Bli medlem
Bli medlem

Du är här

2016-11-15

Basilea Pharmaceutica AG: Basilea's antifungal Cresemba® (isavuconazole) launched in France

Basilea Pharmaceutica AG / Basilea's antifungal Cresemba® (isavuconazole)
launched in France. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
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
asAspergillus
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.1In 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.2Isavuconazole 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.4The 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 websitewww.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@basilea.com |
| |
|investor_relations@basilea.com |
-------------------------------------------------
This press release can be downloaded fromwww.basilea.com.

References

---------------------------------------------------------------------------------
| 1 CresembaUS 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 |
| byAspergillus |
| 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

---------------------------------------
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

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.