South Korea’s Hanmi Pharmaceutical may consider legal action against global biopharma Sanofi, as the French company abruptly decided to halt participation in further research on efpeglenatide, a potential treatment for Type 2 diabetes. The two have been jointly developing efpeglenatide, discovered by Hanmi.
The Korean pharma issued a notice to shareholders Thursday, saying there were still 120 days to renegotiate and that it might take legal action against Sanofi if circumstances warranted it.
“Throughout our ongoing clinical data presentations, Sanofi has always publicly assured the investors that it planned to pursue the phase 3 clinical trial of efpeglenatide to the end,” said a Hanmi official. “We will request that it keep its word.”
Hanmi had licensed out the global rights for three pipelines to Sanofi, including the Type 2 diabetes treatment pipeline efpeglenatide and two other insulin pipelines.
Under the contract, Hanmi is not obligated to return the 200 million-euro ($216 million) upfront payment. But it loses out on the milestone payments it had expected to receive for reaching certain phases in the research, and on the royalties it would have brought in if the two companies had succeeded in commercializing the drug.
While the exact amounts of those payments remain undisclosed, the two firms’ original contract was worth 3.9 billion euros in 2015. That figure was later adjusted to 2.72 billion euros in 2016, reflecting a decrease in fees to be paid by Hanmi for joint research. Hanmi claims Sanofi, seeing greater business potential for efpeglenatide, had wanted to shoulder more of the research costs.
“We believe Sanofi’s decision is unrelated to efpeglenatide’s efficacy and safety. By the time this pipeline reaches the commercial stage, the global market for GLP-1 type drugs will have grown to $10 billion. Upon presentation of the comparison report against competing drug dulaglutide in end-2020 or early 2021, we may find a new global partner other than Sanofi,” Hanmi said in a press release.
Hanmi is currently co-developing neutropenia treatment elapegrastim and breast cancer treatment poziotinib with Spectrum Pharmaceutical; the Orascovery platform with Athenex; and anti-tumor pipeline belvarafenib with Genentech. All three partners are based in the US.
By Lim Jeong-yeo(firstname.lastname@example.org