BASEL, Switzerland, Aug. 24, 2006 (PRIMEZONE) -- Basilea Pharmaceutica Ltd. (SWX:BSLN) reports interim financial results. Three compounds planned to be in phase III by year-end.
Highlights of the six month period include:
-- Positive phase III results in complicated skin infections for
ceftobiprole - March 2006
-- Commencement of ceftobiprole phase III program in community
acquired pneumonia - May 2006
-- U.S. Food and Drug Administration (FDA) fast track designation for
BAL8557 - May 2006
-- Completion of patient accrual in first alitretinoin phase III study
- May 2006
-- Compelling safety and drug-drug interaction data for BAL8557
presented at ISHAM -June 2006
Ceftobiprole
The first comparative phase III trial of ceftobiprole for the treatment of complicated severe skin and soft tissue infections (cSSSI) showed high clinical cure rates including infections due to confirmed methicillin-resistant Staphylococcus aureus (MRSA). Ceftobiprole also demonstrated a good safety profile. A second ongoing cSSSI study includes patients with diabetic foot ulcers to broaden the labeling to include Gram-negative pathogens.
The development program for ceftobiprole was further expanded by opening a phase III study for the treatment of patients with community-acquired pneumonia requiring hospitalization, a common infection in which the incidence of MRSA is rising due to increase in community-associated MRSA.
Ceftobiprole is being developed in collaboration with Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
BAL8557
Invasive fungal infections are associated with high mortality rates. The FDA assigned fast track status to Basilea's antifungal, BAL8557, to support its expeditious development in patients with these severe infections. The compound's broad spectrum of activity, safe intravenous ("i.v.") dosage form together with the good safety and drug-drug interaction profile formed the basis of the fast track designation. The availability of an oral and i.v. dosing form at daily or weekly dosing intervals allows the tailoring of treatment schemes to the clinical setting and adds convenience for patients and physicians.
BAL8557's phase III trial program is planned to be initiated by year-end and will include trials for the treatment of invasive yeast and mold infections.
Alitretinoin
The European/Canadian pivotal trial program completed patient accrual in the largest randomized placebo-controlled study ever performed in patients suffering from severe chronic hand dermatitis who do not respond to topical corticosteroids. More than 1,000 patients entered into this trial that comprises a treatment phase of once-daily oral alitretinoin for 12 to 24 weeks, and an additional observational follow-up period to assess duration of response.
Investment in R&D programs in line with expectations
During the first half of this year, Basilea invested CHF 39.0 million in research and development activities, in line with expectations. Research and development expenses were mainly incurred through conducting alitretinoin phase III clinical trials and preparing BAL8557 phase III clinical trials. Total operating expenses in the first half of 2006 amount to CHF 44.9 million (2005: CHF 40.4 million).
Basilea recognized revenues of CHF 3.9 million in the first half of 2006, including CHF 2.6 million from the release of deferred revenue related to the upfront and milestone payments received from Johnson & Johnson in 2005 for ceftobiprole. Revenues decreased compared to the first half of 2005, as the Company received non-recurring revenues in the first half of 2005 related to the licensing agreement with Johnson & Johnson.
Combined cash and short-term investments totaled CHF 210.3 million at the end of June 2006 compared to CHF 229.6 million as of December 31, 2005.
Key figures
In CHF million, except per share data H1 2006 H1 2005 Cash flow from Operating Activities (33.8) 61.9 Revenues 3.9 19.6 Expenses Research & Development (39.0) (36.8) General & Administrative (5.9) (3.7) Operating Loss (41.0) (20.9) Net Loss (39.8) (20.5) Basic and Diluted Loss per Share, in CHF (5.24) (2.78) Notes: Unaudited consolidated figures in accordance with US GAAP
Commenting on the half-year results, Dr. Anthony Man, CEO of Basilea, said, "The financial and operational results announced today are in line with our budget. Commercial success depends on confirming competitive advantages through robust clinical results. We have wisely focused our financial resources on creating compelling phase II and III data. Basilea's three late-stage molecules address high medical needs. Our significant clinical progress reflects our strong commitment to patients through efficiently bringing our novel molecules closer to the market."
About Basilea
Basilea Pharmaceutica Ltd. (SWX:BSLN) is an independent biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange. Basilea's fully integrated research and development operations are currently focused on new antibacterial and antifungal 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 setting. The company owns a diversified product portfolio including three products for severe medical indications in late stages of clinical development.
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.
Half-year report
Basilea hereby informs its shareholders and market participants that its 2006 Interim Report is available on the internet (www.basilea.com) and can be consulted at, or ordered from the registered offices of Basilea Pharmaceutica Ltd., Grenzacherstrasse 487, CH-4058 Basel, Switzerland.
Conference call
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Thursday, August 24, 2006, 4 p.m. (CET), during which the company will discuss its 2006 financial interim results. Dial-in numbers are:
+41 (0) 91 610 5600 (Europe and ROW) +1 (1) 866 291 4166 (USA) +44 (0) 20 7107 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 (0) 866 416 2558 (USA) +44 (0) 20 7108 6233 (UK)
and will be asked to enter the ID 145 followed by the pound sign.
This press release can be downloaded from www.basilea.com