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Merck Signs $2 Billion Licensing Deal for Weight Loss Pill with Chinese Drugmaker Hansoh Pharma

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Merck announced on Wednesday that it has secured the rights to an experimental weight loss pill from Chinese drugmaker Hansoh Pharma in a deal worth up to $2 billion. This oral drug, currently not in human trials, could position Merck to capitalize on the rapidly expanding obesity drug market, which analysts predict could exceed $100 billion annually by the early 2030s.

While Merck did not specify the diseases it plans to target first with this drug, the deal significantly boosts its potential in the obesity treatment field. The move comes as several other pharmaceutical companies, including Pfizer and Roche, are working to develop competitive oral weight loss medications that can challenge the blockbuster injectable drugs from Novo Nordisk and Eli Lilly.

Under the terms of the agreement, Merck will receive exclusive global rights to develop, manufacture, and commercialize Hansoh Pharma’s HS-10535, an oral drug targeting GLP-1, a gut hormone. GLP-1 is the same target for Novo Nordisk’s popular weight loss drug Wegovy and diabetes medication Ozempic, which work by suppressing appetite and regulating blood sugar levels.

Merck will pay Hansoh Pharma an upfront fee of $112 million for the licensing rights to the drug. Additionally, the deal includes up to $1.9 billion in milestone payments and royalties on future sales, according to a press release from the company.

Merck’s president of Research Laboratories, Dean Li, expressed confidence in the drug’s potential, noting it could offer “additional cardiometabolic benefits beyond weight reduction.” The company has been actively seeking GLP-1 treatments that provide not just weight loss but other health benefits, such as improvements in cardiovascular health, diabetes, and fatty liver disease. Merck CEO Rob Davis highlighted this strategic focus in early 2023, stating that therapies with broader health benefits would be crucial for obtaining reimbursement and establishing long-term market success.

This agreement with Hansoh Pharma adds to the growing trend of Chinese companies entering the global market for GLP-1-based treatments. In a similar deal last year, AstraZeneca licensed an experimental oral GLP-1 drug from Chinese company Eccogene, which is currently in mid-stage development.

 

FDA Approves Eli Lilly’s Zepbound for Sleep Apnea, Expanding its Use in the U.S.

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The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s weight loss drug, Zepbound, for treating moderate-to-severe obstructive sleep apnea (OSA), the most common sleep-related breathing disorder. This approval marks the first drug treatment option for patients with both obesity and OSA, which is characterized by breathing interruptions during sleep due to blocked or narrowed airways. Zepbound, a weekly injection, should be used alongside a reduced-calorie diet and increased physical activity, the FDA stated.

An estimated 80 million people in the U.S. are affected by OSA, with about 20 million suffering from the moderate-to-severe form of the disorder. Alarmingly, 85% of these cases remain undiagnosed, according to Eli Lilly.

Julie Flygare, president and CEO of Project Sleep, a nonprofit focused on sleep health, emphasized that OSA is more than just snoring, urging for greater awareness and conversation about the condition. She expressed hope that Zepbound’s approval would lead to better health outcomes through more informed discussions between patients and healthcare providers.

The approval expands Zepbound’s use beyond obesity treatment, which it was first approved for late last year. The drug’s active ingredient, tirzepatide, is also marketed as Mounjaro, a diabetes treatment. Eli Lilly expects to launch Zepbound for OSA in early 2025 and is also testing the drug for other obesity-related conditions such as fatty liver disease.

Zepbound’s approval may help secure broader insurance coverage, which is a challenge for many weight loss drugs, including Zepbound itself. Current coverage under Medicare for obesity treatments depends on their approval for additional health benefits, like treating OSA.

Zepbound’s approval also highlights the growing body of evidence supporting the health benefits of GLP-1s, a class of medications used for weight loss and diabetes management. Zepbound’s main competitor, Novo Nordisk’s Wegovy, is not approved for OSA.

The new approval provides a significant option for OSA patients who often rely on cumbersome positive airway pressure (PAP) machines to help with breathing. Zepbound offers a more convenient alternative with the potential to resolve OSA symptoms.

In clinical trials, Zepbound demonstrated significant effectiveness in reducing OSA severity. A year-long study showed that Zepbound was more effective than a placebo, with nearly half of patients achieving disease resolution. Zepbound resolved OSA in 43% of patients who were not using PAP therapy and 51.5% of those continuing PAP therapy. This compares to only 13.6% to 14.9% of placebo recipients in the same trials.

The results were based on the apnea-hypopnea index (AHI), which measures the number of blocked or restricted breaths per hour, and used to assess both the severity of OSA and the effectiveness of treatments. Disease resolution is defined as having fewer than five AHI events per hour or a significant reduction in daytime sleepiness, according to Eli Lilly.

 

Eli Lilly’s Alzheimer’s Treatment Approved in China

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China’s medical regulator has approved Eli Lilly’s Kisunla, an Alzheimer’s treatment for early-stage disease, offering patients an additional therapeutic option after the approval of Leqembi, developed by Eisai and Biogen, earlier this year. This marks China’s entry into a select group of major markets—including the United States, Japan, and the UK—where Kisunla is approved, Eli Lilly announced on Tuesday.

Kisunla, like Leqembi, targets the clearance of beta-amyloid, a protein linked to Alzheimer’s disease, from the brain. In a late-stage clinical trial, Kisunla demonstrated a 29% reduction in the progression of memory and cognitive decline compared to a placebo. However, the treatment carries safety concerns, with reports of brain swelling in nearly 25% of patients and brain bleeding in approximately 33%, though most cases were deemed mild.

In response to these risks, Kisunla’s U.S. prescribing label includes the FDA’s strongest “boxed” safety warning, similar to Leqembi’s label. Lilly has addressed concerns by introducing a gradual dosing schedule, which has been shown to reduce the likelihood of severe brain swelling.

A key distinction between Kisunla and Leqembi lies in their dosing approach. Kisunla offers finite dosing, allowing patients to discontinue the treatment once brain scans confirm the absence of amyloid plaques, whereas Leqembi does not.

Kisunla is currently under review by the European Union’s drug regulator. In contrast, Leqembi was rejected by the EU earlier this year due to concerns that the risks of brain swelling outweighed its modest benefits in slowing cognitive decline.

According to the World Health Organization, Alzheimer’s is the leading cause of dementia, accounting for 60%-70% of cases globally.