Korea-US: "Sanofi, Abandoning Diabetes Drug Midway, Faces Compensation Lawsuit if Necessary"

Global pharmaceutical company Sanofi's Chief Executive Officer (CEO) Paul Hudson <이미지:Yonhap News>

[Asia Economy Reporter Choi Dae-yeol] Global pharmaceutical company Sanofi has decided to halt the clinical trials of the diabetes drug efpeglenatide that it had been conducting. This drug was licensed out by Hanmi Pharmaceutical in 2015, and although Sanofi had repeatedly expressed its intention to complete the clinical trials, it suddenly stopped. Critics are pointing to this as an abuse of power by a multinational pharmaceutical company holding the lead in the clinical trials.

On the 14th, Hanmi Pharmaceutical announced, "Our partner Sanofi has notified us of its intention to return the rights to efpeglenatide," adding, "According to the contract, we will negotiate for 120 days before making a final decision." Even after returning the rights, Hanmi will retain the upfront payment of 200 million euros (264.3 billion KRW) already received under the contract.

Sanofi’s decision contradicts its previous public statements. Paul Hudson, who was newly appointed as Sanofi CEO last year, announced new business plans and strategies in December of that year, stating, "We will not conduct new research in the fields of diabetes and cardiovascular diseases," but also said that after completing the global Phase 3 trial of efpeglenatide, they would seek another distributor. While returning rights during drug development is not uncommon, it is rare to stop in the middle of a large-scale clinical trial like this.

Hanmi plans to negotiate to complete the ongoing global Phase 3 clinical trial and will also look for other partners. Since Sanofi unilaterally decided and notified the change in business plans, Hanmi is in a perplexed position. The company stated, "Sanofi has publicly promised patients, researchers, and Hanmi Pharmaceutical several times to complete the global Phase 3 trial, so we will demand that they honor this commitment," adding, "If necessary, we will consider legal actions including damages lawsuits."

Industry insiders view this as an example of a large multinational pharmaceutical company exploiting its influence in global clinical trials. In recent years, as the research capabilities of domestic pharmaceutical and biotech companies have increased, technology exports of new drug candidates have risen. However, global pharmaceutical companies still hold the lead in the development stages to commercialize research results. There is also speculation that the disruption caused by the COVID-19 pandemic to clinical plans was used as an excuse to halt development.

Hanmi Pharmaceutical stated, "This decision is unrelated to the efficacy or safety of efpeglenatide," and added, "At the time of commercialization, the global market for drugs in the same class is expected to grow to a scale of 10 billion dollars, so the market potential is sufficient." They also said, "We expect to find a new global partner by the end of this year or early next year when the results of the superiority comparative clinical trial between efpeglenatide and the competing drug Trulicity (active ingredient dulaglutide) are released."

This content was produced with the assistance of AI translation services.