RegeneRx Biopharmaceuticals signed a term sheet with Lee’s Pharmaceutical for the license of three Phase II thymosin beta 4-based products in China, Hong Kong, and Macau. The agreement covers peptide therapeutics RGN-259, RGN-352, and RGN-137, which are being developed for eye, cardiovascular, and skin diseases.
Lee’s will pay RegeneRx $200,000 upon signing of the term sheet and an additional $200,000 upon signing of the definitive license agreement, which RegeneRx expects to occur within 30–60 days. The deal also includes aggregate milestone payments of up to $3.6 million and royalties ranging from low double digit to high single digit royalties. Lee’s will pay for all developmental costs associated with each product candidate.
RegeneRx shall have an exclusive supply agreement for Tβ4 with Lee’s, although Lee’s will have the option to manufacture Tβ4 for the licensed territory. The firm will provide Tβ4 to Lee’s at no charge for a Phase II ophthalmic trial and will provide Tβ4 to Lee’s for all other developmental and clinical work at a price equal to RegeneRx’ cost.
“We look forward to completing a licensing agreement with Lee’s Pharmaceuticals to develop our Tβ4-based product candidates in China, Hong Kong and Macau, as Lee’s has demonstrated an impressive track record of pharmaceutical product development,” states J.J. Finkelstein, RegeneRx’s president and chief executive officer. “They have the resources to take our product candidates through the Chinese clinical and regulatory process, which we will support with our preclinical and clinical data and with data we generate internally.”
RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. Based on a recently completed Phase II trial in patients with dry eye syndrome, RGN-259 was found to show statistically significant improvements in several signs and symptoms of dry eye. RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases. RegeneRx is initially targeting RGN-352 for the treatment of patients who have suffered an acute myocardial infarction. RGN-137, a topical gel formulation, is currently being evaluated for the treatment of the orphan skin disease epidermolysis bullosa. Other potential uses for RGN-137 include the treatment of chronic dermal wounds and reduction of scar tissue.
Lee’s Pharmaceutical currently markets 11 products in China. Its portfolio includes several different areas such as cardiovascular and infectious diseases, dermatology, oncology, gynecology, ophthalmology, and others. It reportedly has more than 30 products at different stages of development stemming from both internal R&D as well as from the recent acquisition of licensing and distribution rights from various U.S., European, and Japanese companies.