Perrigo Announces Tentative FDA Approval For Generic Version Of Suprep® Oral Solution And Confirms Patent Challenge For Generic Version Of Mirvaso® Gel
DUBLIN, Aug. 23, 2016 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO; TASE) today announced it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for the generic version of Suprep® (sodium sulfate/potassium sulfate/magnesium sulfate) oral solution. The drug is indicated for the treatment of cleansing of the colon in preparation for colonoscopy in adults. Annual sales for the past 12 months ending July 2016 were $178 million.
Perrigo today also announced that it was sued by Galderma Laboratories, L.P. and Nestle Skin Health S.A. over the Company's Paragraph IV ANDA filing for the generic version of Mirvaso® (brimonidine) topical gel .33% which is indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older. Annual sales for the past 12 months ending July 2016 were $34 million.
Perrigo's CEO John T. Hendrickson stated, "These accomplishments demonstrate Perrigo's commitment to our customers and consumers around the world. The team's ability to develop and bring to market high quality, value alternatives in important treatment categories is what continues to drive Perrigo's mission of providing Quality Affordable Healthcare Products® around the world."
Perrigo Company plc, a top five global over-the-counter ("OTC") consumer goods and pharmaceutical company, offers patients and customers high quality products at affordable prices. From its beginnings in 1887 as a packager of generic home remedies, Perrigo, headquartered in Ireland, has grown to become the world's largest manufacturer of OTC products and supplier of infant formulas for the store brand market. The Company is also a leading provider of generic extended topical prescription products and receives royalties from Multiple Sclerosis drug Tysabri®. Perrigo provides Quality Affordable Healthcare Products® across a wide variety of product categories and geographies primarily in North America, Europe, and Australia, as well as other markets, including Israel, China and Latin America. Visit Perrigo online at (http://www.perrigo.com).
Certain statements in this press release are "forward-looking statements." 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 the negative of those terms 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, including the timing, amount and cost of share repurchases, future impairment charges, the ability to achieve its guidance and the ability to execute and achieve the desired benefits of announced initiatives. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-KT for the six-month period ended December 31, 2015, as well as the Company's subsequent filings with the SEC, 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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SOURCE Perrigo Company plc
For further information: Perrigo Contacts: Bradley Joseph, Vice President, Global Investor Relations, (269) 686-3373, firstname.lastname@example.org; Arthur J. Shannon, Vice President, Global Corporate Affairs and European Investor Relations, +353 1709 4709, email@example.com