BioMimetic Sells Dental Business, Reports Positive GEM OS®1 Data
BY LAUREN UZDIENSKI, DECEMBER 18, 2007
There were two big announcements from BioMimetic Therapeutics this week, the first being an announcement that came yesterday on the impending sale of the dental business and the GEM 21S product to Luitpold Pharmaceuticals, which currently markets GEM 21S. BioMimetic will receive $40 million in cash, which will be paid in installments of $30 million at closing, $6 million 18 months of closing and $4 million before December 31, 2009. Additionally, BMTI will receive royalty payments at an undisclosed rate and milestone payments, including a $10 million payment at the time GEM 21S receives regulatory approval in Europe. While lucrative for BioMimetic, the company loses control of GEM 21S, the only product they have so far successfully developed and commercialized.
During a conference call this morning, the company emphasized that they wanted to focus on products in the orthopedics space, highlighting a number of product development events including positive results from a Canadian clinical study evaluating GEM OS®1 in foot and ankle fusions. Following on promising early results from a year ago, the latest data show 90% clinical success in a population of 60 patients, with only 6 patients recommended for revision surgery within a year of the first procedure. Clinical success was defined as return to full weight-bearing and lack of need for revision surgery. Notably, 65% of enrolled patients were considered high risk for poor healing, with factors including history of smoking, obesity, diabetes and prior surgery at the fusion site.
The study also showed that 84 and 87% of patients achieved radiographic fusion at six and nine months, respectively. Among patients in the hindfoot and ankle subgroup, 91 and 93% of patients achieved radiographic fusion at six and nine months, respectively. The ongoing U.S. pivotal trial for GEM OS1 consists entirely of hindfoot and ankle patients, so this result could bode well for that study.
Additionally, the average time to fusion and return to full weight bearing was 86 days, in line with published data. A composite success rate for positive clinical and radiographic outcomes met the study's pre-determined endpoint of 82.5%, and finally, there were no serious adverse events related to the use of GEM OS1.
