Sanofi reports sales growth amid Dupixent's China launch, but reveals PDUFA delay in Pompe disease program
Sanofi released its first quarter earnings report Wednesday, and while the company saw positive news regarding growth and sales — particularly in China — they also revealed for the first time a delay in one of their lead Phase III programs.
The French pharma’s Pompe disease program avalglucosidase alfa saw its PDUFA date pushed back by three months, from May 18 to Aug. 18, Sanofi noted in its investor presentation. No reason was given for the move, and Endpoints News has reached out for comment.
Overall, however, Dupixent continued to prove an emerging cash cow for Sanofi. The Regeneron-partnered drug pulled in more than $1 billion worldwide for a year-over-year increase of 45.6% at the common exchange rate. Dupixent also scored a spot on China’s coveted National Reimbursement Drug List in March, marking the official launch of Dupixent in one of the world’s largest markets.
Sanofi saw total net sales increase by 2.4%, attributed largely to Dupixent’s success.
Two of Sanofi’s other franchises, Praluent and Toujeo, also launched in China this past quarter. Though Praluent sales were down 20.5% due to lower sales in the US, the drug spiked outside the country: Sales grew 20% in Europe and 45.5% outside of the US and Europe.
The Pompe disease program delay is the latest in a string of recent setbacks for patients looking for the first new drug in the illness since 2010. That drug, Lumizyme, was brought under the Sanofi umbrella in the company’s buyout of Genzyme the following year. It’s an enzyme replacement therapy, providing an artificial copy of the enzyme known as GAA, without which patients see irreversible muscle damage resulting from excessive sugar buildup in cells.
Avalglucosidase alfa was designed to more easily enter cells, potentially allowing for faster and more efficient sugar processing. Though the program obtained priority review back in November, analysts expressed skepticism last July after it failed to prove superior to Lumizyme in improving respiratory function in a Phase III trial.
On top of that, Amicus saw its shares hammered in February after its own Pompe disease program flopped the primary in a Phase III study. Here, the Amicus candidate did not manage to achieve statistically significant superiority in a 6-minute walk test among both ERT-naive patients and those who’d been switched from the therapy.
Amicus did reveal, though, that the group that had switched from Lumizyme saw a nominal improvement at a p-value of p=0.046.
Looking ahead to the second quarter, Sanofi highlighted its joint vaccine venture with Merck, as the pair’s pediatric 6-in-1 combination vaccine Vaxelis is expected to launch in the US before the end of June. It’s the first such vaccine to be used in the country, following its launch in Europe back in 2017 and FDA approval in December 2018.
The shot is indicated for children aged between 6 weeks and 4 years old, and inoculates against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type B.