India Pharma Outlook Team | Thursday, 07 December 2023
Dr. Reddy's Laboratories SA and Coya Therapeutics, Inc. announced on that they have engaged into a research and license agreement for COYA 302, an investigational combination medication for the treatment of Amyotrophic Lateral Sclerosis (ALS).
Under the terms of the Agreement, Coya has granted Dr. Reddy’s an exclusive license to commercialize COYA 302, a proprietary co-pack kit containing 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, as per financialexpress.
Coya will continue to commercialize COYA 302 for patients with amyotrophic lateral sclerosis (ALS) in Japan, Mexico, and each South American country. Coya will be in charge of the clinical development of COYA 302 as well as obtaining regulatory approval for COYA 302 for ALS patients in the United States.
“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 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 USD 4.2 million. Coya anticipates that the IND filing will be made in the first half of 2024,” the company said in a statement.
The Agreement also contains development and regulatory milestones worth up to USD 40 million if all such milestones are met.