August 24, 2011 11:43 pm

Botox obtains US approval

for use as a bladder treatment

Botox, the drug best known for filling in brow wrinkles, received approval from US health regulators on Wednesday for the treatment of overactive bladders, boosting the shares of Allergan, its manufacturer.

The US Food and Drug Administration said Botox can be used by people with neurological conditions, such as spinal cord injuries or multiple sclerosis, to alleviate urinary incontinence.

Morgan Stanley analysts estimate the approval could provide Allergan with $59m in annual revenues by 2015. It could generate an additional $457m a year if, as expected, the drug is approved to treat patients with overactive bladders for non-neurological reasons.

Shares of Allergan rose 3.02 per cent to $77.90 on Wednesday.

This month, the Irish Medicines Board issued a similar approval for Botox, opening the door for its use as a bladder drug in Europe.

When injected into the bladder through a cystoscope, Botox decreases incontinence by relaxing the organ and increasing its storage capacity. The effect of the drug lasts for about nine months. Possible side-effects include urinary tract infections and problems retaining urine.

Allergan estimates that about 340,000 people in the US suffer from urinary incontinence due to neurological conditions.

David Pyott, chief executive of Allergan, said this month that he expects the company to boost its sales force to promote the drug.

Botox generates about $1.3bn in annual sales for Allergan, with half of that coming from cosmetic uses. In spite of a weak US economy, cosmetic Botox sales were up 16 per cent year on year in the the second quarter.

Allergan has said that although Botox is widely known for smoothing wrinkles, sales for therapeutic purposes will eventually outpace sales of the drug for cosmetics reasons. It has aggressively promoted the drug for various conditions.

Last year, Allergen paid $600m to settle cin court over  illegally promoting and selling Botox for unapproved uses until 2005. The company also pleaded guilty to a misdemeanour “misbranding” charge.

Botox, first approved 21 years ago for treatment of eye muscle twitches, has been a boon for Allergan and now has seven different approved uses. Doctors use the drug to treat chronic migraine headaches, muscle stiffness and severe armpit sweat.

Allergan said Botox has also been studied and evaluated for about 100 different purposes.

“It’s like an entire pipeline in one drug,” said Les Funtleyder, analyst and fund manager at Miller Tabak.

Sourced & published by Henry Sapiecha

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