Friday, December 08, 2006

A Good Week for Atypical Antipsychotics?

According to a story in the Houston Chronicle, this is the case. First, we had Lilly assuaging investor fears that Zyprexa sales would decline. Then, there was a successful trial of iloperidone, which caused the following, according to the Chronicle: “Shares of Vanda Pharmaceuticals Inc. soared to a new 52-week high after the Rockville, Md.-based biotech drug maker reported early Thursday its schizophrenia treatment, iloperidone, was effective in a late-stage clinical trial. Vanda shares jumped $10.95, or 70.7 percent, to $26.45 in afternoon trading on 28 times their average volume. Shares, which reached a new year-high of $28.67 earlier in the session, had traded between $7.21 and $17 over the past 52 weeks.”

And Wyeth/Lundbeck’s bifeprunox – “On Wednesday, drug makers Wyeth, Solvay Pharmaceuticals Inc. and Lundbeck AS said studies of their schizophrenia treatment bifeprunox showed patients not only scored better on symptom tests, but also battled the common side effect of weight gain.

One study showed that patients taking bifeprunox lost an average of 1.8 pounds over six weeks, while those given a placebo lost an average of 0.2 pounds. While not directly comparable, the companies noted that small subgroups of patients given current antipsychotic drugs -- to validate the study's placebo -- gained an average of 3.7 pounds to 5.3 pounds after six weeks.”

A little bit of background information is needed to put these exciting bits of science in context. As far as bifeprunox goes, PharmaGossip pointed out a while back that this drug is taking a long time to hit the market. See another brief clipping about its delay here. Delays often mean the drug is not as effective as the manufacturer had hoped.

As for iloperidone, one article forecasted that it would hit the market in 2001! Further digging indicated that Titan, which holds the license for iloperidone (to some extent, anyway), was in a spot of trouble for allegedly hiding the drug’s side effect profile. In 1997, according to a report filed with the SEC, “the Company does not have the funds necessary to complete the clinical development of Iloperidone and is currently pursuing several financing alternatives including corporate partnering arrangements and off balance sheet financing to complete development of Iloperidone.” I assume this is where Vanda got involved. I could find not a single published trial of ilopderidone in either PubMed or If anybody can direct me to clinical trials data for this product, I’d love to see it! So this drug has been in the clinical trials phase of development for nearly a decade, and there is no published data to show its efficacy. I’m not impressed.

My personal opinion is that you are better off burning your money than investing in Vanda after the huge jump earlier this week.

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