BURTON-ON-TRENT, England,
September 18, 2014 /PRNewswire/
--
Clinigen Group plc (AIM: CLIN) today announced that the
new first-in-class bactericidal, once-daily, injectable
lipoglycopeptide antibiotic VIBATIV® (telavancin), is now available
to prescribe in Europe for the
treatment of adults with nosocomial pneumonia (also known as
hospital acquired pneumonia - HAP), including ventilator associated
pneumonia (VAP), known or suspected to be caused by
methicillin-resistant Staphylococcus aureus (MRSA) when
other alternatives are not suitable.
VIBATIV® is an innovative treatment for HAP in that it offers a
dual mechanism of action to enable it to kill even drug resistant
strains of Staphylococcus aureus.[1] The
first mechanism is similar to that of vancomycin; VIBATIV® binds to
and prevents polymerisation of bacterial cell wall constituents,
weakening the cell and causing cell death. VIBATIV® also has
a second mode of action where it interacts with the cell membrane,
causing depolarisation; again leading to cell death. The drug's
dual mechanism of action means that even a strain resistant to one
of these mechanisms may be affected by the other mechanism,
suggesting that VIBATIV® may be less prone to resistance than other
antibiotics. Rapidly bactericidal, VIBATIV® is a once daily
IV administered antibiotic and does not require therapeutic drug
level monitoring, unlike vancomycin.
30-70% of patients who acquire HAP currently die despite early
and appropriate treatment, and the condition places a large burden
on healthcare systems.[2] A recent WHO surveillance
report found that in some of the 36 European countries studied,
prevalence of MRSA has been estimated at up to 60% of all studied
S.aureus strains.[3] The report notes that
patients with infections caused by bacteria resistant to a specific
antibacterial drug generally have an increased risk of worse
clinical outcomes and death than those patients infected with the
same bacteria not demonstrating a resistance pattern.3MRSA
infections are recognised as a public health priority in the EU,and
the extra in-hospital costs caused by MRSA across the EU are
estimated to reach EUR 380 million
every year.[4] As a result of these high costs, both
economic and human, there is increasing demand for new tools to
combat infections caused by drug-resistant bacterial strains and
the availability of new antibacterial agents is recognised as
playing an important role in treating MRSA.
VIBATIV® is now available across Europe following the drug's Marketing
Authorisation being reinstated by the European Commission earlier
this year. The VIBATIV® approval was confirmed on the basis of data
from clinical trials and compliance with GMP
requirements.[5]The Marketing Authorisation for VIBATIV®
was suspended in 2012 as the previous single-source drug
manufacturer did not meet the current Good Manufacturing Practice
("cGMP") requirements. It is important to note that no safety or
efficacy concerns were raised over the product itself.
VIBATIV® successfully achieved the primary endpoint of clinical
response versus vancomycin in Phase III non-inferiority studies of
over 1,500 patients with hospital acquired pneumonia.
VIBATIV®achieved higher clinical cure rates versus vancomycin in
patients with pneumonia due to a monomicrobial Staphylococcus
aureus infection.[6] Higher cure rates were also
observed for VIBATIV® in patients with strains of Staphylococcus
aureus that displayed decreased susceptibility to vancomycin
([MIC ≥1μg/ml] [87% vs 74% p = 0.03
]),[6] suggesting that VIBATIV®
may have the potential to treat infections caused by bacteria less
or non-susceptible to antibiotics other than just methicillin. The
efficacy data supporting VIBATIV® was confirmed in a post-hoc
analysis of the Phase III studies (excluding patients with severe
renal insufficiency at baseline) and showed that higher survival
rates were observed in patients treated with VIBATIV® compared to
vancomycin.[7] In July
2014, NICE issued an Evidence Summary reviewing the role of
VIBATIV® in treating HAP and VAP, summarising these
data.[8] NICE Evidence Summaries are quality-assured
summaries of the best available evidence for new medicines, or
existing medicines with new indications or a new formulation,
considered to be of significance to the NHS.
The overall incidence of adverse events was similar for both
vancomycin and VIBATIV®; the most common treatment-emergent adverse
events in both treatment groups were taste disturbance, nausea,
vomiting, diarrhoea, constipation, fungal infections,
sleeplessness, headache, dizziness, raised blood levels of liver
enzymes, itching, rash, tiredness, chills and kidney
problems.[5,6] In
combination, the safety and efficacy data from the Phase III
studies have shown that VIBATIV® has comparable tolerability with
an overall non-inferiority to vancomycin in terms of clinical
response, allied to higher cure rates in certain important groups
of patients.
"HAP caused by MRSA is often more serious and difficult to treat
than similar infections with more drug susceptible strains," said
Professor Matteo
Bassetti, Professor of Infectious Diseases, School of
Medicine and Postgraduate School of Infectious Diseases, University
of Udine, Italy. "We are
increasingly seeing bacteria acquire resistance to antibiotics
previously considered last resort treatments; we need more options
to treat these extremely serious infections. The widespread
availability of a new and effective antibiotic such as VIBATIV® is
therefore very good news for Europe."
HAP is the most common cause of death among infections acquired
in a hospital setting, and is the primary cause of death in
Intensive Care Units (ICUs). Staphylococcus aureus is the
leading cause of Gram-positive bacterial infection in European
ICUs, and MRSA is thought to account for ≥ 25% of all
Staphylococcus aureus strains in Europe although rates have been shown to vary
considerably from country to
country[5]. There is a limited
choice of licensed antibiotic therapies able to treat HAP/VAP
caused by MRSA and other serious Gram-positive bacterial
infections, with only vancomycin, linezolid and teicoplanin
currently available in Europe and
recommended for this use.[6] The
incidence of infections with S.aureus strains that are not
responsive to treatment with vancomycin is
increasing,[9] and the first reported outbreak of
infection due to linezolid- and methicillin-resistant
S.aureus (LRSA) was reported in an intensive care unit in
Spain.[10] The growing
problem of resistance makes it all the more important that new,
effective agents are developed.
"The emergence of so-called 'super bugs' and increasing
resistance among microbes to existing antibiotics has been
recognised internationally as a major clinical challenge," said
Peter George, Group Chief Executive
Officer at Clinigen Group plc. "We are therefore extremely proud to
be making this potentially life-saving medicine available across
Europe for people who may have no
other suitable option to fight a life-threatening infection."
Accessing VIBATIV®
For more information including prescribing information and how
to order VIBATIV®, please visit
http://www.vibativ.eu. Clinigen is committed to
delivering VIBATIV® to hospitals across mainland Europe within 48 hours
About VIBATIV® (telavancin)
VIBATIV® is a bactericidal, once-daily, injectable
lipoglycopeptide antibiotic with a dual mechanism of action whereby
VIBATIV® both inhibits bacterial cell wall synthesis and disrupts
bacterial cell membrane function. VIBATIV® is approved in
the United States (US) for the
treatment of adult patients with (i) complicated skin and skin
structure infections (cSSSI) caused by susceptible isolates of
Gram-positive bacteria, including Staphylococcus aureus,
both methicillin-susceptible (MSSA) and methicillin-resistant
(MRSA) strains, and (ii) hospital-acquired and
ventilator-associated bacterial pneumonia (HAP/VAP) caused by
susceptible isolates of Staphylococcus aureus when
alternative treatments are not suitable. In September 2011, the European Commission granted
Marketing Authorization for VIBATIV® for the treatment of
nosocomial pneumonia (hospital-acquired), including
ventilator-associated pneumonia, known or suspected to be caused by
MRSA when other alternatives are not suitable. VIBATIV® was
discovered and developed by Theravance, Inc., and transferred to
Theravance Biopharma, Inc. in connection with the separation of the
two companies in June 2014.
In May 2012, the European
Commission suspended Marketing Authorization for VIBATIV® because
the previous single-source drug product supplier did not meet the
current Good Manufacturing Practice ("cGMP") requirements for the
manufacture of VIBATIV®. In March this year the European Commission
reinstated the marketing authorisation for VIBATIV® as consistent
product supply was re-established in accordance with European
Commission requirements. Theravance Biopharma Antibiotics, Inc. has
granted Clinigen exclusive commercialization rights to VIBATIV® in
the EU and certain other European countries (including Switzerland and Norway).
For further information, including prescribing information
please visit http://www.vibativ.eu
About Clinigen
The Clinigen Group is a specialty global pharmaceutical company
headquartered in the UK, with offices in the US and Japan. The Group has three operating
businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical
Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen
GAP).
Clinigen GAP develops and implements global access programs for
biotechnology and pharmaceutical companies and has provided access
to unlicensed, licensed and end-of-lifecycle products to thousands
of patients. Clinigen has experience in the implementation of more
than 30 access programs worldwide.
Clinigen SP is focused on acquiring its own intellectual
property in licensed, niche, hospital-only critical care medicines,
increasing the value of these medicines by developing new
formulations and indications, then registering and marketing them
in defined global markets.
For more information, please visit http://www.clinigengroup.com
or http://www.vibativ.eu
References
1. Sahm DF, Benton BM, Jones ME et al. Telavancin demonstrates a
low potential for in vitro selection of resistance among key
target Gram-positive species. Poster C1-0681, Program and Abstracts
of the 46th Interscience Conference on Antimicrobial Agents
and Chemotherapy, San Francisco,
September 27–30 (2006)
2. Scott LJ. Telavancin: A review of its use in patients with
nosocomial pneumonia. Drugs. 2013:73;1829-1839
3. WHO. Antimicrobial resistance: global report on surveillance
2014. Available
from: http://who.int/drugresistance/documents/surveillancereport/en/
[accessed August 2014]
4. Kock R, Becker K, Cookson B et al. Methicillin-resistant
Staphylococcus aureus (MRSA): burden of disease and control
challenges in Europe.
Eurosurveillance. 2010;15(41)
5. VIBATIV® EU Summary of Product Characteristics. Last updated
March 2014. Available online from the
European Medicines Agency at http://www.ema.europa.eu/
6. Rubinstein E, Lalani T, Corey GR et al. Telavancin versus
Vancomycin for Hospital-Acquired Pneumonia due to Gram-positive
Pathogens. Clinical Infectious Diseases. 2011;52(1):31–40
7. Torres A, Rubinstein E, Corey GR et al. Analysis of Phase 3
telavancin nosocomial pneumonia data excluding patients with
severe renal impairment and acute renal failure. Journal of
Antimicrobial Chemotherapy. 2014; 69(4): 1119–1126
8. NICE Evidence Summary: Hospital-acquired pneumonia caused by
methicillin-resistant Staphylococcus aureus: telavancin. Available
from:
http://publications.nice.org.uk/hospital-acquired-pneumonia-caused-by-methicillin-resistant-staphylococcus-aureus-telavancin-esnm44
[accessed August 2014]
9. Rubinstein E, Kollef MH, Nathwani D. Pneumonia caused by
Methicillin-Resistant Staphylococcus aureus. Clinical
Infectious Diseases. 2008; 46:S378–85
10. Sanchez Garcia M, De la Torre MA, Morales G et al. Clinical
outbreak of linezolid-resistant Staphylococcus aureus in an
intensive care unit. The Journal of the American Medical
Association. 2010; 9;303(22):2260-4. doi:
10.1001/jama.2010.757