Paris-based Sanofi reported its third-quarter finances, with most of its categories showing strong growth. However, not everything was rosy
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Paris-based Sanofi reported its third-quarter finances, with most of its categories showing strong growth. Specialty Care Sales grew 20.2%; Vaccines rose 16.5%; Consumer Healthcare (CHC) increased 11.1% driven by Pain care and Digestive Wellness. The only slow performer was General Medicines, which were down 1.7%, although the company is transforming its business model to support core assets growth, up 4.5%.
“Sanofi has delivered outstanding financial reports in the third quarter,” said Paul Hudson, the company’s chief executive officer. “Double-digit sales growth in the period was driven by the remarkable performance of Dupixent, record sales of Vaccines and business momentum in Consumer Healthcare, all in line with our strategic priorities. As a result of our sales performance and strong earnings, we have upgraded our full-year EPS guidance growth to around 14% at CER.”
Of course, not everything was rosy. The company has struggled with its hemophilia drug, fitusiran. Earlier in the year, Sanofi revised its dosing schedule for the drug being used in its Phase III trials to try and decrease the risk of blood clots while still keeping the drug’s efficacy. They are partnered with Alnylam on this drug and hope to compete with Roche’s hemophilia A drug Hemlibra. But in 2020, the Phase III trials were delayed after patients reported blood clots, particularly in patients whose AT levels dropped to 10% or lower. The company reports it will likely not be able to file for regulatory approval until 2024. It was originally expected in 2022.
The company also reported it is delaying its filings for tusamitamab in lung cancer. The drug is a CEACAM5-targeted antibody-drug conjugate. Originally expected to be filed in 2022, it is now delayed until 2023. And another pair of drugs, venglustat in Gaucher disease type 3 and rilzabrutinib in immune thrombocytopenia (ITP), have been postponed until 2024.
Other drugs have also seen delays. Rilzabrutinib, a BTK inhibitor that the company picked up with Principia Biopharma for $3.7 billion, missed a primary endpoint in Phase II for pemphigus. Another drug, amcenestrant, an oral selective estrogen receptor degrader (SERD) for cancer, won’t have a data readout until the first quarter of 2022 when it was expected in this year’s fourth quarter.
Also in its report, Sanofi indicated it was dropping ST400, a drug for transfusion-dependent beta thalassemia. Sanofi partnered with Sangamo on the drug. The two companies are working on SAR445137 (formerly BIVV003) for sickle cell disease, which they will continue to develop. In their statement, Sanofi said, “The parties agreed to terminate the program addressing transfusion-dependent beta-thalassemia (ST400) while focusing resources on the sickle cell disease indication.”
On the regulatory side, the company reported the U.S. Food and Drug Administration (FDA) approved Nexviazyme (avalglucosidase alfa) for Pompe disease within the quarter. The drug was also approved in Japan. The European Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the drug in Europe, although the EC does not consider the drug to qualify as a New Active Substance (NAS), so Sanofi will request a re-examination of the CHMP opinion.
The FDA accepted the BLA resubmission of sutimlimab for hemolysis in adults with cold agglutinin disease with a target action date of February 5, 2022. The company submitted olipudase alfa for Acid Spingomyelinase Deficiency (ASMD) to Japan’s regulatory agency. The FDA also accepted the supplemental BLA for Libtayo (cemiplimab), a PD-1 checkpoint inhibitor for second-line treatment of recurrent or metastatic cervical cancer. The FDA also approved fexinidazole for Trypanosoma brucei gambiense sleeping sickness in patients six years of age and older who weigh at least 20 kg. The FDA granted Fast-Track Designation for SAR443820, a RIPK1 inhibitor in Phase I trials for amyotrophic lateral sclerosis (ALS). And the FDA granted orphan drug designation (ODD) for SAR445088 for chronic inflammatory demyelinating polyneuropathy (CIDP).
The China National Medical Products Administration (NMPA) also approved Dupixent (dupilumab) for moderate-to-severe atopic dermatitis in people 12 years of age and older.
