Japan’s Sumitomo Dainippon Pharma (TYO: 4506) has entered into a strategic collaboration with French diabetes-focused biotech firm Poxel (Euronext: POXEL) for the development and commercialization of imeglimin, an investigational therapeutic agent for type 2 diabetes, in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries.
News of the deal sent the shares of Poxel rocketing more than 40% to 7.56 euros in morning trading today, while the Japanese drugmaker dipped 0.8%.
The partnership enables Sumitomo Dainippon to add an innovative late-stage development product to its well-established diabetes drug franchise in the fast-growing diabetes market in Japan. Poxel also gains a leading pharmaceutical partner for imeglimin with an extensive track record in late-stage development and commercialization in Asia. Diabetes is a fast-growing market in Asia and Japan is the second largest single market for type 2 diabetes outside of the USA.
Around $42 million upfront payment to Poxel
In return for the rights, Poxel is entitled to receive an upfront payment of about4.75 billion yen (~$42 million). The Phase III program for imeglimin in Japan will be a joint development effort between Poxel and Sumitomo Dainippon, with the latter responsible for costs associated with this program and will be responsible for the commercialization of imeglimin in Japan.
In China, South Korea, Taiwan and nine other Southeast Asian countries, Sumitomo Dainippon will be solely responsible for the development and commercialization of imeglimin. In addition, Poxel is entitled to receive future potential development milestone payments of up to 2.75 billion yen, subject to the clinical development of Imeglimin. Furthermore, after launch, Poxel will receive escalating double-digit royalties on net sales and sales-based payments of up to 26.5 billion yen (~$233 million) in accordance with sales goals.
“This is a major milestone for Poxel and for the development of imeglimin and we are extremely pleased to announce this strategic collaboration with Sumitomo Dainippon Pharma. 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, chief executive of Poxel. “Our near-term focus in Japan is to initiate the Phase III program and to work closely with Sumitomo Dainippon Pharma to support the Japanese New Drug Application submission.”
Poxel recently met with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for the imeglimin end of Phase II meeting to discuss the Phase III program plans and the data package required for a Japanese New Drug Application submission. Based on constructive interactions and feedback from the PMDA, the Phase III program in Japan will include three pivotal studies with approximately 1,100 patients and is on track to be initiated by the end of 2017.