organization collaborates with patients and HCPs to define, measure, and advocate the benefits of capturing and measuring long-term patient outcomes as a key driver for improving care. In its short film Measured Outcomes: A Future View of Value-Based Healthcare4, experts discuss the benefits of maintaining long-term relationships with patients and suggest how a system of globally unified benchmarks for outcome analysis could revolutionize the health system. By creating unified criteria, it should be possible to create a forum for the review and comparison of learnings around the world, which, in turn, would promote wider discussion, and the sharing of common goals, challenges, and best practices.
The healthcare industry is already starting to move toward a mind-set of improved patient outcomes‑however, more work still needs to be done to harness the opportunities presented by the evolving healthcare landscape, and especially at a time when a global pandemic is so rapidly changing the experiences of so many patients. Despite many advances in Western culture, the WHO states that HIV is still one of the top threats to global public health in 2019.5 This shows that collaboration, sharing of data, and best practice is needed on a wider scale to truly bring value to patients on a global scale.
Continuing to work in this direction will support an evolution toward personalized healthcare that nurtures patient communities. Technology will remain a critical driver in delivering on this vision and in being able to define and deliver tools and platforms that support a more value-based healthcare model that will ultimately provide benefit to the entire stakeholder group.
BioLife Solutions, Inc.’s recently acquired SciSafe division has been awarded a two-year contract estimated at $2.7 million from an unnamed ‘large pharmaceutical company’ for cold chain management and storage of Covid-19 vaccines.
SciSafe, a provider of biological materials storage founded in 2010, maintains four cGMP-compliant facilities located in New Jersey, Massachusetts and Utah, with an expansion plan focused on the cell and gene therapy clusters located around the world.
While BioLife leadership did not name the pharmaceutical company in the $2.7 million agreement, the company last month reported that SciSafe customers include several Top Five global pharmaceutical companies.
In an interview published last week with Seattle’s Pugent Sound Business Journal, BioLife CEO Mike Rice said the company’s storage technology would not be used for transport of the Covid-19 vaccine, but declined to add further details about the newly signed contract.
BioLife is a developer and supplier of bioproduction tools and services for cell and gene therapies. SciSafe, acquired in September, is expected to contribute approximately $9 million in incremental revenue in 2021, according to BioLife.
IntegriChain, a Philadelphia-based data and managed services company, has introduced GTN Analytics, a service for life sciences manufacturers to improve visibility to the market access datasets that power the accuracy of accruals and forecasting processes, delivers best practices reports and metrics, and offers visualizations of gross-to-net, or GTN, trends.
The new service is complementary to IntegriChain’s GTN Accruals and GTN Forecasts services that integrate financial data with channel and patient data, including national demand, third-party logistics, specialty pharmacy, specialty distribution and rebate data. “Business strategy in life sciences is often stymied because of the inability to connect the impact of channel, contracting, and pricing decisions on net profitability and demand realization,” said Josh Halpern, IntegriChain co-founder and EVP of product and strategy.
According to the company, GTN Analytics improves accuracy and predictability of accruals and forecasts through the following key components:
Data on demand reduces the risk of gross-to-net accrual mistakes and improves overall contract decision making by providing finance and market access teams a consistent way to visualize, extract and integrate data into existing workflows. It allows analytics to quickly access self-service data, including ad hoc analysis, pre-built reports and dashboards, on-demand data exports, and an application programming interface for business intelligence tools.
GTN Reporting allows manufacturers to evaluate key gross-to-net metrics and trends with web-based data visualization and analysis tools. Visualizations align with industry best practices, including product profit and loss statements as well as actual and forecast variance analysis, and provide insights into the effectiveness of contract decision making using datasets from across traditional silos.
GTN Analytics is available to all current IntegriChain GTN customers and demos are being scheduled for other interested parties.
Momentive Technologies and Stevanato Group agreed to supply Momentive’s Pur Q fused quartz vials in Stevanato’s EZ-fill packaging format.
The Pur Q vials are ultra-high-purity fused quartz vials available for pharmaceutical packaging. The EZ-fill secondary packaging provides a fully integrated, ready-to-use option for aseptic fill-finish operations.
Pur Q fused quartz vials. (Image courtesy of Momentive Technologies)
Combined, the move is expected to help biopharmaceutical companies improve the reliability and speed of drug development and production of medications via highly stable primary packaging and an efficient secondary packaging method.
Made from 99.995 percent pure silicon dioxide (SiO2), the Pur Q fused quartz vials have an inert, nonreactive surface that virtually eliminates risk of interaction with packaged drug formulations.
“Due to the vials’ highly inert properties, biopharmaceutical companies will be able to confidently take the container out of the equation when assessing the viability of formulations, helping to accelerate the development of increasingly complex and sensitive biologic drug formulations,” said Robert Koch, global commercial director at Momentive Technologies.
The EZ-fill secondary packaging is designed to mitigate the risk of breakage, cosmetic issues and particulate generation during fill-finish operations. The packaging stores vials safely in a tray, or nest and tub configuration for efficient filling, while minimizing glass-to-glass contact.
EZ-fill packaging stores vials in tray or nest and tub configuration. (Image courtesy of Stevanato Group)
Momentive Technologies, headquartered in Strongsville, Ohio, employs more than 700 workers and maintains seven manufacturing locations in the U.S., Germany, Japan and China. Formerly a division of Momentive Performance Materials, the business became a separate stand-alone entity in January.
Privately owned Stevanato Group, based in Piombino Dese, Italy, is a designer and producer of glass primary packaging for the pharmaceutical industry. In September, the company launched a Technology Excellence Center in Boston to support biopharma companies from early phase development through to commercialization, helping them overcome container-closure system hurdles.
Authentix, Inc., an authentication and information service based in Addison, TX, has acquired the Traceless Authentication Group from Bibliotheca, Inc. a library systems company serving libraries worldwide.
Rochester, NY–based Traceless delivers anticounterfeiting and diversion control options to customers in the global pharmaceuticals, spirits, and apparel industries. The acquisition includes the company’s complete portfolio of patented covert marking solutions as well as its own enterprise cloud-based digital track and trace software technology.
Product lines acquired include Traceless Ultra, Traceless Pro and Traceless Anti-Diversion covert marking systems that can be integrated into existing product production.
“Traceless brings an extensive capability in the worldwide digital tracking of products and consumer-level product marketing, both of which integrate well with our growth strategy,” said Kevin McKenna, CEO of Authentix.
In addition to the U.S., Authentix has offices in the United Kingdom, Saudi Arabia and Africa. MHT Partners, L.P. acted as financial advisor to Authentix in the transaction.
India’s Ministry of Corporate Affairs has granted formal approval to Balaxi Ventures Ltd to change the company’s name to Balaxi Pharmaceuticals Ltd. The move received shareholder okay last month at the company’s annual general meeting.
Hyderabad, India-based Balaxi supplies “frontier” markets in Angola, Guatemala and the Dominican Republic with branded, generic and over-the-counter medicines that address multiple therapeutic segments. The products are procured from World Health Organization GMP-certified contract manufacturers based in India, China and Portugal.
“Considering our focus on pharma business, it is only apt that the company’s name reflects our brand proposition,” Ashish Maheshwari, managing director, commented regarding the name change.
The company maintains an on-ground presence with 38 warehouses and a distribution network featuring a fleet of company-owned vehicles. It reports that it currently is building a branded fast-moving-consumer-goods (FMCG) business to complement its pharmaceutical operations while taking advantage of its established on-ground infrastructure and channel relationships.
Biosimilar medicine availability and use are growing and on track to reduce drug costs by $100 billion over the next five years, according to a new report from the IQVIA Institute for Human Data Science.
The development and approvals of biosimilars have been accelerating in the U.S. over the past two years, bringing a total of 33 approvals across 13 molecules through the 2020 second quarter. Only 22 of these have launched thus far due to legal challenges and commercial agreements.
An additional 108 biosimilars are in development across 22 other molecules and will potentially reach the U.S. market within the next 10 years.
“Contrary to some predictions, biosimilars are not a failed concept; they are in fact becoming a growing part of affordable treatment options available to payers, physicians and patients,” said Murray Aitken, IQVIA senior vice president and executive director of the institute. “It is our estimate that biosimilars could reach $80 billion in aggregate sales over the next five years, including $16 billion to $36 billion in 2024.”
Recent biosimilar launches of bevacizumab, trastuzumab and rituximab are set to reach nearly 60 percent volume share by the end of their second year on the market, significantly higher and faster than prior biosimilars.
The growing willingness by stakeholders across the U.S. to adopt biosimilars is confounded by an extreme heterogeneity across provider groups where biosimilar usage ranges from 0 percent to 100 percent, according to IQVIA.
The differences reflect contracting approaches by manufacturers and providers, and prescriber willingness to adopt biosimilars including the associated issues with changing patient treatment protocols.
Key highlights of the report include:
Savings enabled by the presence of biosimilars are modeled to exceed $100 billion in aggregate over the next five years, though volume and price dynamics remain volatile and significant uncertainty remains.
Price declines for biosimilars significantly vary but are in line with prior IQVIA assumptions of roughly 30 percent discounts. Higher discounts have occurred for many biosimilars, and an increase in the average discount is possible in the future. (IQVIA reported on the overall effects of discounting on pricing in the pharmaceutical sector in its Global Medicine Spending and Usage Trends report released in March.)
The introduction of biosimilars in some cases has triggered 2 percent to 4 percent incremental demand for the molecules, bringing biologic treatments to more patients.
Patients benefit from the use of biosimilars in the form of lower out-of-pocket costs, depending on their insurance plan design.
In the case of insulins, patients with Medicare Part D and commercial insurance are saving an average of about $18 and $13 per prescription, respectively, when using a biosimilar insulin.
Patients who are typically responsible for 20 percent of Medicare Part B costs are benefiting from the lower average sales price of $500 to $1,900 for a standard course of treatment for the three most recently launched biosimilars.
Large pharmaceutical companies, often with existing innovative biologic portfolios, lead the marketing of biosimilars, while the smaller companies that are developing biosimilars are likely to license products to the larger companies for marketing.
The study was produced independently without industry or government funding, according to IQVIA. The full version of the report, including a detailed description of the methodology, is available from the institute.
Abzena, a contract provider of integrated services for biologics and bioconjugates, has invested $60 million into a new facility for late phase and commercial current good manufacturing practice (cGMP) production.
The new 50,000 square foot ‘Lusk’ facility at the company’s site in San Diego houses a process development laboratory and two new cGMP manufacturing cleanrooms for 500L and 2,000L scale in Sartorius single use bioreactors. The facility also houses a good manufacturing practice warehouse and analytical development and quality control laboratories.
The facility will enable the company to deliver Phase I to commercial manufacturing services for biologic projects, according to Abzena.
“Until now our other San Diego site has been focused primarily on development and manufacture of Phase I and II clinical trial materials,” saidMatt LeClair, senior VP, who added that the expansion will allow the company to provide project integration as customers move into Phase III and ultimately commercial manufacture.
The new facility, which received its manufacturing license from the California Food and Drug Branch, has added 125 new positions within the company.
Omnicell, Inc. is rebranding its Population Health Solutions division into EnlivenHealth, a unit dedicated to enabling retail pharmacies and health plans to improve patient outcomes while reducing costs through software-as-a-service technology.
The newly named division serves nearly 30,000 retail pharmacies across the country, delivering patient engagement and personalized communications tools to pharmacists.
Technology services offered include medication synchronization designed to align prescription refills to a single date each month, communications programs that help pharmacies and health plans streamline workflow and create personalized patient care, and at the same time support patient satisfaction and retention.
“The mission of EnlivenHealth is fundamentally about bending the quality and cost curve for healthcare providers and payers,” according to Randall Lipps, chairman, president, CEO and founder of Omnicell. He added that the company’s vision aims to leverage data intelligence, and drive workflow automation, digitization and optimization.
Other EnlivenHealth services include medication therapy management, interactive voice response, patient adherence, opioid mitigation and tailored population health programs.
Progress continues on MilliporeSigma’s new $165-million membrane production plant in Darmstadt, Germany, part of an overall $1.2 billion global headquarters investment that Merck KGaA announced last year.
New membrane production plant. (Image courtesy of MilliporeSigma)
The membranes are critical components in Millipore Express aseptic filters that help ensure the sterility of biological drug products.
“This investment increases our membrane manufacturing capacity and allows for more supply chain diversification,” Chris Ross, interim CEO of MilliporeSigma, said as the company held a topping-out program for the new manufacturing facility this week.
Construction began in March and is expected to be completed in 2022, followed by production process validation and commercialization. The new four-story membrane plant will incorporate immersion membrane casting equipment, quality control laboratories and offices, and add about 55 new jobs, according to the company.
Millipore Express membranes manufactured at the new Darmstadt facility will be processed into filters for pharmaceutical production at MilliporeSigma’s existing device center in Jaffrey, New Hampshire.
The life science business of Germany-based Merck KGaA, which operates as MilliporeSigma in the U.S. and Canada, has some 22,000 employees and 59 manufacturing sites worldwide with products focused on scientific discovery, biomanufacturing and testing services.
The COVID-19 pandemic has created supply chain gaps in critical drug products, especially those needed for the most critical patients in intensive care units across the country.
DARPA established a competitive review process to award grant funding to companies presenting advanced manufacturing technologies. Grant specifics include development funding over the next 24 months, with additional funding for commercialization in the subsequent 12 months.
Continuity Pharma’s mission is to apply new continuous manufacturing capabilities to reshore generic drug products to the U.S., with specific focus on drugs in short supply. The company is working with Purdue Research Foundation to secure additional lab space in Purdue Research Park, West Lafayette, IN.
DARPA, located is Arlington, VA, has approximately 210 government employees, including some 100 program managers, in six technical offices. With a fiscal year 2020 budget of $3.45 billion, the agency oversees roughly 250 research and development programs through a series of contracts, grants and other agreements.
Cryoport, Inc. has completed the acquisitions of MVE Biological Solutions, a global supplier of manufactured vacuum insulated products and cryogenic freezer systems, and CryoPDP, a provider of temperature-controlled logistics for the clinical research, pharmaceutical and cell and gene therapy markets.
In 2019, MVE generated revenue of approximately $84 million and CryoPDP generated approximately $47 million of revenue. With the closings, Cryoport’s annual revenue run rate is more than $160 million and both acquisitions are expected to be immediately accretive to earnings.
These two acquisitions strengthen Cryoport’s ability to support the growing need for integrated temperature-controlled supply chain requirements in life sciences, and expand its client coverage in the global cell and gene therapy market.
With the MVE deal, Cryoport also completed its previously announced private placement issuance of $25 million of common stock and $250 million of newly designated Series C convertible preferred stock to funds affiliated with The Blackstone Group Inc.
It’s taken nine months, but the Trump administration has delivered on one of its politically popular proposals: drug importation from Canada. HHS issued a Final Rule (soon to be published in the Federal Register), “Importation of Prescription Drugs,” [Docket No. FDA-2019-N-5711], scheduled to go into effect after 60 days. The original proposed rule appeared last December.
In the interim, HHS and FDA received some 1,200 comments on the rule, but appears to be much as originally proposed. For now, states and territories (and later, wholesalers or individual pharmacists) can sponsor a Section 804 Importation Program (SIP), managed by the sponsor and overseen by FDA. The Sponsor will select an Importer who will deal with a Foreign Seller (in Canada). The Foreign Seller is to be registered both with Health Canada and with FDA; the Importer is to be a US entity. Those three parties will work together to ensure that only drugs licensed to be sold in Canada and that meet FDA requirements, and are tested for quality by either the manufacturer or the Importer, will be allowed into the US and prescribed to patients.
President Trump touted the program as part of an “America First Health Plan” in a speech in North Carolina on Sept. 25. “This will be a game changer for American seniors. And by allowing you to do this through Canada, we’re doing it very, very quickly. So it goes very fast. And the new rule goes into effect as of today,” he said, but as is often the case with his pronouncements, that isn’t quite true, if only for the 60-day provision.
According to Kaiser Health News, Florida is primed to go forward, and has a request for contractors already in place. Other states—Colorado, Maine, New Hampshire, New Mexico and Vermont—also intend to start programs.
The HHS Final Rule addresses a key obstacle of previous federal efforts to permit importation—that the Secretary of Health needs to certify the safety and cost savings of such a program—by essentially asserting both those points. It’s left to states, the Sponsors, to collect the necessary documentation; as to cost savings, the rule simply sidesteps the matter, saying “We are unable to estimate the cost savings from this final rule because we lack information about the likely size and scope of SIPs, the specific eligible prescription drugs that may be imported, the degree to which these imported drugs will be less expensive than nonimported drugs available in the United States, and which eligible prescription drugs are produced by U.S.-based drug manufacturers.”
For now, drug importation is a two-year test, to be evaluated after that for its savings. Besides the heavy documentation, testing and relabeling rules, the plan also faces a lack of interest from Health Canada (Canada’s population is one-tenth that of the US, and they are already worried about some drug shortages), and the potential litigation from the US pharma industry.
On the heels of what would normally be considered a major acquisition by a relatively small company—Cryoport’s purchase of Paris-based CryoPDP—the company is now leaping ahead with a new acquisition: the life sciences business, MVE Biological Solutions, of Chart Industries. The purchase price is $320 million, which Cryoport is swinging by combining its own cash and stock with the Blackstone investment. Pretty good for a company whose gross revenue in 2019 was $32 million.
When the dust settles on the Cryoport/CryoPDP/MVE combination, the expected revenue run rate will be $160 million, making Cryoport a combination of a major logistics provider to the regenerative medicine market (which includes the fast-growing cellular and genetic therapies [CGTs] field) as well as a supplier of the freezers, refrigerators, dewars and related equipment used in life sciences labs and factories where cryogenic conditions are maintained.
“This marks an exciting time in our growth as we become a larger and more comprehensive global player in supporting the fast growing cell and gene therapy industry and the life sciences industry, at large, with the most advanced and reliable temperature-controlled supply chain solutions in the world,” said Jerrell Shelton, Cryoport CEO.
Cryoport’s background information announcing the deal mentions an estimated 32% CAGR in the number of patients treated by CGTs annually over the next several years, which it then estimates translates into a $1.2-billion “addressable market for cryogenic shipping” by 2027. This is certainly possible; however, the CGT field is still finding its way commercially, with significant payer obstacles to $1-million+ per-patient treatments. A more technological factor is whether the current phase of mostly autologous therapies (which depend on cells from the patient being treated) will be supplanted by allogeneic therapies (using cells for any patient). The former involves a complex process of extracting, manipulating and returning cells for patient infusion; the latter involves “off the shelf” therapy, much as most biologics are administered to patients today. That distinction, in turn, affects the complexity of the supply chain.
In the meantime, Cryoport can keep busy supporting the 1,000+ CGT and tissue engineering trials going on globally (the company is also the preferred logistics provider for several already-commercial CGTs). It has also been bringing along business in refrigerated (2-8°C) biologics logistics, which Pharmaceutical Commerce, in its 2020 Cold Chain Sourcebook, estimates at $17.2 billion currently.
A privately held pharmacy benefit manager, RxAdvance, has the No. 1 spot among 10 specialty pharmacies listed in this year’s Inc. 5000 (see table). With publication of the Inc. 5000, readers get a view of some of the elements of privately-held companies, whose financials are usually not apparent. RxAdvance’s news release does reveal that the company’s overall revenue is $2 billion—and given that its three-year growth rate is 1,071%, that is quite an achievement.
Overall, however, the Inc. 5000 data indicates a slowing of the growth among specialty pharmacies, which has been meteoric over the past decade. PantherRx—which is still showing dramatic, 391% growth—is now No. 1,154 on the list; it entered the Inc. 5000 in 2016 at No. 9 on the list. (Granted, revenue growth gets harder as revenues mount, but its 2016 three-year growth rate was over 13,000%.)
It is important to note that the Inc. 5000 data is not a measure of overall specialty pharmacy (let alone specialty pharmaceutical) trends; the industry is dominated by big, publicly held companies like CVS Health or Cigna-Express Scripts. The past year is also notable for the exit of Diplomat Pharmacy, which grew phenomenally during the 2010s, went public, then stumbled and was acquired by Optum earlier this year.
According to Inc. magazine, publisher, the rankings are based on percentage revenue growth when comparing 2016 and 2019. To qualify, companies must have been founded and generating revenue by March 31, 2016. They had to be U.S.-based, privately held, for profit, and independent—not subsidiaries or divisions of other companies—as of December 31, 2019. The full listing is available here.
The latest sector report from the Alliance for Regenerative Medicine (ARM), covering the first half of 2020, has a surprising finding: Despite the arrival of a global pandemic at the beginning of the year, new investment in cellular and genetic therapies (CGTs) and tissue engineering topped $10.7 billion globally—more than all of 2019. ARM expects the full-year data to exceed the previous record of $13.5 billion, set in 2018. The number of regenerative medicine companies is now 1,001. Notable financings during the half-year include the IPO of Legend Biotech ($487 million); the private financing at Sana Biotechnology ($700 million); and the upfront-payment partnership between uniQure and CSL Behring ($450 million).
ARM counts 1,078 clinical trials going on, with 97 in Phase III in the US—not much of a change from 2019, but notable in that managing clinical trials has been especially challenging during the pandemic. The organization also counts 11 new trials of cell therapies targeting complications of Covid-19. That effort has already caused some heartburn among healthcare observers: given the millions of potential patients, and given the relatively high cost of cell therapies, what will happen if the trials are resoundingly successful?
Drug pricing has always been a controversial topic, but as controversies go, it is one of the hottest ones in healthcare today. Readers of The Price of Global Health will get the perspective of a pharmaceutical industry manager (who is but one player in the multiperspective dynamic going on)—but the book is not a simplistic pitch for higher drug prices. Rather, it provides a valuable overview of the many factors involved in industry, insurer, provider and patient concerns—and with a global perspective that has its own high value.
The Price of Global Health is now in a third edition (previous editions were written in 2011 and 2015), and has been extensively revised. The author is Ed Schoonveld, currently managing partner of the Value and Access Practice with ZS Associates in New York. His prior experience includes stints at Lederle, Wyeth, Eli Lilly and BMS in the U.S. and Europe; he has also served as a consultant in pricing deliberations at the World Trade Organization.
After reading through the book’s sections, one gets a sense of surprise that any new drug can be commercialized at all—and not simply because of payers’ desire to get the lowest possible price. One example: it is well known (at least in the industry) that drugs for life-saving conditions are typically first tested on very sick patients (thus, are third- or fourth-line therapies, rather than the first-line therapy that might be used for a newly diagnosed patient). Most of the time, only if the drug shows efficacy at that stage can it begin the process of gradually rising (through additional trials) to becoming a first-line therapy. This arduous journey can be shut down at the earliest stages, even if the drug candidate has high potential for a less sick, newly diagnosed patient.
As detailed as the book is, it is not an instruction set for actually setting a drug price. Rather, a thorough knowledge of the information in this book is the foundation from which more focused analysis can be conducted to arrive at the pricing that provides the best chance for a successful launch and long life cycle for the drug.
A section at the end of the book details pricing and market considerations globally, for 13 nations, ranging from the US to India. With talk in Washington of an effort to adopt reference pricing for the US market, which would in turn depend on how prices are set especially in single-payer, national systems around the world, this has its own value.
The Price of Global Health: Drug Pricing Strategies to Balance Patient Access and the Funding of Innovation, E. Schoonveld; published by Routledge. an imprint of Taylor & Francis Group, an informa business. ISBN: 978-0-367-27940-0 (hbk), ISBN: 978-0-429-32071-2 (ebk)
Kalderos, a Chicago analytics company, attracted new attention a year ago as it garnered a round of funding and won business from 7 of the top 15 pharma companies to help them manage their interactions with providers over the 340b program. That program, which represented $30 billion in 2019 drug revenue according to DrugChannels.net, enables hospital pharmacies to take significant discounts on drug purchases, ostensibly to provide lower-cost drugs to indigent patients—but the allocation of those funds is at the discretion of the hospital. The sales were up 23% from the year before and have tripled since 2014.
Kalderos’ position in this isn’t to restrict or control 340b sales on behalf of its pharma clients, but rather to enable them to efficiently allocate 340b discounts against other government discount programs—Medicaid, Medicare Part D and some commercial plans. Properly allocating discounts has saved pharma clients $100 million to date (the company launched in 2016), says Jeremy Docken, CEO and co-founder. (Most of these savings come from drugs that received duplicate discounts from state Medicaid programs; also, it’s worth noting that some discounts generate additional price reductions under Average Manufacturers Price [AMP] rules.)
Recently, Kalderos garnered an additional $28 million in Series B funding from Bain Capital Ventures and Mercato Partners. With the additional funding, says Docken, Kalderos is already building out data services for payers and providers, in addition to manufacturers. Transparency and “preventive drug discount management” among all the parties is the goal, he says and ultimately “to further streamline the interactions between participants in the healthcare ecosystem.”
For sure, revenue management and resolving multiple conflicting discount programs will be helpful to all parties involved. The larger question, of course, is whether those parties want to continue the current regulatory setup; the dissatisfaction of manufacturers with the open-endedness of the current 340b setup is growing.
On the horizon, Docken says Kalderos will get involved in patient copay and voucher programs, and perhaps manage them on behalf of pharma. Managing value-based contracting is another potential application. “The ultimate goal is to get discounts to the patients where they are most needed,” he says.