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Ocugen approaches the Finishing Line in the COVID Vaccine race, but is it a winner?

27 Apr Ocugen approaches the Finishing Line in the COVID Vaccine race, but is it a winner?

Covid-19 has bought many biotech companies into the limelight, all promising a possible solution to the pandemic that has disrupted lives worldwide. In February 2021, Ocugen, Inc. (NASDAQ: OCGN) shares catapulted after news of the Company signing a binding letter of intent (LOI) with Bharat Biotech became public. The agreement will see the companies co-develop Bharat Biotech’s COVAXIN for the U.S Market. The vaccine candidate has already obtained an emergency use authorization in India and has demonstrated efficacy in Phase 1 and 2 clinical trials in India.

On April 22, 2021, the Company announced that its Co-development partner, Bharat Biotech, released positive data from a phase III trial of COVAXIN. In the second interim analysis, the candidate demonstrated an efficacy of 78% and 100 % in mild/ moderate and severe COVID-19 including hospitalization respectively. The trial was conducted in over 25,800 patients in the age-group of 18-91 in India and included 2,433 people above the age of 60 and 4500 with co-morbidities.

Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen, commented,

“We continue to be excited by the compelling second interim results of Bharat Biotech’s Phase 3 clinical trial. We believe that COVAXIN can help change the course of this pandemic by preventing severe COVID-19 disease including hospitalizations by 100% as well as significantly limit the spread of asymptomatic COVID-19 infections based on efficacy shown to date. We are dedicated to being a part of the solution to save lives from COVID-19 by bringing COVAXIN to the U.S. market. Based on a traditional vaccine platform that has a long-established safety profile, we believe COVAXIN is an important tool to add to our national arsenal in ending the pandemic.”

The primary endpoint of the study is the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. The secondary endpoint is based on accruing more than 87 symptomatic cases of COVID-19. However, due to the recent surge in cases in India, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% (95%CI: 61-88) against mild, moderate, and severe COVID-19 disease. The trial will be continuing to its pre-planned conclusion.

Ocugen intends to file for an EUA with the FDA and will receive a specified minimum number of doses from Bharat Biotech upon approval. Ocugen will retain 45 percent of the profit from the sale of COVAXIN in the U.S, as per its co-development, supply and commercialization agreement with Bharat Biotech, and will be assisted in technology transfer for manufacturing for the U.S market by the Indian Pharma Company.

Ocugen Inc (NASDAQ: OCGN)

Market Cap: $1.47B; Current Share Price: 11.59 USDChart
Data by YCharts

According to the World Health Organization (WHO), Coronavirus (CoV) is a family of viruses that cause illnesses ranging from common cold to lethal diseases such as the Middle East Respiratory Syndrome (MERS-CoV), Severe Acute Respiratory Syndrome (SARS-CoV) and a new strain of CoV named, novel coronavirus (nCoV). The virus is Zoonotic as it is transmitted from animals to humans, with the presence of many strains that have not yet infected humans. The infection manifests in the form of respiratory symptoms, cough, fever, shortness of breath and can take the form of pneumonia, severe acute respiratory syndrome, kidney failure and even death.

There is no definite cure for treatment or eradication of CoV, with treatment being limited to alleviation of symptoms, and providing support and care to patients. Scientists have been able to sequence the virus genetic code; spurring organizations around the world into action.

Ocugen is a clinical-stage biopharmaceutical company that is focused on creating novel therapeutics to treat blindness diseases. The Company is using its modifier gene therapy platform to develop cutting-edge biologic product candidates for treatment of medical conditions with large unmet needs such as wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.

Image Source: Company

The Company’s pipeline consists of OCU400 intended for the treatment of Inherited Retinal Disorders. The candidate has received orphan drug designation in the U.S as well as EU, and has completed IND enabling studies so far. Ocugen is planning the initiation of Phase 1/2a in 2021. The other candidates in the pipeline include OCU410 for the treatment of Dry-Age Related Macular Degeneration and OCU200 for the treatment of Neovascular Disorders.

Furthermore, Ocugen has entered into a strategic manufacturing partnership with CanSinoBio (6185.HK) for OCU410 (AAV-RORA).

In June 2020, the Company discontinued the Phase 3 trial of OCU300, its lead candidate for ocular Graft vs. Host Disease (oGVHD).

Key Takeaways  

  • The Company intends to file for an EUA with the FDA and roll out the vaccine by H2,2021. Initially the plan is to receive the supply from its co-development partner, Bharat Biotech and follow it up by executing a technology transfer agreement to a U.S site, with an aim to manufacture 100 million doses per year beginning in 2021. The Company also intends to initiate four phase 1/2 trials over the next 18 months for the other candidates in its pipeline such as OCU400 (inherited retinal diseases), OCU410 (Dry AMD) and OCU200 (Diabetic Macular Edema).
  • Ocugen will hold the U.S rights for the candidate, however there are many challenges before the Company, as there are already approved vaccines in the U.S, with more on the way. There is a large market for these vaccines worldwide but to be able to make inroads into the market, Covaxin will have to show that it is as effective as or even better than these already approved products to make any tangible impact. There are new strains emerging like the ones in U.K and South Africa and there is a possibility that the Vaccines that work on one variant may not work on the other.
  • The biggest challenge for the Company will be to compete with giants like AstraZeneca (NASDAQ: AZN) and Pfizer (NYSE: PFE) for a share of the market. These companies already have agreements in place for the supply of their vaccines with governments around the world, while Ocugen currently has none. Most importantly these companies have deep pockets, developmental, regulatory and marketing expertise to fix any issues that may arise on the way, while Ocugen is still a clinical-stage company with a pipeline consisting of candidates yet to reach clinical testing stage.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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