Dr Reddy’s inks pact with Coya Therapeutics for investigational ALS therapy COYA 302
HYDERABAD: Pharma major Dr Reddy’s Laboratories on Wednesday informed the bourses that its wholly-owned subsidiary, Dr Reddy’s Laboratories SA, has inked a development and licence agreement with US-based Coya Therapeutics Inc for the development and commercialisation of an investigational combination biologic therapy for Amyotrophic Lateral Sclerosis (ALS) called COYA 302.
Under the agreement, Dr Reddy’s will get an exclusive licence to commercialise COYA 302, which comprises a proprietary co-pack kit containing a combination of low-dose IL-2 and CTLA-4 Ig (abatacept), in the US, Canada, EU and UK for patients suffering from ALS, while Coya will retain the right to commercialise COYA 302 in markets such as Japan, Mexico and all the South American countries.
The investigational therapy has a dual mechanism of action that will work to suppress chronic and sustained inflammation caused by certain neurodegenerative diseases. The latest agreement comes after the two companies signed an in-licencing pact in early 2023 for its proposed biosimilar abatacept as part of the development and commercialisation of COYA 302.
The Hyderabad-based Dr Reddy’s said while Coya will take up clinical development and seek regulatory approval for COYA 302 for ALS in the US, Dr Reddy’s will make a US$ 7.5 million upfront payment to Coya followed by another US$4.2 million payment when USFDA accepts the investigational new drug application for COYA 302 for treating ALS, which is expected to be done in the first half of 2024.
These payments will be followed by an additional US$4.2 million to Coya when the first patient is dosed in the first Phase 2 trial of COYA 302 for ALS in the US, Dr Reddy’s said in a regulatory filing. The agreement also includes development and regulatory milestones payment of up to US$ 40 million if all the milestones are achieved.
In addition to this, Coya will also be eligible to receive sales-based milestone payments of up to US$ 677.25 million which will be linked to tiers of cumulative net sales being achieved over several years (over the term of the agreement subject to product commercial exclusivity).
Dr Reddy’s will also pay Coya royalties based on a percentage net sales of COYA 302 ranging from low to middle teens, it said.
Under the agreement, Dr Reddy’s will get an exclusive licence to commercialise COYA 302, which comprises a proprietary co-pack kit containing a combination of low-dose IL-2 and CTLA-4 Ig (abatacept), in the US, Canada, EU and UK for patients suffering from ALS, while Coya will retain the right to commercialise COYA 302 in markets such as Japan, Mexico and all the South American countries.
The investigational therapy has a dual mechanism of action that will work to suppress chronic and sustained inflammation caused by certain neurodegenerative diseases. The latest agreement comes after the two companies signed an in-licencing pact in early 2023 for its proposed biosimilar abatacept as part of the development and commercialisation of COYA 302.
The Hyderabad-based Dr Reddy’s said while Coya will take up clinical development and seek regulatory approval for COYA 302 for ALS in the US, Dr Reddy’s will make a US$ 7.5 million upfront payment to Coya followed by another US$4.2 million payment when USFDA accepts the investigational new drug application for COYA 302 for treating ALS, which is expected to be done in the first half of 2024.
These payments will be followed by an additional US$4.2 million to Coya when the first patient is dosed in the first Phase 2 trial of COYA 302 for ALS in the US, Dr Reddy’s said in a regulatory filing. The agreement also includes development and regulatory milestones payment of up to US$ 40 million if all the milestones are achieved.
In addition to this, Coya will also be eligible to receive sales-based milestone payments of up to US$ 677.25 million which will be linked to tiers of cumulative net sales being achieved over several years (over the term of the agreement subject to product commercial exclusivity).
Dr Reddy’s will also pay Coya royalties based on a percentage net sales of COYA 302 ranging from low to middle teens, it said.
