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.

Biotech / Medical : IVAX Insider Trading -- Ignore unavailable to you. Want to Upgrade?

To: 5,17,37,5,101,... who wrote (218)	11/26/1997 9:32:00 PM
From: 5,17,37,5,101,...	Respond to of 756

Wednesday November 26, 3:46 pm Eastern Time FDA to Review Immunex Application for Paclitaxel SEATTLE, Nov. 26 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX - news) announced today that the United States Food and Drug Administration (FDA) accepted for review its abbreviated new drug application (ANDA) for generic Paclitaxel Injection. Paclitaxel, currently marketed by Bristol-Myers Squibb under the trademark Taxol(R), is used to treat metastatic breast and ovarian cancers that have not responded to first-line therapies. Breast and ovarian cancers continue to be leading health concerns for women. The American Cancer Society estimates that this year approximately 180,000 women will be diagnosed with breast cancer and another 27,000 with ovarian cancer. Taxol has become an important therapy when these cancer cases become unresponsive to treatment, or refractory, and U.S. sales are estimated to be more than $500 million in 1997. A recent study by National Economic Research Associates indicates that paclitaxel competition could lead to significant cost savings in the U.S. healthcare system. Bristol-Myers Squibb has enjoyed market exclusivity for Taxol pursuant to provisions of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the ''Waxman-Hatch'' Act. This legislation provides Bristol-Myers Squibb with marketing exclusivity through provisions that bar FDA from accepting paclitaxel ANDAs (generic drug applications) for filing until December 29, 1997. However, a provision of the Waxman-Hatch Act permits a competitor to file an ANDA after four years of exclusivity if the application contains a Paragraph IV patent certification. Two patents recently issued to Bristol-Myers Squibb relating to paclitaxel provide the basis for Immunex's early filing. The Immunex ANDA, which was submitted on August 8, 1997 and accepted for review on October 7, 1997, contains a certification by the company, known as a ''Paragraph IV'' certification, that U.S. Patents 5,641,803 and 5,670,537 held by Bristol-Myers Squibb and relating to Taxol are invalid and not infringed by the Immunex paclitaxel product. If Bristol-Myers Squibb files suit against Immunex, the FDA may withhold clearance of Immunex's ANDA until the earlier of June 2000, which is approximately seven and one-half years after the original clearance of Taxol, or until a court enters a final judgment finding the patents invalid, unenforceable or not infringed. As an incentive for a successful patent challenge, the first ANDA applicant to file and meet FDA requirements is accorded 180 days of marketing co-exclusivity with the reference drug (in this case Taxol). However, there can be no assurance that Immunex's challenge will be successful or provide the basis for a grant of co-exclusivity, that FDA will approve Immunex's ANDA, or that Bristol-Myers Squibb will not obtain or enforce additional patents relating to Taxol. Bristol-Myers Squibb also may seek a legislative extension of Waxman-Hatch exclusivity. If such events occur, Immunex may discontinue development of its paclitaxel product. Immunex's paclitaxel product development ''Paclitaxel Injection could provide Immunex with an opportunity to expand our oncology product line in the United States,'' said Peggy Phillips, senior vice president of pharmaceutical development for Immunex. ''In September Paclitaxel Injection was launched in Canada. We're excited about the possibility of bringing another paclitaxel option to U.S. consumers in the future.'' In July 1997, Immunex received the first approval to market a competing paclitaxel product in North America from the Health Protection Branch in Canada. Boehringer-Ingelheim (Canada) Ltd. has acquired Canadian marketing rights for Immunex's Paclitaxel Injection product and is responsible for product distribution. In Canada, the only approved and available paclitaxel product that is competitive to Taxol is Paclitaxel Injection. The bulk paclitaxel drug in the current formulation of the Inummex product is provided by Hauser, Inc. About paclitaxel Paclitaxel is a chemotherapeutic agent discovered by researchers at the National Cancer Institute (NCI) in 1971. After investing more than 15 years and approximately $32 million in taxpayer dollars in research and development, NCI signed a research agreement in 1991 contracting with Bristol-Myers Squibb to complete product development. Taxol was cleared for marketing the following year (December 1992). Immunex Corporation is a biopharmaceutical company dedicated to developing immune system science to protect human health. The company's products offer hope to patients with cancer, inflammatory and infectious diseases. SOURCE: Immunex Corp.