Latest news with #CDMO
Indian Express
8 hours ago
- Business
- Indian Express
Zydus announces plan to acquire US manufacturing units of Agenus Inc
Zydus Lifesciences on Tuesday announced its plan to acquire Agenus Inc's US-based biologics CMC (Chemistry, Manufacturing, and Control) facilities, marking the Gujarat-based firm's entry into the global biologics contract development and manufacturing organisation (CDMO) business. Agenus Inc. is a clinical-stage immuno-oncology company developing immune therapies, which effectively combat cancer. Zydus, in a statement, said it is set to acquire two biologics manufacturing facilities, located in Emeryville and Berkeley, California, for an upfront consideration of USD 75 million and contingent payment of USD 50 million to be paid over three years, 'subject to achievement of certain revenue milestones'. With this acquisition, Zydus claims it will become a one-stop solution provider across the entire development spectrum of biologics, right from preclinical to toxicology studies, clinical development and now manufacturing. Zydus's CDMO business will operate as an independent entity and will house the acquired manufacturing capabilities, according to the statement. Further, Zydus will also 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). In addition, Zydus will have the first right of negotiation to manufacture any of the future pipeline products developed by Agenus, the statement further read. Dr Sharvil Patel, Managing Director (MD) of Zydus Lifesciences, said, 'The acquisition will give Zydus a strategic foothold in the US 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 prioritising 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.'
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Business Standard
8 hours ago
- Business
- Business Standard
Zydus enters biologics CDMO market with $125 million acquisitions
Zydus Lifesciences has announced its entry into the global biologics contract development and manufacturing organisation (CDMO) market with a planned acquisition of two manufacturing facilities from US-based Agenus for up to $125 million (around ₹1,070 crore). Under the agreement, Zydus will acquire Agenus' biologics facilities in Emeryville and Berkeley, California, for an upfront payment of $75 million (₹642 crore). It will come with an additional $50 million (₹428 crore) payable over three years, contingent upon achieving certain revenue milestones. The acquisition gives Zydus immediate biologics manufacturing capabilities and a base in California, considered a major hub for biotechnology in the US. The company said the acquired facilities would allow it to offer end-to-end services from pre-clinical development through largescale commercial manufacturing. The CDMO business will be housed under a new independent entity. As part of the transaction, Zydus will also become the exclusive contract manufacturer for two of Agenus' late-stage immuno-oncology candidates, Botensilimab and Balstilimab. It will hold the first right of negotiation for future pipeline products. The acquired facilities include an experienced professional team, which Zydus plans to expand. The company said it expects to create additional jobs and contribute to the local economy of California. Sharvil Patel, managing director, Zydus Lifesciences, said, 'The acquisition will give Zydus a strategic foothold in the US and enhance our ability to partner with innovation-centric entities, advancing new products and prioritising patient-centric solutions. This move strengthens our long-term biologics vision and positions us to better serve the needs of the global biopharmaceutical industry.' According to estimates cited by Zydus, the global biologics CDMO market is projected to grow at a compound annual growth rate (CAGR) of 15.7 per cent between 2025 and 2034, reaching around $84.9 billion by 2034. The market's growth is being driven by increasing complexity of therapies, a shift towards biologics, and limited manufacturing infrastructure among small biotech companies.
Mint
9 hours ago
- Business
- Mint
Zydus buys Agenus' biologics plants in US for $125 mn, licenses cancer therapy
Zydus Lifesciences announced on Tuesday it is acquiring two biologics contract manufacturing facilities in California from US-based Agenus Inc for a total consideration of up to $125 million. The deal includes an upfront payment of $75 million, with the remaining $50 million to be paid over the following three years. The Ahmedabad-based pharmaceutical firm said the acquisition will establish its presence in the rapidly-expanding global biologics contract development and manufacturing organization (CDMO) sector. Zydus is also acquiring a 5.9% stake in Agenus for $16 million, through its wholly-owned subsidiary Zynext Ventures USA LLC, it said in an exchange filing on Tuesday. The drugmaker has also entered into a licensing agreement with Agenus to commercialise its investigational Botensilimab (BOT) and Balstilimab (BAL) combination therapy in India and Sri Lanka. Agenus is a clinical-stage immuno-oncology company committed to developing immune therapies against cancer. The move to acquire biologics manufacturing facilities in the US aligns with Zydus' strategic focus on biologics as a key growth driver this year. Also Read: Glenmark-Ichnos cancer drug shows 74% response in phase-1 trial "The acquisition will give Zydus a strategic foothold in the US for biologics manufacturing in the global hub for biotech innovation, California," managing director Sharvil Patel said in a statement. 'This move strengthens our long-term biologics vision and positions us to better serve the evolving needs of the global biopharmaceutical industry," he added. Additionally, the acquisition gives the company a stronger manufacturing presence in the US, amid ongoing uncertainties over potential American tariffs on pharmaceutical imports. In the company's earnings call last month, Patel had said the company is evaluating opportunities for local manufacturing in the US. 'We have committed to making a good amount of investments in the US with our foray into specialty and other areas," he told investors. Exclusive manufacturer to Agenus Under the terms of the agreement, Zydus will acquire two modern biologics manufacturing facilities from Agenus in Emeryville and Berkeley, California, for an upfront consideration of $75 million and contingent payment of $50 million to be paid over three years subject to achievement of certain revenue milestone. The acquisition provides Zydus immediate access to advanced biologics manufacturing capabilities and a foothold in California, a leading global biotech hub. The move also enables Zydus to 'leverage supply chain dynamics and a favourable geopolitical environment to expand its reach in the U.S. and globally," it said in the release. Also Read: KKR provides $600 mn financing to Manipal Group to fuel its corporate expansion The CDMO business will operate as an independent entity and will house the acquired manufacturing capabilities. As part of the transaction, Zydus will become the exclusive contract manufacturer for Agenus, and provide manufacturing services for the clinical and commercial supply of two identified Phase-3 ready immuno-oncology products - Botensilimab and Balstilimab. Zydus will also have the first right of negotiation to manufacture any of the future pipeline products by Agenus. Agenus reported a turnover of $103.46 million in 2024, according to the exchange filing. Agenus' lead programme comprising Botensilimab and Balstilimab is a next-generation immunotherapy platform designed to strengthen and sustain the immune system's response against tumour cells. The platform, which is currently in advanced clinical trials, has demonstrated significant clinical activity across nine cancer types in more than 1,200 patients, including both late-stage and patients who have undergone neoadjuvant, or primary, therapy. As part of the licensing agreement inked with Agenus, Zydus will be responsible for clinical development and regulatory approvals of the licensed products in India and Sri Lanka and will pay 5% royalty on net sales upon successful approval and commercialization. Also Read: Young heirs take charge as Indian pharma firms plan succession Zydus will expand the reach of the therapy within its initial indications, as well as drive its expansion into other high unmet need indications and earlier lines of treatment, including primary treatments, the company said.
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Business Standard
10 hours ago
- Business
- Business Standard
Zydus signs deal with Agenus for BOT and BAL cancer therapies in India
Zydus Lifesciences Limited has signed a definitive agreement with Agenus Inc. to acquire commercial rights for India and Sri Lanka for the investigational combination therapy Botensilimab (BOT) and Balstilimab (BAL). Agenus is a clinical-stage immuno-oncology company focused on developing immune therapies for the treatment of cancer. 'Our licensing partnership with Agenus aligns with Zydus' overarching biologics vision and our aim to advance novel solutions for high-unmet need areas,' said Dr Sharvil Patel, Managing Director of Zydus Lifesciences. The BOT and BAL combination is a next-generation immunotherapy platform aimed at enhancing and sustaining the immune system's ability to respond to tumour cells. BOT is an investigational anti-CTLA-4 antibody designed to activate immune cells and generate durable immune responses. BAL is an investigational anti-PD-1 antibody that blocks the PD-1 pathway, thereby supporting T cell activity against cancer cells. This combination is currently in advanced clinical trials and has shown clinical activity in more than 1,200 patients across nine types of cancer, including colorectal cancer, melanoma, lung cancer, ovarian cancer, gastric cancer, pancreatic cancer and non-small cell lung cancer. The trials cover both late-stage and neoadjuvant (pre-surgery) treatment settings. Under the terms of the agreement, Zydus will be responsible for clinical development and regulatory approvals of the licensed products in India and Sri Lanka. Upon successful approval and commercialisation, Zydus will pay a 5 per cent royalty on net sales. 'Agenus' robust pipeline and research in immuno-oncology, along with Zydus' reach as the largest Indian oncology player, mark a significant step forward in our collective fight against cancer. We are confident that this collaboration will bring transformative therapies to patients who need them most in the India and Sri Lanka markets,' Dr Patel added. Zydus also stated its intention to broaden the use of the BOT and BAL combination therapy beyond current indications. The company aims to expand into other high-unmet-need indications, earlier lines of treatment, and additional neoadjuvant applications. CDMO agreement In a parallel development, Zydus Lifesciences announced its entry into the global biologics contract development and manufacturing organization (CDMO) sector through an agreement to acquire the biologics CMC facilities of Nasdaq-listed Agenus Inc. in the United States. As part of the CDMO agreement, Zydus will purchase two biologics manufacturing sites located in Emeryville and Berkeley, California, for an upfront payment of $75 million. An additional $50 million will be paid over a period of three years, contingent on the achievement of specified revenue milestones. estimates the global biologics CDMO market will reach approximately $84.9 billion by 2034, with a compound annual growth rate of 15.7 per cent from 2025 to 2034.
Yahoo
5 days ago
- Business
- Yahoo
Scinai Reports Q1 2025 Financial Results Highlighting Strong CDMO Revenue Momentum and Reduced Cash Burn
JERUSALEM, May 30th, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company focused on developing novel and innovative biological drug candidates for the treatment of inflammation and immunology (I&I) related diseases and on providing CDMO services through its Scinai Bioservices business unit, today announced its financial results for the first three months ended March 31, 2025. Three (3) Months of 2025 Financial Summary Revenues for the three months ended March 31, 2025, totaled $586 thousand. The Company's CDMO unit began generating revenues in the second quarter ended June 30, 2024. As disclosed in the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the SEC on May 7, 2025, CDMO revenues for the full year 2024 were $658 thousand. The year-over-year increase in revenues for the first quarter of 2025 reflects a higher number of contracts executed during the period, driven by continued growth in the CDMO business. R&D expenses for the three months ended March 31, 2025, amounted to $1,296 thousand, compared to $1,568 thousand for the same period in 2024. The decrease was primarily due to lower wages and reduced direct R&D expenses. Marketing, general and administrative expenses for the three months ended March 31, 2025, amounted to $500 thousand compared to $484 thousand for the three months ended March 31, 2024. Financial income, net, for the three months ended March 31, 2025, amounted to $11 thousand, compared to financial expenses of $231 thousand for the same period in 2024. The improvement was primarily due to the conversion of the EIB loan into preferred shares of the Company stock in the third quarter of 2024. Net loss for the three months ended March 31, 2025, was $1,557 thousand, compared to a net loss of $2,159 thousand for the three months ended March 31, 2024. The decrease was primarily due to lower R&D expenses, reduced financial expenses, and the recognition of gross income. As of March 31, 2025, Scinai had cash and cash equivalents and short-term deposits of $1,018 thousand compared to $1,964 thousand as of March 31, 2024. About Scinai Immunotherapeutics Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of nanosized VHH antibodies (nanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing biological drug development, analytical methods development, clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution services for early stage biotech drug development projects. Company website: Company Contacts Investor Relations - Allele Capital Partners | +1 978 857 5075 | aeriksen@ Business Development | +972 8 930 2529 | bd@ Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to; the risk that the Company will otherwise be unable to remain compliant with the continued listing requirements of Nasdaq; lower than anticipated revenues of Scinai's CDMO business in 2025 and thereafter; failure to sign agreements with other potential clients of the CDMO business; a delay in the commencement and results of pre-clinical and clinical studies, including the Phase 1/2a study for psoriasis, the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license other nanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of nanoAbs will not be met or that Scinai will not be successful in bringing the nanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for nanoAbs, if any; the risk that our business strategy may not be successful; Scinai's ability to acquire rights to additional product opportunities; Scinai's ability to enter into collaborations on terms acceptable to Scinai or at all; timing of receipt of regulatory approval of Scinai's manufacturing facility in Jerusalem, if at all or when required; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on May 7, 2025, and the Company's subsequent filings with the SEC. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason. Logo - View original content: SOURCE Scinai Immunotherapeutics Ltd. 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
