Basilea Pharmaceutica’s Antibiotic BAL30072 Shows Activity against Superbugs Expressing the NDM-1 Resistance Factor

BASEL, SWITZERLAND--(Marketwire - May 09, 2011) -

Basilea Pharmaceutica AG /Basilea’s antibiotic BAL30072 shows activity against superbugs expressingtheNDM-1 resistance factor. Processed and transmitted by Thomson Reuters ONE.The issuer is solely responsible for the content of this announcement.

New research data on Basilea’s antibacterialcompounds was presented in Milan, Italy, at the European Congress ofClinicalMicrobiology and Infectious Disease (ECCMID) and the International CongressofChemotherapy (ICC) joint meeting. Basilea’s novel antibiotic BAL30072 wasshownto be active against multidrug-resistant Gram-negative bacteria thatexpress theNDM-1 resistance factor.

Multidrug-resistant Gram-negative pathogens are appearing with increasingfrequency in hospitals around the world and have been associated withprolongedhospital stays, higher healthcare costs and increased mortality.

Recently, Gram-negative bacteria that harbour the so-called New Delhimetallo-beta-lactamase 1 (NDM-1) alongside with several other resistance mechanismshavetriggered increased medical concern. NDM-1 is an enzyme that leads toresistancetowards antibiotics that have been the mainstay of treatment of clinicallyimportant pathogens such as Escherichia coli or Klebsiella pneumoniae.Thesebacteria may cause systemic infections including severe lung andcomplicatedurinary tract infections.

Bacteria expressing NDM-1 were discovered only recently but are now beingobserved with increasing frequency in many countries all over the world.

BAL30072, a novel sulfactam antibiotic currently in phase I clinicaltesting

In-vitro data presented at ECCMID/ICC show for the first time that BAL30072isactive against multidrug-resistant clinical isolates of Gram-negativebacteriaharbouring NDM-1.BAL30072 is resistant to degradation by NDM-1 and was therefore active, atclinically achievable concentrations, against many of the highly resistantisolates tested while standard anti-Gram-negative antibiotics such asmeropenem,ceftazidime or aztreonam covered only a minority of the strains. BAL30072andmeropenem combined had enhanced activity and resulted in inhibition of morethan90% of the isolates.

Also at ECCMID/ICC, in-vitro data was presented that demonstrated thepotentactivity of BAL30072 against meropenem-resistant strains of Acinetobacterbaumannii, a clinically important Gram-negative pathogen in hospital-acquiredpneumonia, for which only few therapeutic options exist. BAL30072 wastestedalongside reference drugs currently used for the treatment of Acinetobacterinfections and showed greater activity than all the marketed beta-lactamantibiotics as well as most of the other comparators.

The new data confirm the therapeutic potential of Basilea’s phase IcompoundBAL30072. The drug shows potent activity against a broad range ofmultidrug-resistant Gram-negative bacteria, including those harbouring NDM-1, and mayoffer a future treatment option for potentially life-threatening Gram-negativeinfections where currently only limited therapeutic options exist.

+------------------------------------------------------------------------+| Publications on BAL30072 at the 21(st) ECCMID / 27(th) || ICC Annual Meetings || ||-- Activity of the novel sulfactam BAL30072, alone and in combination || with meropenem, against Enterobacteriaceae harbouring NDM-1 beta- || lactamase - T.R. Walsh, J. Weeks, M. Toleman, W.J. Stubbings, M.G.P.|| Page, M.E. Jones; poster #P1146 || ||-- In vitro activity of the siderophore sulfactam BAL30072 against || meropenem non-susceptible Acinetobacter baumannii - P.G. Higgins, D.|| Stefanik, M.G.P. Page, M. Hackel, H. Seifert; poster #P1184 |+------------------------------------------------------------------------+

Ceftobiprole, a novel broad-spectrum cephalosporin antibiotic

In addition, new data on ceftobiprole was presented at ECCMID/ICC.Ceftobiproleis a novel cephalosporin antibiotic with broad coverage of both Gram-positivebacteria, including the superbug methicillin-resistant Staphylococcusaureus(MRSA), and many clinically important Gram-negative bacteria.

+------------------------------------------------------------------------+| Publications on ceftobiprole at the 21(st) ECCMID / 27(th) || ICC Annual Meetings || ||-- Ceftobiprole efficacy in vitro on Panton-Valentine leukocidin || production and in vivo in a rabbit community-associated || methicillin-resistant Staphylococcus aureus osteomyelitis model - A.|| Saleh Mghir, A. Dinh, O. Dumitrescu, G. Lina, Y. Boutrad, F. || Vandenesch, J. Etienne, A.C. Cremieux; poster #P1068 || ||-- In vitro susceptibility of ceftobiprole, vancomycin and fosfomycin || against recent clinical bloodstream isolates of methicillin- || resistant Staphylococcus aureus in the General Hospital of Vienna - || C. Kratzer, C. Dungl, S. Tobudic, K. Karaca, N. Kreischitz, W. || Graninger; abstract #R2365 |+------------------------------------------------------------------------+

For further information please visit www.eccmid-icc2011.org

About BAL30072

BAL30072 is a novel siderophore (iron-binding) sulfactam antibiotic,currentlyin phase I of clinical testing, with a unique mode of action, conferringpotentbactericidal activity against Gram-negative pathogens. The compound can actlikea “Trojan horse” by exploiting natural nutrient uptake systems of pathogenstogain access to its intracellular target. BAL30072 is stable towards manytypesof beta-lactamase enzymes, including many of the extended-spectrum beta-lactamases (ESBLs), carbapenemases and metallo-beta-lactamases includingNDM-1,which can deactivate most of the currently marketed beta-lactam antibioticssuchas cephalosporins and carbapenems.

About ceftobiprole

Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin antibioticexhibitingactivity against a wide spectrum of Gram-positive bacteria, including thesuperbug methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae as well as many clinically importantGram-negative bacteria, including Pseudomonas spp. Ceftobiprole’s key featuresmayallow physicians to use it as the first treatment when MRSA is proven orsuspected. Basilea owns full global rights to ceftobiprole.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, andlisted onthe SIX Swiss Exchange (SIX: BSLN). Its fully integrated research anddevelopmentoperations are focused on antibiotics, antifungals and oncology drugs, aswellas on the development of dermatology drugs, targeting the medical challengeofresistance and non-response to current treatment options in the hospitalandspecialty care setting.Basilea is currently marketing Toctino® (alitretinoin), the onlyapprovedtreatment for severe chronic hand eczema unresponsive to potent topicalcorticosteroids, in Denmark, Finland, France, Germany, Switzerland and theUnited Kingdom and has appointed distributors for Toctino® in otherselectedEuropean markets, Canada, Israel and Mexico. Furthermore, a phase IIIclinicalprogram on alitretinoin for the treatment of severe chronic hand eczema isongoing in the U.S. For its phase III compound isavuconazole, a potentialbest-in-class azole antifungal for the treatment of life-threatening invasivefungalinfections, the company has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc. In addition, Basilea isdevelopingceftobiprole, a late-stage novel anti-MRSA broad-spectrum cephalosporinantibiotic, for the first-line treatment of potentially life-threateningresistant bacterial infections. Ceftobiprole has a broad coverage of bothGram-positive bacteria, including methicillin-resistant Staphylococcus aureus(MRSA),and many clinically important Gram-negative bacteria such as Pseudomonasspp.

Disclaimer

This communication expressly or implicitly contains certain forward-lookingstatements concerning Basilea Pharmaceutica Ltd. and its business. Suchstatements involve certain known and unknown risks, uncertainties and otherfactors, which could cause the actual results, financial condition, performanceor achievements of Basilea Pharmaceutica Ltd. to be materially differentfromany future results, performance or achievements expressed or implied bysuchforward-looking statements. Basilea Pharmaceutica Ltd. is providing thiscommunication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, futureevents or otherwise.

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

Basilea Pharmaceutica AGGrenzacherstrasse 487P.O Box Basel Switzerland

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