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Ipsen and Medicis today announced that the Food and Drug Administration ("FDA") has accepted the filing of Ipsen's Biologics License Application ("BLA") for Reloxin(R), its botulinum toxin type A in aesthetic use (glabellar lines) in the United States
SCOTTSDALE, AZ, USA and PARIS, France | May 19, 2008 | Ipsen (Paris:IPN) and Medicis (NYSE:MRX) today announced that the Food and Drug Administration ("FDA") has accepted the filing of Ipsen's Biologics License Application ("BLA") for Reloxin(R), its botulinum toxin type A in aesthetic use (glabellar lines) in the United States. This acceptance signifies the start of the review process of the dossier.
In accordance with the agreement between the two parties, Medicis will pay Ipsen approximately $25 million in connection with the announcement made today. Subject to approval of the BLA by the FDA, Medicis will pay to Ipsen a further $75 million and will commercialize Reloxin(R) in the U.S.
About Ipsen's Botulinum Toxin Type A
As of April 2008, Ipsen's botulinum toxin type A, developed in the field of aesthetic medicine in the U.S., Canada and Japan under the trademark Reloxin(R), is approved for aesthetic indications in 23 countries: Argentina, Australia, Belarus, Brazil, Columbia, Ecuador, Egypt, El Salvador, Germany, Honduras, Israel, Kazakhstan, Mexico, Moldova, New Zealand, Philippines, Slovak Republic, South Korea, Ukraine, Uruguay, Venezuela, Vietnam, and Russia (in Russia, it is the first botulinum toxin type A approved in this field). Ipsen is also pursuing regulatory approval for medical indications for the product in certain additional key international markets.
Dysport(R) is a neuromuscular blocking toxin which acts to block acetylcholine release, hence reducing muscular spasm, and was initially developed for the treatment of motor disorders and various forms of muscular spasticity, including cervical dystonia (a chronic condition in which the neck is twisted or deviated), spasticity of the lower limbs (heal) in children with cerebral palsy, blepharospasm (involuntary eye closure) and hemifacial spasm. It was later developed for the treatment of a wide variety of neuromuscular disorders and aesthetic medicine. Dysport(R) was originally launched in the United Kingdom in 1991 and has marketing authorisations in over 70 countries (at 31 March 2008). Ipsen has also recently filed a BLA for Dysport(R) in cervical dystonia to the FDA.
About Ipsen
Ipsen is a European pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4,000. The company's development strategy is based on a combination of products in targeted therapeutic areas (oncology, endocrinology and neuromuscular disorders) which are growth drivers, and primary care products which contribute significantly to its research financing. This strategy is also supported by an active policy of partnerships. The location of its four R&D centres (Paris, Boston, Barcelona, London) gives the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. In 2007, Research and Development expenditure was EUR185 million, in excess of 20% of consolidated sales, which amounted to EUR920.5 million while total revenues amounted to EUR993.8 million (in IFRS). More than 700 people in Research & Development are dedicated to the discovery and development of innovative drugs for patient care. Ipsen's shares are traded on Segment A of Eurolist by Euronext(TM) (stock code: IPN, ISIN code: FR0010259150). Ipsen's shares are eligible to the "Service de Reglement Differe" ("SRD") and the Group is part of the SBF 120 index. For more information on Ipsen, visit our website at www.ipsen.com.
SOURCE: Ipsen and Medicis |
