Paris, France and Seoul, Korea - Nov. 5, 2015 - Sanofi and Hanmi Pharmaceutical Co., Ltd. announced today a worldwide license agreement to develop a portfolio of experimental, long-acting diabetes treatments.
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 milestones, as well as double digit royalties on net sales. Sanofi will obtain an exclusive worldwide license to develop and commercialize 1.) efpeglenatide, a late-stage long-acting glucagon-like peptide-1 receptor agonists (GLP1-RA); 2.) a weekly insulin and 3.) a fixed-dosed weekly GLP-1-RA/insulin drug combination. Collectively, these therapeutic offerings are known as the "Quantum Project" utilizing Hanmi's proprietary Long Acting Protein / Peptide Discovery Platform LAPSCOVERY technology. Hanmi will retain an exclusive option to co-commercialize the products in Korea and China.
"The agreement to develop these three investigational diabetes medicines confirms Sanofi's long-term commitment to people with this disease," said Pascale Witz, Executive Vice President, Sanofi, who will lead the Global Diabetes and Cardiovascular Care Business Unit in the company's new organizational structure. "We now have the opportunity to expand our existing portfolio by including medicines that are administered weekly as well as daily, which could extend our reach in basal insulin and expand our GLP-1-RA and GLP-RA/insulin combination prospects. In these ways, we aim to complement our current offerings and work to serve a broader patient population."
The Quantum Portfolio is based on Hanmi's proprietary LAPSCOVERY (Long Acting Protein/Peptide Discovery) Technology which is a platform technology that prolongs the duration of action of biologics. 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.
"We are pleased that Sanofi with its long heritage and as a proven leader with solid track of success in diabetes, has recognized the value of Hanmi's Quantum Project," said Dr. Gwan Sun Lee, CEO/President of Hanmi Pharmaceutical. "We are confident that we have found the right partner and are excited for the potential this license agreement with Sanofi will bring to the development of Hanmi's Quantum Project and possibilities this could offer to people with diabetes."
Hanmi presented data from five clinical and non-clinical studies on efpeglenatide at the 75th ADA Scientific Session in June. For more information, see here.
The agreement is subject to customary closing conditions including review under the Hart-Scott-Rodino Antitrust Improvements Act.
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices including blood glucose monitoring systems. Sanofi markets injectable, inhaled and oral medications for people with type 1 or type 2 diabetes.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Hanmi Pharmaceutical Co., Ltd.
Hanmi Pharmaceutical is a Korea-based global pharmaceutical company focused on the development and commercialization of new pharmaceutical products. The Company is fully integrated from R&D through manufacturing, marketing and sales with an established presence in Korea as well as China. The Company invests over 20 percent of its sales in R&D and has over 20 programs in clinical development in three main areas: 1) novel long-acting biologics based on the Company's LAPSCOVERY(TM) platform including weekly insulin, weekly to monthly GLP-1, and their combinations (Quantum Project) in diabetes and obesity; 2) novel targeted agents against cancer and autoimmune disorders; and 3) fixed-dose combination programs. More information on Hanmi is available at www.hanmipharm.com.
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