Dr Reddy’s Laboratories SA, a wholly-owned subsidiary of Dr Reddy’s Laboratories, has entered into an agreement for the development and commercialisation of COYA 302, an investigational combination therapy for the treatment of Amyotrophic Lateral Sclerosis (ALS).
Under the terms of the agreement, Coya has granted Dr. Reddy’s an exclusive licence to commercialise COYA 302, a proprietary co-pack kit containing a combination of low-dose IL-2 and CTLA-4 Ig (abatacept) in the US, Canada, the European Union and the UK.
This agreement is in addition to the in-licensing agreement with Dr Reddy’s, signed in early 2023.
Coya retains the right to commercialise COYA 302 for patients with amyotrophic lateral sclerosis (ALS) in Japan, Mexico, and countries in South America. Coya will be responsible for the clinical development of COYA 302 and for seeking regulatory approval.
Hyderabad-based Dr Reddy’s will make a $7.5-million upfront payment to Coya. Upon the first FDA acceptance of an investigational new drug (IND) application for COYA 302 , Dr Reddy’s will pay Coya an additional $4.2 million.
Upon dosing of the first patient in the first Phase-2 trial in the US, 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 includes development and regulatory milestones of 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 of net sales of COYA 302, ranging from the low to middle teens. Coya is not a related party to Dr. Reddy’s or its promoters/ promoter group.
Marc Kikuchi, Chief Executive Officer of Dr. Reddy’s North America, said: “We are pleased to partner Coya Therapeutics on this investigational therapy, which may have a unique place in treating patients with this progressive neurodegenerative disease. 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.’‘
``Dr. Reddy’s biosimilars/ biologics business is part of our key strategic initiatives expected to drive both near-term and long-term growth,’‘ he added.
Howard Berman, Chief Executive Officer of Coya, said: “While the agreement provides the financial resources to execute on the Phase-2 clinical program for COYA 302 in ALS, the strategic value of the partnership contributes much more than capital.’‘
COYA 302 was developed out of the multi-year translational research collaboration between Coya and Houston Methodist in the laboratory of Dr. Stanley Appel.