Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it has reached agreement with Daiichi Sankyo, Inc. and Genzyme Corporation to settle pending patent litigation relating to its generic versions of WELCHOL® (colesevelam HCl) tablets, 625 mg and oral suspensions, 1.875 gm/packet and 3.75 gm/packet products. Under the terms of the settlement, Impax will be permitted to launch its tablet product on March 2, 2015 or earlier under certain circumstances. The settlement further provides for the launch of the oral suspension products, under terms that were not disclosed. As a result of this settlement, the litigation will be dismissed. The Company believes that it is the first to file an ANDA with a paragraph IV certification with respect to the colesevelam HCl 625mg tablet product, and expects to be entitled to at least three months of market exclusivity prior to the launch of additional ANDA products. Upon the agreed-upon launch dates, Global Pharmaceuticals, Impax’s generic division, will commercialize the products. WELCHOL® is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor and for the treatment of type 2 diabetes mellitus. According to Wolters Kluwer Health, U.S. sales of WELCHOL® Tablets and WELCHOL Oral Suspension were approximately $325 million and $65 million, respectively, for the twelve-month period ending May 2011. 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 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 periodic reports filed 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.
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