HAYWARD, Calif., Mar 02, 2010 (BUSINESS WIRE) -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version of FLOMAX(R) (tamsulosin hydrochloride) 0.4mg capsules. The Company also announced that it is commencing shipment through Global Pharmaceuticals, Impax's generic division.
Larry Hsu, Ph.D., president and chief executive officer of Impax Laboratories, said: "We are pleased to report the final approval of our ANDA and that we are immediately commencing nation-wide shipment of our generic to FLOMAX(R). This represents a significant milestone and opportunity for our Company, having the potential to be our largest product launch to date under Global Pharmaceuticals label. Such an opportunity could not be possible if it weren't for the substantial effort from many of our employees. Their efforts have been instrumental in preparing us to be positioned to capture as much of the market opportunity as possible within a limited shared exclusivity period."
As previously announced, in October 2009, the Company reached agreement with Astellas Pharma Inc. and Boehringer Ingelheim Pharmaceuticals, Inc. to settle U.S. patent litigation related to the Comany's ANDA for its generic FLOMAX(R) capsules. The settlement of the litigation provided the Company with the opportunity to launch its generic tamsulosin hydrochloride product on March 2, 2010, prior to the expiration of pediatric exclusivity.
Boehringer Ingelheim Pharmaceuticals, Inc. markets FLOMAX(R) for the functional symptoms of benign prostatic hyperplasia. According to Wolters Kluwer Health, U.S. sales of FLOMAX(R) 0.4mg capsules were approximately $2.1 billion for the 12 months ended December 31, 2009.
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: http://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 the Company'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; ability to timely file periodic reports required by the Exchange Act; ability to maintain an effective system of internal control over financial reporting; ability to sustain profitability and positive cash flows; ability to maintain sufficient capital to fund operations; any delays or unanticipated expenses in connection with the construction of our Taiwan facility; ability to successfully develop and commercialize pharmaceutical products; the uncertainty of patent litigation; consumer acceptance and demand for new pharmaceutical products; the impact of competitive products and pricing; the difficulty of predicting Food and Drug Administration filings and approvals; inexperience in conducting clinical trials and submitting new drug applications; reliance on key alliance agreements; the availability of raw materials; the regulatory environment; exposure to product liability claims; fluctuations in operating results and other risks described in our Annual Report on Form 10-K for the year ended December 31, 2008. 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.
SOURCE: Impax Laboratories, Inc.
Impax Laboratories, Inc.
Mark Donohue, 215-933-3526
Sr. Director, Investor Relations and Corporate Communications