Vical is conducting the allovectin study under a Special Protocol Assessment from the FDA that gave the OK to use durable response as the primary endpoint, but that doesn't necessarily relieve the company of demonstrating that allovectin can prolong the survival of skin cancer patients. Recently, two experimental skin cancer drugs, one from Bristol-Myers Squibb (BMY) and the other from Roche -- have produced positive phase III results that include a survival benefit. If allovectin cannot match the efficacy of these two drugs, results from its phase III study, even if positive, may be clinically irrelevant.
Chris C. asks, "Do you have any indication of when the FDA is going to meet regarding Mela Sciences' (MELA) MelaFind application? I thought the date was early January but see no indication of such. Any insight or information you have is much appreciated."
The last we heard from Mela was in November when an FDA advisory panel voted (surprisingly) to endorse the approval of the company's MELAFind skin cancer-detection device. The positive panel vote came over the strong objections of the FDA, which voiced strong objections to MELAFind's approvability.
Advisory panel votes aren't binding on the FDA, and the agency doesn't have a deadline by which it needs to make an approval decision, so it's impossible to predict when that FDA decision may come.Mela has not had much to say publicly since November but I do hear CEO Joe Gulfo has been meeting privately with investors, saying he expects FDA approval and talking up MELAFind launch plans. Whether or not Mela has met with the FDA since the November panel isn't clear, although the company hasn't made any announcement about an FDA meeting. [Mela and FDA do not have to meet again before the agency makes a decision.] Whenever FDA does rule, my prediction is that MELAFind will not be approved.
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.
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