FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Aug. 31, 1999--
ANDRX CORPORATION (Nasdaq: ADRX) today announced that the United States Food and Drug Administration (FDA) has accepted its Abbreviated New Drug Application (ANDA) submissions for bioequivalent versions of three medications.
The first, Wellbutrin SR(R), is a buproprion hydrochloride extended-release tablet marketed by Glaxo Wellcome, Inc. for the treatment of depression. The second, Zyban(R), also marketed by Glaxo Wellcome, Inc., is a buproprion hydrochloride extended-release tablet prescribed for the cessation of smoking. The third, K-Dur(R), is a potassium chloride extended-release tablet prescribed as a potassium supplement, which is marketed by Key Pharmaceuticals, Inc., a subsidiary of Schering Plough Corporation.
Together, these branded products reported 1998 sales in the US in excess of $750 million.
All three of these ANDA products employ patented or patent pending sustained release technologies developed by Andrx and these filings all contained Paragraph IV certifications. Andrx believes that the 45-day statutory time frame for Key Pharmaceuticals to file a patent infringement suit related to the ANDA for K-Dur(R) has passed. Andrx intends to introduce its cost-effective versions of these products into the marketplace when it is practicable, as it did in June 1999 and October 1997, when Andrx began selling bioequivalent versions of Cardizem(R) CD and Dilacor(R) XR.
Andrx believes that it was the first company to have its ANDAs accepted for filing for the principal strength of Wellbutrin SR(R) (150 mg) and Zyban(R), and that its ANDAs will be entitled to 180-days of marketing exclusivity. These filings represent the fifth and sixth times that Andrx believes it has been the first company to file ANDAs that will make bioequivalent versions of controlled-release products available to the public before the brand's patent protection expires. Andrx is presently in litigation with Astra AG, Elan Pharmaceuticals, Inc. and Biovail Corporation International, for the ability to market generic versions of Prilosec(R) (the largest selling drug in the United States and throughout the world), Naprelan(R) and Tiazac(R), respectively.
Dr. Chih-Ming Chen, Co-Chairman and Chief Scientific Officer of Andrx, said, "As demonstrated by Schering Plough's apparent decision not to file a Paragraph IV suit against our generic K-Dur(R), our ANDA product employ distinctively different drug delivery technologies than does the Schering Plough product. Our generic versions of Wellbutrin SR(R) and Zyban(R) utilize our Peltab -- pellets in a tablet -- technology, and not the hydrogel matrix tablet technology that is employed by the Glaxo Wellcome products. We hope that Glaxo Wellcome will make the same determination as Schering Plough."
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 (NASDAQ: CYBA), 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.
Contact: Elliot F. Hahn, Ph.D., President of Andrx Corporation, 4001 S.W. 47th Avenue, Fort Lauderdale, Florida 33314, 954-584-0300. This release and additional information about Andrx Corporation are also available on the Internet at: http://www.Andrx.com.
COPYRIGHT 1999 Business Wire
COPYRIGHT 2000 Gale Group