April 24, 2015
Basilea reports isavuconazole and ceftobiprole data to be presented at ECCMID
Basel, Switzerland, April 24, 2015 - Basilea Pharmaceutica Ltd. (SIX: BSLN) reported today that a broad range of scientific data will be presented on the antifungal isavuconazole and the antibiotic ceftobiprole at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) held in Copenhagen, Denmark, from 25 - 28 April 2015.
The presentations at ECCMID will include more detailed analyses of the isavuconazole data from two phase 3 clinical trials in adult patients with invasive fungal infections: SECURE, a randomized, double-blind, active-control study of adult patients with invasive aspergillosis, and VITAL, an open-label non-comparative study of isavuconazole in adult patients with invasive aspergillosis and renal impairment or in patients with invasive fungal disease caused by other fungi, including those causing mucormycosis.
Additionally, posters and oral presentations will feature ceftobiprole, such as data on the activity spectrum of ceftobiprole against current clinical pathogens causing respiratory tract infections and its activity in community- and hospital-acquired pneumonia (CAP and HAP), including early- and late-onset HAP. In addition, pharmacokinetics, safety and tolerability of high-dose ceftobiprole in the intensive care setting are being presented.
HAP is one of the most common infectious diseases acquired in hospitals, affecting 0.5-1.7% of hospitalized patients.1 It is caused by a wide spectrum of Gram-positive bacteria such as Staphylococcus aureus, particularly methicillin-resistant strains (MRSA), and Gram-negative bacteria. In MRSA pneumonia treatment failure rates are high and have been attributed to inadequate antibiotic therapy.2
| Isavuconazole posters at ECCMID 2015 |
| Ceftobiprole posters and presentations at ECCMID 2015 |
| BAL30072 posters at ECCMID 2015 |
For further information please visit www.eccmid.org.
Isavuconazole is an azole antifungal and the active agent of the prodrug isavuconazonium sulfate (U.S. trade name CRESEMBA®). Isavuconazole is being co-developed with Astellas Pharma Inc.
Isavuconazole was approved in March 2015 by the U.S. Food and Drug Administration (FDA) for patients 18 years of age and older for the treatment of invasive aspergillosis and invasive mucormycosis. These are life-threatening fungal infections predominantly occurring in immunocompromised patients. Basilea's partner Astellas will market the drug as CRESEMBA®.
A European Marketing Authorization Application for these indications, submitted by Basilea, is currently under review by the European Medicines Agency. Outside the U.S., isavuconazole is an investigational product and currently not approved for commercial use.
The following Important Safety Information for CRESEMBA® (isavuconazonium sulfate) is applicable only to the product approved in the United States:
CRESEMBA® is contraindicated in persons with known hypersensitivity to isavuconazole.
Coadministration of strong CYP3A4 inhibitors, such as ketoconazole or high-dose ritonavir (400 mg every 12 hours), with CRESEMBA® is contraindicated because strong CYP3A4 inhibitors can significantly increase the plasma concentration of isavuconazole.
Coadministration of strong CYP3A4 inducers, such as rifampin, carbamazepine, St. John's wort, or long acting barbiturates with CRESEMBA® is contraindicated because strong CYP3A4 inducers can significantly decrease the plasma concentration of isavuconazole.
CRESEMBA® shortened the QTc interval in a concentration-related manner. CRESEMBA® is contraindicated in patients with familial short QT syndrome.
Hepatic Adverse Drug Reactions (e.g., elevations in ALT, AST, alkaline phosphatase, total bilirubin) have been reported in clinical trials and were generally reversible and did not require discontinuation of CRESEMBA®. Cases of severe hepatic adverse drug reactions including hepatitis, cholestasis or hepatic failure including death have been reported in patients with serious underlying medical conditions (e.g., hematologic malignancy) during treatment with azole antifungal agents, including CRESEMBA®. Evaluate liver tests at the start and during therapy. Monitor patients who develop liver abnormalities during CRESEMBA therapy for severe hepatic injury. Discontinue if clinical signs and symptoms consistent with liver disease develop that may be attributable to CRESEMBA®.
Infusion-related reactions including hypotension, dyspnea, chills, dizziness, paresthesia, and hypoesthesia were reported during intravenous administration of CRESEMBA®. Discontinue the infusion of CRESEMBA® if these reactions occur.
Serious hypersensitivity and severe skin reactions, such as anaphylaxis or Stevens Johnson syndrome, have been reported during treatment with other azole antifungal agents. Discontinue CRESEMBA® if a patient develops a severe cutaneous adverse reaction. Caution should be used when prescribing CRESEMBA® to patients with hypersensitivity to other azoles.
During pregnancy, CRESEMBA® may cause fetal harm when administered, and should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the fetus. Women who become pregnant while receiving CRESEMBA® are encouraged to contact their physician.
Following dilution, CRESEMBA® intravenous formulation may form precipitate from the insoluble isavuconazole. Administer CRESEMBA® through an in-line filter.
The most frequent adverse events among CRESEMBA®-treated patients were: nausea (26%), vomiting (25%), diarrhea (22%), headache (17%), elevated liver chemistry tests (16%), hypokalemia (14%), constipation (13%), dyspnea (12%), cough (12%), peripheral edema (11%), and back pain (10%).
The adverse reactions which most often led to permanent discontinuation of CRESEMBA® therapy during the clinical trials were: confusional state (0.7%), acute renal failure (0.7%), increased blood bilirubin (0.5%), convulsion (0.5%), dyspnea (0.5%), epilepsy (0.5%), respiratory failure (0.5%), and vomiting (0.5%).
For full U.S. Prescribing Information, please visit here.
Ceftobiprole (ceftobiprole medocaril) is a broad-spectrum intravenous cephalosporin antibiotic with rapid bactericidal activity against Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and susceptible Pseudomonas spp.3
Ceftobiprole is currently approved in thirteen European countries for the treatment of community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP) (excluding ventilator-associated pneumonia (VAP)) in adults under the trade name of Zevtera® or Mabelio®.4
Safety information for ceftobiprole:
As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported. In case of severe hypersensitivity reactions, treatment with ceftobiprole must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to ceftobiprole, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if ceftobiprole is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.
The most common adverse reactions occurring in >= 3% of patients treated with were nausea, vomiting, diarrhoea, infusion site reactions, hypersensitivity (including urticaria, pruritic rash and drug hypersensitivity) and dysgeusia.
The use of ceftobiprole may result in overgrowth of non-susceptible organisms, including fungi. Appropriate measures should be taken if evidence of super-infection occurs during therapy.
Seizures have been associated with the use of ceftobiprole. Seizures occurred most commonly in patients with pre-existing central nervous system (CNS)/seizure disorders during treatment with ceftobiprole. Therefore caution is advised when treating these patients.
Clostridium difficile-associated diarrhoea has been reported with use of ceftobiprole and may range in severity from mild to life-threatening. This diagnosis should be considered in patients with diarrhoea during or subsequent to the administration of ceftobiprole. Discontinuation of therapy with ceftobiprole and the administration of specific treatment for C. difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Ceftobiprole has not been shown to be effective in the treatment of patients with VAP. Ceftobiprole should not be initiated in patients with VAP. It is recommended that in patients with HAP who subsequently require ventilation, ceftobiprole should be used with caution.
See full prescribing information for ceftobiprole (UK Summary of Product Characteristics) here.
BAL30072 is an investigational phase 1 intravenous monosulfactam antibiotic with activity against many clinically relevant multidrug-resistant Gram-negative bacteria.
Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products that address increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company uses the integrated research, development and commercial operations of its subsidiary Basilea Pharmaceutica International Ltd. to develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com.
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. 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. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. 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:
|Media Relations||Investor Relations|
| Peer Nils Schröder, PhD |
Head Public Relations &
+41 61 606 1102
| Barbara Zink, PhD, MBA |
Head Corporate Development
+41 61 606 1233
This press release can be downloaded from www.basilea.com.
1 R. Masterton et al. Hospital-acquired pneumonia guidelines in Europe: a review of their status and future development. Journal of Antimicrobial Chemotherapy 2007 (60), 206-213
2 C. Woods, G. Colice. Methicillin-resistant Staphylococcus aureus pneumonia in adults. Expert Review of Respiratory Medicine 2014 (8), 641-651
3 Y. Y. Syed. Ceftobiprole medocaril: A review of its use in patients with hospital- or community-acquired pneumonia. Drugs 2014 (74), 1523-1542
4 Ceftobiprole (European trade name Zevtera® or Mabelio®, depending on the country) has received national licenses for the treatment of CAP and HAP (excluding VAP) in adults in Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Norway, Spain, Sweden, Switzerland and the United Kingdom. Reimbursement and pricing authorization in several countries including Spain is ongoing.