Healthcare Industry News:  sanofi-aventis 

Biopharmaceuticals Generics FDA

 News Release - August 3, 2009

Perrigo Announces FDA Approval for Generic Version of NASACORT(R) AQ

ALLEGAN, Mich., Aug. 3 (Healthcare Sales & Marketing Network) -- Perrigo Company (Nasdaq: PRGO; TASE) today announced that its partner Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA ; previously Barr Laboratories Inc.) has received final approval from the U.S. Food and Drug Administration to market Triamcinolone Acetonide Nasal Spray containing a paragraph IV certification. Perrigo's partner Teva was the first applicant to file a complete ANDA with a Paragraph IV certification for NASACORT AQ. The product was developed at Perrigo.

Under the terms of a previously disclosed settlement, Teva will be able to market the ANDA product which is manufactured by Perrigo under license from sanofi-aventis commencing on June 15, 2011. Perrigo will share in the costs and benefits in Teva's marketing of the products under the agreement.

The product is the AB-rated equivalent to Sanofi - Aventis' Nasacort(R) AQ, indicated for the treatment of the nasal symptoms of seasonal and year round allergies in adults and children six years of age and older. Sales for the brand were approximately $305 million, according to Wolters Kluwer data for the twelve months ending June 2009.

Perrigo's Chairman and CEO Joseph C. Papa concluded, "This approval is a terrific example of Perrigo's strategic focus on developing challenging products in the extended topical categories. It further demonstrates our strategy to deliver quality affordable healthcare for generic prescriptions and over the counter products."

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products. The Company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The Company's primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico and the United Kingdom. Visit Perrigo on the Internet (http://www.perrigo.com).

Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended June 28, 2008, as well as the Company's subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


Source: Perrigo

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