Tentative Approval Received on Generic Version of HalfLytely® and Bisacodyl Tablets Bowel Prep Kit
Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced on May 26, 2010 that it had acquired rights to Novel Laboratories' pending ANDA for HalfLytely® and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablets). On May 27, 2010, Novel received tentative approval from the U.S. Food and Drug Administration on its ANDA for the generic version of HalfLytely®. Annual sales for the Braintree Laboratories brand were approximately $80 million according to Wolters Kluwer.
Novel is believed to be first to file and Perrigo expects to be in a position to launch a generic version to HalfLytely® and Bisacodyl Tablets Bowel Prep Kit at the expiration on the brand exclusivity, on or about September 25, with 180 days of generic exclusivity. The company has not been sued. Under terms of the Perrigo/Novel agreement, Novel will manufacture the product exclusively for Perrigo.
Perrigo's Chairman and CEO Joseph C. Papa concluded, "We are excited to see that tentative approval has been received so quickly. This reflects well on Novel's strong track record of bringing high-value generic products into the market."
Novel's President and CEO Veerappan S. Subramanian stated, "We are pleased to receive this tentative approval for a first launch generic, our second in a week, which completes our colon-cleansing product line. With Perrigo as a strategic partner, we will enhance our position in the generic pharmaceutical marketplace."
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, Australia, 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 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.
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