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HAYWARD, Calif.--([ BUSINESS WIRE ])--Impax Laboratories, Inc.(NASDAQ: IPXL) today announced that it has reached agreement with Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), to settle pending U.S. litigation with regard to the production and sale of generic formulations of RENVELA (sevelamer carbonate 800 mg tablet and oral suspension 2.4g and 0.8g) and RENAGEL (sevelamer hydrochloride 400 mg and 800 mg tablets). Under the terms of the settlement, Genzyme has agreed to grant Impax a license to sell a generic version of RENVELA tablets on March 16, 2014 or earlier under certain circumstances. Genzyme has also agreed to grant Impax a license to sell a generic version of RENVELA for oral suspension and of RENAGEL on September 16, 2014 or earlier under certain circumstances.

The Company believes that it is the first to file an ANDA with a paragraph IV certification with respect to the sevelamer carbonate 800 mg tablet product, and expects to be entitled to 180-days of market exclusivity prior to the launch of additional ANDA products. Upon the agreed-upon launch dates, Global Pharmaceuticals, Impaxas generic division, intends to commercialize the products.

RENAGEL and RENVELA are both indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

As reported by Sanofi, net sales of RENAGEL and RENVELA were 415 million a' ($512 million based on a current exchange rate of $1.257) from April 1, 2011 to the end of the year. In the first half of 2012, net sales of RENAGEL and RENVELA were 312 million a' ($392 million based on a current exchange rate of $1.257).

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 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, Philadelphia and Taiwan 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 Companyas 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, the effect of current economic conditions on the Companyas industry, business, financial position and results of operations, fluctuations in the Companyas revenues and operating income, the Companyas ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer, the impact of consolidation of the Companyas customer base, the impact of competition, the Companyas ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Companyas Taiwan facility, the effect of foreign economic, political, legal and other risks on the Companyas operations abroad, the uncertainty of patent litigation, increased government scrutiny on the Companyas agreements with brand pharmaceutical companies, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, the Companyas inexperience in conducting clinical trials and submitting new drug applications, the Companyas ability to successfully conduct clinical trials, the Companyas reliance on third parties to conduct clinical trials and testing, the availability of raw materials and impact of interruptions in the Companyas supply chain, the use of controlled substances in the Companyas products, disruptions or failures in the Companyas information technology systems and network infrastructure, the Companyas reliance on alliance and collaboration agreements, the Companyas dependence on certain employees, the Companyas ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, the Companyas ability to protect the Companyas intellectual property, exposure to product liability claims, changes in tax regulations, the Companyas ability to manage the Companyas growth, including through potential acquisitions, the restrictions imposed by the Companyas credit facility, uncertainties involved in the preparation of the Companyas financial statements, the Companyas ability to maintain an effective system of internal control over financial reporting, any manufacturing difficulties or delays, the effect of terrorist attacks on the Companyas business, the location of the Companyas manufacturing and research and development facilities near earthquake fault lines and other risks described in the Companyas 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.