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Biotech / Medical : anika research(anik) -- Ignore unavailable to you. Want to Upgrade?

To: John McCarthy who wrote (94)	2/2/1998 10:21:00 AM
From: Joe T. Kelly	Read Replies (2) \| Respond to of 328

Feb 20th FDA meeting on osteoporosis is this when activity will resume ? Anyone have any ideas as to possible date of approval ? Thanks, Joe

To: John McCarthy who wrote (94)	2/12/1998 9:06:00 PM
From: chirodoc	Read Replies (2) \| Respond to of 328

Anika Therapeutics Names Michael Slater Vice President Quality Systems and Regulatory Affairs BusinessWire, Thursday, February 12, 1998 at 07:35 WOBURN, Mass.--(BW HealthWire)--Feb. 12, 1998--(NASDAQ:ANIK) . . . ANIKA THERAPEUTICS, INC. today announced Michael R. Slater, formerly a senior executive with ImmuLogic Pharmaceutical Corporation and Biogen, Inc., has joined the company as vice president, quality systems and regulatory affairs. He fills a post vacated by Mary Ellen Freddo, who left Anika for personal reasons. Slater, 51, most recently ran an independent regulatory affairs consulting practice. From 1995 to 1996, he was executive vice president, development operations for Waltham-based ImmuLogic Pharmaceutical Corporation where he was responsible for regulatory affairs, quality assurance, production, process development and formulation studies. For the 12 years prior, he was with Biogen, Inc., serving for 10 years as vice president, regulatory affairs. Slater began his corporate career with Hoescht Pharmaceuticals, U.K. Slater holds a bachelor's degree from the Metropolitan University of Leeds, England. Among his numerous professional qualifications and memberships, he was a member of the Biotechnology Advisory Committee and Subcommittee on FDA affairs of the Pharmaceutical Research Manufacturers' Association and a member of the FDA Committee of the Biotechnology Industry Association. "With one of our key products, ORTHOVISC(r), under review with the FDA, and being commercialized internationally through the Zimmer division of Bristol-Myers Squibb and select European distributors, Michael is joining us at an important time," said J. Melville Engle, Anika president and chief executive officer. "We welcome his expertise and expect that Michael will play a key role in obtaining regulatory approvals and expanding sales," Engle added. Anika Therapeutics, Inc. develops, manufactures and commercializes therapeutic products and devices intended to promote the protection and healing of bone, cartilage and soft tissue. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. Anika's currently marketed products consist of ORTHOVISC for the treatment of osteoarthritis in humans and HYVISC(r) for the treatment of equine osteoarthritis. Anika also manufactures AMVISC(r) and AMVISC(r) Plus, HA products used as viscoelastic supplements in ophthalmic surgery for Chiron Vision, a division of Chiron Corporation. Therapies currently under development include INCERT(r), an HA product designed to prevent post-surgical adhesions and HA oligosaccharides for the treatment of cancer. Anika is also collaborating with Orquest, Inc. to manufacture OSSIGEL(tm), an injectable formulation of basic fibroblast growth factor combined with HA designed to accelerate the healing of bone fractures

To: John McCarthy who wrote (94)	2/27/1998 10:45:00 PM
From: Mike Relyea	Respond to of 328

John, You asked in your post #410 on the Biomatrix thread: What is TMJ? How big is the market (can you post a link)? Have they filed with the FDA already on this? The following is from an Information Statement, dated 29 April 1993, provided to MedChem shareholders in connection with the spin-off of Anika to MedChem shareholders: "TMJ dysfunction is a painful condition affecting the joint connection the lower jaw to the cranium, which afflicts millions of people in the United States alone. TMJ dysfunction may develop slowly over a period of years after a jaw injury or may result from personal habits, such as chewing pencils or ice, grinding teeth or clenching the jaw from tension. TMJ dysfunction is a widespread problem that can be segregated into various categories. Among these are: Displace Meniscus with Reduction ("DMN"), characterized by joint pain, limited movement and locking of the jaw. The vast majority of intra-articular TMJ problems tend to be symptomatic of DMR, as opposed to DMN. The exact prevalence of TMJ dysfunction is not known. According to published sources, many studies conducted over the past twenty years have found that sever TMJ problems are most common in women between the ages of 20 and 40. These studies have found that approximately 19% of this female population (or over eight million women in the United States) experience TMJ disorders of varying levels of severity, and approximately 7% (or three million women in the United States) experience disorders sever enough to require treatment. Women over the age of 40 and men constitute additional potential markets for the treatment of TMJ dysfunction. To date, conservative no-surgical treatment of DMR and DMN has been limited to extensive physical therapy, which is frequently unsuccessful. Surgical treatment for sever cases of TMJ dysfunction is complex, traumatic, painful, costly, often unsuccessful and, in some cases, unsafe.. . . . . . . MedChem submitted a PMA application to the FDA in September 1991 based upon the ORTHOVISC study. In December 1992, the FDA accepted for filing Anika's PMA application for ORTHOVISC. Unless additional issues are raised by the FDA during its review of the PMA application and the related clinical data, Anika anticipates that an FDA advisory panel will complete its review of the PMA application by the end of 1993 or early 1994, although Anika cannot predict when the remaining stages of the FDA review process will be completed." You asked: Lastly, what's your 2 cents on why BIOX has not moved? My comment: Entire biotech sector is down. You asked: Do you have any insight as to how well SYNVISC is doing out there in the real world? My comment: No, but based on what I've read and Biomatrix's sales increases, I think it will do well. Mike