Sanofi’s dengue shot Dengvaxia wins FDA priority review despite controversial past

Sanofi has weathered controversy with its world-first dengue vaccine, Dengvaxia, but the company is pressing ahead, and on Tuesday said the FDA had not only accepted its application for approval, but also granted a priority review.

The FDA is set to decide on Sanofi’s vaccine by May 1, 2019. In granting the priority review, the FDA determined the vaccine could be the first medical tool to prevent a serious disease with unmet need. Recipients would need to have confirmation of a prior dengue infection because of safety risks in those who haven’t, a Sanofi executive said, a factor that could complicate a broad rollout.

With an approval, officials could use the vaccine in the U.S. Virgin Islands and Puerto Rico, where the dengue burden is high, according to the company.  (see more details on FiercePharma)

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Changes in the global diabetes market

When it comes to the diabetes market, Novo Nordisk is the absolute industry leader. In 2017, the global diabetes market sales were 46.1 billion US dollars. The Novo Nordisk family accounted for about 30% of the global diabetes market share. The TOP10 companies in the field mainly include Sanofi, Eli Lilly, Merck and so on.

In recent years, with the launch of Tresiba/Xultophy/Ryzodeg and Somarupeptide, Novo Nordisk will continue to occupy an important position in the diabetes market. Evaluate Pharma predicts that its market share will climb to 35.5% in 2024. In addition, from the perspective of drugs, insulin certainly contributes most of the sales, but it is clear that GLP-1R agonist diabetes drugs are rapidly expanding and will expand further in the future.

Novo Nordisk

Sanofi blockbuster-to-be skin drug Dupixent fails to win gatekeeper’s backing

Sanofi’s new atopic dermatitis launch Dupixent has hit a roadblock with the influential cost-effectiveness gatekeepers in England. The National Institute for Health and Care Excellence rejected the blockbuster hopeful, despite finding that it’s an innovative drug for patients who have a strong need for new treatments.

The obstacle? It’s likely price, if NICE history holds. The agency found that Dupixent is a “step change” in managing the disease, Sanofi said Tuesday, but couldn’t sign off on its use because of cost-effectiveness concerns. The guidance isn’t final, and the process now goes to a consultation period until April 24.

Sanofi

Sanofi will purchase the Belgian biologics company(Ablynx) for $4.8 billion

The French pharma giant Sanofi announced this morning that it will buy the Belgium-based antibody drug developer Ablynx for $4.8 billion in cash. The deal will further bolster Sanofi’s rare blood disease portfolio and pipeline and gives it access to Ablynx’s small-sized antibodies, called nanobodies.

Sanofi emphasized that the long-term value lies in Ablynx’s nanobody technology. Normal antibodies are composed of two main segments, a heavy chain and light chain. Nanobodies are heavy-chain-only antibodies that are derived from camels and llamas. The end result is a smaller-than-normal antibody drug that can be delivered more easily.

(cr: http://cen.acs.org/articles/96/web/2018/01/Sanofi-boost-rare-blood-disease.html)

Sanofi

Deals for Juno and Bioverativ put CAR-T and hemophilia in spotlight

Launching what is expected to be a busy year for drug industry acquisitions, Celgene says it will acquire the CAR T-cell cancer immunotherapy company Juno Therapeutics for about $9 billion, and Sanofi has signed a deal to buy the rare blood disease company Bioverativ for nearly $11.6 billion.

Last year was a slow one for drug industry mergers and acquisitions, with only a handful of deals surpassing $1 billion. Analysts are forecasting a heavier M&A season for 2018, and that prediction looks on track so far.

Juno’s pipeline is entirely based on CAR T-cell immunotherapy, a gene therapy in which a cancer patient’s immune cells are removed from their body, turbocharged via genetic engineering, and reinjected to target cancer. Bioverativ’s biggest selling points are its marketed blood clotting factor replacement therapies for hemophilia, although it’s also working on gene therapies for the disease.

(cr: https://cen.acs.org/articles/96/web/2018/01/Deals-Juno-Bioverativ-put-CAR.html)

Sanofi buys rights to Principia’s BTK inhibitor

Sanofi has bought itself rights to Principia BioPharma’s experimental tyrosine kinase (BTK) inhibitor PRN2246, in a deal potentially worth more than $800 million to the latter firm.

The experimental oral therapy, which is designed to access the brain and spinal cord by crossing the blood-brain barrier to impact immune cell and brain cell signaling, has shown promise in multiple sclerosis (MS) and also has potential in other central nervous system (CNS) diseases.

(original source: http://www.pharmatimes.com/news/sanofi_buys_rights_to_principias_btk_inhibitor_1210958)