Cyclacel isn't in a position to make a big splash at this year's ASCO meeting. The sapacitabine phase III study in elderly AML patients only recent began enrolling patients, so results are still a ways off. A poster detailing an early pilot study treating AML patients with a combination of sapacitabine and decitabine will be presented at ASCO, but it's not a significant stock-moving event.
Greg O. email about
"I have done some checking with doctors I know, mainly endocrinologists and urologists, and almost every single one says that if/when Libigel is approved they will start prescribing it to their female patients who need it. They currently won't use anything including the male version (Androgel) because it is way too strong, even if using a fraction of a dose. Some say the demand for Libigel for women is a strong as the pre-approval of Viagra was for men. Biosante also has other drugs in the pipeline but [Libigel] could be a $1 billion-a-year drug. What do you know or feel about the company going forward?"
I wrote an
extensive piece on Biosante
in a February 2010 mailbag and my position on the stock and Libigel hasn't changed. Go back and read it.
The Cliff Notes version: I believe the Libigel efficacy and safety studies will work, mainly because what Biosante is doing -- using low-dose testosterone to treat women with female sexual dysfunction -- has worked in the past.
I believe anyone who predicts a slam-dunk FDA approval for Libigel is a fool. Many people with strong opinions refuse to believe that female sexual dysfunction is a real disease. Some go as far as calling what Biosante and others in the field are doing blatant disease mongering. Still others strongly believe FSD is a true disease that deserves a pharmacologic treatment. If men with erectile dysfunction can take Viagra, why can't a woman take Libigel, they argue. This strenuous debate will color the Libigel FDA approval process and make its outcome far from certain.
Lastly, I still believe that Biosante needs a big-time marketing partner for Libigel, and the fact that no deal has been announced to date suggests suitors are skittish or reluctant to take on the challenge of promoting a drug in a brand new and controversial disease.
On the topic of hepatitis C drugs, Robert S. asks,
"Thanks for information on the approval of Merck's(MRK - Get Report) drug. Why did FDA approve Merck's drug before the one from Vertex Pharmaceuticals(VRTX - Get Report)? Does this reflect better preparation on the part of Merck?"
The simple and most innocuous explanation is that Merck submitted Victrelis for FDA approval two weeks or so before Vertex submitted Incivek. Therefore, FDA approved Victrelis first and is likely to follow quickly with the approval of Incivek on Monday, May 23.