BioSante Is Ready for Some Action

Talk about getting excited. BioSante Pharmaceuticals (Nasdaq: BPAX  ) is up 38% this month without a single press release from the company. Bloomberg published an article in which CRO Stephen Simes says the company is looking for a partner or a buyer of the whole company, but that only seems to have been an aphrodisiac for a desire that was already there.

It appears investors are opening positions in BioSante in anticipation of the release of company data from two clinical trials for its female sexual-dysfunction treatment, LibiGel, by the end of the year.

There are two risks here. First the placebo effect comes into play in subjective readouts like the desire to have sex. Taking a drug, whether it contains active ingredients or not, could be enough to push women toward a higher libido, making it harder to prove that the drug works.

The second concern is safety. The FDA is likely to see a female sexual-dysfunction drug as a lifestyle drug. Unlike diabetes or high cholesterol, not treating the disease is not life-threatening -- even if the women's husbands would claim otherwise. Boehringer Ingelheim, Pfizer (NYSE: PFE  ) , and Procter & Gamble (NYSE: PG  ) all stopped developing female sexual-dysfunction drugs because of safety issues.

LibiGel is in a long-term study checking for the risk of cardiovascular events and breast cancer. So far, the data-monitoring board has allowed the trial to continue, which should give investors a little confidence, but it's not a guarantee that the long-term study will end in BioSante's favor.

I could see Pfizer, Eli Lilly (NYSE: LLY  ) , Bayer, or GlaxoSmithKline (NYSE: GSK  ) licensing LibiGel, since they all sell erectile-dysfunction drugs. But I have a hard time seeing them getting turned on to the drug until it proves itself in the clinic -- and maybe not until it gets past the FDA.

Even at this inflated level, there's still plenty of upside for BioSante if LibiGel is approved, but it also means there's further to fall.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Check out his holdings and a short bio. The Motley Fool owns shares of GlaxoSmithKline. Motley Fool newsletter services have recommended buying shares of Pfizer, GlaxoSmithKline, and Procter & Gamble. Try any of our Foolish newsletter services free for 30 days. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.


Read/Post Comments (7) | Recommend This Article (6)

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  • Report this Comment On July 13, 2011, at 5:39 PM, DrGmoney wrote:

    Dr Orelli, The Libigel efficacy studies are are designed as randomized double blinded placebo control studies. There could be a placebo effect in both arms of the study but it should be equalized by randomization. The studies are powered to demonstrate a stat sig difference between Libigel and control arm regardless of placebo effect. I am strongly puzzled about your article's reference to placebo effect that would be expected in any similiar study regardless of the type of drug being studied

    Secondly, The DMC monitoring the FDA SPA designed Cardiovascular/Breast Cancer safety trial closed the enrollment early because as they stated "there is a greater than 90% probability" that the trial will prove Libigel to be safe. Dr G

  • Report this Comment On July 13, 2011, at 6:47 PM, p53 wrote:

    This piece appears to miss an important principle in the design of randomized, blinded, controlled studies namely the accounting of any placebo effect. As to the second point regarding safety, testosterone, the active ingredient in Libigel, is present in women normally and women with hyposexual desire disorder (low libido) have been shown to exhibit low serum testosterone. Because the female libido is more complicated than the male (where increased blood flow to the penis esults in an erection), altering the balance of testosterone o estradiol just slightly would lausibly make a noticeable difference in libido. Thus, the monitoring of the studies performed to date by BioSante have not demonstrated any hint of a safety issue thus far with 3,000 women enrolled in the trial to date. To assume there would be a safety issue now is to under appreciate the role of testosterone pharmacokinetics and toxicology.

    p53

  • Report this Comment On July 13, 2011, at 9:41 PM, Olddognwtrx wrote:

    this article is a joke

  • Report this Comment On July 13, 2011, at 10:28 PM, t4cbjn8 wrote:

    This article is subjective. It is more opinion.

  • Report this Comment On July 14, 2011, at 12:47 PM, aginsurance wrote:

    In the Bloomberg article CEO Simes doesn't say he is looking for a partner. No, no sir, he says a lot of companies are willing to partner up with BPAX but he doesn't know yet if he will. Big difference.

  • Report this Comment On July 14, 2011, at 11:59 PM, TMFBiologyFool wrote:

    Sorry I didn't spell it out: high placebo levels in both arms affects the ability of a trial to show an effect. Consider a trial where you're shooting for a 50% effect (30% from drug and 20% from placebo). Comparing 50% to 20% gives you a p-value of 0.02 -- Winner!

    Now placebo jumps from 20% to 40%. Comparing 70% to 40% with the same number of patients gives you a higher p-value. Higher than 0.05? Looser.

    If you can predict with near certainty the placebo level, it's not a problem; just make sure you have enough patients to get a statistically significant result for the drug response you're looking for. You can be pretty accurate for diseases like cancer. It's much harder for pain, libido and other subjective measurements.

  • Report this Comment On July 17, 2011, at 11:19 PM, Jersey40 wrote:

    The study to show that Libigel has already been completed and compared to placebo. Libigel was 279% better than placebo. Does this makes sense? Of course it does, testosterone drives libido in men and women. Given women some testosterone, and there libido increases. There is no debate on this point.

    Is a little testosterone safe. The long term data will be what one would really want to see(10-15 yr data), but short term data is very unlikely to show any problems. There is probably even an equal chance that long term, placing women on a little testosterone increases bone density and muscle mass and leads to decrease fractures (hip fracture) which represent major morbidity for older women. Unlikely to effect breast cancer (again, may even decrease risk). Problems with heart or liver long term would the only concern, but we don't know at these small amounts if this will ever show.

    Probably the only real question is how the FDA will view the problem. Will they admit that hypoactive sexual desire is a real health problem. They will certainly be under some political pressure as this is the first medication to really help women with sexual freedom and men have had help for years. We do have to remember that viagra type pills are much different in that they help men with the physical ability for an erection and not with libido. Nonetheless, the men have a pill and women don't. Testosterone is widely used (and increasingly used) for low libido in men. This probably represents more risk to them than women (? prostate cancer risk). Still, it is difficult to predict what the FDA will do; they are known to like data that shows that the drug works compared to placebo (which the study cleary shows libigel does), they do like to see the drug is safe (data supporting this) and finally they like the drug to be treating a disorder that needs treating (talk to most men and a majority complain about their spouses desire far less than theirs; talk to women and the thought of increased libido could really do wonders for their feeling of well-being); then add that older women will have a little more energy, strength, and stronger bones: this sounds really good and that's why i have been investing in BPAX.

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