Chris C. asks, "Do you have any indication of when the FDA is going to meet regarding Mela Sciences'(MELA - Get Report) MelaFind application? I thought the date was early January but see no indication of such. Any insight or information you have is much appreciated."
Steve M. asks, "I was wondering if you could give us an update on Labopharm(DDSS) and their new [antidepressant] drug Oleptro? I am trying to understand why Labopharm will not update shareholders on Oleptro approval in Canada?" Oleptro's U.S. commercial launch is not going well. For the week ended Dec. 31, IMS reported 545 total prescriptions for Oleptro, down from 659 and 676 in the previous two weeks of December, according to RBC Dominion analyst Doug Miehm. For the entire fourth quarter, Oleptro generated 6,500 prescriptions, well below the 25,000 expected by Miehm. Even with a post-holiday bounce expected, Miehm lowered his current and future sales estimates for Oleptro to take into account the weak launch. "Oleptro has yet to gain traction in the targeted anti-depressant market," Miehm wrote in a Jan. 10 research note. "While we recognize that it can take time for a new drug to make material in-roads, the drug is still lagging the weak Aplenzin launch by a concerning amount. As such, Labopharm has begun to sell assets, Ryzolt, in order to meet near-term obligations. Future deals (Oleptro in Canada) plus milestone payments will certainly help but it is critical that the U.S. Oleptro growth accelerate to ensure that a sustainable stream of cash flow can be generated relative to the company's significant ongoing expenses and net cash balances. Based on our reduced Oleptro outlook, it appears the company will require additional financing this year and could dilute current investors." I wrote about Oleptro and its potential marketing woes last April.