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EU to Review Novo Nordisk’s Ozempic Over Eye Disease Concerns

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The European Medicines Agency (EMA) announced it would evaluate two recent Danish studies linking Novo Nordisk’s diabetes medication, Ozempic, to an increased risk of a rare eye disease known as non-arteritic anterior ischemic optic neuropathy (NAION).

The studies, published earlier this week, revealed that Ozempic could more than double the likelihood of patients with type 2 diabetes developing NAION. This condition, which can lead to sudden vision loss, occurs when blood flow to the optic nerve is reduced.

Previously, the EMA had reviewed other research but found no conclusive evidence connecting Ozempic to the rare eye disease. However, the agency stated late Tuesday that the findings from these new Danish studies may provide significant new information, prompting further investigation.

Ozempic, which is also widely prescribed for weight loss, has become one of Novo Nordisk’s most successful drugs, contributing to the company’s dominant position in the diabetes and obesity treatment market.

The EMA did not specify a timeline for the review but emphasized its commitment to ensuring the safety of all medications in the EU market.

 

Merck Strikes $2 Billion Deal with Hansoh Pharma for Oral Weight-Loss Drug

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Merck (MRK.N) has entered a licensing agreement worth up to $2 billion with Chinese biotech firm Hansoh Pharma (3692.HK) for the development of an experimental oral weight-loss drug, HS-10535. This move positions Merck as a new competitor in the race to deliver an alternative to injectable weight-loss treatments.

Details of the Agreement

Under the agreement, Merck will assume responsibility for developing, manufacturing, and commercializing the drug. Hansoh’s HS-10535 is a GLP-1 receptor agonist candidate, designed to emulate the effects of injectable weight-loss drugs like Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro.

Merck will pay Hansoh an upfront fee of $112 million for the exclusive license, with potential milestone payments of up to $1.9 billion based on development, regulatory progress, and sales achievements. Hansoh will also receive royalties on future sales.

Competitive Landscape

Merck faces stiff competition in the burgeoning weight-loss market. Its oral drug candidate will likely trail behind rivals such as Eli Lilly’s orforglipron, which is further along in development. Other pharmaceutical giants, including Pfizer, Amgen, and Structure Therapeutics, are also testing oral obesity treatments, while AstraZeneca has partnered with China’s Eccogene on a similar initiative.

HS-10535 is currently in the preclinical testing phase, focusing on animal studies, meaning it could be several years before it reaches commercial availability. However, Merck sees potential in the drug not only for weight loss but also for delivering cardiometabolic benefits, according to Merck Research Laboratories president Dean Li.

Merck’s Broader Strategy

This deal reflects Merck’s broader focus on second- and third-generation weight-loss treatments, particularly oral solutions that may offer added convenience over injectables. Beyond HS-10535, Merck is also developing efinopegdutide, a GLP-1 candidate targeting metabolic dysfunction-associated steatohepatitis (MASH), a severe fatty liver disease associated with obesity.

Despite entering the weight-loss race later than its competitors, Merck aims to carve a niche in the field by emphasizing treatments that address obesity-related conditions alongside weight reduction.

Market Response and Implications

Shares of Merck rose slightly to $100.80 in premarket trading following the announcement. Analysts, however, expressed concerns about the timing, as Merck’s drug will likely lag behind more advanced contenders.

Weight-loss treatments, particularly GLP-1 receptor agonists, are shaping up to be a multibillion-dollar market, driven by increasing global demand for effective and convenient solutions to obesity. The licensing deal with Hansoh signifies Merck’s commitment to becoming a key player in this competitive market.

 

Regulatory Conditions Cleared for Novo Holdings’ $16.5 Billion Catalent Acquisition

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Novo Holdings announced on Saturday that all regulatory conditions for its $16.5 billion acquisition of U.S. contract drug manufacturer Catalent have been fulfilled. The companies anticipate completing the transaction in the coming days.

The acquisition, initially agreed upon in February, is part of Novo Holdings’ strategy to increase production of the blockbuster weight-loss drug Wegovy, developed by its affiliate Novo Nordisk. As part of the agreement, Novo Holdings will sell three of Catalent’s factories located in Italy, Belgium, and the United States to Novo Nordisk for $11 billion. These facilities specialize in filling injection pens under sterile conditions.

Novo Holdings is the controlling shareholder of Novo Nordisk, the Danish pharmaceutical giant behind the popular GLP-1 injectable drug Wegovy. Novo Nordisk stated that while the acquisition aligns with its strategic goals, it is expected to have a mid single-digit negative impact on operating profit growth in 2025. Consequently, the company does not plan to initiate a share buyback program for the year.

Regulatory and Antitrust Scrutiny

The deal has faced close regulatory scrutiny. Earlier in December, the European Commission granted EU antitrust approval, stating that the merger posed no competition concerns within the European Economic Area (EEA).

In the United States, the acquisition drew criticism from consumer groups, labor unions, and policymakers. U.S. Senator Elizabeth Warren urged the Federal Trade Commission (FTC) to scrutinize the deal, citing potential concerns. The FTC had requested additional information on the acquisition in May, but no further updates have been issued.

Strategic Implications

The transaction underscores Novo Holdings’ commitment to expanding its role in the manufacturing and distribution of high-demand pharmaceuticals. By integrating Catalent’s production capabilities, Novo Holdings aims to meet the growing demand for weight-loss treatments while maintaining compliance with global competition regulations.