PARIS & MONTREAL--(BUSINESS WIRE)--Regulatory News:
Ipsen (Paris:IPN) (Euronext: IPN, ADR: IPSEY) today announced that Health Canada has granted a marketing authorization for Dysport® (Botulinum toxin type A for injection) for the temporary improvement in the appearance of moderate to severe frown lines (glabellar lines) in adult patients younger than 65 years of age. Medicis Aesthetics Canada, a division of Valeant Pharmaceuticals, will market Dysport® for use in aesthetic medicine in Canada. Launch is expected in April 2013.
Pierre Boulud, Executive Vice-President, Corporate Strategy, Ipsen’s group, stated: “This presentation is in line with Ipsen’s commitment to an increased focus and investment behind Dysport® and to extend its geographical footprint. After its approval in 2009 in the United States, Dysport® will now be available in Canada for the treatment of glabellar lines.”
About Dysport®
The active substance in Dysport® is a botulinum neurotoxin type A complex which acts at the level of the neuromuscular junction in the targeted muscle to block acetylcholine secretion, thereby reducing muscular spasm. It was initially developed to treat motor disorders and various forms of muscular spasticity, including cervical dystonia (or spasmodic torticollis, a chronic condition in which the neck is twisted or deviated), spasticity of the upper/lower part of the body in adults after a stroke, dynamic equinus foot deformity in children with cerebral palsy, blepharospasm (involuntary contraction of the eyelids) and hemifacial spasm (involuntary contraction of the muscles located on one side of the face). Dysport® was later developed for the treatment of a wide variety of neuromuscular disorders, as well as for use in aesthetic medicine. On 31 December 2012, Dysport® had marketing authorizations in force in 75 countries. In Canada, Dysport® has been approved for the temporary improvement in the appearance of moderate to severe frown lines (glabellar lines) in adult patients younger than 65 years of age since June 12th, 2012.
About the agreement with Valeant
In March 2006, the Ipsen Group signed an agreement with the Medicis Group (USA) granting the latter the exclusive right to develop, sell and market certain formulations of botulinum toxin type A for use in aesthetic medicine indications approved in the United States and Canada. On December 11th, 2012, Medicis was acquired by Valeant, who has succeeded Medicis in its rights of Dysport® in North America.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.2 billion in 2012. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by three franchises: neurology, endocrinology and uro-oncology. Moreover, the Group has an active policy of partnerships. Ipsen's R&D is focused on its innovative and differentiated technological platforms, peptides and toxins. In 2012, R&D expenditure totaled close to €250 million, representing more than 20% of Group sales. The Group has close to 4,900 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
About Valeant Canada
Committed to Canada
As part of one of the world’s fastest growing international pharmaceutical companies, Valeant Canada is committed to bringing quality products to Canadians that benefit their wellbeing.
Our commitment to patient health can be felt in pharmacies, healthcare practices and hospitals across the country, as Valeant Canada manufactures, markets and distributes a wide selection of pharmaceutical products. A strong commercial infrastructure enables us to provide new, cutting-edge, effective pharmaceutical and consumer products to Canadians.
While we are proud to offer Canadians a wide range of quality products, we are equally proud to have the best employees working for us across the country, and at global headquarters in Montreal.
Committed to bringing quality products to you
Valeant Canada has a diverse product portfolio in several therapeutic areas, including Pain Management, Cardiovascular Disease, Neurology and Dermatology, and we continue to expand these areas with new offerings. And, as leaders in new research and development in dermatology, Valeant Canada is also excited to have established an R&D center of excellence for consumer dermatology in Laval, Quebec.
Ipsen Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today.
Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from Generics that might translate into a loss of market share.
Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group cannot be certain that its partners will fulfill their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance.
The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law.
The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.