News Release Detail
Mylan Announces Omeprazole Launch
On June 2, 2003, Mylan reported that the U.S. Food and Drug Administration had granted final approval for Mylan Pharmaceuticals' Abbreviated New Drug Application for those strengths, as well as tentative approval for the 40 mg strength. Omeprazole is the generic version of AstraZeneca LP's Prilosec®. A decision on Mylan's motion for summary judgment of noninfringement in the pending patent infringement litigation has not yet been rendered.
Furthermore, at this time, Mylan reiterates its previously-announced fiscal 2004 earnings guidance of $1.67 to $1.77 per diluted share.
Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories, Inc. and Bertek Pharmaceuticals Inc. that develop, manufacture and market an extensive line of generic and proprietary prescription products. For more information about Mylan, visit www.mylan.com.
This press release includes statements that constitute "forward-looking statements", including with regard to Mylan Pharmaceuticals' sale of omeprazole capsules and Mylan's projected fiscal 2004 earnings. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: uncertainties regarding the unresolved patent infringement allegations against the Company, including the possibility that the patent holder may seek, and may be granted, injunctive relief or money damages; the possible negative effects of any interruption of manufacturing of the omeprazole capsules at the Company's facility; the Company's ability to successfully develop, license or otherwise acquire and introduce new products on a timely basis in relation to competing product introductions; the Company's ability to obtain required FDA approvals for new products on a timely basis; uncertainties regarding continued market acceptance of and demand for the Company's products; the Company's periodic dependence on a relatively small group of products as a significant source of its net revenue or net income; the effects of vigorous competition on commercial acceptance of the Company's products and their pricing; the high cost and uncertainty associated with compliance with extensive regulation of the pharmaceutical industry; the significant research and development expenditures the Company makes to develop products, the commercial success of which is uncertain; the possible loss of business from, or the effects of any consolidation of, the Company's concentrated customer base; the potential costs and product introduction delays that may result from the use of legal, regulatory and legislative strategies by the Company's competitors; the Company's dependence on third party suppliers and distributors for raw materials; uncertainties regarding patent, intellectual and other proprietary property protections; the expending of substantial resources associated with litigation involving patent or other intellectual property protection of competing products; possible reductions in reimbursement rates for pharmaceutical products; possible negative effects on product pricing of current or future legislative or regulatory programs; the Company's exposure to lawsuits and contingencies associated with its business; uncertainties regarding the Company's performance under indemnification clauses in certain material agreements; the Company's exposure to risks inherent in acquisitions or joint ventures; uncertainties and matters beyond the control of management, which could affect the Company's earnings guidance, as well as the subjectivity inherent in any probability weighted analysis underlying the Company's assumptions and estimates with respect to the future; and the other risks detailed in the Company's periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release.
CONTACT: Mylan Laboratories Inc. Kris King, 724/514-1800
SOURCE: Mylan Laboratories Inc.