Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Strategies & Market Trends : The 56 Point TA; Charts With an Attitude -- Ignore unavailable to you. Want to Upgrade?

To: Doug R who wrote (22205)	10/19/1998 1:42:00 PM
From: Barbara Barry	Read Replies (1) \| Respond to of 79270

Doug, Thanks.That was my thinking. BB cairns.net.au

To: Doug R who wrote (22205)	10/19/1998 4:33:00 PM
From: Magnatizer	Respond to of 79270

ANIK is now a cat candidate Anika says FDA needs more product data Monday, October 19, 1998 12:17 PM Mail this article to a friend new! WOBURN, Mass., Oct 19 (Reuters) - Anika Therapeutics Inc. said on Monday that the Food and Drug Administration requested additional clinical data to prove the effectiveness of its ORTHOVISC treatment for osteoarthritis of the knee. "We are obviously disappointed that the FDA has indicated that more clinical data is necessary for ORTHOVISC to be approved," J. Melville Engle, president and chief executive officer, said in a statement. Anika said it received a letter from the FDA's Center for Devices and Radiological Health stating that the company's pre-market approval application for the product was not approval. The letter found that the data in its clinical trial failed to demonstrate effectiveness according to the study's pre-determined success criteria. The agency recommended that the company consult with the FDA over the design of a new study and that data in the current pre-market approval application may be included to support a future application, Anika said. Also, Anika noted that the Therapeutic Goods Administration of Australia has issued an initial decision to deny the ORTHOVISC application. An appeal will be filed as allowed under their system of approval. ORTHOVISC is currently being sold in Canada, Spain and Turkey and has received the CE Mark facilitating sale throughout the European Union, Anika said. Anika expects that its marketing partner, Zimmer Inc., a unit of Bristol-Myers Squibb Co. (Nyse:BMY) , will commence supplemental clinical studies shortly in Canada and other countries to support its marketing efforts, the company said. Data from these studies may also be used to support the new application. Spending for a new clinical trial will hurt Anika's financial results, but Anika said it believes the combination of the revenues from its international ORTHOVISC business and the Amvisc product line should be sufficient to fund its operations including expenses related to the clinical trial. In the clinical trial conducted by Anika, 226 patients with osteoarthritis of the knee were enrolled at 10 U.S. medical centers. The study was designed to assess the safety and effectiveness of ORTHOVISC in comparison to a saline placebo and entailed three intra-articular injections over a two-week period. Addressing safety, there were no serious device-related adverse events in the ORTHOVISC treatment group and there was no statistical difference in adverse events between the ORTHOVISC group and the saline placebo group. Anika, whose shares were down 7-3/4 at 4-1/4 at midday Monday following news of the FDA request for more information, said the study showed statistical significance in the WOMAC Pain Score measure, pain on standing, and other endpoints in the study. ORTHOVISC is an ultra-pure, high-molecular weight form of hyaluronic acid that is designed to emulate natural hyaluronic acid that coats, lubricates and provides shock absorption in healthy joints. Anika also makes HYVISC, which treats equine osteoarthritis. Quote for referenced ticker symbols: BMY, ANIK © 1998, Reuters ht david