Perrigo Acknowledges Settlement of NASACORT(R) AQ Nasal Spray Patent Litigation
ALLEGAN, Mich., Nov. 19 /PRNewswire-FirstCall/ -- Perrigo Company
(Nasdaq: PRGO; TASE) today acknowledges the settlement of patent litigation
brought by Sanofi-Aventis (NYSE: SNY) against Barr Laboratories, Inc. a
subsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL). The suit was brought in
the U.S. District Court of Delaware 2006 based upon Barr's filing of an ANDA
for Triamcinolone Acetonide Nasal Spray containing a paragraph IV
certification. Barr believes that it is the first to file an Abbreviated New
Drug Application (ANDA) containing a paragraph IV certification for NASACORT
AQ. Barr developed its Triamcinolone Acetonide Nasal Spray product with
Perrigo Company and the ANDA is awaiting final approval from FDA.
Under the terms of the settlement, Barr will be able to market the ANDA
product under license from Sanofi-Aventis as early as June 15, 2011 if Barr's
ANDA is approved by that date, or earlier in certain circumstances. In
addition, even if Barr's ANDA is not approved, Barr will have a license to
launch a generic version of NASACORT AQ, supplied by Sanofi-Aventis, on
December 1, 2013, or earlier, in certain circumstances. Upon product launch,
Barr would pay Sanofi-Aventis a royalty. Perrigo will share in the costs and
benefits of the settlement agreement between Barr and Sanofi-Aventis and in
Barr's marketing of the products under the agreement.
NASACORT AQ (Triamcinolone Acetonide) Nasal Spray is indicated for the
treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in
adults and children 6 years of age and older. NASACORT AQ had annual sales of
approximately $336 million for the twelve months ended September 2008, based
on Wolters Kluwer Health sales data.
Perrigo Company is a leading global healthcare supplier that develops,
manufactures and distributes OTC and 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 facilities are the United States, 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 28, 2008, 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.