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 financial
results reflecting the advancement of its two marketed products
Toctino® and ZEFTERAT/ZevteraT.

Basilea focuses on preparing additional Toctino® launches in Europe
and Canada, working towards ceftobiprole regulatory approval in key
markets as well as on bringing forward its broad-spectrum antifungal
isavuconazole currently in phase III clinical trials.

Financial summary

Combined cash and short-term investments amounted to CHF 224.9
million as of June 30, 2009, compared to CHF 293.6 million at
year-end 2008. Revenue and other income increased to CHF 12.2 million
compared to CHF 5.3 million in the prior year period, mainly as a
result of the increased product sales due to successful first
launches of Toctino® in Europe. Research and development expenses
amounted to CHF 44.5 million in the first half of 2009 compared to
CHF 49.0 million in the prior year period, mainly reflecting the
continuous investment in the phase III clinical trials of
isavuconazole and Toctino® in the U.S. General and administrative
expenses increased to CHF 34.8 million compared to CHF 29.4 million
in the first half of 2008 due to investments in commercialization of
Toctino®.

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 of
Basilea Pharmaceutica Ltd. for the first half of 2009 can be found on
the company's website at www.basilea.com.

Ron Scott, Chief Financial Officer, commented, "Our financial results
in the first half of 2009 reflect our successful launch of Toctino in
the first wave of European countries. We are pleased with the
acceptance of Toctino by patients and physicians and we look forward
to maximizing the sales potential of Toctino as we roll out the
product into additional countries. Our half-year financials reflect a
solid cash basis, diligent cost control as well as investment in
launches of Toctino and ZEFTERA/Zevtera. We continue to invest in the
phase III clinical trials of isavuconazole and the ongoing U.S. phase
III program of Toctino."

"We have reached a new milestone for Basilea as we report for the
first time full six months' product sales," stated Dr. Anthony Man,
CEO. "We aim to expand the availability of Toctino in second half
2009 and are working together with Johnson&Johnson PRD towards
ceftobiprole regulatory approval in key markets. We remain focused on
our key value drivers and on successfully advancing the priority
clinical programs of our innovative pipeline."

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

Product and pipeline update

Toctino® (alitretinoin) - only approved therapy for severe chronic
hand 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 and
through 2010. Regulatory decisions on the Marketing Authorization
Applications filed in Switzerland and Canada, and in 15 additional
European countries are anticipated during the second half of 2009 and
the first half of 2010, respectively. Regulatory filings in
additional territories such as Latin America and the Middle East are
planned this year. In the U.S., the first multi-centered, controlled
clinical phase III study on alitretinoin for patients with severe
refractory chronic hand eczema is ongoing. Following the positive
Final Appraisal Determination issued in July and in the absence of
any appeals a final guidance by the National Institute for Health and
Clinical Excellence (NICE) is expected at the end of August this
year.

ZEFTERAT/ZevteraT (ceftobiprole) - the first approved anti-MRSA
broad-spectrum cephalosporin antibiotic for the treatment of severe
skin infections

The clinical site inspections in relation to the November 2008
Complete Response Letter issued to Johnson&Johnson Pharmaceutical
Research and Development, L.L.C. (PRD) by the U.S. Food and Drug
Administration (FDA) regarding the New Drug Application (NDA) and the
European Medicines Agency (EMEA)-led Good Clinical Practice
inspections have been completed. Subject to acceptability of the
resubmission a decision by the FDA on the complete response could
occur in the first half of 2010. The EMEA Committee for Medicinal
Products for Human Use (CHMP) could potentially issue a
recommendation to the EU Commission by the end of 2009.

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

Isavuconazole is currently in phase III development for the treatment
of patients with severe invasive fungal infections. Patient
recruitment to the trials was temporarily impacted by a clinical
supply delay which has been addressed. Clinical drug supply is
scheduled to be available by year-end. As a consequence recruitment
time will be extended and phase III top-line results are anticipated
to become available in 2011.

Early-stage programs

BAL30072, a novel antibiotic against the most difficult-to-treat
multi-resistant Gram-negative bacteria, and BAL27862, a novel
anti-cancer compound with activity against a broad range of tumor
types, including those unresponsive to standard therapeutics such as
Taxol, are currently undergoing pre-IND (Investigational New Drug)
studies. Subject to successful completion of pre-IND studies, the
initiation of phase I clinical trials is planned for the second half
of 2010.

Key events for the period January to June 2009

Toctino® (alitretinoin) - the only therapy approved for severe
chronic 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-MRSA
broad-spectrum cephalosporin antibiotic for the treatment of severe
skin 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-negative
bacteria

* 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 conference
call on Friday, August 14, 2009, 4 p.m. (CEST), during which the
company 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 until
Monday, August 17, 2009, 6 p.m. (CEST). Participants requesting a
digital 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 integrated
research and development operations are currently focused on new
antibacterial, antifungal and oncology agents to fight drug
resistance and on the development of dermatology drugs. Basilea's
products are targeted to satisfy high medical and patient needs in
the hospital and specialty care setting. The company owns a
diversified portfolio including two commercialized drugs (Toctino®,
ZEFTERAT/ZevteraT) and one investigational drug in phase III
(isavuconazole). Toctino® (alitretinoin) is marketed in the United
Kingdom, Denmark and Germany and is approved in Austria, Belgium,
Finland, France, Luxemburg, the Netherlands and Spain. Alitretinoin
has been recommended for approval in Italy and is under regulatory
review in Canada, Switzerland and 15 additional European countries.
Furthermore a phase III clinical trial on alitretinoin for the
treatment of severe chronic hand eczema is ongoing in the U.S.
Ceftobiprole is marketed in Canada under the brand name ZEFTERAT
and in Switzerland under ZevteraT. Marketing applications for
ceftobiprole were submitted in the U.S., the EU and several other
countries. The company has set up commercial organizations in UK,
Denmark, Germany and Canada, while it is building sales and marketing
organizations in other countries to commercialize alitretinoin and to
co-promote ceftobiprole, subject to approval.

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.

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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http://hugin.info/134390/R/1334700/316960.pdf

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