DUBLIN, Aug. 4, 2017 /PRNewswire/ -- Perrigo Company plc
(NYSE; TASE: PRGO) today announced it has received tentative
approval from the U.S. Food and Drug Administration for the generic
version of Mirvaso® (brimonidine) topical gel 0.33%.
Perrigo previously settled litigation with Galderma Laboratories,
L.P. and Nestle Skin Health S.A. for this product.
Mirvaso® (brimonidine) topical gel 0.33% is indicated
for the topical treatment of persistent (nontransient) erythema of
rosacea in adults 18 years of age or older. Annual market sales for
the 12 months ending June 2016 were
$31 million.
Perrigo Executive Vice President and President Rx
Pharmaceuticals John Wesolowski stated, "The R&D team continues
its relentless efforts to achieve regulatory approvals for new
products. This tentative approval reflects our continued dedication
to developing extended topical products for patients."
About Perrigo
Perrigo Company plc, a leading global healthcare company,
delivers value to its customers and consumers by
providing Quality Affordable Healthcare Products®.
Founded in 1887 as a packager of home remedies, Perrigo has built a
unique business model that is best described as the convergence of
a fast-moving consumer goods company, a high-quality pharmaceutical
manufacturing organization and a world-class supply chain network.
Perrigo is the world's largest manufacturer of over-the-counter
("OTC") healthcare products and supplier of infant formulas for the
store brand market. The Company also is a leading provider of
branded OTC products throughout Europe and the U.S., as
well as a leading producer of "extended topical" prescription
drugs. Perrigo, headquartered in Ireland, sells its products
primarily in North America and Europe, as well as in
other markets,
including Australia, Israel and China. Visit
Perrigo online at (http://www.perrigo.com).
Forward-Looking Statements
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 any
share repurchases; future impairment charges; the success of
management transition; customer acceptance of new products;
competition from other industry participants, some of whom have
greater marketing resources or larger market shares in certain
product categories than the Company does; pricing pressures from
customers and consumers; potential third-party claims and
litigation, including litigation relating to the Company's
restatement of previously-filed financial information; potential
impacts of ongoing or future government investigations and
regulatory initiatives; general economic conditions; fluctuations
in currency exchange rates and interest rates; the consummation of
announced acquisitions or dispositions, and the Company's ability
to realize the desired benefits thereof; the Company's ability to
achieve its guidance; and the Company's ability to execute and
achieve the desired benefits of announced cost-reduction efforts
and other initiatives. In addition, the Company may identify
and be unable to remediate one or more material weaknesses in its
internal control over financial reporting. Furthermore, the Company
and/or its subsidiaries may incur additional tax liabilities in
respect of 2016 and prior years as a result of any restatement or
may be found to have breached certain provisions of Irish company
legislation in respect of prior financial statements and if so may
incur additional expenses and penalties. These and other important
factors, including those discussed under "Risk Factors" in the
Company's Form 10-K for the year ended December 31, 2016, as
well as the Company's subsequent filings with the United States
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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SOURCE Perrigo Company plc