Troubled Trimel touts effect of its female sexual disorder drug Tefina

Canada's Trimel Pharmaceuticals, a penny stock biotech which issued a "going concern" warning about its financial status earlier this year, is touting the results of a midstage drug designed to correct female sexual disorder.

According to the Toronto-based biotech, investigators found that one of three doses of their experimental therapy Tefina significantly increased the average number of orgasms for the women in the drug arm during an 84-day period to 2.3, compared to 1.7 in the placebo arm. "Improvements" were also seen in secondary endpoints, but the biotech claimed that they had yet to determine if they were statistically significant. Their statement did not include any data on the other two doses.

Tefina is described as a nasal testosterone gel, which was used in the drug arm of a study that enrolled 253 patients.

In its annual report, Trimel reported that it had burned through $32 million last year, leaving it with $18 million in cash. The financial report spurred a warning that the biotech would have to raise more money to continue operations.

"Management is exploring commercial or strategic transactions with respect to one or more of its products under development as well as a number of financing options to raise additional funds," stated their annual report. Trimel soon after reported that it had raised close to $10 million in a follow-on offering. Its shares closed yesterday at 70 cents.

Several biotechs have been focused on female sexual dysfunction, concentrating on a gender that has largely missed out as male sexual dysfunction developed into a blockbuster drug category. Boehringer Ingelheim threw in the towel on flibanserin, then outlicensed it to the small biotech Sprout Pharmaceuticals, which has been struggling to obtain FDA approval for improving women's desire for sex. Regulators were unimpressed by the drug's "modest" signs of efficacy, though research work continues. And BioSante's LibiGel failed two late-stage studies before the troubled company was bought out.

"These results mark an important milestone in the development of Tefina," said Trimel CEO Tom Rossi. "They provide further evidence that Tefina could represent an important treatment option for the many women who suffer from this disorder. On behalf of Trimel and its various stakeholders, I am extremely excited about this positive outcome and look forward to advancing this product towards commercialization."

- here's the release