Basilea's antifungal Cresemba® (isavuconazole) launched in France
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Basilea's antifungal Cresemba® (isavuconazole) launched in France
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Basel, Switzerland, November 15, 2016 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announces that it has launched its antifungal Cresemba(®) (isavuconazole) in
France and that it has sponsored a symposium on current challenges and recent
opportunities in the treatment of invasive mold infections. The event was held
on November 10, 2016 in Paris, France, and was co-chaired by Professor Élie
Azoulay, Medical Intensive Care, Saint-Louis Teaching Hospital, Paris; Professor
Jean-Pierre Gangneux, Laboratory of Parasitology and Mycology, University
Hospital Rennes, and Professor Olivier Lortholary, Department of Infectious
Diseases, Necker - Enfants Malades Hospital, Paris.
David Veitch, Basilea's Chief Commercial Officer, commented: "We are excited to
have launched Cresemba in France. The symposium provided an opportunity both for
clinicians to discuss important clinical data and to share their experiences in
the management of patients with potentially life-threatening invasive mold
infections. Cresemba addresses an important medical need for these patients."
Isavuconazole was approved by the European Commission in October 2015 for the
treatment of adults with invasive aspergillosis and the treatment of adults with
mucormycosis for whom amphotericin B is inappropriate. Invasive aspergillosis
and mucormycosis are life-threatening fungal infections that often affect
immunocompromised patients, such as patients with cancer and after
transplantation. Invasive aspergillosis is often fatal. Mucormycosis (also known
as zygomycosis) is a rapidly progressive invasive fungal infection, often
affecting the nose and sinuses with high mortality.
Professor Raoul Herbrecht, Department of Oncology and Hematology, Hautepierre
University Hospital Strasbourg, stated: "There is a significant medical need in
invasive aspergillosis and mucormycosis. They can cause severe morbidity and
rapid deterioration in a patient's condition and may be associated with
mortality rates approaching 100% if untreated or if effective treatment is
delayed. Isavuconazole's safety and tolerability profile can be beneficial for
highly vulnerable patients with invasive mold infections, as for instance
patients with comorbidities or the need for long-term use, or high-risk patients
receiving concomitant medications such as immunosuppressants."
Professor Jean-Pierre Gangneux added: "There are gaps in the spectrum of various
currently available antifungal drugs. Isavuconazole is characterized by a broad
spectrum with activity against filamentous fungi such as Aspergillus spp. and
Mucorales."
About Cresemba (isavuconazole)
Isavuconazole is an intravenous (i.v.) and oral azole antifungal and the active
agent of the prodrug isavuconazonium sulfate. It is approved in the United
States for patients 18 years of age and older in the treatment of invasive
aspergillosis and invasive mucormycosis.(1) In Europe, isavuconazole received
marketing authorization for the treatment of adult patients with invasive
aspergillosis and for the treatment of adult patients with mucormycosis for whom
amphotericin B is inappropriate.(2) Isavuconazole has orphan drug designation
for the approved indications in Europe and the US. Basilea is marketing
isavuconazole as Cresemba in Germany, Italy, the UK, France and Austria and is
seeking national pricing and reimbursement in additional EU countries. In the
US, the drug is marketed by Basilea's license partner Astellas Pharma US.
Outside the US and the EU, isavuconazole is currently not approved for
commercial use. The European marketing authorization is valid in all
28 European Union (EU) member states, as well as in Iceland, Liechtenstein and
Norway.
About the isavuconazole invasive aspergillosis and mucormycosis studies
The approval of Cresemba is based on results from the isavuconazole development
program. The safety and efficacy profile of isavuconazole in adult patients with
invasive aspergillosis was demonstrated based on data from two phase 3 clinical
studies: SECURE, a randomized, double-blind, active-control study in 516
patients (intent-to-treat population, ITT) with invasive aspergillosis, and
VITAL, an open-label non-comparative 146-patient study (ITT) of isavuconazole in
the treatment of invasive aspergillosis patients with renal impairment, or
invasive fungal disease (IFD) caused by emerging molds, yeasts or dimorphic
fungi, including invasive mucormycosis.
In the SECURE study, isavuconazole was non-inferior to voriconazole based on the
primary endpoint of all-cause mortality at Day 42 in the intent-to-treat
population. All-cause mortality through Day 42 was 19% in the isavuconazole
treatment group and 20% in the voriconazole treatment group.(3)
In the SECURE study, similar rates of non-fatal adverse events were observed for
isavuconazole and the comparator, voriconazole. Further, the percentage of study
drug-related adverse events in invasive aspergillosis patients was 42% for
isavuconazole and 60% for voriconazole. In addition, the percentage of
treatment-emergent adverse events in the system organ classes of hepatobiliary
disorders was 9% for isavuconazole versus 16% for voriconazole; skin or
subcutaneous tissue disorders was 33% for isavuconazole versus 42% for
voriconazole; and eye disorders was 15% for isavuconazole versus 27% for
voriconazole.(3)
The safety and efficacy profile of isavuconazole in patients with mucormycosis
was demonstrated based on data from the VITAL study, which included a
subpopulation of 37 patients with proven or probable mucormycosis, of whom 21
received isavuconazole as primary treatment for their infection. All-cause
mortality at Day 42 was 38% which is similar to mortality rates reported in
literature for the treatment of mucormycosis. In this trial the rate of overall
response against mucormycosis at the end of therapy was 31%, with an additional
29% exhibiting a stable response. For patients receiving isavuconazole as
primary therapy, this number was 32%, with an additional 32% having stable
disease.(4) The efficacy of isavuconazole for the treatment of mucormycosis has
not been evaluated in concurrent, controlled clinical trials.
The most frequent adverse events for patients treated with isavuconazole in
clinical phase 3 studies were nausea (26%), vomiting (25%), diarrhea (22%),
headache (17%), elevated liver chemistry tests (17%), hypokalemia (14%),
constipation (13%), dyspnea (12%), cough (12%), peripheral edema (11%), and back
pain (10%).
About Basilea
Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products
that address increasing resistance and non-response to current treatment options
in the therapeutic areas of bacterial infections, fungal infections and cancer.
The company uses the integrated research, development and commercial operations
of its subsidiary Basilea Pharmaceutica International Ltd. to discover, develop
and commercialize innovative pharmaceutical products to meet the medical needs
of patients with serious and potentially 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.
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 Public Relations & Corporate Communications |
| +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 Cresemba US prescribing information [Accessed: November 07, 2016]
2 European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu
[Accessed: November 07, 2016]
3 J. A. Maertens, I. I. Raad, K. A. Marr et al. Isavuconazole versus
voriconazole for primary treatment of invasive mould disease caused by
Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-
controlled, non-inferiority trial. The Lancet 2016 (387), 760-769
4 F. M. Marty et al. Isavuconazole treatment for mucormycosis: a single-arm
open-label trial and case-control analysis. The Lancet Infectious Diseases
2016, published online on May 8, 2016
Press Release (PDF):
http://hugin.info/134390/R/2056860/770488.pdf
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Source: Basilea Pharmaceutica AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 15.11.2016 - 07:15 Uhr
Sprache: Deutsch
News-ID 506931
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contact information:
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Business News
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