Hanmi Pharmaceutical said Thursday that Sanofi informed it of intention to return all rights concerning efpeglenatide, a new diabetes drug candidate, including its commercialization, distribution and clinical trial rights, to Hanmi.
|Hanmi headquarters in Bangi-dong, eastern Seoul.|
Developed by Hanmi, efpeglenatide is a once-weekly GLP-1 receptor agonist for treating type 2 diabetes. The company licensed out the treatment to Sanofi in November 2015. The therapy employs Hanmi's lapscovery delivery technology, which extends the life of a peptide or protein in the body while enhancing its efficacy and potency.
The two companies will finalize the decision after conducting 120 days of negotiations, as stated in the initial contract. However, Hanmi will not return the 200 million euros (about 264.3 billion won) upfront payment it had already received, even after the return of rights.
Sanofi's notification came after the two companies announced that they are looking for a new partner to commercialize and distribute efpeglenatide globally in December.
At the time, Sanofi CEO Paul Hudson unveiled the company's new strategy for drive innovation and growth. As part of the plan, Hudson noted that Sanofi would discontinue research in diabetes and cardiovascular diseases and will not pursue plans to launch efpeglenatide.
Hudson added that Sanofi would complete the global phase 3 clinical trial for the drug before handing off the candidate to a new partner.
Hanmi also emphasized that Sanofi's policy is irrelevant concerning the efficacy and safety of efpeglenatide and that the details of the licensing agreement with Hanmi have not changed.
However, the recent decision by Sanofi seems to have caught Hanmi off guard, according to industry sources.
Hanmi stressed that the notice was a unilateral decision made by changes in Sanofi's business plan last year.
“Hanmi will demand Sanofi keeps up the contract as it had promised to patients, researchers, and Hanmi that it would complete phase 3 global clinical trials,” a company spokesperson said. “We will also review legal proceedings, including litigation, if necessary."
The return of rights does not mean that Sanofi would halt its global phase 3 clinical trials, he added.
"We plan to discuss in detail with Sanofi for the next 120 days with regards to the clinical trials," the company spokesperson told Korea Biomedical Review. "Even if Sanofi does not keep its promise of completing the global phase 3 clinical trial, we will be looking for various options to complete the clinical trial."
As Sanofi had continuously stated that the decision is independent of the effectiveness and safety of efpeglenatide, and the global GLP-1 market is expected to grow to $10 billion at the time of commercialization of efpeglenatide, Hanmi believes that the marketability of the drug is still sufficient, he added.
The company also stressed that it expects to find a new global partner after the results of the comparative clinical trial between efpeglenatide and competing drug Trulicity are announced later this year or early next year.
Despite the company's explanation, Hanmi's shares went into a downward spiral. As of 10 a.m. Thursday, the company's stock price stood at 259,000 won ($211) per share, down 7.17 percent from the previous trading day.
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