Latest news with #ZydusLifesciencesLtd
Mint
6 days ago
- Business
- Mint
Zydus to Enter Global Biologics CDMO Business Plans
New Jersey, United States & Ahmedabad, Gujarat, India – Business Wire India 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 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 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. Sujatha Rajesh (Media Relations), Zydus Lifesciences Limited, +91-9974051180 Arvind Bothra (Investor Relations), Zydus Lifesciences Limited, +91-7045656895
Business Standard
7 days ago
- Business
- Business Standard
Zydus to Enter Global Biologics CDMO Business Plans to Acquire Agenus' U.S. Manufacturing Facilities to Accelerate Development of Innovative Therapies
BusinessWire India New Jersey [US]/ Ahmedabad (Gujarat) [India], June 3: 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.
Mint
21-05-2025
- Business
- Mint
Zydus bets big on vaccines and medtech
Mumbai: Zydus Lifesciences Ltd is looking to ramp up its vaccines and medtech portfolio over the next few years, the company's top executive told investors during an earnings call Tuesday evening. The drugmaker, which announced its Q4FY25 results the same day, expects double-digit revenue growth in FY26, led by strong performance in both domestic and international markets, as well as newer businesses such as biologics, vaccines, and medtech. '...led by strong growths in India and international markets and also our new growth themes like biologics, vaccines and all scaling up,' managing director Sharvil Patel told investors. The company expects to outperform the Indian pharmaceutical market in FY26, while projecting single-digit growth in the US. The management has guided for an Ebitda margin of about 26% in FY26. Zydus closed FY25 with its highest-ever operating profit and margins. Consolidated revenue rose 19% year-on-year to ₹ 23,241.5 crore, with an Ebitda margin of 30.4%. Patel said he is 'quite upbeat and positive on the overall trajectory for the business and the opportunity' in vaccines. In FY25, Zydus began development of the world's first combination vaccine for shigellosis (bacillary dysentery) and typhoid, with support from the Gates Foundation. 'We shall conduct early stage development, animal immunogenicity studies and the regulatory preclinical tox studies for this combination vaccine,' he said. The company also received regulatory approval to begin phase 2 clinical trials for its bivalent TCV vaccine in the March quarter. '...with potential access now to both India's public [market] and the WHO pre-qualified public markets we are seeing a good trajectory for the vaccines in terms of scaling it up,' he said. Zydus' vaccine strategy spans three core areas, according to Patel. In India, the business is performing well, and the company expects to be a significant contender in upcoming public tenders. 'We believe that we are a critical contender in the public tenders for the MR (Measles Rubella) vaccine that has come out, and we believe that will be an important MR tender supply for Zydus in the coming year,' he said. It is also seeing demand from multilateral agencies. '...we will be able to participate in some of these tenders. So that could offer additional opportunities in the coming years,' Patel said, referring to UNICEF and the Pan American Health Organisation (PAHO). The company plans to register some of its products in markets such as Egypt, which could open up further opportunities. 'Our non-tender sales are doing very well. We are selling, I think, the highest doses of the flu vaccines now. We are selling out all capacities on our rabies vaccine. We have the other two vaccines that are coming up and the new vaccines that are getting added to the portfolio,' Patel said. Zydus entered the medtech space last fiscal with the acquisition of a majority stake in French orthopaedic company Amplitude Surgical SA. The company is also developing capabilities in nephrology and cardiovascular devices organically. 'Medical devices is an important area for the organization and we have had important both organic as well as inorganic opportunities that we have looked at and have been successful at,' Patel said. 'Some of these are already revenue generating and profit making businesses. So, we will look to add more geographies, bring down cost and increase and grow this business,' he added. 'It is not going to be short term…the scale up we'll really get to see after three years.' Zydus is forecasting high single-digit growth in the US market in FY26, though it faces pressure from tapering sales of its Revlimid generic and a decline in market share for its Asacol HD generic. The company has a pipeline of 14-15 critical launches lined up for FY27, and believes its base business in the US–now over $1 billion in revenue–remains strong. Addressing concerns over potential import tariffs in the US, Patel said the company is evaluating opportunities for local manufacturing. 'But any of these decisions will require a lot of time for setting up, so it's not something that can happen in the short term,' he said. 'We have committed to making a good amount of investments in the US with our foray into specialty and other areas.'
New Indian Express
30-04-2025
- Business
- New Indian Express
Zydus Lifesciences gets USFDA nod for generic cholesterol lowering drug
NEW DELHI: Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to manufacture the generic version of cholesterol lowering Niacin extended-release tablets. The approval by the US Food and Drug Administration (USFDA) is for Niacin extended-release tablets of strengths 500 mg, 750 mg, and 1,000 mg, Zydus Lifesciences Ltd said in a regulatory filing. The Niacin-extended-release tablets will be produced at the group's manufacturing site at Moraiya, Ahmedabad, the company said. Niacin is indicated to reduce elevated total cholesterol (TC), LDL cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase HDL cholesterol (HDL-C) in patients with primary hyperlipidaemia and mixed dyslipidaemia. It is also indicated to reduce the risk of recurrent myocardial infarction in patients with a history of myocardial infarction and hyperlipidaemia and to reduce TG (triglyceride) in adult patients with severe hypertriglyceridemia. Citing IQVIA MAT February (2025) data, the company said the niacin-extended-release tablets had annual sales of USD 5.5 million in the United States.
Time of India
30-04-2025
- Health
- Time of India
Zydus Lifesciences gets USFDA nod for generic cholesterol lowering drug
Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to manufacture the generic version of cholesterol lowering Niacin extended-release tablets. The approval by the US Food and Drug Administration (USFDA) is for Niacin extended-release tablets of strengths 500 mg, 750 mg, and 1,000 mg, Zydus Lifesciences Ltd said in a regulatory filing. #Pahalgam Terrorist Attack The groundwork before India mounts a strike at Pakistan India considers closing airspace to Pakistani carriers amid rising tensions Cold Start: India's answer to Pakistan's nuclear threats The Niacin-extended-release tablets will be produced at the group's manufacturing site at Moraiya, Ahmedabad, the company said. Niacin is indicated to reduce elevated total cholesterol (TC), LDL cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase HDL cholesterol (HDL-C) in patients with primary hyperlipidaemia and mixed dyslipidaemia. It is also indicated to reduce the risk of recurrent myocardial infarction in patients with a history of myocardial infarction and hyperlipidaemia and to reduce TG (triglyceride) in adult patients with severe hypertriglyceridemia. Citing IQVIA MAT February (2025) data, the company said the niacin-extended-release tablets had annual sales of USD 5.5 million in the United States.
