Botox Must Warn of Muscle Weakness as U.S. Market Expands

-Bloomberg

05/02/2009 - Allergan Inc. was ordered by U.S. regulators to strengthen precautions on its wrinkle smoother Botox, hours after the first major competition to the treatment was approved for sale.

Botulinum toxins used to relax forehead lines and treat neurological disorders may cause muscle weakness or breathing difficulties if the poison spreads beyond the site of injection, the Food and Drug Administration said today. All manufacturers were ordered to add a boxed warning to their prescribing information and implement programs to minimize the risks.

The new safety programs may benefit Dysport, whose approval was announced today by its makers, Ipsen SA and Medicis Pharmaceutical Corp. The product will compete with Botox in treating a neck twisting disorder called cervical dystonia, and in cosmetics, where the American Society for Aesthetic Plastic Surgery estimates that almost 2.5 million Americans got Botox injections last year.

“On the competitive side, it puts the two on much more of an equal playing field,” said Corey Davis, an analyst at Natixis Bleichroeder in New York, in a phone interview today. “Because Botox was already on the market, nobody thought something like this could be forced on the company.”

Allergan shares fell 1.3 percent, or 62 cents, to $46.66 at 4:15 p.m. in New York Stock Exchange composite trading, while Medicis shares jumped 18 percent to $16.07. It was Medicis’s biggest percentage gain since March 19. Ipsen shares rose 5.4 percent to 31.08 euros in Paris trading.

Botox controls about 83 percent of the global market for neurotoxins that relax muscles or nerves, according to Allergan. The drug accounted for almost a third of the Irvine, California- based company’s revenue last year with $1.3 billion in sales, split between cosmetic and therapeutic uses.

Hospitalizations, Deaths

The FDA reviewed reports of children and adults who died or were hospitalized after getting botulinum toxins. Most serious side effects occurred with higher doses to treat arm and leg spasms, a use not approved by the agency, and cervical dystonia.

“They’re commonly used and we don’t mean in any way to discourage that use,” Ellis Unger, acting deputy director of the FDA’s Office of Drug Evaluation, told reporters today on a conference call. “People just need to understand the risks that are involved so they can make informed risk-benefit decisions.”

Botox was approved almost 20 years ago for medical uses. The FDA cleared it for smoothing wrinkles in 2002, which quickly became fashionable among aging celebrities as a nonsurgical way to appear younger. Its only competition in the U.S. before now has been Myobloc, a toxin sold by closely held Solstice Neurosciences Inc., of Malvern, Pennsylvania, for cervical dystonia.

Deaths ‘Very Rare’

Unger declined to say how many cases of illnesses were reported, noting deaths were “very, very rare.” Public Citizen, a consumer advocacy group in Washington, filed a petition with regulators last year calling for stricter warnings on Botox and Myobloc. The group said 180 reports of harmful side effects, including deaths of 12 adults and four children, were reported to the FDA from November 1997 to December 2006.

Allergan said in February that it would cut 5 percent of its workforce to brace for competition and lower demand for cosmetic procedures in the recession.

Medicis and Ipsen surprised some analysts by announcing early today that the FDA had approved Dysport as a wrinkle smoother and treatment for cervical dystonia. The agency had delayed a decision while deciding how best to minimize risks seen with other botulinum toxins. The companies applied to sell the drug for aesthetic uses under a separate name, Reloxin.

New Opportunity

“We are excited to be entering the market for the most popular nonsurgical aesthetic procedure in the U.S., and anticipate being highly competitive,” said Jonah Shacknai, chief executive officer of Medicis, in a statement today.

Scottsdale, Arizona-based Medicis plans to start selling the drug for aesthetic uses in the U.S. within 30 to 60 days. Approval will trigger a $75 million payment to Ipsen, which developed the drug. The Boulogne Billancourt, France-based company said it will handle sales for cervical dystonia, beginning in the second half of this year.

Dysport may be priced 15 percent lower than Botox, helping it take almost a third of the cosmetic market over time, said Gary Nachman, an analyst at Leerink Swann & Co. in New York, in a phone interview last month. He estimates annual sales of Dysport for aesthetic uses will be $160 million by 2012.

The FDA urged doctors not to interchange different botulinum products because the dosage strengths aren’t equivalent. Patients should also be aware that side effects may take weeks to develop, the agency said.

“With the approval of another botulinum toxin, the FDA’s request for updated class safety labeling and the reinforcement of non-interchangeability is timely and responsible,” said Sef Kurstjens, Allergan’s chief medical officer, in a statement.

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