Anika Therapeutics Files Pre-Market Application With U.S. FDA For ORTHOVISC.WOBURN, Mass.--(BW HealthWire)--Jan. 5, 1998--(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 ) Anika Therapeutics, Inc. announced on Dec. 31, 1997 it submitted a Pre-Market Approval Application (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) to the U.S. 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. ) seeking approval to market ORTHOVISC, an injectable form of hyaluronic acid (HA) for treatment of osteoarthritis of the knee. Anika's PMA application to the FDA includes clinical data on 226 patients from studies conducted at 10 centers throughout the U.S. The Company's pivotal clinical trial, completed in June 1997, was designed to evaluate the safety and effectiveness of the use of ORTHOVISC in reducing joint pain and other symptoms associated with osteoarthritis in the knee. Osteoarthritis is a degenerative joint disease degenerative joint disease n. Abbr. DJD See osteoarthritis. degenerative joint disease Osteoarthritis, see there characterized by joint pain, stiffness and the loss of mobility. Over 16 million Americans are afflicted with some type of osteoarthritis. ORTHOVISC is an ultra-pure, high molecular weight, naturally derived hyaluronic acid (HA), designed to emulate the 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" , lubricating and cushioning properties of natural HA contained in the synovial fluid of a healthy joint. ORTHOVISC is injected into the joint space three times over a two week period to provide viscosupplementation and pain relief. ORTHOVISC is currently approved for sale in Europe, Canada and Turkey. Last month, Anika signed a marketing and distribution agreement potentially worth up to $23 million in licensing payments with Zimmer, Inc. a subsidiary of Bristol-Myers Squibb to represent ORTHOVISC in the U.S., Canada and select Asia-Pacific markets. The Company also signed an agreement in October with Grupo Ferrer Internacional S.A. to distribute ORTHOVISC in Spain and Portugal. Registrations for marketing approval have also been filed in Australia and New Zealand. "We are encouraged by the results of the pivotal ORTHOVISC clinical trial and that we met our goal of filing the PMA by year end," said J. Melville Engle, president and chief executive officer. Engle added that the company has been pleased with ORTHOVISC sales in Turkey and expects to commence sales in Canada, Spain and Portugal in early 1998. Two other HA products for osteoarthritis of the knee, Synvisc, distributed by Wyeth Laboratories Inc., and Hyalgan, distributed by Sanofi Pharmaceuticals Inc. and Orthologic, recently received FDA approval for marketing and have been launched in the U.S. Anika Therapeutics, Inc. is a leading developer and manufacturer of technologically advanced hyaluronic acid products for surgical and therapeutic medical applications. Anika has ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9001 certification for the manufacture of ORTHOVISC and AMVISC(R) and AMVISC Plus(R). The company's commercial product portfolio includes: ORTHOVISC for the treatment of osteoarthritis; AMVISC and AMVISC Plus to maintain eye shape and protect delicate tissues during ophthalmic surgery; and HYVISC(R)for the treatment of equine osteoarthritis. Products under development include: INCERT(R) for the prevention of surgical adhesions and HA oligosaccharides oligosaccharides (ol´igōsak´  rīdz),n. for the treatment of cancer. Anika also has a multi-year agreement with Orquest to produce OSSIGEL(TM), an injectable formulation of hyaluronic acid and basic fibroblast growth factor Basic fibroblast growth factor, also known as bFGF or FGF2, is a member of the fibroblast growth factor family. In normal tissue, basic fibroblast growth factor is present in basement membranes and in the subendothelial extracellular matrix of blood for acceleration of bone fracture healing. -0- This press release includes forward-looking statements within the meaning of Section 27A of the Securities Exchange Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company's actual results could differ materially from those set forth in the forward-looking statements. Certain factors that might cause such a difference include the ability to obtain FDC FDC - Floppy Disk Controller approval for ORTHOVISC and the timing of any such approval, the ability of the Company's distribution partners to successfully market ORTHOVISC as well as the factors set forth as Risk Factors in the Company's Final Prospectus filed with the Securities and Exchange Commission on November 25, 1997. CONTACT: Anika Therapeutics, Inc. Sean Moran, C.F.O., 617/932-6616, x102 OR Pondel Parsons & Wilkinson Susan Klein, 508/358-4315 Robert Whetstone whetstone, natural or manufactured stone used as an abrasive solid to sharpen tools. It is used dry, with water, or with oil. Such a stone of the finer grade used with oil is usually called an oilstone. , 310/207-9300 |
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