Levetiracetam

Ensuring patients have access to the medicines they need through long-term commitment to patients and scientific innovation Building on long-standing U.S. presence, expanded investments in research, manufacturing infrastructure, and highly skilled jobs will strengthen economic growth For nearly a century, UCB's investment in differentiated science has fueled a robust pipeline of innovation, advancing the breakthroughs of tomorrow BRUSSELS and ATLANTA, Aug. 31, 2026 /PRNewswire/ -- UCB, a global biopharmaceutical company focused on improving the lives of people living with severe diseases, today announced that they've come to an agreement with the U.S. government that will continue to support patient access to important medicines while enabling significant investment in the research, development, and manufacturing of medicines for people living with severe neurological and immunological diseases. "At UCB, we are guided by a clear purpose: to create value for patients now and into the future," said UCB's CEO Jean-Christophe Tellier: "Working with the U.S. Government reflects our commitment to support access to medicines for people who need them, while continuing to advance the science and innovation that can make a meaningful difference for people living with severe diseases. These priorities, and our contribution to the United States through research, manufacturing, and highly skilled jobs, are essential to our long-term commitment to patients." UCB will: Take a more balanced pricing approach for future medicine launches across developed nations Participate in the Government's GENEROUS program Continue its onshore manufacturing investment to serve patients with medicines made in the United States Earlier this year, UCB committed to expanding its U.S. manufacturing footprint, anchored by a new biologics manufacturing facility in Georgia — the largest manufacturing investment in the company's history. The facility is expected to generate approximately $5 billion in U.S. economic impact and create approximately 330+ permanent, highly skilled jobs, helping to strengthen domestic biopharmaceutical manufacturing and supply chain resilience of recently approved and future pipeline medicines in immunology and rare disease. The agreement supports UCB's ability to execute our strategy and continue delivering innovative medicines to patients in the U.S. and around the world. As a result, UCB will not be subject to Section 232 Pharmaceutical tariffs on all current products or future pricing mandates. Specific terms remain confidential. Separately, UCB will donate Keppra® (levetiracetam), which is recognized by the FDA as an Essential Medicine, active pharmaceutical ingredient (API) and tablets to the Administration for Strategic Preparedness and Response's (ASPR) National Stockpile. This donation will help strengthen the resilience of the U.S. essential medicines supply chain, support national preparedness efforts, and help safeguard access to a critical treatment for patients when it is needed most. About UCB in the U.S. UCB has maintained a significant U.S. presence for decades, including its U.S. headquarters and eight offices across six communities in California, Georgia, Massachusetts, North Carolina, Washington, and Washington, D.C. With nearly 2,000 U.S. employees focused on research, development, and commercial operations across the country, UCB is adding a U.S. biomanufacturing campus in Georgia, which will create 330+ new, highly skilled jobs. UCB has increased its U.S. workforce by more than 70% since 2017, with over 25% of U.S. employees dedicated to R&D. Over the last decade, UCB has made significant investments in U.S. companies through acquisitions and partnerships and has achieved 15 FDA approvals, advancing innovation, supporting high-quality jobs, and delivering meaningful progress for patients. About UCB UCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 9 000 people in approximately 40 countries, the company generated revenue of € 7.7 billion in 2025. UCB is listed on Euronext Brussels (symbol: UCB). For further information, contact UCB: Investor Relations Yvonne Naughton T +44-750-057 0135 email [email protected] Sahar Yazdian T +32.2.559.91.37 email [email protected] Corporate Communications Laurent Schots T +32.2.559.92.64 Email [email protected] U.S. Communications Erica Puntel T 404.938.5359 Email [email protected] Forward looking statements This document contains forward-looking statements, including, without limitation, statements containing the words "potential", "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guaranteeing future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document. Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues, supply chain disruption and business continuity risks; potential or actual data security and data privacy breaches, or disruptions of UCB's information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in laws and/or rules pertaining to tax and duties or the administration of such laws and/or rules, and hiring, retention and compliance of employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB. UCB expressly disclaims any obligation to update any forward-looking statements in this document, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. SOURCE UCB 21% more press release views with Request a Demo

Anamarija Mrkic /Getty Images A batch of a chemotherapy product made at a Sun facility with a history of quality and compliance issues is being withdrawn from the U.S. market. Sun Pharma is recalling one batch of a chemotherapy drug from the U.S. after detecting glass particles in some of the vials. The recall affects 675 vials of doxorubicin hydrochloride liposome, an intravenous chemotherapy drug used to treat AIDS-related Kaposi sarcoma, multiple myeloma and ovarian cancer. Sun is notifying its distributor and customers of the recall and arranging the return of affected products. Organizations with recalled vials should stop using the products and return them to their place of purchase. Sun has not received any adverse event reports related to the batch, but there is potential for the glass particles to harm patients. Intravenous administration of the recalled drug could cause local irritation or swelling as patients react to the foreign material. Blood vessel blockages and life-threatening blood clots are also possible. Patients should contact their physician if they have problems linked to the drug. The Indian drugmaker investigated the source of the problem and has “taken corrective and preventive actions,” but hasn’t shared further details yet. The product label states the vials were manufactured at a Sun facility in Halol, India. That facility has a history of quality and compliance problems dating back more than 10 years. In 2014, FDA inspectors listed 19 pages of problems at the facility. The next year, the FDA sent a warning letter and rescinded the approval of Sun’s epilepsy drug Elepsia XR due to issues at the site. The company received a Form 483 with nine observations after the FDA inspected the plant in 2016. The next year, the FDA rejected a request for approval of Elepsia XR based on inspection findings. Inspectors issued another Form 483 when they returned to the plant in 2018 but ultimately found Sun had resolved the problems raised in the warning letter. Deals Sun Pharma beams up Organon in $11.75B acquisition Sun Pharmaceutical is bringing Merck spinoff Organon into the fold, paying $11.75 billion in hopes of becoming a top global biosimilar player. April 27, 2026 · 1 min read · Gabrielle Masson Read more However, the FDA sent another Form 483 in 2019. The next year, the FDA classified the facility as “official action indicated” (OAI). The status can precede a warning letter and rejections for drugs made at the affected facility. An FDA inspection performed in 2022 triggered another warning letter. Inspectors found fault with Sun’s vial-filling equipment, which they said caused friction that introduced “blackish fine metallic particles.” The FDA imposed an import alert on products made at the facility. Inspectors visited the site again last year, leading to a Form 483 in June. In September, the FDA again classified the facility as OAI.