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Basilea Pharmaceutica (BSLN.SW) Initiates Multiple Ascending Dose Phase I Study With Novel Antibiotic BAL30072 Active against Multidrug-Resistant Gram-Negative Bacteria



9/7/2011 9:23:36 AM

BASEL, SWITZERLAND--(Marketwire - September 07, 2011) - Basilea Pharmaceutica AG / Basilea initiates multiple ascending dose phase I study with novel antibiotic BAL30072 active against multidrug-resistant Gram-negative bacteria . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

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 infections and over half of the infections occurring in intensive care units. Infections with multidrug-resistant Gram-negative bacteria are associated with increased mortality, prolonged hospital stays and higher healthcare costs.

"We are very excited by the development of BAL30072. It has the potential to fill the enormous treatment gap against resistant Gram-negative bacteria that are claiming the lives of patients in increasing numbers. This multiple dose 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 2012," said Dr. Anthony Man, CEO of Basilea Pharmaceutica International Ltd.

BAL30072 is a novel sulfactam antibiotic that in in vitro and in vivo models demonstrated potent bactericidal activity against a broad range of multidrug- resistant Gram-negative pathogens such as Pseudomonas or Acinetobacter species. It overcomes bacterial resistance by several mechanisms and is not easily destroyed by bacterial beta-lactamase enzymes, such as extended-spectrum beta- lactamases (ESBLs), carbapenemases and the recently characterized New Delhi metallo-beta-lactamase 1 (NDM-1), which cause resistance against many currently marketed anti­biotics.

Following the successful completion of the single ascending dose phase I trial, in which BAL30072 was safe and well tolerated and displayed dose- proportional pharmacokinetic properties, Basilea is now commencing a double-blind, randomized, placebo-controlled study that assesses the pharmacokinetics, safety and tolerability of BAL30072 after multiple ascending intravenous infusions in healthy volunteers.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SWISS: BSLN). Basilea Pharmaceutica International's fully integrated research and development operations are focused on antibiotics, antifungals and oncology drugs, as well as on the development of dermatology drugs, targeting the medical challenge of resistance and non-response to current treatment options in the hospital and specialty care setting.

Basilea is currently marketing Toctino® (alitretinoin), the only approved 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 Toctino® in other selected European markets, Canada, Israel, Mexico and the Republic of Korea. A phase III clinical program on alitretinoin for the treatment of severe 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 infections, the company has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc.

In addition, Basilea is developing ceftobiprole, a late-stage novel anti- MRSA (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 Gram- positive bacteria, including MRSA, and many clinically important Gram- negative 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 drug- resistant cancers are in phase I clinical testing.

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.

This press release can be downloaded from www.basilea.com.

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Basilea Pharmaceutica AG Grenzacherstrasse 487
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;

Press Release (PDF) : http://hugin.info/134390/R/1544560/473402.pdf

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and 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 Thomson Reuters ONE

[HUG#1544560]


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Peer Nils Schroder, Ph.D.
Head Public Relations &
Corporate Communications
+41 61 606 1102
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Barbara Zink, Ph.D., MBA
Head Corporate Development
+41 61 606 1233
Email Contact


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