CHADDS FORD, Pa., Feb. 27 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) announced today that it has licensed from Grunenthal the exclusive rights to develop and market the investigational drug axomadol in the United States and Canada. Axomadol is a patented new chemical entity discovered by Grunenthal and currently in Phase II development for the treatment of moderate to moderately severe chronic pain and diabetic peripheral neuropathic pain.
Under the license agreement signed by both companies, Endo will pay Grunenthal an upfront cash payment as well as additional payments to Grunenthal that are linked to the achievement of future clinical, regulatory and commercial milestones. In addition, Grunenthal will receive a transfer price including cost of goods and royalties on net sales of the product in the US and Canada. The product will be manufactured by Grunenthal. Endo will participate with Grunenthal in joint product development and commercialization committees and be responsible for all clinical development, product registration, marketing and sales activities in the Endo territories, while Grunenthal will be responsible outside the US and Canada.
Ivan Gergel, M.D., Endo's executive vice president of research and development, said: "We believe axomadol has potential efficacy, safety and scheduling advantages over other current pain therapies that make it a compelling drug development opportunity and new product candidate for Endo. We look forward to working with Grunenthal to continue the development program for this compound and to evaluate further its clinical and commercial potential."
Prof. Eric-Paul Paques, executive board member of Grunenthal responsible for research and development, said: "Endo is an excellent partner for successfully developing and marketing our compound axomadol. We are pleased to cooperate on our new chemical entity axomadol in order to complement the efficacious and safe treatment options available for moderate to severe pain relief. This cooperation once more confirms Grunenthal's innovative power in pain research."
Grunenthal is an expert in pain therapy and gynaecology and a pioneer in intelligent, user-friendly drug delivery technologies. The company discovers, develops, produces and markets high therapeutic value pharmaceuticals that contribute to patients' ability to control their own lives. Grunenthal is an independent, family-owned German company with companies in 32 countries all over the world. Founded in 1946, the company employs 1,900 people in Germany and 5,300 worldwide. In 2007, Grunenthal achieved revenues of 846 million Euros. More information: www.grunenthal.com
JSB Partners LP acted as transaction advisor to Grunenthal.
Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used primarily to treat and manage pain. 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. The company markets its branded pharmaceutical products to physicians in pain management, neurology, surgery, oncology, and primary care. More information, including this and past press releases of Endo Pharmaceuticals, is available at www.endo.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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. Risks and uncertainties include the satisfaction of closing conditions for the acquisition, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act; the tender of a majority of the outstanding shares of common stock of Indevus; 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 potential that market segment growth will not follow historical patterns; general industry conditions and competition; business and economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment; 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/A for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on April 29, 2008. The forward-looking statements in this press release and on the related conference call 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|
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