Kamada to Commercialize Three Biosimilar Products in Israel

Shots:

  • Kamada signs an agreement with two undisclosed international pharmacies to commercialize three biosimilar product candidates in Israel. The two pharmaceutical companies will be responsible for the development, manufacturing, and supply of three products
  • Following the approval from EMA and IMOH, the three products are expected to be launched in Israel b/w 2022 and 2024
  • The collaboration will expand Kamada’s biosimilar portfolio in Israel which already includes six products previously licensed from Alvotech

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Globes English

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Y-Biologics Signs a License Agreement with 3D Medicines for YBL-013 in the Territory of Greater China

Shots:

  • Y-Biologics to receive ~$2M up front and eligible to receive ~$85M as development, regulatory, & commercialization milestones along with royalties on sales in the territory
  • 3D Medicines will get an exclusive right to develop, manufacture, and commercialize YBL-013 in China with the expansion of collaboration in the US and other regions
  • Both the companies will share IND development costs. YBL-013 is a T cell bi-specific engager based on ALiCE platform technology and targets CD3 on T cell and PD-L1 on cancer cell

Click here ­to­ read full press release/ article | Ref: PRNasia | Image: Y-Biologics

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Myovant Signs Agreement with Pfizer to Develop and Commercialize Relugolix in Oncology and Women’s Health

Shots:

  • Myovant & Pfizer will jointly develop & commercialize ORGOVYX (relugolix) in advanced prostate cancer & if approved, relugolix combination tablet in women’s health in the US & Canada. Myovant will receive ~$4.2B including $650M upfront, $200M in regulatory milestones for FDA approvals for relugolix combination tablet in women’s health, and tiered sales milestones upon reaching certain thresholds up to $2.5 billion in net sales for prostate cancer and women’s health indications
  • Additionally, Pfizer will receive an exclusive option to commercialize relugolix in oncology outside the US and Canada, excluding certain Asian countries and if Pfizer exercises the option to commercialize relugolix in oncology, Myovant will receive $50M and is eligible to receive double-digit royalties.
  • Relugolix is a GnRH receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol. Relugolix (120mg) is FDA approved as ORGOVYX for adult patients with advanced prostate cancer

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Myovant

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Aurobindo Pharma Sign Agreement with COVAXX to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

Shots:

  • In the agreement, Aurobindo has obtained the exclusive rights to develop, manufacture & sell COVAXX’s UB-612 vaccine in India & UNICEF & also non-exclusive rights in other selected emerging & developing markets
  • UB-612 is presently being assessed in P-I will be manufactured by Aurobindo in its Hyderabad facility has a manufacturing capacity of 220M doses with an upcoming capacity of ~480M doses by June 2021
  • COVAXX’s UB-612 is the first multitope, synthetic peptide-based COVID-19 vaccine candidate in P-I and plans to initiate P-II/II by Q1 2021 in Asia, Latin America, and the USA

Click here ­to­ read full press release/ article | Ref: PRNewswire  | Image: The Loadstar

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GSK Signs an Exclusive License Agreement with Surface Oncology to Develop and Commercialize SRF813

Shots:

  • Surface Oncology to receive ~$85 M upfront and ~$730 M as milestones along with royalties on net sales of SRF813
  • GSK to get an exclusive right to develop and commercialize Surface Oncology’s preclinical program, SRF813
  • SRF813 is an IgG1 Ab targeting PVRIG (also k/a CD112), currently in IND-enabling studies with anticipated IND submission in 2021

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Emergency Physicians Monthly

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Schrödinger Signs a $2.7B Agreement with BMS to Develop and Commercialize Therapies in Multiple Disease Areas

Shots:

  • Schrödinger to receive $55M upfront and is eligible to receive $2.7B as preclinical, development, regulatory & commercial milestones along with royalties on sales of each product commercialized by BMS
  • Schrödinger to grant BMS exclusive WW rights to develop & commercialize the development candidates emerges from the collaboration
  • The collaboration will merge Schrödinger’s computational platform & drug discovery capabilities with BMS’ expertise in development & commercialization to advance small molecule therapies targeting oncology, immunology & neurological disorders. The collaboration includes two of Schrödinger’s early-stage programs and additional undisclosed targets

Click here ­to­ read full press release/ article | Ref: BusinessWire | Image: Schrödinger

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Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS

Shots:

  • Mesoblast to receive $25M up front and $25M as equity investment with additional payments and royalties on achievement of development, regulatory and commercial milestones
  • Novartis to acquire the exclusive WW rights to develop, commercialize & manufacture remestemcel-L for ARDS & access to a cell-therapy based platform with WW rights to a range of potential indications. Novartis has the option to distribute remestemcel-L for GVHD (outside Japan)
  • Both parties have rights to co-fund development & commercialization for other non-respiratory indications. Remestemcel-L is currently being studied in COVID-19-related ARDS in an ongoing P-III study while Novartis plans to initiate a P-III study in non-COVID-19-related ARDS

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Market Watch

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Prestige Signs an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel

Shots:

  • Teva to get an exclusive right to commercialize Tuznu in Israel, leveraging its marketing capabilities and experience in bringing pharmaceutical products to market and will be responsible for local registration, sales, and marketing in Israel
  • Prestige will assume responsibility for product registration with the EMA and commercial supply of Tuznue from its manufacturing facilities in Osong, Korea
  • Tuznue is biosimilar referencing Roche’s Herceptin (trastuzumab), used to treat HER2-overexpressing BC & m-gastric adenocarcinoma. Additionally, the EMA has accepted an MAA for Tuznue based on the global clinical trial results

Click here ­to­ read full press release/ article | Ref: BusinessWire | Image: BioSpectrum Asia

The post Prestige Signs an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel first appeared on PharmaShots.

AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer

Shots:

  • Fusion to receive up front, as well as development milestones and other payments. The companies will jointly discover, develop, and have an option to co-commercialize novel TATs in the US while AstraZeneca will lead commercialization in the ROW with equal profit & loss sharing globally
  • The collaboration leverages Fusion’s TAT platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of Abs and cancer therapies, including DDRis
  • Additionally, the companies will exclusively explore certain specified combination strategies between TATs (including Fusion’s FPI-1434) and AstraZeneca’s therapies for the treatment of multiple cancers. Both companies will retain full rights to their respective assets

Click here to­ read the full press release/ article | Ref: Fusion Pharmaceuticals | Image: Moffitt

The post AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer first appeared on PharmaShots.

ImmunoGen Signs an Agreement with Huadong to Develop & Commercialize Mirvetuximab Soravtansine in Greater China

Shots:

  • ImmunoGen to receive $40M up front, ~$265M as development, regulatory & commercial milestones and is eligible to receive royalties on sales of mirvetuximab in Greater China and will retain all rights to mirvetuximab in the US & ROW
  • The collaboration accelerates the development path for mirvetuximab in Greater China and expands Huadong’s oncology portfolio with innovative ADC and combines ImmunoGen’s lead clinical program with Huadong’s regional oncology expertise
  • Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a FRα binding antibody, cleavable linker & the maytansinoid DM4 to kill the targeted cancer cells

Click here ­to­ read full press release/ article | Ref: ImmunoGen | Image: PNGitem

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Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan

Shots:

  • Isofol to receive $100M as up front, development, regulatory and commercial milestones, and clinical development cost and is eligible to receive royalties on sales of the therapy and retain its right to the therapy in ROW
  • Solasia will lead clinical development activities in Japan and will be responsible for registrational filing and approval in the licensed territory. The collaboration will initially focus on the development and commercialization of arfolitixorin as 1L treatment for mCRC patients and may extend it to other indications
  • Arfolitixorin is currently being evaluated in the ongoing global P-III AGENT study, conducted in the US, Canada, EU, Australia, and Japan. Isofol and Solasia plan to expand the study with additional sites in Japan while Isofol will remain as global sponsor of the study

Click here ­to­ read full press release/ article | Ref: Isofol | Image: CNN

Teva and Alvotech Collaborate to Commercialize Five Biosimilar Candidates in the US

Shots:

  • Alvotech will lead the development, registration, and supply of the biosimilars, while Teva will be exclusively commercializing the products in the US. Alvotech will receive upfront with subsequent milestone payments over the next several years
  • The companies will share the profit from the commercialization of the biosimilars. The collaboration leverages Teva’s commercial presence and extensive infrastructure in the US along with Alvotech’s experience and state-of-the-art biologics manufacturing
  • The collaboration will improve patient access for high-quality biosimilar medicines in the US

Click here ­to­ read full press release/ article | Ref: Teva | Image: PharmaShots




Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China

Shots:

  • Chi-Med to receive 70%-80% of Elunate sales in the form of royalties, manufacturing costs and service payments with no upfront regarding this amendment. Lilly will maintain the exclusive commercialization rights and will continue to consolidate the sales of Elunate in China while Chi-Med retains all rights to fruquintinib outside of China
  • The agreement allows the company to deploy full resources of both companies to maximize the potential of the Elunate in China. From Oct 01, 2020, Chi-Med will be responsible to develop and execute all medical detailing, promotion, and marketing activities for the product in China
  • Fruquintinib is a highly selective and potent oral VEGFR 1/2/3 inhibitor, acts by minimizing off-target toxicities, improve tolerability and provide more consistent target coverage

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: StraitTimes




AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

Shots:

  • Daichii Sankyo to receive $1B as upfront of which $350M is due upon execution, $325M after 12mos. and $325M after 24 mos., ~$5B as contingent payment including $1B as regulatory milestones, and $4B as commercial milestones, making a total deal value up to ~6B
  • The companies will jointly develop and commercialize DS-1062 globally and share equal development & commercialization costs, except in Japan where Daiichi Sankyo will maintain exclusive rights and manufacture and supply DS-1062
  • Daiichi Sankyo is expected to book sales in the US, certain EU countries, and other markets where the company has affiliates while AstraZeneca is expected to book sales in other markets globally, including China, Australia, Canada, and Russia. DS-1062 is a TROP2 directed DXd ADC, currently in P-I study for NSCLC and TNBC

Click here ­to­ read full press release/ article | Ref: Daichii Sankyo | Image: Pahrmashots

Related News: Daiichi Sankyo in Talks with AstraZeneca for the Supply of AZD1222 to Combat COVID-19 in Japan