Basilea announces distribution agreement with Hikma for CRESEMBA® (isavuconazole) in the MENA region
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG /
Basilea announces distribution agreement with Hikma for CRESEMBA®
(isavuconazole) in the MENA region
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* Basilea extending its agreement with Hikma to include antifungal CRESEMBA(®)
in addition to antibiotic Zevtera(®)
Basel, Switzerland, August 17, 2016 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today that the company has extended its distribution and supply
agreement for the Middle East and North Africa (MENA) region with Hikma
Pharmaceuticals LLC (Hikma) to include the antifungal CRESEMBA(®)
(isavuconazole) in addition to Zevtera(®) (ceftobiprole).
In October 2015, Basilea signed an exclusive distribution and supply agreement
with Hikma for Basilea's broad-spectrum hospital antibiotic Zevtera(®) for the
MENA region. Under the terms of the amended agreement, Hikma has the exclusive
right to register, distribute and market isavuconazole across the region.
Isavuconazole received European marketing authorization in October 2015 for the
treatment of adult patients with invasive aspergillosis and for the treatment of
adult patients with mucormycosis for whom amphotericin B is inappropriate.(1)
The European regulatory dossier will be the basis for regulatory filings in MENA
countries.
David Veitch, Basilea's Chief Commercial Officer, stated: "With this extension
of our partnership with Hikma, a leading pharmaceutical company in the Middle
East and North Africa region, we are building on a successful collaboration that
was established last year which has already led to the first regulatory
submissions for ceftobiprole in the MENA region. We look forward to our two
anti-infective brands being available to physicians and patients in the MENA
region for the treatment of severe and often life-threatening infections. Our
partnership with Hikma is in line with our strategy to commercialize both
CRESEMBA and Zevtera in as many regions as possible to maximize their global
potential to benefit patients, physicians and Basilea."
About isavuconazole
Isavuconazole is an intravenous (i.v.) and oral azole antifungal and the active
agent of the prodrug isavuconazonium sulfate. It was approved in March 2015 by
the United States Food and Drug Administration (FDA) for patients 18 years of
age and older in the treatment of invasive aspergillosis and invasive
mucormycosis.(2) The European marketing authorization was granted in October
2015 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.(1) Isavuconazole has orphan drug designation
for the approved indications in Europe and the US. Basilea commercializes
isavuconazole as CRESEMBA(®) in Germany, Italy, the UK and Austria. The drug is
commercialized in the US by Basilea's license partner Astellas Pharma US.
Outside the US and the EU, isavuconazole is not approved for commercial use.
About invasive aspergillosis and mucormycosis
Invasive aspergillosis and mucormycosis are life-threatening fungal infections
that predominantly affect immunocompromised patients, such as cancer patients.
Invasive aspergillosis is known for high morbidity and mortality. Mucormycosis
(also known as zygomycosis) is a rapidly progressing and life-threatening
invasive fungal infection, known for high morbidity and mortality.
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:
+----------------------------------------------------+
| Peer Nils Schröder, PhD |
| Head Corporate Communications & Investor Relations |
| +41 61 606 1102 |
| media_relations(at)basilea.com |
| investor_relations(at)basilea.com |
+----------------------------------------------------+
This press release can be downloaded from www.basilea.com.
References
1 European Public Assessment Report (EPAR) for CRESEMBA(®):
http://www.ema.europa.eu
[Accessed: August 16, 2016]
2 CRESEMBA(®) US prescribing information [Accessed: August 16, 2016]
Press release (PDF):
http://hugin.info/134390/R/2035557/758133.pdf
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Source: Basilea Pharmaceutica AG via GlobeNewswire
[HUG#2035557]
Unternehmensinformation / Kurzprofil:
Datum: 17.08.2016 - 07:15 Uhr
Sprache: Deutsch
News-ID 489542
Anzahl Zeichen: 6937
contact information:
Town:
Basel
Kategorie:
Business News
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