September 12, 2017
Basilea announces distribution agreement with Cardiome to commercialize antibiotic Zevtera®/Mabelio® (ceftobiprole) in Europe and Israel
Basel, Switzerland, September 12, 2017 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that Basilea Pharmaceutica International Ltd. (Basilea) has entered into a distribution agreement with Cardiome Pharma Corp. (Cardiome; NASDAQ: CRME, TSX: COM) for Basilea's antibiotic Zevtera®/Mabelio® (ceftobiprole) in Europe (excluding Nordic countries) and Israel.
Under the terms of the agreement, Cardiome is granted an exclusive license to commercialize ceftobiprole in more than 30 countries in Europe and in Israel. Basilea will receive an upfront payment of CHF 5 million and is eligible for additional payments upon achievement of pre-specified regulatory and commercial milestones.
Ceftobiprole is currently approved in 13 European countries and commercialized in Italy, France, Germany, the U.K., Austria and Switzerland under the brand name Zevtera or Mabelio. Cardiome will assume responsibility for regulatory activities and commercialization in the territory. Basilea will supply Cardiome with the product at a transfer price.
Ronald Scott, Basilea's Chief Executive Officer, stated: "Zevtera addresses a major worldwide medical need for antibiotics against resistant bacterial pathogens. We are very pleased to collaborate with Cardiome in European markets and Israel. Cardiome is one of the few companies that has recently launched a novel hospital antibiotic in Europe. We will support Cardiome to further increase product sales in Europe and Israel."
He added: "We have now partnered Zevtera in about 80 countries and look forward to Zevtera being available to patients in additional territories around the world. We are also preparing phase 3 clinical trials to potentially further extend ceftobiprole's label to include the treatment of bloodstream infections caused by Staphylococcus aureus and acute bacterial skin and skin structure infections, both important indications for patients suffering from resistant bacterial infections."
Basilea remains responsible for the commercialization of ceftobiprole in the territory during the transition of the commercial activities to Cardiome, which is expected to be completed by the end of this year.
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.1 Ceftobiprole is currently approved for sale in 13 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).1 Basilea is preparing a clinical phase 3 program aiming at the regulatory approval of ceftobiprole in the United States. It consists of two cross-supportive phase 3 studies, one in the treatment of Staphylococcus aureus bacteremia (bloodstream infections) and the second one in acute bacterial skin and skin structure infections (ABSSSI). The program receives funding from the Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, under contract number HHSO100201600002C. Subject of a successful outcome of these studies, there may an option to apply for label extensions in Europe and other regions.
About hospital-acquired and community-acquired pneumonia
Hospital-acquired pneumonia (HAP) is one of the most common hospital-acquired infections and has been shown to have among the highest mortality rates of all hospital-acquired infections.2 Methicillin-resistant Staphylococcus aureus (MRSA) is one of the most frequent causes of hospital-acquired pneumonia.3 Community-acquired pneumonia (CAP) is a common condition with up to 60% of the patients requiring hospital admission and intravenous antibiotics.4 Prompt empiric intervention with an appropriate broad-spectrum antibiotic treatment is considered a best medical practice. The increasing incidence of bacteria resistant to many established antibiotics is a major concern.
Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company developing products that address the medical challenge of increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. 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.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a revenue-generating, specialty pharmaceutical company focused on providing innovative, high-quality brands that meet the needs of acute care physicians and patients. With a commercial presence and distribution network covering over 60 countries worldwide, Cardiome develops, acquires and commercializes brands for the in-hospital, acute care market segment. The Company's portfolio of approved and marketed brands includes: Xydalba(TM) (dalbavancin hydrochloride), for the treatment of acute bacterial skin and skin structure infections (ABSSSI); Zevtera®/Mabelio® (ceftobiprole medocaril sodium) a cephalosporin antibiotic for the treatment of community- and hospital-acquired pneumonia (CAP, HAP); Brinavess® (vernakalant IV) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm; Aggrastat® (tirofiban hydrochloride) for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome, and Esmocard® and Esmocard Lyo® (esmolol hydrochloride), a short-acting beta-blocker used to control rapid heart rate in a number of cardiovascular indications. Cardiome's pipeline of product candidates includes Trevyent®, a drug device combination that is designed to deliver Remodulin® (treprostinil) the world's leading treatment for pulmonary arterial hypertension.
Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit Cardiome's web site at www.cardiome.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:
| 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 UK Summary of Product Characteristics (SPC) Zevtera®: www.mhra.gov.uk
[Accessed: September 11, 2017]
2 C. Rotstein et al. Clinical practice guidelines for hospital-acquired pneumonia and ventilator-associated pneumonia in adults. Canadian Journal of Infectious Diseases & Medical Microbiology 2008 (19), 19-53
3 R. N. Jones. Microbial etiologies of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Clinical Infectious Diseases 2010 (51), S81-S87
4 W. I. Sligl et al. Severe community-acquired pneumonia. Critical Care Clinics 2013 (29), 563-601