Returned license-outs for new drugs one after another

It’s not going well for biotech companies

Olix Pharmaceutical and Curacle had their license-out agreements terminated for 'macular degeneration treatment candidates'

Voronoi has been notified of the return of its license for an anticancer candidate…will overcome through an in-house development

Korean biopharmaceutical companies have been receiving termination notifications from their partnering companies for their licensed-out new drug candidates one after another.

 

Olix Pharmaceuticals and Curacle recently received notifications of contract terminations from France’s Thea Open Innovation.

 

Voronoi’s license-out agreement for its new anticancer candidate was terminated in April.

 

In the past two months, three accounts of license-out of new drug candidates were returned.

 

The industry views this as a result of changes in the development strategies of contracting companies.

 

Companies that had their rights returned rights are planning to change their strategies to in-house development.

 

Olix Pharmaceuticals, Curacle, and Voronoi received termination notifications of their license-out agreements in the past two months Olix Pharmaceuticals announced that they received termination notifications of their licensed-out agreement for 'OLX301A,' which was under development for the treatment of dry and wet age-related macular degeneration, on June 24th.

 

In March 2019, Olix Pharmaceuticals signed a license-out agreement with France’s Thea Open Innovation for its OLX301A.

 

In October 2020, the company expanded the contract for OLX301A and added a license-out agreement for 'OLX301D,' a candidate for the treatment of wet age-related macular degeneration and subretinal fibrosis.

 

Both contracts amounted to 166.95 million euros (approximately KRW 230 billion).

 

In 2019, Olix Pharmaceuticals received an upfront payment of 2 million euros (approximately KRW 3 billion).

 

In 2020, the upfront payment from the company expanded to 5.3 million euros (approximately KRW 7.9 billion).

 

Then, the company additionally received milestone technology fees in 2022 and 2023, amounting to 1.33 million euros (approximately KRW 2 billion) and 400,000 euros (approximately KRW 600 million), respectively.

 

The total amount that Olix Pharmaceutical received from the contract with Thea Open Innovation amounts to 7.03 million euros (approximately KRW 10.4 billion).

 

This amount is non-refundable.

 

Olix Pharmaceuticals, Curacle, and Voronoi received termination notifications of their license-out agreements in the past two months.

Last month, Curacle was notified of the licensing return.

 

Curacle announced that the company received notification of the return of the license for 'CU06,' which was under development for the treatment of diabetic macular edema and wet age-related macular degeneration.

 

Curacle received the return of the rights from France’s Thea Open Innovation, just like Olix Pharmaceutical.

 

In October 2021, Curacle had signed a licensing agreement with Thea Open Innovation for a contract totaling US$163.50 million (approximately KRW 190 billion).

 

As part of the agreement, Curacle received a non-refundable upfront payment of US$6 million (approximately KRW 7 billion).

 

In April, Voronoi also received notification of the return of the technology from METiS Therapeutics, a biotech company in the United States.

 

In September 2022, Voronoi entered into a contract to transfer its technology of a pan-RAF inhibitor targeting solid cancers.

 

The total contract amount was up to US$482.2 million (approximately KRW 670 billion), and Voronoi received US$1.7 million (approximately KRW 2.4 billion) cash up front, including the research milestone.

 

Licenses were returned…K-bio will overcome via an in-house development strategy Companies that have had their license-outs returned are aiming to overcome this through in-house developments.

 

These companies have explained that the return of licensed-out products is a result of the partnering companies' shift in development strategies, rather than a failure to demonstrate the efficacy of these candidates.

 

Therefore, the companies are considering either continuing the development in-house or seeking another licensing opportunity.

 

Olix Pharmaceutical said, “We will internally develop technology and conduct clinical trials in the future.” OLX301A obtained U.S.

 

FDA approval for an IND for a phase 1 trial in August 2022.

 

OLX301D is currently in the preclinical phase.

 

Curacle also stated, “We will regain all the rights of CU06’s global licensing and clinical trial development in the future.” They explained, “Regardless of the licensing returns, we plan to conduct further clinical trials without delays.” Curacle explained, “We confirmed the vision improvement effects and safety of the drug through our recently completed CU06 Phase 2a trials.” And added, “During the researchers meeting at the ‘Association for Research in Vision and Ophthalmology (ARVO)’ conference in the United States, we received a lot of advice regarding the vision improvement effects.

 

As a result, we plan to conduct further develop CU06 without any delays.” Voronoi stated, “We will review the development data and decide on future development.”