Impax Laboratories & Endo Pharmaceuticals Settle Pending Litigation for Opana® ER & Announce Development & Co-Promotion Agre...
June 08 2010 - 9:15AM
Business Wire
Impax Laboratories, Inc. (Nasdaq: IPXL) today
announced that it has reached agreement with Endo Pharmaceuticals
(Nasdaq: ENDP) and Penwest Pharmaceuticals (Nasdaq PPCO) to settle
pending U.S. litigation with regard to the production and sale of
generic formulations of OPANA® ER (oxymorphone hydrochloride)
Extended Release tablets. Under the terms of the settlement, Endo
and Penwest have agreed to grant Impax a license to sell a generic
of OPANA® ER on Jan. 1, 2013 or earlier under certain
circumstances.
Separately, Endo and Impax have entered into a Development and
Co-Promotion Agreement under which Endo will pay Impax certain
milestones up to $40 million related to the development of an Impax
branded pipeline product and obtain right to co-promote the product
outside of the field of neurology in the US. Further terms of the
settlement were not disclosed.
Larry Hsu, Ph.D., President and Chief Executive Officer of IMPAX
Laboratories, said, “We are pleased to resolve all patent
uncertainties and look forward to working with Endo on the
development of a next generation Parkinson’s Disease product. We
welcome the opportunity to collaborate with a highly respected
company on a brand product.”
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, Philadelphia and Taiwan
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 the Company’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, the effect of current economic conditions on the
Company’s industry, business, financial position, results of
operations and market value of its common stock, the ability to
maintain an effective system of internal control over financial
reporting, fluctuations in revenues and operating income,
reductions or loss of business with any significant customer, the
impact of competitive pricing and products and regulatory actions
on the Company’s products, the ability to sustain profitability and
positive cash flows, the ability to maintain sufficient capital to
fund operations, any delays or unanticipated expenses in connection
with the operation of the Taiwan facility, the ability to
successfully develop and commercialize pharmaceutical products, the
uncertainty of patent litigation, consumer acceptance and demand
for new pharmaceutical products, the difficulty of predicting Food
and Drug Administration filings and approvals, the inexperience of
the Company in conducting clinical trials and submitting new drug
applications, reliance on key alliance and collaboration
agreements, the availability of raw materials, the ability to
comply with legal and regulatory requirements governing the
healthcare industry, the regulatory environment, exposure to
product liability claims and other risks described in the Company’s
periodic reports filed 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.
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