Allergan And Perrigo Receive FDA Approval Of Three Extended Release Products Equivalent To Mucinex® And Mucinex® DM

Sep 10, 2015, 16:34 ET from Allergan plc

DUBLIN, Sept. 10, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN) and its partner Perrigo Company plc (NYSE: PRGO; TASE) announced today that Allergan has received U.S. Food and Drug Administration (FDA) approval for its Abbreviated New Drug Applications for three Mucinex® equivalent products.

  • Mucinex® DM Regular Strength (guaifenesin 600mg and dextromethorphan 30mg)
  • Mucinex® DM Maximum Strength (guaifenesin 1200mg and dextromethorphan 60mg)
  • Mucinex® Maximum Strength (guaifenesin 1200mg)

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Perrigo will begin shipments of the products to its retail and wholesale customers in the U.S in time for the 2016 cough and cold season. These products will be packaged and marketed as store brands which will give consumers high quality, value alternatives to these Mucinex® extended-release products.

Mucinex® Maximum Strength is an expectorant indicated to relieve chest congestion and thin and loosen mucus.  Sales for the last twelve months were $73 million

Mucinex® DM Regular and Maximum Strengths are expectorants indicated to control coughs and thin and loosen mucus.  Mucinex® DM Regular and Maximum Strengths sales for the last twelve months were $67 million and $104 million, respectively.

Robert Stewart, Allergan's Executive Vice President & President, Generics and Global Operations, stated, "The FDA approval of these products highlights Allergan's world-class generic R&D capabilities and underscores our commitment to continued innovation and focus on complex and high-barrier to entry products within our generics business. We are pleased that our partnership with Perrigo allows us to provide consumers with high-quality, affordable options such as the Mucinex® equivalent products."

Perrigo's Chairman, President and CEO Joseph C. Papa stated, "These approvals are a significant milestone in the partnership between Perrigo and Allergan, and we are pleased to be the first company to bring these difficult to manufacture products to the market. This is another excellent example of Perrigo's commitment to making quality healthcare more affordable for consumers across the globe."  

About Allergan

Allergan plc, headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma.  Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world. 

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

For more information, visit Allergan's website at www.allergan.com.

About Perrigo

Perrigo Company plc is a top five global over-the-counter ("OTC") consumer goods and leading specialty pharmaceutical company, offering patients and customers high- quality products at affordable prices. From the Company's beginning in 1887 as a packager of home remedies, it has grown to become the world's largest manufacturer of OTC healthcare 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 it receives royalties from sales of the multiple sclerosis drug Tysabri®. The Company provides "Quality Affordable Healthcare Products®" across a wide variety of product categories and geographies, primarily in North America, Europe and Australia, as well as in other markets, including Israel and China. Visit Perrigo online at (http://www.perrigo.com).

Allergan Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the risks associated with acquisition transactions; the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 (such periodic public filings having been filed under the "Actavis plc" name) and from time to time in Allergan's other investor communications. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

Perrigo Forward Looking Statement

Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and 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, including but not limited to, the successful integration of the Omega Pharma Invest NV business and future actions that may be taken by Mylan N.V. in furtherance of its unsolicited proposal to acquire control of the Company.  These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended June 28, 2015, 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.

ALLERGAN CONTACTS
Investors:
Lisa Defranceso
(862) 261-7152

Media:
Mark Marmur
(862) 261-7558

PERRIGO CONTACTS
Arthur J. Shannon, Vice President, Investor Relations and Global Communications
(269) 686-1709
E-mail: ajshannon@perrigo.com

Bradley Joseph, Director, Investor Relations and Global Communications
(269) 686-3373
E-mail: bradley.joseph@perrigo.com

SOURCE Allergan plc



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