Date: 2017-10-30
Type of information: Development agreement
Compound: imeglimin
Company: Poxel (France) Sumitomo Dainippon Pharma (Japan)
Therapeutic area: Metabolic diseases
Type agreement: development - commercialisation
Action mechanism:
- glimin. Imeglimin is the first in a new chemical class of oral anti-diabetic agents, the glimins. Imeglimin acts on three main target organs involved in glucose homeostasis: the liver, the muscle, and the pancreas and has therefore a distinct mode of action compared to existing treatments for Type 2 diabetes. Imeglimin has shown a significant anti-diabetic efficacy combined with an excellent tolerance in earlier monotherapy clinical trials.
- Imeglimin has completed Phase 2 development in over 850 patients in the United States and Europe.
Disease: type 2 diabetes
Details:
- • On October 30, 2017, Sumitomo Dainippon Pharma and Poxel announced the signing of a strategic partnership 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.
- The Phase 3 program for Imeglimin in Japan will be a joint development effort between Poxel and Sumitomo Dainippon Pharma. Sumitomo Dainippon Pharma will be 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 Pharma will be solely responsible for the development and commercialization of imeglimin. Poxel recently met with the Pharmaceuticals and Medical Devices Agency (PMDA” in Japan for the imeglimin end of Phase 2 meeting to discuss the Phase 3 program plans and the data package required for a Japanese New Drug Application (JNDA) submission. Based on constructive interactions and feedback from the PMDA, the Phase 3 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.
Financial terms:
- Under the agreement, Poxel is entitled to receive an upfront payment of approximately ?4.75 billion (approximately €36 million, $42 million). In addition, Poxel is entitled to receive future potential development milestone payments of up to ?2.75 billion (approximately €21 million, $24 million), 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 (approximately €198 million, $233 million) in accordance with sales goals.
Latest news:
- • On December 27, 2017, Poxel and Sumitomo Dainippon Pharma announced the initiation of the Phase 3 program for imeglimin in Japan. Referred to as TIMES (Trials of IMeglimin for Efficacy and Safety), the Imeglimin Phase 3 program in Japan will include three pivotal trials to evaluate Imeglimin’s efficacy and safety in approximately 1,100 patients.
Is general: Yes
