France’s Ipsen has filed applications to get two approvals in the USA for Reloxin/Dysport, the firm’s botulinum toxin treatment which is expected to be the firm’s major earnings growth driver in the future.

First up is a Biologics License Application filed with the US Food and Drug Administration by Ipsen’s partner Medicis which signed up with the French firm in March 2006 to develop, distribute and commercialise Reloxin (botulinum toxin type A) in the USA, Canada and Japan for aesthetic use by physicians.

If the FDA accepts the Reloxin filing, and a decision will be made within the next 10 months, Medicis will pay Ipsen some $25 million but the Paris-headquartered firm will be looking for much more than that once the treatment enters a highly-lucrative market. According to the American Society for Aesthetic Plastic Surgery, injections of botulinum toxin type A were the number one non-surgical procedure (over three million) in 2006, and Ipsen says that the retail US aesthetic market is worth $300-$400 million. Allergan's Botox (also botulinum toxin type A) product is the market leader.

Secondly, a BLA has been submitted for Dysport for the treatment of patients with cervical dystonia, which was granted orphan drug status by the FDA. The submission is based on data from two Phase III studies of 252 patients followed-up for up to 12 treatment cycles. Dysport was originally launched in the UK in 1991 and at the end of last year, it was available in over 70 countries.

Completing a busy day for Ipsen, the firm noted that it has extended its existing European partnership with Switzerland's Galderma so that the latter will promote Dysport for use in aesthetic medicine and dermatological indications in Brazil, Argentina and Paraguay. Chief operating officer Christophe Jean said the deal will increase exposure of the product in those three important South American markets.