With the deal in hand, Roivant has stepped into the world of metabolic diseases.
Roivant Sciences struck a deal worth up to $650 million with France-based Poxel SA to develop and market imeglimin, an oral type 2 diabetes treatment, in the United States and Europe. With the deal in hand, Roivant has stepped into the world of metabolic diseases.
Shares of Poxel SA jumped more than 15 percent following the announcement.
Poxel said its oral treatment imeglimin targets the two main defects seen in patients with type 2 diabetes -- The pancreas by increasing insulin secretion, in a glucose-dependent manner; and the muscles and liver by decreasing the excess production of glucose by the liver while increasing the effectiveness of insulin or ‘insulin sensitivity’ in the muscles. In Phase I and Phase II studies involving more than 1,200 type 2 diabetes patients, Poxel said imeglimin has met endpoints including a statistically significant decrease of HbA1c and fasting plasma glucose versus placebo. Poxel said the drug also has a favorable safety profile.
Roivant, helmed by biotech billionaire Vivek Ramaswamy, said the partnership with Poxel provides the company with “an innovative late-stage development program” for its pipeline. Roivant also noted that Poxel will gain a strategic development and licensing agreement for imeglimin beyond the company’s partnership with Japan-based Sumitomo Dainippon Pharma. Poxel SA has been moving forward with development of imeglimin in Japan. Now with Roivant’s financing, the company can move forward with development across Europe and the U.S. In Japan, the company has a target date of 2020 for filing for approval of imeglimin.
Poxel Chief Executive Officer Thomas Kuhn praised the partnership with Roivant. In a statement, he said the Swiss-based Roivant’s vision “complements Poxel’s strategy of bringing novel treatments for type 2 diabetes and other metabolic disorders to patients.” Kuhn said 2018 is shaping up to be a transformative year for Poxel.
Before Phase III trials can be launched, the companies said it will initiate differentiation studies to confirm imeglimin’s potential in sensitive patient populations, such as those with chronic kidney disease, as well as manufacturing of the drug product for use in the Phase III program. The companies hope to launch the Phase III trial by 2019.
Ramaswamy said the deal with Poxel fits Roivant’s strategy of in-licensing late-stage development candidates in underserved therapeutic areas.
“This agreement represents the beginning of our focus on metabolic diseases and imeglimin, with its compelling and consistent data, will be a cornerstone program. We are looking forward to rapidly advancing its development,” Ramaswamy said in a statement.
Earlier this month, Roivant struck another deal with ArQule, Inc. to develop derazantinib, a pan-FGFR (fibroblast growth factor receptor) inhibitor, in Greater China.
Under terms of the agreement, Poxel will receive an upfront payment of $35 million. Roivant will invest another $15 million in Poxel to acquire 1,431,399 newly-issued ordinary shares. If the imeglimin development goes smoothly, Poxel would then be eligible for up to $600 million in development and regulatory milestone payments. If imeglimin is launched, then Poxel will be entitled to double-digit royalties.
Roivant will be responsible for development and commercialization costs and Poxel will contribute $25 million to the development program. The parties will decide on a potential co-promotion prior to commercialization.
