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Novartis Considers Takeover Bid for Biotech Firm Avidity Biosciences

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Swiss pharmaceutical giant Novartis is reportedly exploring a potential acquisition of U.S.-based biotech company Avidity Biosciences, according to the Financial Times. The discussions are said to be in early stages, with Novartis aiming to strengthen its portfolio of treatments for rare genetic disorders.

Shares of Avidity surged 23% to $47.10 following the news, giving the company a market valuation of approximately $4.6 billion. Avidity is focused on developing therapies for rare muscle diseases, including its lead candidate del-zota, targeting a rare form of Duchenne muscular dystrophy. The company is also developing two other treatments for serious muscle disorders.

Sources familiar with the talks noted that while Novartis has expressed interest recently, there is no guarantee a deal will materialize, as other suitors could enter or negotiations might fall through. Avidity is working with advisers to evaluate strategic options. Both companies declined to comment.

This potential acquisition fits into Novartis’ broader strategy in 2025 to expand its drug pipeline through targeted deals. Earlier this year, Novartis agreed to acquire Anthos Therapeutics for $3.1 billion to boost its cardiovascular treatments and struck a deal to acquire Regulus Therapeutics for up to $1.7 billion, targeting kidney disease therapies. Additionally, Novartis partnered with Matchpoint Therapeutics in a deal worth up to $1 billion to develop oral medicines for inflammatory conditions.

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.

Medicare Drug Price Negotiations: Short-Term Stability, Long-Term Concerns for Pharma

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The conclusion of the first round of Medicare drug price negotiations marks a significant milestone, though the final negotiated prices for the selected medications remain undisclosed. These prices, set to be revealed in early September, will come into effect in 2026. While the pharmaceutical industry continues to view these negotiations as a long-term threat to innovation and profits, there appears to be a sense of short-term stability among drugmakers based on recent earnings calls from key companies like Bristol Myers Squibb, Johnson & Johnson, and others.

Executives from major pharmaceutical companies have expressed varying degrees of confidence regarding the immediate impact of these negotiations. Bristol Myers Squibb CEO Christopher Boerner mentioned that the company has received the final price for its blood thinner Eliquis, shared with Pfizer, and is “increasingly confident” in navigating the impact. AbbVie CEO Robert Michael noted that the expected sales impact on its leukemia drug Imbruvica is included in financial forecasts, with AbbVie still expecting to meet its long-term outlook. Similarly, J&J Worldwide Chairman Jennifer Taubert expressed confidence in the company’s long-term growth despite new prices for its blood thinner Xarelto and psoriasis treatment Stelara.

However, Novartis CEO Vasant Narasimhan acknowledged that while the short-term impact on its drugs, such as the heart failure drug Entresto, might be manageable, the policy’s long-term effects are concerning. Narasimhan criticized the policy for its negative implications on innovation and patient care.

Despite the immediate stabilization, the pharmaceutical industry remains strongly opposed to Medicare drug price negotiations, labeling them as bad public policy. Executives like Boerner from Bristol Myers Squibb highlighted concerns about the long-term implications on innovation due to the Inflation Reduction Act (IRA). Legal challenges from companies like Merck and Novartis are ongoing, with similar claims from other industry players and trade groups being recently rejected.

The Medicare drug price negotiation authority, established under President Joe Biden’s Inflation Reduction Act, aims to make medications more affordable for older Americans. While the immediate concerns over the new Medicare drug prices have somewhat subsided, the pharmaceutical industry remains wary of the long-term impacts. The upcoming price disclosures in September will provide clearer insights into how these negotiations will shape the market and influence future strategies for drugmakers.