CHADDS FORD, Pa., June 8 /PRNewswire-FirstCall/ -- Endo
Pharmaceuticals (Nasdaq: ENDP) and Penwest Pharmaceuticals (Nasdaq:
PPCO) announced today that the companies have settled litigation
with Impax Laboratories, Inc. (Nasdaq: IPXL) regarding 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. Impax Laboratories will
have 180-days of exclusivity for 5, 10, 20, 30 and 40 mg tablets.
Further terms of the settlement were not disclosed.
Endo and Penwest also announced that they have executed an
amendment to their existing strategic collaboration agreement under
which the royalty rate on net sales of Opana ER would now be capped
at 22 percent during the period from April
1, 2010 through Dec. 31, 2012,
subject to adjustment in the fourth quarter of 2012, and 20 percent
during calendar 2013, subject to adjustment in the fourth quarter
of 2013.
About Penwest Pharmaceuticals
Penwest is a drug development company focused on identifying and
developing products that address unmet medical needs, primarily for
rare disorders of the nervous system. Penwest is currently
developing A0001, or a-tocopherolquinone, a coenzyme Q10 analog
demonstrated to improve mitochondrial function in-vitro. Penwest is
also applying its drug delivery technologies and drug formulation
expertise to the formulation of our collaborators' product
candidates under licensing collaborations.
Penwest Forward-Looking Statements
The matters discussed herein contain forward-looking statements
for purposes of the safe harbor provisions under The Private
Securities Litigation Reform Act of 1995 that involve risks and
uncertainties, which may cause the actual results in future periods
to be materially different from any future performance suggested
herein. For this purpose, any statements contained herein that are
not statements of historical fact may be deemed to be
forward-looking statements. Without limiting the foregoing, the
words, "believes," "anticipates," "plans," "expects," "intends,"
"potential," "appears," "estimates," "projects," "targets," "may,"
"could," and similar expressions are intended to identify
forward-looking statements. Important factors that could cause
results to differ materially include the following: the timing of
clinical trials, such as the Phase IIa clinical trials referenced
above, and risks related to patient enrollment; risks relating to
the commercial success of Opana ER, including our reliance on Endo
Pharmaceuticals Inc. for the commercial success of Opana ER, risks
of generic competition and risks that Opana ER will not generate
the revenues anticipated; the need for capital; regulatory risks
relating to drugs in development, including the timing and outcome
of regulatory submissions and regulatory actions with respect to
A0001; whether the results of clinical trials will be indicative of
the results of future clinical trials and will warrant further
clinical trials, warrant submission of an application for
regulatory approval of, or warrant the regulatory approval of, the
product that is the subject of the trial; whether the patents and
patent applications owned by us will protect the Company's products
and technology; actual and potential competition; and other risks
as set forth under the caption Risk Factors in Penwest's Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission on May 10, 2010, which
risk factors are incorporated herein by reference.
The forward-looking statements contained in this press release
speak only as of the date of the statements made. Penwest disclaims
any intention or obligation to update any forward-looking
statements, and these statements should not be relied upon as
representing the Company's estimates or views as of any date
subsequent to the date of this release.
TIMERx is a registered trademark of Penwest. All other
trademarks referenced herein are the property of their respective
owners.
About Endo
Endo Pharmaceuticals is a specialty pharmaceutical company
engaged in the research, development, sale and marketing of branded
and generic prescription pharmaceuticals used to treat and manage
pain, prostate cancer and the early onset of puberty in children,
or central precocious puberty (CPP). Its products include
LIDODERM®, a topical patch to relieve the pain of postherpetic
neuralgia; Percocet® and Percodan® tablets for the relief of
moderate-to-moderately severe pain; FROVA® tablets for the acute
treatment of migraine attacks with or without aura in adults;
OPANA® tablets for the relief of moderate-to-severe acute pain
where the use of an opioid is appropriate; OPANA® ER tablets for
the relief of moderate-to-severe pain in patients requiring
continuous, around-the-clock opioid treatment for an extended
period of time; Voltaren® Gel, which is owned and licensed by
Novartis AG, a nonsteroidal anti-inflammatory drug indicated for
the relief of the pain of osteoarthritis of joints amenable to
topical treatment, such as those of the hands and the knees;
VANTAS® for the palliative treatment of advanced prostate cancer;
SUPPRELIN® LA for the treatment of early onset puberty in children;
and VALSTAR™ for the treatment of BCG-refractory carcinoma in
situ (CIS) of the urinary bladder in patients for whom
immediate cystectomy would be associated with unacceptable medical
risks. The company markets its branded pharmaceutical
products to physicians in pain management, urology, endocrinology,
oncology, neurology, surgery and primary care. More information,
including this and past press releases of Endo Pharmaceuticals, is
available at www.endo.com.
Endo Forward Looking Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the company's financial position,
results of operations, market position, product development and
business strategy, as well as estimates of future total revenues,
future expenses, future net income and future earnings per share.
Statements including words such as "believes," "expects,"
"anticipates," "intends," "estimates," "plan," "will," "may"
"intend," "guidance" or similar expressions are forward-looking
statements. Because these statements reflect our current views,
expectations and beliefs concerning future events, these
forward-looking statements involve risks and uncertainties.
Investors should note that many factors could affect our future
financial results and could cause our actual results to differ
materially from those expressed in forward-looking statements
contained in this press release. These factors include, but are not
limited to: our ability to successfully develop, commercialize and
market new products; timing and results of pre-clinical or clinical
trials on new products; our ability to obtain regulatory approval
of any of our pipeline products; competition for the business of
our branded and generic products, and in connection with our
acquisition of rights to intellectual property assets; market
acceptance of our future products; government regulation of the
pharmaceutical industry; our dependence on a small number of
products; our dependence on outside manufacturers for the
manufacture of a majority of our products; our dependence on third
parties to supply raw materials and to provide services for certain
core aspects of our business; new regulatory action or lawsuits
relating to our use of narcotics in most of our core products; our
exposure to product liability claims and product recalls and the
possibility that we may not be able to adequately insure ourselves;
the successful efforts of manufacturers of branded pharmaceuticals
to use litigation and legislative and regulatory efforts to limit
the use of generics and certain other products; our ability to
successfully implement our acquisition and in-licensing strategy;
regulatory or other limits on the availability of controlled
substances that constitute the active ingredients of some of our
products and products in development; the availability of
third-party reimbursement for our products; the outcome of any
pending or future litigation or claims by third parties or the
government, and the performance of indemnitors with respect to
claims for which we have been indemnified; our dependence on sales
to a limited number of large pharmacy chains and wholesale drug
distributors for a large portion of our total revenues; a
determination by a regulatory agency that we are engaging or have
engaged in inappropriate sales or marketing activities, including
promoting the "off-label" use of our products and other risks and
uncertainties, including those detailed from time to time in our
periodic reports filed with the Securities and Exchange Commission,
including our current reports on Form 8-K, quarterly reports on
Form 10-Q and annual reports on Form 10-K, particularly the
discussion under the caption "Item 1A, RISK FACTORS" in our annual
report on Form 10-K for the year ended December 31, 2009, which was filed with the
Securities and Exchange Commission on February 26, 2010. The forward-looking statements
in this press release are qualified by these risk factors. These
are factors that, individually or in the aggregate, we think could
cause our actual results to differ materially from expected and
historical results. We assume no obligation to publicly update any
forward-looking statements, whether as a result of new information,
future developments or otherwise.
SOURCE Endo Pharmaceuticals