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

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• FS is a full-time employee of Bayer Pharma; AY and AH have received partial compensation for data entry from Bayer Pharma; GD has received payment for statistical analyses from Bayer Pharma.
• “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.
• Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.
• In addition, body weight was reduced by 12.9 kg, from an average of 106.6 to 93.7 kg.

Nebido for the treatment of male hypogonadism (testosterone deficiency) is available in over 80 countries since 2004. In 2021, the product contributed sales of 117 million Euro to Bayer’s overall sales of more than 44 billion Euro. Patches are available for scrotal and non-scrotal sites; they provide stable pharmacokinetics and are an alternative to painful injections. Absorption is superior at the scrotum because of its high skin vascularity.

Testosterone Replacement Therapy: Navigating the Pharmacologic Landscape

“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.” 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. 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.

FS is a full-time employee of Bayer Pharma; AY and AH have received partial compensation for data entry from Bayer Pharma; GD has received payment for statistical analyses from Bayer Pharma. Finally, mean plasma glucose levels declined from 105.8 to 97.0 mg/dL over the 4-year period. “Without separating those with elevated glucose from those with normal glucose at baseline, we saw a mean reduction in the first 1.5 years, and then the levels stabilized,” he said.

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T implants (testosterone implants) were administered once (800mg dose) or at weeks 0 and 12 (400mg). TE (testosterone enanthate) at 100mg was administered by im injection once weekly. TU (testosterone undecanoate) was administered either orally (80mg) twice daily or im (1000mg) every 6 weeks.

• LaingBuisson has been serving clients for over 30 years with insights, analysis and data on market structures, policy and strategy across healthcare, social care and education.
• T therapy in men in all three classes of obesity increased prostate volume.
• In class III obesity, all 47 patients lost ⩾5% of their baseline weight, 45 (95.7%) ⩾10%, 42 (89.4%) ⩾15%, 28 (59.6%) ⩾20%, 11 (23.4%) ⩾25% and no patient gained weight (Table 3).
• This incidence rate is low compared with an untreated population of a similar age, as reported previously.56 It should be made clear that all patients were monitored closely, according to the guidelines of the European Association of Urology.
• Small-scale work with a bioadhesive buccal tablet of testosterone has shown that adequate serum concentrations can be obtained and that the buccal tablet (administered twice daily) causes few adverse reactions [102].

Testosterone is absorbed and delivered into the superior vena cava, thereby bypassing hepatic first-pass metabolism. Transdermal gels are hydroalcoholic gels for delivering testosterone transdermally. Showering must be avoided for 6 h, as well as intimate skin contact with others, as transfer of testosterone may occur. The only available oral TU (Restandol) has low bioavailability and requires twice or thrice daily dosing. Inclusion criteria were two separate morning measures of total testosterone ⩽12.1 nmol l−1 and the presence of hypogonadal symptoms measured by the Aging Males’ symptoms scale (AMS). 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.

The changes in weight were statistically significant for all 8 years vs previous year. The change from baseline was −25.3±0.5 kg, percent change from baseline −21.6±0.4%. The observed changes https://360-virtualtour.ca/unveiling-the-top-rated-steroid-shops-in-the-us/ were statistically significant for the first 6 years vs previous year. BMI decreased from 37.32±1.45 to 29.49±1.71, mean change from baseline −8.15±0.17 kg m−12 (Figures 2a–d; Table 2).

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As shown in Figures 2a–d and Table 2, in all three classes of obesity, T therapy produced significant WL, decrease in WC and BMI. In patients with class I obesity, mean weight decreased from 102.6±6.4 to 84.1±4.9 kg; the changes in weight were statistically significant for all 8 years vs previous year. The change from baseline was −17.4±0.5 kg and the percent change from baseline −16.8±0.4%. BMI decreased from 32.69±1.4 to 27.07±1.57, mean change from baseline −5.52±0.15 kg m−2. As shown in Table 2, T therapy resulted in significant improvement in quality of life as assessed by the marked and significant reduction in the AMS (32-point reduction in class I; 33-point reduction in class II and 38-point reduction in class III) (Table 2). Similarly, a significant reduction was recorded in IPSS in all classes of obesity, indicating that T therapy improves lower urinary tract symptoms in obese men and also improves urinary flow.

There was a significant improvement in lipid profiles, with total serum cholesterol dropping from 297.7 to 194.5 mg/dL, triglycerides dropping from 290.4 to 194.2 mg/dL, and low-density-lipoprotein cholesterol dropping from 160.4 to 118.3 mg/dL. Grünenthal also acquired the European rights (excluding Spain and the UK) to statin CRESTOR™  from AstraZeneca, the rights to Qutenza™ (capsaicin 8% patch) from Astellas Pharma Europe, and has the global rights (excluding Japan) to AstraZeneca’s migraine therapy Zomig™. Nebido is the market leader in the testosterone market where currently only 8% of potential patients are treated. LaingBuisson has been serving clients for over 30 years with insights, analysis and data on market structures, policy and strategy across healthcare, social care and education. “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. “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.

The latest deal to buy testosterone treatment Nebido from Bayer will expand its existing portfolio of medicines. This patient-centric project encourages market awareness and growth initiatives, which was inspiring. The team’s original approach of transparent learning delivers positive results and we really enjoyed reading about this project. An integrated multichannel strategy was developed to support the educational programme which provided an intelligent matrix of content that evolved customer conversations across channels from event registration through to remote-detailing discussions with multichannel account managers.

It is converted to DHT before being absorbed, so monitoring should be by measuring DHT, not testosterone levels. This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

In class III obesity, all 47 patients lost ⩾5% of their baseline weight, 45 (95.7%) ⩾10%, 42 (89.4%) ⩾15%, 28 (59.6%) ⩾20%, 11 (23.4%) ⩾25% and no patient gained weight (Table 3). “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, 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.”