In 2009, Unigene licensed its proprietary late-stage oral calcitonin program to Tarsa Therapeutics, a venture-financed company founded to conduct Phase 3 clinical testing and oversee commercialization arrangements for the oral calcitonin product. Tarsa owns exclusive development and worldwide commercialization rights to Unigene’s oral calcitonin product, with the exception of China. Unigene currently owns a 20% stake in Tarsa on a fully diluted basis, subject to the potential for further dilution, and is eligible to receive sales-related milestone payments and royalties on worldwide sales.
In April 2004, Unigene signed licensing and clinical supply agreements with Novartis Pharma AG to provide for the recombinant production of salmon calcitonin, the active ingredient used in various products for the treatment of osteoporosis. Under the terms of this license, Unigene is eligible to receive a total of $18.7 million in upfront and milestone payments and bulk calcitonin sales. In addition, Unigene will receive royalties on sales of any current or future Novartis products that contain calcitonin using Unigene’s process. The license agreement grants Novartis a worldwide license to produce recombinant calcitonin under Unigene’s patented process for manufacturing recombinant peptides. Unigene has, to date, manufactured and supplied calcitonin to Novartis to support their clinical development program, and has supported efforts by the Sandoz subsidiary of Novartis to implement Unigene’s process in their facilities. Unigene retains the right to purchase calcitonin from Sandoz in support of its own programs, and remains free to develop and commercialize its own products containing calcitonin.
On May 19, 2011, the Company signed a Clinical Manufacturing Services Agreement with Cara Therapeutics, Inc. Unigene will use its validated, proprietary peptide manufacturing technology to provide clinical trial material for Cara’s Phase 1 study of investigational drug, CR845, a peripherally acting kappa opioid agonist being developed for the treatment of both acute and chronic pain. Cara’s Phase 1 study is expected to begin in the second half of 2011.
In November 2002, Unigene signed an exclusive licensing agreement with Upsher-Smith to market Fortical® Salmon Calcitonin nasal spray in the U.S. Under the terms of that agreement, Unigene received $10 million in up-front and milestone payments and continues to receive royalties on sales of the marketed product. Unigene manufactures and sells the filled product to Upsher-Smith, who packages, distributes and markets the product nationwide.
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