April 12, 2019
Basilea reports isavuconazole (Cresemba®) and ceftobiprole (Zevtera®) presentations at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)
Basel, Switzerland, April 12, 2019 – Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that a broad range of posters and presentations on the antifungal isavuconazole (Cresemba®) and the antibiotic ceftobiprole (Zevtera®) will be presented at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), held in Amsterdam, the Netherlands, from April 13 to 16, 2019.
One of the oral presentations with isavuconazole will report data from a phase 1 study in pediatric patients. The study is part of the pediatric investigation plan that was agreed with the U.S. and European regulatory authorities, FDA and EMA. Upon completion of this plan, isavuconazole may receive an additional two years of market exclusivity in the European Union and six months in the U.S. Another oral presentation will report on an open-label trial of isavuconazole prophylaxis against invasive fungal infection in adult patients undergoing allogeneic haematopoietic stem cell transplantation.
The details of the presentations are as follows:
| Isavuconazole at ECCMID 2019|
Saturday, 13 April 2019 – 10:00-12:00 CEST, Hall H
Oral Session OS017– Issues in antifungal treatment
Paper Poster Session PS007 – Clinical pharmacokinetics, treatment strategies and prescribing of antifungals
Mini-oral ePoster Session OE151 – Antifungals: novel drugs, novel dosing?
Paper Poster Session PS099 – MIC testing various species
Paper Poster Session PS114 – Current issues in clinical pharmacokinetics
Paper Poster Session PS126 – Conventional approaches in fungal diagnostics
| Ceftobiprole at ECCMID 2019|
Monday,15 April 2019, 13:30-14:30 CEST, Paper Poster Arena
Paper Poster Session PS107– In vitro activity of newer antibacterial agents
Paper Poster Session PS161 – Resistance mechanisms in Gram-positive cocci
For further information please visit www.eccmid.org.
About isavuconazole (Cresemba®)
Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba. In the 28 European Union member states, as well as in Iceland, Liechtenstein and Norway, isavuconazole is approved for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.1 Cresemba is also approved in the United States and several additional countries in and outside of Europe. It has U.S. and European orphan drug designation for its approved indications. Basilea has entered into several license and distribution agreements for isavuconazole covering the United States, Europe, China, Japan, Latin America, Asia-Pacific, the Middle East and North Africa (MENA) region, Canada, Russia, Turkey and Israel.2
About ceftobiprole (Zevtera®)
Ceftobiprole is a cephalosporin antibiotic for intravenous administration with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp.3 Ceftobiprole is approved in major European countries and several non-European countries for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).3 It is commercialized under the trade names Zevtera and Mabelio. Basilea has entered into license and distribution agreements for the brand in Europe, Latin America, China, Canada, Israel, and the Middle East and North Africa (MENA) region. Ceftobiprole is currently in a phase 3 clinical program for registration in the U.S.
Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company, focused on the development of products that address the medical challenges in the therapeutic areas of oncology and anti-infectives. With two commercialized drugs, the company is committed to discovering, developing and commercializing 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, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd. 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. 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:
| Peer Nils Schröder, PhD|
Head of Corporate Communications & Investor Relations
+41 61 606 1102
This press release can be downloaded from www.basilea.com.
1 European Public Assessment Report (EPAR) Cresemba: www.ema.europa.eu
[Accessed: April 11, 2019]
2 The registration status and approved indications may vary from country to country.
3 U.K. Summary of Product Characteristics (SPC) Zevtera: www.mhra.gov.uk
[Accessed: April 11, 2019]
- Press release (PDF)