It turns out that the FDA complete response letter (CRL) Sanofi and partner Regeneron recently received for their experimental IL-6 inhibitor, and Humira competitor, sarilumab is not the only manufacturing-related issue delaying the French drugmaker’s turnaround efforts. Clinical trials for a new long-term diabetes treatment have been pushed back because South Korea partner Hanmi Pharmaceutical has had a glitch in manufacturing.
On Monday, Sanofi declined to comment beyond what CEO Olivier Brandicourt said during the drugmaker’s Q3 earnings call and what the company said in its earnings release, which was not much. “Our Phase III starts have been delayed from this quarter to 2017 for the long-acting GLP-1, and that is due to a manufacturing issue,” Brandicourt told analysts.
The earnings release simply said, “Efpeglenatide start of Phase III in Diabetes has been delayed from Q4 2016 into 2017 due to manufacturing delays by Hanmi. Sanofi will provide more details once the new timelines have been finalized.”
Last year, Sanofi placed a sizable bet on Hanmi’s work in long-acting GLP-1 diabetes treatments when it struck a deal to pay the the South Korean company €400 million ($434 million) upfront and up to €3.5 billion in development and sales milestones as well as double-digit royalties on net sales.
In return Sanofi gets an exclusive worldwide license to develop and commercialize the GLP-1 treatments, which it hopes will help its struggling diabetes business. Hanmi retains an exclusive option to co-commercialize the drugs in South Korea and China.
Of course, it is because its diabetes franchise, anchored by Lantus, is struggling that Sanofi has also branched into other areas with Regeneron. The two were hoping for an approval for sarilumab on Oct. 28, the day Sanofi reported earnings. Instead, the companies announced that the FDA slapped the drug with a CRL related to “manufacturing deficiencies” at a Sanofi fill-finish facility, delaying its potential approval.
The companies said that "satisfactory resolution of these deficiencies is required before the BLA can be approved.” Sanofi has submitted a comprehensive corrective action plan to the FDA and is implementing the corrective actions specified in that plan. Sanofi pointed out that the CRL didn’t identify any “concerns relating to the safety or efficacy of sarilumab."
It was a blow to the companies, which are expecting the drug to do well in competition with AbbVie's Humira, the best-selling drug in the world. The experimental treatment outperformed Humira in a Phase III head-to-head study in rheumatoid arthritis. Their candidate, before the delay, was projected by EvaluatePharma to reach 2020 sales of $1.8 billion.
In August, Sanofi had other work pairing a basal insulin with a GLP-1 delayed until at least this month because the FDA asked for more data on the dual-drug delivery pen--a device that triggered debate during an FDA advisory panel review in May.
Competition has already undercut Lantus, which is still the top-selling long-acting insulin on the market but is facing biosimilar competition outside the U.S. and by next year in the states. Sales in Q3 fell 9.8% to €1.39 billion on pricing pressures and patients switching to the drugmaker’s follow-up, Toujeo, which brought in €167 million. Still, Sanofi reported revenue and earnings that beat analyst projections