Basilea Pharmaceutica International Ltd has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc for Basilea's azole antifungal agent isavuconazole in phase-III clinical development for the treatment of life-threatening invasive fungal infections on a worldwide basis, including an option for Japan.
Under the terms of the agreement, Basilea will receive an upfront payment of CHF 75 million and will be eligible to receive up to CHF 478 million in additional payments on achievement of pre-specified development and sales milestones. Basilea will also receive significant double-digit tiered royalties on sales. Astellas is granted an exclusive right to commercialize isavuconazole whereas Basilea retains an option to co-promote the product in the United States, Canada, major European countries and the People's Republic of China. Basilea and Astellas 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 in the treatment of patients with invasive fungal infections caused by Aspergillus or other filamentous fungi (mold infections) and Candida fungi (yeast infections). 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.
"Astellas has a successful track record in developing and commercializing antifungals in the hospital sector internationally. We look forward to work together with Astellas to achieve isavuconazole's full potential as a novel therapeutic option for treating serious and life-threatening fungal infections. This partnership further validates the unique and highly competitive profile of isavuconazole and its potential as a best-in-class antifungal," said Dr Anthony Man, CEO Basilea Pharmaceutica Ltd. "The financial contribution from this partnership allows us to further expand Basilea's commercial efforts in key markets as needed as well as advance our promising pipeline projects."
"We are excited to be working with Basilea to develop and commercialize isavuconazole for the treatment of life-threatening invasive fungal infections," said Masafumi Nogimori, president and CEO, Astellas Pharma Inc. "Astellas has already experience in the development and marketing of the echinocandin antifungal agent Mycamine (micafungin) worldwide and is committed to focus on infectious diseases. This partnership is an important step to further expand our business and to reinforce our franchise in infectious diseases."
Pre-clinical and clinical data generated to date indicate that isavuconazole has the potential to overcome many limitations of current therapies for the treatment of invasive fungal infections.
Basilea Pharmaceutica's integrated research and development operations are currently focused on new antibacterial, antifungal and oncology 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 and specialty care setting.
Astellas Pharma is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.