Replies to post #4410 on Biotech Values

[DewDiligence]

Thanks for the R&R update.

BPA is a simple story. The M.O.A. of testosterone is well known and the main issues for a drug are the pharmacokinetics (fluctuating plasma levels are especially bad for women) and the convenience (a gel is much better than a patch). I think Saturday’s BPA presentation on LibiGel will be anti-climactic given the already-released top-line data.

Interestingly (and tangentially apropos to our prior discussion of Finasteride), the CEO of CBRX, a fringe player in hormone drugs, claims that his company’s testosterone drug is superior to either a patch or a gel because it does not allow 5-alpha-reductase in the skin to metabolize testosterone into DHT. I’m inclined to think this argument is a red herring.

[Skeptic]

"Other comments, cgtk, I think it's way too risky to be long heading into the data. May even be a good short, but probably too unpredictable for me."

RKRW - very surprised by your comments here. Mgmt on the cc the other day seemed near giddy when talking about the upcoming data event (some time before the end of December). The trials are very well put together, the DSMB review went smoothly, BMY was willing to put some big bucks into this, and the better sell side firms out there (Lehman and Needham) love the story.

I'd really like to know what the basis of your statement is.

TIA

[DewDiligence]

Re: VVUS, BPA:

>> I did see BPA. ceo made an interesting comment about vvus whom he doesn't seem so worried about. <<

I meant to ask you about this but forgot. What exactly did Mr. Simes say about VVUS? T.i.a.

--
VVUS up on testosterone drug study:

[VVUS is competing with BPA, CLGY, and PG in the female HSDD market.]

http://tinyurl.com/6m4eo

>>
By Laura Gilcrest
CBS MarketWatch
5:03 PM ET Nov. 16, 2004

WASHINGTON (CBS.MW) -- Vivus shares jumped more than 7 percent Tuesday after the Mountain View, Calif.-based firm announced it had completed a Phase 2 study of Testosterone MDTS to treat female sexual dysfunction.

The metered-dose transdermal spray therapy is intended as treatment for Hypoactive Sexual Desire Disorder, a condition that Vivus said affects about 25 percent of women. Vivus shares shot up 7.11 percent in Tuesday trading, closing at $6.18.

Testosterone MDTS delivers a preset dose of testosterone to the skin where it is released into the bloodstream over 24 hours, the company said.

Vivus said it would release in the first quarter of 2005 the results of the six-month, placebo-based Phase 2 study involving 260 women.

The clinical trial is being conducted in Australia by Acrux Limited, which licenses the technology to Vivus.
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