Anika Therapeutics Completes Pivotal Clinical Study of ORTHOVISC.WOBURN, Mass.--(BW HealthWire)--Sept. 2, 1997-- Preliminary Results Promising; Company to File 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 by Year End 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 Small Cap:ANIK) today announced it has completed its pivotal clinical study of ORTHOVISC (intra-articular injection of hyaluronic acid for the treatment of osteoarthritis of the knee). Based on the analysis of the data, the company plans to file a Pre-Market Approval (PMA) application with 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. ) by the end of the year. The 226-patient, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, placebo-controlled, pivotal clinical study was conducted at 10 centers in the U.S. The study was designed to evaluate the utility of ORTHOVISC in the reduction of joint pain and overall symptoms associated with osteoarthritis, a chronic, debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction joint disease characterized by joint pain, stiffness and loss of motion afflicting nearly 16 million Americans. 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" and cushioning properties of natural HA contained in the synovial fluid of a healthy joint that coats, lubricates and provides shock absorption protection to joint tissues. ORTHOVISC is injected into the joint space three times over a two week period to provide viscosupplementation. "We are encouraged by the promising results of the pivotal clinical study and believe that ORTHOVISC could benefit patients suffering from osteoarthritis of the knee," stated J. Melville Engle, president and chief executive officer. ORTHOVISC is approved for marketing in Canada, Turkey, Europe and certain other countries. Two other HA products for osteoarthritis of the knee (Synvisc, distributed by Wyeth Ayerst and Hyalgan, distributed by Sanofi and Orthologic) recently received FDA approval for marketing in the United States. 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. The company's commercial product portfolio includes: ORTHOVISC for the treatment of osteoarthritis; AMVISC to maintain eye shape and protect delicate tissues during opthalmic surgery; and HYVISC for the treatment of equine osteoarthritis. Products under development include: INCERT for the prevention of surgical adhesions and HA oligosaccharides oligosaccharides (ol´igōsak´  rīdz),n. for the treatment of cancer. Anika recently executed a multi-year agreement to collaborate with Orquest to produce OSSIGEL, 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 the 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 and are subject to a number of risks, such as the results of the FDA's review of the Company's planned PMA application. CONTACT: Anika Therapeutics, Inc. Pondel Parsons & Wilkinson Sean Moran, C.F.O. Susan Klein, (508) 358-4315 (617) 932-6616, x102 Robert Whetstone, (310) 207-9300 |
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