Ocugen, Inc. to Commercialize COVAXIN™ in Mexico, Rights Now Encompassing All of North America

Research, News, and Market Data on Ocugen

•  Ocugen responsible for commercialization of COVAXIN™ in Mexico

•  COVAXIN™, already authorized for emergency use in adults by health regulators in Mexico, has been submitted for Emergency Use Authorization for children aged 2-18 years

MALVERN, Pa. and HYDERABAD, India, April 18, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals and vaccines, and Bharat Biotech (BBIL), a global leader in vaccine innovation, today announced that they have entered into an amendment to their Co-development, Supply and Commercialization Agreement to expand Ocugen’s exclusive territory to include commercialization of COVAXIN™ in Mexico. This gives Ocugen COVAXIN™ commercialization rights for all of North America.

“We’re excited to commercialize COVAXIN™ in Mexico, as authorities there have made conquering this pandemic a major priority. After meeting with Mexico’s Secretary of Foreign Affairs, Marcelo Ebrard, in Delhi, we are encouraged by the role COVAXIN™ can play in Mexico’s continuing efforts to defeat the COVID-19 pandemic. COVAXIN™ is currently under review by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) for emergency use among children between 2 and 18 years of age, and Ocugen is prepared to collaborate with the public health community to help their efforts. We also thank Bharat Biotech for helping make this opportunity a reality,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-founder of Ocugen, Inc.

COVAXIN™ can be an ideal vaccination option for Mexico at this stage of the pandemic. As a whole virion, inactivated vaccine, it elicits robust cellular immune memory to SARS-CoV-2 and Variants of Concern. It offers logistical advantages that could support vaccine access in hard-to-reach communities.

“We are delighted to announce our partnership with Ocugen for Mexico, along with the United States and Canada. COVAXIN™ is a safe and efficacious inactivated vaccine for all age groups as evident from its data from global introduction. We are fully supportive of team Ocugen in our endeavor to expedite technology transfer activities towards commercial scale manufacturing of COVAXIN™ in North America,” said Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech.

The license extension between Ocugen and Bharat Biotech with respect to commercialization in Mexico includes the same profit share structure as in the United States.

About COVAXIN™ (BBV152)
COVAXIN™ is a whole virion, inactivated vaccine that combines an inactivated SARS-CoV-2 antigen with an adjuvant (6?g + Algel–IMDG[TLR7/8]). It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform. With supplies of more than 350 million doses globally for adults and children, COVAXIN™ is currently authorized under emergency use in more than 25 countries, including Mexico, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) added COVAXIN™ to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of COVID-19 vaccination certificates with India that includes vaccination using COVAXIN™.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals and vaccines that improve health and offer hope for people and global communities. We are making an impact through courageous innovation, taking science in new directions in service of patients. Our breakthrough modifier gene therapy platform has the potential to treat multiple diseases with one drug and we are advancing research in other therapeutic areas to offer new options for people with unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

About Bharat Biotech
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Prequalifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. Having delivered more than 5 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis (JENVAC^®), Rabies, Chikungunya, Zika, Cholera, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO^®, ROTAVAC^®, ROTAVAC 5D^®, and Typbar TCV^® combatting polio, rotavirus, typhoid infections, respectively. As a leader of pandemic vaccines, Bharat Biotech has successfully delivered COVAXIN^®, India’s 1st indigenous vaccine against COVID-19. In November 2021, COVAXIN^® received WHO EUL. The acquisition of Chiron Behring Vaccines has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer with Chirorab^® and Indirab^®. To learn more about Bharat Biotech, visit www.bharatbiotech.com

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, Ocugen’s plans with respect to development and commercialization of COVAXIN™ in Mexico. Ocugen may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in Ocugen’s periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that Ocugen makes in this press release speak only as of the date of this press release. Except as required by law, Ocugen assumes no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ken Inchausti
Head, Investor Relations & Communications
ken.inchausti@ocugen.com

Please submit investor-related inquiries to: IR@ocugen.com

Structures Considered Key to Gene Expression are Surprisingly Fleeting

Anne Trafton | MIT News Office

In human chromosomes, DNA is coated by proteins to form an exceedingly long beaded string. This “string” is folded into numerous loops, which are believed to help cells control gene expression and facilitate DNA repair, among other functions. A new study from MIT suggests that these loops are very dynamic and shorter-lived than previously thought.

In the new study, the researchers were able to monitor the movement of one stretch of the genome in a living cell for about two hours. They saw that this stretch was fully looped for only 3 to 6 percent of the time, with the loop lasting for only about 10 to 30 minutes. The findings suggest that scientists’ current understanding of how loops influence gene expression may need to be revised, the researchers say.

“Many models in the field have been these pictures of static loops regulating these processes. What our new paper shows is that this picture is not really correct,” says Anders Sejr Hansen, the Underwood-Prescott Career Development Assistant Professor of Biological Engineering at MIT. “We suggest that the functional state of these domains is much more dynamic.”

Hansen is one of the senior authors of the new study, along with Leonid Mirny, a professor in MIT’s Institute for Medical Engineering and Science and the Department of Physics, and Christoph Zechner, a group leader at the Max Planck Institute of Molecular Cell Biology and Genetics in Dresden, Germany, and the Center for Systems Biology Dresden. MIT postdoc Michele Gabriele, recent Harvard University PhD recipient Hugo Brandão, and MIT graduate student Simon Grosse-Holz are the lead authors of the paper, which appears today in Science.

Out of the Loop

Using computer simulations and experimental data, scientists including Mirny’s group at MIT have shown that loops in the genome are formed by a process called extrusion, in which a molecular motor promotes the growth of progressively larger loops. The motor stops each time it encounters a “stop sign” on DNA. The motor that extrudes such loops is a protein complex called cohesin, while the DNA-bound protein CTCF serves as the stop sign. These cohesin-mediated loops between CTCF sites were seen in previous experiments.

However, those experiments only offered a snapshot of a moment in time, with no information on how the loops change over time. In their new study, the researchers developed techniques that allowed them to fluorescently label CTCF DNA sites so they could image the DNA loops over several hours. They also created a new computational method that can infer the looping events from the imaging data.

“This method was crucial for us to distinguish signal from noise in our experimental data and quantify looping,” Zechner says. “We believe that such approaches will become increasingly important for biology as we continue to push the limits of detection with experiments.”

The researchers used their method to image a stretch of the genome in mouse embryonic stem cells. “If we put our data in the context of one cell division cycle, which lasts about 12 hours, the fully formed loop only actually exists for about 20 to 45 minutes, or about 3 to 6 percent of the time,” Grosse-Holz says.

“If the loop is only present for such a tiny period of the cell cycle and very short-lived, we shouldn’t think of this fully looped state as being the primary regulator of gene expression,” Hansen says. “We think we need new models for how the 3D structure of the genome regulates gene expression, DNA repair, and other functional downstream processes.”

While fully formed loops were rare, the researchers found that partially extruded loops were present about 92 percent of the time. These smaller loops have been difficult to observe with the previous methods of detecting loops in the genome.

“In this study, by integrating our experimental data with polymer simulations, we have now been able to quantify the relative extents of the unlooped, partially extruded, and fully looped states,” Brandão says.

“Since these interactions are very short, but very frequent, the previous methodologies were not able to fully capture their dynamics,” Gabriele adds. “With our new technique, we can start to resolve transitions between fully looped and unlooped states.”

The researchers hypothesize that these partial loops may play more important roles in gene regulation than fully formed loops. Strands of DNA run along each other as loops begin to form and then fall apart, and these interactions may help regulatory elements such as enhancers and gene promoters find each other.

“More than 90 percent of the time, there are some transient loops, and presumably what’s important is having those loops that are being perpetually extruded,” Mirny says. “The process of extrusion itself may be more important than the fully looped state that only occurs for a short period of time.”

More Loops to Study

Since most of the other loops in the genome are weaker than the one the researchers studied in this paper, they suspect that many other loops will also prove to be highly transient. They now plan to use their new technique study some of those other loops, in a variety of cell types.

“There are about 10,000 of these loops, and we’ve looked at one,” Hansen says. “We have a lot of indirect evidence to suggest that the results would be generalizable, but we haven’t demonstrated that. Using the technology platform we’ve set up, which combines new experimental and computational methods, we can begin to approach other loops in the genome.”

The researchers also plan to investigate the role of specific loops in disease. Many diseases, including a neurodevelopmental disorder called FOXG1 syndrome, could be linked to faulty loop dynamics. The researchers are now studying how both the normal and mutated form of the FOXG1 gene, as well as the cancer-causing gene MYC, are affected by genome loop formation.

Suggested Reading

What is the Approval Process for Medical Devices?

Scientists Now Better Understand Viral Mutations

The Basket of Goods Will Become Financially Heavier

Detailed Data Sharing Plans for Medical Research are Soon Due

Stay up to date. Follow us: