Basilea reports 2009 interim results

BASEL, SWITZERLAND--(Marketwire - August 14, 2009) -

Basilea Pharmaceutica Ltd.(SIX: BSLN) announces its 2009 interim financial results.

Basilea Pharmaceutica Ltd. announced today its 2009 interim financialresults reflecting the advancement of its two marketed productsToctino® and ZEFTERAT/ZevteraT.

Basilea focuses on preparing additional Toctino® launches in Europeand Canada, working towards ceftobiprole regulatory approval in keymarkets as well as on bringing forward its broad-spectrum antifungalisavuconazole currently in phase III clinical trials.

Financial summary

Combined cash and short-term investments amounted to CHF 224.9million as of June 30, 2009, compared to CHF 293.6 million atyear-end 2008. Revenue and other income increased to CHF 12.2 millioncompared to CHF 5.3 million in the prior year period, mainly as aresult of the increased product sales due to successful firstlaunches of Toctino® in Europe. Research and development expensesamounted to CHF 44.5 million in the first half of 2009 compared toCHF 49.0 million in the prior year period, mainly reflecting thecontinuous investment in the phase III clinical trials ofisavuconazole and Toctino® in the U.S. General and administrativeexpenses increased to CHF 34.8 million compared to CHF 29.4 millionin the first half of 2008 due to investments in commercialization ofToctino®.

Key figures

+-------------------------------------------------------------------+| (in CHF million), except per share data | H1 2009 | H1 2008 ||-----------------------------------------------+---------+---------|| Revenues and other income | 12.2 | 5.3 ||-----------------------------------------------+---------+---------|| Expenses | | ||-----------------------------------------------+---------+---------|| Cost of Sales | (0.7) | - ||-----------------------------------------------+---------+---------|| Research & Development | (44.5) | (49.0) ||-----------------------------------------------+---------+---------|| Selling, General & Administrative | (34.8) | (29.4) ||-----------------------------------------------+---------+---------|| Operating Loss | (67.8) | (73.1) ||-----------------------------------------------+---------+---------|| Net Loss | (66.5) | (67.9) ||-----------------------------------------------+---------+---------|| Cash Flow from Operating Activities | (68.2) | (66.5) ||-----------------------------------------------+---------+---------|| Basic and Diluted Loss per Share in CHF | (6.95) | (7.11) |+-------------------------------------------------------------------+

Note: Unaudited consolidated figures in conformity with US GAAP

The unaudited condensed consolidated interim financial statements ofBasilea Pharmaceutica Ltd. for the first half of 2009 can be found onthe company's website at www.basilea.com.

Ron Scott, Chief Financial Officer, commented, "Our financial resultsin the first half of 2009 reflect our successful launch of Toctino inthe first wave of European countries. We are pleased with theacceptance of Toctino by patients and physicians and we look forwardto maximizing the sales potential of Toctino as we roll out theproduct into additional countries. Our half-year financials reflect asolid cash basis, diligent cost control as well as investment inlaunches of Toctino and ZEFTERA/Zevtera. We continue to invest in thephase III clinical trials of isavuconazole and the ongoing U.S. phaseIII program of Toctino."

"We have reached a new milestone for Basilea as we report for thefirst time full six months' product sales," stated Dr. Anthony Man,CEO. "We aim to expand the availability of Toctino in second half2009 and are working together with Johnson&Johnson PRD towardsceftobiprole regulatory approval in key markets. We remain focused onour key value drivers and on successfully advancing the priorityclinical programs of our innovative pipeline."

Management reconfirms guidance for the year. Toctino® sales areestimated at around 15-20 million Swiss Francs. Net loss is estimatedat between 12-13 million Swiss Francs per month.

Product and pipeline update

Toctino® (alitretinoin) - only approved therapy for severe chronichand eczema unresponsive to topical corticosteroids

Following the submissions of pricing and reimbursement dossiers,decisions from authorities in France, Finland, Spain, Benelux,Austria and Italy are expected during the second half of 2009 andthrough 2010. Regulatory decisions on the Marketing AuthorizationApplications filed in Switzerland and Canada, and in 15 additionalEuropean countries are anticipated during the second half of 2009 andthe first half of 2010, respectively. Regulatory filings inadditional territories such as Latin America and the Middle East areplanned this year. In the U.S., the first multi-centered, controlledclinical phase III study on alitretinoin for patients with severerefractory chronic hand eczema is ongoing. Following the positiveFinal Appraisal Determination issued in July and in the absence ofany appeals a final guidance by the National Institute for Health andClinical Excellence (NICE) is expected at the end of August thisyear.

ZEFTERAT/ZevteraT (ceftobiprole) - the first approved anti-MRSAbroad-spectrum cephalosporin antibiotic for the treatment of severeskin infections

The clinical site inspections in relation to the November 2008Complete Response Letter issued to Johnson&Johnson PharmaceuticalResearch and Development, L.L.C. (PRD) by the U.S. Food and DrugAdministration (FDA) regarding the New Drug Application (NDA) and theEuropean Medicines Agency (EMEA)-led Good Clinical Practiceinspections have been completed. Subject to acceptability of theresubmission a decision by the FDA on the complete response couldoccur in the first half of 2010. The EMEA Committee for MedicinalProducts for Human Use (CHMP) could potentially issue arecommendation to the EU Commission by the end of 2009.

Isavuconazole - broad-spectrum azole-antifungal for the treatment ofsevere invasive fungal infections

Isavuconazole is currently in phase III development for the treatmentof patients with severe invasive fungal infections. Patientrecruitment to the trials was temporarily impacted by a clinicalsupply delay which has been addressed. Clinical drug supply isscheduled to be available by year-end. As a consequence recruitmenttime will be extended and phase III top-line results are anticipatedto become available in 2011.

Early-stage programs

BAL30072, a novel antibiotic against the most difficult-to-treatmulti-resistant Gram-negative bacteria, and BAL27862, a novelanti-cancer compound with activity against a broad range of tumortypes, including those unresponsive to standard therapeutics such asTaxol, are currently undergoing pre-IND (Investigational New Drug)studies. Subject to successful completion of pre-IND studies, theinitiation of phase I clinical trials is planned for the second halfof 2010.

Key events for the period January to June 2009

Toctino® (alitretinoin) - the only therapy approved for severechronic hand eczema unresponsive to topical corticosteroids

* Preliminary NICE recommendations Preliminary positive recommendations with some limitations on the use of Toctino® within its licensed indication developed by Appraisal Committee of the National Institute for Health and Clinical Excellence (NICE). * Expansion of potential European commercial availability Marketing Authorization Application submitted for Toctino® in 13 additional European Union (EU) Member States as well as in Norway and Iceland. * Inclusion in new German dermatology treatment guidelines Toctino® incorporated in the new treatment guidelines for the management of hand eczema from the German Society of Dermatology. * Acceptance for use by the Scottish Medicines Consortium Toctino® accepted by Scottish Medicines Consortium (SMC) for use within National Health Service Scotland for the treatment of adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids. The SMC considered Toctino's economic case demonstrated. * Series of European approvals Marketing authorizations received for Toctino® in Austria, Belgium, Luxemburg, the Netherlands and Spain for the treatment of adults with severe CHE unresponsive to potent topical corticosteroids.

ZEFTERAT/ZevteraT (ceftobiprole) - the first approved anti-MRSAbroad-spectrum cephalosporin antibiotic for the treatment of severeskin infections

* Arbitration claims filed against Johnson&Johnson Arbitration claims filed against Johnson&Johnson over its handling of ceftobiprole clinical studies. * Review process in EU delayed European Medicines Agency (EMEA) halted the European Commission decision process on ceftobiprole for the treatment of complicated skin and soft tissue infections pending completion of Good Clinical Practice inspections.

BAL30072 - novel antibiotic against multi-resistant Gram-negativebacteria

* New data presented at ECCMID New in-vitro efficacy data on BAL30072 were presented at the European Congress of Clinical Microbiology and Infectious Disease (ECCMID).

Conference call

Basilea Pharmaceutica Ltd. invites you to participate in a conferencecall on Friday, August 14, 2009, 4 p.m. (CEST), during which thecompany will discuss today's press release.Dial-in numbers are:

+41 (0) 91 610 56 00 (Europe and ROW)+1 (1) 866 291 4166 (USA)+44 (0) 207 107 0611 (UK)

A playback will be available 1 hour after the conference call untilMonday, August 17, 2009, 6 p.m. (CEST). Participants requesting adigital playback may dial:

+41 (0) 91 612 4330 (Europe)+1 (1) 866 416 2558 (USA)+44 (0) 207 108 6233 (UK)

and will be asked to enter the ID 17790 followed by the # sign.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland,and listed on the SIX Swiss Exchange (SIX: BSLN). Basilea's integratedresearch and development operations are currently focused on newantibacterial, antifungal and oncology agents to fight drugresistance and on the development of dermatology drugs. Basilea'sproducts are targeted to satisfy high medical and patient needs inthe hospital and specialty care setting. The company owns adiversified portfolio including two commercialized drugs (Toctino®,ZEFTERAT/ZevteraT) and one investigational drug in phase III(isavuconazole). Toctino® (alitretinoin) is marketed in the UnitedKingdom, Denmark and Germany and is approved in Austria, Belgium,Finland, France, Luxemburg, the Netherlands and Spain. Alitretinoinhas been recommended for approval in Italy and is under regulatoryreview in Canada, Switzerland and 15 additional European countries.Furthermore a phase III clinical trial on alitretinoin for thetreatment of severe chronic hand eczema is ongoing in the U.S.Ceftobiprole is marketed in Canada under the brand name ZEFTERATand in Switzerland under ZevteraT. Marketing applications forceftobiprole were submitted in the U.S., the EU and several othercountries. The company has set up commercial organizations in UK,Denmark, Germany and Canada, while it is building sales and marketingorganizations in other countries to commercialize alitretinoin and toco-promote ceftobiprole, subject to approval.

Disclaimer

This communication expressly or implicitly contains certainforward-looking statements concerning Basilea Pharmaceutica Ltd. andits business. Such statements involve certain known and unknownrisks, uncertainties and other factors, which could cause the actualresults, financial condition, performance or achievements of BasileaPharmaceutica Ltd. to be materially different from any futureresults, performance or achievements expressed or implied by suchforward-looking statements. Basilea Pharmaceutica Ltd. is providingthis communication as of this date and does not undertake to updateany forward-looking statements contained herein as a result of newinformation, future events or otherwise.

For further information, please contact:

+-------------------------------------------------------------------+| Media Relations | Investor Relations ||----------------------------------+--------------------------------|| Jean-Christophe Britt, Ph.D. | Barbara Zink, Ph.D. || Corporate Communication & Public | Head Corporate Development || Relations | +41 61 606 1233 || +41 61 606 1354 | investor_relations@basilea.com || media_relations@basilea.com | |+-------------------------------------------------------------------+

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