Dr Reddy’s signs pact with Coya for investigational therapy of ALS

Pharma major Dr Reddy’s Laboratories Ltd and Coya Therapeutics, Inc
have entered into a development and license agreement for the development and commercialisation of COYA 302, an investigational combination therapy for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Dr Reddy’s Laboratories SA, a wholly-owned subsidiary of Dr Reddy’s Laboratories Ltd has entered into the contract with Coya. Dr Reddy’s will make a $7.5 million upfront payment to Coya for the purpose. Coya 302 is an investigational product, which is not yet approved by the US Food and Drug Administration or any other regulatory agency.

Under the terms of the agreement, Coya has granted Dr Reddy’s an exclusive license to commercialise COYA 302, a proprietary co-pack kit containing a combination of low dose IL-2 and CTLA-4 Ig (abatacept) in the United States, Canada, the European Union and the United Kingdom for ALS.

This agreement is in addition to the in-licensing agreement with Dr Reddy’s signed in early 20231.

ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. ALS is characterised by the gradual degeneration and death of motor neurons, which are responsible for controlling voluntary muscles. As these motor neurons die, the ability of the brain to initiate and control muscle movement is lost.

“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,” said Marc Kikuchi, CEO of Dr Reddy’s North America in a press statement.

Coya retains the right to commercialise COYA 302 for patients with amyotrophic lateral sclerosis (ALS) in Japan, Mexico, and each country in South America. 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 United States.

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 $4.2 million. Upon dosing of the first patient in the first Phase 2 trial of COYA 302 for the treatment of ALS in the United States, Dr Reddy’s will pay Coya an additional $ 4.2 million. Coya anticipates that the IND filing will be made in the first half of 2024. The agreement also includes development and regulatory milestones up to $40 million should all such development and regulatory milestones be achieved.

Additionally, Coya is eligible to receive sales-based milestone payments of up to $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).

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

COYA 302 was developed out of the multi-year translational research collaboration between Coya and Houston Methodist in the laboratory of Dr Stanley Appel, an internationally renowned researcher and clinician.

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