ALLEGAN, Mich., May 5 Perrigo (Nasdaq: PRGO; TASE) today announced that it has acquired the exclusive U.S. store brand rights to sell and distribute Dextromehtorphan Polistirex Extended Release Suspension Cough Suppressant, the generic version of Reckitt Benckiser's Delsym® from Tris Pharma. Tris believes it has a first to file ANDA application for the generic that can entitle it to 180 days of generic exclusivity upon approval. Tris and Reckitt Benckiser are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Tris ANDA filing. Under the agreement Perrigo and Tris will share profits, and Perrigo will pay Tris certain milestone payments.
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Delsym® is indicated for 12-hour cough relief. It is estimated that it has annual sales of approximately $125 million dollars, according to data provided by Information Resources, Inc.
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Perrigo's Chairman and CEO Joseph C. Papa stated, "This is another example of Perrigo's strategic focus on introducing new products which will make quality healthcare more affordable to American consumers."
Tris' CEO Ketan Mehta stated, "Tris was able to file this first ever generic of a sustained release liquid product via Tris' proprietary OralXR+ technology. We are pleased to work with Perrigo, the clear OTC store brand leader with this important product."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products, infant formula, 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, Australia, Israel, Mexico and the United Kingdom. Visit Perrigo on the Internet (http://www.perrigo.com).
Tris Pharma is a privately owned, product-focused, specialty pharmaceutical company engaged in the research and development of innovative drug delivery technologies. Through its OralXR+ platform, Tris has pioneered the delivery of sustained release in the liquid, chewable/ODT and strip dosage forms so patients do not have to swallow a pill. Tris' Nobuse platform provides abuse-deterrence for opioids and other abuse-prone drugs. The company has more than 20 Rx and OTC products in development with pharmaceutical partners. Tris' R&D and manufacturing facilities are located in Monmouth Junction, New Jersey. Visit Tris on the Internet (http://www.trispharma.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 27, 2009, 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 Company
