News: IMPAX Sued Based on ANDA for Generic Flomax(R). Genetic …
IMPAX Laboratories, Inc. today announced Boehringer Ingelheim
Pharmaceuticals Inc. (”Boehringer”) and Astellas Pharma Inc.
(”Astellas”) have filed suit for patent infringement in the United
States District Court for the Northern District of California based on
the Company’s submission of Abbreviated New Drug Application (”ANDA”)
for tamsulosin hydrochloride capsules (0.4 mg), generic of Flomax(R),
to the Food and Drug Administration. In connection with this ANDA,
IMPAX provided notice to Boehringer and Astellas that its submission
includes a Paragraph IV certification stating the Company believes its
product does not infringe any valid or enforceable claim of U.S.
Patent No. 4,703,063.
Flomax(R) capsules are indicated for the treatment of the signs
and symptoms of benign prostatic hyperplasia. According to Wolters
Kluwer Health, U.S. sales of Flomax(R) capsules were approximately
$1.5 billion in the 12 months ended May 2008.
About IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc. is a technology based specialty
pharmaceutical company applying its formulation expertise and drug
delivery technology to the development of controlled-release and
specialty generics in addition to the development of branded products.
IMPAX markets its generic products through its Global Pharmaceuticals
division and markets its branded products through the IMPAX
Pharmaceuticals division. Additionally, where strategically
appropriate, IMPAX has developed marketing partnerships to fully
leverage its technology platform. IMPAX Laboratories is headquartered
in Hayward, California, and has a full range of capabilities in its
Hayward and Philadelphia facilities. For more information, please
visit the Company’s Web site at: www.impaxlabs.com.
“Safe Harbor” statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical, these statements are
forward-looking in nature and express the beliefs and expectations of
management. Such statements are based on current expectations and
involve a number of known and unknown risks and uncertainties that
could cause IMPAX’s future results, performance or achievements to
differ significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Such risks
and uncertainties include, but are not limited to, possible adverse
effects resulting from the delisting of and suspension of trading in
IMPAX’s stock, IMPAX’s failure to file any periodic reports subsequent
to its quarterly report on Form 10-Q for the quarter ended September
30, 2004, the SEC’s revocation of the registration of IMPAX’s common
stock under section 12 of the Securities Exchange Act of 1934, the
actual time that will be required to file a registration statement on
Form 10 with respect to such stock, IMPAX’s ability to obtain
sufficient capital to fund its operations, the difficulty of
predicting FDA filings and approvals, consumer acceptance and demand
for new pharmaceutical products, the impact of competitive products
and pricing, IMPAX’s ability to successfully develop and commercialize
pharmaceutical products, IMPAX’s reliance on key strategic alliances,
the uncertainty of patent litigation, the availability of raw
materials, the regulatory environment, dependence on patent and other
protection for innovative products, exposure to product liability
claims, fluctuations in operating results and other risks detailed
from time to time in IMPAX’s filings with the Securities and Exchange
Commission. Forward-looking statements speak only as to the date on
which they are made, and IMPAX undertakes no obligation to update
publicly or revise any forward-looking statement, regardless of
whether new information becomes available, future developments occur
or otherwise.
