Basilea reports on commercial progress of antifungal Cresemba® in Europe
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG /
Basilea reports on commercial progress of antifungal Cresemba® in Europe
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The issuer is solely responsible for the content of this announcement.
* Cresemba launched by Pfizer in Spain and is now commercially available in
all Top-5 EU markets
* Marketing authorization received for Switzerland
Basel, Switzerland, November 2, 2017 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today that its licensing partner Pfizer recently launched the
antifungal drug Cresemba(®) (isavuconazole) in Spain. Pfizer is now
commercializing the product in the major EU markets and Austria. In addition,
Swissmedic approved Cresemba for the treatment of adult patients with invasive
aspergillosis and for the treatment of adult patients with mucormycosis for whom
amphotericin B is inappropriate.
David Veitch, Chief Commercial Officer of Basilea, said: "Cresemba's launch in
Spain by our licensing partner Pfizer is an important step in expanding the
availability of this important treatment option to even more patients across
Europe who are suffering from invasive aspergillosis and mucormycosis. These are
severe mold infections that predominantly affect immunocompromised patients,
such as patients with cancer and after transplantation. In addition, we are very
pleased with the progress we have made in transitioning Cresemba to our partner
Pfizer. The two organizations have successfully completed the transition of
commercialization responsibilities in the markets in Europe where Cresemba was
previously marketed by Basilea."
In July, Basilea had completed an exclusive license agreement with Pfizer for
Cresemba in Europe (excluding the Nordics), Russia, Turkey and Israel. Basilea
received an upfront payment of CHF 70 million and is also eligible to receive up
to USD 427 million in additional payments upon achievement of pre-specified
regulatory and sales milestones. In addition, Basilea will also receive
royalties in the mid-teen range on Pfizer's sales.
Cresemba is currently being marketed in the U.S. by Basilea's licensing partner
Astellas Pharma US; in Germany, Italy, the United Kingdom, France, Spain and
Austria by Pfizer; and in the Nordic countries by Basilea's distribution partner
Unimedic Pharma AB.
About Cresemba (isavuconazole)
Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized
under the trade name Cresemba. Basilea has entered into several license and
distributions agreements covering the Unites States, Europe, Japan, Latin
America, the Middle East and North Africa region, Canada, Russia, Turkey and
Israel. Isavuconazole is approved in the United States for patients 18 years of
age and older in the treatment of invasive aspergillosis and invasive
mucormycosis.(1 )In Europe (28 European Union member states, as well as in
Iceland, Liechtenstein and Norway) Isavuconazole is approved for the treatment
of adult patients with invasive aspergillosis and for the treatment of adult
patients with mucormycosis for whom amphotericin B is inappropriate.(2, )In
Switzerland, Cresemba is approved for the treatment of adult patients with
invasive aspergillosis and for the treatment of mucormycosis in adult patients
who are resistant to or intolerant of amphotericin B and in adult patients with
moderate to severe renal impairment.(3 )Isavuconazole has U.S. and European
orphan drug designation for the approved indications. Outside the U.S. and
Europe, the drug is currently not approved for commercial use.
About Basilea
Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company
developing products that address the medical challenge of increasing resistance
and non-response to current treatment options in the therapeutic areas of
bacterial infections, fungal infections and cancer. The company is committed to
discovering, developing and commercializing innovative pharmaceutical products
to meet the medical needs of patients with serious and 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 of 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 Cresemba US prescribing information [Accessed: November 1, 2017]
2 European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu
[Accessed: November 1, 2017]
3 Full indication: Swissmedic-approved information for healthcare
professionals as of August 2017
Press release (PDF):
http://hugin.info/134390/R/2146638/823116.pdf
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The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Basilea Pharmaceutica AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 02.11.2017 - 07:15 Uhr
Sprache: Deutsch
News-ID 566295
Anzahl Zeichen: 6837
contact information:
Town:
Basel
Kategorie:
Business News
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