FDA Accepts New Drug Application for NEBIDOR Submitted by Indevus Pharmaceuticals, Inc

FDA Accepts New Drug Application for NEBIDOR Submitted by Indevus Pharmaceuticals, Inc

There were no major adverse cardiovascular events in the testosterone group, but there were 28 nonfatal strokes and 25 nonfatal myocardial infractions in the control group. Prostate volume increased slightly in the testosterone group, but not to any clinically meaningful degree, and stayed virtually unchanged in the control group. Additionally, there was a “marked reduction” in C-reactive protein levels over the 4-year period, from 7.1 to 1.6mg/L, which was not surprising because “testosterone has recently been shown in a number of studies to be an anti-inflammatory agent,” he said.

  • Management and investors will be hoping that Nebido lives up to its potential.
  • If a user or application submits more than 10 requests per second, further requests from the IP address(es) may be limited for a brief period.
  • “Testosterone goes far beyond being a sex hormone; it is very important in terms of both metabolic and cardiovascular disease, and you have tremendously beneficial effects on both,” he noted.
  • These factors include those discussed in Bayer’s public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
  • About Grünenthal Grünenthal is a global leader in pain management and related diseases.
  • This April, Endo reported the results of a long-term phase III study showing that 94% of the study’s 130 participants managed to maintain normal testosterone levels over a period of 21 months.

In terms of percent weight change, subjects lost around 5% of their initial weight after about 15 months, and about 10% after 3.5 to 4.0 years of treatment, he added. At the end of the 48-month study period, the average reduction in waist circumference was “quite substantial,” at 8.0 cm, and showed “consistent and progressive decline” as far out as 60 months in some cases, he said. Select at least one primary interest below to receive curated, daily newsletters designed by senior editors so you can quickly scan the latest news and analysis in your area of practice. BehaVR, a pioneering force in digital therapeutics (DTx) experiences, and Fern Health, a virtual chronic pain management program, today announced the … “Nevertheless, all of this has been confirmed by other studies with much shorter follow-up, so they support the idea that, potentially, you get continued benefits over time,” added Dr Trost.

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As such it will not be just Endo hoping for approval; Indevus shareholders will also have their fingers crossed on Wednesday. Endo estimates that there are currently 4-5 million men in the US suffering from the hypogonadism, creating a market that it says was worth approximately $675m in 2007. The company also believes that the space will grow more than 10% annually as more and more patients are diagnosed in what it thinks is a highly under-treated condition. Next week could mark the first significant return from Endo Pharmaceuticals’ $370m acquisition of Indevus Pharmaceuticals if Nebido, a drug for hypogonadism, manages to get US approval by its September 2 PDUFA date. Coauthor L.J. Gooren reports receiving lecture honoraria from Organon, Bayer Schering Pharma, and Haider; and receiving travel grants from Bayer Schering Pharma and Takeda. A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence.

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  • The sale is expected to be completed towards the end of the year, after resolving the question of the US market, where Endo Pharmaceuticals owns the licence to sell the drug under the name of Aveed.
  • Dr. Saad said that epidemiologic studies consistently suggest that testosterone deficiency are found in about 50% of men with type 2 diabetes.
  • “Testosterone deficiency affects one in six men over 50 years1; representing a significant burden,” said Gabriel Baertschi, CEO Grünenthal.

Indevus acquired U.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005. NEBIDO(R) is a long-acting depot preparation of testosterone undecanoate, developed for the treatment of male hypogonadism. As a science-based, fully-integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion.


Dr. Saad said that epidemiologic studies consistently suggest that testosterone deficiency are found in about 50% of men with type2 diabetes. In this context, he said, screening of diabetic men “may be justified, but in the world of diabetes treatment, testosterone deficiency is still not well known.” “With HDL [high-density lipoprotein], we saw a phenomenon that we cannot yet explain,” said Dr. Saad. “There was a rise in HDL during the first 24 months of treatment and then a drop. We don’t know how this came about, Testosterone propionate but maybe it was related to a massive drop in total cholesterol in some of the men who had levels between 350 and 400 mg/dL at baseline.” A total of 147 hypogonadal men from 38 to 83 years of age participated in the study, all of whom had presented at a urology clinic with testosterone levels between 0.14 and 3.51 ng/mL. “The long-term data are intriguing and the magnitude of changes came as a surprise, even to many experts who have been working with testosterone for decades,” Dr. Saad told Medscape Medical News.

  • She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots.
  • Nebido™ for the treatment of male hypogonadism (testosterone deficiency) is available in over 80 countries since 2004.
  • “Grünenthal’s strong track record of acquiring established brands has significantly improved our profitability, allowing us to invest in research and development and create the next generation of pain therapies.”
  • The Company’s approved products include SANCTURA(R) XR and SANCTURA(R) for overactive bladder, VANTAS(R) for advanced prostate cancer, SUPPRELIN(R) LA for central precocious puberty, and DELATESTRYL(R) to treat male hypogonadism.
  • “With the completion of this deal, we can now work to bring this meaningful treatment to even more people globally.”

We are focusing all of our activities and efforts on working towards our vision of a world free of pain. About Grünenthal Grünenthal is a global leader in pain management and related diseases. Nebido™ for the treatment of male hypogonadism (testosterone deficiency) is available in over 80 countries since 2004. NebidoTM is approved and successfully commercialised in over 80 countries. Patent protection exists until March 2024 in the EU and until May 2027 in the US. It has demonstrated a robust safety and efficacy profile backed with solid long-term data.

The result of this larger patient trial was most probably the basis of the group’s response to the approvable letter, and if the regulator has been satisfied about the reasons for the small number of post injection reactions then the drug could get approval next week. This could mean that Nebido, which will have to change its name if it is approved, is on the market by the end of the year or the start of the first quarter. One in six men over 50 have symptoms of testosterone deficiency, but too few of them receive appropriate treatment, said Grünenthal CEO Gabriel Baertschi. The male hypogonadism treatment has patent exclusivity in the EU until March 2024 and in the U.S. until May 2027, although it is not sold in the U.S. However, the FDA approved Aveed, a similar drug from Endo Pharmaceuticals, in 2014.

The transaction has been financed from cash and by a €200 million loan facility. The same pattern of change over time was observed on the erectile function domain of the International Index of Erectile Function (IIEF-EF); erectile function improved in the testosterone group but worsened in the control group. In its first set back in June 2008, Nebido was served an approvable letter after the regulator expressed concern about a small number of patients in the European study arm who had experienced breathing difficulties after injection. The company put the events down to a rare reaction due to a known complication of oil-based depot injections.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. In 2021, Grünenthal employed around 4,500 people and achieved sales of € 1.5 bn. “With long-term testosterone, we see a reduction in waist circumference, which means that there is a reduction in visceral fat, we see a reduction in overall obesity, and we see tremendous reduction in body weight,” Dr Saad confirmed. At the time, the registry was not supported by industry, but it was later championed by Dr Saad as a project that needed some form of financial backing because 4 to 5 years into the registry’s existence, the data were beginning to look extremely tantalizing. As to how much they get will depend on whether Nebido is approved with or without any label restrictions. The remainder of the outstanding sum will be paid out depending on future sales.

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Berlin, July 14, 2022 – Bayer and Grünenthal have entered into a definitive agreement regarding the sale of Bayer’s men’s health product Nebido™ (testosterone undecanoate), for a purchase price totaling up to 500 million Euro. The deal, which Bayer said would help it focus its Pharma business on key areas of future medical innovation, is expected to close by the end of 2022, according to the company. Dr Saad is therapeutic area head of global medical affairs andrology at Bayer AG.

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