Unigene Laboratories, Inc. (OTCBB: UGNE) and Tarsa Therapeutics, Inc. today announced that Unigene has licensed its Phase III oral calcitonin program to Tarsa, a new company formed by a syndicate of three venture capital funds specializing in the life sciences: MVM Life Science Partners, Quaker BioVentures and Novo A/S. Simultaneously, Tarsa announced the closing of a $24 million Series A financing from the investor syndicate.
As part of the agreement, Unigene will own 25% of Tarsa on a fully diluted basis and will be eligible to receive milestone payments based on the achievement of certain sales benchmarks, as well as royalties on product sales. Tarsa will be solely responsible for the costs of the global Phase III clinical program that has recently been initiated and also has reimbursed Unigene for its Phase III expenditures to date.
Calcitonin is approved for the treatment of osteoporosis, but its use has been limited as it is currently available only in intranasal and injectable forms. The oral formulation that Unigene has licensed to Tarsa has been shown in prior clinical studies to deliver the desired blood levels of calcitonin and reduce levels of plasma CTx-1, an established marker of bone resorption. It has the potential to offer a new therapeutic option for osteoporosis patients as the first FDA-approved and commercially available oral formulation of calcitonin.
Tarsa also announced that David Brand has joined the company as President, CEO and Director. He brings over 30 years of global pharmaceutical experience in product development, acquisitions, marketing and operational management with GlaxoSmithKline (GSK), its predecessor companies, and most recently served as President and CEO of Cardiokine Inc.
Mr. Brand stated, “Calcitonin has been proven safe and effective in the treatment of osteoporosis in large numbers of patients over many years, and current worldwide sales are estimated at about half a billion dollars. The broader use of calcitonin, however, has been limited by its availability solely in injectable and intranasal forms. Tarsa’s unique, once-daily oral calcitonin tablet has the potential to offer patients the proven safety and efficacy of calcitonin, with the significant advantage of easier administration and enhanced long-term compliance.”