Grünenthal Acquires Rights to Nebido From Bayer for Up to $503 Million 2022-07-15

Grünenthal Acquires Rights to Nebido From Bayer for Up to $503 Million 2022-07-15

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  • “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.”
  • Endo is hoping that this more convenient dosing schedule will enable it to quickly capture market share and drive sales, which are currently seen at $194m by 2014.
  • However, there is no incentive for any company to do a prospective long-term study on testosterone because the drug is not patent protected.
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  • 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.

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 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 type2 diabetes.

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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 steroids in bodybuilding 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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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.

  • In fiscal 2021, the Group employed around 100,000 people and had sales of EUR 44.1 billion.
  • It is used for the treatment of clinical symptoms such as regression of secondary sexual characteristics, change in body composition, asthenia, reduced libido or erectile dysfunction due to low testosterone levels (testosterone deficiency).
  • At baseline, the average level of glycosylated hemoglobin (HbA1c) in the men with diabetes was about 8%, meaning that the majority of men had poor glycemic control with standard diabetic treatment, said Dr Saad.
  • The remainder of the outstanding sum will be paid out depending on future sales.
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  • 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.

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.

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.

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“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.

FDA and Indevus agree over Nebido NDA

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.

UK struggles with high levels of stress-related work absence

“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.

Updated: 26/01/2024 — 22:26

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