Healthcare Industry News: dermal filler
News Release - July 24, 2007
Anika Therapeutics Receives FDA Approval for ELEVESS(TM) ProductInjectable Soft Tissue Filler Targets Rapidly Growing Cosmetic Dermatology Market; Addresses Facial Wrinkles and Scar Remediation
WOBURN, Mass.--(HSMN NewsFeed)--Anika Therapeutics, Inc. (Nasdaq: ANIK ) today announced that it has received U.S. FDA approval for commercial sale of its corrective and aesthetic dermatology product. This product is licensed to Galderma Pharma, S.A. who will launch it worldwide under its proprietary brand name, ELEVESS(TM). ELEVESS is an injectable soft tissue filler for facial wrinkles and scar remediation. The product is based on Anika's chemically modified hyaluronic acid (HA) proprietary technology and incorporates lidocaine, a local anesthetic. ELEVESS offers the highest concentration of cross-linked HA available in a dermal filler, which results in a long duration of effect. Anika previously announced on April 12, 2007 that it had received CE Mark certification for ELEVESS for commercial sale in the European Union.
"With FDA approval of ELEVESS, we are now positioned to benefit from the rapid growth in the global market for aesthetic fillers," said Charles H. Sherwood, Ph.D., Anika's president and chief executive officer. The global aesthetic filler market is estimated to grow from $600 million in 2006 to more than $1 billion in 2010. The U.S. represented approximately 50% of that market last year.
"ELEVESS is the first commercial HA product approved in the U.S. for the aesthetic filler market that incorporates lidocaine, which we believe significantly enhances ELEVESS' competitive positioning," added Sherwood. "Lidocaine improves patient comfort and satisfaction, providing physicians with a new alternative for their aesthetic practice."
ELEVESS is the first in a family of products expected to be developed in partnership with Galderma Pharma S.A., a joint venture between Nestle and L'Oreal, for cosmetic tissue augmentation therapies. The commercialization of ELEVESS is aligned with Galderma's strategy to offer a wide range of corrective and aesthetic treatments, complementing its family of therapeutic solutions. Galderma's performance and reputation for success has established them as one of the premier global dermatology companies.
About Anika Therapeutics, Inc.
Headquartered in Woburn, Mass., Anika Therapeutics, Inc. develops, manufactures and commercializes therapeutic products for tissue protection, healing and repair. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. Anika's products include ORTHOVISC®, a treatment for osteoarthritis of the knee available internationally and marketed in the U.S. by DePuy Mitek; HYVISC®, a treatment for equine osteoarthritis marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc.; and the ELEVESS(TM) family of cosmetic dermatology products for facial wrinkles, scar remediation and lip augmentation (Europe only), which will be marketed by Galderma Pharma. Anika also develops and manufactures Amvisc® and Amvisc Plus®, HA viscoelastic products for ophthalmic surgery. Anika also produces STAARVISC(TM)-II, which is distributed by STAAR Surgical Company and Shellgel(TM) for Cytosol Ophthalmics, Inc.
The statements made in this press release which are not statements of historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including, without limitation, statements that may be identified by words such as "expectations," "remains," "focus," "expected," "prospective," "expanding," "building," "continue," "progress," "plan," "efforts," "hope," "believe," "objectives," "opportunities," "will," "seek," and other expressions which are predictions of or indicate future events and trends and which do not constitute historical matters identify forward-looking statements. These statements also include statements regarding: (i) Anika's expectations regarding its cosmetic dermatology product, ELEVESS(TM),including its expectations regarding a worldwide launch by Galderma, (ii) product gross margin, (iii) international sales of ORTHOVISC® and the impact on ORTHOVISC sales from international distribution agreements and product registrations around the world, and (iv) prospects for domestic ORTHOVISC sales. These statements are based upon the current beliefs and expectations of Anika's management and are subject to significant risks, uncertainties and other factors. Anika's actual results could differ materially from any anticipated future results, performance or achievements described in the forward-looking statements as a result of a number of factors including: (i) Anika's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all, obtain clinical data to support a pre-market approval application and/or FDA approval, and/or receive FDA or other regulatory approvals of its products, or that such approvals will not be obtained in a timely manner or without the need for additional clinical trials; (ii) Anika's research and product development efforts and their relative success, including whether Anika has any meaningful sales of any new products resulting from such efforts; (iii) the cost effectiveness and efficiency of our manufacturing operations and production planning; (iv) the strength of the economies in which Anika operates or will be operating, as well as the political stability of any of those geographic areas or (v) future determinations by Anika to allocate resources to products and in directions not presently contemplated. Any delay in receiving any regulatory approvals may adversely affect Anika's competitive position. Even if regulatory approvals are obtained, there is a risk that meaningful sales of the products may not be achieved. There is also a risk that (i) Anika's existing distributors (including its distributor in Turkey) or customers will not continue to place orders at historical levels or that any of them will seek to modify or terminate existing arrangements, (ii) Anika's efforts to enter into long-term marketing and distribution arrangements, including with new international distributors for ORTHOVISC, will not be successful, (iii) new distribution arrangements, including the agreement with Galderma Pharma S.A. pertaining to its ELEVESS(TM) product, will not result in meaningful sales of Anika's products, (iv) Anika will be unable to achieve performance and sales threshold milestones in its distribution agreements, (v) competitive products will adversely impact Anika's product sales, (vi) the estimated size(s) of the markets which Anika has targeted its products will fail to be achieved, (vii) lack of adequate coverage and reimbursement provided by governments and other third party payers for Anika's products and services, including non-reimbursement of ORTHOVISC in Turkey, could have a material adverse effect on our results of operations, or (viii) increased sales of Anika's products, including HYVISC®, ORTHOVISC , or its ophthalmic products, will not continue or sales will decrease or not reach historical sales levels, or even if such increases occur that such increases will improve gross margins, any of which may have a material adverse effect on Anika's business and operations. Certain other factors that might cause Anika's actual results to differ materially from those in the forward-looking statements include those set forth under the headings "Business," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in each of Anika's Annual Report on Form 10-K for the year ended December 31, 2006, Form 10-Q for the quarter ended March 31, 2007, as well as those described in Anika's other press releases and SEC filings.
Source: Anika Therapeutics
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