Sanofi Collaborates on Diabetes with Lexicon and Hanmi
French drugmaker Sanofi has entered into two separate collaborations to develop and commercialize diabetes treatments. An agreement with US-based Lexicon Pharmaceuticals centers on sotagliflozin, an investigational oral dual inhibitor of sodium-glucose transporters 1 and 2, while that with South Korea’s Hanmi Pharmaceutical aims to develop a portfolio of products. Sotagliflozin is currently undergoing two Phase 3 trials in type 1 diabetes and results are expected during the second half of 2016. Phase 3 trials in type 2 diabetes are expected to start next year.
According to collaboration partners, sotagliflozin has shown encouraging results in Phase 2 studies, including lowering blood sugar, improving glycemic variability and reducing the mealtime dose of insulin in type 1 diabetics. For people with type 2 diabetes, including those with renal impairment, Phase 2 studies showed lower blood sugar, weight loss and improvements in blood pressure.
Lexicon said Sanofi’s focus and history of innovation for treating diabetes made it well positioned to unlock sotagliflozin’s full potential. Under the terms of the deal, Lexicon will receive an upfront payment of $300 million and various milestone payments worth up to $1.4 billion, as well as royalties on net sales.
Sanofi will gain an exclusive worldwide license to develop, manufacture and commercialize sotagliflozin. It will lead activities for type 2 diabetes and will be solely responsible for commercializing the drug to treat type 1 diabetics outside the US. Lexicon will lead clinical development relating to type 1 diabetes and will have the option to co-promote and commercialize the treatment in the US.
The exclusive worldwide licensing agreement with Hanmi Pharmaceutical gives Sanofi rights to develop and commercialize a long-acting three-drug combination to treat diabetes based on Hanmi’s Lapscovery (Long Acting Protein/Peptide Discovery) technology. The platform technology prolongs a drug’s period of action with the objective of minimizing its frequency and the dose required. This, said Hamni, could potentially lower the number of adverse reactions and optimize efficacy.
The drug combination, known as the Quantum Project, includes: efpeglenatide, a late-stage, long-acting glucagon-like peptide-1 receptor agonist (GLP1-RA); a weekly insulin dose; and a weekly fixed-dose of a GLP1-RA/insulin mixture.
Hanmi will receive an upfront payment of €400 million and is eligible for up to €3.5 billion in development, registration and sales milestones, as well as double-digit royalties on net sales. The company will also retain an exclusive option to co-commercialize the products in Korea and China. Sanofi said the deal expands its existing portfolio by adding medicines that are administered weekly as well as daily.
