Endo Pharmaceuticals to Partner With ProStrakan to Commercialize FORTESTA(TM) in the U.S.
CHADDS FORD, Pa., Aug. 26 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) today announced that it has signed an agreement with U.K.-based ProStrakan Group plc (LSE: PSK) for the exclusive right to commercialize FORTESTA(TM) (testosterone gel) 2 percent in the United States.
FORTESTA, a patented 2 percent testosterone transdermal gel for testosterone replacement therapy in male hypogonadism, utilizes a metered dose delivery system designed to permit accurate dose adjustment to individual patient requirements. This product is in registration in the U.S., where the Food and Drug Administration (FDA) is currently reviewing ProStrakan's New Drug Application submission.
Under the terms of the agreement, Endo Pharmaceuticals has agreed to make an upfront payment to ProStrakan of $10 million, with the potential for up to $40 million more in milestone payments by the end of 2010 for regulatory approval and the achievement of certain commercial milestones. Endo Pharmaceuticals has also agreed to pay ProStrakan an additional $160 million upon the achievement of certain sales targets. ProStrakan will exclusively supply FORTESTA to Endo Pharmaceuticals in the U.S. for an undisclosed supply price.
"We are committed to advancing men's health with effective new medicines. Being in a position to potentially offer this treatment, alongside our new long-acting injectable testosterone product, will help fill an important gap in testosterone replacement," said David Holveck, president and chief executive officer of Endo Pharmaceuticals. "This treatment option is synergistic with our recent therapeutic expansion and strengthens our portfolio in urology and endocrinology."
FORTESTA (branded variously as Tostran, Tostrex and Itnogen) is marketed across Europe by ProStrakan's own, in-house sales forces and is out-licensed by ProStrakan to Bayer Schering Pharma (BSP) in 147 countries, in many of which FORTESTA is planned to be promoted alongside Nebido((R)), which is Endo Pharmaceuticals' testosterone undecanoate product, or long-acting injectable, currently under regulatory review with the FDA in the United States.
Hypogonadism, or low testosterone, is a common yet largely under-recognized and under-treated condition. An estimated 13.8 million American men have testosterone levels characterized as below normal (testosterone <300ng/dl). Yet despite this high prevalence, only about 9 percent of men with low testosterone are treated with testosterone replacement therapy.
ProStrakan Group plc is a rapidly growing specialty pharmaceutical company engaged in the development and commercialization of prescription medicines for the treatment of unmet therapeutic needs in major markets.
ProStrakan's head office is located in Galashiels, Scotland. The company's development capabilities are centered in Galashiels and Bedminster, New Jersey, USA. Sales and marketing of ProStrakan's portfolio of products are handled by commercial subsidiaries in the U.K., U.S., France, Germany, Spain and other EU countries. www.prostrakan.com
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; 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; SANCTURA((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.
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 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 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.