Dr Reddy's & Coya Partner for ALS Treatment Drug

New Delhi, Dec 6 (PTI) Dr Reddy's Laboratories on Wednesday said its unit has inked 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 license agreement for the development and commercialisation of COYA 302, an investigational combination therapy for ALS, the Hyderabad-based drugmaker said in a statement.

As per the terms of the agreement, Coya has granted Dr Reddy's an exclusive licence to commercialise COYA 302 in the US, Canada, the European Union and the UK for ALS.

Coya retains the right to commercialise COYA 302 in Japan, Mexico, and each country in South America.

As per the agreement, Coya will have responsibility for the clinical development of COYA 302 and for seeking regulatory approval for COYA 302 for patients with ALS in the US.

As per the deal, Dr Reddy's will make a USD 7.5 million upfront payment to Coya.

Upon the first FDA acceptance of an Investigational New Drug (IND) application for COYA 302 for the treatment of ALS, Dr Reddy's will pay Coya an additional USD 4.2 million.

Upon 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 will pay Coya an additional USD 4.2 million.

Coya anticipates that the IND filing will be made in the first half of 2024, Dr Reddy's said.

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

Additionally, Coya is eligible to receive sales-based milestone payments of up to USD 677.25 million linked to tiers of cumulative net sales being achieved over several years (over the term of the agreement subject to product commercial exclusivity), the drug firm said.

In addition, Dr Reddy's will pay Coya royalties based on a percentage net sales of COYA 302 ranging from low to middle teens, it said.

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