Under the terms, CuraTeQ has been granted exclusive license rights to commercialize BFI-751 (Ustekinumab biosimilar) in all major regulated markets including US, EU, UK, and Canada.

Aurobindo Pharma has announced that its wholly owned subsidiary CuraTeQ Biologics has entered into an exclusive licence deal with the US-based BioFactura to commercialise an Ustekinumab biosimilar product.

The move is aimed at expanding the company’s immunology products portfolio. The BFI-751 is a proposed biosimilar to Stelara (Ustekinumab), which is an antibody that works by blocking both interleukins IL-12 and IL-23 and is used for treating Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, the company said in an exchange filing.

The global drug sales of Ustekinumab was close to $10 billion in 2022.

Both the parties have agreed to a profit-sharing arrangement with CuraTeQ receiving 57-60 percent of the profits depending upon the markets. BioFactura will receive licence fees of $33.5 million spread across different milestones leading to commercialisation in regulated markets.

Under the terms, CuraTeQ has been granted exclusive licence rights to commercialise BFI-751 in all major regulated markets including the US, EU, UK, and Canada.

“We are excited by the prospect of this Ustekinumab biosimilar advancing to Phase 3 clinical studies in the due course of time. Ustekinumab fits into our expanding immunology products portfolio very well and we will use our presence across key markets to commercialise this product,” Dr Satakarni Makkapati, CEO – Biologics, Vaccines and Peptides, Aurobindo Pharma, said.

Additionally, CuraTeQ will have the global manufacturing rights for this product, which will be produced at CuraTeQ facilities in Hyderabad. It  intends to file this product in India and Emerging Markets as early as in 2024 and the regulated markets filing is expected to begin in 2026.

The Aurobindo Pharma stock has been on fire lately, gaining over 70 percent in 2023 so far. The stock got a boost last week when the company announced that its breast cancer biosimilar product BP02 (Trastuzumab or biosimilar to Herceptin) has met its primary endpoint in the Phase-3 clinical trial. This biosimilar product has also been developed by CuraTeQ.

As per analysts at ICICI Securities, Aurobindo Pharma’s new ventures on biosimilars, peptides and PLI are on track and will likely drive growth FY25 onwards.

For FY24, Aurobindo Pharma has guided for improved traction in both oral solids as well as injectables. Coupled with moderation in input costs, Kotak Institutional Equities expects this to lead to a strong 310 basis points YoY expansion in Ebitda margin in FY24.

Article reposted from Money Control