Sanofi hails broader promise of eczema medicine
Development comes after loss of patent protection on blockbuster drugs
Sanofi has hailed an eczema medicine tipped to be the biggest drug launch of the year as an “inflection point” as it tries to plug a revenue gap left by patent expiries on top-selling products.
If, as expected, US regulators approve Dupixent for treatment of the serious skin condition, analysts say the drug could generate peak annual sales of up to $6bn.
The development follows a difficult period for the French drugmaker that has lost patent protection on blockbuster medicines and twice failed to buy cutting-edge biotechnology companies, losing out in recent months to rivals Johnson & Johnson and Pfizer.
During late-stage clinical trials, about two-thirds of patients taking Dupixent with a steroid cream saw a dramatic improvement in their eczema, while nearly 40 per cent achieved clear or almost clear skin. Participants also reported a marked reduction in itching, the number one complaint among sufferers of atopic dermatitis.
The pathway targeted by Dupixent is also thought to have a role in several other conditions. Sanofi, in collaboration with Regeneron, a biotech that discovered the drug and will take half of the profits, is trialling the medicine in people with asthma, nasal polyps and food allergies, as well as children with atopic dermatitis.
Elias Zerhouni, president of global research and development at Sanofi, said the medicine marked “an inflection point . . . It is a pipeline in a single drug”.
The company has been under pressure to make up for the loss of patent protection two years ago on the last major drug in its portfolio. Lantus, the insulin medicine, had sales of more than $6bn in 2015. Analysts have estimated revenues generated by the drug will fall to about $2.9bn a year in 2020, emphasising the scale of the company’s challenge.
Dr Zerhouni said: “For Sanofi it’s really essential to overcome the patent cliff . . . We have to truly innovate with breakthrough drugs that can attack disease with two targets at once or three targets at once.”
Underlining the size of the potential market for Dupixent, he pointed out that more than 300m patients around the world suffered from asthma, “and it’s increasing in incidence”.
Adnan Butt, analyst at RBC Capital Markets, compared Dupixent with anti-inflammatory drugs such as AbbVie’s Humira and J&J’s Remicade. They were first approved for arthritis but went on to become top-selling medicines after being proven to work in a wide range of illnesses, generating a combined $23bn in sales last year.
“The revenue numbers could be very big based on the prevalence of severe-to-moderate atopic dermatitis in the wider population,” said Mr Butt.
Dr Zerhouni, who took the R&D helm after heading the National Institutes of Health in the US, said he had pushed the tie-up with Regeneron “in an effort to catch up in the field of biologics and to move [Sanofi] from being a traditional pharma company to a bio-pharma company. Because I just believed that science required that.”
His scientists were now focusing on other multi-targeted treatments, including one for diabetes, for which they were “developing molecules that have two and even three therapeutic actions at once. That is where the revolution is going to be,” he added.