Sanofi just got its first cancer drug approved in a decade. Here's the pharma giant's plan to rejoin the fight against cancer under new CEO Paul Hudson.

Andrew DunnMar 3, 2020, 23:23 IST

The French drugmaker Sanofi has officially re-entered oncology, as the Food and Drug Administration approved the multiple myeloma treatment Sarclisa on Monday.
Sanofi's last new cancer drug was a chemotherapy approved a decade ago. Under new leadership, the company plans to advance several more cancer therapies, a top Sanofi executive told Business Insider.
"Sarclisa is our re-entry into oncology," Sanofi's development leader Dietmar Berger said in an interview. "You see a very meaningful pipeline behind that."
In his first few months as CEO, Paul Hudson has begun shaking up the $120 billion pharma giant. In December, he announced Sanofi will stop diabetes and cardiovascular research, while inking a $2.5 billion deal to acquire Synthorx and expand its immuno-oncology pipeline.
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Sanofi is back in the fight against cancer.

On Monday, the French pharmaceutical giant won US approval for Sarclisa, a therapy for a type of blood cancer called multiple myeloma. Sarclisa is the company's first cancer drug to get approved since 2010.

"Sarclisa is our re-entry into oncology," Dietmar Berger, Sanofi's head of development, told Business Insider in an interview before the approval. "You see a very meaningful pipeline behind that."

Sanofi is a $120 billion drugmaker better known for its work in diabetes and vaccines. Under new CEO Paul Hudson, the company is betting a significant portion of its future on finding new oncology drugs. Cancer treatments are now the largest area of Sanofi's research, making up 28 of its 85 clinical projects.

Hudson, less than six months into his CEO tenure, announced in December 2019 that Sanofi would stop its research efforts in diabetes and heart diseases, saying the company's history in these areas "shouldn't dictate some poor investment decisions because we're still looking backwards."

The first major acquisition under Hudson was scooping up the biotech Synthorx for $2.5 billion to boost its efforts in a type of cancer research called immuno-oncology, which uses the body's immune system to fight the disease.

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Sanofi has to catch up with rivals who are ahead of it in cancer treatments

Sanofi's internal research has languished in years past, with the majority of Sanofi's new drugs coming by buying them instead of developing them. That remains true with Sarclisa, which was acquired through a 2017 licensing deal with the small biotech company ImmunoGen.

But Sanofi has recently built up its research capabilities, Berger said, adding that the company is now prepared to compete in the next round of immunotherapies.

Within the space, most big pharma firms are ahead of Sanofi, with a portfolio of cancer drugs already on the market, and significant research underway in newer treatment areas like cell therapies or immuno-oncology.

Sarclisa is no exception, as Sanofi is already playing from behind. Johnson & Johnson's Darzalex was approved nearly five years ago. It's a rival cancer drug that targets the same protein as Sanofi's therapy. The French pharma priced its drug at $5,200 for a typical infusion, cheaper than J&J's version.

SVB Leerink analyst Geoffrey Porges projects J&J Darzalex will dominate over the next few years, forecasting Sarclisa to grow to just 7% of the market by 2025. That translates to modest annual sales of about $800 million by 2025 for Sanofi's therapy.

But Sanofi executives argue Sarclisa is a meaningful start, and they plan to build upon it as a foundational therapy. The company is running trials testing it in patients with earlier cases of multiple myeloma, as well as in combination with cancer drugs made by rival companies.

Berger called the drug "exquisitely combinable" given its safety and tolerability profile so far.

Treatments from the $2.5 billion Synthorx acquisition will pair with Sarclisa. The biotech firm has shown its platform can massively increase the number of natural killer cells in patients, which attack myeloma cells. That boost could improve the efficacy of Sarclisa, R&D head John Reed said in December.

Sanofi is working to speed up research on new treatments

While that Sarclisa combination represents a near-term opportunity, Sanofi's leadership faces a greater challenge in changing the ways of working at a company of more than 100,000 employees to speed up research on new treatments.

Researchers previously had to go through 33 committees to advance a drug candidate, Reed said in a previous interview. He's chopped that number down to three.

The company had also made starting new projects a key metric of success for employees. The new R&D head also scrapped that, saying he's focused on speedy completion more than starting new projects.

"Cultural change is one of the key things we need to look into, and we are," Berger said. "There needs to be a stronger focus on prioritization and bringing transformative medicines to patients as quickly as possible."

Berger highlighted three areas he's focused on to improve Sanofi's research efforts. First, he said is focusing on diseases where there is a deep scientific understanding of biology.

Second, the company has built up its capabilities to use a range of platforms, or new disease-fighting technologies, including antibodies, gene therapy, and even nanobodies, which are based off the antibodies of alpacas.

Berger said the third element is working with regulators and payers in new ways, highlighting the potential for new trial designs that test one drug against multiple diseases simultaneously, use digital approaches, and apply real-world evidence.

"Culture change is over long periods of time," Berger said. "I would say we are in the middle of it."

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Sanofi just got its first cancer drug approved in a decade. Here's the pharma giant's plan to rejoin the fight against cancer under new CEO Paul Hudson.

Sanofi has to catch up with rivals who are ahead of it in cancer treatments

Sanofi is working to speed up research on new treatments