France’s Ipsen and Swiss partner Galderma have been boosted by the news that French regulators have given the green light to the new wrinkle therapy Azzalure, a competitor to Allergan's Botox, as a treatment for frown lines.

Specifically, the Agence Française de Securite Sanitaire des Produits de Sante (AFSSAPS) has approved Azzalure (botulinum toxin type A) for the temporary improvement of moderate-to-severe glabellar lines - vertical lines between the eyebrows - in patients aged 65 years and under “when the severity of these lines has an important psychological impact on the patient”.

Ipsen said that the approval was based on several clinical trials involving more than 2,600 patients. Azzalure, which will be marketed by Galderma in France before the end of the first half of 2009, received the collective green light from 15 European countries in January and has bagged three other market approvals for the treatment in the UK, Denmark and Portugal.

Azzalure is a muscle relaxant that is already marketed as a treatment for cervical dystonia, under the brandname Dysport. However its use as an aesthetic therapy is potentially a very lucrative one.

Ipsen noted that the global “corrective and aesthetic marketplace” was estimated in 2008 at 5 billion euros and in Europe, the average annual growth expected between 2009 and 2012 is 13.2%, “driven by dramatic rise in the popularity of easy to use and non invasive treatments, such as botulinum toxin procedures”. The latter already represent 60% of specialist procedures in Europe.

Now all eyes will be on a review to be carried out by the US Food and Drug Administration on April 13 on the treatment. If approved, it will be distributed by Ipsen’s partner Medicis Pharmaceutical Corp under the name Reloxin.