Allergan Shares Fall After FDA Faults Pill
The Food and Drug Administration said Friday that a psoriasis drug being developed by Irvine-based Allergan Inc. could cause birth defects when used by pregnant women. Allergan shares slipped nearly 4% on the news.
The drug, called Tazoral, was effective in treating psoriasis, the report said, but harmed animal fetuses in lower dosages than did Accutane, an acne pill linked to severe brain and heart defects and other abnormalities.
Some analysts predicted that safety concerns would delay FDA approval of Allergan’s oral drug, even though Allergan has told the FDA it would address the issue by tracking all doctors, pharmacies and women who prescribe, dispense and use Tazoral. Wall Street had expected the psoriasis pill to reach the market in September.
Allergan’s shares slid $3.27, or 3.7%, to $85.18 on the New York Stock Exchange.
Tazoral and Accutane are retinoids, a class of medications linked to physical deformities and mental disabilities in the children of women on the drugs. The FDA said in its report that efforts to prevent pregnancies in Accutane users had failed, adding to the agency’s concerns about Tazoral.
The report will be reviewed Monday at a meeting of medical advisors to the FDA. The committee can recommend for or against FDA approval of Tazoral. The agency typically follows the advice of its outside experts.
Analysts said Tazoral was important to Allergan, whose best-known product is Botox, an anti-wrinkle treatment. Tazoral could compensate for lost sales of Alphagan, Allergan’s lucrative glaucoma treatment that faces generic competition, they said. David Maris of Banc of America Securities said Tazoral could have peak annual sales of $260 million. Allergan has said sales of the drug could eventually reach $500 million, Maris said. The company had total revenue of $1.8 billion in 2003.
In its report, the FDA said Tazoral was effective when compared with a placebo pill as a treatment for moderate to severe psoriasis, a skin disorder that causes excessive peeling and itching. Many of the existing treatments for psoriasis are only partially effective.
Besides the risk of birth defects, Tazoral posed other side effects, including loss of bone density, the report said.
The greatest risk cited by the report was that of birth defects. Four women in Tazoral studies became pregnant, the report said. Two had abortions, one had a miscarriage, and one gave birth to an apparently healthy baby.
But the agency noted the drug was similar to Accutane, which has been connected to birth defects in 160 children since it was introduced in 1982.
The FDA said numerous birth defects occurred in the offspring of pregnant rabbits and rats that were given Tazoral.
The FDA said it was worried about off-label use of Tazoral in patients with acne, which affects 85% of Americans between ages 12 and 24 and is more widespread than psoriasis. The report noted that four studies on Tazoral as an acne treatment were presented at the American College of Dermatology meeting in February, and a trade journal, Dermatology Times, reported that the drug improved the quality of life for patients with severe acne.
Allergan spokeswoman Stephanie Fagan said the drug was aimed at the 1.5 million Americans with moderate to severe psoriasis.
Fagan said Allergan intended to work with the FDA to develop its patient registry. Fagan said Allergan couldn’t elaborate on the proposal until after the FDA committee meeting Monday.
