Latest news with #Zydus'
Business Standard
16-07-2025
- Business
- Business Standard
Zydus' Matoda facility completes Remote Regulatory Assessment of USFDA
Zydus Lifesciences announced that the USFDA conducted a Remote Regulatory Assessment (RRA) at Zydus' formulations manufacturing facility at Matoda in Gujarat for the Prior Approval Supplement (PAS) of Atorvastatin Calcium Tablets USP, 10 mg, 20 mg, 40 mg and 80 mg. At the closure, there were no observations noted, and the site was recommended for approval.
Yahoo
04-06-2025
- Business
- Yahoo
Agenus and Zydus sign agreements for botensilimab and balstilimab
Agenus has signed $141m partnership agreements with Zydus Lifesciences and its subsidiaries to enhance clinical developments and advance manufacturing globally while expanding patient access to botensilimab and balstilimab (BOT/BAL). The agreement includes an exchange of Agenus' biologics chemistry, manufacturing and controls facilities in Emeryville and Berkeley in the US state of California for $75m upfront. Agenus will receive up to an extra $50m in contingent payments obtained by production orders for BOT/BAL. Zydus plans to launch a BioCDMO [contract development and manufacturing organisation] business using these facilities as its flagship US sites provide biologics contract manufacturing services to biopharmaceutical companies across the globe. Agenus will be Zydus' inaugural BioCDMO customer as a result of an exclusive manufacturing agreement for BOT/BAL. This ensures that the combination regimen's biologics licence application (BLA) and launch readiness needs are met effectively. Agenus will give Zydus an exclusive licence for the development and commercialisation of BOT and BAL in Sri Lanka and India. This move benefits Zydus' established regional presence and infrastructure. In return, it will pay a 5% royalty to Agenus on net sales within those countries. Zydus will also make an equity investment in Agenus through the purchase of 2.1 million common stock shares at $7.50 per share. This $16m in gross proceeds will be used by Agenus for working capital purposes and for accelerating ongoing clinical development, registration and potential commercialisation related to BOT/BAL. Agenus CEO Dr Garo Armen stated: 'With a trade agreement between the US and India seemingly imminent, there is a renewed sense of confidence by trading partners in both countries in the future of Indian-American relations. 'There is also a growing recognition by both countries of the need for the US to ensure that biopharma supply chains are secure. We are working with Zydus to accelerate future clinical trials for BOT/BAL and eventually its global footprint in oncology therapeutics. This agreement is an expression of confidence in the future of Agenus and in the regulatory environment of the US.' By combining Agenus' research capabilities with Zydus' manufacturing strength globally, along with operational expertise, the partnership will help advancements in cancer immunotherapy in India and internationally. "Agenus and Zydus sign agreements for botensilimab and balstilimab" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Upturn
03-06-2025
- Business
- Business Upturn
Agenus and Zydus Lifesciences Enter $141M Strategic Collaboration to Advance BOT/BAL, Expand Zydus' Biologics Manufacturing in the US
LEXINGTON, Mass., United States: $75M upfront payment to Agenus for the transfer of manufacturing assets $50M of contingent payments to Agenus Exclusive license for BOT/BAL in India and Sri Lanka $16M equity investment at $7.50 per share Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced it has signed definitive partnership agreements with Zydus Lifesciences Ltd. (NSE: ZYDUSLIFE), including its subsidiaries/affiliates, hereafter referred to as 'Zydus,' designed to accelerate clinical development, scale global manufacturing, and expand patient access to botensilimab and balstilimab (BOT/BAL). The strategic collaboration includes an exchange of Agenus' state-of-the-art biologics CMC facilities in Emeryville, CA and Berkeley, CA for upfront consideration of $75M; Agenus to receive up to an additional $50M in contingent payments triggered by BOT/BAL production orders. Zydus, an India-based multinational pharmaceutical company with over 27,000 employees and operations in 55 countries, will launch a BioCDMO business using the facilities as their flagship U.S. sites to provide biologics contract manufacturing services to biopharmaceutical companies globally. Agenus will become Zydus' first BioCDMO customer through an exclusive manufacturing agreement for BOT/BAL to ensure the combination regimen's BLA and launch readiness needs. This collaboration enables Agenus to unlock the value of its manufacturing assets and secure strategic capital to drive BOT/BAL toward global regulatory engagement and commercialization. Agenus will also grant Zydus an exclusive license to develop and commercialize BOT and BAL in India and Sri Lanka, capitalizing on Zydus' established local market presence and infrastructure. Zydus will pay Agenus a 5 percent royalty on net sales in those countries. In a demonstration of mutual commitment, Zydus will also make a strategic equity investment in Agenus by purchasing approximately 2.1 million shares of common stock at $7.50 per share, totaling approximately $16 million in gross proceeds. Agenus intends to apply the net proceeds from the sale of the purchased shares for working capital and general corporate purposes, and will accelerate ongoing clinical development, registration and potential commercialization of BOT/BAL. By uniting Agenus' pioneering research and development capabilities with Zydus' worldwide manufacturing, commercialization and operational strength, this partnership sets the stage for a new era in cancer immunotherapy in India and beyond. 'With a trade agreement between the United States and India seemingly imminent, there is a renewed sense of confidence by trading partners in both countries in the future of Indian-American relations,' said Dr. Garo Armen, CEO of Agenus. 'There is also a growing recognition by both countries of the need for the United States to ensure that biopharma supply chains are secure. We are working with Zydus to accelerate future clinical trials for BOT/BAL and eventually its global footprint in oncology therapeutics. This agreement is an expression of confidence in the future of Agenus and in the regulatory environment of the United States. The administration has created an environment that has brought these two trading partners together. The United States is the second largest trading partner with India. For these reasons and the strong collaborative spirit we feel with our new partners at Zydus, we decided to enter into this partnership now.' 'We are thrilled to be partnering with Agenus to advance BOT/BAL, which has the potential to benefit thousands of patients in our core markets of India and Sri Lanka annually and millions of solid tumor patients globally. We plan to run clinical trials testing BOT/BAL in both early-stage and late-stage disease, along with expansion beyond colorectal cancer to other major disease settings like triple negative breast cancer,' said Dr. Sharvil Patel, Managing Director at Zydus Lifesciences Ltd. The transaction is subject to customary closing conditions and satisfactory due diligence. The parties aim to complete closing agreements within 60 days. Conference Call and Webcast Date/Time: Tuesday, June 3rd; 4:30 p.m. ET To access dial-in numbers, please register at: . Conference ID: 12788 Advisors As part of this effort, Agenus was advised by Biotech Value Advisors (BVA), a strategic advisory firm, which provided guidance on transaction structure, partner selection and negotiations. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. About Zydus Lifesciences Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27,000 people worldwide, including 1,400 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit About Botensilimab (BOT) Botensilimab (BOT) is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to 'cold' tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus' investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit . About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words 'may,' 'believes,' 'expects,' 'anticipates,' 'hopes,' 'intends,' 'plans,' 'forecasts,' 'estimates,' 'will,' 'establish,' 'potential,' 'superiority,' 'best in class,' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same.
Cision Canada
03-06-2025
- Business
- Cision Canada
Zydus to enter global biologics CDMO business: Plans to acquire Agenus' U.S. manufacturing facilities to accelerate development of innovative therapies
The acquisition will establish Zydus' presence in fast growing global biologics CDMO space. Acquired capabilities include cutting-edge biologics development and manufacturing services to serve the needs of global innovative biotechnology companies. AHMEDABAD, India and PENNINGTON, N.J., June 3, 2025 /CNW/ -- Zydus Lifesciences Ltd. (including its subsidiaries/affiliates, hereafter referred to as 'Zydus' today announced its entry into the global biologics contract development and manufacturing organization (CDMO) business through its plan to acquire Agenus Inc.'s (NASDAQ: AGEN) U.S.-based biologics CMC facilities. This acquisition marks Zydus' strategic investment in U.S.-based manufacturing for biologics thereby adding a sustainable growth driver for the group. Agenus Inc. is a clinical-stage immuno-oncology company committed to developing immune therapies that effectively combat cancer. Under the terms of the agreement, Zydus will acquire two state-of-the-art biologics manufacturing facilities from Agenus in Emeryville and Berkeley, California (US) for an upfront consideration of US$75 million and contingent payment of US$50 million to be paid over three years subject to achievement of certain revenue milestone. This acquisition provides Zydus immediate access to advanced biologics manufacturing capabilities and establishes a key presence in California, a leading global biotechnology hub. This strategic move enables Zydus to leverage supply chain dynamics and a favourable geopolitical environment to expand its reach in the U.S. and globally. With this acquisition Zydus will now become a one stop solution provider across the entire development spectrum of biologics, right from pre-clinical to toxicology studies, clinical development and now manufacturing. Zydus' CDMO business will operate as an independent entity and will house the acquired manufacturing capabilities. The facilities come with an experienced professional team with strong capabilities and requisite industry expertise to deliver high-quality biologics development and manufacturing services to global biotech and pharmaceutical companies. As a part of transaction Zydus will become an exclusive contract manufacturer for Agenus and will provide manufacturing services for clinical and commercial supply of two identified Phase-3 ready immuno-oncology products, Botensilimab (BOT) and Balstilimab (BAL). Zydus will also have first right of negotiation to manufacture any of the future pipeline products developed by Agenus. Zydus intends to further expand the team and help create new jobs in the region and contribute to the local economy. Speaking on the development, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Ltd. said, "The acquisition will give Zydus a strategic foothold in the U.S. for biologics manufacturing in the global hub for biotech innovation, California. It will enhance our ability to partner with innovation-centric entities, advancing new products and prioritizing patient-centric solutions. This move strengthens our long-term biologics vision and positions us to better serve the evolving needs of the global biopharmaceutical industry." The global biologics CDMO market is experiencing significant growth, driven by the increasing complexity of therapies, the rise of biologics in clinical pipelines, and a growing number of emerging biotech companies lacking internal manufacturing capabilities. According to the Global Biologics CDMO Market Size is expected to be worth around US$ 84.9 Billion by 2034, growing at a CAGR of 15.7% between 2025 to 2034. As demand surges for reliable, agile, and scalable partners, Zydus' entry into this space positions it to tap into significant long-term growth opportunities and support innovation across the global biopharmaceutical landscape. About Zydus Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 27,000 people worldwide, including 1,400 scientists engaged in R & D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars. For more details visit: About Agenus Agenus Inc. is a clinical-stage immuno-oncology company committed to developing immune therapies that effectively combat cancer. Leveraging proprietary scientific platforms, the company's pipeline includes multiple checkpoint antibody candidates, vaccines, and cell therapies. Headquartered in Lexington, MA, Agenus operates globally, driving innovations to bring better cancer treatments to patients. For more details visit: Forward-Looking Statements: This press release contains forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These risks and uncertainties include, but are not limited to, the successful integration of the acquired business, market conditions, and other factors.
Business Wire
03-06-2025
- Business
- Business Wire
Agenus and Zydus Lifesciences Enter $141M Strategic Collaboration to Advance BOT/BAL, Expand Zydus' Biologics Manufacturing in the US
LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced it has signed definitive partnership agreements with Zydus Lifesciences Ltd. (NSE: ZYDUSLIFE), including its subsidiaries/affiliates, hereafter referred to as 'Zydus,' designed to accelerate clinical development, scale global manufacturing, and expand patient access to botensilimab and balstilimab (BOT/BAL). The strategic collaboration includes an exchange of Agenus' state-of-the-art biologics CMC facilities in Emeryville, CA and Berkeley, CA for upfront consideration of $75M; Agenus to receive up to an additional $50M in contingent payments triggered by BOT/BAL production orders. Zydus, an India-based multinational pharmaceutical company with over 27,000 employees and operations in 55 countries, will launch a BioCDMO business using the facilities as their flagship U.S. sites to provide biologics contract manufacturing services to biopharmaceutical companies globally. Agenus will become Zydus' first BioCDMO customer through an exclusive manufacturing agreement for BOT/BAL to ensure the combination regimen's BLA and launch readiness needs. This collaboration enables Agenus to unlock the value of its manufacturing assets and secure strategic capital to drive BOT/BAL toward global regulatory engagement and commercialization. Agenus will also grant Zydus an exclusive license to develop and commercialize BOT and BAL in India and Sri Lanka, capitalizing on Zydus' established local market presence and infrastructure. Zydus will pay Agenus a 5 percent royalty on net sales in those countries. In a demonstration of mutual commitment, Zydus will also make a strategic equity investment in Agenus by purchasing approximately 2.1 million shares of common stock at $7.50 per share, totaling approximately $16 million in gross proceeds. Agenus intends to apply the net proceeds from the sale of the purchased shares for working capital and general corporate purposes, and will accelerate ongoing clinical development, registration and potential commercialization of BOT/BAL. By uniting Agenus' pioneering research and development capabilities with Zydus' worldwide manufacturing, commercialization and operational strength, this partnership sets the stage for a new era in cancer immunotherapy in India and beyond. 'With a trade agreement between the United States and India seemingly imminent, there is a renewed sense of confidence by trading partners in both countries in the future of Indian-American relations,' said Dr. Garo Armen, CEO of Agenus. 'There is also a growing recognition by both countries of the need for the United States to ensure that biopharma supply chains are secure. We are working with Zydus to accelerate future clinical trials for BOT/BAL and eventually its global footprint in oncology therapeutics. This agreement is an expression of confidence in the future of Agenus and in the regulatory environment of the United States. The administration has created an environment that has brought these two trading partners together. The United States is the second largest trading partner with India. For these reasons and the strong collaborative spirit we feel with our new partners at Zydus, we decided to enter into this partnership now.' 'We are thrilled to be partnering with Agenus to advance BOT/BAL, which has the potential to benefit thousands of patients in our core markets of India and Sri Lanka annually and millions of solid tumor patients globally. We plan to run clinical trials testing BOT/BAL in both early-stage and late-stage disease, along with expansion beyond colorectal cancer to other major disease settings like triple negative breast cancer,' said Dr. Sharvil Patel, Managing Director at Zydus Lifesciences Ltd. The transaction is subject to customary closing conditions and satisfactory due diligence. The parties aim to complete closing agreements within 60 days. Conference Call and Webcast Date/Time: Tuesday, June 3 rd; 4:30 p.m. ET To access dial-in numbers, please register at: Conference ID: 12788 Advisors As part of this effort, Agenus was advised by Biotech Value Advisors (BVA), a strategic advisory firm, which provided guidance on transaction structure, partner selection and negotiations. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. About Zydus Lifesciences Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27,000 people worldwide, including 1,400 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit About Botensilimab (BOT) Botensilimab (BOT) is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to 'cold' tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus' investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," 'establish,' 'potential,' 'superiority,' 'best in class,' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
