BASEL, SWITZERLAND--(Marketwire - September 07, 2011) - Basilea Pharmaceutica AG /
Basilea initiates multiple ascending dose phase I study with novel
BAL30072 active against multidrug-resistant Gram-negative bacteria
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Basel, Switzerland, September 7, 2011 - Basilea Pharmaceutica Ltd. (SWISS: BSLN)
announced today the initiation of the second phase I study with its novel
sulfactam antibiotic BAL30072.
Gram-negative pathogens account for more than a third of all hospital
and over half of the infections occurring in intensive care units.
with multidrug-resistant Gram-negative bacteria are associated with
mortality, prolonged hospital stays and higher healthcare costs.
"We are very excited by the development of BAL30072. It has the potential
fill the enormous treatment gap against resistant Gram-negative bacteria
are claiming the lives of patients in increasing numbers. This multiple
study will build upon the excellent results from our first human study of
BAL30072 and we aim to complete this second study in the first part of
said Dr. Anthony Man, CEO of Basilea Pharmaceutica International Ltd.
BAL30072 is a novel sulfactam antibiotic that in in vitro and in vivo
demonstrated potent bactericidal activity against a broad range of
resistant Gram-negative pathogens such as Pseudomonas or Acinetobacter
It overcomes bacterial resistance by several mechanisms and is not easily
destroyed by bacterial beta-lactamase enzymes, such as extended-spectrum
lactamases (ESBLs), carbapenemases and the recently characterized New Delhi
metallo-beta-lactamase 1 (NDM-1), which cause resistance against many
Following the successful completion of the single ascending dose phase I
in which BAL30072 was safe and well tolerated and displayed dose-
pharmacokinetic properties, Basilea is now commencing a double-blind,
randomized, placebo-controlled study that assesses the pharmacokinetics,
and tolerability of BAL30072 after multiple ascending intravenous infusions
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and
the SIX Swiss Exchange (SWISS: BSLN). Basilea Pharmaceutica International's
integrated research and development operations are focused on antibiotics,
antifungals and oncology drugs, as well as on the development of
drugs, targeting the medical challenge of resistance and non-response to
treatment options in the hospital and specialty care setting.
Basilea is currently marketing Toctino® (alitretinoin), the only
treatment for adults with severe chronic hand eczema unresponsive to potent
topical corticosteroids, in Denmark, Finland, France, Germany, Norway,
Switzerland and the United Kingdom and has appointed distributors for
in other selected European markets, Canada, Israel, Mexico and the Republic
Korea. A phase III clinical program on alitretinoin for the treatment of
chronic hand eczema is ongoing in the U.S.
For its phase III compound isavuconazole, a potential best-in-class azole
antifungal for the treatment of life-threatening invasive fungal
company has entered into a license, co-development and co-promotion
with Astellas Pharma Inc.
In addition, Basilea is developing ceftobiprole, a late-stage novel anti-
(methicillin-resistant Staphylococcus aureus) broad-spectrum cephalosporin
antibiotic, for the first-line treatment of potentially life-threatening
resistant bacterial infections. Ceftobiprole has a broad coverage of both
positive bacteria, including MRSA, and many clinically important Gram-
bacteria such as Pseudomonas spp.
Basilea's BAL30072, a novel antibiotic for the treatment of resistant Gram-
negative infections, and the oncology drug BAL101553 for the treatment of
resistant cancers are in phase I clinical testing.
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,
or achievements of Basilea Pharmaceutica Ltd. to be materially different
any future results, performance or achievements expressed or implied by
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.
This press release can be downloaded from www.basilea.com.
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Basilea Pharmaceutica AG
P.O Box Basel Switzerland
Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München;
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