Basilea reports isavuconazole orphan drug designation by U.S. FDA
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Basilea reports isavuconazole orphan drug designation by U.S. FDA
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Basel, Switzerland, May 28, 2013 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
reported today that the U.S. Food and Drug Administration (FDA) has granted
orphan drug designation to isavuconazole for the treatment of invasive
aspergillosis.
An FDA orphan drug designation provides several benefits to the sponsor
including a seven-year market exclusivity from product approval in the U.S.
Isavuconazole was previously granted FDA fast track status that is designed to
facilitate development and expedite the review of drugs to treat serious
diseases and that fill an unmet medical need in order to get important new drugs
to patients earlier.
Prof. Achim Kaufhold, Basilea's Chief Medical Officer, commented: "Invasive
aspergillosis is a life-threatening infection caused by Aspergillus molds. It
typically affects patients with an impaired or weakened immune system such as
transplant and cancer patients and is associated with high mortality. The
granting of orphan designation for isavuconazole in the U.S. reflects the high
medical need and is an important regulatory milestone for Basilea and our
partner Astellas."
Topline data from two isavuconazole phase 3 studies are expected in the second
half of 2013. These include the SECURE phase 3 registration study, evaluating
safety and efficacy of once-daily isavuconazole versus twice-daily voriconazole
for the primary treatment of invasive fungal disease caused by Aspergillus
species and from the open-label VITAL study investigating isavuconazole for the
treatment of patients with invasive life-threatening fungal disease caused by
emerging fungi and the treatment of aspergillosis patients with pre-existing
renal impairment.
The isavuconazole ACTIVE phase 3 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, will continue to recruit into 2014.
Invasive aspergillosis is estimated to occur in 5-13 % of recipients of bone
marrow transplants,
5-25 % of patients who have received heart or lung transplants, and 10-20 % of
patients who are receiving intensive chemotherapy for leukemia.(1 )Mortality
rates for transplant patients with invasive aspergillosis have been reported to
be between 34 and 58 %.(2)
About isavuconazole
Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational
intravenous and oral broad-spectrum antifungal. In collaboration with Astellas
Pharma Inc., isavuconazole is being investigated in phase 3 clinical studies for
the treatment of severe invasive fungal infections. The drug 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 in-vitro activity against
less prevalent but often fatal molds including those that cause mucormycosis. In
clinical studies to date, isavuconazole achieved predictable drug levels
supporting reliable dosing and a switch from intravenous administration to a
once-daily oral dose. The intravenous formulation of isavuconazole, which is
water-soluble, does not contain potentially kidney damaging solubilizers and has
the potential to be given also to patients with pre-existing renal impairment.
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 Harman EM, Medscape Reference, Drugs, Diseases & Procedures, Aspergillosis
Clinical Presentation, http://emedicine.medscape.com/article/296052-overview
2 Baddley JW et al. Factors Associated with Mortality in Transplant Patients
with Invasive Aspergillosis. Clinical Infectious Disease 2010 (50), 1559-1567
Press release (PDF):
http://hugin.info/134390/R/1704872/563819.pdf
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
[HUG#1704872]
Unternehmensinformation / Kurzprofil:
Datum: 28.05.2013 - 07:15 Uhr
Sprache: Deutsch
News-ID 263661
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