HAYWARD, Calif.--(BUSINESS WIRE)--
IMPAX Laboratories, Inc. (OTC: IPXL) today confirmed that the
U.S. Food and Drug Administration (FDA) has granted final approval of
the Company’s Abbreviated New Drug Application (ANDA) for generic
versions of SOLODYN(R) (minocycline HCI) 45mg, 90mg and 135mg
Extended-release Tablets. Medicis markets SOLODYN(R) for the treatment
of moderate-to-severe acne.
As previously announced on December 1, 2008, IMPAX and Medicis entered
into a Settlement and License Agreement, under which IMPAX has a license
to market its generic versions of SOLODYN(R) 45mg, 90mg and 135mg
through Global Pharmaceuticals, IMPAX’s generic division, under the
SOLODYN(R) intellectual property rights belonging to Medicis, no later
than November 2011. Upon launch of its generic formulations of
SOLODYN(R), IMPAX may be required to pay Medicis a royalty, based on
sales of those generic formulations by IMPAX under terms described in
the Settlement and License Agreement.
According to Wolters Kluwer Health, U.S. sales of SOLODYN(R) were
approximately $340 million across all strengths for the 12 month period
ending December 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, 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.
Source: IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc.
Mark Donohue, Sr. Director Investor
Relations
(215) 933-3526
www.impaxlabs.com