Basilea to launch Zevtera(r)/Mabelio(r) (ceftobiprole medocaril) in Europe through a commercial services provider
BASEL, Switzerland, July 21, 2014 (GLOBE NEWSWIRE) -- Basilea
Pharmaceutica Ltd. (SIX: BSLN) reports that it has entered into an
agreement with Quintiles (NYSE: Q) for the commercialization of
Zevtera(R)/Mabelio(R) (ceftobiprole medocaril) in Europe.
Under the agreement, Quintiles will provide commercial services
including a dedicated field force, medical science liaisons, and market
access support in selected countries.
"At a time when antibiotic resistance is a major healthcare threat
throughout Europe, we are very pleased to be launching Zevtera/Mabelio,
a new broad-spectrum antibiotic also covering MRSA and providing
physicians with a new option to treat severe bacterial infections,"
said Ronald Scott, Basilea's Chief Executive Officer. "Basilea has the
potential opportunity to launch two hospital products in Europe;
ceftobiprole followed by isavuconazole in the event of regulatory
approval. This could afford the company significant commercialization
synergies. We have initially opted to commercialize our products in
Europe through Quintiles in order to retain flexibility and to more
fully participate in the economic upside of our products. The agreement
with Quintiles allows us to scale and optimize our resources during the
launch of Zevtera/Mabelio on a country-by-country basis."
He added: "We have made significant progress on national pricing and
reimbursement and anticipate launching Zevtera in Germany in the second
half of 2014, followed by launches in other key European markets in
2015. In parallel, we continue to assess opportunities for distribution
and licensing partnerships in other parts of the world."
Basilea's financial guidance for 2014 remains unchanged, with total
operating expenses estimated at CHF 8 to 9 million per month and
operating loss estimated at CHF 4 to 5 million per month.
About Ceftobiprole
Ceftobiprole (ceftobiprole medocaril, trademarks Zevtera(R),
Mabelio(R)) is a broad-spectrum intravenous cephalosporin antibiotic
for the potential empiric treatment of severe bacterial infections
where Gram-positive bacteria, such as methicillin-resistant
Staphylococcus aureus (MRSA) and Gram-negative pathogens, such as
Pseudomonas are suspected. It has gained regulatory authorization from
twelve European states1 for the treatment of hospital-acquired
pneumonia (HAP, excluding ventilator-associated pneumonia, VAP) and
community-acquired pneumonia (CAP) in patients 18 years of age and
older, and is currently under regulatory review in Switzerland.
Ceftobiprole demonstrated broad-spectrum in-vitro bactericidal activity
against Gram-positive bacteria including methicillin-resistant and
vancomycin-resistant Staphylococcus aureus (MRSA, VRSA) and penicillin-
and ceftriaxone-resistant Streptococcus pneumoniae (PRSP, CRSP) as well
as Gram-negative pathogens including strains of Enterobacteriaceae and
Pseudomonas.2, 3
About hospital-acquired and community-acquired pneumonia
Hospital-acquired pneumonia is one of the most common infections in the
hospital, accounting for approximately 25% of all intensive care unit
(ICU) infections, and is associated with significant mortality.4, 5
Community-acquired pneumonia is a common condition with up to 60% of
the patients requiring hospital admission and intravenous antibiotics.6
Prompt empiric intervention with an appropriate broad-spectrum
antibiotic treatment is accepted as best medical practice. The
increasing incidence of bacteria resistant to many established
antibiotics is a major concern.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and
listed on the SIX Swiss Exchange (SIX: BSLN). Through the fully
integrated research and development operations of its Swiss subsidiary
Basilea Pharmaceutica International Ltd., the company focuses on
innovative pharmaceutical products in the therapeutic areas of
bacterial infections, fungal infections and oncology, targeting the
medical challenge of rising resistance and non-response to current
treatment options.
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:
Media Relations Investor Relations
Peer Nils Schroder, PhD Barbara Zink, PhD, MBA
Head Public Relations & Head Corporate Development
Corporate Communications
+41 61 606 1102 +41 61 606 1233
[email protected] [email protected]
This press release can be downloaded from www.basilea.com.
References
1 Ceftobiprole has received national licenses in Austria, Belgium,
Denmark, Finland, France, Germany, Norway, Spain, Sweden and the United
Kingdom; national authorization in Luxembourg and Italy is ongoing.
2 A. Walkty et al. In vitro activity of ceftobiprole against frequently
encountered aerobic and facultative Gram-positive and Gram-negative
bacterial pathogens: results of the CANWARD 2007-2009 study. Diagnostic
Microbiology and Infectious Disease 2011 (69), 348-355
3 D. J. Farrell et al. Ceftobiprole activity against over 60,000
clinical bacterial pathogens isolated in Europe, Turkey and Israel from
2005 to 2010. Antimicrobial Agents and Chemotherapy 2014 (58),
3882-3888
4 A. Torres et al. Treatment guidelines and outcomes of
hospital-acquired and ventilator-associated pneumonia. Clinical
Infectious Diseases 2010 (51), S48-S53
5 F. Barbier et al. Hospital-acquired pneumonia and
ventilator-associated pneumonia: recent advances in epidemiology and
management. Current Opinion in Pulmonary Medicine 2013 (19), 216-228
6 W. I. Sligl et al. Severe community-acquired pneumonia. Critical Care
Clinics 2013 (29), 563-601
Press release (PDF) http://hugin.info/134390/R/1831672/635582.pdf