Unigene Laboratories ($UGNE) has garnered more clinical validation for its delivery and manufacturing technology that enables peptide drugs to be taken orally. Venture-backed Tarsa Therapeutics, in which Unigene has a 20% ownership stake, has reported upbeat results from a Phase III study of Ostora, an oral formulation of calcitonin, in treating postmenopausal osteoporosis. Unigene developed the drug and licensed it to Tarsa in 2009.
The oral therapy met all efficacy goals in the 565-patient, randomized, double-blind, placebo-controlled study, including the primary endpoint of "percentage change in lumbar spine bone mineral density (BMD) after one year of treatment," according to the companies. The safety profile of the oral therapy was not substantially different from that of the calcitonin nasal spray or the placebo. There was also evidence of the oral formulation being less immunogenic than the nasal version.
The results of the late-stage study, which were put on display Sept. 18 at the American Society for Bone and Mineral Research annual meeting, "clearly [illustrate] how Unigene's Peptelligence platform is pioneering oral peptide production and delivery, having successfully overcome the often mission critical challenges of Phase III clinical development and could potentially be the first oral natural peptide to market," Unigene CEO Ashleigh Palmer said in a statement.
Unigene expects an NDA filing before the end of the year, thus paving the way for another potential commercial win. The company's first product to market was Fortical, a nasal calcitonin product approved to treat postmenopausal osteoporosis. It is marketed in the U.S. by Upsher-Smith. Unigene also has ongoing deals to commercialize its tech with Big Pharma firms GlaxoSmithKline ($GSK) and Novartis ($NVS).
- here's the release