PRESS RELEASE Basilea Presents Compelling Clinical and Preclinical Data on its Novel Broad- spectrum Antifungal BAL8557 Basel, Switzerland, June 27, 2006 - Basilea Pharmaceutica Ltd. (SWX:BSLN) presents data on its antifungal BAL8557 showing a promising safety and drug- drug interaction profile. Additional data confirms broad-spectrum antifungal activity.
At the International Society for Human and Animal Mycology (ISHAM) meeting in Paris, Basilea presents five clinical posters demonstrating a favorable drug-drug interaction profile for BAL8557. Another four posters show BAL8557's broad-spectrum to include difficult to treat pathogens. In addition, there are two oral presentations on clinical phase II safety results and on in vitro activity towards resistant Histoplasma capsulatum, respectively. "BAL8557 has the potential to be a leading antifungal drug for the treatment of severe invasive fungal infections with its intravenous and oral formulations, a broad-spectrum and a promising drug-drug interaction profile. Because of its potential to fulfill high medical needs unmet by current therapies, BAL8557 was recently granted FDA fast track designation," stated Dr. Rienk Pypstra, Chief Development Officer at Basilea. Promising Drug-Drug Interaction Profile
Hospitalized patients requiring systemic antifungal therapies are often immunocompromised, such as HIV/AIDS, cancer or transplant patients, and receive multi-drug medications capable of producing drug-drug interactions and adverse events. Thus drug-drug interaction and safety profile are important aspects of new antifungal therapies. The studies presented at ISHAM show that BAL8557 has a promising drug-drug interaction profile. Ciclosporin and tacrolimus are frequently used and important immunosuppressant drugs in transplant medicine. BAL8557 had no significant impact on the pharmacokinetics of ciclosporin and a relatively modest effect on tacrolimus. In addition, BAL8557 did not affect the kinetics of warfarin, a widely used anticoagulant drug. Safety Results of Phase II Esophageal candidiasis Study
Excellent clinical efficacy in Candida esophagitis was published as a late-breaker at the Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) 2005. The presentation at ISHAM this week highlights in addition the good safety and tolerability profile, and the linear and therefore predictable pharmacokinetics of BAL8557. Furthermore BAL8557 did not show a prolongation of cardiac conductance, often associated with the azole class.
Selected Microbiology Highlights In vitro activity data against emerging pathogens, typically associated with high mortality are presented in two posters. BAL4815, the active principle of BAL8557, displayed consistent activity against a large collection of voriconazole-resistant zygomycetes. None of the isolates showed a Minimum Inhibitory Concentration (MIC) for BAL4815 of greater than 4 mg/L.In addition, Histoplasma capsulatum isolates with acquired resistance to fluconazole and diminished susceptibility to voriconazole were highly susceptible to BAL4815 with no cross resistance seen. Dr. Anthony Man, Chief Executive Officer of Basilea commented, "These scientific and clinical data highlight the many potential advantages and the competitive product profile of BAL8557. This is our second anti-infective asset for the hospital market and ideally complements our leading antibiotic ceftobiprole. Both products address the significant challenges of severe hospital infections faced by the medical community and highlight our commitment as a key player in the anti-infective sector."
New Scientific Data Presented on BAL8557 at ISHAM 2006
• A-565 / BAL8557 a Water-soluble Azole in a Phase II Double-blind Esophageal candidiasis Trial:
Safety, QT Analysis, and Pharmacokinetics of three Different Dosing Regimens. Schmitt-Hoffmann A, Hardenberg J, Sauer J, Viljoen J, Mitha I, Voiriot P, Heep M.
In Vitro Activity of a New Triazole, BAL8557, Against Histoplasma capsulatum Isolates
from Patients who Failed Flucanozole Therapy. Wheat LJ, Connolly P, Smedema M, Durkin M, Goldman M.
• P-0136 / Effect of BAL8557, a Water-soluble Azole Pro-drug, on the Pharmacokinetics of
Ciclosporin. Schmitt-Hoffmann A, Roos B, Sauer J, Maares J, Brown T, Spickermann J, Roehrle M, Heep M.
• P-0318 / Effect of Ketoconazole on the Pharmacokinetics of BAL4815 at Steady State after
Multiple Oral Daily Doses of BAL8557 (WSA) and Ketoconazole. Schmitt-Hoffmann A, Roos B, Sauer J, Maares J, Spickermann J, Iersel MP, Heep M.
• P-0319 / Effect of Rifampicin on the Pharmacokinetics of BAL4815 at Steady State after Multiple
Oral Daily Doses of BAL8557 (WAS) and Rifampicin. Schmitt-Hoffmann A, Roos B, Sauer J, Maares J, Spickermann J, Iersel MP, Heep M.
• P-0320 / Effect of BAL8557, a Water-soluble Azole Pro-drug (WSA), on the Pharmacokinetics of
Tacrolimus. Schmitt-Hoffmann A, Roos B, Sauer J, Maares J, Brown T, Spickermann J, Roehrle M, Heep M.
• P-0321 / Effect of BAL8557, a Water-soluble Azole Pro-drug (WSA), on the Pharmacokinetics of
S- and R-Warfarin. Schmitt-Hoffmann A, Roos B, Sauer J, Maares J, Brown T, Spickermann J, Allison M, Heep M.
In Vitro Activity of BAL4815, a New Water-soluble Broad-spectrum Triazole, Against
Opportunistic Filamentous and Dimorphic Fungi. Gonzàlez GM and Heep M.
In Vitro Activity of BAL4815 Against Zygomycetes. Warn P, Sharp A, Denning D.
• P-0556 / Comparison of the In Vitro Activity of BAL4815 and Fluconazole against Cryptococcus neoformans. De la Escalera CM, Aller AI, López-Oviedo E, Martos AI, Romero A, Castro C, Martín-Mazuelos E.
In Vitro Activity of BAL4815 (a New Azole) against Filamentous Fungi. De la Escalera
CM, Aller AI, López-Oviedo E, Martos AI, Romero A, Castro C, Cantón E, Martín-Mazuelos E.
About the Antifungal BAL8557
BAL8557, Basilea's novel broad-spectrum antifungal, is an investigational drug in development for the treatment of severe invasive fungal infections. BAL8557 is suitable for simple intravenous administration and its excellent oral absorption allows a convenient once-daily or even once-weekly dosing. Basilea successfully completed its phase II trial with both high clinical cures rates and a safety profile comparable to gold standard therapy. BAL8557 phase III trials are currently in preparation.
The Need for New Antifungal Therapies
The expansion of the immunocompromised patient population including cancer patients with chemotherapy induced neutropenia, transplant recipients receiving immunosuppressive therapy and HIV infected patients has led to an increased incidence of invasive fungal infections. In major markets alone, an estimated nine million patients are at risk for invasive fungal infections with more than two million patients treated. Currently available antifungal drugs are reported to fail in more than 50% of patients with acute invasive aspergillosis and in 20-30% of patients with candidemia. There is a high medical need to address the limitations of current therapies, most importantly the gaps in the antifungal spectrum, unwanted side effects, limited dosing flexibility as well as the development of resistance.
Basilea Pharmaceutica Ltd. (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 in the hospital market 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.
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: General Information
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