French drugmaker Ipsen and partner Medicis Pharmaceutical Corp have received a boost with the news that regulators in the USA have approved Dysport as an anti-wrinkle treatment as well as for cervical dystonia.

The approvals from the US Food and Drug Administration, which have come earlier than expected, give the green light to Dysport (abobotulinumtoxin A) for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain, and the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows). Medicis expects to launch Dysport, (the previous proposed brandname Reloxin has been dropped) in the USA as an anti-wrinkle treatment within the next 30 to 60 days, while Ipsen will start marketing the treatment for cervical dystonia during the second half of the year.

Jonah Shacknai, Medicis’ chief executive, said “we are excited to be entering the market for the most popular nonsurgical aesthetic procedure in the USA, and anticipate being highly competitive”. His counterpart at Ipsen, Jean-Luc Belingard, noted that the approvals have “closely collaborated” with the FDA on the labelling and risk evaluation andmitigation strategy for Dysport and added that “today marks a major strategic milestone in our history, being now in a position to effectively market four products in the USA”.

In March 2006, Ipsen granted Medicis rights to Dysport in the USA, Canada and Japan and the FDA approval means that the Paris-based firm will get a $75 million payment. It will now receive royalties equivalent to some 30% of net sales.

This is surprising new, seeing as how just a fortnight ago, Ipsen and Medicis said they were still involved in discussions with the FDA regarding the labelling and REMS. Dysport will now compete with Allergan’s Botox.