Basilea announces that European Commission maintained isavuconazole's orphan drug status
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG /
Basilea announces that European Commission maintained isavuconazole's orphan
drug status
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Basel, Switzerland, October 23, 2015 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today that the orphan drug designation of the antifungal isavuconazole
for the treatment of invasive aspergillosis and mucormycosis has been
maintained. Accordingly, isavuconazole will benefit from ten years of market
exclusivity associated with orphan medicinal product status in the European
Union.
About isavuconazole
Isavuconazole is an intravenous and oral azole antifungal and the active agent
of the prodrug isavuconazonium sulfate. The drug is being co-developed with
Astellas Pharma Inc. under an agreement granting Astellas a license to
commercialize isavuconazole in the U.S.; Basilea holds full rights to
commercialize isavuconazole in markets outside the United States. On March
6, 2015, the United States Food and Drug Administration (FDA) approved Astellas'
New Drug Application (NDA) for the use of isavuconazonium sulfate for patients
18 years of age and older in the treatment of invasive aspergillosis and
invasive mucormycosis. Astellas markets the drug as CRESEMBA® in the United
States. On October 15, 2015, the European Commission granted marketing
authorization to isavuconazole for the treatment of adult patients with invasive
aspergillosis and for the treatment of adult patients with mucormycosis for whom
amphotericin B is inappropriate. The European marketing authorization is valid
in all 28 European Union (EU) member states, as well as in Iceland,
Liechtenstein and Norway. Outside the United States and the EU, isavuconazole is
currently an investigational product and not approved for commercial use.
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:
+-----------------------------+--------------------------------+
| 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.
Press release (PDF):
http://hugin.info/134390/R/1961018/714984.pdf
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other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Basilea Pharmaceutica AG via GlobeNewswire
[HUG#1961018]
Unternehmensinformation / Kurzprofil:
Datum: 23.10.2015 - 07:15 Uhr
Sprache: Deutsch
News-ID 428985
Anzahl Zeichen: 5096
contact information:
Town:
Basel
Kategorie:
Business News
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