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Bharat Biotech’s US Partner For Covaxin, Ocugen, Faces court

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Hello everyone my name is Suraj and you’re Reading The Indies Times after the unceremonious exit from brazil indigenous vaccine maker Bharath biotech is looking at an uncertain

The lawsuit has been filed by u.s law firm Pomeranz citing certain violations of the u.s federal securities law the firm faces allegations of fraud by its investors and all of this has

a coaxial connection so what is that connection why are investors showing Bharat biotech’s u.s partner and what does it mean for Bharat biotech we will try and understand in this video

Today but before that if you are watching this video on youtube please make sure you subscribe to our channel you like this video and you comment below it and if you are watching this

video on facebook please do like our page and share this video to as many people as possible on february 2nd of this year almost 15 days into the rollout of vaccine drive

In india the news hit the headlines the joint statement issued at the time said that nasdaq listed biopharmaceutical firm ocugen and Bharath biotic have entered into a definitive

agreement to co-develop supply and commercialize co-vaccine for the u.s market oxygen will have u.s rights to the vaccine candidate and it will also be responsible for

Clinical development regulatory approval including the emergency use authorization and commercialization for the u.s market initial doses for use in the u.s will be supplied by the indian

vaccine maker so this is what the joint statement said before that in the month of december 2020 oxygen and biotic had signed a binding letter of intent to co-develop co-vaccine for the u.s

Market now first let us understand what exactly is oxygen according to its linkedin bio oxygen is a biopharmaceutical company which is focused on discovering developing and commercializing gene therapies to cure blindness diseases and developing a vaccine to fight covid19 now the company’s major focus is products for

Eye diseases however as the pandemic hit the world and race for developing vaccines started off the company partnered with india’s bharat biotech to develop co-vaccine in the u.s market

now one must here understand that the pharma race in the pandemic ridden world and what it is about vaccine demands are up and the pharma companies producing vaccines are in high demand countries are procuring millions of

Doses of vaccines and as of today there are only limited options available to choose from the vaccine basket co-vaccine is among the few vaccines that are available in the market today and are one among the best while pfizer and

modern vaccines are being widely used in the united states concerns are mounting over the emergence of new variants of the virus in the month of april white house chief

Medical advisor in america’s top pandemic expert dr anthony fauci had said that co-vaccine was found to neutralize the 617 variants

of coronavirus now this endorsement not only boosted co-vaccines market potential but also of oxygen and it is also

reflected in its share price now let us talk about oxygen shares hitting high now here is an interesting tale how the partnership

With bharati biotic boosted oxygen’s share prices on nasdaq two months before

oxygen announced its partnership with bharat biotech it was facing the threat of its shares being delisted from nasdaq now nasdaq requires

companies to maintain a minimum bid price of dollar one to stay on the trading platform occasion failed to do so however in the month of february the

Company entered into definitive agreement with bharat biotique and also claimed to seek emergency use authorization for the same from u.s fda this collaboration which gave occugen u.s rights to this lucrative vaccine candidate drove the stock prices up on february 5th the company submitted investor presentation that described in great

Detail the co-vaccine vaccine characteristics the unmet need in the united states and oxygen’s plan to develop and file an emergency use authorization with the u.s food and drug administration within a month of this announcement shares of oxygen which were barely meeting the minimum trading listing price of dollar one apiece

Shot up to dollar eighteen this however came at a time when Bharat biotech had not submitted its phase three data to indian regulators yet in the month

of April Bharat biotech announced impressive data from the second interim analysis of its phase 3 study of co-vaccine which showed 78 percent of overall efficacy

Against covid19 disease 100 efficacy against severe covid19 disease including hospitalization and 70 percent efficacy against asymptomatic

covid19 infection now let us talk about when oxygen said that there is no emergency use authorization for the vaccine now this rally that we just spoke about took a beating in the month of June when the FDA rejected the company’s

Emergency use application in the same month u.s also asked indian students who were vaccinated with co-vaccine to get re-vaccinated as the vaccine candidate was not

approved by the who back then on June 10 2021 occasion issued a press release announcing that it would pursue a biologics license application with the FDA instead of the previously announced emergency use authorization

Now this news hit the market and its share prices on Nasdaq also on the release of the news the company’s share price declined from 9.31 per share of occasion stock

on June 9 2021 to close at 6.69 per share on June 10 2021 a drop of approximately 28.14 percent interestingly it was in the month of may itself that us FDA had said that it will not entertain any new

Emergency use authorization applications on covet vaccines and despite this oxygen promoter in a public statement claimed

that they won’t be impacted by this however within next two weeks in new statement oxygen said that us FDA has asked it to apply for a full approval which essentially means emergency use

Authorization was not granted to them and the share prices crashed after that many investors who had pinned hopes on the vaccine

rollout had to suffer losses now let us talk about the Pennsylvania class action lawsuit this class action lawsuit was filed in the district of Pennsylvania on July 19 against oxygen and its promoters the shareholders of oxygen

Alleged that the company’s promoters Shankar musnori and Sanjay Subramanyam committed fraud by deliberately sharing materially false and misleading statements over the progress of the co-vaccine between

February 2nd and June 10. it said and I quote each of the individual defendants is liable as a participant in a fraudulent scheme that deceived the investing public

Regarding oxygen’s business operations management and the intrinsic value of its securities now occugen has called the lawsuit without any merit and

said that it will fight it vigorously now there are certain aspects and questions that we must be talking about in the context of the above discussion that we just had first at a time when oxygen partnered

With Bharat biotech it did not have phase 3 data of its vaccine candidate co-vaccine as per the USDA rules the companies seeking emergency use authorization have to produce full details of the vaccine

including the complete phase 3 data and data on the vaccine’s response to the u.s population Bharat biotech had neither and still oxygen said it is on track to receive emergency use

Authorization from us fda secondly when in the month of may the USDA said that it will not issue any more emergency use authorizations

FDA

why did the company say that it will have no impact on its application third after their share prices rose occasion apparently sold shares worth 10 million dollars between the month of March and April all while promising that it will get

Emergency use authorization now remember it was also the time when the vaccine received a good review from dr Anthony Fauci number four now this question is for Bharat biotech when both companies signed a binding letter of intent in the month of December 2020 the occasion share price was hovering around 29 cents since then it increased almost 800

Percent until the month of February 2021. didn’t co-vaccine makers check the company’s financials show did they tie-up with a company that was on

the verge of being delisted from Nasdaq why did it select oxygen as its u.s partner and on what basis the company that majorly focuses on eye diseases if we have to look at the broader picture here is what is

Look likes a u.s company on a verge of being re-listed got a booster after it partnered with Bharath biotech to produce a co-vaccine for

u.s market it made promises of seeking emergency use authorization for the vaccine and people invested in the stocks hoping for a positive outcome this drove the share prices up company sold shares worth 10 million dollars however the bubble burst when the u.s

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