BioFactura and CuraTeQ Enter Exclusive License Agreement to Commercialize Biosimilar for Stelara
July 10, 2023
BioFactura, Inc. and CuraTeQ Biologics Private Limited, a subsidiary of Aurobindo Pharma Limited, have signed an exclusive commercial license agreement for BFI-751, a biosimilar to Stelara (Ustekinumab). Stelara 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. This new partnership paves the way for increased accessibility for patients around the world suffering from these and potentially other immune and inflammatory diseases.
BioFactura, based in Frederick, MD leverages its patented StableFast™ Biomanufacturing platform to develop high-value biodefense medical countermeasures and biosimilars. The company completed its Phase 1 study of BFI-751 in October 2022 and met the primary endpoint of clinical bioequivalence; which, along with a strong bioanalytical comparative data, had put the company on track for a promising deal such as this one.
Under the terms of the agreement, CuraTeQ gains exclusive rights to commercialize BFI-751 in major regulated markets worldwide, including the US, EU, UK, Canada, ANZ, and other emerging markets. Additionally, CuraTeQ will have global manufacturing rights for the product, producing it at their facilities in Hyderabad, India. BioFactura plans to initiate a global Phase 3 trial as the next significant milestone in product 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. BioFactura will receive license fees not exceeding $33.5 million spread across different milestones leading to commercialization and will obtain up to 43% profit sharing depending on the territory.
Dr. Satakarni Makkapati, CEO – Biologics, Vaccines and Peptides, Aurobindo Pharma commented on the deal; stating, “BioFactura has demonstrated bio-equivalence of BFI-751 vs 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.”
“This agreement underscores our investment intentions in biosimilars business,” Mr. Nithyananda Reddy, MD and Vice Chairman, Aurobindo Pharma. “It is our commitment to improve lives of patients suffering from these debilitating immune and inflammatory diseases by delivering them access to cost-effective and high quality biosimilars such as Ustekinumab.”
Commenting on the development, Darryl Sampey, Ph.D., President and CEO of BioFactura said, “The development of our BFI-751 biosimilar to Stelara has been an all-encompassing endeavor at BioFactura which led to the impressive clinical results of our pivotal bio-comparability trial. With CuraTeQ, we have found the optimal partner to successfully complete the journey and bring this important product to market.”
Additionally, Jeffrey N Hausfeld, MD, MBA., Chairman and Chief Medical Officer of BioFactura, stated, “The purpose and regulatory framework of bringing biosimilars into the mainstream of healthcare systems worldwide should be focused on improving outcomes, quality of life, accessibility, and enhancing the patient experience, with medicines proven to be as potent, pure, safe, and effective as the branded drugs. We are proud to partner with CuraTeQ to bring BioFactura’s high quality biosimilar of Ustekinumab to the global marketplace in order to fulfill these goals.”
About BioFactura, Inc.
BioFactura, Inc. (Frederick MD) develops and commercializes high-value biodefense medical countermeasures and biosimilars (i.e., follow-on biologics or generic biopharmaceuticals) using its patented StableFast™ Biomanufacturing Platform, the optimal system for bringing these drugs to market with faster, lower cost, superior-quality manufacture. For over 15 years, BioFactura has been advancing life-saving medicines from the research bench to the patient using its innovative drug development and manufacturing technologies. Current and past programs include biodefense drugs against smallpox and Ebola, novel medicines for cancer, and low-cost/high-quality biosimilars for autoimmune and infectious diseases. www.biofactura.com
About CuraTeQ Biologics Private Limited
Curateq Biologics, a subsidiary of Aurobindo Pharma Ltd, is engaged in the research and development of recombinant biologics, especially in areas of biosimilars drug substance development and proteins formulations. Curateq Biologics is headquartered in Hyderabad, Telangana, India.
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