DANBURY, Conn., CHADDS FORD, Pa., and ALISO VIEJO, Calif., June 9, 2009 (GLOBE NEWSWIRE) -- Penwest Pharmaceuticals Co. (Nasdaq:PPCO), Endo Pharmaceuticals (Nasdaq:ENDP) and Valeant Pharmaceuticals (NYSE:VRX) today announced that Endo has signed an exclusive license with Valeant allowing it to market OPANA ER in Canada, Australia and New Zealand. OPANA ER, the extended release formulation of oxymorphone, was jointly developed by Penwest and Endo.
This agreement is the first one resulting from the collaborative work Penwest and Endo began late last year to license OPANA ER in territories outside the U.S. Under the terms of the collaboration agreement between Penwest and Endo, the two companies have agreed to share equally in the proceeds received from Valeant for OPANA ER under the terms of the licensing agreement.
The agreement with Valeant also includes rights to OPANA(r), the immediate release formulation of oxymorphone developed by Endo.
The terms of the licensing agreement call for a payment of C$2 million upfront and payments totaling up to C$1 million when certain sales milestones are reached in Canada and A$1.1 million when certain regulatory and sales milestones are met in Australia. In addition, Valeant has agreed to pay royalties ranging from 10% to 20% of net sales of the OPANA products in each of the three countries, subject to royalty reductions upon patent expiry or generic entry.
Jennifer L. Good, President and Chief Executive Officer of Penwest, said, "We are very pleased with the agreement with Valeant to license OPANA ER in Canada, Australia and New Zealand, all of which are regions where Valeant has a strong regulatory and commercial presence. As the first licensing agreement for OPANA ER outside the U.S., this deal represents the achievement of one of the deliverables we committed to our shareholders in optimizing the value of this important asset for them. We continue to work toward achieving additional licensing deals for OPANA ER in other territories outside the U.S."
"We are pleased to be able to add a successful product such as OPANA ER to our current product portfolios in Canada, Australia and New Zealand," stated J. Michael Pearson, Chairman and Chief Executive Officer of Valeant. "The addition of this product will extend our successful pain franchise in Canada, while providing Valeant with an opportunity to broaden our therapeutic scope in Australia and New Zealand."
Demand for analgesic narcotics in Canada, a market that includes long-acting opioids, such as versions of oxycodone, morphine, fentanyl and hydromorphone, has been growing at double digit rates annually over the past several years. In 2008, analgesic narcotics in Canada represented approximately a C$400 million market.
OPANA ER received FDA approval in June 2006, and is currently marketed by Endo as a treatment for moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.
As recently reported by Endo, combined net sales for the OPANA franchise increased 31 percent to $52.8 million for the first quarter 2009, compared with $40.3 million in the same period a year ago, while prescription volume for OPANA ER and OPANA increased 58 percent in the first quarter 2009, compared with the first quarter of 2008.
Indication
OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. OPANA ER is not intended for use as an as needed analgesic. OPANA ER is not indicated for pain in the immediate post-operative period (12-24 hours following surgery) for patients not previously taking opioids because of the risk of oversedation and respiratory depression requiring reversal with opioid agonists. OPANA ER is not indicated for pain in the post-operative period if the pain is mild or not expected to persist for an extended period of time.
OPANA ER has a boxed warning as follows:
WARNING: OPANA ER contains oxymorphone, which is a morphine-like opiod agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.
Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
OPANA ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
OPANA ER is NOT intended for use as an as needed analgesic.
OPANA ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone.
Patients must not consume alcoholic beverages, or prescription or nonprescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.
About the Companies
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, overactive bladder, 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; and Voltaren(r) Gel, 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. Voltaren(r) Gel is owned and licensed by Novartis AG; SAMCTURA(r) and its XR version for treatment of overactive bladder, VANTAS(r) for the palliative treatment of advanced prostate cancer, and SUPPRELIN(r) LA for the treatment of early onset puberty in children. The company markets its branded pharmaceutical products to physicians in pain management, neurology, surgery, oncology, endocrinology and primary care. More information, including this and past press releases of Endo Pharmaceuticals, is available at www.endo.com.
About Penwest
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, a coenzyme Q analog drug candidate for inherited mitochondrial respiratory chain diseases. Penwest is also applying its drug delivery technologies and drug formulation expertise to the formulation of product candidates under licensing collaborations with partners.
About Valeant
Valeant Pharmaceuticals International (NYSE:VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology and dermatology. More information about Valeant can be found at www.valeant.com.
Endo Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the acquisition of Indevus, the company's financial position, results of operations, market position, product development and business strategy, as well as estimates of future net sales, 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: the possibility that the transaction will not be completed, or if completed, not completed on a timely basis; the possibility that the acquisition of Indevus is not complementary to Endo; the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; competition in our industry, including for branded and generic products, and in connection with our acquisition of rights to assets, including intellectual property; government regulation of the pharmaceutical industry; our dependence on a small number of products and on outside manufacturers for the manufacture 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 controlled substances in many 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; our ability to protect our proprietary technology; our ability to successfully implement our in-licensing and acquisition strategy; the availability of third-party reimbursement for our products; the outcome of any pending or future litigation or claims by the government; our dependence on sales to a limited number of large pharmacy chains and wholesale drug distributors for a large portion of our total net sales; a determination by a regulatory agency that we are engaging in inappropriate sales or marketing activities, including promoting the "off-label" use of our products; the loss of branded product exclusivity periods and related intellectual property; and exposure to securities that are subject to market risk including auction-rate securities the market for which is currently illiquid; 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, 2008, which was filed with the Securities and Exchange Commission on March 2, 2009. 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.
Penwest Forward-Looking Statements
The matters discussed herein contain forward-looking statements 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: risks relating to the commercial success of OPANA ER, including our reliance on Endo Pharmaceuticals Inc. for the commercial success of OPANA ER and risks of generic competition; the need for capital; regulatory risks relating to drugs in development, including the timing and outcome of regulatory submissions and regulatory actions; uncertainty of success of collaborations; the timing of clinical trials; whether the results of clinical trials 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 Annual Report on Form 10-Q filed with the Securities and Exchange Commission on May 11, 2009, 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 letter.
TIMERx is a registered trademark of Penwest. All other trademarks referenced herein are the property of their respective owners.
Valeant Forward-Looking Statements
This press release may contain forward-looking statements, including, but not limited to, statements regarding the future growth in Valeant's pain franchise and the impact of the OPANA ER licensing agreement on Valeant's business. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties related to our ability to successfully market OPANA and its impact on the growth of Valeant's pain franchise and on Valeant's business, and other risks and uncertainties discussed in the company's most recent annual or quarterly report filed with the SEC, which factors are incorporated herein by reference. These risks are among the factors that could cause actual results to differ materially from the expectations described in the forward-looking statements and undue reliance should not be placed on any of these forward-looking statements. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.