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Allergan’s oral Tazarotene to go before advisory panel:

[The panel meeting for Tazoral applies to the psoriasis indication only, but Allergan plans to test the same drug as an oral treatment for wet AMD. Tazoral is a close cousin of Accutane, the acne med from Roche. Roche is so worried about the possibility of birth defects, a side effect of this class of retinoid drugs, that even male patients are required to sign a statement confirming that they are not pregnant!]

http://biz.yahoo.com/rb/040709/health_allergan_3.html

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Allergan Shares Fall Ahead of Meeting

WASHINGTON July 9 (Reuters) - Shares of Allergan (NYSE:AGN) fell nearly 4 percent on Friday ahead of a key meeting over whether the company's new oral psoriasis medicine should be approved by the government and how best to prevent birth defects from the drug.

While company studies have shown the drug, called Tazoral, can treat severe psoriasis with fewer side effects, it still presents the danger of irregular skulls, cleft palates and other problems in infants.

An advisory panel of outside medical experts will have to balance those concerns when they meet on Monday to discuss whether to recommend the U.S. Food and Drug Administration (FDA) approve the treatment for severe psoriasis.

The agency usually follows the recommendation of its advisory panels.

Like its cream and gel cousins, the capsule version of tazarotene is part of a class of vitamin A-derived drugs called retinoids known to cause birth defects. Studies have shown the oral dose can also cause vision problems, back pain and headaches.

In a report released on Friday on the FDA's Web site, www.fda.gov, agency staff said Tazoral was shown to work well.

David Maris, an analyst for Banc of America Securities, said the report was "not surprising," and he expected the panel review would be "favorable."

Shares of Allergan closed down $3.27, or 3.7 percent to $85.18 on Friday on the New York Stock Exchange. "Risk averse investors may wish to wait for the panel review," Maris said, adding the stock was "near our target price."

Allergan's topical versions are approved to treat acne, wrinkling and milder psoriasis. But a company-funded study earlier this year found the capsule was safer and brought more long-term relief for severe psoriasis' scaly bumps and thick, flaky skin.

But the FDA suggests restrictions for female patients taking retinoids. The panelists will also discuss what steps Allergan should take to provide pregnancy warning information to doctors and patients taking the drug.

Manufacturers of other retinoids, most notably Accutane maker Roche (ROG.VX), have struggled to balance treating women and preventing infant risk. Roche urges doctors who prescribe Accutane to require routine pregnancy tests and counsel female patients to use two methods of birth control.

Allergan spokeswoman Caroline Vanhove said the company would likely follow "a similar program."

FDA staff also wrote in the report that they were worried that doctors, who are familiar with topical tazarotene acne medications, would use the oral form instead.

Earlier plans to spend $80 million to $100 million to seek approval for the drug as a treatment for acne, which affects nearly 17 million Americans, are "on hold," Vanhove said.

Psoriasis is not as common as acne, but it affects about 6 million to 8 million Americans and can be difficult to treat. About 1.5 million people have severe psoriasis.

Tazarotene is not a blockbuster for Allergan, which ranks its dermatology line behind its eye care and Botox products. Last year, combined sales of Tarozac [sic] and Avage, topical versions of tazarotene, grew 29 percent to $80 million.
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