Ipsen and Medicis have submitted a Biologics License Application (BLA) for Reloxin® to the FDA.
Upon FDA’s acceptance of the Reloxin filing, Medicis will pay Ipsen $25 million in accordance with the agreement between the parties. In March 2006, Ipsen granted Medicis the rights to develop, distribute, and commercialize Ipsen’s botulinum toxin product in the US, Canada, and Japan for aesthetic use by physicians. Medicis anticipates a response from FDA in approximately 10 months following FDA’s receipt of the Reloxin submission.
According to the American Society for Aesthetic Plastic Surgery, injections of botulinum toxin type A were the number one nonsurgical procedure in 2006, with more than 3 million total procedures. Current growth estimates in botulinum toxin type A in dollars are estimated to be in excess of 20% over the prior year.
"We are extremely pleased to announce the submission of the BLA for Reloxin with FDA," says Jonah Shacknai, chairman and CEO of Medicis. "Congratulations to the Medicis team and our talented consultants who worked tirelessly to achieve our filing. Our team has dedicated many hours compiling what we believe to be a strong filing for an important product. Our shareholders owe these persons a tremendous debt of gratitude for their extraordinary efforts. We appreciate the support given to us by our colleagues at Ipsen, and look forward to a continued excellent relationship with them as we prepare for the potential of commercializing Reloxin in the growing, multi-million dollar aesthetic botulinum toxin market in the US."
Ipsen is a specialty pharmaceutical group with more than 20 products on the market that are targeted towards oncology, endocrinology, and neuromuscular disorders.
Medicis is a specialty pharmaceutical company, which focuses primarily on the treatment of dermatological and aesthetic conditions.
[www.medicalnewstoday.com, December 7, 2007]