Basilea Announces Global Partnership With Astellas for Its Antifungal Isavuconazole
Basilea Pharmaceutica AG / Basilea announces global partnership with Astellas for its antifungal isavuconazole processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Basilea (SWISS: BSLN) announced today that Basilea Pharmaceutica International Ltd. has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc. (TSE: 4503) 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. Isavuconazole is given by intravenous infusion or oral capsules with high oral bioavailability that provides an option for intravenous-oral step-down. The drug has predictable and dose proportional pharmacokinetics that are important to ensure adequate therapeutic drug levels in patients with life-threatening fungal infections. Human studies to-date suggest the potential for fewer clinical drug-drug interactions. The intravenous dose form has the potential to be given safely to patients with renal impairment.
The clinical program includes three international phase III trials with centers in the U.S., Europe and other regions that target respectively, yeast infections (candidemia / invasive candida infections), mold infections (invasive aspergillosis) and finally rare molds and renally impaired patients with aspergillosis.
Recently, an Independent Data Safety Monitoring Board recommended the continuation of the phase III clinical trial of isavuconazole for the treatment of invasive Aspergillus infections based on a futility analysis of the first 180 patients.
Isavuconazole has been granted fast track designation by the U.S. Food and Drug Administration (FDA).
About invasive fungal infections
Invasive fungal infections are life-threatening. Immunocompromised individuals like cancer or transplant patients are at special risk of acquiring fungal infections, mainly caused by Candida and Aspergillus species and associated with mortality rates between 30% and 90%. It has been shown that early treatment with highly effective antifungals reduces patient mortality.
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Wednesday, February 24, 4 p.m. (CET), during which the company will discuss today's press release.
Dial-in numbers are:
+41 (0) 91 610 56 00 (Europe and ROW)
+1 (1) 866 291 4166 (USA)
+44 (0) 207 107 0611 (UK)
A playback will be available 1 hour after the conference call until Friday, February 26, 6 p.m. (CET). Participants requesting a digital playback may dial:
+41 (0) 91 612 4330 (Europe)
+1 (1) 866 416 2558 (USA)
+44 (0) 207 108 6233 (UK)
and will be asked to enter the ID 10203 followed by the # sign.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX: BSLN). Basilea'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.
The company owns a diversified portfolio including two commercialized drugs (Toctino®, ZEFTERATM/ ZevteraTM) and one investigational drug (isavuconazole) in phase III clinical development. Toctino® (alitretinoin) is marketed in Denmark, France, Germany, Switzerland and the United Kingdom and is approved in Austria, Belgium, Canada, Finland, Luxemburg, the Netherlands and Spain. Toctino® has been recommended for approval in 16 European countries. Furthermore, a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S.
Ceftobiprole is marketed in Canada under the brand name ZEFTERATM and in Switzerland under ZevteraTM. Basilea has set up commercial organizations in Canada, France, Germany, the Nordics, Switzerland and the United Kingdom, while it is building sales and marketing organizations in other countries to commercialize alitretinoin.
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Astellas has approximately 15,000 employees worldwide. The organization is committed to becoming a global category leader by rapidly establishing a business model in urology, immunology & infectious diseases, neuroscience, DM complications & metabolic diseases and oncology. Astellas has discovered an over-active bladder (OAB) medication, Vesicare® and an immunosuppressive agent, Prograf® (tacrolimus), which have enabled them to become an established leader in both urology and transplant. For more information on Astellas Pharma Inc., please visit www.astellas.com/en.
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.