Date: 2015-11-05
Type of information: Licensing agreement
Compound: long-acting diabetes treatments including efpeglenatide, a weekly insulin and a fixed-dosed weekly GLP-1-RA/insulin drug combination
Company: Hanmi Pharmaceutical (South Korea) Sanofi (France)
Therapeutic area: Metabolic diseases
Type agreement: licensing
Action mechanism: insulin/glucagon-like peptide-1 (GLP-1) receptor agonist/Glucagon-like Peptide 1 (GLP-1) analogue
Disease: diabetes
Details: * On November 5, 2015, Sanofi and Hanmi Pharmaceutical announced y a worldwide license agreement to develop a portfolio of experimental, long-acting diabetes treatments. Sanofi will obtain an exclusive worldwide license to develop and commercialize efpeglenatide, a late-stage long-acting glucagon-like peptide-1 receptor agonists (GLP1-RA); a weekly insulin and a fixed-dosed weekly GLP-1-RA/insulin drug combination. Hanmi will retain an exclusive option to co-commercialize the products in Korea and China. Collectively, these therapeutic offerings are known as the “Quantum Project” utilizing Hanmi’s proprietary Long Acting Protein / Peptide Discovery Platform LAPSCOVERY technology. This long acting delivery technology enables a peptide or protein to extend its half-life from weekly to monthly. The objective is to minimize the frequency of treatment and the dose required, thereby potentially lowering the adverse event rates and optimizing efficacy, according to Hamni. Hanmi presented data from five clinical and non-clinical studies on efpeglenatide at the 75th ADA Scientific Session in June. In Study HM-EXC-204, efpeglenatide was used as once-monthly in three doses, 8mg, 12mg, and 16mg in 86 type 2 diabetes patients, who were on stable metformin treatment or treatment naive. After 16 week treatment, HbA1c was reached to below 7% and the patients achieving the target HbA1c 7% was more than 60% in all efpeglenatide groups. The body weight loss from baseline was observed as - 2.03kg, - 2.27kg, - 2.37kg and 0.86kg in the groups administered with 8mg, 12mg, 16mg and placebo, respectively. In Study HM-EXC-205, a total of 297 obesity patients who do not have diabetes were allocated at either once weekly regimen (4mg, 6mg) or every other week regimen (6mg, 8mg). The body weight loss from baseline were - 6.68kg and - 7.30kg in once-weekly 4mg and 6mg groups; - 6.67kg and - 7.41kg in every other week 6mg and 8mg groups; and + 0.07kg in placebo group, respectively. Final result of 12 week dose finding study in T2DM patients with once weekly regimen (Study HM-EXC-203) was also presented by Study Principal Investigator, Dr. Julio Rosenstocko (Dallas Diabetes and Endocrine Center, USA). The study was a randomized, double blind for efpeglenatide groups or partially open label for active control, liraglutide group. A total of 254 type 2 diabetes patients who were on stable metformin treatment or treatment naïve was allocated to 0.3mg, 1mg, 2mg, 3mg, and 4mg of efpeglenatide, a placebo and liraglutide 1.8mg, respectively. After 12 week treatment, HbA1c changes were -1.41% and -1.61% at 3mg and 4mg of efpeglenatide ; – 1.38% at Liraglutide 1.8mg; -0.4% at Placebo, respectively. The body weight loss from baseline were -2.66 kg and -3.47 kg at 3mg and 4mg of efpeglenatide ; -3.54 kg at Liraglutide 1.8mg; -1.18 kg at Placebo, respectively. The agreement is subject to customary closing conditions including review under the Hart-Scott-Rodino Antitrust Improvements Act.
Financial terms: Under the terms of the agreement, Hanmi will receive an upfront payment of €400 million and is eligible for up to €3.5 billion in development, registration and sales milestone, as well as double digit royalties on net sales.
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