Correction: In an earlier version of this article, the name of Generex' Oral-lyn was misspelled. It has been corrected. We'd also like to note that Oral-lyn has been discussed in medical journals and presented at medical association meetings over the last ten years. TheStreet.com regrets the error.BOSTON ( TheStreet) --Do diabetics hate insulin injections so much that a more convenient alternative to needle sticks could be commercially lucrative? Pfizer ( PFE) found the answer to be a resounding "No" when the launch of its Exubera inhaled insulin device crashed and burned soon after hitting the market in 2006. Diabetes patients found the insulin dosing required for Exubera to be confusing, concerns about lung problems lingered, and the design of the Exubera device was embarrassingly bad. It looked exactly like a medium-sized bong -- not exactly something diabetics wanted to carry around with them.
I had a mini debate on Twitter this week with a @jimcollins, a Sequenom ( SQNM) bull who was exacerbated by what he considered to be an unjustified drop in the Sequenom's stock following Monday's quarterly conference call. "I didn't hear anything on the conference call to cause a 20% drop," wrote @jimcollins. In a later tweet, he remarked, "Did people expect Harry
Thinking about Monday's FDA panel meeting for Cell Therapeutics' ( CTIC) lymphoma drug pixantrone, @upstateChris on Twitter asks, "Bold enough to make a guess on the outcome?" Yes. FDA panels can be unpredictable, so I'll generously give pixantrone a 25% chance of receiving a positive vote for approval from the FDA's outside cancer experts. That means I'm 75% certain that pixantrone gets a negative vote. I covered the seven reasons for being bearishly inclined towards pixantrone going into Monday's panel meeting. A housekeeping note: The FDA panel Monday is discussing Cell Therapeutics' pixantrone during the morning session, which means a vote should come around between 11 am and noon. I expect Cell Therapeutics to be halted for trading during its session. I will be live-blogging the panel meeting, so check back for the excitement.
Steve M. writes, "I was reading one of your articles about important biotech dates and remember that there was a pay site you can subscribe to get theses dates. I failed to write down the name of the site. Would it be possible to send it to me?" I like Sagient Research and its BioMedTracker web site, which provides a comprehensive and updated database on drugs in development, including key FDA approval decision dates and clinical trial timelines. It's a great service geared more for institutional investors in terms of pricing (unfortunately), but it's still something that I think an active retail investor could find very useful.
Changing gears: Do geographical differences matter when it comes to the validity of clinical trial data? For Medivation ( MDVN) and its Alzheimer's drug Dimebon, a positive phase II study from Russia looks foolishly deceptive in the face of negative Dimebon results from a phase III study done in Europe and the U.S. Eric B. writes, "I know that Targacept ( TRGT) had a small number of U.S. patients for their Phase II depression study (single digit percentage). The vast majority were in India. Is India more reliable than Russia? Yes, but it sure would have been nice if Targacept had disclosed the results by geography. Targacept says that any such comparison wouldn't be statistically significant because of the small number of U.S. patients. Huh? It's not about statistical significance. It's about seeing if the U.S. results raise questions... Bottom line, Targacept's Phase II results are worth less than they would be if they were 100% from the U.S." I'm a fan of Targacept and its depression drug TC-5214, but I'll concede Eric's point. The fact that the phase II study was conducted primarily in India probably is an overhang and may be one reason why the Targacept's stock price isn't higher. (The lack of near-term Targacept catalysts, including a long weight for phase III data, weighs on the stock, too.) I ran Eric's comment by a hedge fund analyst source who focuses on neuro-psych drugs. He can't be quoted by name, but he's also a Targacept bull. "I think India has more experience conducting clinical trials and is better equipped to handle the issues that eventually turned Dimebon into a false hope, but until we see corroboration of the data elsewhere (or a publication/presentation splitting geography), the question will be outstanding," he says.
Kevin C. emails, "Adam, I would like to get your opinion on Somaxon Pharmaceuticals ( SOMX). They will receive an FDA decision by March 20th and the stock has been running the past month. What do you believe are the odds of approval this time, and what do you believe is the market potential of Silenor if approved?" Oops. I'm a tad late since the FDA approved Silenor as a new treatment for insomnia on Thursday. The positive news, helped along by a small float and few shares to short, sent Somaxon's stock price into orbit. At Thursday's close, Somaxon was up 133% to $9.21 a share on colossal volume of 47 million shares.