Dr. Reddys Laboratories and Coya Therapeutics have joined forces to develop and commercialize COYA 302, a promising combination therapy for amyotrophic lateral sclerosis (ALS).
Dr. Reddy's Laboratories, a prominent pharmaceutical company based in Hyderabad, India, announced a significant collaboration with Coya Therapeutics Inc. on Wednesday. The partnership aims to develop and commercialize COYA 302, an investigational combination therapy holding promise for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.
Exclusive Licensing Agreement
Under the terms of the development and license agreement, Coya has granted Dr. Reddy's an exclusive license to commercialize COYA 302 in the United States, Canada, the European Union, and the United Kingdom for the treatment of ALS. Coya retains the rights to commercialize the therapy in Japan, Mexico, and South American countries.
Financial Terms
As part of the agreement, Dr. Reddy's will make an upfront payment of USD 7.5 million to Coya. Subsequent payments are tied to specific milestones. Upon the first FDA acceptance of an Investigational New Drug (IND) application for COYA 302 for ALS treatment, Dr. Reddy's will pay an additional USD 4.2 million. Another USD 4.2 million payment will be made upon administering a dose to the first patient in the first Phase 2 trial of COYA 302 for ALS in the US.
Development and Regulatory Milestones
The agreement outlines development and regulatory milestones that could result in additional payments of up to USD 40 million to Coya. These milestones are contingent on achieving specific development and regulatory goals.
Sales-Based Milestone Payments and Royalties
Coya is also eligible to receive sales-based milestone payments of up to USD 677.25 million linked to cumulative net sales achieved over several years during the term of the agreement, subject to product commercial exclusivity. Additionally, Dr. Reddy's will pay Coya royalties ranging from low to middle teens based on a percentage of net sales of COYA 302.
Commitment to Patient Access
Expressing enthusiasm about the collaboration, Marc Kikuchi, Chief Executive Officer of Dr. Reddy's North America, highlighted the potential of COYA 302 to reach a broader patient population worldwide. He emphasized the company's goal of serving over 1.5 billion patients by 2030.
Dr. Reddy's partnership with Coya Therapeutics represents a significant step forward in the development of a promising therapy for ALS. The collaboration combines the expertise and resources of both companies, aiming to bring hope to patients battling this debilitating disease.
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