Latest news with #Zevtera
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
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 while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
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
Yahoo
18-02-2025
- Business
- Yahoo
Basilea reports strong 2024 full-year results with significant increase in revenue, profit and operating cash flow
Total revenue increased by 32% to CHF 209m Operating profit tripled to CHF 61m Operating cash flow significantly increased to CHF 74m Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, February 18, 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 its results for the financial year ended December 31, 2024. David Veitch, Chief Executive Officer, stated: '2024 was a very successful year. We have achieved major milestones, including the approval of Zevtera in the United States and the subsequent partnering with Innoviva Specialty Therapeutics, IST, for the commercialization of Zevtera in the US. While Cresemba remains our most successful commercial brand, we expect increasing growth contributions from Zevtera, as the US represents 80-90% of its global commercial opportunity. Zevtera is also making progress in existing markets, as demonstrated by the achievement of the sales milestone in Europe in 2024, and by its inclusion in the National Reimbursement Drug List in China at the end of 2024. Cresemba gained approval in Europe for the use in children, which not only makes the antifungal available for this vulnerable population, but this also extended market exclusivity until October 2027.' He continued: 'In 2025, we will focus on further advancing our portfolio, first by starting the second phase 3 study with our potential next lead product, fosmanogepix, in mold infections. In addition, we are continuing the preclinical work with the antifungal BAL2062 and the LptA inhibitor antibiotic, BAL2420, in preparation for the subsequent clinical studies, planned to start in 2026. For the early-stage asset tonabacase, we have completed our pre-clinical profiling and taken the decision not to pursue further development. This decision demonstrates that we are focused on stringent risk-return criteria when making portfolio decisions. Another major achievement was the execution of a new BARDA-OTA contract, providing us with reimbursement of up to USD 268 million, which is 60% of the expected development costs for our clinical programs included in the OTA.' Adesh Kaul, Chief Financial Officer, said: '2024 has been an outstanding year for Basilea, marking now our third year in a row of reporting a net profit and positive operating cash flows. Total revenue grew by 32%, to CHF 209 million, driven by the strong in-market sales of Cresemba, which generated royalties of CHF 97 million, which is an increase of more than 20% year-on-year. We also reported milestone payments of almost CHF 40 million, exceeding the already high levels in 2023 and including first sales milestones from Japan and the Middle East North Africa region for Cresemba. We achieved a strong operating profit of CHF 61 million, tripling the 2023 operating profit, and reported a net profit of CHF 78 million. We continue to generate significant positive cash flow and ended the year with CHF 125 million of cash, cash equivalents and restricted cash and a net cash position of almost CHF 29 million. In summary, we are in an excellent financial position to keep on progressing our R&D projects, seizing in-licensing and acquisition opportunities to broaden our pipeline, while strengthening our balance sheet in these times of increased volatility and macroeconomic uncertainty.' Financial summary For the full year (FY) 2024, Basilea recognized total revenue of CHF 208.5m (FY 2023: CHF 157.6m). This included royalty income of CHF 96.7m (FY 2023: CHF 78.9m) from Cresemba, which increased by 22.6% year-on-year, and product revenue of CHF 57.8m (FY 2023: CHF 37.9m), which increased by 52.5% year-on-year. Milestone and upfront payments increased to CHF 40.4m (FY 2023: CHF 33.5m). Other revenue amounted to CHF 13.7m (FY 2023: CHF 7.4m). This included CHF 10.2m BARDA reimbursements (FY 2023: CHF 4.2m) for remaining activities related to the phase 3 program for ceftobiprole and under the Other Transaction Agreement (OTA) executed in September 2024.1 In 2024, Basilea invested CHF 77.1m (FY 2023: CHF 77.9m) in research and development, mainly for the phase 3 program with fosmanogepix, the preclinical profiling of BAL2062 and tonabacase, the acquisition and preclinical activities for the LptA inhibitor program, the remainder of the phase 3 ceftobiprole program and for research work on compounds in the Company's early-stage portfolio. Selling, general and administrative expenses, including costs for the commercialization of Cresemba and Zevtera, amounted to CHF 31.5m (FY 2023: CHF 33.8m) and cost of products sold increased to CHF 38.7m (FY 2023: CHF 26.8m), reflecting the significant increase in product revenue. Basilea recorded an operating profit of CHF 61.2m (FY 2023: CHF 19.2m). As a consequence of its sustained profitability and its positive mid-term financial outlook, the Company recognized deferred tax assets of CHF 17.3m, which led to a net profit of CHF 77.6m (FY 2023: CHF 10.5m), resulting in basic and diluted earnings per share of CHF 6.42 and CHF 5.83, respectively (FY 2023: basic and diluted earnings per share CHF 0.87 and CHF 0.86, respectively). In 2024, a positive net cash flow of CHF 74.4m was provided by operating activities (FY 2023: CHF 14.2m). The Company repaid the remaining CHF 15.6m of a CHF 75.0m senior secured loan by end of March 2024. Basilea shows a net cash position of CHF 28.6m as of December 31, 2024 (December 31, 2023: net financial debt of CHF 46.6m). Cash and cash equivalents and restricted cash amounted to CHF 124.6m as of December 31, 2024 (December 31, 2023: CHF 64.3m). Key financial figures (in CHFm, except per share data) FY 2024 FY 2023 Product revenue 57.8 37.9 Contract revenue 137.0 112.4 Other revenue 13.7 7.4 Total revenue 208.5 157.6 Cost of products sold (38.7) (26.8) Research & development expenses, net (77.1) (77.9) Selling, general & administrative expenses (31.5) (33.8) Total cost and operating expenses (147.4) (138.4) Operating profit 61.2 19.2 Profit before taxes 60.3 10.5 Income taxes 17.3 0.0 Net profit 77.6 10.5 Net cash provided by operating activities 74.4 14.2 Basic earnings per share, in CHF 6.42 0.87 Diluted earnings per share, in CHF 5.83 0.86 (in CHFm) Dec 31, 2024 Dec 31, 2023 Cash and cash equivalents and restricted cash 124.6 64.3 Note: Consolidated figures in conformity with US GAAP; rounding was applied consistently. The consolidated financial statements of Basilea Pharmaceutica Ltd, Allschwil for the financial year 2024 can be found on the company's website at 2025 Financial guidance – significantly growing royalty income and maintaining high operating profit, while increasing R&D investments to advance pipeline Basilea provides the following guidance for the FY 2025: Total revenue is expected to increase by 5.5% to CHF 220 million driven by an increase in BARDA and CARB-X reimbursements. The expected 14% increase in royalty income to CHF 110 million reflects primarily the continued strong double-digit sales growth of Cresemba in its key markets, and fully offsets the impact of the previously announced decrease in product supply to Pfizer. Following a year of exceptionally high milestone payments in 2024, milestone and upfront payments in 2025 are expected to be in the average range of the last few years of around CHF 35 million. The increase in cost and operating expenses reflects our continued investment in progressing our exciting R&D portfolio of first-in-class antifungals and antibacterials and is largely offset by the increase in BARDA and CARB-X reimbursements. As a result, we expect to maintain the high operating profit level of 2024. We expect no material cash outflow related to income taxes thanks to the use of tax loss carry forwards, but a 12% income tax rate will be reflected in the 2025 net profit, in contrast to a CHF 17.3 million one-time gain from the recognition of deferred tax assets in 2024. (in CHFm) FY 2025e FY 2024 Cresemba and Zevtera-related revenue ~190 194.8 of which royalty income ~110 96.7 Total revenue ~220 208.5 Research & development expenses, net ~88 77.1 Operating profit ~62 61.2 Nominations to the board of directors The board of directors has nominated Leonard Kruimer, Dr. Martin Nicklasson, Dr. Nicole Onetto., Dr. Carole Sable and Dr. Thomas Werner for re-election as board members. After serving on the board of directors for 14 years, Domenico Scala has decided not to stand for re-election. The board has nominated Stephan Schindler for election as a new board member and chairman. Domenico Scala, chairman, said: 'After having served on the board of directors since 2011, and the last nine years as chairman, I decided to not seek re-election at the annual general meeting. In the recent years, Basilea has made significant progress transforming into a focused organization and a leading anti-infectives company. It has an innovative pipeline, robust financials and a highly committed leadership team. The company being in such a strong position, I feel it is the right time to step down as board member and chairman.' The board of directors is proposing the nomination of Stephan Schindler as chairman of the board of directors. He is a highly accomplished executive in the life science industry with over 30 years of experience across finance, operations, corporate governance, and board leadership. From 2009 to 2021 he was Chief Financial Officer of Bachem Holding AG. Prior to this, he was head of Finance of DSM Nutritional Products and previously held various senior finance roles at Roche. He is currently serving on the board of the University Children's Hospital Basel, as chairman of the board of Evolva Holding AG and as board member of Arcondis Holding AG. Mr. Schindler was born and educated in Switzerland and holds Swiss citizenship. Conference call and webcast Basilea Pharmaceutica Ltd, Allschwil will host a conference call and webcast today, Tuesday, February 18, 2025, at 4 p.m. (CET), to discuss the company's financial and operating results and to provide an outlook. Via audio webcast with presentation The live audio webcast of the results presentation can be followed here: Please note that there is no function to ask questions via webcast. For questions, please additionally dial-in via phone (see below). Via phone To listen by phone and ask questions, please use the dial-in details below. To ensure prompt access, please call approximately 10-15 minutes prior to the scheduled start of the call. +41 (0) 58 310 5000 (Switzerland, Europe and RoW) +1 (1) 866 291 4166 (USA) +44 (0) 207 107 0613 (UK) Replay The webcast, along with the presentation will be available online (same link as live audio webcast above) shortly after the event and accessible for three months. 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, PhDHead 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 Biomedical Advanced Research and Development Authority (BARDA) OTA number 75A50124C00033. BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the United States' Department of Health and Human Services Attachment Press release (PDF)
Yahoo
28-01-2025
- Business
- Yahoo
Strong sales growth for Cresemba and Zevtera trigger further milestone payments to Basilea
Allschwil, Switzerland, January 28, 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, reported today that the sales in 2024 of the antifungal Cresemba® (isavuconazole) and the antibiotic Zevtera® (ceftobiprole) exceeded thresholds triggering sales milestone payments from distribution partners to Basilea, in the total amount of approximately CHF 2.2 million. For Cresemba, this comprises a milestone payment for sales in Canada, by AVIR Pharma Inc, as well as the first sales milestone payment for the Middle East and North Africa (MENA) region, by Hikma Pharmaceuticals LLC. For Zevtera, this reflects a milestone payment in Europe, by Advanz Pharma. David Veitch, Chief Executive Officer, said: 'We are very pleased with the commercial progress of our two commercialized brands in Canada, the MENA region and Europe. Their continued growth confirms that Cresemba and Zevtera are serving significant medical needs around the world.' Basilea's commercial partnerships cover well over 100 countries worldwide. By year-end 2024, Cresemba was marketed in more than 70 countries while Zevtera was marketed in 20 countries. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between October 2023 and September 2024 amounted to USD 533 million, a 20 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.1 About Cresemba® (isavuconazole) Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba®. In Canada, Cresemba is approved for use in adults and pediatrics from 1 year up to 18 years for the treatment of invasive aspergillosis and invasive mucormycosis.2 In countries of the MENA region, it is indicated in adults for the treatment of invasive aspergillosis and for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate. Isavuconazole is also approved in the United States (US),3 the EU4 and several additional countries in Europe and beyond, including Japan and China.5 About Zevtera® (ceftobiprole medocaril sodium) 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.6 In several countries in Europe, the brand is approved 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).6 Zevtera is also approved in the United States7, 8, China and several other countries.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 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@ This press release can be downloaded from References IQVIA Analytics Link, September 2024. In-market sales reported as moving annual total (MAT) in US dollar. Health Canada, Cresemba® (isavuconazole) Product Monograph: [Accessed: January 27, 2025] Full US prescribing information: [Accessed: January 27, 2025] European Public Assessment Report (EPAR): [Accessed: January 27, 2025] The registration status and approved indications may vary from country to country. Summary of Product Characteristics (SmPC) Zevtera: [Accessed: January 27, 2025] Full US prescribing information: Basilea's ceftobiprole phase 3 program is 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. 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. Attachment Press release (PDF)
