Bayer Schering Pharma Presents Innovations in Men’s Healthcare at the 22nd Annual Meeting of the European Association of Urology EAU

This study investigated effects of long-term TRT up to 8 years in hypogonadal men with different obesity classes. We are committed to facilitating access to treatment for even more patients in need,” commented Gabriel Baertschi, CEO of Grünenthal. One in six men over 50 live with the symptoms of testosterone deficiency[1]. We are committed to facilitating access to treatment for even more patients in need, says Gabriel Baertschi, Grünenthal CEO. Grünenthals 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. For hypogonadal men, long-term treatment with an injectable form of testosterone improves sexual and urinary function, and, in hyopogonadal men with type2 diabetes, it also improves glycemic control, registry data out to 8 years indicate.

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. Grünenthal will acquire the global product rights to Nebido™ for an upfront purchase price of up to 500 million Euro, subject to customary closing adjustments, including the contract business in the U.S, where Endo Pharmaceuticals has licensed the compound under the name Aveed from Bayer. The transaction is expected to close by the end of 2022, pending the satisfaction of customary closing conditions, including approval by the competition authorities.

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The change from baseline was −30.5±0.7 kg and the percent change from baseline −23.6±0.5%. Changes were statistically significant for the first 6 years vs previous year. BMI decreased from 41.93±1.48 to 32.46±1.59, mean change from baseline −9.96±0.29 kg m−2 (Figures 2a–d; Table 2). In patients with class II obesity, weight decreased from 116.8±6.9 to 91.3±6.3 kg.

• The most frequent adverse events reported were injection site discomfort, acne, coughing after the injection, changes in mood and behavior, and skin rashes or facial swelling.
• “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.”
• The Bayer Lighthouse Project was developed to help UK healthcare professionals identify and treat patients with hypogonadism, a condition that is under-diagnosed and under-treated by clinicians.
• However, the fact that WL had not been expected validates the results as patients had not gone into the study with the intention to lose weight.
• “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 formulation of TU in tea seed oil (in China) and castor oil (in Germany) for intramuscular use has yielded longer acting testosterone depots with more favorable pharmacokinetics. TU alone (tea seed oil) was found to induce azoospermia in 96% (23/24) of Asian men (500 or 1000 mg in tea seed oil every 4 weeks) and in 57% (8/14) of Caucasian men (1000mg in castor oil every 6 weeks) studied. Phase III contraceptive efficacy trials using TU alone are in progress in China. A combination of TU with a progestogen has been studied in Caucasian subjects (see Table I). DMPA (depot medroxyprogesterone acetate) was administered by a single im injection.

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We propose use of T treatment as a novel therapeutic strategy for managing overweight and obesity in hypogonadal men with TD. TU is partially absorbed by the intestinal lymphatics when given orally; it has low bioavailability and requires twice or thrice daily dosing, making it a poor candidate for an oral contraceptive. However, its preparation in tea seed oil (in China) and castor oil (in Germany) for use as an IM injection has yielded longer-lasting T depots with more favorable pharmacokinetics than TE.

• In 2021, the product contributed sales of 117 million Euro to Bayer’s overall sales of more than 44 billion Euro.
• In patients with class II obesity, weight decreased from 116.8±6.9 to 91.3±6.3 kg.
• Sperm rebound during the treatment phases of the study occurred in 1.3% of participants.
• “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.

In any cohort of middle-aged hypogonadal men, obesity is almost ubiquitous, and the registry cohort was no exception. “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. 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. Of 123 men who used “AndroGel 1%” for periods up to 42 months, 12 had some local skin irritation, but only one discontinued treatment as a result [112].

Buccal testosterone tablets provide sustained release of testosterone and also bypass first-pass metabolism in the liver. 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]. Common adverse effects of buccal testosterone include gum irritation, pain, and tenderness, and edema [103] and headache [102]. Figure 1 shows that irrespective of the class of obesity, TU treatment of obese patients restored total T levels within the physiological range during the first year and these levels were maintained in the physiological range over 8 years of follow-up. Long-term testosterone replacement therapy (TRT) up to 5 years has been shown to produce progressive and sustainable weight loss (WL) in hypogonadal men.

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A Phase II contraceptive efficacy trial of IM TU injections was conducted in China, enrolling 308 men who received an initial loading dose of TU 1000mg IM, followed by TU 500 mg at monthly intervals until they reached severe oligozoospermia (defined as ≤ 3 million/mL). Only 9 men were unable to achieve levels sufficient to enter the efficacy phase (failure of suppression in 2.9% of participants). No pregnancies occurred among the 296 couples who entered the 6-month efficacy phase and maintained adequately low sperm concentrations over a 143 person-year length of exposure. The only pregnancy observed during the efficacy phase was in the case of a man who demonstrated sperm rebound, where sperm concentration rose above the threshold for contraceptive efficacy after suppression. The mean length of time required for achieving azoospermia was 108 days (Gu et al., 2003). Of note, the link between sperm rebound—seen in 2.3% of men in the efficacy phase—and pregnancy in this study, as predicted by concentrations between 1.1 and 3 million/mL led to recommendations to decrease the threshold for contraceptive efficacy to ≤ 1 million/mL.

A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism

Join over 187,400 biopharma colleagues who rely on Endpoints News every business day for the latest developments in drug discovery, development, and commercialization. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news. Grünenthal has invested over €2 billion in successful M&A transactions over the last several years.

733 couples completed the study, giving a total of 1554 person-years of contraceptive exposure, during which nine pregnancies were observed, six of which could be attributed to sperm rebound concentrations between 2 and 8 million/mL—a failure rate of 1.1% at 24 months. Sperm rebound during the treatment phases of the study occurred in 1.3% of participants. The most frequent adverse events reported were injection site discomfort, acne, coughing after the injection, changes in mood and behavior, and skin rashes or facial swelling.

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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. It can also be used to treat clinical symptoms such as regression of secondary sexual characteristics, change in body composition, asthenia, reduced libido or erectile dysfunction. “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 https://vam.vn/new-study-reveals-optimal-trenbolone-acetate/ 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.” “We need to do our best to convince healthcare professionals and the authorities that testosterone is actually a very beneficial treatment that confers many health benefits on these men, including less cardiovascular disease and fewer cardiovascular events,” he explained. One in six men over 50 have symptoms of testosterone deficiency, but too few of them receive appropriate treatment, said Grünenthal CEO Gabriel Baertschi.

In this study, only one patient was dropped out in 8 years, due to moving to a new geographical location. T therapy produced sustained WL without recidivism.35, 36, 38 It is possible that T therapy in obese men with TD may prove useful in treatment of the underlying patho-physiological conditions of obesity. In this report, we summarize our findings on long-term T therapy in men with TD with varying classes of obesity. The data presented suggest significant improvement in WL, reduction in WC and BMI.