Anika Therapeutics Announces Exclusive U.S. Distribution Agreement for Elevess Injectable Dermal Filler.Anika's HA-based Dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. Filler Incorporating Lidocaine lidocaine /li·do·caine/ (li´do-kan) an anesthetic with sedative, analgesic, and cardiac depressant properties, applied topically in the form of the base or hydrochloride salt as a local anesthetic; also used in the latter form as a to be Distributed by Artes Medical BEDFORD, Mass. -- Anika Therapeutics, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ANIK ANIK Canadian COMSAT ), a leader in products for tissue protection, healing and repair based on hyaluronic acid hyaluronic acid: see mucopolysaccharide. Hyaluronic acid A polysaccharide which is an integral part of the gel-like substance of animal connective tissue; it supposedly serves as a lubricant and shock absorbent in the joints. (HA) technology, announced today that it has signed an exclusive agreement with Artes Medical, Inc. (NASDAQ:ARTE), a medical aesthetics company, to distribute and market ELEVESS[TM], Anika's cross-linked hyaluronic acid-based (HA) injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. dermal filler. ELEVESS is an injectable filler that reduces the appearance of facial wrinkles and folds such as nasolabial folds, and is the first HA-based dermal filler approved by the Food and Drug Administration ("FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ") to incorporate the anesthetic lidocaine to improve patient comfort. Artes Medical manufactures, markets and sells ArteFill([R]), the first and only FDA-approved, nonresorbable dermal filler for the correction of smile lines. "We are very pleased to reach this agreement with Artes Medical to distribute ELEVESS, our breakthrough dermal filler product," said Anika President and Chief Executive Officer Charles H. Sherwood, Ph.D. "After undertaking an extensive search with a number of potential commercialization partners, we believe that Artes Medical possesses the capabilities that can help ELEVESS achieve its full potential in the marketplace. Artes' highly experienced sales force has well established relationships with the leading aesthetic physicians in markets throughout the United States. In addition, their complementary product, deep understanding of the injectable dermal filler marketplace and compatible culture make this a highly synergistic agreement for both companies." Under the terms of the agreement, Artes Medical will receive exclusive distribution and marketing rights for ELEVESS in the United States. "Going forward, we are actively seeking partners with characteristics and capabilities similar to Artes Medical to help us distribute ELEVESS in Europe, Canada, and the rest of the world," said Sherwood. "Our hopes are high for this product and we are eager for an increasing number of doctors and patients to experience its benefits." About ELEVESS: Anika's ELEVESS is the first FDA approved injectable dermal filler to combine hyaluronic acid (HA) and lidocaine, a local anesthetic local anesthetic n. An agent that, when applied directly to mucous membranes or when injected about the nerves, produces loss of sensation by inhibiting nerve excitation or conduction. that improves patient comfort, and provides physicians with a new alternative for their aesthetic practice. Hyaluronic acid is a naturally occurring polymer found throughout the body and is present in the skin, where it supports skin structure and elasticity. Designed for longer durability based on its proprietary cross-linking technology and its high concentration of Anika's chemically modified hyaluronic acid, ELEVESS has been approved for sale in the United States, the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community and Canada. About Anika Therapeutics, Inc. Headquartered in Bedford, 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 biocompatible /bio·com·pat·i·ble/ (-kom-pat´i-b'l) being harmonious with life; not having toxic or injurious effects on biological function. polymer found throughout the body. Anika's products include ORTHOVISC([R]), a treatment for osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. of the knee available internationally and marketed in the U.S. by DePuy Mitek; HYVISC[R], a treatment for equine osteoarthritis marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc.; the ELEVESS[TM] family of aesthetic dermatology products for facial wrinkles, scar remediation and lip augmentation; AMVISC[R], AMVISC[R] Plus, STAARVISC[TM]-II and Shellgel[TM] injectable viscoelastic Adj. 1. viscoelastic - having viscous as well as elastic properties natural philosophy, physics - the science of matter and energy and their interactions; "his favorite subject was physics" HA products for ophthalmic surgery; INCERT([R]), an HA-based anti-adhesive for surgical applications; ORTHOVISC([R]) Mini a treatment for osteoarthritis targeting small joints and available in Europe; MONOVISC[TM] a single-injection osteoarthritis product based on its proprietary cross-linking technology and available in Europe; and next generation products for joint health and aesthetic dermatology based on the Company's proprietary, chemically modified HA. Forward-Looking StatementsThe 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(s)," "efforts," "hope," "believe," "objectives," "opportunities," "will," "seek," "expect" and other expressions which are predictions of or indicate future events and trends and which do not constitute historical matters identify forward-looking statements. Specifically, these statements include a risk that (i) a material amount of sales of ELEVESS will not occur, (ii) the Company's efforts to enter into long-term marketing and distribution arrangements with new international distributors for ELEVESS, will not be successful, (iii)) competitive products will adversely impact the Company's product sales, or (iv) the markets for which the Company has targeted its products will fail to be achieved, any of which may have a material adverse effect on the Company's business and operations. Certain other factors that might cause the Company'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 Management's discussion and analysis (MD&A) A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial of Financial Condition and Results of Operations" in each of the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2007 and on Form 10-Q Form 10-Q See 10-Q. for the period ended March 31, 2008, as well as those described in the Company's other press releases and SEC filings. |
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