Basilea reports that isavuconazole receives Qualified Infectious Disease Product (QIDP) designation from U.S. FDA for the treatment of invasive aspergillosis
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Basilea Pharmaceutica AG /
Basilea reports that isavuconazole receives Qualified Infectious Disease Product
(QIDP) designation from U.S. FDA for the treatment of invasive aspergillosis
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The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, December 3, 2013 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today that the U.S. Food and Drug Administration (FDA) designated
isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment
of invasive aspergillosis.
QIDP status provides priority review and a five-year extension of market
exclusivity following product approval in the United States. These incentives
were granted under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act
as part of the FDA Safety and Innovation Act.
The five-year extension is in addition to the seven-year exclusivity based on
isavuconazole's FDA orphan drug designation for the treatment of invasive
aspergillosis. In the U.S., isavuconazole also received orphan drug designation
for the treatment of zygomycosis, a life-threatening invasive fungal infection
(IFI) caused by emerging molds.
Ronald Scott, Basilea's Chief Executive Officer, commented: "We are very pleased
that isavuconazole received QIDP designation for the treatment of invasive
aspergillosis. Fungal pathogens are a major threat to public health and the
inclusion of Aspergillus species on the list of qualifying pathogens under the
GAIN Act highlights the high medical need of patients suffering from these
potentially life-threatening infections. The evidence obtained to date from pre-
clinical and clinical data suggests that isavuconazole may have the potential to
become an important treatment option for these patients. Analyses of the SECURE
and VITAL phase 3 study data are currently being completed to support a
potential filing in the first half of 2014."
IFIs are debilitating or life-threatening infections that attack internal
tissues or organs and can spread through the bloodstream. Fungi commonly
involved in IFIs include Aspergillus (molds) and Candida (yeasts).[1],[2]
Invasive aspergillosis typically affects patients with an impaired or weakened
immune system. It is estimated to occur in 5-13% of recipients of bone marrow
transplants often associated with leukemia, 5-25% of patients who have received
heart or lung transplants, and 10-20% of patients who are receiving intensive
chemotherapy for leukemia.[3] ( )Mortality rates for transplant patients with
invasive aspergillosis have been reported to be between 34 and 58%.[4]
( )Zygomycosis is an important emerging fungal infection, associated with high
morbidity and mortality. Mortality rates have been reported to be as high as
80% in infected transplant patients.[5]
About isavuconazole
Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational
once-daily intravenous and oral broad-spectrum antifungal for the potential
treatment of severe invasive and life-threatening fungal infections. It is
currently in phase 3 of clinical development. Isavuconazole demonstrated in-
vitro and in-vivo coverage of a broad range of yeasts (such as Candida species)
and molds (such as Aspergillus species) as well as activity in in-vitro studies
and animal models against emerging and often fatal molds including those that
cause zygomycosis. Isavuconazole received U.S. FDA fast-track status and U.S.
orphan drug designation for invasive aspergillosis and zygomycosis.
Isavuconazole is being co-developed with Astellas Pharma Inc.
About the isavuconazole phase 3 program
The phase 3 program with isavuconazole includes three studies, SECURE, VITAL and
ACTIVE. Recently, positive topline results were reported from the SECURE study,
a global randomized, double-blind phase 3 study, designed to evaluate the safety
and efficacy of once-daily isavuconazole versus twice-daily voriconazole in the
primary treatment of invasive fungal disease caused by Aspergillus species or
certain other filamentous fungi. Isavuconazole demonstrated non-inferiority
versus voriconazole. Isavuconazole was effective as determined by the primary
endpoint of all-cause mortality through day 42 in the intent-to-treat population
(N=516). Study drug-related adverse events were reported in 42.4% of the
isavuconazole and 59.8% of the voriconazole treatment group. Overall drug- and
non-drug-related adverse events were reported in 96.1% and 98.5% of patients in
the isavuconazole and voriconazole treatment groups, respectively.
The VITAL study is an open-label phase 3 study including patients with invasive
fungal disease caused by emerging fungal pathogens such as Zygomycetes and
patients with aspergillosis and pre-existing renal impairment. Enrollment into
VITAL has been completed (N=150). Based on the investigator reported data,
approximately 45 patients were enrolled with zygomycosis and a similar number of
patients were enrolled with pre-existing renal impairment. Review of diagnosis
and outcomes by an Independent Data Review Committee is ongoing.
The phase 3 ACTIVE study is a randomized, double-blind study evaluating the use
of isavuconazole i.v. and oral versus caspofungin i.v. followed by oral
voriconazole for the treatment of invasive Candida infections. The ACTIVE study
continues to recruit with anticipated completion of enrollment in the first part
of 2015.
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 Schröder, PhD | Barbara Zink, PhD, MBA |
| Head Public Relations & | Head Corporate Development |
| Corporate Communications | |
| +41 61 606 1102 | +41 61 606 1233 |
| media_relations(at)basilea.com | investor_relations(at)basilea.com |
+-----------------------------+--------------------------------+
This press release can be downloaded from www.basilea.com.
References
[1] Alangaden GJ. Nosocomial Fungal Infections: Epidemiology, Infection Control,
and Prevention. Infectious Disease Clinics of North America 2011 (25), 201-225
[2] Lass-Flörl C. The Changing Face of Epidemiology of Invasive Fungal Disease
in Europe. Mycoses 2009 (52), 197-205
[3] Harman EM. Medscape Reference, Drugs, Diseases & Procedures, Aspergillosis
Clinical Presentation. http://emedicine.medscape.com/article/296052-overview
[4] Baddley JW et al. Factors Associated with Mortality in Transplant Patients
with Invasive Aspergillosis. Clinical Infectious Diseases 2010 (50), 1559-1567
[5] Greenberg RN et al. Zygomycosis (Mucormycosis): Emerging Clinical Importance
and New Treatments. Current Opinion in Infectious Diseases 2004 (17), 517-525
Press release (PDF):
http://hugin.info/134390/R/1747190/588259.pdf
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Source: Basilea Pharmaceutica AG via GlobeNewswire
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Datum: 03.12.2013 - 07:15 Uhr
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