HAYWARD, Calif. (December 31, 2008) – IMPAX Laboratories, Inc. today announced that Warner Chilcott Laboratories Ireland Limited, Warner Chilcott Company, Inc., Warner Chilcott (US) LLC, and Mayne Pharma International PTY. LTD have filed suit for patent infringement in the United States District Court for the District of New Jersey based on the Company’s submission of Abbreviated New Drug Application (“ANDA”) for doxycycline hyclate delayed-release tablets (75 and 100 mg), generic of Doryx®, to the Food and Drug Administration. In connection with this ANDA, IMPAX provided notice that its submission includes a Paragraph IV certification stating the Company believes its product does not infringe U.S. Patent No. 6,958,161, or the patent is invalid or unenforceable.
Doryx® is a tetracycline-class antibacterial indicated for rickettsial infections, sexually transmitted infections, respiratory tract infections, specific bacterial infections, ophthalmic infections, anthrax, including inhalational anthrax (post-exposure), alternative treatment for selected infections when penicillin is contraindicated, adjunctive therapy in acute intestinal amebiasis and severe acne, and prophylaxis of malaria. According to Wolters Kluwer Health, U.S. sales of Doryx® were approximately $151 million in the 12 months ended October 31, 2008.
About IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and markets its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause IMPAX's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, possible adverse effects resulting from the delisting of and suspension of trading in IMPAX's stock, IMPAX’s failure to file any periodic reports subsequent to its quarterly report on Form 10-Q for the quarter ended September 30, 2004, the SEC’s revocation of the registration of IMPAX’s common stock under section 12 of the Securities Exchange Act of 1934, the actual time that will be required to,file a registration statement on Form 10 with respect to such stock, IMPAX's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, IMPAX's ability to successfully develop and commercialize pharmaceutical products, IMPAX's reliance on key strategic alliances, the uncertainty of patent litigation, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in IMPAX's filings with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and IMPAX undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.
Company Contacts:
IMPAX Laboratories, Inc.
Larry Hsu, Ph.D. President & CEO
(510) 476-2000, Ext. 1111
Arthur Koch, CFO
(215) 933-0351
Mark Donohue, Sr. Director IR
(215) 933-3526
www.impaxlabs.com