Basilea announces distribution agreement with Cardiome to commercialize antibiotic Zevtera®/Mabelio® (ceftobiprole) in Europe and Israel
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG /
Basilea announces distribution agreement with Cardiome to commercialize
antibiotic Zevtera®/Mabelio® (ceftobiprole) in Europe and Israel
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
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.
About ceftobiprole
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.
About Basilea
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.
Disclaimer
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 |
| media_relations(at)basilea.com |
| investor_relations(at)basilea.com |
+-------------------------------------------------------+
This press release can be downloaded from www.basilea.com.
References
1 UK Summary of Product Characteristics (SPC) Zevtera(®):
http://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
Press release (PDF) :
http://hugin.info/134390/R/2133226/815637.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Basilea Pharmaceutica AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 12.09.2017 - 07:15 Uhr
Sprache: Deutsch
News-ID 559494
Anzahl Zeichen: 10033
contact information:
Town:
Basel
Kategorie:
Business News
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