Janssen Sciences Ireland UC

BENGALURU, India, Aug. 29, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today that the Company has signed a settlement and license agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara®, in Europe, the United Kingdom (UK), Canada, and Japan. Under the terms of this settlement agreement, Biocon Biologics has resolved patent disputes with Janssen to secure market entry dates in Europe, the UK, Canada, and Japan. Regulatory filings in these markets are currently under review. Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025, once approved by the U.S. FDA. The U.S. FDA has accepted the Company's Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: "This settlement agreement is testament to our proven track record of science and innovation and is another key milestone in our journey to bring our biosimilar Bmab 1200 (bUstekinumab) to global markets. Bmab 1200 will significantly strengthen our immunology franchise, enabling us to offer an affordable and effective treatment option for patients impacted by autoimmune diseases." Stelara® (Ustekinumab) is a monoclonal antibody medication that prevents abnormal regulation of interleukin IL-12/23 associated immune diseases and has been approved for the treatment of psoriasis, Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The reference brand, Stelara®, had worldwide sales of $10.85 billion in 20231. 1 Johnson & Johnson Reported 2023 Sales All trademarks, registered or unregistered, are the property of their respective owners. Product launches in all the countries/ regions are subject to regulatory approval. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 12 biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website ; Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates. Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. SOURCE Biocon Biologics Ltd.

The regulatory filings for Bmab 1200 in certain markets are currently under review. Credit: Corona Borealis Studio/Shutterstock. Biocon Biologics has reached a settlement and licence agreement with Janssen Biotech, Janssen Sciences Ireland and Johnson & Johnson (collectively called Janssen) for the commercialisation of Bmab 1200 (bUstekinumab), a proposed biosimilar to Stelara (Ustekinumab). Biocon plans to commercialise the product in key markets such as Europe, the United Kingdom, Canada and Japan on receipt of regulatory approvals. The agreement resolves patent disputes between the parties and enables market entry for Biocon Biologics’ product in these regions. The regulatory filings for Bmab 1200 are currently under review. The development follows the company’s previous announcement of a settlement agreement in the US, which permits the launch of Bmab 1200 no later than 22 February 2025, pending approval from the US Food and Drug Administration (FDA). See Also: AstraZeneca may pull plug on UK vaccine manufacturing plans Ginkgo Bioworks gets grant for modified aav capsid proteins and virus vectors The FDA has accepted the company’s biologics licence application for Bmab 1200 under the 351(k) pathway. Stelara is a monoclonal antibody indicated to treat various immune-mediated ailments by targeting interleukin IL-12/23. It is approved for conditions such as psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The reference brand, Stelara, reported global sales of $10.85bn in 2023. Biocon Biologics CEO and managing director Shreehas Tambe stated: “This settlement agreement is testament to our proven track record of science and innovation and is another key milestone in our journey to bring our biosimilar Bmab 1200 (bUstekinumab) to global markets. “Bmab 1200 will significantly strengthen our immunology franchise, enabling us to offer an affordable and effective treatment option for patients impacted by autoimmune diseases.” In May 2024, Biocon entered an exclusive licence and supply agreement with Handok to commercialise synthetic Liraglutide in South Korea.

Agreement provides Quanterix a license to extensively studied p-Tau 217 antibodies to enable global access to plasma-based testing for Alzheimer’s Disease research and diagnostics BILLERICA, Mass.--(BUSINESS WIRE)-- Quanterix Corporation (NASDAQ: QTRX), a leading provider of ultra-sensitive research products and high-definition diagnostics, today announced the signing of a license agreement with Janssen Sciences Ireland UC (Janssen), a Johnson & Johnson (J&J) Company. Under this agreement, Quanterix will receive worldwide, non-exclusive rights to J&J’s extensively studied p-Tau 217 antibodies and assay designs for potential use in clinical research and diagnostic products, further strengthening Quanterix’s position at the forefront of the Alzheimer's Disease (AD) biomarker field. Under the terms of the license agreement, Janssen will grant Quanterix a worldwide non-exclusive license for J&J-developed technology to produce Simoa p-Tau 217 research-use only (RUO) assay kits for global distribution. Furthermore, under the agreement Quanterix will launch a Laboratory Developed Test (LDT) based on the J&J p-Tau 217 antibodies and assay, offered through Accelerator under the Lucent Diagnostics brand. These advances mark a significant milestone for Quanterix's continued leadership in advancing Alzheimer's Disease diagnosis and treatment, providing a path for the first scalable immunoassay-based p-Tau 217 test to potentially become widely available to researchers and clinicians. p-Tau 217 has emerged as a top performing biomarker for AD, enabling clinical sensitivity and specificity in blood1. Highly sensitive and specific blood-based biomarker tests may improve diagnosis by expanding access to treatments for millions of individuals with early Alzheimer’s Disease, which is currently detected using positron emission tomography (PET) or lumbar puncture for CSF biomarkers. These methods are expensive, lack wide availability, and are invasive. There is growing consensus that high performing blood-based biomarker tests may be an appropriate alternative for patient care. "This collaboration demonstrates the scientific advances that are possible when Simoa’s ultra-sensitive detection is combined with clinically validated antibodies and critical reagents,” said Masoud Toloue, CEO of Quanterix. “Providing access to high-performing blood-based p-Tau 217 assays are an important step as we work with several partners to build the global infrastructure for non-invasive testing of Alzheimer’s Disease.” For more information about Quanterix’s work in neurology, visit: . About Quanterix From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. The Company’s Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Limit of Quantification (LoQ) of conventional analog methods. Its industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology and infectious disease. Quanterix has been a trusted partner of the scientific community for nearly two decades, powering research published in more than 2,000 peer-reviewed journals. Find additional information about the Billerica, Massachusetts-based company at or follow us on Twitter and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release are based on Quanterix’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause Quanterix’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Quanterix’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, Quanterix assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. 1Brum WS, Cullen NC, Janelidze S, et al. A two-step workflow based on plasma p-tau217 to screen for amyloid β positivity with further confirmatory testing only in uncertain cases. Nat Aging. 2023;3(9):1079-1090