Tokyo, Japan, February 24, 2010 - Astellas Pharma Inc. (“Astellas”; headquarters: Tokyo; President and CEO: Masafumi Nogimori) announced today that it has entered into a license, co-development and co-promotion agreement with Basilea Pharmaceutica International Ltd. (“Basilea”; a subsidiary of Basilea Pharmaceutica Ltd. (headquarters: Basel, Switzerland; CEO: Dr. Anthony Man)) for Basilea’s isavuconazole on a worldwide basis, including an option for Japan.
Isavuconazole, an azole antifungal agent, is currently undergoing international phase III trials with centers in the US, Europe and other regions in patients with invasive fungal infections caused by Aspergillus or other filamentous fungi (mold infections) and Candida fungi (yeast infections).
Pre-clinical and clinical data generated to date indicate that isavuconazole shows high oral bioavailability; this provides an option to develop both an intravenous infusion and oral capsules. Isavuconazole has predictable and dose proportional pharmacokinetics that are important in helping to achieve adequate therapeutic drug levels in patients with life-threatening fungal infections.
Under the terms of the agreement, Astellas is granted exclusive rights to develop and commercialize isavuconazole in the territory whereas Basilea retains an option to co-promote the product in the US, Canada, major European countries and China. Astellas will pay an upfront of CHF 75 million and up to CHF 478 million on achievement of pre-specified development and sales milestones. Astellas will also pay double-digit tiered royalties on sales.
The companies will jointly participate in the development of isavuconazole. Astellas will lead the development and contribute the majority of the investments required for completing the clinical development program investigating isavuconazole, and Basilea will contribute the remaining development costs. Basilea will initially manage manufacturing. Astellas has the right to take over the management of manufacturing and will bear manufacturing costs for commercial supply and commercialization costs.
Invasive fungal infections are life-threatening. Immunocompromised individuals including cancer or transplant patients are at special risk of acquiring life-threatening fungal infections, mainly caused by Candida and Aspergillus species, which are associated with mortality rates between 30% and 90%. It has been shown that early treatment with effective antifungals reduces patient mortality.
Astellas already has experience in the development and marketing of Anti-Infective agents through the worldwide launch of its antifungal agent Mycamine® (micafungin), and in November 2009, the launch in the United States of an antibiotic VIBATIVTM (telavancin). VIBATIV is a once-daily injectable antibiotic for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by gram-positive pathogens including MRSA. Astellas is liaising with regulatory authorities to bring telavancin to patients in Europe as part of its ongoing commitment to challenging infectious diseases. This new partnership is an important step to further expand our business and to reinforce Astellas’ presence and commitment in the area of infectious diseases.