Latest news with #CDMO
Mint
a day ago
- Business
- Mint
Piramal Pharma's loss narrows to Rs82 crore in June quarter
Piramal Pharma Ltd will focus on increasing capacities for its contract development and manufacturing business, its largest revenue driver, even as it expects muted growth in 2025-26, chairperson Nandini Piramal said on Tuesday. The company is aiming to double its revenues to $2 billion by 2029-30, Piramal told Mint in a post-results interview. The Mumbai-based firm plans to spend $100-125 million in 2025 on capacity expansion. '...but even to reach our 2029-30 goals, we will have to continue to spend on capex…obviously, there is maintenance and compliance capex, but we will continue to spend on de-bottlenecking and increasing capacities where needed,' Piramal said. The company on Monday reported a 1% year-on-year decline in its June-quarter revenue at ₹ 1,934 crore, missing the Bloomberg estimate of ₹ 2,047 crore based on a poll of seven brokerages. Its Ebitda fell 26% to ₹ 165 crore, with Ebitda margin contracting to 9% compared to 11% in Q1FY25. Ebitda is short for earnings before interest, taxes, depreciation, and amortization. Its net loss stood at ₹ 82 crore, down 8% on-year. The Saridon maker said the revenue was impacted by the destocking of one of its largest CDMO (Contract Development and Manufacturing Organization) products. It anticipated 2025-26 growth to remain muted due to this and funding uncertainty for biotechs in the US. 'What we're quite pleased at is that if you take away the de-stocking event, we've grown at mid-teens, and we've also seen a more balanced growth in our overseas sites,' Piramal said, adding that the second half of the fiscal year is expected to be stronger. The company anticipates mid-single-digit revenue growth, mid-teens Ebitda growth, and an improvement in profitability in 2025-26, said Piramal. The firm expects a recovery in 2026-27, Piramal had told Mint in an earlier conversation. In the first three months of 2025-26, Piramal Pharma commenced expansion of two of its US facilities, Lexington, Kentucky, and Riverview, Michigan, for which it had previously announced a $90 million investment. The company has 15 global CDMO facilities, with four in North America, two in the UK and nine in India. Piramal's focus on capacity expansion comes as interest in Indian CDMOs, especially those with niche and differentiated capabilities, grows. As global pharma innovators and biotechs look at derisking their operations and shifting supply chains away from China, Indian firms are poised to grab a large share of this lucrative business. While companies, including Piramal, have seen an increase in requests for proposals (RFPs), indicating growing interest, the switch to actual clients is still slow. Piramal told Mint earlier that customers were pausing decision-making. Domestic factors in the US, like tax and interest rates and FDA funding cuts, were also slowing down biotech recovery. Export-focused CDMO peers such as Divi's Laboratories, Sai Life Sciences, and Syngene International are also aggressively ramping up capacities. Piramal is banking on its differentiated offerings for growth. Its Lexington and Riverview expansions will play a vital role in the development and manufacturing of antibody-drug conjugates (ADC). ADCs are a type of cancer therapy designed to deliver chemotherapy directly to cells, and have seen huge interest from innovators over the last few years. Piramal's differentiated products, including ADCs, sterile fill finish, payload link, high-potent APIs, and on-patent commercial product development, have been growing faster than the rest of the business, and 'will be the driver going forward', said Piramal. The company is not exploring inorganic growth for its CDMO business yet. 'We would do licensing and brand acquisitions in the complex hospital generics business or the consumer healthcare business. I think those are the most likely candidates for acquisitions rather than more facilities and new capabilities,' said Piramal. Piramal Pharma's stock price dipped over 3% to ₹ 196.8 per share on Tuesday morning on National Stock Exchange before settling at ₹ 206.03, up 0.82% at market close.
Business Wire
a day ago
- Business
- Business Wire
AGC Biologics' Heidelberg Site Supplies Drug Substance for Phase II Studies of Valneva's Tetravalent Shigella Vaccine Candidate
SEATTLE & HEIDELBERG, Germany--(BUSINESS WIRE)-- AGC Biologics, your friendly CDMO expert, today announced a development and manufacturing services agreement with specialty vaccine company Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) to supply drug substance for an investigational four-valent Shigella bioconjugate vaccine at the CDMO's Heidelberg facility. Valneva exclusively licensed the vaccine candidate from LimmaTech Biologics AG, which previously worked with AGC Biologics to establish GMP-compliant manufacturing and quality control of the vaccine's complex protein-polysaccharide conjugates for first-in-human studies. The objective of the new partnership with Valneva is to establish phase II supply relying on the ability of AGC Biologics' Heidelberg site to guide complex molecules through clinical stages. Valneva and LimmaTech announced the launch of a Phase 2 infant study in April, and a Phase 2b Human Challenge Study (CHIM) in November 2024. Shigellosis is the second leading cause of fatal diarrheal disease worldwide, strongly contributing to pediatric morbidity and mortality. It is estimated that up to 165 million infections are due to Shigella, of which 62.3 million occur in children younger than five years. Developing an effective vaccine to prevent this deadly disease is a public health imperative for many areas of the world. "Our site's unique ability to handle complex molecules and multi-valent assets can help this potentially life-saving program reach its next clinical milestone," said Dieter Kramer, Senior Vice President and General Manager, AGC Biologics Heidelberg. "We appreciate Valneva entrusting our team of experts with this challenge and are honored to contribute to efforts that aim to prevent millions of deadly infections in the future." AGC Biologics runs multiple cGMP microbial fermentation lines at its Heidelberg facility. The site has produced biologics products for 40 years. It offers developers freedom-to-operate strain development, proven experience with different bacterial and yeast systems, proprietary plasmid DNA (pDNA) and messenger RNA (mRNA) platforms, large-scale tanks for late-phase protein refolding, the ability to take on early-phase and fast track projects, and late-phase and commercial expertise. To learn more about the microbial system-based biologics, pDNA and mRNA manufacturing site in Heidelberg, visit For more information on AGC Biologics' global CDMO services across all modalities, go to About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,600 Team Members worldwide. AGC Biologics is a part of AGC Inc.'s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit
Yahoo
a day ago
- Business
- Yahoo
ViroCell Biologics and AvenCell Therapeutics Announce Retroviral Vector Manufacturing Collaboration to Accelerate Development of Novel Allogeneic CAR-T Therapies for Blood Cancers
AvenCell selected ViroCell for retroviral vector CDMO services to drive its pipeline of innovative allogeneic CAR T-cell therapies, based on ViroCell's deep expertise and track record. LONDON & NEW YORK, July 29, 2025--(BUSINESS WIRE)--ViroCell Biologics ("ViroCell"), a specialist viral vector Contract Development and Manufacturing Organisation ("CDMO") for cell and gene therapy (CGT) clinical trials, announces a manufacturing collaboration with and the successful delivery of a novel retroviral vector to AvenCell Therapeutics, Inc. ("AvenCell"), a leading clinical-stage cell therapy company focused on advancing allogeneic switchable CAR-T cell therapies. This first retroviral vector will be used to manufacture AVC-203, an investigational CD19/CD20 dual-targeted cell therapy for the treatment of B cell malignancies and autoimmune diseases. AvenCell's AV203 is its second investigational cell therapy using its differentiated allogeneic engineering to provide an "off-the-shelf" product engineered to overcome graft-versus-host disease as well as graft rejection by host T and Natural Killer ("NK") cells. AVC-203 is designed to achieve superior efficacy compared to currently-approved CAR-Ts while enabling immediate treatment and greater patient access at much lower cost and complexity. The further inclusion of AvenCell's RevCAR™ receptor in AVC203 allows for additional antigen targeting (with "off/on" capability in vivo) beyond CD19 and CD20. AvenCell selected ViroCell as its partner to manufacture the retroviral vector for this program based on the CDMO's expertise and track record in delivering high yield vectors at speed. Incorporating a cell line acquired by AvenCell into the GMP manufacturing process, ViroCell successfully delivered a high yield vector while meeting AvenCell's accelerated timeline. This program evidences ViroCell's ability to deliver a bespoke, complex manufacturing process in the allogeneic CAR-T cell therapy space, ultimately, enabling AvenCell's timelines for clinical entry. AvenCell's AVC-203 is expected to enter a first-in-human phase I study in patients with relapsed/refractory B cell lymphoma in H2/2025. John W. Hadden II, CEO of ViroCell, commented: "We are thrilled to partner with AvenCell and support their innovative allogeneic CAR-T therapy platform. I am proud of Team ViroCell's accomplishments on the successful end-to-end delivery of this retroviral vector and accelerating a novel therapy into clinical development in an area of high unmet need. We look forward to continuing our work with AvenCell on their exciting platform." Andrew Schiermeier, Ph.D., CEO, AvenCell, added: "We are delighted with ViroCell's performance in process development and GMP manufacture of this complex retroviral vector. We selected ViroCell to support our platform because we knew that they could execute reliably in areas where other CDMOs can't. The delivery of this retroviral vector for AVC-203 is proof that our trust in ViroCell was well placed." Notes to editor: ViroCell ViroCell Biologics is an innovation-driven Contract Development and Manufacturing Organization ("CDMO") focused exclusively on the design, de-risking, and GMP manufacture of viral vectors for clinical trials. Built around one of the most prolific academic viral vector manufacturing teams, ViroCell was created to address the global demand for precisely engineered viral vectors. The team leverages its deep track record to help clients to de-risk and accelerate novel cell and gene therapies into and through clinical development, with a mission of being the partner of choice for corporate and academic innovators. Focused initially on manufacturing lentiviral and retroviral vectors, ViroCell enables clients to start clinical trials on a scalable platform, delivering value by reducing costs, time and regulatory risk. AvenCell Therapeutics AvenCell derives its name from the French word "avenir" to reflect the aim to be the FUTURE of cell therapy. AvenCell is building a truly transformative cell therapy company that targets difficult-to-treat cancers, with its lead programs focusing on acute myeloid leukemia (AML) and additional programs targeting other hematological malignancies. AvenCell was formed with the goal to create truly allogeneic cells that persist as long or longer than autologous therapies and develop a universal and switchable construct that allows complete control and target redirection of T cells after they are infused into a patient. Integration of these two platforms allows for complete separation of the manufacturing of cells from ultimate patient and cancer target, thus providing significant scalability potential at orders of magnitude more efficient than current approaches. AvenCell Therapeutics, Inc. was launched in 2021 by Blackstone Life Sciences, Cellex Cell Professionals, and Intellia Therapeutics. AvenCell is headquartered in Watertown, Massachusetts with additional R&D and manufacturing operations in Dresden, Germany. View source version on Contacts For more information, please contact: ViroCell John W. Hadden II, CEOinfo@ For media enquiries, please contact: ViroCell – FTI Consulting Simon Conway / Tim StamperViroCell@ +44 (0)20 3727 1000 AvenCell – H Advisors Emma +1 (917) 763-6685 擷取數據時發生錯誤 登入存取你的投資組合 擷取數據時發生錯誤 擷取數據時發生錯誤 擷取數據時發生錯誤 擷取數據時發生錯誤
Business Wire
a day ago
- Business
- Business Wire
ViroCell Biologics and AvenCell Therapeutics Announce Retroviral Vector Manufacturing Collaboration to Accelerate Development of Novel Allogeneic CAR-T Therapies for Blood Cancers
LONDON & NEW YORK--(BUSINESS WIRE)--ViroCell Biologics ('ViroCell'), a specialist viral vector Contract Development and Manufacturing Organisation ('CDMO') for cell and gene therapy (CGT) clinical trials, announces a manufacturing collaboration with and the successful delivery of a novel retroviral vector to AvenCell Therapeutics, Inc. ('AvenCell'), a leading clinical-stage cell therapy company focused on advancing allogeneic switchable CAR-T cell therapies. This first retroviral vector will be used to manufacture AVC-203, an investigational CD19/CD20 dual-targeted cell therapy for the treatment of B cell malignancies and autoimmune diseases. AvenCell's AV203 is its second investigational cell therapy using its differentiated allogeneic engineering to provide an 'off-the-shelf' product engineered to overcome graft-versus-host disease as well as graft rejection by host T and Natural Killer ('NK') cells. AVC-203 is designed to achieve superior efficacy compared to currently-approved CAR-Ts while enabling immediate treatment and greater patient access at much lower cost and complexity. The further inclusion of AvenCell's RevCAR™ receptor in AVC203 allows for additional antigen targeting (with 'off/on' capability in vivo) beyond CD19 and CD20. AvenCell selected ViroCell as its partner to manufacture the retroviral vector for this program based on the CDMO's expertise and track record in delivering high yield vectors at speed. Incorporating a cell line acquired by AvenCell into the GMP manufacturing process, ViroCell successfully delivered a high yield vector while meeting AvenCell's accelerated timeline. This program evidences ViroCell's ability to deliver a bespoke, complex manufacturing process in the allogeneic CAR-T cell therapy space, ultimately, enabling AvenCell's timelines for clinical entry. AvenCell's AVC-203 is expected to enter a first-in-human phase I study in patients with relapsed/refractory B cell lymphoma in H2/2025. John W. Hadden II, CEO of ViroCell, commented: 'We are thrilled to partner with AvenCell and support their innovative allogeneic CAR-T therapy platform. I am proud of Team ViroCell's accomplishments on the successful end-to-end delivery of this retroviral vector and accelerating a novel therapy into clinical development in an area of high unmet need. We look forward to continuing our work with AvenCell on their exciting platform.' Andrew Schiermeier, Ph.D., CEO, AvenCell, added: 'We are delighted with ViroCell's performance in process development and GMP manufacture of this complex retroviral vector. We selected ViroCell to support our platform because we knew that they could execute reliably in areas where other CDMOs can't. The delivery of this retroviral vector for AVC-203 is proof that our trust in ViroCell was well placed.' Notes to editor: ViroCell ViroCell Biologics is an innovation-driven Contract Development and Manufacturing Organization ('CDMO') focused exclusively on the design, de-risking, and GMP manufacture of viral vectors for clinical trials. Built around one of the most prolific academic viral vector manufacturing teams, ViroCell was created to address the global demand for precisely engineered viral vectors. The team leverages its deep track record to help clients to de-risk and accelerate novel cell and gene therapies into and through clinical development, with a mission of being the partner of choice for corporate and academic innovators. Focused initially on manufacturing lentiviral and retroviral vectors, ViroCell enables clients to start clinical trials on a scalable platform, delivering value by reducing costs, time and regulatory risk. AvenCell Therapeutics AvenCell derives its name from the French word 'avenir' to reflect the aim to be the FUTURE of cell therapy. AvenCell is building a truly transformative cell therapy company that targets difficult-to-treat cancers, with its lead programs focusing on acute myeloid leukemia (AML) and additional programs targeting other hematological malignancies. AvenCell was formed with the goal to create truly allogeneic cells that persist as long or longer than autologous therapies and develop a universal and switchable construct that allows complete control and target redirection of T cells after they are infused into a patient. Integration of these two platforms allows for complete separation of the manufacturing of cells from ultimate patient and cancer target, thus providing significant scalability potential at orders of magnitude more efficient than current approaches. AvenCell Therapeutics, Inc. was launched in 2021 by Blackstone Life Sciences, Cellex Cell Professionals, and Intellia Therapeutics. AvenCell is headquartered in Watertown, Massachusetts with additional R&D and manufacturing operations in Dresden, Germany.
Business Standard
a day ago
- Business
- Business Standard
Piramal Pharma posts loss of Rs 82 crore in Q1; EBITDA margin declines to 9%
Piramal Pharma has reported a consolidated net loss of Rs 82 crore in Q1 FY26 as against a net loss of Rs 89 crore recorded in Q1 FY25. Revenue from operations for the period under review declined by 1% year-over-year (YoY) to Rs 1,934 crore. EBITDA fell by 26% to Rs 165 crore in Q1 FY26 from Rs 224 crore in Q1 FY25. EBITDA margin for Q1 FY26 was 9% as against 11% in Q1 FY25, primarily impacted by inventory destocking. This was partly offset by improved profitability of the overseas facilities in the CDMO business. The company posted a pre-tax loss of Rs 79 crore in the June25 quarter as against a pre-tax loss of Rs 45 crore registered in the same period last year. Nandini Piramal, chairperson, Piramal Pharma, said: Excluding the impact of destocking in one large on-patent commercial product, our CDMO business delivered mid-teen revenue growth during the quarter accompanied by improvement in EBITDA margin, especially at our overseas sites. Growth in our CHG business is also expected to pick up for the remaining part of the year given the timing of some of the institutional orders. Our consumer business delivered healthy growth, in-line with our expectations, driven by power brands and e commerce sales. Withstanding the near-term challenges, we believe we are on track to achieve our FY2030 aspirations of becoming a $2 billion revenue company with 25% EBITDA margin and high-teen ROCE. Piramal Pharma (PPL) offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 17 global facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the-counter products. The scrip tumbled 4.80% to currently trade at Rs 194.55 on the BSE.
