I hope everyone printed this week's
column on FDA approval decision dates for 2008. You've told me this is the kind of information that biotech investors crave, so I hope the list helps in planning for next year. I'm working on another calendar detailing upcoming phase III trial results, so look for that in the next week. Another note about the FDA calendar: Several people wondered why I left off companies like Genitope ( GTOP), Dendreon ( DNDN) or Pain Therapeutics ( PTIE). As I said, I omitted companies that either 1) didn't have phase III data reported yet, or 2) hadn't yet filed for FDA approval. Once a company files with the FDA and the application is accepted, they'll be put on the list. I'll update the calendar as we move through next year. Speaking of Pain Therapeutics, the company is the subject of my first email, from Robin K: "Adam, you correctly called out Remi Barbier a while ago on his 'fuzzy math.' What are your thoughts on Thursday's Remoxy results?" A blast from the past. Robin is referring to a column from June 2004 about a study run by Pain Therapeutics' demonstrating the superior abuse-resistant qualities of its painkiller Remoxy over Oxycontin. As I pointed out back then, the claims of superiority made by Pain Therapeutics and its CEO Remi Barbier were overstated because someone at the company didn't know how to use a calculator. In other words, the math in the press release was wrong.
I hadn't thought about that story in a long time, but I checked, and amazingly, Pain Therapeutics still hasn't corrected the details of that Remoxy study in the June 2004 press release on its Web site. So much for quality control, I guess. Fast forward three-plus years, and Pain Therapeutics is still working on pushing Remoxy to market as an abuse-resistant, long-acting form of oxycodone, a powerful painkiller and the active ingredient in Oxycontin. Last year, it signed a lucrative marketing partnership with King Pharmaceuticals On Thursday, positive results from a phase III study were announced, demonstrating Remoxy's superiority over placebo in patients with chronic osteoarthritis. Pain Therapeutics and King plan on filing Remoxy with the FDA in the second quarter of 2008, anticipating an approval and launch in the second quarter of 2009. The study results pushed Pain Therapeutics shares up 6% to $10.81 on Thursday. That put the stock up 20% for the year -- not bad at all. (The stock slipped Friday to $10.53.) I don't take issue with the need for better abuse-resistant painkillers. The abuse of Oxycontin, and opioids in general, is a problem in this country, so I can see doctors turning to a chronic painkiller with less potential for abuse. But the jury is still out on whether Remoxy is that product. Thursday's results were fine, but then, comparing an oxycodone-containing product with a sugar pill isn't exactly setting the bar very high. We still don't know how well Remoxy performs against other painkillers.
The FDA has already said it's very wary of allowing companies to make specific abuse-resistant claims for these types of potent painkillers, so it remains to be seen how effective the marketing message will be for Pain Therapeutics and its partner King Pharmaceuticals. Pricing of Remoxy vs. Oycontin and insurance reimbursement will also be a factor. The biggest hurdle for Remoxy could be the courts. Purdue Pharma, the maker of Oxycontin, has already sued successfully to remove generic versions of long-acting oxycodone from the market because these products violate Purdue patents. Purdue's next patent infringement target is likely to be Remoxy, if the drug is approved. Pain Therapeutics says Remoxy doesn't infringe Purdue patents, but if Purdue sues, the issue will be decided in court. Whatever the outcome, Remoxy's launch will be delayed. Ken S. writes: "What do you the think of Favrille ? The independent review board saw the unblinded controls
of Favid and said they are consistent with the literature. Does that mean the treatment arm is working?" Favrille is testing a cancer vaccine called Favid for non-Hodgkin's lymphoma that is very similar (some say almost identical) to Genitope's cancer vaccine MyVax. In this way, the fortunes of the companies are linked. As I wrote recently, Genitope is getting set to release results from its phase III MyVax study later this month. These data will obviously be important for Genitope, but they'll also influence Favrille shares. The Favid phase III study will report out results no later than July 2008, according to the latest update from Favrille. As Ken said, an independent review board has looked at data from the study, but I would caution against making any judgments on Favid's success or failure based on that review. This email came in from Larry F. "Any thoughts on Nuvelo ? It is trading well under cash with a couple possible compounds." Nuvelo is a heartbreaker of a stock. The company was zipping through 2006 until December, when it just imploded. Two phase III studies of its clot-busting drug alfimeprase came up negative. It was a shocker. The stock collapsed, and Nuvelo lost its partnership with German drug firm Bayer. Fortunately, Nuvelo had cash in the bank. The company has now restructured costs and is working again, on its own, to get alfimeprase approved as a drug to unclog intravenous catheters and as a treatment for ischemic stroke. Nuvelo also has a couple of early-stage drugs in its pipeline. At its closing price of $2.12 on Friday, Nuvelo is trading just slightly higher than its cash-per-share level of around $2, so in essence, the market isn't placing much value on alfimeprase or on the rest of the pipeline. I like Nuvelo and hope it can recover from the disastrous events of a year ago. Expect data from the new alfimeprase study in catheter occlusion -- dubbed Sonoma-3 -- in the first half of 2008. This isn't a big commercial opportunity, but if the report is positive, it should breathe some life back into Nuvelo shares.