Hanmi on legal action against Sanofi returning efpeglenatide

Five years after licensing out the biologic in 2015, the French-based company changes R&D plan

Taking back previous announcement to “finish phase 3 trial and seek for a new partner to take over”

Hanmi says “No prior discussion on the subject was attempted, business decision made solely by Sanofi”

A multinational pharmaceutical company Sanofi has decided to return the rights on antidiabetic candidate medicine efpeglenatide back to Hanmi Pharmaceutical.

 

Apparently, the French-based company is putting an abrupt brake on the development of efpeglenatide, licensed out as the biggest Korean-developed pipeline in 2015.

 

Hanmi Pharmaceutical explains “The decision was solely made by Sanofi with their shift in business plan,” and stated it would review taking a legal response.

 

A view over Hanmi Pharmaceutical headquarters

On May 14, Hanmi Pharmaceutical released news that Sanofi has notified the intention to return the licensed out efpeglenatide, currently undergoing a series of phase 3 clinical trials.

 

According to the contract terms, the two companies are to finalize the decision on the retuning of the rights after 120 days of negotiation.

 

Even if the French company returns the right, the Korean company is not subjected to return EUR 200 million (approximately 260 billion won) already received from the partner company.

 

Hanmi Pharmaceutical official elaborated, “We have decided to negotiate with Sanofi to complete the ongoing phase 3 global study on efpeglenatide as it is close to the end,” and said the company “plans to seek for a new global partner company.” A glucagon-like peptide-1 (GLP-1) receptor agonist, efpeglenatide is an innovative bio drug candidate to treat patients with diabetes by administering the drug once-weekly or once-monthly at most.

 

The candidate drug is based on Hanmi Pharmaceutical’s core platform technology ‘Labscovery,’ which prolongs the short half-life period of biologics and reduces administration frequency and dose to lessen the adverse reaction and improve effect.

 

In November 2015, Hanmi Pharmaceutical and Sanofi had signed a license-out deal valued at 390 million euros on the Quantum Project (efpeglenatide, long-acting insulin, efpeglenatide plus long-acting insulin combination).

 

Although the contract terms have been revised twice since then, the deal is still the biggest license out deal a Korean pharmaceutical company holds to the date.

 

Hanmi Pharmaceutical claims Sanofi’s decision to return their rights over efpeglenatide were unreasonable, because the global company is dropping the already agreed upon phase 3 clinical study.

 

Intending to take a legal action, Hanmi Pharmaceutical official said, “Sanofi’s decision was made without discussing with Hanmi Pharmaceutical.” After a new CEO took over the office in last September, Sanofi has unveiled a widely reformed R&D plan to halt diabetes and cardiovascular related research but to strategically concentrate on four main sectors including oncology, hematology, rare disease and neurology.

 

When the announcement was made, Sanofi officially noted the multinational company would give up the rights to commercialize and distribute the antidiabetic pipeline efpeglenatide and search for a new partner, however, the ongoing phase 3 clinical trials would be completed with the company.

 

At the moment, Sanofi is conducting five global phase 3 clinical trials related to efpeglenatide.

 

Hanmi Pharmaceutical stressed Sanofi giving up on the efpeglenatide rights is unrelated to the medicine’s efficacy and safety.

 

Hanmi Pharmaceutical official stated, “As Sanofi has publicly promised affected patients, investigators and Hanmi Pharmaceutical that the global phase 3 clinical trials would be fully conducted, we would demand Sanofi to keep their word,” and “Further legal actions pursuing litigation would be reviewed, if need be.” The Korean company official stressed, “Efpeglenatide is a promising pipeline, as the global GLP-1 receptor agonist market would be worth approximately USD 10 billion by the time the candidate medicine is commercialized,” and “the biologic would be able to find a new global partner at around the end of the year or the beginning of next year, when the outcomes of the superiority trial against efpeglenatide’s competitor Trulicity would be released.”