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Histogenics and Ocugen Enter into Definitive Merger Agreement to Create Nasdaq-Listed Clinical-Stage Company Developing Novel Ocular Gene Therapies and Biotherapeutics
“Since Ocugen’s founding, we have sought to develop innovative therapies to treat rare and underserved eye diseases through a combination of therapeutic approaches that utilize small molecules, biologics, and gene therapies,” said Shankar Musunuri, Ph.D., M.B.A., Chairman, Chief Executive Officer and Co-Founder of Ocugen. “We have developed a broad pipeline which includes OCU300, an orphan drug candidate for ocular graft versus host disease, and OCU310 for dry eye disease; our modifier gene therapy platform and OCU400, a gene augmentation therapy for patients with inherited retinal diseases caused by mutations in the NR2E3 gene, which recently received orphan drug designation from the FDA. We’ve also made pre-clinical progress toward our retinal disease programs which includes novel biologic therapies for wet- age-related macular degeneration, diabetic macular edema and diabetic retinopathy, as well as for retinitis pigmentosa.”
“This transaction with Ocugen reflects the continued commitment of our management team and Board of Directors to deliver value to stockholders and make a difference in patients’ lives,” said
Ocugen’s broad pipeline of promising ophthalmology programs in development include:
Modifier Gene Therapy Platform
Ocugen’s modifier gene therapy platform is licensed from the
OCU400 (NR2E3-AAV) for the treatment of NR2E3 mutation-associated retinal degenerative diseases consists of a functional copy of the NHR gene, NR2E3, delivered to target cells in the retina using an adeno-associated viral (AAV) vector. OCU400 is a novel gene therapy currently in development as a gene augmentation therapy product for the treatment of NR2E3-mutation associated retinal degenerative diseases, and in
OCU410 (RORA-AAV) is a second in-line modifier gene therapy being developed for the treatment of dry age-related macular degeneration (AMD). OCU410 utilizes an AAV delivery platform for retinal delivery of the RORA gene (RAR Related Orphan Receptor A). OCU410 is currently in preclinical development.
Ocular Surface Disease Programs
OCU300 (brimonidine 0.18%, OcuNanoE™), is currently in a Phase 3 clinical trial for the treatment of ocular graft versus host disease (oGVHD), which develops in approximately 60% of patients following an allogeneic bone marrow transplant. OCU300 consists of
Ocugen has developed its proprietary OcuNanoE™ nanoemulsion formulation to deliver drugs more efficiently to relevant ocular tissues, provide protection to the ocular surface, and potentially increase overall efficacy compared to conventional eye drops. We recently completed our first Phase 3 clinical trial of OCU310 (brimonidine 0.2%, OcuNanoE™) for the treatment of dry eye disease. We are waiting for a full dataset from this trial and will provide an update once we complete full analysis.
Retinal Disease Programs
Ocugen has two protein biologic preclinical programs in development, focused on treating inflammatory, degenerative and neovascular diseases of the eye. OCU200 is being developed for the treatment of wet AMD and OCU100 for the treatment of retinitis pigmentosa (RP). OCU100 has received Orphan Drug Designation from both the
OCU200 is a biologic product candidate in preclinical development for the treatment of wet AMD, a severely sight-threatening disease caused by the abnormal growth and infiltration of new, leaky blood vessels into the retina. OCU200 is a novel fusion protein consisting of two naturally occurring molecules, transferrin and tumstatin, that are present normally in retinal tissues. In preclinical studies, OCU200 demonstrated superior efficacy compared to anti-VEGF therapies in reducing choroid neovascularization (CNV) lesion areas in laser-induced rats and mice CNV models. We believe these results highlight the potential for OCU200 to deliver disease modification for wet-AMD and other high-need ocular neovascular diseases, such as diabetic macular edema (DME) and diabetic retinopathy (DR).
OCU100 is a protein-based biologic in preclinical development for the treatment of retinitis pigmentosa (RP), which is a class of diseases that leads to the progressive degeneration of the retina and blindness. There is currently no
About the Proposed Merger
The merger is structured as a stock-for-stock transaction whereby all of Ocugen’s outstanding shares of common stock and securities convertible into or exercisable for Ocugen’s common stock will be converted into
Upon closing of the transaction,
Conference Call Information
To access the live conference call, please dial 1.877.930.8064 from the U.S. and
Ocugen is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Ocugen offers a diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases. For more information on Ocugen, please visit www.ocugen.com.
Additional Information about the Proposed Merger and Where to Find It
In connection with the proposed merger,
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in connection with the proposed merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Participants in the Solicitation
This press release contains forward-looking statements based upon Histogenics’ and Ocugen’s current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, statements about the structure, timing and completion of the proposed Merger; the combined company’s listing on Nasdaq after closing of the proposed Merger; the possibility that any grant, sale or transfer of rights to NeoCart technology will occur; expectations regarding the ownership structure of the combined company; the expected executive officers and directors of the combined company; the combined company’s expected cash position at the closing of the proposed Merger; the future operations and success of the combined company, including with respect to the continued development of Histogenics’ NeoCart technology and Ocugen’s product pipeline; the nature, strategy and focus of the combined company; the success, cost and timing of the combined company’s product development activities, studies and clinical trials, the success of competing products that are or become available, the combined company’s ability to obtain
Histogenics Contact: Investor Relations: Tel: +1 (781) 547-7909 InvestorRelations@histogenics.com Ocugen Contact:
Kelly A. BeckVice President, Investor Relations & Administration 484-328-4698 firstname.lastname@example.org
Source: Histogenics Corporation