Aurobindo Pharma on Friday announced that its wholly owned subsidiary CuraTeQ Biologics has entered into an exclusive licence deal with USA based BioFactura Inc, USA to commercialize BFI-751, a proposed biosimilar to Stelara (Ustekinumab), the company announced through an exchange filing.
Ustekinumab is a recombinant monoclonal antibody which is used for treating Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.
Purpose of entering the agreement
The purpose of entering the agreement is to commercialize Ustekinumab biosimilar on an exclusive license right basis in all major regulated markets including US, EU, UK, Canada, ANZ and certain other semiregulated and emerging markets worldwide.
BioFactura plans to begin a global Phase 3 trial of the product as a next milestone. CuraTeQ intends to file this product in India and Emerging Markets as early as in 2024. The regulated markets filing is expected to begin in 2026. The global sales reported for Stelara (Ustekinumab) is around USD 9.72 Bn for the year 2022.
Profit-sharing arrangement
A profit-sharing arrangement has been agreed by both the parties with CuraTeQ receiving 57 - 60% of the profits depending upon the markets. CuraTeQ to have global manufacturing rights for the Ustekinumab biosimilar.
Aurobindo Pharma Shares
The shares of Aurobindo Pharma on Friday at 3:30pm IST were at ₹746.35, down by 1.96 percent.
