Bladder nod for Botox first step to $400M in extra sales

Allergan ($AGN) has successfully opened up a new field for Botox: bladder control. The company won FDA approval for use of the injectable muscle relaxant to prevent overactive bladder in patients with neurological problems, including spinal cord injury and multiple sclerosis. That's not a big market; analysts expect it to garner only $40 million to $59 million in extra sales, depending on who you ask. But it could signal much broader use, and soon.

Allergan CEO David Pyott has pinned big hopes on Botox for the bladder. The company is in the midst of a late-stage trial testing the wrinkle-fighting med against garden-variety urinary incontinence. And that kind of overactive bladder affects scads more many, in fact, that some analysts have said the indication could add more than $400 million to Botox sales. "This approval ... may bode well for the eventual approval of Botox in idiopathic (of unknown cause) overactive bladder," Leerink Swann's Seamus Fernandez, who forecasts a more modest $210 million, said in a note to investors.

Medical uses for Botox--which include the newly approved indication for migraine headache--are an important strategy for keeping sales up. Cosmetic use now accounts for about half of the drug's $1.5 billion in annual sales, but the drug has some wrinkle-fighting competitors, such as the Medicis Pharmaceutical ($MRX) drug Dysport. "[I]t's more difficult for competitors to get into these areas as opposed to the cosmetic side, where they're probably going to see continued market share losses," Morningstar analyst Michael Waterhouse told Reuters.

The new overactive bladder approval is matched by a similar OK from the Irish Medicines Board that was gained last month. That OK paves the way for the new indication in several key European markets. Other therapeutic uses approved include muscle stiffness, excessive sweating and eye muscle spasms. The drug has been studied for more than 100 medical conditions, as the New York Times notes. "Anything from writer's cramp to anal fissure to Parkinson's disease," spokeswoman Caroline Van Hove said. "That's why we say it's a pipeline in a vial."

- read the FDA announcement
- see the Reuters story
- get the Financial Times article
- check out the NYT story