Dr Reddy's, Coya Therapeutics ink licensing agreement for ALS cure drug

Dr. Reddy's Laboratories said on Wednesday that its unit has entered into a licensing agreement with Coya Therapeutics Inc to develop a combination therapy for the treatment of amyotrophic lateral sclerosis (ALS).

Dr Reddy's Laboratories SA and Coya have entered into a development and licensing agreement for the development and commercialization of COYA 302, an investigational combination therapy for ALS, the Hyderabad-based drugmaker said in a statement.

Under the terms of the agreement, Coya Dr. Reddy's has been granted an exclusive license to commercialize COYA 302 for ALS in the US, Canada, the European Union and the United Kingdom.

Coya reserves the right to commercialize COYA 302 in Japan, Mexico and any country in South America.

Under the agreement, Coya will be responsible for the clinical development of COYA 302 and for seeking regulatory approval for COYA 302 for patients with ALS in the US.

Under the agreement, Dr. Reddy's to make an upfront payment of $7.5 million to Coya.

Upon the FDA's initial acceptance of an Investigational New Drug (IND) application for COYA 302 for the treatment of ALS, Dr. Reddy's Coya to pay another $4.2 million.

When administering a dose to the first patient in the first Phase 2 trial of COYA 302 for the treatment of ALS in the US, Dr. Reddy's Coya to pay another $4.2 million.

Coya expects the IND application to be filed in the first half of 2024, Dr. Reddy's said.

The agreement also includes development and regulatory milestones of up to $40 million, should all such development and regulatory milestones be achieved, it added.

In addition, Coya is eligible to receive sales-based milestone payments of up to $677.25 million, tied to levels of cumulative net sales achieved over multiple years (over the term of the agreement, subject to commercial exclusivity of the product), according to the drug company.

In addition, Dr. Reddy's Coya royalties pay based on a percentage of COYA 302's net sales, ranging from low to mid-teens, the report said.

“With this promising biologic product, we hope to reach many more patients around the world, in line with our goal of serving more than 1.5 billion patients by 2030,” said Marc Kikuchi, Chief Executive Officer of Dr Reddy's North America.