Before I open this week's Biotech Mailbag, I'd like to share some news. On Monday, TheStreet.com is launching Biotech Select, our new subscription-based biotech investment newsletter, written by yours truly. Biotech Select is a natural extension of what I do now at TheStreet.com, with the added fun (and pressure!) of actually picking and managing biotech stocks in a model portfolio. Many of you have written to me over the past two years, asking that TheStreet.com start up a biotech newsletter. It took awhile, but we listened. So yeah, now I'm turning into one of those investment newsletter writers. I'm working hard to make sure that Biotech Select is smart, insightful and filled with good biotech stock picks. I can guarantee that it will be fun to read because I'm not changing my writing style one bit. I'm also not disappearing from the TheStreet.com Web sites. You'll still see me here writing up a storm on biotech and generally trying to cause as much trouble as possible. I live for the hate mail, so I can't let that end. And absolutely, the Biotech Mailbag will continue. It's a very popular, regular column and one that I truly enjoy writing, so please, continue to send in your biotech-related questions and comments and I'll respond as best as I can. I hope you'll consider a subscription to Biotech Select. If you're interested, you can find more information here, including a discount offer for charter members. Now, on to your emails. John R. took a look at the new diabetes data from Xoma's ( XOMA - Get Report) lead drug XOMA 052 released this week and asked, "Is this as revolutionary as I think it is? Why am I the only one to think this is huge?" XOMA 052 would be revolutionary and huge if the drug is proven to work against diabetes. We're not there yet, although Monday's data was a nice start.
Larry A. wants my thoughts on Vivus ( VVUS - Get Report) and its obesity drug candidate Qnexa. It's hard to argue with Vivus' stock performance of late. At its current price around $8.50 a share, Vivus is up about 70% since May and is outperforming the two big biotech rivals Orexigen ( OREX) and Arena Pharmaceuticals ( ARNA - Get Report) as they all race to develop a new and effective obesity drug. The previous knock on Vivus had been that the clinical data for its obesity drug combo Qnexa came from a small, single-center phase II study, which made it hard to believe the 10% weight loss at full face value. But in May and June, Vivus released data from a larger phase II study conducted in Type 2 diabetics. The Qnexa weight loss in that study was 8%, so perhaps the first study wasn't a fluke after all.
Next, an email from Stephen V. "Adam, you published an article several months ago listing the dates some drugs would be considered for approval by the FDA. Where can I find a list similar to that with respect to Acapodene 80mg by GTX ( GTXI), particularly when the FDA is going to meet?" GTX is not expected to complete its FDA approval application for Acapodene (or toremifene, as the company prefers) until the fourth quarter, so it's premature to get specific about when the drug might be approved. If GTX meets its deadline, broadly speaking, Acapodene could be approved mid- to late 2009, depending on whether the FDA grants priority review. GTX is developing an 80mg version of toremifene as a treatment for the side effects of androgen-deprivation therapy in men with prostate cancer. This is the indication being filed with the FDA later this year. Also under way is a phase III study testing a 20mg dose of toremifene for the prevention of prostate cancer in men with a premalignant lesion on their prostates.
Onward. Can you believe that there are still some investors out there who believe Northfield Labs ( NFLD) and its experimental blood substitute Polyheme has a chance of being approved by the FDA?
In the wake of Pfizer's decision to license the Alzheimer's drug Dimebon from Medivation ( MDVN) (and for big bucks, too), several readers emailed to ask about other unpartnered Alzheimer's drugs in clinical trials. The two public companies that come to mind immediately are Prana ( PRAN), based in Australia, and Canada-based Allon Therapeutics ( NPC). I'm more familiar with Prana's Alzheimer's drug PBT-2 than I am with Allon's, which goes by the moniker AL-108. Both are in phase II development. I don't have room to go into details here, but let's just say that I walked away rather unimpressed after spending a good bit of time staring at PBT-2 data. I don't know as much about AL-108, but it does target "Tau tangles" -- the other major anti-Alzheimer's theory out there (the beta amyloid plaque hypothesis being the other, more dominant). Whether these drugs work or not can be divorced completely from the question of whether Prana or Allon can land a Big Pharma partner. At this point, the latter is probably more relevant and important to investors than the former. The rumors about Prana being close to a partnership deal wax and wane. They've picked up a bit since the Pfizer-Medivation deal was announced. Are the rumors true or is it wishful thinking? Sadly, I can't say, but the partnership bar for Alzheimer's drugs isn't all that high. I think there are plenty of large drug companies willing to spend some money for a shot at a Alzheimer's blockbuster.
This final, short email this week comes from a guy with a great name. Adam writes: "I think you are a monkey." OK! Well, that just about says it all. On that note, this monkey is signing off until next week. That is, unless I get lost in the jungle. And please, take a look at the offer for Biotech Select!