ALLEGAN, Mich. - January 23, 2012 - Perrigo Company (Nasdaq:
PRGO;TASE) announced that it has filed with the U.S. Food and
Drug Administration (FDA) an Abbreviated New Drug Application
(ANDA) for azelastine hydrochloride nasal spray (0.15%) and
has notified Meda Pharmaceuticals, Inc., the owner of the New
Drug Application (NDA) of its filing. The ANDA filing
involved contributions from both Perrigo and Impax
Laboratories, Inc. (Nasdaq: IPXL), who will share costs and
benefits of this project.
On January 19, 2012, Meda Pharmaceuticals filed suit against
Perrigo in the United States District Court for the District
of New Jersey, alleging patent infringement. This action
formally initiates the process under the Hatch-Waxman
Act.
Astepro® Nasal Spray is a prescription medicine for people 12
years of age and older and is approved to treat nasal
symptoms caused by seasonal allergies or environmental
irritants. Annual sales were approximately $114 million
annually, as measured by Wolters Kluwer Health.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This
filing is another example of our investment in new products
and expansion of our extended topical product portfolio. We
are pleased to partner with Impax on this important product
opportunity. As always, Perrigo is committed to making
quality healthcare more affordable for our customers."
Impax's President and CEO Larry Hsu, P.h.D. stated,
"We are excited to collaborate with Perrigo on this
product as we continue to execute our strategy of
diversifying our product base."
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).
1
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 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.
Arthur J. Shannon, Vice President, Investor Relations and
Communication
(269) 686-1709
E-mail: ajshannon@perrigo.com
Bradley Joseph, Senior Manager, Investor Relations and
Communication
(269) 686-3373
E-mail: bradley.joseph@perrigo.com
2
distribué par | Ce noodl a été diffusé par Perrigo Company et initialement mise en ligne sur le site http://www.perrigo.com. La version originale est disponible ici. Ce noodl a été distribué par noodls dans son format d'origine et sans modification sur 2012-01-23 16:13:46 PM et restera accessible depuis ce lien permanent. Cette annonce est protégée par les règles du droit d'auteur et toute autre loi applicable, et son propriétaire est seul responsable de sa véracité et de son originalité. |
Documents associés | |
Perrigo Confirms Filing for Generic Version of Astepro® Nasal Spray and Announcement of Patent Infringement Lawsuit by Meda Pharmaceuticals |