SANTA BARBARA, Calif.--(BUSINESS WIRE)--Feb. 6, 2004--Inamed Corporation (Nasdaq:IMDC - News): Phase II Data will be Presented Today at American Academy of Dermatology Annual Meeting Phase III Trials Anticipated to Begin Early This Year No Serious Drug-Related Adverse Events Inamed Corporation (Nasdaq:IMDC - News), a global health care company, and its partner Ipsen, a European mid-sized specialist pharmaceutical company, will report today at the 62nd annual meeting of the American Academy of Dermatology (AAD) that the Phase II dosing study of their botulinum toxin type A product for the treatment of glabellar lines, which are the wrinkles that form between the facial eyebrows, was successfully completed. The Phase II data were presented in early January 2004 to the U.S. Food & Drug Administration and a 50 unit dose was accepted for the proposed Phase III clinical program.
Inamed plans to begin Phase III trials early in 2004, and will select a trademark for the cosmetic indications. The product is currently available and marketed outside North America by Ipsen for various indications under the trade name DYSPORT®. Inamed has exclusive marketing rights to the cosmetic indications of Ipsen's botulinum toxin type A in the United States, Canada and Japan.
"We have completed another key milestone in the development of our product pipeline," said Nick Teti, Chairman, President and CEO of Inamed Corporation. "We are pleased with the progress and results to date and look forward to beginning Phase III studies."
"We are pleased that our partnership with Inamed is progressing well and look forward to completing development of our botulinum toxin product together" said Alistair Stokes, Ipsen's Executive Vice President, Corporate Development.
"We've successfully identified a dose of Inamed's botulinum toxin type A product that provides the optimal balance in terms of efficacy and safety," said Gary D. Monheit, M.D., Co-Principal Investigator of the Phase II study and Associate Professor, Department of Dermatology and Ophthalmology, University of Alabama at Birmingham. "I'm very excited to see the product move into Phase III trials. It worked well and we did not experience any serious drug-related adverse events during this phase."
This botulinum toxin type A product is an injectable form of sterile, purified botulinum toxin made from Clostridium botulinum toxin type A hemagglutinin complex. Small doses of the toxin are injected into targeted muscles to relax them and prevent them from contracting. The product is registered and marketed by Ipsen as DYSPORT® in more than 60 countries for various indications.
Study Methodology and Results
Inamed and Ipsen designed Phase II as a randomized, double-blinded, placebo-controlled study to determine the optimal dosage of their botulinum toxin type A product for the treatment of glabellar lines. Doses of 20, 50 and 75 units were tested against a placebo control. Investigators used a validated, photographic scale of wrinkle severity to assess the efficacy of the product, and both investigators' and patients' assessments of improvement were considered.
About Inamed Corporation
Inamed (Nasdaq:IMDC - News) is a global healthcare company with over 25 years of experience developing, manufacturing and marketing innovative, high-quality, science-based products. Current products include breast implants for aesthetic augmentation and for reconstructive surgery; a range of dermal products to treat facial wrinkles; and minimally invasive devices for obesity intervention, including the Lap-Band System for morbid obesity. The company's website is www.inamed.com.
Inamed Aesthetics is a leader in the facial aesthetics and cosmetic dermatology markets around the world. In March 2003, the Company's CosmoDerm(TM) and CosmoPlast(TM) human-based collagen dermal fillers were approved by the FDA as the first fillers not requiring a skin test. The Company's Zyderm® and Zyplast® bovine-based collagen dermal fillers have been marketed in the United States since 1981 and 1985, respectively, and are considered by many to be the "Gold Standard" in the treatment of soft tissue contour deficiencies, such as wrinkles and scars. In January 2004, the Company announced a key portfolio expansion with the exclusive and non-exclusive licensing agreement with the Corneal Group for its Juvederm® family of products. Juvederm® is a full range of dermal filler products based on non-animal, cross-linked hyaluronic acid technology. This comprehensive array of facial aesthetic products will position Inamed as the only company able to offer collagen-based dermal fillers, hyaluronic acid-based dermal fillers and botulinum toxin type A products for the facial rejuvenation market.
About Ipsen
Present in over 110 countries with a total staff of nearly 3700, the Ipsen Group had a turnover of EUR 718 million in 2002, 27.1% outside Western Europe.
The Group is focused on developing innovative products in targeted disease areas: oncology, endocrinology, neurology and haematology. Ipsen currently has over 20 products on the market, including those marketed to specialists in disease areas that represent the main source of Ipsen's future growth, as well as predominantly natural-based products that represent the historical base of the Group's business in other disease areas. In 2002, 18.2% of Ipsen's turnover was reinvested in Research and Development, carried out from 4 centers: Paris, Boston, Barcelona and London by an international network of about 550 scientists.
The Group's website is www.ipsen.com
Forward-Looking Statements
This press release contains, in addition to historical information, forward-looking statements. Such statements are based on management's current estimates and expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in the forward-looking statements. Inamed is providing this information as of February 6, 2004, and expressly disclaims any duty to update information contained in this press release.
Forward-looking statements in this press release include, without limitation, express and implied statements regarding Inamed's research and development, business development, product development, and regulatory approval. These forward-looking statements involve risks and uncertainties which could cause actual results to differ materially from those expressed or implied here. Readers are referred to the documents filed by Inamed with the Securities and Exchange Commission, specifically the most recent reports which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements, including but not limited to: competition from existing and/or new products; failure or delay of clinical trials; uncertainty in receiving timely regulatory approval or market acceptance for new products; dependence on a single supplier for each of Inamed's botulinum toxin type A product, bovine and human collagen-based products and hyaluronic acid based products; and failure of our collaborative partners to perform.
The information contained in this press release is a statement of Inamed's present intention, belief or expectation and is based upon, among other things, the existing regulatory environment, industry conditions, market conditions and prices, the economy in general and Inamed's assumptions. Inamed may change its intention, belief or expectation, at any time and without notice, based upon any changes in such factors, in Inamed's assumptions or otherwise. Inamed undertakes no obligation to review or confirm analysts' expectations or estimates or to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
By including any information in this press release, Inamed does not necessarily acknowledge that disclosure of such information is required by applicable law or that the information is material.
Contact:
Inamed Corporation Charlie Huiner, Director Corporate Development & Investor Relations 805-692-5425 or Michele Parisi, 925-864-5028 (Media)
Source: Inamed Corporation