Latest news with #Basilea
Business Upturn
29-07-2025
- Business
- Business Upturn
Basilea initiates phase 3 study with antifungal fosmanogepix in invasive mold infections
By GlobeNewswire Published on July 29, 2025, 10:15 IST Study to evaluate the efficacy and safety of fosmanogepix in adults with invasive mold infections Study completion expected in Q1 2028 Allschwil, Switzerland, July 29, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today the initiation of FORWARD-IM, a phase 3 registrational study evaluating the efficacy and safety of its broad-spectrum antifungal fosmanogepix for the treatment of adult patients with invasive mold infections.[1] Fosmanogepix is a first-in-class antifungal with a novel mechanism of action and is available in both intravenous and oral formulations. It has been evaluated for efficacy and safety in a phase 1 and phase 2 program, including three open-label phase 2 studies for the treatment of Candidemia, including Candida auris , and invasive mold infections.[2, 3, 4, 5, 6] The FORWARD-IM study is the second phase 3 study for fosmanogepix, following the initiation of FAST-IC in September 2024, a randomized, double-blind phase 3 registrational study in adult patients with candidemia and/or invasive candidiasis.[7] Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: 'Our phase 3 program with fosmanogepix allows us to fully explore the clinical benefit of this important new treatment option for invasive fungal infections. Its broad-spectrum activity against multidrug-resistant molds and yeasts highlights the unique potential of fosmanogepix to address significant gaps in current antifungal therapies. Fosmanogepix has shown promising efficacy in earlier clinical studies and in the ongoing expanded access program. The initiation of our second phase 3 study is a significant milestone for fosmanogepix and demonstrates our commitment to advancing our innovative pipeline for the benefit of patients.' FORWARD-IM is an interventional, open-label, two-cohort phase 3 study in adult patients with invasive mold infections caused by Aspergillus spp., Fusarium spp., Lomentospora prolificans , Mucorales fungi, or other multidrug-resistant molds. The first cohort will enroll approximately 160 patients, randomized in a 2:1 ratio to receive either fosmanogepix or current standard-of-care therapy. The second cohort will enroll approximately 60 patients who have developed intolerance, toxicities, lack of clinical response, or whose fungal isolate is resistant to standard-of-care therapy. All patients in the second cohort will receive fosmanogepix. The completion of the study and publication of results are expected in 2028. The Swiss-based global company PSI CRO AG is managing the phase 3 program. Basilea acquired fosmanogepix from Amplyx Pharmaceuticals, Inc., an affiliate of Pfizer Inc. Pfizer retains a right of first negotiation for commercializing fosmanogepix, once phase 3 development is successfully completed. This project is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration of Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50124C00033. The contract and federal funding are not an endorsement of the study results, product, or company. About fosmanogepix Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus , including multi-drug-resistant strains, such as Candida auris and Candida glabrata , as well as rare difficult-to-treat molds including Fusarium spp., Lomentospora prolificans , Scedosporium spp., and some fungi from the Mucorales order.[2] Fosmanogepix intravenous and oral formulations have been evaluated in phase 2 studies for the treatment of patients with Candidemia, including Candida auris , and invasive mold infections.[4, 5, 6] Fosmanogepix has received Fast Track and Orphan Drug designations from the US Food and Drug Administration (FDA) for seven separate indications, and is designated as a Qualified Infectious Disease Product (QIDP). About invasive mold infections Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., Lomentospora prolificans , Scedosporium spp., and Mucorales fungi) are life-threatening infections that predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.[8, 9] About invasive candidiasis Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients hospitalized in intensive care units. Candida species are ranked as the fourth main cause of bloodstream infections in hospitals in the US.[10] The prognosis of invasive candidiasis remains unfavorable, with a reported mortality rate as high as 40%, even when patients receive antifungal therapy.[11] About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as 'believe', 'assume', 'expect', 'forecast', 'project', 'may', 'could', 'might', 'will' or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: This press release can be downloaded from References FORWARD-IM (FOsmanogepix study Run Worldwide as Antifungal treatment in Resistant Disease caused by Invasive Molds): identifier: NCT06925321 K. J. Shaw, A. S. Ibrahim. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239 M. R. Hodges, E. Ople, P. Wedel et al. Safety and Pharmacokinetics of Intravenous and Oral Fosmanogepix, a First-in-Class Antifungal Agent, in Healthy Volunteers. Antimicrobial Agents and Chemotherapy 2023 (67), e01623-22 J. A. Vazquez, P. G. Pappas, K. Boffard et al. Clinical Efficacy and Safety of a Novel Antifungal, Fosmanogepix, in Patients with Candidemia Caused by Candida auris: Results from a Phase 2 Trial. Antimicrobial Agents and Chemotherapy2023 (67), e01419-22 P. G. Pappas, J. A. Vazquez, I. Oren et al. Clinical safety and efficacy of novel antifungal, fosmanogepix, for the treatment of candidaemia: results from a Phase 2 trial. Journal of Antimicrobial Chemotherapy 2023 (78), 2471-2480 M.R. Hodges, M. Tawadrous, O.A. Cornely et al. Fosmanogepix for the Treatment of Invasive Mold Diseases Caused by Aspergillus Species and Rare Molds: A Phase 2, Open-Label Study (AEGIS). Clinical Infectious Diseases 2025 Apr 9:ciaf185 FAST-IC (Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis): identifier: NCT05421858 J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434 M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10 Candidemia (Blood Infection) and Other Candida Infections. 2019 Factsheet by the American Thoracic Society: (Accessed: July 28, 2025) B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456 Attachment Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
Yahoo
08-07-2025
- Business
- Yahoo
Basilea receives USD 39 million funding under BARDA agreement to continue to advance novel antifungals fosmanogepix and BAL2062
Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, July 08, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, committed the next USD 39 million to Basilea to continue to advance the development of Basilea's novel antifungals fosmanogepix and BAL2062. This additional funding is based on the successful completion of a milestone within the 'Other Transaction Agreement' (OTA, agreement number 75A50124C00033) that was awarded on September 30, 2024, and which allows for potential funding of up to approximately USD 268 million in total to develop antifungal and antibacterial assets. David Veitch, Chief Executive Officer of Basilea, said: 'We are very pleased to receive the continued funding under the OTA with BARDA to support the development of our antifungal drug candidates fosmanogepix and BAL2062. Both compounds offer a novel mechanism of action and represent new therapeutic options for patients with aspergillosis, candidiasis or other life-threatening fungal infections. These infections primarily affect patients with weakened immune systems, such as cancer or transplant patients. Infections with difficult-to-treat rare molds or with resistance to current therapies are increasing. Hence, there continues to be a high medical need for new innovative antifungals.' He added: 'This second tranche of funding within the BARDA OTA will support the ongoing phase 3 study with fosmanogepix in yeast infections and the second phase 3 study, in mold infections, which is expected to start soon. It also provides funding for the preparation for the start of the phase 2 study for our antifungal BAL2062.' The USD 39 million is in addition to the initial USD 29 million BARDA committed at the signing of the OTA in September 2024. BARDA's financial contribution is about 60% of the total costs of the supported projects over the term of the OTA, which could provide a total potential non-dilutive funding of up to approximately USD 268 million, over up to 12 years, if all additional options to extend the contract are exercised by BARDA, upon successful completion of pre-defined milestones, including clinical and regulatory activities. About fosmanogepix Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.1 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris infections, and invasive mold infections.1 A phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis is ongoing and the initiation of a second phase 3 study, in the treatment of adult patients with invasive mold infections, is expected soon.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for a number of indications, and is designated as a Qualified Infectious Disease Product (QIDP). About BAL2062 BAL2062 is a first-in-class antifungal, derived from a natural product, and has demonstrated fungicidal activity against clinically important molds such as Aspergillus spp., including azole-resistant strains.3 Safety and tolerability have been demonstrated in a previously completed phase 1 study with single and multiple ascending intravenous (i.v.) doses.4 The drug candidate has Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designation from the US Food and Drug Administration (FDA) for invasive aspergillosis. About invasive mold infections Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., Scedosporium spp., and Mucorales fungi) are life-threatening infections that predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.5, 6 About invasive candidiasis Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients hospitalized in intensive care units. Candida species are ranked as the fourth main cause of bloodstream infections in hospitals in the US.7 The prognosis of invasive candidiasis remains difficult, with a reported mortality rate for invasive candidiasis as high as 40%, even when patients receive antifungal therapy.8 About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. This project has been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50124C00033. The contract and federal funding are not an endorsement of the study results, product, or company. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone +41 61 606 1102 E-mail media_relations@ This ad hoc announcement can be downloaded from References K. J. Shaw, A. S. Ibrahim. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239 FAST study (candidemia/invasive candidiasis): identifier NCT05421858; FORWARD study (invasive mold infections): identifier NCT06925321 K. J. Shaw. GR-2397: Review of the Novel Siderophore-like Antifungal Agent for the Treatment of Invasive Aspergillosis. Journal of Fungi (Basel) 2022 (8), 909 identifier NCT02956499: M. P. Mammen, D. Armas, F. H. Hughes et al. First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults. Antimicrobial Agents and Chemotherapy 2019 (63), e00969-19 J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434 M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10 Candidemia (Blood Infection) and Other Candida Infections. 2019 Factsheet by the American Thoracic Society: (Accessed: July 07, 2025) B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456 Attachment Press release (PDF)
Yahoo
05-06-2025
- Business
- Yahoo
Strong Cresemba® (isavuconazole) sales performance in Asia Pacific and China triggers further milestone payment to Basilea
Allschwil, Switzerland, June 05, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the continued strong sales performance of the antifungal Cresemba® (isavuconazole) by its license partner Pfizer Inc. in the Asia Pacific region and China exceeded the sales threshold triggering the second USD 2.5 million milestone payment this year. David Veitch, Basilea's Chief Executive Officer, stated: 'This milestone payment for the Asia Pacific region, including China, reflects the strong and growing global demand for novel antifungal therapies. Continued growth of Cresemba, particularly in China, where uptake has been especially robust, reinforces its significant clinical value for patients facing life-threatening infections. We congratulate our partner Pfizer for their ongoing commitment to making Cresemba available to patients in need.' The license agreement between Basilea and Pfizer for Cresemba covers Europe (excluding the Nordic countries) as well as China and 16 countries in the Asia Pacific region. Cresemba is marketed in more than 70 countries. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between January and December 2024 amounted to USD 562 million, a 19 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.1 About Cresemba® (isavuconazole) Cresemba, with the active ingredient isavuconazole, is an intravenous (i.v.) and oral azole antifungal. Basilea has entered into several license and distribution agreements for Cresemba covering approximately 115 countries. In China, the oral and intravenous formulations are approved for the treatment of adult patients with invasive aspergillosis and invasive mucormycosis. Isavuconazole is also approved in the European Union2, the United Kingdom3, the United States (US)4 and several additional countries including in the Asia Pacific region.5 About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial or fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhDHead of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone +41 61 606 1102 E-mail media_relations@ This press release can be downloaded from References IQVIA Analytics Link, December 2024. In-market sales reported as moving annual total (MAT) in US dollar. European Public Assessment Report (EPAR) Cresemba: [Accessed: June 04, 2025] Summary of Product Characteristics (SmPC) Cresemba: [Accessed: June 04, 2025] Full US prescribing information: [Accessed: June 04, 2025] The registration status and approved indications may vary from country to country. Attachment Press release (PDF)
Yahoo
05-06-2025
- Business
- Yahoo
Strong Cresemba® (isavuconazole) sales performance in Asia Pacific and China triggers further milestone payment to Basilea
Allschwil, Switzerland, June 05, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the continued strong sales performance of the antifungal Cresemba® (isavuconazole) by its license partner Pfizer Inc. in the Asia Pacific region and China exceeded the sales threshold triggering the second USD 2.5 million milestone payment this year. David Veitch, Basilea's Chief Executive Officer, stated: 'This milestone payment for the Asia Pacific region, including China, reflects the strong and growing global demand for novel antifungal therapies. Continued growth of Cresemba, particularly in China, where uptake has been especially robust, reinforces its significant clinical value for patients facing life-threatening infections. We congratulate our partner Pfizer for their ongoing commitment to making Cresemba available to patients in need.' The license agreement between Basilea and Pfizer for Cresemba covers Europe (excluding the Nordic countries) as well as China and 16 countries in the Asia Pacific region. Cresemba is marketed in more than 70 countries. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between January and December 2024 amounted to USD 562 million, a 19 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.1 About Cresemba® (isavuconazole) Cresemba, with the active ingredient isavuconazole, is an intravenous (i.v.) and oral azole antifungal. Basilea has entered into several license and distribution agreements for Cresemba covering approximately 115 countries. In China, the oral and intravenous formulations are approved for the treatment of adult patients with invasive aspergillosis and invasive mucormycosis. Isavuconazole is also approved in the European Union2, the United Kingdom3, the United States (US)4 and several additional countries including in the Asia Pacific region.5 About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial or fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhDHead of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone +41 61 606 1102 E-mail media_relations@ This press release can be downloaded from References IQVIA Analytics Link, December 2024. In-market sales reported as moving annual total (MAT) in US dollar. European Public Assessment Report (EPAR) Cresemba: [Accessed: June 04, 2025] Summary of Product Characteristics (SmPC) Cresemba: [Accessed: June 04, 2025] Full US prescribing information: [Accessed: June 04, 2025] The registration status and approved indications may vary from country to country. Attachment Press release (PDF)
Yahoo
20-05-2025
- Health
- Yahoo
Basilea announces commercial availability of antibiotic Zevtera® (ceftobiprole) in the United States
Allschwil, Switzerland, May 20, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that its antibiotic Zevtera® (ceftobiprole medocaril for injection) is now commercially available in the United States through Basilea's partner Innoviva Specialty Therapeutics, Inc., a wholly owned subsidiary of Innoviva, Inc. (NASDAQ: INVA). Zevtera is used in hospitals for the treatment of bacterial infections, such as those caused by Staphylococcus aureus bacteria, including methicillin-resistant strains (MRSA). It is the only advanced-generation cephalosporin approved by the United States Food and Drug Administration (FDA) for the treatment of adult patients with Staphylococcus aureus bacteremia (SAB), including those with right-sided infective endocarditis. It is also indicated in the United States to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for the treatment of adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). David Veitch, Chief Executive Officer of Basilea, stated: 'We congratulate our partner Innoviva Specialty Therapeutics on making Zevtera commercially available in the United States, which is a significant milestone for the brand. We are proud of Zevtera being the first MRSA active antibiotic approved for SAB in the US in more than a decade. There is a high medical need for treatments targeting Staphylococcus aureus infections, particularly Staphylococcus aureus bacteremia. Our team is pleased to be supporting Innoviva Specialty Therapeutics in bringing Zevtera to patients in the US who are suffering from these severe infections.' 'The availability of Zevtera in the US marks the introduction of our second novel therapy in two years, addressing drug-resistant pathogens that pose significant health risks, particularly in hospitals and out-patient settings,' said Pavel Raifeld, Chief Executive Officer of Innoviva. 'This portfolio expansion demonstrates our commitment to delivering therapies that offer physicians new options for treating some of the most challenging and potentially deadly diseases by leveraging our market-leading hospital platform.' Basilea entered into an exclusive distribution and license agreement with Innoviva Specialty Therapeutics in December 2024. Under the terms of the agreement, Basilea will receive tiered royalties on net sales in the high-teens to mid-twenties percentage range. Basilea will be eligible to receive sales milestones of up to USD 223 million. In addition, Innoviva Specialty Therapeutics will purchase its demand for Zevtera drug product from Basilea. About Zevtera® (ceftobiprole medocaril sodium for injection) Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria.1 In several countries in Europe and beyond, the brand is currently approved and marketed as Zevtera® and Mabelio® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP). In the United States, Zevtera is approved and marketed for the treatment of adult patients with Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP)2. Basilea's ceftobiprole phase 3 program was funded in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C. The contract and federal funding are not an endorsement of the study results, product, or company. Basilea has been awarded approximately USD 111 million, or approximately 75 percent of the costs related to the Staphylococcus aureus bacteremia (SAB) and acute bacterial skin and skin structure infections (ABSSSI) phase 3 studies, regulatory activities and non-clinical work. Important US safety information for Zevtera (US trade name: ZEVTERA®) INDICATIONS & USAGE Indications ZEVTERA® (ceftobiprole medocaril sodium for injection), for intravenous use, is indicated for the treatment of: Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. Adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, and Klebsiella pneumoniae. Adult and pediatric patients (3 months to less than 18 years) with community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin- susceptible isolates), Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Escherichia coli, and Klebsiella pneumoniae. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. IMPORTANT SAFETY INFORMATION Contraindications: ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class. Warnings and Precautions: Increased mortality with unapproved use in ventilator-associated bacterial pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved. Serious hypersensitivity reactions, including anaphylaxis, were observed in ZEVTERA-treated patients in clinical trials. Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with ZEVTERA is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta-lactam antibacterial drugs should be made. Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been established. Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment. Seizures and other adverse central nervous system (CNS) reactions have been reported during treatment with ZEVTERA and other cephalosporins. If CNS adverse reactions, including seizures, occur, evaluate patients to determine whether ZEVTERA should be discontinued. Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with ZEVTERA should be assessed. Adverse Reactions: SAB (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia, pyrexia, abdominal pain, fungal infection, headache, and dyspnea. ABSSSI (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increase, rash, vomiting, and dysgeusia. CABP (adult and pediatric patients 3 months to less than 18 years of age): Adult Patients: The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension, and dizziness. Pediatric Patients: The most common adverse reactions occurring in ≥ 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis, and pyrexia. For full US prescribing information, please visit: You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact: Innoviva Specialty Therapeutics, Inc.™1‑800‑651‑3861medinfo@ Food and Drug Administration1‑800‑FDA‑ About bacteremia (SAB) Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection associated with significant morbidity and mortality.3 Complications include concomitant infections such as bone, joint or heart valve infections, persistent bacteremia or bacteremia in patients on dialysis. With a 30-day all-cause mortality of around 20% there is a high medical need for improved therapies for SAB.4 About acute bacterial skin and skin structure infections (ABSSSI) Acute bacterial skin and skin structure infections (ABSSSI) are common infections in the healthcare setting. Staphylococcus aureus is the most common pathogen associated with these infections, which can be difficult to treat if methicillin-resistant Staphylococcus aureus (MRSA) is involved.5 About community-acquired bacterial pneumonia (CABP) Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity and mortality worldwide. It is the leading cause of infectious disease-related death in the US.6 About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics ('IST'), and a portfolio of strategic investments in healthcare assets. Innoviva's other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the US. About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone +41 61 606 1102 E-mail media_relations@ investor_relations@ This press release can be downloaded from References Summary of Product Characteristics (SmPC) Zevtera: [Accessed: May 19, 2025] Full US prescribing information: [Accessed: May 19, 2025] A. P. Kourtis, K. Hatfield, J. Baggs et al. Vital signs: Epidemiology and recent trends in methicillin-resistant and in methicillin-susceptible Staphylococcus aureus bloodstream infections – United States. Morbidity and Mortality Weekly Report 2019 (68), 214-219 K. Hamed, M. Engelhardt, M. E. Jones et al. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial. Future Microbiology 2020 (1), 35-48 J. Edelsberg, C. Taneja, M. Zervos et al. Trends in US hospital admissions for skin and soft tissue infections. Emerging Infectious Diseases 2009 (15), 1516-1518 J. A. Ramirez, T. L. Wiemken, P. Peyrani et al. Adults hospitalized with pneumonia in the United States: Incidence, epidemiology, and mortality. Clinical Infectious Diseases 2017 (65), 1807-1812 Attachment Press release (PDF)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
