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  #1  
Old 08-26-2009, 10:33 AM
Anonymous
 
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Arrow Fortesta - testosterone gel for Urology

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."


About FORTESTA

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.


About Hypogonadism

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.


About ProStrakan

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


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; 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.
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  #2  
Old 08-26-2009, 06:38 PM
Anonymous
 
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Default Re: Fortesta - testosterone gel for Urology

What is the PDUFA date on this?
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  #3  
Old 10-05-2009, 06:23 PM
Anonymous
 
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Arrow Re: Fortesta - testosterone gel for Urology

Endo rises on analyst upgrade and profit estimates
Endo Pharma upgraded before FDA ruling on Fortesta; analyst says profits will top views

On Monday October 5, 2009, 12:22 pm EDT
Buzz up! 0 Print.Companies:Endo Pharmaceuticals Holdings Inc.
NEW YORK (AP) -- Shares of Endo Pharmaceutical Holdings Inc. rose Monday after an analyst upgraded the stock, predicting better-than-expected third-quarter and full-year results for Endo.

Oppenheimer analyst John Newman raised his rating to "Outperform" from "Perform" and set a price target of $27 per share, which would be an 18-month high for shares of the Chadds Ford, Pa., company. Newman thinks Endo will surpass Wall Street's profit expectations, and he said its testosterone injection Fortesta will be approved later this month.

In midday trading, Endo stock rose $1.59, or 7.2 percent, to $23.70. The shares have traded between $13.87 and $26.14 over the last year.

Newman expects Endo to earn a profit of 65 cents per share in the third quarter, which is a penny ahead of Wall Street estimates. He projects a profit of $2.72 per share for the year, which is more than Endo is forecasting. Thomson Reuters says analysts are expecting $2.70 per share.

Fortesta is a long-acting injectable testosterone replacement, and is designed for use by men whose bodies do not produce enough of the hormone. Endo bought the U.S. rights to Fortesta from its developer, ProStrakan Group, in August.
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  #4  
Old 11-11-2009, 05:41 PM
Anonymous
 
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Default Re: Fortesta - testosterone gel for Urology

.
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  #5  
Old 11-29-2009, 08:33 AM
Anonymous
 
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Rant Re: Fortesta - testosterone gel for Urology

Quote:
Originally Posted by Anonymous View Post
Endo rises on analyst upgrade and profit estimates
Endo Pharma upgraded before FDA ruling on Fortesta; analyst says profits will top views

On Monday October 5, 2009, 12:22 pm EDT
Buzz up! 0 Print.Companies:Endo Pharmaceuticals Holdings Inc.
NEW YORK (AP) -- Shares of Endo Pharmaceutical Holdings Inc. rose Monday after an analyst upgraded the stock, predicting better-than-expected third-quarter and full-year results for Endo.

Oppenheimer analyst John Newman raised his rating to "Outperform" from "Perform" and set a price target of $27 per share, which would be an 18-month high for shares of the Chadds Ford, Pa., company. Newman thinks Endo will surpass Wall Street's profit expectations, and he said its testosterone injection Fortesta will be approved later this month.

In midday trading, Endo stock rose $1.59, or 7.2 percent, to $23.70. The shares have traded between $13.87 and $26.14 over the last year.

Newman expects Endo to earn a profit of 65 cents per share in the third quarter, which is a penny ahead of Wall Street estimates. He projects a profit of $2.72 per share for the year, which is more than Endo is forecasting. Thomson Reuters says analysts are expecting $2.70 per share.

Fortesta is a long-acting injectable testosterone replacement, and is designed for use by men whose bodies do not produce enough of the hormone. Endo bought the U.S. rights to Fortesta from its developer, ProStrakan Group, in August.
Yet another very imperfect product from Prostrakan. Over 50% of men will have intolerable skin reactions. The stuff is full of penetration enhancers. God knows what targets Dr Mengele (Totten) is expecting with this shit! More people to be butchered down the foodchain because these lifestyle executives can't get it right.
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  #6  
Old 11-29-2009, 06:08 PM
Anonymous
 
Posts: n/a
Default Re: Fortesta - testosterone gel for Urology

check todays Philly Inq front page article. testosterone replacement being questioned. it won't matter if product is bad if the market goes away as female HR did.
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  #7  
Old 03-17-2010, 08:12 PM
Anonymous
 
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Exclamation Re: Fortesta - testosterone gel for Urology

Another crappy product.
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  #8  
Old 07-24-2010, 08:24 PM
Anonymous
 
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Default Re: Fortesta - testosterone gel for Urology

Any news on this?
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  #9  
Old 07-24-2010, 08:26 PM
Anonymous
 
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Smile Re: Fortesta - testosterone gel for Urology

ProStrakan Group Novel Testosterone Gel Significantly Improves Insulin Sensitivity and Sexual Function in Hypogonadal Men With Type 2 Diabetes and Metabolic Syndrome
6/18/2008 8:01:06 AM

BEDMINSTER, N.J., June 17 /PRNewswire/ -- New data from a 12-month, international, multi-center study showed that treatment for low testosterone with Tostran(R), a topical, metered dose 2% testosterone gel, significantly improves insulin sensitivity and sexual function among hypogonadal men with Type 2 diabetes and/or Metabolic Syndrome. These data were presented today at the Endocrine Society's 90th Annual Meeting in San Francisco. Tostran, also marketed as Fortigel, Tostrex and Itnogen, is available in 13 countries across Europe, and ProStrakan , an international specialty pharmaceutical company, plans to file Tostran with U.S. regulatory authorities later this year.

The Testosterone replacement In hypogonadal men with either MEtabolic Syndrome or type 2 diabetes (TIMES 2) study looked at the effects of Tostran on insulin resistance, diabetic control, lipids, quality of life and symptoms of hypogonadism. The placebo-controlled study of 220 hypogonadal men met its primary endpoint by showing a statistically significant improvement in insulin sensitivity in testosterone treated patients at six and 12 months (p=0.05 and p=0.01, respectively), as measured by homeostasis model assessment as an index of insulin resistance (HOMA-IR). Further, measured by the Index of Erectile Function (IIEF), patients using the testosterone gel saw significant improvement in sexual function at six and 12 months (p <0.05).

"These data tell us that replacement therapy for low testosterone in hypogonadal males not only improves sexual function but, more importantly, can also have impact on insulin sensitivity," said lead investigator T. Hugh Jones BSc, MD, FRCP, Consultant Physician & Endocrinologist and Hon. Professor of Andrology, Barnsley Hospital and University of Sheffield, UK. "The TIMES 2 study indicates for the first time the role that testosterone may play over the long-term in hypogonadal men with Type 2 diabetes."

In U.S. men aged 40-69 years, it is estimated that there are about 481,000 new cases of hypogonadism per year. Overall, approximately 2.4 million U.S. men suffer from the condition.(1) Hypogonadism results from a deficiency in testosterone secretion that may occur naturally with increasing age, or as a result of disorders of the hypothalamus, pituitary glands or testes. Men with the condition can experience reduced libido and sexual function, reductions in energy and body strength, changed physique, alterations in well-being, and reduced quality of life.(2)

"Awareness of the problems caused by low testosterone is becoming more widespread and its connection to health issues like diabetes continues to become increasingly apparent," said Professor Jones. "As the incidence of hypogonadism continues to grow along with the aging population, we need to be acutely aware and implement a more rigorous screening program, particularly in men with Type 2 diabetes."

About TIMES 2

The TIMES 2 study was a randomized, double-blind, placebo-controlled, multi-center, international study to assess the effect of daily transdermal testosterone replacement therapy in hypogonadal men with Type 2 diabetes and/or Metabolic Syndrome.

The primary endpoint of the study was to determine the effect of 2% testosterone gel (Tostran) on insulin resistance in all patients. This was measured by sampling the patients' blood and measuring insulin and glucose levels to calculate HOMA-IR, an index of insulin resistance. Insulin resistance is a major biochemical defect in Type 2 diabetes and Metabolic Syndrome. It is associated not only with the development of high blood sugars but also with abnormalities in the lipid profile and other biochemical changes which increase the risk of cardiovascular disease.

Secondary endpoints included: change in lipid profile and abdominal obesity; glycemic control as measured by HbA1c; sexual satisfaction and other quality of life scores.

The study, which was conducted in Belgium, France, Germany, Italy, Netherlands, Spain, Sweden and the UK, recruited 220 patients who were randomized to 2% testosterone gel treatment, or placebo gel, applied once a day to the thigh or abdomen. The study followed patients on treatment for one year.

About TOSTRAN

Tostran is the first metered dose 2% testosterone gel for use as replacement therapy in male hypogonadism, a condition with serious consequences and associations. Following its launch in Sweden in 2005, where it has over 30 percent of the testosterone gel market, Tostran is now available in all main European countries. ProStrakan plans to file Tostran with the U.S. Food and Drug Administration.

About ProStrakan

Scottish-based ProStrakan is one of Europe's fastest growing pharmaceutical companies, with new U.S. headquarters in Bedminster, New Jersey. Listed on the main London Stock Exchange, ProStrakan is committed to developing innovative therapies to improve the lives of patients. Our current products range from cancer, women's health, men's health, anesthesiology, and cardiovascular disease. For more information on ProStrakan, please visit www.ProStrakan-USA.com.

CONTACT: Susan Rood, Chamberlain Communications, +1-212-884-0643, for
ProStrakan US; or Callum Spreng, Corporate Comms Director, ProStrakan
Corporate (UK), +44(0)1896-664103

Web site: http://www.ProStrakan-USA.com/
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  #10  
Old 07-24-2010, 08:27 PM
Anonymous
 
Posts: n/a
Default Re: Fortesta - testosterone gel for Urology

Endo partners with ProStrakan to market testosterone transdermal gel
Posted on: Thu, 27 Aug 2009 05:09:00 EDT

Aug 27, 2009 (Datamonitor via COMTEX) --
PKNGF | Quote | Chart | News | PowerRating -- US-based Endo Pharmaceuticals has signed an agreement with ProStrakan Group, a UK-based specialty pharmaceutical company, for the exclusive right to commercialize Fortesta 2% in the US.

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 US for an undisclosed supply price.

Fortesta, a patented 2% 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 US, where the FDA is currently reviewing ProStrakan's new drug application submission.

David Holveck, president and CEO of Endo Pharmaceuticals, said: "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. This treatment option is synergistic with our recent therapeutic expansion and strengthens our portfolio in urology and endocrinology."
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  #11  
Old 07-24-2010, 08:59 PM
Anonymous
 
Posts: n/a
Default Re: Fortesta - testosterone gel for Urology

In 2008, the total US testosterone market was valued at US$873m, with transdermal gels representing 85% of this market (source: IMS Health).
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  #12  
Old 07-25-2010, 12:45 AM
Anonymous
 
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Default Re: Fortesta - testosterone gel for Urology

I didn't realize the potential for this product was that big. Hopefully it come through.
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  #13  
Old 03-03-2012, 09:13 PM
Anonymous
 
Posts: n/a
Default Re: Fortesta - testosterone gel for Urology

Please tell me is Fortesta a bio-identical hormone?
I would like to know and appreciate your comments
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