FortestaTreatment for Hypogonadism -- Male
Fortesta Now FDA Approved - December 29, 2010
Endo Pharmaceuticals Gives Update on Regulatory Status of Fortesta
CHADDS FORD, Pa., Oct. 19 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Fortesta (testosterone) 2% Gel for men diagnosed with low testosterone (Low T), also known as hypogonadism.
"The potential of this action was considered in the structure of the deal to in-license this product," said Dr. Ivan Gergel, M.D., executive vice president, R&D, Endo Pharmaceuticals. "We will continue to work closely with the FDA to address their questions and we expect to file a complete response, mid-2010. Endo is committed to bringing Fortesta to market to offer men another option for testosterone replacement therapy."
In August 2009, Endo signed an agreement with U.K.-based ProStrakan Group Plc to acquire exclusive U.S. rights to commercialize the testosterone 2% gel, branded variously as Tostran, Tostrex and Itnogen outside the U.S. The testosterone 2% gel 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.
Low T, also known as hypogonadism, is a condition in men characterized by the body's failure to produce normal amounts of the hormone testosterone. It is associated with symptoms including decreased energy and mood, fatigue, loss of muscle mass, decreased libido and erectile dysfunction. In addition, there is increasing evidence of the link between Low T and other serious medical conditions including diabetes, cardiovascular disease and metabolic syndrome. Because the symptoms of Low T are often similar to those caused by other medical conditions, more than 91 percent of men with the condition go undiagnosed.
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®, a topical patch to relieve the pain of postherpetic neuralgia; Percocet® and Percodan® tablets for the relief of moderate-to-moderately severe pain; FROVA® tablets for the acute treatment of migraine attacks with or without aura in adults; OPANA® tablets for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate; OPANA® 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® 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® for the palliative treatment of advanced prostate cancer; SUPPRELIN® LA for the treatment of early onset puberty in children; and VALSTAR 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 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 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.
Source: Endo Pharmaceuticals
CONTACT: Investors/Media: Blaine Davis, +1-610-459-7158, or Media: Kevin
Wiggins, +1-610-459-7281, or Investors: Jonathan Neely, +1-610-459-6645
Web Site: http://www.endo.com/
Posted: October 2009
- Endo Pharmaceuticals Receives FDA Approval for Fortesta (Testosterone) Gel as a Class III Product for Topical Use for Men With Low Testosterone - December 30, 2010
- Endo Pharmaceuticals Completes Next Step in Regulatory Process for Fortesta for Men With Low Testosterone - July 1, 2010
- Endo Pharmaceuticals to Partner With ProStrakan to Commercialize Fortesta in the U.S. - August 26, 2009