Tarsa Therapeutics receives license for Phase III oral calcitonin program

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.”

While at GSK, Mr. Brand held senior management positions in marketing, business development and international operations. He led the launch activities for the blockbuster products Paxil® and Kytril® and subsequently was responsible for pre-launch commercial development plans for Coreg®, Hycamtin® and Requip®. He also led the business units that launched Requip and Avandia®. As CEO of Cardiokine Mr. Brand assembled a management and development team that closed a $50 million financing round and completed a worldwide development and marketing agreement for lead product lixivaptan with Biogen Idec.

“The new company assembled by this investor syndicate includes an outstanding group of professionals who have the knowledge and experience to ensure that the value of this asset is fully realized,” noted Dr. Ronald S. Levy, Executive Vice President of Unigene. “We have always believed that this program has substantial commercial potential. Accordingly, it was important for us to retain a significant portion of that value for Unigene’s shareholders, and this structure enables us to accomplish that. The oral calcitonin program will be Tarsa’s number one priority, and they intend to commit their substantial resources and considerable expertise to successfully advancing the Phase III program in the shortest possible time frame.”

“We view Tarsa as a creative partnership between the management team, Unigene and this investor group, committed to completing the Phase III program and enabling registration and commercialization of a compelling new therapy in a focused and efficient manner,” added Dr. Eric Bednarski of MVM Life Science Partners.

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