France draws US$ 2.25 bn investment from Big Pharma; Sanofi strikes US$ 1.2 bn deal with Novavax

By PharmaCompass

2024-05-16

Impressions: 923

In this week’s news, France attracted investments from pharma majors such as Sanofi, Pfizer, AstraZeneca and GSK during the ‘Choose France’ summit.

In approvals, the US Food and Drug Administration (FDA) expanded the use of Bristol Myers Squibb’s cancer cell therapy Breyanzi for the treatment of adults with follicular lymphoma. The agency also okayed Roche’s HPV self-testing kit for cervical cancer.

In deals, beleaguered Novavax signed a US$ 1.2 billion deal with Sanofi to license and commercialize its existing Covid vaccine and develop a combo jab to protect against Covid and influenza. AbbVie and Gilgamesh signed a deal worth over US$ 2 billion to develop a new class of psychedelic compounds to treat psychiatric conditions.

Takeda grabbed the opportunity to license Alzheimer’s therapies from AC Immune, including an Alzheimer’s vaccine. Novo Nordisk tied up with Metaphore to develop next-generation obesity drugs.

And deaths from drug overdose reduced for the first time in six years in the US, giving hope that the ongoing opioid crisis in the country might be receding.

France draws US$ 2.25 bn investment from Sanofi, Pfizer, Astra, GSK

During the ‘Choose France’ summit held this week, Sanofi said it is investing over € 1 billion (US$ 1.1 billion) to create new bioproduction capacity at its sites in Vitry-sur-Seine, Le Trait, and Lyon Gerland. This new investment will create over 500 jobs.

Meanwhile, Pfizer pledged another € 500 million (US$ 539 million) toward its five-year investment plan in France, bringing the total to over € 1.5 billion (US$ 1.63 billion). AstraZeneca announced an investment of € 360 million (US$ 388 million) at its production facility in Dunkirk. Others to announce investments in France were GSK with € 140 million (US$ 151 million), AbbVie with € 36 million (US$ 39 million), and Novartis with € 30 million (US$ 32 million).

Sanofi bails out Novavax, pays US$ 1.2 bn to commercialize, develop Covid jabs

Novavax has received a timely shot in the arm, as Sanofi will pay the former up to US$ 1.2 billion in exchange for a license to commercialize its existing Covid vaccine and develop a combo jab to protect against Covid and influenza. The struggling Maryland biotech’s management, or lack thereof, has come under fire from investors. Sanofi can also use Novavax’s Matrix-M adjuvant technology to develop new vaccines. Novavax will receive another US$ 200 million for this. Sanofi also gets a minority 4.9 percent stake in Novavax.

AbbVie, Gilgamesh ink deal to develop psychedelic drugs for psychiatric conditions

AbbVie and Gilgamesh Pharmaceuticals have inked a deal potentially worth over US$ 2 billion to develop a new class of psychedelic compounds to treat psychiatric conditions. The collaboration marries AbbVie’s expertise in psychiatry and Gilgamesh’s innovative research platform to discover novel neuroplastogens (a novel class of compounds inducing rapid and enduring neuroplasticity).

US drug overdose deaths drop for first time in six years: In a rare ray of hope in the ongoing US opioid crisis, overdose deaths in the country fell for the first time in six years, according to preliminary data released by the Centers for Disease Control and Prevention (CDC). However, drug overdose deaths in 2023 still went over the 100,000 mark. Overall, drug overdoses claimed 107,543 lives in the US last year compared to 111,029 in 2022, a 3 percent drop.

FDA expands use of BMS’ Breyanzi to treat follicular lymphoma

FDA has expanded the use of Bristol Myers Squibb’s cancer cell therapy Breyanzi for the treatment of adults with a type of blood cancer known as follicular lymphoma that has returned or has not responded to prior treatments. This marks the fourth approval fo r Breyanzi.

FDA okays Roche’s HPV self-testing kit for cervical cancer: Roche said FDA has approved its cobas human papillomavirus (HPV) self-collection solution, one of the first available in the US. The move is expected to significantly improve access to testing by providing women the option to privately collect their own sample.

WHO clears Takeda’s dengue vaccine: WHO has granted prequalification to Takeda’s dengue vaccine TAK-003, thereby okaying it to be procured by agencies like UNICEF and PAHO. This is only the second dengue vaccine to receive WHO prequalification. Sanofi’s Dengvaxia received it in 2020 for people aged between six and 45 years.

Takeda seizes option to license Alzheimer’s therapies from AC Immune

Takeda is paying Swiss biotech AC Immune US$ 100 million upfront and betting a further US$ 2.1 billion for an exclusive option to license global rights to an Alzheimer’s vaccine and “active immunotherapies targeting toxic forms of amyloid beta.”

Novo ties up with Metaphore to develop obesity drugs: In its quest to develop novel treatment approaches for cardiometabolic and rare diseases, Novo Nordisk has penned a strategic partnership with Flagship Pioneering company Metaphore Biotechnologies. The Danish Big Pharma will pay up to US$ 600 million in upfront, development, and commercial milestone payments to develop up to two next-generation therapeutics for obesity management.

Five die in MacroGenics’ prostate cancer trial; Keytruda fails phase 3 trial

MacroGenics reported five deaths as well as an over 50 percent rate of grade 3 or worse adverse events in a phase 2 trial. Its investigational ADC (vobramitamab duocarmazine) was being trialed in the treatment of metastatic castration-resistant prostate cancer. Two of the fatalities were deemed to be unrelated to the study. The other three deaths are still being investigated.

Keytruda-chemo combo fails in late-stage trial: Merck’s Keytruda, in combination with chemotherapy as adjuvant treatment with or without radiotherapy, did not meet its primary endpoint of disease-free survival (DFS) for the treatment of patients with newly diagnosed, high-risk endometrial cancer after surgery.

Novo’s hemophilia drug, Cytokinetics’ heart drug score late-stage wins

Novo Nordisk’s Mim8 has hit its primary endpoint in a late-stage trial to treat people with hemophilia A. This paves the way for filing for approval later this year and competing with Roche’s Hemlibra (emicizumab-kxwh) that raked in CHF 4.1 billion (US$ 4.5 billion) last year. The once-weekly and once-monthly Mim8 demonstrated superior reductions of 97 percent and 99 percent in treated bleeds, respectively, compared to those who received no prophylaxis treatment.

Late-stage win for Cytokinetics’ heart drug: Primary data from Cytokinetics’ highly anticipated phase 3 trial showed that its investigational cardiac myosin blocker aficamten significantly improved exercise capacity in patients with obstructive hypertrophic cardiomyopathy. Approval will pit it against Bristol Myers Squibb’s oral drug Camzyos (mavacamten), which was the main candidate in BMS’ US$ 13.1 billion acquisition of MyoKardia.

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