In 2009, Unigene licensed its late-stage oral calcitonin formulation to Tarsa, a venture-financed company founded exclusively to conduct Phase 3 clinical testing and prepare Unigene’s proprietary oral calcitonin formulation for commercialization. Unigene currently owns a 20%, fully-diluted, stake in Tarsa, subject to possible future dilution.
The Company has announced that the positive, statistically significant Phase 3 results released by its licensee, Tarsa Therapeutics, validate its industry leading, proprietary oral peptide drug delivery technology. The data demonstrated that OSTORA™ achieved all of the efficacy endpoints in the ORACAL trial and indicated that the safety profile of OSTORA did not substantially differ from nasal calcitonin or placebo. The results support Tarsa’s plans for a New Drug Application (NDA) submission to the Food and Drug Administration (FDA). The study design and endpoints were agreed with the FDA through a formalized Special Protocol Assessment (SPA) process. Tarsa also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA).
Currently, we are concentrating our peptide development expertise on advancing the Company’s oral formulation of a recombinantly produced parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal and the development of our lead proprietary preclinical metabolic program, UGP281 for obesity.
On December 10, 2010, Unigene entered into an amended and restated exclusive worldwide license agreement with GlaxoSmithKline (GSK) to develop and commercialize an oral formulation of a recombinantly produced PTH analog for the treatment of osteoporosis in postmenopausal women. Under the terms of the amended and restated agreement, Unigene is responsible for the manufacture of the PTH and the conduct of the Phase 2 study. The Company received an upfront payment of $4 million in December 2010 to cover costs associated with the Phase 2 study, and also received an additional $4 million payment in May 2011 upon completion of Phase 2 patient enrollment, and is eligible to receive further payments of up to approximately $140 million based on the achievement of regulatory and commercialization milestones. In addition, Unigene is eligible to receive tiered double-digit royalties in the low-to-mid teens on global sales. Once the Phase 2 study has been completed and based on a review of the data, GSK may elect to assume responsibility for all future development and commercialization of the product.
We commenced patient dosing for the Phase 2 oral PTH study in March 2011 and announced the completion of enrollment in April 2011. This multicenter, double blind, randomized, repeat dose, placebo controlled study will include an open label comparator arm and will evaluate approximately 90 postmenopausal osteoporotic women for a period of 24 weeks. The primary endpoint will be an increase in bone mineral density in subjects at 24 weeks compared to baseline. Top-line results are expected by the end of 2011.
Furthermore, in August, 2011 Unigene entered into a separate Development Services and Clinical Supply Agreement with GSK. Under the terms of the agreement, Unigene will receive up to approximately $2.2 million in milestone payments from GSK to undertake certain development and manufacturing activities. These activities are related to the active pharmaceutical ingredient and finished drug product for an oral formulation of a recombinantly produced PTH in advance of GSK’s potential decision to study the molecule in a Phase 3 program.
Our lead metabolic program is in advanced pre-clinical development. In February 2011, we announced our plans to accelerate the development of our lead proprietary anorexigenic peptide, UGP281. An anorexigenic peptide is one that diminishes or controls appetite and offers potential therapeutic benefit to morbidly obese patients. We expect to file an Investigational New Drug (IND) application with the FDA and initiate Phase 1 clinical studies in the first half of 2012. Additionally, the Company has developed a pharmacologically distinct sister analog for potential early stage licensing to a veterinary partner for companion animal obesity to help subsidize a portion of the human proof of concept development costs of UGP281.
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