Dr. Reddy to acquire Glenmark’s brands Momat Rino (for Russia, Kazakhstan, and Uzbekistan), Momat Rino Advance (for Russia), Momat A (for Kazakhstan & Uzbekistan), Glenspray, and Glenspray Active (for Ukraine) along-with rights to the trademarks, dossiers, and patents for the mentioned territories
The acquired products will further strengthen Dr. Reddy’s presence in the anti-allergy segment in the countries
The divestiture of the Momat Rino brand and its extension complements Glenmark’s strategy to launch Ryaltris in Russia and CIS countries. The launch will strengthen Glenmark’s respiratory franchise in the territories
Click here to read full press release/ article | Ref: Businesswire | Image: Businesswire
The developer of Russia’s COVID-19 vaccine Sputnik V has pledged to make it available for less than $10 per dose – or $20 per two-dose course – on the same day as revealing new clinical data with the shot.
Sputnik V’s efficacy has remained high at 91.4% according to the latest analysis, which comes from almost 19,000 subjects who were assessed seven days after the second dose of the vaccine, administered 28 days after the first.
Preliminary data from a smaller group of patients 21 days after the second shot suggests an efficacy of 95%, according to a press release from the Gamaleya Institute and Russian Direct Investment Fund (RDIF).
That puts the efficacy of the adenovirus-based vaccine ahead the 70% overall efficacy seen with AstraZeneca/University of Oxford’s AZD1222 jab – also based on an adenoviral vector – although AZ said yesterday there was a protective efficacy of 90% among patients receiving the vaccine as a half dose, followed by a full dose at least one month later.
AZ’s trial also had a higher number of confirmed cases of COVID-19 to power the analysis, at 131 cases, while there were 39 cases in the Russian study by the latest data cutoff. The next analysis for Sputnik V will be made when there are 78 confirmed coronavirus cases.
Sputnik V’s developers say its high level of efficacy comes from the use of two different adenoviral vectors which “allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.”
At the moment scientists only have the top-line data from press releases to go on so it is impossible to make any judgments about the relative efficacy of the two vaccines, or indeed the two mRNA-based shots from Pfizer/BioNTech and Moderna that have also shown efficacy rates above 90% in clinical trials.
The RDIF has echoed the position voiced by AZ that its adenoviral vaccine will be cheaper than the mRNA shots – by two to three times – and also has the advantage of being stored using regular refrigeration temperature of +2 to +8 degrees Celsius.
Pfizer and Moderna’s vaccines require much lower temperatures to prevent their active ingredients from breaking down.
“Such a regime enables the distribution of the vaccine in international markets, as well as expanding its use in hard-to-reach regions, including areas with tropical climates,” it said.
Russia will provide Sputnik V to its domestic population free of charge, so the $10 per dose price applies to international markets.
Capacity to make the vaccine is currently enough to immunise 500 million people per year, and the first international deliveries will be made to customers in January. Other orders will start to be fulfilled from March.
Russia approved Sputnik V in August, making it the first coronavirus vaccine worldwide to be licensed worldwide.
So far it has accepted orders for 1.2 billion doses from more than 50 countries, including Brazil, India, Mexico and Hungary – the latter deal reportedly putting the EU member state at odds with the European Commission as Sputnik V hasn’t yet been approved by the EMA.
In the second positive piece of COVID-19 vaccine news in a week, Russia’s Sputnik V candidate has been shown to be 92% effective at the interim point of a 40,000-patient study.
The preliminary assessment is based on 20 coronavirus cases split between the vaccinated and placebo arms of the study at 21 days, according to a press statement issued this morning by the Gamaleya Institute which developed the shot and the Russian Direct Investment Fund (RDIF).
They say the positive interim results will be followed by “mass vaccination in Russia against COVID-19 in the coming weeks.” The country has had more than 1.8 million confirmed coronavirus infections, and just over 31,000 deaths.
The readout from the study comes at a point when 20,000 people have been given the first of the two-dose regimen for the adenovirus-based vaccine, and 16,000 have had the second. There were no unexpected adverse events as yet, with most side effects injection site reactions or minor flu-like symptoms.
Sputnik V has already been approved in Russia ahead of the phase 3 trial results, getting a green light in August on the strength of early-stage data in 100 patients. Since then, around 10,000 people have received it and monitoring of those subjects “confirmed vaccine efficacy at a rate of over 90%,” according to the statement.
The update comes just a couple of days after BioNTech and Pfizer reported a 90% efficacy rate at 28 days with their mRNA-based candidate BNT162b2 from an evaluation of 94 cases in a phase 3 trial involving 43,538 subjects.
In both these cases only the top-line data is available, and medical experts are waiting anxiously for a full look at the data sets, to see for example if the vaccines are able to reduce the rate of severe COVID-19, prevent asymptomatic infection with SARS-CoV-2, and cut viral transmission rates.
It’s also not clear how well they work in different patient populations, such as older people, children and different ethnic backgrounds, and how long protection will last.
The Gamaleya Institute and RDIF says they will follow up all patients in the study for six months, after which final results will be reported. In the meantime, phase 3 trials of Sputnik V are also underway in Belarus, United Arab Emirates and Venezuela, with a phase 2/3 study on the go in India.
Russia’s minister of health Mikhail Marushko hailed the results, saying they show Sputnik V is “an efficient solution to stop the spread of coronavirus infection, а preventive healthcare tool, and this is the most successful path to defeat the pandemic.”
Requests for more than 1.2 billion doses of Sputnik V have already come in from over 50 countries, according to the RDIF, which says it has contracts in pace that will allow production of 500 million doses of V vaccine outside Russia every year.
In other news, the 60,000-patient ENSEMBLE trial of Johnson & Johnson’s coronavirus vaccine candidate has started to resume in Europe after a suspension caused by an unexplained illness in a test subject in October. The trial was cleared to restart in the US a few days later.
Meanwhile, Brazilian regulator Anvisa has suspended clinical testing of a shot being developed by China’s Sinovac Biotech after a “severe adverse incident” – reported to be fatality – in the phase 3 CoronaVac trial being conducted in the country.
The study is also being conducted in Turkey and Indonesia, but dosing hasn’t been suspended int those countries, according to a BBC report.
Russia’s sovereign wealth fund has filed applications with the World Health Organization (WHO) that if approved could see the Sputnik V coronavirus vaccine backed for use in many countries around the world.
The applications are for two WHO mechanisms, aimed at providing a route to market for vaccines, drugs and other healthcare products that answer public health needs, particularly in low- and middle-income countries.
The Russian Direct Investment Fund (RDIF) has filed the state-owned Gamaleya Institute’s Sputnik V (Gam-COVID-Vac) for emergency use listing (EUL) – a process set up in response to Ebola that provides a route to approval for use of medicines for public health emergencies by WHO member states.
It is also going after WHO prequalification, which mainly covers essential medicines and supports use by the UN and other non-governmental organisations.
Both mechanisms cover review of safety and efficacy data, as well as ensuring the product meets manufacturing and quality assurance standards. Gilead Sciences COVID-19 therapy Veklury (remdesivir) was added to the prequalification list earlier this month.
Russia has reportedly been discussing prequalification of the Sputnik V with the WHO since the summer. In a statement, the RDIF said WHO registration “will make the Russian vaccine available globally in a shorter time frame than usual procedures and will support global efforts to prevent the coronavirus infection.”
Approval would also allow Sputnik V to be included in the list of medicines used by international procurement agencies and countries to guide bulk purchasing of medicines.
The applications come after Russia approved Sputnik V in August, the first coronavirus vaccine worldwide to get a green light, and after the country said it has accepted orders for 200 million doses of Sputnik V from Brazil, India and Mexico. It has suggested it will be able to make a billion doses of the shot per year from 2021.
There has however been some debate about the lack of data behind the shot, and concerns that Russia rushed development to claim a political victory in the race to get a COVID-19 vaccine approved.
Preliminary results published in The Lancet last month covered just 76 people, which found an antibody response within 21 days and T-cell response within 28 days, with no serious adverse events recorded out to 42 days of follow-up.
It is in two phase 3 trials, including the RESIST study which has a target enrolment of 40,000 subjects and is due to generate results in the spring.
The vaccine is based on two adenovirus vectors (Ad5 and Ad26) fused with the spike protein from the SARS-CoV-2 coronavirus. Immunisation requires two doses, with the Ad26-based shot given first and the Ad5 21 days later.
“We express our gratitude to WHO for its active cooperation and look forward to the successful completion of the prequalification process at all major stages,” commented Kirill Dmitriev, CEO of the RDIF.
The WHO’s regularly updated listing of COVID-19 vaccines in development puts Sputnik V sixth out of 44 candidates that have advanced into human testing.
UK starts review of Moderna’s mRNA-1273
Separately, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has kicked off a rolling review of another late-stage coronavirus vaccine – Moderna’s mRNA-1273 – shortly after the US biotech completed enrollment in the phase 3 COVE trial.
The UK agency has started its review of the jab before the European Medicines Agency (EMA), but after a rolling review for mRNA-1273 was started in Canada.
The rolling submission allows regulators to start looking at available preclinical, manufacturing and clinical data in advance of the readout of COVE, potentially shortening the review time.
If COVE is positive and mRNA-1273 gets approved, Moderna has said it is on track to deliver up to 500 million doses per year, and possibly up to a billion doses per year beginning in 2021.
Sanofi will shortly start human trials of a second coronavirus vaccine, developed with US biotech Translate Bio, after reporting that it stimulated antibodies against SARS-CoV-2 in preclinical testing.
The French drugmaker’s Sanofi Pasteur vaccines division says it is planning a phase 1/2 trial of the mRNA-based vaccine, called MRT5500, before the end of the year. It started human testing of a protein subunit vaccine with partner GlaxoSmithKline last month.
There are already three other RNA-based vaccines in trials for COVID-19 from Moderna, Pfizer/BioNTech and CureVac, out of 42 candidates in clinical development, according to the World Health Organization’s latest update.
Among these, Pfizer/BioNTech’s BNT162b2 looks like it could claim the lead among the late-stage COVID-19 vaccine programmes, after safety issues halted trials of rival shots from Johnson & Johnson and AstraZeneca.
Data from a 195-patient phase 1 trial of BNT162b2 were published in the New England Journal of Medicine this week, showing that the shot stimulated neutralising antibodies to SARS-CoV-2 at a level similar or greater than those found in people who have recovered from infection with the virus.
Another vaccine – called BNT162b1 – was also effective in stimulating an antibody response but was associated with more systemic side effects, according to the trial investigators.
In preclinical testing involving mice and non-human primates, two doses of MRT500 also elicited a strong neutralising antibody response against SARS-CoV-2 that according to Sanofi were significantly higher than those observed in COVID-19 patients.
Sanofi and Massachusetts-based Translate Bio started to work together on the mRNA vaccine programme in March, and expanded the effort in June to include all infectious disease areas after identifying promising lead candidates.
Under the expanded deal, Translate stands to receive $425 million in upfront payment and Sanofi common stock, plus up to $1.9 billion in milestone payments, providing another endorsement of the potential for mRNA to generate vaccines.
Russia approves second shot
Sanofi is one of the signatories of a pledge by nine leading companies in the race to develop a COVID-19 vaccine that they will only apply for approval after phase 3 studies have been completed and their candidates have been thoroughly tested.
Russia however has forged ahead with its controversial approach to the pandemic by approving a second SARS-CoV-2 vaccine based on only preliminary human testing, just three months after clearing the Gamaleya Institute’s Sputnik V shot on similarly scant data.
The latest – called EpiVacCorona – was developed by the Vektor State Research Center of Virology and Biotechnology and has been cleared on the strength of clinical testing in just 100 subjects, according to local media reports.
Russian president Vladimir Putin announced the latest approval on state television. adding to concern that Russia has been rushing vaccines to approval in order to claim political capital.
Both the approved vaccines are now in phase 3 trials involving tens of thousands of patients, but results from those are not expected until mid-2021. Regardless, Russia has said it had accepted orders for 200 million doses of Sputnik V from Brazil, India and Mexico.
Russia is the world’s fourth-most affected country by the coronavirus pandemic with a total of 1.37 million cases and a little over 23,000 deaths.
Chinese inactivated vaccine safe
Also this week, A Chinese COVID-19 vaccine based on inactivated coronavirus has been shown to be safe and stimulate an antibody response in a preliminary 640-patient phase 1/2 trial has been published in The Lancet Infectious Disease journal.
Developed by the Beijing Institute of Biological Products, the BBIBP-CorV vaccine was given as a two-dose regimen and was found the be safe across a broad age range – from 18 to 80 – and stimulated a neutralising antibody response in all immunised subjects by day 42, the final day of follow-up.
Antibody levels were lower in older recipients, however. The authors said the results were encouraging, but it is not possible to say yet whether the vaccine will be protective against SARS-CoV-2 infection.
The company manufacturing the Oxford University coronavirus vaccine has denied it is in talks with the Trump administration about fast-tracking its vaccine for emergency use ahead of November’s presidential elections.
With both Russia and China pressing ahead with inoculations involving experimental vaccines yet to pass final efficacy and safety trials, the Trump administration has become increasingly frustrated with the Food and Drug Administration (FDA), which the president has tried to suggest is slowing approval of a vaccine for “political reasons”.
Russian President Vladimir Putin said a vaccine developed at a Moscow research institute that appears to still be in Phase I development among fewer than 100 participants had undergone all necessary tests.
The UK security minister James Brokenshire has said Britain is “more than 95%” sure that Russian state-sponsored hackers targeted UK, US and Canadian organisations involved in developing a coronavirus vaccine.
Brokenshire said the National Cyber Security Centre (NCSC) and its counterparts in the other countries were confident “Russian intelligence agencies” were responsible for the attacks on drug companies and research groups.
A joint report by cybersecurity agencies in the U.K. and Canada, endorsed by their U.S. counterparts, states that the hacker group Cozy Bear had been targeting organizations involved with Covid-19 vaccine development efforts.