Allergan, Inc. : Allergan Studies Botox For Bladder, Other Illnesses
03/28/2012| 03:32pm US/Eastern
--Allergan files for approval of Botox for overactive bladder
--Company aims to expand market to patients with idiopathic bladder
--Also looking at Botox to treat osteoarthritis, Crows feet
(Updated to add details from Allergan meeting in New York, beginning in paragraph two.)
By Anjali Athavaley
Allergan Inc. (AGN) filed applications with U.S. and European regulators for approval to sell Botox as a treatment for overactive bladder as new data showed the injectable neurotoxin significantly reduced bladder leakage compared to a placebo.
Separately, at its research and development day in New York, Allergan said it also is pursuing approval of its best-selling drug for osteoarthritis and crow's feet.
Botox is approved for both cosmetic use, such as fighting wrinkles, and for various medical issues, including urinary incontinence in patients with neurological conditions. Allergan is now aiming to gain U.S. approval for bladder leakage when the causes are unknown, a potentially more lucrative market.
The drug is a form of the botulinum toxin, made from the bacteria that cause botulism, a deadly illness that essentially paralyzes the muscles that control breathing; however, the toxin also can be harnessed to temporarily paralyze and relax specific muscles.
Botox had $1.59 billion in sales last year, according to Allergan, with 51% coming from therapeutic uses and 49% from aesthetic sales. For 2012, Allergan has projected Botox sales between $1.75 billion and $1.8 billion.
Wednesday, Allergan said that in two Phase III clinical trials, Botox met the primary endpoints of significantly reducing leaky bladder episodes in patients who don't respond to oral medications considered the standard of care. An estimated 3.2 million Americans are on those medications, but Allergan said more than half discontinue them because they don't find them effective, Allergan said.
Patients with overactive-bladder symptoms were randomly assigned to treatment with Botox or placebo injections. In both studies, there was a significant decrease in the number of daily incontinence episodes in patients treated with Botox compared with the placebo, Allergan said.
Side effects were mostly limited to the urinary tract, with infection rates between 15% and 20% in patients treated with Botox. Patients getting Botox in both studies reported improved quality of life.
Based on the results, Allergan has submitted a supplemental biologics license application with the U.S. Food and Drug Administration and an application with European Regulatory authorities to approve the use of Botox by adult patients not managed by an anticholinergic treatment.
Larry Biegelsen, an analyst at Wells Fargo, said in a note that the applications came ahead of Street expectations. He added that rates of side effects appear favorable compared to Phase II results, which showed urinary tract infection rates of 34% to 48%.
At its meeting in New York, Allergan also said it is pursuing approval of Botox for osteoarthritis and crow's feet.
The company said it expects U.S. approval for crow's feet in 2013 and sees the new indication generating annual peak sales of $100 million. Allergan also has started Phase II studies for the osteoarthritis indication and considers osteoarthritis to be a $4.4 billion market opportunity in the U.S. and Europe.
Allergan has been expanding its pipeline of late, with moves such as buying Vicept Therapeutics Inc., the developer of a cream to treat rosacea, and striking a deal with Map Pharmaceuticals Inc. (MAPP) to jointly promote Map's experimental migraine treatment Levadex.
The company reported last month that its fourth-quarter earnings rose 6.3% as higher specialty-pharmaceuticals sales contributed to a 7.1% revenue jump.
Shares were down fractionally to $93.80 in Wednesday trading. The stock is up 7% this year.
-By Anjali Athavaley, Dow Jones Newswires; 212-416-4912; email@example.com
--Melodie Warner contributed to this article.