A Melnyk Comeback? A Little Shpritz, A Lot Of Sex
October 10th, 2011 // 3:17 pm @ jmpickett
Who’s a hockey puck? Eugene Melnyk, whose tenure as chairman of Biovail was marked by turmoil and controversy, seems determined to make a comeback. And as the largest shareholder in Trimel Pharmaceuticals, he may yet find a way. The nascent drugmaker says its successfully completed a test for an experimental sexual dysfunction medicine delivered in the form of a nasal spray and will meet with the FDA next month.
Dubbed TBS-2, the Trimel spray is being developed to treat anorgasmia in women. For those unaware, anorgasmia is the term for regular difficulty reaching orgasm after receiving what would be considered sufficient sexual stimulation. Trimel, however, did not release results, even top-line data, from its most recent test (read the statement).
The drugmaker does have a few programs in various stages to develop meds for other maladies. But its spray is likely to generate the sort of attention that Melnyk, who owns the Ottawa Senators hockey team, will want. After all, female sexual dysfunction is… hot. For one thing, there is an ongoing debate over the extent to which this is a legitimate medical condition, or at least the sort of problem that should be treated with drugs (read this).
And a spray is likely to attract still more interest. To date, industry focus has largely been on developing pills. Boehringer Ingelheim, for instance, tried to win FDA approval last year to treat what it was calling Hypoactive Sexual Desire Disorder in women, but failed and lost its desire to continue further development (see here).
nasal-sprayFor its part, Trimel says TBS-2 is a “bioadhesive intranasal low-dose gel formulation of testosterone†and maintains there are “virtually no androgen-related side effects such as acne, facial and body hair growth or deepening of the voice.†What’s more, there is “no expected risk of skin-to-skin transfer of testosterone to third parties†with its nasal applicator†In other words, you shouldn’t have to worry that an inaccurate shpritz would travel up the nostril of someone nearby and cause them to… react.
As for Melnyk, his sex-in-a-shpritz device may overshadow the tumult of the past. Last May, he agreed to sanctions imposed by Canadian securities regulators as a result of misleading disclosures following a 2003 traffic accident involving a shipment of meds. The Ontario Securities Commission alleged Melnyk knew a forecast revenue loss would not be as large as the $10 million to $20 million estimate that appeared in a press release issued at the time. An OSC panel decided Biovail seized on the accident to explain quarterly earnings, instead of acknowledging weak product sales.
A similar lawsuit was settled with the US Securities and Exchange Commission, which accused Melnyk and the drugmaker of repeatedly overstating earnings and hiding losses to meet earnings forecasts, and misleading investors about the reasons for its poor performance. As part of his deal with the SEC, Melnyk agreed to a five-year ban as a director or officer of a public company in the US, and paid $150,000 in fines. Melnyk is not a Trimel director, but is listed as a key shareholder (look here).
However, Melnyk raised quite a stink over the episode. Along the way, Biovail filed a group of $4.6 billion lawsuits over allegations that research analysts and hedge funds conspired to drive down its stock price. Last year, the lawsuits were dropped and Biovail agreed to pay $10 million to SAC and issued a rare public apology (read this), as well as paying more than $138 million to settle a shareholder lawsuit. One analyst, though, took it on the chin for telling the truth.
Source: Pharmalot
