Basilea reports granting of U.S. orphan drug designation to isavuconazole for the treatment of invasive candidiasis
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Basilea Pharmaceutica AG /
Basilea reports granting of U.S. orphan drug designation to isavuconazole for
the treatment of invasive candidiasis
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Basel, Switzerland, November 3, 2014 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
reports today that the U.S. Food and Drug Administration (FDA) has granted
orphan drug designation to isavuconazole for the treatment of invasive
candidiasis/candidemia, a potentially life-threatening infection caused by
Candida yeasts. Isavuconazole has previously been granted orphan drug status in
the European Union and the U.S. for the treatment of invasive aspergillosis and
mucormycosis.
An FDA orphan drug designation provides several benefits to the sponsor
including a seven-year period of market exclusivity in the U.S., should the FDA
grant orphan drug exclusivity at approval.
Prof. Achim Kaufhold, Basilea's Chief Medical Officer, said: "Invasive
candidiasis is a serious bloodstream infection that is associated with high
morbidity and mortality. The FDA's grant of orphan drug designation is a further
milestone in the development of isavuconazole and underscores the growing need
for additional drugs to treat invasive candidiasis."
Previously, the FDA also designated isavuconazole as a Qualified Infectious
Disease Product (QIDP) for the treatment of invasive aspergillosis, mucormycosis
and candidiasis under the Generating Antibiotic Incentives Now (GAIN) Act. QIDP
status provides priority review and a five-year extension of market exclusivity
if the drug receives approval in the U.S.
Isavuconazole is currently under regulatory review by the U.S. FDA and the
European Medicines Agency (EMA) for the treatment of invasive aspergillosis and
mucormycosis in adults. In accordance with the FDA Prescription Drug User Fee
Act (PDUFA), the FDA designated the date of March 8, 2015 for the completion of
the U.S. New Drug Application review. The regulatory review of the European
Marketing Authorization Application is anticipated to be completed by the fourth
quarter of 2015.
About invasive candidiasis
Infections by Candida yeasts are serious invasive fungal infections and are
associated with high morbidity and mortality. Estimates of the attributable
mortality of Candida bloodstream infections (candidemia) range from 15% to
49%.(1, 2, 3)
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on
the SIX Swiss Exchange (SIX: BSLN). Through the integrated research, development
and commercial operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd., the company develops and commercializes 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.
Isavuconazole (active moiety of the prodrug isavuconazonium sulfate) is an
investigational once-daily intravenous and oral broad-spectrum antifungal for
the potential treatment of life-threatening invasive fungal infections which
predominantly occur in immunocompromised patients such as cancer patients
undergoing chemotherapy.
Isavuconazole for the treatment of candidiasis is currently explored in the
phase 3 study ACTIVE, which evaluates the safety and efficacy of intravenously
(i.v.) and orally administered isavuconazole versus i.v. caspofungin followed by
oral voriconazole in the treatment of invasive Candida infections. Enrolment
into the ACTIVE study is anticipated to be completed by early 2015.
Information regarding isavuconazole clinical studies is available at
www.clinicaltrials.gov.
Isavuconazole is being co-developed with Astellas Pharma Inc. Basilea holds full
rights to isavuconazole in markets outside of the U.S. and Canada where Astellas
is the exclusive license holder.
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 J. Morgan et al. Excess mortality, hospital stay, and cost due to
candidemia: a case-control study using data from population-based candidemia
surveillance. Infection Control and Hospital Epidemiology 2005 (26), 540-547
2 T. E. Zaoutis et al. The epidemiology and attributable outcomes of
candidemia in adults and children hospitalized in the United States: a
propensity analysis. Clinical Infectious Diseases 2005 (41), 1232-1239
3 O. Gudlaugsson et al. Attributable mortality of nosocomial candidemia,
revisited. Clinical Infectious Diseases 2003 (37), 1172-1177
Press release (PDF):
http://hugin.info/134390/R/1867752/656351.pdf
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Source: Basilea Pharmaceutica AG via GlobeNewswire
[HUG#1867752]
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Datum: 03.11.2014 - 07:15 Uhr
Sprache: Deutsch
News-ID 348868
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