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Ipsen and Medicis today announced the submission of the Biologics License Application for Reloxin® to the U.S. Food and Drug Administration
PARIS, FRANCE and SCOTTSDALE, AZ, USA | December 6, 2007 | Ipsen (Euronext:FR0010259150; IPN) and Medicis (NYSE:MRX) today announced the submission of theBiologics License Application (“BLA”) for Reloxin®1 to the U.S. Food and Drug Administration(“FDA”). Upon FDA’s acceptance of the Reloxin® filing, Medicis will pay Ipsen approximately$25 million in accordance with the agreement between the parties. In March 2006, Ipsengranted Medicis the rights to develop, distribute and commercialize Ipsen's botulinum toxinproduct in the United States, Canada and Japan for aesthetic use by physicians. Medicisanticipates a response from FDA in approximately 10 months following FDA’s receipt of theReloxin® submission.
According to the American Society for Aesthetic Plastic Surgery, injections of botulinum toxintype A were the number one non-surgical procedure in 2006, with over 3 million totalprocedures. Current growth estimates in botulinum toxin type A in dollars are estimated to bein excess of 20 percent over the prior year.2 This translates into a retail U.S. aesthetic marketof approximately $300 million-$400 million.
“We are extremely pleased to announce the submission of the BLA for Reloxin® with FDA,”said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. “Congratulations tothe 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 animportant product. Our shareholders owe these persons a tremendous debt of gratitude fortheir 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 thepotential of commercializing Reloxin® in the growing, multi-million dollar aesthetic botulinumtoxin market in the U.S.”
Jean-Luc Bélingard, Chairman and Chief Executive Officer of Ipsen, stated: "The submissionof the Reloxin® dossier to the FDA by our partner Medicis is an important milestone forIpsen's future growth, and we are very pleased that such an important project was carried outin a rigorous and timely manner. Both Ipsen and Medicis are dedicated to bring this productto market, so that Reloxin® may be a success in the U.S.."
About Ipsen’s botulinum toxin type A
As of October 2007, Ipsen’s botulinum toxin type A, developed in the field of aesthetic medicine in theU.S., Canada and Japan under the trademark Reloxin®, is approved for aesthetic indications in 21countries: Argentina, Australia, Belarus, Brazil, Columbia, Ecuador, Egypt, Germany, Honduras, Israel,Kazakhstan, Mexico, Moldova, New Zealand, Philippines, Slovak Republic, Ukraine, Uruguay,Venezuela, Vietnam, and Russia (in Russia, it is the first botulinum toxin type A approved in this field).1 The proposed name for the product in the U.S. aesthetic market is Reloxin®, and it is called Dysport® for medical and aestheticmarkets outside the U.S.2 American Society for Aesthetic Plastic Surgery, Cosmetic Surgery National Data Bank Statistics, 2006 and Allergan companyIpsen is also pursuing regulatory approval for medical indications for the product in certain additionalkey international markets.Dysport® is a neuromuscular blocking agent which acts as a neuromuscular blocking toxin, which wasinitially 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 ofthe lower limbs in children with cerebral palsy, blepharospasm (involuntary eye closure) and hemifacialspasm. It was later developed for the treatment of a wide variety of neuromuscular disorders Dysport®was originally launched in the United Kingdom in 1991 and has marketing authorisations in over 70countries (at 31 December 2006). Ipsen has just recently submitted a BLA for Dysport® in cervicaldystonia to the FDA.
About Medicis
Medicis is the leading independent specialty pharmaceutical company in the United States focusingprimarily on the treatment of dermatological and aesthetic conditions. The Company is dedicated tohelping patients attain a healthy and youthful appearance and self-image. Medicis has leadingbranded prescription products in a number of therapeutic and aesthetic categories. The Company'sproducts have earned wide acceptance by both physicians and patients due to their clinicaleffectiveness, high quality and cosmetic elegance.The Company's products include the prescription brands RESTYLANE® (hyaluronic acid), PERLANE®(hyaluronic acid), DYNACIN® (minocycline HCl), LOPROX® (ciclopirox), PLEXION® (sodiumsulfacetamide/sulfur), SOLODYN® (minocycline HCl, USP) Extended Release Tablets, TRIAZ®(benzoyl peroxide), LIDEX® (fluocinonide) Cream, 0.05%, VANOS® (fluocinonide) Cream, 0.1%,SYNALAR® (fluocinolone acetonide), and ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%)Gel, BUPHENYL® (sodium phenylbutyrate) and AMMONUL® (sodium phenylacetate/sodiumbenzoate), prescription products indicated in the treatment of Urea Cycle Disorder, and the over-thecounterbrand ESOTERICA®. For more information about Medicis, please visit the Company's websiteat www.medicis.com.
About Ipsen
Ipsen is an innovation driven international specialty pharmaceutical group with over 20 products on themarket and a total worldwide staff of nearly 4,000. The company’s development strategy is based on acombination of products in targeted therapeutic areas (oncology, endocrinology and neuromusculardisorders) which are growth drivers, and primary care products which contribute significantly to itsresearch financing. This strategy is also supported by an active policy of partnerships. The location ofits four Research and Development centres (Paris, Boston, Barcelona, London) gives the Group acompetitive edge in gaining access to leading university research teams and highly qualifiedpersonnel. In 2006, R&D expenditure was €178.3 million, i.e. 20.7% of consolidated sales, whichamounted to €861.7 million while total revenues amounted to €945.3 million (in IFRS). 700 people inR&D are dedicated to the discovery and development of innovative drugs for patient care. Ipsen’sshares are traded on Segment A of Eurolist by EuronextTM (stock code: IPN, ISIN code:FR0010259150). Ipsen’s shares are eligible to the “Service de Règlement Différé” (“SRD”) and theGroup is part of the SBF 250 index. From 24 December 2007, the Group will be part of the SBF 120index. For more information on Ipsen, visit our website at www.ipsen.com.Medicis
SOURCE: IPSEN
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