Bayer to sell Nebido testosterone treatment in deal worth up to $500 million

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• Bayer has sold off the rights to Nebido (testosterone undecanoate), its injectable treatment for testosterone deficiency, to Grünenthal for approximately $503 million.
• We are keen to hear new ideas and discover assets that are relevant to our business.
• There were only two deaths in the testosterone group, and neither was related to treatment.
• For Grünenthal, the acquisition is the second largest in the company’s history.

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.

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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 8.0cm, 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.

• “The majority of us who really keep up on these data are supportive of the concept that testosterone is beneficial in appropriately selected patients,” Dr Trost said.
• Its proceeds will support investments in future medical innovation and bring forward transformative treatment options for patients.
• NEBIDO(R) is a long-acting depot preparation of testosterone undecanoate, developed for the treatment of male hypogonadism.
• BehaVR, a pioneering force in digital therapeutics (DTx) experiences, and Fern Health, a virtual chronic pain management program, today announced the …
• Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US.
• Only one in ten men between the age of 30 to 79 with symptomatic androgen deficiency receive treatment[4].

If it is approved the product would be the first long-acting testosterone treatment in the US and go some way to justifying Endo’s purchase of originator Indevus, which at the time garnered a less than enthusiastic response (Endo hits the acquisition trail, January 6, 2009). The NDA contains data from six clinical studies in which over 400 patients received at least one dose of NEBIDO, with over 300 of these patients treated for more than one year. In total, over 3,000 injections of NEBIDO have been given to hypogonadal males during the clinical development program. In addition, the NDA includes post-marketing data from safety reporting through June 2007, reflecting the world-wide experience from over 260,000 injections of NEBIDO. However, only one in ten men between the age of 30 to 79 with symptomatic androgen deficiency receive treatment2. The condition is caused by a reduced or absent secretion of testosterone from the testes.

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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.

• UBS Investment Bank acted as financial advisor to Bayer, while Allen & Overy provided legal advice.
• 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.
• We are focusing all of our activities and efforts on working towards our vision of a world free of pain.
• There was also an initial significant decrease in levels of liver enzymes, with aspartate aminotransferase dropping from 43.9 to 22.0 U/L and alanine aminotransferase dropping from 46.6 to 22.8 U/L over the first 24 months, and then leveling off.
• Indevus acquired U.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.

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 https://www.floristeriahuila.com/new-resource-guide-reveals-safe-steroid-suppliers/ 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.

“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. Another “unique effect” of testosterone is the fact that it “automatically” builds muscle mass — one of the main reasons it is abused when taken in supraphysiological doses. Over the 8 years, the men in the testosterone group lost more than 13% of their body weight, whereas the men in the control group gained 0.09%.

A mix of strong entrepreneurial spirit, close collaboration and outstanding performance define our approach to leadership alongside a commitment to diversity and inclusivity. UBS Investment Bank acted as financial advisor to Bayer, while Allen & Overy provided legal advice.

Grünenthal acquires testosterone treatment Nebido™ from Bayer

He said it is possible that cholesterol levels improved with the help of other medications. “This study was done in a urology office. It is possible that once these patients were diagnosed with severe dyslipidemia, they were referred back to internal medicine practitioners and put on other medication.” She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. Note that this policy may change as the SEC manages SEC.gov to ensure that the website performs efficiently and remains available to all users. In July 2022, Grünenthal and Bayer announced they had entered into a definitive agreement regarding the sale of NebidoTM, with an expected closing date by the end of 2022 following the satisfaction of customary closing conditions, including approval by the competition authorities.

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“Both the IPPS and the residual bladder volumes increased over 8 years in the untreated group. This is not surprising because we know urinary function doesn’t improve with age,” Dr Saad noted. As the table below shows, despite the inconvenience of gels the current best selling product, Solvay’s Androgel, last year generated revenues of $495m and is forecast to grow by 7% annually over the next six years to $743m in 2014. In addition, body weight was reduced by 12.9 kg, from an average of 106.6 to 93.7 kg. Positive effects were maintained for at least 60 months, reported Farid Saad, PhD, from Bayer Schering Pharma in Berlin, Germany, which sponsored the prospective observational study.