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Opella manufactures Doliprane, a popular painkiller in France. Credit: Marc Bruxelle / Shutterstock

Sanofi has entered exclusive talks with US private equity company Clayton Dubilier & Rice (CD&R) over the sale of the former’s consumer health business Opella, with a deal also reached with the French Government to quell political fears over loss of regional jobs and production.

The exclusive negotiations are for the potential sale of a controlling 50% stake in Opella, which is the third-largest business in the world in the over-the-counter and vitamins, minerals & supplements market, according to Sanofi. The French pharma company said the deal, which saw CD&R prevail over rival France-based bidder PAI Partners, would close no earlier than Q2 2025.

Sanofi has placed an enterprise value of €16bn ($17bn) on Opella, around 14 times the estimated core earnings (EBITDA) for 2024, as per a 21 October press release.

Shares in the French pharma opened 0.69% down at market open on 21 October compared to the previous day’s market close. The company has a market cap of $136.3bn. 

The European Commission (EC) has imposed a fine of €462.6m ($502m) on Teva Pharmaceuticals Industries after investigating the company’s practices regarding the standard-of-care multiple sclerosis treatment, Copaxone.

The fine relates to the company’s attempts to delay the entry of competitors to Copaxone by artificially extending the therapy’s patent protection and disseminating misleading information about rival products.

Teva held a basic patent for Copaxone’s active ingredient, glatiramer acetate, which expired in 2015.

However, the commission found that Teva extended Copaxone’s exclusivity by misusing patent procedures and disseminating false information. The markets affected include Czechia, Belgium, Germany, Italy, the Netherlands, Poland, and Spain.

A modified dosing regimen with Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) has shown a reduction in amyloid-related imaging abnormalities with oedema/effusion (ARIA-E).

Lilly announced data for the TRAILBLAZER-ALZ 6 Phase IIIb trial (NCT05738486) on 29 October at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) Conference in Madrid, Spain.

Lilly is discussing the results of this study with global regulators, with the intent to submit for a potential label update for Kisunla.

The TRAILBLAZER-6 trial evaluated the impact of different dosing regimens of Kisunla on the rates of ARIA-E and amyloid clearance in adults with early symptomatic Alzheimer’s disease.

The incidence of ARIA-E was 14% in patients receiving the modified titration compared with 24% for those receiving the standard dosing regimen, a 41% lower relative risk.

The US District Court for the District of Columbia has upheld the decision by the US Food and Drug Administration (FDA) to keep Avadel Pharmaceutical’s narcolepsy drug, Lumryz (sodium oxybate) on the market, rejecting Jazz Pharmaceuticals’ attempt to overturn the FDA approval.

Jazz argued that the approval infringed on the seven-year market exclusivity granted to its narcolepsy drug, Xywav (sodium oxybate), under the Orphan Drug Act (ODA) in 2020. The FDA had granted Xywav exclusivity, which typically prevents the approval of any similar orphan drug for the same condition.

However, in May 2023, the FDA approved Avadel’s Lumryz, which contains the same active ingredient but differs in its dosing regimen. Unlike Xywav’s split-dose schedule – requiring users to wake up for a second dose – Lumryz is taken as a single nightly dose, which the FDA deemed as “clinically superior” due to its added convenience for patients.

As the UK Government presses ahead with laws to create a smoke-free generation, tens of thousands of smokers will now benefit from an improved version of a smoking cessation pill thanks to a roll-out by the National Health Service (NHS). 

Varenicline will be offered to around 85,000 smokers in England to help them kick the habit alongside behavioural support, as per a 12 November press release. 

NHS England states that the tablet is as effective as vapes in helping people stop smoking, and even better than nicotine-replacement gum or patches. Around a quarter of those taking varenicline in tandem with behavioural support stop smoking for at least six months, the health service said. 

Varenicline helps block cravings for nicotine, the addictive chemical found in tobacco products. The drug also helps with withdrawal symptoms such as irritability and sleep issues.