Anika Therapeutics Announces Biomatrix Withdraws Lawsuit Against the Company.WOBURN, Mass.--(BUSINESS WIRE)--Jan. 14, 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 inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . announced today that a lawsuit regarding product claims brought by Biomatrix, Inc. against Anika in November 1997 has been voluntarily withdrawn with no payment or concessions from Anika. On November 25, 1997, Biomatrix, a competitor of Anika, filed a lawsuit against the company in the United States District Court United States District Court In the U.S., any of the 94 trial courts of general jurisdiction in the federal judicial system. Each state, as well as the District of Columbia and the Commonwealth of Puerto Rico, has at least one federal district court. for Massachusetts alleging that Anika had made false and misleading statements regarding Biomatrix's Synvisc(r) product and Anika's ORTHOVISC product and sought injunctive relief and damages. Anika stated at the time that it believed that Biomatrix's claims were without merit and that it would vigorously seek to protect its rights regarding such claims. On December 23, 1997, Anika filed a motion seeking to dismiss certain claims made by Biomatrix in the litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. . Subsequently, Biomatrix voluntarily offered to dismiss the litigation without prejudice and with no payment or concessions from Anika. On January 8, 1998, Biomatrix filed with the court a Stipulation of Dismissal Without Prejudice dismissal without prejudice n. see dismissal. and it has been executed by both parties. "We are pleased that Biomatrix has chosen to withdraw this lawsuit which we firmly believe was without merit," said J. Melville Engle, Anika president and chief executive officer of Anika. "We will continue to vigorously protect our rights to make product claims with respect to our technology." Engle added. ORTHOVISC is an injectable form of hyaluronic acid intended for the symptomatic treatment of osteoarthritis of 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. More than 16 million Americans are afflicted with some type of osteoarthritis. ORTHOVISC is an ultra-pure, high molecular weight, naturally derived hyalronic acid (HA) product, 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 unto the joint space three times over a two week period to provide viscosupplementation and pain relief. Last month Anika submitted a Pre-Market Approval Application to the U.S. Food and Drug Administration seeking approval to market ORTHOVISC. In November 1997, 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. Anika also signed an agreement in October 1997 with Grupo Ferrer Internacional S.A. to distribute ORTHOVISC in Spain and Portugal. ORTHOVISC is currently approved for sale in Europe, Canada, and Turkey. Registrations for marketing approval have also been filed in Australia and New Zealand. Two other HA products for osteoarthritis of the knee, Synvisc, manufactures by Biomatrix, and Hyalgan, manufactures by Fidia, S.P.A., have recently received 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. 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 application. 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, 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. Product 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 FDA 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, 310/207-9300 |
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