BASEL, Switzerland, Aug. 24, 2005 (PRIMEZONE) -- Basilea realizes CHF 95.9 million from Johnson & Johnson under ceftobiprole license agreement in the first half of 2005; cash and short-term investments increase to CHF 255.1 million as of June 30, 2005.
Basilea Pharmaceutica Ltd. (SWX:BSLN) reports its interim results for the first half of 2005. The company, which is focused on the development of drugs for infectious diseases and dermatology, made significant progress in generating value from its late-stage pipeline and integrated R&D operations in the period.
Highlights of the six month period include:
Signing of a global collaboration with Cilag GmbH International, a Johnson & Johnson company, for the development, manufacture and marketing of Basilea's novel antibiotic, ceftobiprole (BAL5788). The agreement could be worth up to CHF 370 million in upfront and milestone payments and foresees royalty payments to Basilea upon commercialization.
Ceftobiprole moved into international Phase III trials in hospital-acquired pneumonia in partnership with Johnson & Johnson Pharmaceutical Research and Development, L.L.C. It is already in Phase III trials for complicated skin and skin structure infections, and has fast-track designation from the US FDA for both these indications. Ceftobiprole's NDA filing is anticipated in 2007.
BAL8557, a novel antifungal for severe infections targeting a broad spectrum of fungi including less common, but important pathogens, completed patient accrual in its Phase II trials for the treatment of oesophageal candidiasis. Basilea's antifungal is expected to facilitate efficient empirical treatment as it may be given both orally and via intravenous infusion, and has the potential for a favorable safety profile compared to existing treatments.
Entry into preclinical development of a new topical antibiotic for acne BAL19403.
Strong cash position and focused R&D spend
During the first half of this year, Basilea received CHF 78.0 million of the potential CHF 370 million in upfront and milestone payments under its license agreement with Cilag GmbH International for its novel broad-spectrum cephalosporin antibiotic ceftobiprole.
Those payments are recorded as deferred revenue and recognized over the term of the license agreement. Correspondingly, CHF 1.5 million of those payments was recognized as revenue during the first half of 2005. In addition, Basilea recognized revenues of CHF 17.9 million related to the reimbursement of expenses and R&D services provided under the agreement. As a result of the payments received from Johnson & Johnson, combined cash and short-term investments increased to CHF 255.1 million at the end of June 2005 (compared to CHF 203.2 million as of December 31, 2004) and net loss was reduced to CHF 20.5 million (H1 2004: CHF 31.5 million). The increase in R&D spending resulted primarily from progress in late stage development of Alitretinoin (BAL4079) for the treatment of chronic refractory hand dermatitis and BAL8557, a novel antifungal for serious fungal infections.
Key figures in CHF (millions) H1 2005 H1 2004 Cashflow from Operating Activities 61.9 (25.8) Revenues 19.6 0.1 Expenses Research & Development (36.8) (28.5) General & Administrative (3.7) (3.3) Operating Loss (20.9) (31.6) Net Loss (20.5) (31.5) Basic and Diluted Loss per Share in CHF (2.78) (4.91) Notes: Unaudited consolidated figures in accordance with US GAAP
Commenting on the half-year results, Dr Anthony Man, CEO of Basilea, said, "The results announced today confirm Basilea's progress in generating value from our late-stage development portfolio. Our deal with Johnson & Johnson underscores our ability to optimize the value of our programs. Basilea is uniquely positioned in anti-infectives with both a late-stage development portfolio plus a significant research pipeline."
An advancing pipeline
Alitretinoin, Basilea's vitamin A derivative for chronic hand dermatitis, refractory to conventional treatment, has recruited over half of the patients needed for its European/Canadian Phase III trial. There is currently no approved therapy for this condition, which affects an estimated one million patients in leading markets.
Basilea's broad spectrum antifungal, BAL8557, has completed patient accrual in its Phase II dose finding study and results are expected in the second half of 2005. Preparations for Phase III studies are underway. In addition to its clinical trial activities, Basilea is conducting preclinical studies for its novel topical acne antibiotic BAL19403. About Basilea
Basilea Pharmaceutica Ltd. (BSLN) is a biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange. Basilea was founded in October 2000 to discover, develop and bring innovative medicines to the market. The company's fully integrated research and development operations are focused on new anti-bacterial and anti-fungal agents to fight drug resistance, as well as on dermatology drugs.
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 2005 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 invites you to participate in an investor conference call on Wednesday, August 24, 2005 at 4 p.m. (CET) during which the company will discuss its 2005 interim financial results.
Dial-in numbers: +41 (0) 91 610 56 00 (Europe and ROW) +1 (1) 866 291 4166 (USA) +44 (0) 20 7107 0611 (UK)
The press release can be downloaded from www.basilea.com
The press release can also be downloaded from the following link: http://hugin.info/134390/R/1008124/155697.pdf