FDA turns back Botox rival Reloxin (update)

January 31st, 2008, 7:13 am · Post a Comment · posted by Colin Stewart

COSMETIC MEDICINE

The Food and Drug Administration has rejected the application for approval of the wrinkle-smoothing drug Reloxin, says drug maker Medicis Pharmaceutical Corp. of Scottsdale, Ariz.

The denial, based on problems with paperwork the company submitted, doesn’t eliminate Reloxin from its position as the No. 1 potential rival to Botox as a wrinkle fighter. But Medicis said in a Securities and Exchange Commission filing that the move could delay the FDA’s eventual approval of it.

Medicis had hoped to start selling Reloxin later this year, but now the company has to aim for a launch date sometime in 2009.

An estimated five-month delay will mean the Irvine-based Allergan will sell about $30 million more Botox next year, says Wachovia Capital Markets analyst Larry Biegelsen.

Both Reloxin and Botox are injectable versions of botulinum toxin, with similar effects against facial wrinkles according to doctors who have used both.

The FDA said the application didn’t spell out Medicis’ responsibilities as manufacturer of the product, which is made by the French drug maker Ipsen.

Medicis says it will work with the FDA and Ipsen promptly to resolve the issue so it can refile the application.

In early trading this morning, Medicis shares dropped 13 percent, to $19.02. Allergan shares rose 5 percent, to $67.54.

This post includes information from the Associated Press and Reuters. It was updated at 7:20 a.m. to include stock prices.

Reader comments: We want this to be a place where people discuss and debate ideas that foster stronger communities. We expect people to differ -- judgment and opinion are subjective -- and we encourage free speech and the exchange of ideas. But you are participating in a community that is intended for all of our users and we prohibit profanity, vulgarity, racial, sexual and homophobic remarks, threats, harassment and personal attacks. Here's the full User Agreement. Thank you for making this a safe place worth preserving and sharing. Share this: The icons below make it easy to share this post with others. First icon e-mails a link.