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Testosterone Undecanoate Achieves and Maintains Normal Testosterone Levels in Hypogonadal Men With Five Injections Per Year, New Data Show

Posted on: Tuesday, 28 April 2009, 07:30 CDT

Long-term Data Presented at AUA Annual Meeting

CHICAGO, April 28 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) today released new long-term clinical trial data in men with hypogonadism who were treated for 21 months with testosterone undecanoate (NEBIDO(R) -- 750 mg) injection, a long-acting testosterone replacement therapy in development in the U.S. for treatment of hypogonadism. Results showed that average testosterone levels were maintained within the normal range over the 21-month study, and NEBIDO was generally well tolerated. The long-term clinical trial data were presented at the annual meeting of the American Urological Association.

Previously reported Phase III data evaluated NEBIDO's effectiveness and safety over the initial six-month treatment period in these hypogonadal men, with 94 percent of patients achieving an average testosterone level within the normal range (300-1000 ng/dL) over the 10-week treatment interval. At initiation of treatment, the average testosterone level for the patients rose into the normal range at the first sampling point, four days following the first injection. The new long-term data showed that average testosterone levels remained in the normal range throughout the 21-month study, and that NEBIDO was generally well tolerated. NEBIDO is currently under review at the U.S. Food and Drug Administration.

"Symptoms of low testosterone can be non-specific and may be dismissed as the natural consequence of aging," said Dr. Abraham Morgentaler, a leading investigator of the study and Director of Men's Health Boston, and Associate Clinical Professor of Urology at Harvard Medical School. "But treating hypogonadism can result in significant health benefits for patients."

STUDY RESULTS

This open-label study enrolled 130 hypogonadal men with serum testosterone levels below 300 ng/dL at study entry. NEBIDO was dosed as an intramuscular injection (750 mg) at baseline, at week four, and then every 10 weeks throughout the remainder of the 21-month study. Approximately 70 percent of patients completed all NEBIDO injections.

Evaluation of testosterone levels showed that average concentrations were consistent from one injection to the next.

Safety data showed that NEBIDO was generally well tolerated over the 21-month study, with reported side effects typically characterized as mild and non-serious. The most common side effects reported were acne (6.2 percent) and increased prostate specific antigen (5.4 percent).

Dr. Morgentaler noted: "Because men who suffer from hypogonadism need to remain on treatment for life, it is very important that they can have a treatment option that is well tolerated. Transdermal patches and gels that must be applied to the skin on a daily basis can be effective when used appropriately, but they are associated with variable patient compliance and may require extra care to prevent transfer of topical testosterone to partners or children. Long-term injections may offer hypogonadal men a convenient new option."

ABOUT HYPOGONADISM

Hypogonadism, also known as low testosterone, is a common yet largely under-recognized and under-treated condition that affects an estimated 13.8 million men in the United States. Only 9 percent of American men with low testosterone are currently being treated with testosterone replacement therapy.

Low testosterone is associated with a broad range of physical, psychological and sexual symptoms including decreased energy and mood, fatigue, loss of muscle mass, decreased libido and erectile dysfunction. In addition, low testosterone is associated with other serious medical conditions including diabetes, cardiovascular disease and metabolic syndrome.

NEBIDO(R) is a registered trademark of Bayer Schering Pharma.

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; Sanctura(R) and its XR version for treatment of overactive bladder, Vantas(R) for the palliative treatment of advanced prostate cancer, and Supprelin(R) for the treatment of early onset puberty in children. 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 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.

SOURCE Endo Pharmaceuticals

Source: PR Newswire

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