Perrigo announces FDA final approval of Tris Pharma’s Dextromethorphan Polistirex extended-release oral Suspension
ALLEGAN, Mich. – May 30, 2012 – Perrigo Company (Nasdaq: PRGO;TASE) today announced that the U.S. Food and Drug Administration has granted final approval to Tris Pharma for its abbreviated new drug application (ANDA) for Dextromethorphan Polistirex Extended-Release Oral Suspension, the store brand equivalent to Reckitt Benckiser’s Delsym® suspension. As the exclusive marketer and distributor of this product for the store brand over-the-counter (OTC) market in the United States, Perrigo expects to begin shipping its product during its first fiscal quarter of 2013.
Litigation between Tris and Reckitt Benckiser is ongoing in the United States District Court for the District of New Jersey, where the court has previously granted summary judgment of non-infringement of the asserted patent claims. As the Tris ANDA was the first one submitted with a paragraph IV certification, marketing of the product is entitled to 180 days of generic exclusivity.
Delsym® is indicated for the treatment of cough due to minor throat and bronchial irritation. Perrigo estimates the past 52-weeks sales for the brand were approximately $110 million.
Perrigo’s Chairman and CEO Joseph C. Papa stated, “This approval further highlights our ability to bring new products to our consumers and reinforces our continued focus of making quality healthcare more affordable. We are pleased to add this important new product to our retail and wholesale customers’ store brand product portfolios when we begin shipments to them for the upcoming cough/cold/flu season.”
Tris Pharma is a technology driven specialty pharmaceutical company which pioneered sustained release in liquid and other unique dosage forms such as chewable/ODT and film strip.
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients (API). The Company is the world’s largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The Company’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia. Visit Perrigo on the Internet. http://www.perrigo.com.
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, forwardlooking 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 25, 2011, 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.
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About Tris Pharma:
Tris Pharma is an emerging specialty pharmaceutical company focused on the research and development of drug delivery technologies based products. 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. Tris’ R&D and manufacturing facilities are located in Monmouth Junction, New Jersey, USA. For more information, please visit https://staging.trispharma.com