Basilea reports that ceftobiprole received QIDP designation from U.S. FDA for the treatment of lung and skin infections
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG /
Basilea reports that ceftobiprole received QIDP designation from U.S. FDA for
the treatment of lung and skin infections
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The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, August 12, 2015 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today that the U.S. Food and Drug Administration (FDA) designated its
investigational drug ceftobiprole as a Qualified Infectious Disease Product. The
designation relates to the potential use of the drug in the treatment of
community-acquired bacterial pneumonia and acute bacterial skin and skin
structure infections.
Qualified Infectious Disease Product (QIDP) status, granted under the Generating
Antibiotic Incentives Now (GAIN) Act, provides certain incentives for the
development of antibiotics, such as priority review if the product is submitted
for approval in the United States, and a five-year extension of certain periods
of market exclusivity that may be applicable should it be approved.
Ronald Scott, Basilea's Chief Executive Officer, commented: "Serious bacterial
lung and skin infections often involve pathogens resistant to currently
available antibiotics. Basilea is committed to address the issue of resistance
in underserved areas of high medical need. We are in discussions with potential
collaborators for the clinical development of ceftobiprole in the U.S."
About ceftobiprole
Ceftobiprole (ceftobiprole medocaril) is a broad-spectrum intravenous
cephalosporin antibiotic being developed for use against certain Gram-positive
and Gram-negative bacteria, including clinical isolates that are resistant to
existing therapies.(1) Ceftobiprole is currently approved in thirteen European
countries for the treatment of community-acquired pneumonia and hospital-
acquired pneumonia (excluding ventilator-associated pneumonia) in adults.(2 )
Ceftobiprole is not approved for any use in the United States.
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.
References
1 Y. Y. Syed. Ceftobiprole medocaril: A review of its use in patients with
hospital- or community-acquired pneumonia. Drugs 2014 (74), 1523-1542
2 Ceftobiprole (European trade name Zevtera(®) or Mabelio(®), depending on the
country) has received national licenses for the treatment of community-
acquired pneumonia and hospital-acquired pneumonia (excluding ventilator-
associated pneumonia) in adults in Austria, Belgium, Denmark, Finland,
France, Germany, Italy, Luxembourg, Norway, Spain, Sweden, Switzerland and
the United Kingdom. Ceftobiprole is not registered in the United States.
Press release (PDF):
http://hugin.info/134390/R/1944975/704938.pdf
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Basilea Pharmaceutica AG via GlobeNewswire
[HUG#1944975]
Unternehmensinformation / Kurzprofil:
Datum: 12.08.2015 - 07:15 Uhr
Sprache: Deutsch
News-ID 413056
Anzahl Zeichen: 5943
contact information:
Town:
Basel
Kategorie:
Business News
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