Grünenthal closes deal to acquire testosterone therapy Nebido from Bayer for 495 million

“The findings are more than promising, especially when it comes to obesity, for which neither medicine nor the pharmaceutical industry has found a good answer.” In fiscal 2021, the Group employed around 100,000 people and had sales of EUR 44.1 billion. To allow for equitable access to all users, SEC reserves the right to limit requests originating from undeclared automated tools. Your request has been identified as part of a network of automated tools outside of the acceptable policy and will be managed until action is taken to declare your traffic. For Grünenthal, the acquisition is the second largest in the company’s history.

• 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.
• Bayer is advised inhouse by senior legal counsel Lukas Delahaye, senior legal counsel Elske Henny and legal counsel Dr Judith Junk.
• NebidoTM is the only available injectable long-acting depot preparation of testosterone undecanoate, developed for the treatment of male hypogonadism.

“One in six men over 50 live with the symptoms of testosterone deficiency[1]. Too few of these patients receive appropriate treatment[2]. We are committed to facilitating access to treatment for even more patients in need,” says Gabriel Baertschi, Grünenthal CEO. “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.” This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management.

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Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for NEBIDO , its long-acting injectable testosterone preparation for the treatment of male hypogonadism. The FDA Prescription Drug User Fee Act (PDUFA) target action date for NEBIDO is June 27, 2008. To ensure our website performs well for all users, the SEC monitors the frequency of requests for SEC.gov content to ensure automated searches do not impact the ability of others to access SEC.gov content. We reserve the right to block IP addresses that submit excessive requests. Current guidelines limit users to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests. Endo will be hoping that this will be a mere formality because of the drug’s efficacy in late stage trials, however it has already received one knock back from the regulator.

• At the same time, the Group aims to increase its earning power and create value through innovation and growth.
• One in six men over 50 have symptoms of testosterone deficiency, but too few of them receive appropriate treatment, said Grünenthal CEO Gabriel Baertschi.
• She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots.
• 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.

“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. “But that’s not a man with normal testosterone who just wants a boost in life; it’s men with low-testosterone symptoms and consistently low testosterone values who are most likely to benefit significantly from treatment.” However, there is no incentive for any company to do a prospective long-term study on testosterone because the drug is not patent protected. These are “probably going to be the best long-term data we have, and there are shortcomings,” he said. Dr Saad’s team used the registry to identify a group of men diagnosed with hypogonadism who received a testosterone injection every 3 months, and a control group of men diagnosed with hypogonadism who chose not to be treated with testosterone, matched for age, waist circumference, and BMI.

General Business Overview

Of this group, less than ten percent are currently receiving treatment with testosterone therapy. Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. This divestment is part of the ongoing transformation of Bayer’s pharmaceuticals business which focuses on key areas with high potential for the future. Its proceeds will support investments in future medical innovation and bring forward transformative treatment options for patients.

• The Bayer brand stands for trust, reliability and quality throughout the world.
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• It has demonstrated a robust safety and efficacy profile backed with solid long-term data.
• In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros.
• 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.

Only one in ten men between the age of 30 to 79 with symptomatic androgen deficiency receive treatment[4]. Only one in ten men between the age of 30 to 79 with symptomatic androgen deficiency receive treatment4. About Indevus Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development and commercialization of products to treat conditions in urology and endocrinology. The Company’s approved products include SANCTURA XR and SANCTURA for overactive bladder, VANTAS for advanced prostate cancer, SUPPRELIN LA for central precocious puberty, and DELATESTRYL to treat male hypogonadism. The Indevus development pipeline contains multiple compounds within the Company’s core therapeutic areas in addition to several partnered or partnerable programs. The most advanced compounds in development include VALSTAR for bladder cancer, NEBIDOfor male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, octreotide for acromegaly, and pagoclone for stuttering.

“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%.

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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.

To continue reading, fill out the form below to activate a free 7-day trial of Law360. We are keen to hear new ideas and discover assets that are relevant to our business. Bayer is advised inhouse by senior legal counsel Lukas Delahaye, senior legal counsel Elske Henny and legal counsel Dr Judith Junk. For more information, please see the SEC’s Web Site Privacy and Security Policy.

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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. The medication is used to treat men with low or no testosterone due to medical conditions such as hypogonadism. These data are very intriguing, said Landon Trost, MD, head of andrology and male infertility at the Mayo Clinic https://hotelviggiano.it/unveiling-the-top-steroid-shops-dominating-the-us/ in Rochester, Minnesota, who is a member of the American Urological Association guideline committee on hypogonadism. “When you restore testosterone to normal levels, behavior changes in a subtle manner. Anecdotally, men reported walking and cycling more and getting involved in sports, so they became more active than before,” said Dr Saad. Not surprisingly, approximately 35% of the men in both groups had type 2 diabetes.