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BioFactura, Inc. announced the publication of the phase 1 study for BFI-751, a biosimilar candidate to Stelara (ustekinumab) in the peer reviewed journal, Clinical Pharmacology in Drug Development FREDERICK, MD, USA I September 11, 2023 I BioFactura, Inc. announced the publication of the phase 1 study for BFI-751, a biosimilar candidate to Stelara (ustekinumab) (Jeffrey N. Hausfeld, Rodeina Challand, Kristi McLendon et al; Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI-751): Results From a Randomized Phase 1Trial. Clinical Pharmacology, in Drug Development, 2023, 0(0) 1–12). Pairwise comparisons among the 3 treatments all met the standard bioequivalence criteria that the 90% confidence interval of the geometric mean ratios of AUC from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum concentration are completely within the acceptance interval of 80.00%–125.00%. There were no marked differences in the safety, immunogenicity, and tolerability profiles for subjects receiving BFI-751 as compared to EU or US ustekinumab. Treatment-emergent adverse events were mild to moderate for all treatment groups. There was no marked difference in the overall incidence of injection site reactions after dosing among treatment groups. https://accp1-onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/10.1002/cpdd.1305 . This successful pivotal study paves the way to conduct a global efficacy and safety trial in in adult male and female subjects with moderate to severe plaque psoriasis, due to start early 2024. Jeffrey Hausfeld MD, MBA, Chief Medical Officer, and Chairman of the Board stated, "…BioFactura will continue to focus on the development of high quality and reasonably priced biosimilar products to add value and improved outcomes for patients around the globe." Commenting on the development, Rodeina Challand, VP Scientific affairs said: "This is a critical milestone in the development of a biosimilar candidate for Stelara. Comparative PK studies are considered pivotal for demonstrating biosimilarity between the biosimilar candidate and the reference product". Jeffrey Hausfeld MD, MBA, Chief Medical Officer, and Chairman of the Board stated: "Being part of the cadre of physicians that introduced the adoption of generics from branded small molecule drugs in the 1980's has provided me with a clear perspective of the controversies and trajectory of acceptance of biosimilars in the marketplace by patients, payors and physicians. While all stakeholders work through the debates of the need and benefits of interchangeable switching studies, and large Phase 3 safety and efficacy trials for biosimilar regulatory approvals, BioFactura will continue to focus on the development of high quality and reasonably priced biosimilar products to add value and improved outcomes for patients around the globe." On July 10, 2023, BioFactura, Inc. announced that CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has entered into an exclusive global license to commercialize BFI-751, BioFactura's proposed biosimilar to Stelara (Ustekinumab). 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. Media Contact Jeffrey Hausfeld MD, MBA, BioFactura, 301-792-8601, This email address is being protected from spambots. You need JavaScript enabled to view it. // , www.biofactura.com SOURCE: BioFactura

Frederick, Maryland, September 11, 2023: BioFactura, Inc. announced the publication of the phase 1 study for BFI-751, a biosimilar candidate to Stelara (ustekinumab) (Jeffrey N. Hausfeld, Rodeina Challand, Kristi McLendon et al; Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI-751): Results From a Randomized Phase 1Trial. Clinical Pharmacology, in Drug Development, 2023, 0(0) 1–12). Pairwise comparisons among the 3 treatments all met the standard bioequivalence criteria that the 90% confidence interval of the geometric mean ratios of AUC from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum concentration are completely within the acceptance interval of 80.00%–125.00%. There were no marked differences in the safety, immunogenicity, and tolerability profiles for subjects receiving BFI-751 as compared to EU or US ustekinumab. Treatment-emergent adverse events were mild to moderate for all treatment groups. There was no marked difference in the overall incidence of injection site reactions after dosing among treatment groups. https://accp1-onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/10.1002/cpdd.1305 This successful pivotal study paves the way to conduct a global efficacy and safety trial in in adult male and female subjects with moderate to severe plaque psoriasis, due to start early 2024. Commenting on the development, Rodeina Challand, VP Scientific affairs said: “This is a critical milestone in the development of a biosimilar candidate for Stelara. Comparative PK studies are considered pivotal for demonstrating biosimilarity between the biosimilar candidate and the reference product”. Jeffrey Hausfeld MD, MBA, Chief Medical Officer, and Chairman of the Board stated: “Being part of the cadre of physicians that introduced the adoption of generics from branded small molecule drugs in the 1980’s has provided me with a clear perspective of the controversies and trajectory of acceptance of biosimilars in the marketplace by patients, payors and physicians. While all stakeholders work through the debates of the need and benefits of interchangeable switching studies, and large Phase 3 safety and efficacy trials for biosimilar regulatory approvals, BioFactura will continue to focus on the development of high quality and reasonably priced biosimilar products to add value and improved outcomes for patients around the globe.” On July 10, 2023, BioFactura, Inc. announced that CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has entered into an exclusive global license to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara (ustekinumab).

Frederick, Maryland, July 10, 2023: BioFactura, Inc. today announced that CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has entered into an exclusive license to commercialize BFI-751, BioFactura’s 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. Under the terms of the agreement, CuraTeQ has been granted exclusive license rights to commercialize BFI-751 in all major regulated markets including US, EU, UK, Canada, ANZ 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. 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. Commenting on the deal with BioFactura, Dr. Satakarni Makkapati, CEO – Biologics, Vaccines and Peptides, Aurobindo Pharma said, “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.” Commenting on the deal with BioFactura, Mr. Nithyananda Reddy, MD and Vice Chairman, Aurobindo Pharma said, “This agreement underscores our investment intentions in biosimilars business. 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 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.