Unigene musculoskeletal news

Unigene said in its 2Q12 earnings that it will need to obtain "significant" funding to continue operations, address its debt and restructure its balance sheet. The company also noted that it was "unlikely" that Victory Park Capital would pay off a portion of the company's debt in September. The news follows a recommendation from EMA's CHMP that calcitonin-containing medicines should be used only for short-term treatment because of an increased risk of cancer. Unigene said its cash flow will fund operations into 4Q12. At June 30, Unigene had $1.7 million in cash and a six-month operating loss of $3.1 million (see BioCentury, June 11 & Aug. 13).

Unigene's Ostora oral recombinant salmon calcitonin, to which Tarsa Therapeutics Inc. (Philadelphia, Pa.) has worldwide development and commercialization rights outside of China, is in Phase III testing to treat osteoporosis. Tarsa said it is evaluating opportunities to appeal the CHMP recommendation and plans to discuss the situation with FDA. Because the osteoclast inhibitor is not yet approved in Europe, the companies do not have the right to formally appeal the recommendation. Tarsa originally planned to submit an NDA to FDA this year and an MAA in Europe shortly thereafter. Tarsa said that plans to submit the NDA are ongoing, but could not disclose details regarding the MAA. Unigene said regulatory authorities, including FDA, could take action as a result of the recommendation, including the withdrawal of calcitonin-containing products from the market or limiting their use. The company said this could reduce or eliminate osteoporosis drug Fortical calcitonin sales and royalties. The osteoclast inhibitor is marketed by Upsher-Smith Laboratories Inc. (Maple Grove, Minn.) in the U.S. to treat osteoporosis in postmenopausal women (see BioCentury, Oct. 26, 2009). ...