AEGiS-PRn: Pharmaceutical Resources Files ANDA Submission for Megestrol Acetate Oral Suspension

Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

Pharmaceutical Resources Files ANDA Submission for Megestrol Acetate Oral Suspension

PRNewswire - October 8, 1999

SPRING VALLEY, N.Y., Oct. 8 /PRNewswire/ -- Par Pharmaceutical, a wholly owned subsidiary of Pharmaceutical Resources, Inc. ("PRI") (NYSE: PRX; PCX), has filed an abbreviated new drug application (ANDA) for megestrol acetate oral suspension with the FDA. Par believes that it was the first company to have its ANDA accepted for filing by the FDA, and that it should be entitled to a 180-day period of marketing exclusivity after approval of the product. This product was developed by Par at its Spring Valley, New York facility.

Megestrol acetate oral suspension, is the generic version of Bristol-Myers Squibb's Megace(R) Oral Suspension. Megace(R) Oral Suspension is currently prescribed for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). U.S. sales of Megace(R) Oral Suspension were approximately $100 million over the past twelve months. Par and other generic companies currently market megestrol acetate tablets but not the oral suspension.

The basic compound patent for Megace(R) has expired. Megace(R) Oral Suspension received orphan drug exclusivity that expires September 10, 2000. Bristol Myers Squibb has a formulation patent for Megace(R) Oral Suspension expiring in 2011.

Par filed a paragraph IV certification as part of its ANDA submission regarding the formulation patent. Par strongly believes that its distinct and unique formulation does not infringe the one remaining Bristol Myers Squibb formulation patent. BMS has sued Par claiming patent infringement and Par intends to vigorously defend this action.

Par anticipates marketing this product as soon as possible after September 10, 2000. However, Par may be excluded from the market for a period of 30 months based on current legislation. The duration and/or final outcome of the litigation and the FDA's treatment of exclusivity are subject to many factors beyond the direct control of Par.

PRI is a holding company with subsidiaries that develop, manufacture, and distribute generic pharmaceutical products.

Certain statements in this press release may constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those concerning management's expectations with respect to future events or future financial performance. Any such statements that refer to PRI's anticipated future results, product performance, or other non-historical facts are forward-looking and reflect PRI's current perspective of existing trends and information. These statements involve risks and uncertainties that cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the uncertainty associated with complex litigation, including the eventual outcome and litigation costs and expenses incurred along the way, the success of PRI's product development activities, and the timeliness with which regulatory authorizations and product introduction may be achieved, market acceptance of PRI's products, the availability on commercially reasonable terms of raw materials, successful compliance with extensive, costly, complex, and evolving governmental regulations and restrictions, exposure to product liability, and other risks and uncertainties detailed in PRI's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, 10-Q, and Form 8-K reports.

SOURCE Pharmaceutical Resources, Inc.

CONTACT: Kenneth I. Sawyer, Chief Executive Officer of Pharmaceutical Resources, Inc., 914-425-7100/
991008
PR991015

Copyright © 1999 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019 http://www.prnewswire.com.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Elton John AIDS Foundation UK, the National Library of Medicine, AIDS Walk of Orange County, and donations from users like you.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1999. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .