Sanofi to sell 50% stake in Opella to CD&R, to retain French workforce; AbbVie bags FDA nod for Parkinson’s therapy Vyalev

By PharmaCompass

2024-10-24

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In this week’s Phispers, Sanofi has entered into exclusive talks with US private equity firm CD&R to sell a controlling 50 percent stake in its consumer health unit Opella, valued at US$ 17 billion. Under a trilateral agreement, CD&R will retain key factories, research, management, and Opella’s 1,700 workforce in France.

Gilead Sciences has decided to withdraw Trodelvy from the US bladder cancer market after the drug failed to meet survival endpoints in a confirmatory trial.

The US Food and Drug Administration (FDA) has approved AbbVie’s Vyalev, a novel 24-hour subcutaneous infusion therapy for advanced Parkinson’s disease. Astellas has secured a landmark FDA approval for Vyloy as the world’s first therapy targeting CLDN18.2 proteins in gastric cancer.

Pfizer’s respiratory syncytial virus (RSV) vaccine Abrysvo became the first to be authorized for at-risk adults between the ages of 18 and 49 years.

Novo Nordisk reported that its oral diabetes drug Rybelsus reduced cardiovascular events by 14 percent in a major trial, setting the stage for label expansion applications.

Meanwhile, Roche’s CEO Thomas Schinecker has said authorities should block the takeover of contract drug manufacturer Catalent by Novo Holdings, the controlling shareholder of Novo Nordisk.

With less than two weeks to go for the US Presidential election, the Biden administration has proposed a groundbreaking rule requiring private insurers to cover over-the-counter (OTC) contraceptives at no cost starting 2025. This could potentially benefit 52 million women with private health insurance.

Sanofi in talks to sell 50% controlling stake in Opella to US private equity giant CD&R

Sanofi is in exclusive negotiations to sell a 50 percent controlling stake in its consumer health business, Opella, to US private equity firm Clayton, Dubilier & Rice (CD&R). French public investment bank Bpifrance is expected to become a minority shareholder, picking up a stake of around 2 percent, and giving the state a seat on Opella’s board.

Sanofi, which is joining a growing number of drugmakers shedding consumer-related businesses, said Opella had been valued at around € 16 billion (US$ 17 billion). The French drugmaker will continue to own a 48 percent stake. Under a trilateral agreement with Sanofi and CD&R, France’s economy minister, Antoine Armand, stated that Opella’s new American owners will retain key factories, research, management, and its 1,700 workforce in France. Sanofi reportedly faces penalties of over € 100 million (US$ 108 million) if production and jobs are not kept in France. Opella employs 11,000 people globally and sells popular French paracetamol brand Doliprane.

Merck acquires Modifi: Merck has acquired New Haven, Connecticut-based Modifi Biosciences in a deal worth up to US$ 1.3 billion. Modifi is a pre-clinical stage biotech that is into the development of direct DNA modification enabled cancer therapeutics. Merck will pay Modifi US$ 30 million upfront and up to US$ 1.3 billion in milestone payments in exchange for a new class of therapies being developed against difficult-to-treat brain tumors, including glioblastomas.

Block Catalent takeover, says Roche CEO: Roche’s CEO Thomas Schinecker has said authorities should block the takeover of contract drug manufacturer Catalent by Novo Holdings, the controlling shareholder of Novo Nordisk. Schinecker said the takeover could adversely impact competition in the booming market for weight-loss drugs. Last week, consumer groups and two large labor unions in the US had also urged the US Federal Trade Commission to block the takeover. “Limiting the competition in this space is not a good idea,” Schinecker said.

AbbVie wins FDA nod for subcutaneous Parkinson’s drug Vyalev

AbbVie secured FDA approval for Vyalev, a breakthrough therapy for advanced Parkinson's disease that offers round-the-clock symptom control through subcutaneous infusion. The treatment represents a significant advancement in managing motor fluctuations in late-stage patients. The newly approved therapy utilizes foscarbidopa and foslevodopa, innovative prodrug versions of traditional Parkinson’s medications that become active once in the patient’s system. What sets Vyalev apart is its continuous delivery method via a subcutaneous pump. Market analysts are optimistic about Vyalev’s potential, suggesting it could become one of AbbVie’s most successful new products, with projected peak sales exceeding US$ 2 billion.

FDA okays Astellas’ gastric cancer drug: FDA approved world’s first therapy targeting CLDN18.2 proteins in gastric cancer, Vyloy (zolbetuximab). It was okayed for use along with chemotherapy in treating advanced gastric or gastroesophageal junction adenocarcinoma in adults with HER2-negative, CLDN18.2-positive tumors that are either locally advanced, inoperable or have spread. This regulatory success validates Astellas’ US$ 1.4 billion acquisition of Ganymed Pharmaceuticals in 2016.

FDA expands approval of Pfizer’s RSV jab: FDA has expanded the approval of Pfizer’s RSV jab to adults aged between 18 and 50 years. This makes Abrysvo the first and only RSV vaccine authorized for at-risk adults aged between 18 and 50 years to prevent RSV-associated lower respiratory tract disease (LRTD). Abrysvo is already approved for adults 60 years and older and for protecting infants through maternal vaccination during the mid-third trimester of pregnancy.

Gilead withdraws Trodelvy from US bladder cancer market: After failing to demonstrate survival benefits in a key confirmatory study, Gilead Sciences said it will pull Trodelvy (sacituzumab govitecan-hziy) from the US bladder cancer market. The targeted cancer therapy, which received accelerated FDA approval in 2021 for treating metastatic urothelial cancer, did not achieve its primary endpoint.

Novo’s oral diabetes drug Rybelsus slashes heart-related risks by 14%

Novo Nordisk said its oral diabetes drug Rybelsus (semaglutide) demonstrated significant cardiovascular benefits in a late-stage trial, reducing the risk of major cardiac events by 14 percent compared to placebo. The positive results mirror the cardiovascular benefits already established by Ozempic, the injectable version of semaglutide, which received FDA approval for reducing cardiovascular risks in type 2 diabetes patients with heart disease in 2020.

Biden proposes rule to make contraceptives free: The Biden administration has proposed a rule that would revolutionize access to birth control, requiring private insurers to cover OTC contraceptives at no cost to patients starting in 2025. The initiative would benefit approximately 52 million women of reproductive age with private health insurance.

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MARKET INTEL by PharmaCompass

Sanofi in talks to sell 50% controlling stake in Opella to US private equity giant CD&R

AbbVie wins FDA nod for subcutaneous Parkinson’s drug Vyalev

Novo’s oral diabetes drug Rybelsus slashes heart-related risks by 14%