Anika Therapeutics Receives FDA Approvable Letter For Its Cosmetic Tissue Augmentation Product

Main Category: Cosmetic Medicine / Plastic Surgery
Also Included In: Dermatology
Article Date: 29 Nov 2006 - 0:00 PDT

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Anika Therapeutics, Inc. (Nasdaq: ANIK) today announced that it has received an FDA approvable letter for its cosmetic tissue augmentation ("CTA") product. CTA is an injectable soft tissue filler for facial wrinkles, scar remediation and lip augmentation. The product is based on Anika's chemically modified hyaluronic acid (HA) proprietary technology and incorporates lidocaine, a local anesthetic. The final approval is expected by the end of 2006.

"Receiving PMA approval for our cosmetic tissue augmentation product represents a major achievement for Anika," said Charles H. Sherwood, Ph.D., Anika's president and chief executive officer. "This approval is an important step towards commercialization of a family of dermal filler products worldwide."

The global market for cosmetic fillers has been estimated at between $400 and $500 million, with the United States representing about 50% of that market. According to the most recent American Society for Aesthetic Plastic Surgery reports, non surgical procedures using hyaluronic acid soft tissue fillers showed annual growth of 35%.

Anika anticipates filing amendments with the FDA and European Union regulators to enhance product features prior to the launch of the CTA product. Commercialization of this enhanced version of the CTA product is estimated to commence in mid-2007.

The CTA product is the first in a family of products expected to be developed and commercialized with Galderma Pharma S.A., a joint venture between Nestle and L'Oreal, for cosmetic tissue augmentation therapies. Galderma's worldwide performance and reputation for success has established them as one of the premier dermatological companies. This project continues Galderma's commitment to provide innovative therapeutic skincare solutions to meet the needs of dermatology patients and physicians.

About Anika Therapeutics, Inc.

Headquartered in Woburn, Mass., Anika Therapeutics, Inc. (http://www.anikatherapeutics.com) develops, manufactures and commercializes therapeutic products for tissue protection, healing and repair. These products are based on hyaluronic acid, a naturally occurring, biocompatible polymer found throughout the body. Anika products include ORTHOVISC(R), a treatment for osteoarthritis of the knee available internationally and marketed in the U.S. by DePuy Mitek and Hyvisc(R), a treatment for equine osteoarthritis marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc. Anika developed and manufactures Amvisc(R) and Amvisc Plus(R), HA viscoelastic products for ophthalmic surgery. It also produces STAARVISC(TM)-II, which is distributed by STAAR Surgical Company and Shellgel(TM) for Cytosol Ophthalmics, Inc.

Anika Therapeutics, 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 "should," "anticipates," "estimated," "expected," "strive," "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. These statements also include statements regarding: (i) the company's expectations regarding its cosmetic tissue augmentation product, (ii) its goal to obtain U.S. and European Union marketing approval for its initial and enhanced cosmetic tissue augmentation products, (iii) the size of the CTA market, (iv) the ability or likelihood to resolve manufacturing issues, and (v) its ability to develop and commercialize a family of products. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks, uncertainties and other factors. The company'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) the company's ability to receive FDA or other regulatory approvals of its products, or that such approvals will be obtained in a timely manner or without the need for additional clinical trials; or (ii) the company's research and product development efforts and their relative success, including whether the company can successfully develop a family of CTA products, or if developed, such products will achieve commercial success. Any delay in receiving any regulatory approvals may adversely affect the company's competitive position. Even if regulatory approvals are obtained, there is a risk that (i) the agreement with Galderma Pharma S.A. pertaining to its CTA product, will not result in meaningful sales of the company's products, (ii) the company will be unable to achieve performance and sales threshold milestones in its distribution agreements, (iii) competitive products will adversely impact the company's product sales, or (iv) the estimated size of the market which the company has targeted its products will fail to be achieved. 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 of Financial Condition and Results of Operations" in each of the company's Annual Report on Form 10-K for the year ended December 31, 2005, and its Quarterly Report on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2006 and Current Reports on Form 8-K, as well as those described in the company's other press releases and SEC filings.

Anika Therapeutics, Inc.
http://www.anikatherapeutics.com

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