French pharma Ipsen and its US partner Medicis have resubmitted a Biologics License Application to the US Food and Drug Administration for use of their botulinum toxin type A product Reloxin in aesthetic indications.

According to Ipsen, the new BLA should address the concerns cited by US regulators when it declined to file the Reloxin in January this year, which relate primarily to sponsorship and ownership of the filing, and a response from the FDA is expected within the standard 10-month timeframe.

"We are pleased to have responded to the administrative issues raised by the FDA in coordination with Medicis in a timely and efficient manner, commented Jean-Luc Belingard, Chairman and Chief Executive Officer of Ipsen. Given Ipsens botulinum toxin positive track record on a global basis, we look forward to entering the North American market following FDA approval of Reloxin, he added.

Ipsen granted Medicis the rights to develop, distribute and commercialise its botulinum toxin product in the United States, Canada and Japan for aesthetic use by physicians in March 2006. Under the terms of their agreement, the FDAs acceptance of the Reloxin submission will trigger a milestone payment of around $25 million to Ipsen.

The US aesthetic sector alone is thought to be worth $300-$400 million, and the groups will be hoping that if Reloxin wins the green light it will be able to claim a substantial portion of this lucrative market from the current leader, Allergan's Botox (also botulinum toxin type A).