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Basilea presents new research data on a biomarker for its novel oncology drug candidate BAL101553 at AACR


April 4, 2012 - Basel, Switzerland

Research data on a potential biomarkerpredicting response to Basilea's novel microtubule-targeting phase Ioncologydrug candidate BAL101553 were presented at the American Association ofCancerResearch (AACR) Annual Meeting in Chicago, Illinois, USA.

BAL101553 is a novel small molecule that arrests tumor cell proliferationandinduces tumor cell death through a characteristic destabilizing effect onmicrotubules, an intracellular network essential for cell division.

Anti-cancer activity of BAL101553 has been demonstrated across a broadpanel ofpreclinical models of human cancer, including those resistant againstconventional microtubule-targeting drugs such as taxanes or vincaalkaloids. Theinjectable form of BAL101553 is currently being tested in a phase Iclinicalprogram with patients suffering from advanced solid tumors. Phase I dataareexpected in the second half of 2012.

Results of collaborative studies between the Basilea research group and theteamof Dr. Michael Boutros, Deutsches Krebsforschungszentrum (DKFZ),Heidelberg,Germany, were presented at AACR. These preclinical studies demonstrate thatBubR1 protein kinase function is required for the antiproliferative actionofBAL27862 (the active moiety of BAL101553) in tumor cells. BubR1 plays a keyregulatory role in the assembly of the microtubule mitotic spindle requiredforcell division. Using small interfering RNA (siRNA) approaches and diversecancermodels, it was found that susceptibility to BAL27862 correlated with BubR1expression levels. The work presented at AACR provides a robust datasetacrosstumor types, supportive of the further evaluation of BubR1 as a potentialmarkerof tumor response to BAL101553.

"The identification of BubR1 as a potential predictive biomarker, based onthedemonstrated correlation between BubR1 expression and sensitivity of cancercells to BAL101553, is a result of Basilea's strategy to ultimatelyoptimizetreatment of cancer patients by selecting as early as possible those mostlikelyto benefit from this novel drug," said Dr. Laurenz Kellenberger, Basilea'sChiefScientific Officer.


+-------------------------------------------------------------------------+
|Poster on BAL101553/BAL27862 at the AACR Annual Meeting 2012 |
| |
| * BubR1 function is required for the antiproliferative activity of the |
| novel microtubule-targeting drug BAL27862 (active moiety of the |
| prodrug BAL101553) - H. Lane, K. Burger, F. Bachmann, A. Tzankov, |
| M. Boutros, D. Gilbert; poster/abstract #3795 |
+-------------------------------------------------------------------------+

For further information please visit www.aacr.org

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, andlisted onthe SIX Swiss Exchange (SIX: BSLN). Through the fully integrated researchanddevelopment operations of its Swiss subsidiary Basilea PharmaceuticaInternational Ltd. the company focuses on innovative pharmaceuticalproducts inthe therapeutic areas of bacterial infections, fungal infections, oncologyandskin diseases, targeting the medical challenge of rising resistance andnon-response to current treatment options in the hospital and specialty caresetting. The Basilea group includes affiliates in European countries aswell asin China.

Basilea is currently marketing Toctino® (oral alitretinoin), approvedinEuropean countries, Canada and Israel for the treatment of adults withseverechronic hand eczema unresponsive to potent topical corticosteroids, inDenmark,Finland, France, Germany, Norway, Switzerland and the United Kingdom andhasappointed distributors for Toctino® in other selected Europeanmarkets, Canada,Israel, Mexico and the Republic of Korea. In the U.S., oral alitretinoin isaninvestigational drug. Topline data from the U.S. phase III study (HANDEL)onoral alitretinoin have been recently reported. The results are consistentwithprevious randomized international studies.

For its phase III compound isavuconazole, a potential best-in-class azoleantifungal for the treatment of life-threatening invasive fungalinfections, thecompany has entered into a license, co-development and co-promotionagreementwith Astellas Pharma Inc.

In addition, Basilea is developing ceftobiprole, a late-stage novel anti-MRSA(methicillin-resistant Staphylococcus aureus) broad-spectrum cephalosporinantibiotic, for the first-line treatment of potentially life-threateningresistant bacterial infections. Ceftobiprole has a broad coverage of bothGram-positive bacteria, including MRSA, and many clinically important Gram-negativebacteria such as Pseudomonas spp.

Basilea's BAL30072, a novel investigational antibiotic for the treatment ofresistant Gram-negative infections, and the oncology drug candidateBAL101553for the treatment of drug-resistant cancers are in phase I clinicaltesting.

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, anticipated results, performance or achievements expressed orimplied by such forward-looking statements. Basilea Pharmaceutica Ltd. isproviding this communication as of this date and does not undertake toupdateany forward-looking statements contained herein as a result of newinformation,future events or otherwise.

For further information, please contact:

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

Press release (PDF):

http://hugin.info/134390/R/1599990/504964.pdf

This announcement is distributed by Thomson Reuters on behalf ofThomson 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#1599990]

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