The FDA has finally approved a Botox alternative for the US market. Formerly announced as Reloxin, Medicis' Dysport is the first of a small wave of so-called "Botox killers" we have been waiting for for some time. Dysport is also the name of a drug marketed in Europe for cosmetic indications. The FDA's approval of Reloxin puts Medicis in the enviable position — at least temporariy — of being the first firm to break Allergan's monopoly of offering a botulinum Type A-based product for use by aesthetic practitioners in the US. In the small pond that is the plastic surgery market, this is VERY big news.
From BNET Pharma: Allergan Could Lose a Third of Botox Market With FDA's Approval of Medicis' Dysport (hat tip to Cathleen):
The FDA has approved a competitor to Allergan’s Botox. The new wrinkle-fighting drug will be marketed by Medicis as Dysport. (Medicis had intended to call it Reloxin, but apparently it’s become Dysport.) Medicis partner Ipsen will market Dysport for cervical dystonia. Medicis anticipates shipping DYSPORT(TM) for aesthetic use in the U.S. during the next 30 to 60 days.
Bloomberg has reported that compeition between Medicis and Allergan is likely to get stiff:
Reloxin may be priced 15 percent lower than Botox, helping it take almost a third of the 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 Reloxin will be $160 million by 2012.
Meanwhile, the FDA has issued its recommendation on labeling changes for Allergan's Botox, and the news ain't pretty. Botox Must Carry Strong Warning on Risks: U.S. FDA:
WASHINGTON (Reuters) – Allergan Inc's wrinkle-filler Botox and a similar product must carry a strong warning about the risks of severe complications if the injected botulinum toxin spreads in the body, U.S. regulators said today.
The Food and Drug Administration said the move followed the investigation of deaths and hospitalizations of children, most of whom were given one of the products to treat cerebral palsy. Most harm in adults occurred after treatment of spasticity or cervical dystonia, the FDA said.
The agency said "no definitive serious adverse events" related to toxin spread had been identified with dermatologic use of Botox at specific approved doses.
Deaths were reported in adults, but "it is not possible to attribute them to the botulinum toxin because the patients also suffered from complications of their pre-existing conditions," the FDA said.
Allergan shares were down 3.5 percent to $45.65 in afternoon trading on the New York Stock Exchange.
The FDA said the information must be highlighted in a boxed warning, the strongest type for prescription drugs. The action applies to Botox and Myobloc, made by Solstice Neurosciences Inc.
Allergan said in a statement the company would work with the FDA to update the label for Botox. An official at Solstice Neurosciences could not immediately be reached.
Earlier on Thursday, Medicis Pharmaceutical Corp and Ipsen announced they had received FDA approval for a rival product called Dysport. The companies said they also were asked to include a boxed warning about the risks if the toxin spreads.