VANCOUVER, Sept. 12, 2017 /PRNewswire/ - Cardiome Pharma
Corp. (NASDAQ: CRME / TSX: COM) today announced that it has entered
into a distribution and license agreement with Basilea for its
antibiotic Zevtera®/Mabelio®. Under the terms
of the agreement, Basilea has granted Cardiome an exclusive license
to commercialize ceftobiprole in 34 European countries and
Israel. Cardiome will provide
Basilea with an upfront payment and additional milestone payments
based upon achievement of certain commercial and regulatory
milestones. As a result of the agreement, Cardiome will be
responsible for the registration, promotion and commercialization
of Zevtera®/Mabelio® in the covered
countries. The drug is currently marketed in Germany, Italy, the United
Kingdom, France,
Austria and Switzerland. Cardiome plans to commercialize
Zevtera®/Mabelio® in every European country
where it currently has a direct sales force, with the potential for
further distribution and expansion.
Zevtera®/Mabelio® has shown sales growth
since its launch.
"The addition of Zevtera®/Mabelio® to our
product portfolio is an important step in our Company's strategic
growth as it fits well alongside our previous license of
Xydalba™ (dalbavancin hydrochloride), which was launched
earlier this year. Ceftobiprole allows us to expand our offering of
differentiated hospital products to our European customers while
increasing the operating leverage within our commercial
infrastructure" said Hugues Sachot, Cardiome's Chief Commercial
Officer. "We expect to begin to recognize revenues from
Zevtera®/Mabelio® immediately and our sales
force will be ready to accelerate commercialization of this
important antibiotic after the successful transition of
Zevtera®/Mabelio® from Basilea to Cardiome in
the months to come."
"Zevtera addresses a significant medical need for patients who
are suffering from hospital- and community-acquired pneumonia.
Cardiome has a strong presence in the specialty care market in key
European countries and we look forward to supporting Cardiome in
bringing Zevtera to even more patients across Europe," said David
Veitch, Basilea's Chief Commercial Officer.
About ceftobiprole
Ceftobiprole (ceftobiprole
medocaril sodium) 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 Ceftobiprole is currently
commercialized in Italy,
France, Germany, the U.K., Austria and Switzerland under the brand name
Zevtera® or Mabelio®. 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.
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™ (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
our web site at www.cardiome.com.
References
- UK Summary of Product Characteristics (SPC) Zevtera®:
http://www.mhra.gov.uk/ [Accessed: September 12, 2017]
- 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
- R. N. Jones. Microbial
etiologies of hospital-acquired bacterial pneumonia and
ventilator-associated bacterial pneumonia. Clinical Infectious
Diseases 2010 (51), S81-S87
- W. I. Sligl et al. Severe
community-acquired pneumonia. Critical Care Clinics 2013 (29),
563-601
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March 29, 2017 (see for example,
"Risk Factors" in the Annual Information Form for the year ended
December 31, 2016), in the Form 6-K
filed August 10, 2017, and in our
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SOURCE Cardiome Pharma Corp.