Dive Brief:
- In a deal covering 12 Southeast Asian countries including China, South Korea and Taiwan, Sumitomo Dainippon Pharma has snagged rights to a Phase 3 ready drug, imeglimin, to add to its growing type 2 diabetes franchise.
- Imeglimin's developer, the French biopharma Poxel SA, will get an upfront payment of ¥4.75 billion ($42 million), along with potential development milestone payments, sales-based payments and escalating double-digit royalties that could be worth up to ¥29.25 billion ($257 million).
- Sumitomo Dainippon Pharma will pick up clinical trial and commercialization costs. A set of three pivotal Phase 3 studies, carried out as a joint effort between the two companies, is expected to begin in Japan before the end of 2017.
Editor's Note: A previous version of this article mischaracterized the relationship between Poxel and Enyo Pharma.
Dive Insight:
Sumitomo Dainippon Pharma has until now had an emphasis on R&D in psychiatry & neurology and oncology, with a wider focus on commercialization in psychiatry & neurology, diabetes & cardiovascular disease and in specialty medicines. This deal expands the Japanese company's R&D outlook as well as strengthening its future domestic revenue base in an increasing market – diabetes is fast growing in Asia, and the Japanese diabetes market is second only to the U.S.
Poxel, a spinout of Merck Serono in 2009, is developing a number of drugs for the treatment of type 2 diabetes. These include imeglimin, which has completed Phase 2 development, XL770, a direct AMPK activator in Phase 1, and oral GLP-1 agonist, GK activator and 11 beta HSD1 inhibitor discovery programs. Poxel was previously developing PXL007 (EYP001), a FXR agonist for the treatment of hepatitis B, but the company licensed the drug to Enyo Pharma in 2015.
As well as a welcome boost of almost 43% in its share price yesterday, the deal gives Poxel cash and future income to support the company's ongoing development, as well as a partner with years of experience in late-stage development and commercialization in Asia, and in sales and marketing of drugs in metabolic disease.
"Given imeglimin’s unique profile and novel mechanism of action, which we believe is well-suited for Asian patients, it has the potential to be a very important new oral therapy for the treatment of type 2 diabetes," said Thomas Kuhn, CEO of Poxel. "Our near-term focus in Japan is to initiate the Phase 3 program and to work closely with Sumitomo Dainippon Pharma to support the Japanese new drug application submission."
Imeglimin is the first of a class of drugs known as the glimins. It is orally available, and lowers glucose by targeting mitochondria in the liver, muscle and pancreas. It has potential both as a monotherapy and in combination with drugs with other mechanisms of action.