Funding Clears Path for OCU300 Investigational New Drug (IND) Application
Company Receives Notice of Allowance for Patent Pertaining to OCU100
MALVERN, PA, and AURORA, CO, December 15, 2016 – Ocugen, Inc., a biopharmaceutical company developing treatments for sight-threatening diseases, today announced that it has closed a $6 million round of Series A funding, including $1 million in funds raised through EB5 Life Sciences LP. A group of ex-Pharma executives led the raise, including former Sandoz US Chief Executive Officer, Dr. Bernhard Hampl. The EB5 Life Sciences LP offering remains open with the potential of raising an additional $9 million under the sponsorship of the Global City Regional Center LLC (GCRC).
“We are pleased with the outcome of this round of financing and encouraged by the confidence demonstrated by our investors in our innovative programs and our mission as a company,” stated Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-Founder of Ocugen. “With this funding, we will continue our efforts to aggressively advance the OCU300 program toward an IND submission within a year, bringing this much needed therapy closer to the patients who need it.”
OCU300 is a repurposed drug with an established safety track record in ocular applications that is being developed for the treatment of ocular graft versus host disease (oGVHD) under the U.S. Food and Drug Agency’s 505(b)(2) regulatory pathway. Ocular GVHD is a common complication that occurs in patients who have undergone allogenic hematological stem cell transplantation (allo-SCT), or bone marrow transplants. There is currently no therapy indicated for the treatment of this condition. According to a post-hoc analysis of OCU300 administered to patients with oGVHD in an exploratory observational study, there was beneficial effect in approximately 90 percent of patients without significant side effects.
“Ocugen is taking a well accepted approach to rapid product development that will address a pressing unmet need in ophthalmology, oGVHD, a condition that continues to put a significant burden on patients,” commented Dr. Bernhard Hampl, Lead Investor. “I am very impressed with the progress Ocugen has made to date with OCU300 and excited about the opportunity that lies ahead as it advances this program toward late-stage clinical trials. ”
“We are very excited to have broken new ground in the EB5 industry by attracting foreign investor funds in the area of life sciences,” stated Ahsan Nasratullah, CEO of Global City Regional Center LLC. “We are looking forward to completing the offering for EB5 Life Sciences LP to continue funding Ocugen, Inc. and hope to play a leading role in structuring EB5 investor funds into these high-impact life science businesses,” said Mr. Nasratullah.
Ocugen also announced today that it has received Notice of Allowance from the United States Patent and Trademark Office for its patent application entitled “LEDGF Peptides and Formulations Thereof for Treatment of Degenerative Disorders”. This patent (Patent Number 9529760) covers compositions of matter, methods of production, and methods of use for OCU100, a recombinant form of Lens Epithelial Derived Growth Factor (LEDGF) which has been shown to rescue photoreceptor function and morphology in well-established models of retinal degeneration.
Ocugen has a broad pipeline which includes both clinical stage and pre-clinical programs addressing large areas of unmet medical need. The Company’s programs are focused on activating novel biologic pathways to treat inflammatory, degenerative, and neovascular diseases of the eye and are designed to deliver value over the near, mid and long term.
About Ocugen, Inc.
Ocugen is advancing two novel biologicals and a marketed drug product as a re-purposed drug under the U.S. Food and Drug Administration’s 505(b)(2) regulatory pathway to treat sight threatening ocular disorders. OCU100 is a recombinant form of lens epithelium derived growth factor. It received orphan-drug status from the U.S. Food and Drug Administration for treatment of retinitis pigmentosa (RP), a rare eye disease. Its second asset, OCU200, is an anti- angiogenic tumstatin fusion protein being developed for treatment of wet age-related macular degeneration (AMD). OCU300 is being developed through the FDA’s 505(b)(2) pathway for the treatment of ocular graft versus host disease (oGVHD).
About Global City Regional Center LLC and its EB5 Life Sciences LP:
GLOBAL CITY REGIONAL CENTER, LLC (GCRC) is a mutli-state “Regional Center” designated by the United States Citizenship and Immigration Services (“USCIS”) in 2013, which serves to promote economic growth, regional productivity improvement and job creation in the greater Philadelphia region in PA and Southern NJ. The US Congress created the EB-5 Program in 1990 to benefit the U.S. economy by attracting investments from qualified foreign investors into job creating projects and further enhanced it in 1992 by permitting the designation of Regional Centers like Global City to pool EB-5 capital from multiple foreign investors for investment in economic development projects. Since 2013, through the EB5 program, each year over $4 Billion in investment have come into the US economy, but mostly in real estate and service industry projects. EB5 investment into Ocugen will open new funding opportunities for both the EB5 foreign investors and life science businesses here at home.
GCRC performs expert due diligence and advises the job creating projects that it sponsors to effectively promote the investment opportunity to foreign EB5 markets including Bangladesh, China, India, and Canada. For more information, contact Ahsan Nasratullah, 215-279-8855, firstname.lastname@example.org.Media Contact:
Michael Parks, Pitch360