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Novartis Must Face Whistleblower Claims of Paying Kickbacks for MS Drug Promotion

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A U.S. appeals court on Friday revived a whistleblower lawsuit against Swiss pharmaceutical company Novartis, accusing the company of paying illegal kickbacks to doctors to promote its multiple sclerosis drug, Gilenya. The 2nd U.S. Circuit Court of Appeals in Manhattan ruled 3-0 that Steven Camburn, a former Novartis sales representative, can proceed with his claims that Novartis violated the federal False Claims Act through fraudulent “sham” speaker events designed to increase Gilenya sales.

Camburn alleges that Novartis paid doctors substantial sums of money and treated them to dinners at upscale restaurants to speak at events that were presented as educational but were actually social gatherings. These events allegedly led to fraudulent claims being submitted to government health insurance programs, including Medicare, Medicaid, and TRICARE, for Gilenya prescriptions influenced by kickbacks.

Circuit Judge Myrna Perez stated that Camburn’s allegations—including the holding of speaker events with minimal attendance, excessive payments for canceled events, and selecting doctors who would promote prescriptions—created a “strong inference” of Novartis’ intent to induce fraud. The court aligned with other federal appeals courts, agreeing that when compensation has the purpose of inducing the purchase of federally reimbursable healthcare products, it violates the federal Anti-Kickback Statute.

The decision reversed a September 2022 dismissal by U.S. District Judge Kimba Wood and sent the case back to her court for further proceedings. Camburn’s lawyer, James Miller, expressed confidence in addressing the core allegations in court.

Camburn filed the lawsuit in May 2013, shortly after Gilenya was approved for federal use. The drug’s sales have since declined due to competition from generics, dropping from $3.22 billion in 2019 to $925 million in 2023, with only $443 million in sales in the first nine months of 2024.

In 2020, Novartis agreed to pay over $729 million to settle U.S. government charges for similar kickback violations. The case is identified as US ex rel Camburn v. Novartis Pharmaceuticals Corp, 2nd U.S. Circuit Court of Appeals, No. 22-2708.

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.