Thomas P. emails, "You may recall that Transcept Pharmaceuticals (TSPT) received a complete response letter last year for their insomnia drug Intermezzo. One of the things requested by the FDA was an automobile-driving test to see if there were any residual effects of the drug after taking it upon waking in the middle of the night. (If approved, Intermezzo would be the only insomnia drug taken at a time other than bedtime.) The CEO recently reported in a presentation that the driving test, at four and three hours after taking the drug, had been completed, and that the results would be released this quarter, prior to the anticipated refiling for approval in first quarter 2011. He remarked that driving three hours after taking the drug was not recommended, but that residual effects of the drug were not significant after two and a half hours. While this is not a major trial, it is certainly of importance for a timely and successful refiling. With so much else going on this month, I can understand why you haven't mentioned this to date." I followed up with Transcept spokesman Greg Mann, who confirmed for me via email that the Intermezzo driving study was complete and that the company would release results in the fourth quarter. "It's an interesting study design, to say the least. We believe this is the first time that highway driving results could serve as the basis of an FDA review," Mann said. As Thomas points out, Intermezzo is unique in that the sleeping tablet is intended for people who have trouble falling back to sleep after waking up in the middle of the night. The FDA denied approval initially in part because of concerns that taking Intermezzo too late at night would cause people to be impaired the next day. That's problematic, of course, for people who may get into their car to drive to work. I'm not familiar with the CEO comments about the results of the Intermezzo driving study mentioned by Thomas, but it will be important for Transcept to demonstrate that people can drive safely (no weaving) three or four hours after taking the sleeping tablet (which consists of a very low dose of zolpidem, the active ingredient in Ambien.) If the driving study is positive, the next worry for Transcept investors will be guessing how the FDA reacts to the data. Will the study be enough to ease regulators' concerns about next-day impairment? Transcept shares were trading in the $14 range before last October's FDA complete response letter. More recently, the stock's been trading between $6 and $7.
Hanne S. asks, "Can you please comment on the rumors/uptrend regarding Delcath Systems (DCTH)? What other catalysts are coming up besides the buyout rumor? Thanks for your feedback." Last week's rumor that Bristol-Myers Squibb ( BMY) was interested in acquiring Delcath for $15 a share was nothing more than trading-room chatter designed to make someone a quick buck. Don't believe it.
Bob P. writes, "Thanks for your short but to-the-point outlook on Vanda Pharmaceuticals (VNDA - Get Report). But you have to admit something is going on. With the stock trading at cash, the last couple of weeks have added about 33% to the stock's value. Any chance you would talk to management and reconsider? If investor relations doesn't want to speak with you, don't feel bad, I can't get through either." Bob's referring to my sarcastic remark last week that the slow launch of Somaxon Pharmaceuticals' ( SOMX) sleeping pill was making the combined Novartis-Vanda marketing effort for the schizophrenia drug Fanapt look absolutely rocket like. Vanda shares have moved from $6.50 to 8 in the past two weeks, but that's nothing more than overly optimistic buying from retail investors desperate for an improvement in third-quarter Fanapt sales. Fanapt precscriptions are growing week over week, according to data collected by IMS Health, but the overall scripts and market-share figures are still tiny compared with the competition and do nothing to reverse the reality of Fanapt's underperforming commercial launch. At the end of the third quarter, Fanapt captured just 0.2% of total market share for all atypical anti-psychotics, according to IMS data. A lot of Vanda bulls compare Fanapt's slow start to the similar slow start experienced by Pfizer's ( PFE) Geodon, but c'mon, Fanapt is getting beat by Saphris and Invega, two other recently launched antipsychotics. The question Vanda followers should be asking is if Fanapt can beat Saphris, which has just 0.4% market share. Scott R. hacks at me for "being totally wrong about Vanda. You've missed this big move and will never admit you're wrong." Well, I called Vanda fully valued at $12 one year ago and that was giving the company credit for about $200 million in Fanapt sales. I threw more cold water on the stock when the initial Fanapt scripts came up lame and Vanda shares fell to $6, so I haven't missed a thing. One more item for Vanda fans to ponder as we wait for third-quarter results: What's the status of the Internal Revenue Service ruling on the tax implications of Novartis' $197 million licensing payment? Back in August, Vanda said it expected a decision in two months, which is right about now. A negative IRS ruling will force Vanda to write a big check to the government, cutting its cash cushion considerably.
Fan mail from Bob M.: "Your job is to write biased articles. You comment on stocks because it's fun. You have zero background in biotechnology, you have no medical or scientific credentials. Talk about leading lemmings over the cliff. Why would anyone believe a word that you say? TheStreet is certainly getting what they payed
Lastly, Adrian S. emails, "Really enjoy your articles. I sent you one email on this already and surprised you haven't jumped in on this yet. Labopharm (DDSS) looks to have a lot of promise at this juncture, having just launched Oleptro in the U.S. with their partner Angelini. With Canadian Oleptro approval and tramadol/acetaminophen combo approval in Europe by year's end I think it makes for an exciting near term story. What are your thoughts?" Not so fast, Adrian. Oleptro's U.S. launch isn't going well, even slower than expectations, which weren't all that high to begin with. And while the positive opinion from European regulators for the tramadol/acetaminophen combo is encouraging, launch is probably a year away and may be met with the same indifference there as tramadol. Labopharm is still a show-me stock. --Written by Adam Feuerstein in Boston. >To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: email@example.com.