Aurobindo Pharma arm enters into license agreement with US company; shares fall

Under the terms of the agreement, CuraTeQ has been granted exclusive license rights to commercialise BFI-751 in all major regulated markets, certain semi-regulated, and emerging markets worldwide.

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Aurobindo Pharma share price erased opening gains and turned red on July 10 as its wholly owned subsidiary CuraTeQ Biologics announced that it has entered into an exclusive license agreement with the United States-based BioFactura to commercialise an antibody used to treat many digestive and skin ailments.

At 09:37 am, Aurobindo Pharma was quoting at Rs 731.90, down Rs 11.80, or 1.59 percent on the BSE. The share touched a 52-week high of Rs 765 and a 52-week low of Rs 397.30 on 06 July, 2023 and 03 February, 2023, respectively.

Currently, the stock is trading 4.33 percent below its 52-week high and 84.22 percent above its 52-week low.

BFI-751, is a proposed biosimilar to Stelara (Ustekinumab). Ustekinumab is a recombinant monoclonal 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 global drug sales of Ustekinumab stood at close to $10 billion in 2022 presenting a significant opportunity with a good number of indications and a wider use, the company said.

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Under the terms of the agreement, CuraTeQ has been granted exclusive license rights to commercialise BFI-751 in all major regulated markets including the US, the European Union, the United Kingdom, Australia and New Zealand, and certain other semi-regulated and emerging markets worldwide.

Additionally, CuraTeQ will have the global manufacturing rights for this product, which will be produced at CuraTeQ facilities in Hyderabad, India

BioFactura plans to begin a global Phase 3 trial of the product as the next logical milestone in development. CuraTeQ 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, Aurobindo Pharma added.

“BioFactura has demonstrated bio-equivalence of BFI-751 versus US and EU registered originator product Stelara in a three-arm Phase 1 study conducted in 200 plus healthy subjects. 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 commercialize this product,” said Satakarni Makkapati, CEO – Biologics, Vaccines and Peptides, Aurobindo Pharma.

Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. It develops, manufactures, and commercialises a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.

The company has 24 manufacturing and packaging facilities that are approved by leading regulatory agencies including the USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA.