SOURCE: Basilea Pharmaceutica AG

August 22, 2007 12:15 ET

Basilea Reports 2007 Interim Results

BASEL, SWITZERLAND--(Marketwire - August 22, 2007) - Basilea Pharmaceutica Ltd. (SWX: BSLN) announces its 2007 interim financial results - Basilea prepares to commercialize its product candidates.

Basilea Pharmaceutica Ltd. announced today its 2007 interim financial results reflecting its activities in establishing an international sales and marketing organization and in manufacturing registration and commercialization material for its product candidates. Basilea continued to achieve major milestones in the first half of 2007 announcing positive phase III clinical trial results for ceftobiprole and alitretinoin and regulatory filings of ceftobiprole in the U.S., Europe and Canada together with its partner Johnson & Johnson. Regulatory filings for alitretinoin are expected for the second half of 2007.

Financial Summary

Combined cash and short-term investments amounted to CHF 366.0 million as of June 30, 2007, compared to CHF 176.6 million at year-end 2006. In addition, the Company held long-term bank deposits of CHF 105.0 million. The increase in available funds results mainly from net proceeds in the amount of CHF 310.1 million from a secondary offering, that was completed in March 2007.

Research and development expenses amounted to CHF 60.6 million in the first half of 2007 compared to CHF 39.0 million in the prior year period. This increase resulted primarily from initiation of the phase III clinical program for isavuconazole, as well as from expenses of CHF 10.6 million related to the manufacturing of alitretinoin commercialization material. General and administrative expenses amounted to CHF 10.8 million in the first six months of 2007 reflecting initial set up costs for an international sales and marketing organization. The net loss in the first half of 2007 consequently amounted to CHF 64.4 million compared to CHF 39.8 million in the respective period in 2006. Basic and diluted loss per share amounted to CHF 7.40 for the first six months in 2007 as compared to CHF 5.24 in the first half of 2006.

The decrease in net cash used for operating activities compared to the prior year period is mainly the result of a CHF 24.5 million milestone payment received related to the regulatory filing of ceftobiprole in the U.S., as well as from changes in working capital.

Key Figures

+-------------------------------------------------------------+
|                                         | H1 2007 | H1 2006 |
| (in CHF million), except per share data |         |         |
|-----------------------------------------+---------+---------|
| Revenues                                |     3.4 |     3.9 |
|-----------------------------------------+---------+---------|
| Expenses                                |         |         |
|-----------------------------------------+---------+---------|
|                  Research & Development |  (60.6) |  (39.0) |
|-----------------------------------------+---------+---------|
|                General & Administrative |  (10.8) |   (5.9) |
|-----------------------------------------+---------+---------|
| Operating Loss                          |  (68.1) |  (41.0) |
|-----------------------------------------+---------+---------|
| Net Loss                                |  (64.4) |  (39.8) |
|-----------------------------------------+---------+---------|
| Cash Flow from Operating Activities     |  (28.0) |  (33.8) |
|-----------------------------------------+---------+---------|
| Basic and Diluted Loss per Share in CHF |  (7.40) |  (5.24) |
+-------------------------------------------------------------+

Notes: Unaudited consolidated figures in conformity with US GAAP

The unaudited condensed consolidated interim financial statements of Basilea Pharmaceutica Ltd. for the first half of 2007 can be found on the company's website at http://www.basilea.com.

Ron Scott, Chief Financial Officer, commented, "Our results in the first half of 2007 were in line with our expectations reflecting our pre-marketing activities and our investment in our late-stage clinical compounds. We invested significant amounts in the first half of 2007 for alitretinoin launch material and the establishment of an international sales and marketing organization. In addition, we invested in phase III clinical trials for isavuconazole, our third compound to enter phase III. Operating loss consequently increased in the first half of 2007 compared to the prior period, as expected. The achievement of a regulatory filing milestone for ceftobiprole, together with our partner Johnson & Johnson, resulted in a payment of CHF 24.5 million reducing cash used from operations."

"Our financial results reflect the solid execution against our plans to prepare for our international sales and marketing organization and the potential launch of ceftobirole and alitretinoin as well as our full commitment to bring isavuconazole through its last stage of clinical development", stated Dr. Anthony Man, CEO.

Product highlights for the six-month period include:

Ceftobiprole - Anti-MRSA Broad-spectrum Antibiotic

* Top-line results of second pivotal phase III trial in complicated skin and skin structure infections (cSSSI) demonstrated that ceftobiprole monotherapy was as effective as a broad-spectrum two-drug combination therapy covering Gram-positive, including methicillin-resistant Staphylococcus aureus (MRSA) infections, Gram-negative infections and difficult-to-treat diabetic foot infections.

* A New Drug Application (NDA) for ceftobiprole was submitted to the U.S. Food and Drug Administration (FDA) for the proposed treatment of cSSSI including diabetic foot infections.

* The Swiss health authority Swissmedic granted ceftobiprole an accelerated assessment of the planned market authorization application.

* A Marketing Authorization Application (MAA) was submitted to the European Medicines Agency (EMEA) for the proposed treatment of complicated skin and soft tissue infections (cSSTI) including diabetic foot infections.

Alitretinoin - Chronic Hand Eczema Compound

* Results of the pivotal phase III study demonstrated that alitretinoin was highly effective in treating patients suffering from severe refractory chronic hand eczema (CHE).

* Results of the second pivotal phase III study showed that patients suffering from severe CHE and who eventually relapse after initial response to alitretinoin, benefited from re-treatment.


Products in Pre-registration and Phase III Development

Ceftobiprole is Basilea's lead antibacterial product and is the first of a new class of anti-MRSA broad-spectrum cephalosporin antibiotics. It is specially designed to inhibit penicillin-resistant targets in many Gram-positive cocci, resulting in potent bactericidal activity towards MRSA and penicillin-resistant Streptococcus pneumoniae (PRSP). In clinical trials, ceftobiprole has demonstrated a broad-spectrum profile targeting other Gram-positive and Gram-negative pathogens. In addition, it has shown a low potential to select resistance in vitro. In the trials, ceftobiprole was well tolerated with a safety profile consistent with the cephalosporin class of antibiotics. FDA granted ceftobiprole fast track designation for the treatment of hospital-acquired (nosocomial) pneumonia, including ventilator-associated pneumonia due to suspected or proven MRSA.

Ceftobiprole is currently in clinical phase III testing in hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) and in hospitalized patients with community-acquired pneumonia (CAP) with anticipated completion in the second half of the year. In addition, ceftobiprole's safety and efficacy is being investigated in patients with febrile neutropenia.

Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag GmbH International. Ortho-McNeil, Inc., will market ceftobiprole in the U.S. and Janssen-Cilag companies will market the product in Europe and Asia. Basilea has exercised its co-promotion rights for ceftobiprole in North America and major European countries, and maintains an option to co-promote the drug in Japan and China.

Alitretinoin is an investigational drug being developed by Basilea as a novel treatment for severe refractory Chronic Hand Eczema (CHE), a complex disease for which no effective treatment options are currently available. Alitretinoin has been shown to be effective and generally well tolerated in phase II and phase III clinical studies in patients with severe refractory CHE. Alitretinoin is a teratogen and therefore pregnancy prevention measures must be in place for all women of child-bearing potential who receive alitretinoin. Within days after discontinuation of therapy, alitretinoin levels return to endogenous levels. In clinical studies the post-treatment contraceptive period was four weeks.

Isavuconazole has a potent and broad spectrum of activity against both yeasts and molds. This new triazole is developed as a water-soluble pro-drug to allow intravenous administration without contraindication in renally impaired patients. In addition, taken as convenient once daily or once weekly capsules, the prodrug results in rapid and complete absorption and distribution of isavuconazole to infected tissues. Basilea successfully completed its phase II trial with both high clinical cures rates and a safety profile comparable to gold standard fluconazole therapy and with a more flexible dosing schedule. Clinical drug interaction studies have illustrated attractive pharmacokinetic features and the potential for less drug-drug interactions than a number of broad-spectrum antifungal drugs in current use. Isavuconazole is in phase III testing with two global primary-treatment phase III trials for the treatment of invasive yeast and mold infections.

About Basilea

Basilea Pharmaceutica Ltd. is an integrated biopharmaceutical company headquartered in Basel, Switzerland, listed on the SWX Swiss Exchange (SWX: BSLN). Our focus is on the discovery, development and commercialization of innovative medicines to satisfy high medical and patient needs in the hospital and specialty pharmaceutical setting. Basilea has a diversified product portfolio including novel treatments for resistant bacterial infections, systemic fungal infections and severe skin diseases. The highly competitive product pipeline comprises one drug candidate in pre-registration, two in clinical phase III and substantial early-stage programs. Basilea is currently building its sales and marketing organization in the U.S. and major European markets to promote alitretinoin and co-promote ceftobiprole.

Conference Call

Basilea Pharmaceutica Ltd. invites you to participate in a conference call on August 23, 2007, 4 p.m. (CET), during which the company will discuss today's press release.

Dial-in numbers are:
+41 (0) 91 610 5600    (Europe und ROW)
+1  (1) 866 291 4166  (USA)
+44 (0) 207 107 0611 (UK)

The playback will be available 1 hour after the conference call for
48 hrs. 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 581 followed by the # sign.

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.

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

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