ANDRX ANDA For Prilosec is Tentatively Approved
Final FDA Approval Would Authorize Generic Launch of Largest Selling Pharmaceutical in U.S. Today
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--March 27, 2000--ANDRX CORPORATION (Nasdaq:ADRX - news) today announced that the United States Food and Drug Administration (FDA) has tentatively approved its Abbreviated New Drug Application (ANDA) filed for a bioequivalent version of Prilosec© (Omeprazole Delayed-release Capsules), 10 mg, 20 mg and 40 mg strengths. Prilosec©, marketed by Astra Zeneca Plc, is used for the treatment of duodenal/gastric ulcers and gastro-esophageal reflux disease (GERD) and had total U.S. brand sales exceeding $3.5 billion in 1999. Prilosec© is the largest selling prescription drug in the United States and the world.
``This is the fifth, and most important tentative or final ANDA approval Andrx has received from the FDA since 1997. Our R&D team has once again demonstrated its scientific and technical strength in achieving this FDA approval of a difficult-to-replicate product', said Chih-Ming J. Chen, Ph.D., Co-Chairman and Chief Scientific Officer of Andrx. ``The question of when Andrx can begin marketing this important product is now in the hands of our legal team and the courts.'
As is common in this sector of the pharmaceutical industry, Andrx' bioequivalent version of Prilosec© is the subject of patent infringement litigation. The action, brought by Astra Zeneca, is currently pending in the US District Court for the Southern District of New York. Since Andrx has not challenged the validity of the patent for the basic compound of omeprazole, final approval of the Andrx ANDA can occur no sooner than April 5, 2001, the current expiration date of that patent. The life of that patent could be extended six months to October 5, 2001, if Astra Zeneca is awarded pediatric exclusivity extension by the FDA.
``This product is of great significance to American consumers' said Scott Lodin, Andrx Vice President and General Counsel. ``With this tentative approval in hand, we are hopeful that the Court in the infringement action will see through any efforts by Astra Zeneca to foment delay. The swift and successful conclusion of litigation will allow Andrx once again to benefit consumers with a lower priced product.'
Andrx is engaged in the formulation and commercialization of oral controlled-release pharmaceuticals utilizing its proprietary drug delivery technologies. In its ANDA program, the Company is developing generic versions of selected high sales volume controlled-release brand name pharmaceuticals. In its NDA program, the Company is developing its own brand name formulations of certain existing drugs that it believes may be improved by the application of the Company's drug delivery technologies. The Company also markets and distributes pharmaceutical products manufactured by third parties and, through its Cybear, Inc. subsidiary is developing internet-based software and applications for the healthcare industry.
Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained in this report that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as ``may,' ``will,' ``expect,' ``believe,' ``anticipate,' ``intend,' ``could,' ``would,' ``estimate,' or ``continue' or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties, including those risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission.
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Contact:
Andrx Corporation, Fort Lauderdale
Elliot F. Hahn, Ph.D., President, 954/584-0300
andrx.com |
