i am a very happy person today, esp. since i bought in 2 days ago!...now, we wait for the favorable ruling on prilosec and we move another 10 points?.
Andrx ANDAs for Wellbutrin SR/Zyban Receive Summary Judgement of Non-Infringement
FORT LAUDERDALE, Fla., Mar 1, 2002 (BUSINESS WIRE) -- ANDRX CORPORATION -- Andrx Group (Nasdaq: ADRX chart, msgs) today announced that Judge Wilkie D. Ferguson, Jr. of the United States District Court for the Southern District of Florida has issued an order granting Andrx's motion for summary judgment of non-infringement with regard to Andrx's bioequivalent versions of Wellbutrin SR(R) and Zyban(R). The court also denied the cross motion for summary judgement by Glaxo Wellcome Plc ("Glaxo"). Marketed by Glaxo, Wellbutrin SR is a buproprion hydrochloride extended-release tablet marketed for the treatment of depression, which generated 2001 brand sales of approximately $1.1 billion and Zyban is a buproprion hydrochloride extended-release tablet prescribed for the cessation of smoking, which achieved 2001 brand sales of nearly $93 million.
Andrx filed abbreviated new drug applications (ANDAs) for its bioequivalent versions of all strengths of these two products in mid-1999. Glaxo commenced patent infringement litigation against Andrx in October 1999, within the 45-day period following its receipt of Andrx's notice that its ANDA products did not infringe Glaxo's patents. While the statutory thirty-month stay during which Andrx's products cannot receive FDA approval expires in March 2002, Andrx does not anticipate receiving FDA approval at that time. Andrx believes that it has addressed all of FDA's concerns and that FDA approval should be received by mid-year.
Andrx believes that it was the first company to have its ANDAs accepted for filing for the principal strength of Wellbutrin SR (150 mg) and Zyban, and that its ANDAs will be entitled to 180-days of marketing exclusivity. This exclusivity period is expected to begin following the launch of each of Andrx's products.
Commenting on the news, Elliot F. Hahn, Ph.D., Chief Executive Officer and President of Andrx, stated: "While the whole world is watching our Prilosec battle, I am obviously pleased that Andrx's legal position has once again been upheld. Judge Ferguson's order will enable Andrx to offer consumers cost-effective bioequivalent alternatives to billion dollar plus products. As I said last week, while the process may be gut-wrenching, slow and expensive, we remain confident that our legal team will ultimately prevail in these patent litigation battles."
Andrx Corporation is a specialty pharmaceutical company engaged in the formulation and commercialization of oral controlled-release generic and brand pharmaceuticals utilizing its proprietary drug delivery technologies.
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," "to," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative or other variations thereof or comparable terminology is 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.
This release and additional information about Andrx Corporation are also available on the Internet at: andrx.com. |
