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Basilea Pharmaceutica (BSLN.SW) Announces Conclusion of BAL30072 Phase I Multiple Ascending Dose Study

10/25/2011 8:26:33 AM

BASEL, SWITZERLAND--(Marketwire - October 25, 2011) -

Basilea Pharmaceutica AG / Basilea announces conclusion of BAL30072 phase I multiple ascending dose study . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

Basilea Pharmaceutica Ltd. (SWISS: BSLN) announced today that it has concluded the second phase I study with its novel sulfactam antibiotic BAL30072 for the potential treatment of life- threatening multidrug-resistant Gram-negative infections.

Basilea has completed the double-blind, randomized, placebo-controlled dose- ranging study in healthy volunteers assessing the pharmacokinetics, safety and tolerability of BAL30072 after multiple ascending doses of intravenous infusions. The drug was clinically well tolerated with no significant clinical adverse events. The limiting factor for the highest dose regimen tested was transiently elevated liver enzyme levels.

"Having established the maximum dose of this particular dosing regimen we will now optimize alternative dosing regimens including combinations. Co- administration of BAL30072 with other antibiotics such as the penem class follows the observation that combinations extend the excellent spectrum of activity of BAL30072 against multidrug-resistant Gram-negative infections, involving Pseudomonas, Acinetobacter and Enterobacteriaceae even further," said Prof. Achim Kaufhold, Chief Medical Officer of Basilea Pharmaceutica Ltd.

The multiple ascending dose study was initiated following the successful completion of the single ascending dose phase I trial, in which BAL30072 was well tolerated and displayed dose-proportional pharmacokinetic properties.

Following the analyses of the pharmacokinetic data obtained in the multiple- ascending dose study and the completion of ongoing preclinical studies such as PK/PD modeling in animals, Basilea plans to expand the phase I program in 2012 to include studies evaluating additional dosing regimens of BAL30072 mono and combination therapies in preparation to entering phase II studies of BAL30072 in patients with Gram-negative infections in 2013.

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.

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.


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.

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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE


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