Tuesday, June 08, 2010 10:06:58 AM
PPCO $3.20
Endo and Penwest Enter Into Agreement with Sandoz to Settle OPANA(R) ER Patent
Litigation
CHADDS FORD, Pa., June 8, 2010 /PRNewswire via COMTEX/ -- Endo Pharmaceuticals
(ENDP) and Penwest Pharmaceuticals (PPCO) announced today that the companies have
settled litigation with Sandoz, Inc. regarding the production and sale of generic
formulations of OPANA(R) ER (oxymorphone hydrochloride) Extended Release tablets.
Under the terms of the settlement, Endo and Penwest have agreed to grant Sandoz a
license to sell a generic of OPANA(R) ER on Sept. 15, 2012. Further terms of the
settlement were not disclosed.
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(R), a topical patch to relieve the pain of postherpetic
neuralgia; Percocet(R) and Percodan(R) tablets for the relief of
moderate-to-moderately severe pain; FROVA(R) tablets for the acute treatment of
migraine attacks with or without aura in adults; OPANA(R) tablets for the relief
of moderate-to-severe acute pain where the use of an opioid is appropriate;
OPANA(R) 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(R) 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(R) for the palliative treatment of advanced prostate cancer; SUPPRELIN(R)
LA for the treatment of early onset puberty in children; and VALSTAR(TM) 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 http://www.endo.com.
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
Copyright (C) 2010 PR Newswire. All rights reserved
Endo and Penwest Enter Into Agreement with Sandoz to Settle OPANA(R) ER Patent
Litigation
CHADDS FORD, Pa., June 8, 2010 /PRNewswire via COMTEX/ -- Endo Pharmaceuticals
(ENDP) and Penwest Pharmaceuticals (PPCO) announced today that the companies have
settled litigation with Sandoz, Inc. regarding the production and sale of generic
formulations of OPANA(R) ER (oxymorphone hydrochloride) Extended Release tablets.
Under the terms of the settlement, Endo and Penwest have agreed to grant Sandoz a
license to sell a generic of OPANA(R) ER on Sept. 15, 2012. Further terms of the
settlement were not disclosed.
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(R), a topical patch to relieve the pain of postherpetic
neuralgia; Percocet(R) and Percodan(R) tablets for the relief of
moderate-to-moderately severe pain; FROVA(R) tablets for the acute treatment of
migraine attacks with or without aura in adults; OPANA(R) tablets for the relief
of moderate-to-severe acute pain where the use of an opioid is appropriate;
OPANA(R) 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(R) 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(R) for the palliative treatment of advanced prostate cancer; SUPPRELIN(R)
LA for the treatment of early onset puberty in children; and VALSTAR(TM) 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 http://www.endo.com.
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
Copyright (C) 2010 PR Newswire. All rights reserved
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