HQ Team
September 19, 2024: The US-based Biomedical Advanced Research and Development Authority will help Switzerland’s Basilea Pharmaceutica Ltd., to develop antifungals and antibacterials with an initial funding of $29 million.
A multi-year Other Transaction Agreement (OTA) allows for potential funding of up to $268 million over 12 years to develop the assets of the Allschwil-based commercial-stage company, according to a statement.
The BARDA is part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services. As a result of the agreement, Basilea increased its revenue guidance for the full year 2024.
“Basilea has been working with BARDA since 2013,” said David Veitch, Chief Executive Officer of Basilea.
Two antifungal candidates
“In continuing this partnership through an OTA, we will be leveraging our strong portfolio and the capabilities of our organization to develop urgently needed novel antifungals and antibacterials. We believe this long-term partnership will also lead to the successful implementation of our strategy to become a leading anti-infectives company.”
The initial BARDA funds of $29 million have been committed to support the development of the antifungals fosmanogepix and BAL2062. BARDA’s financial contribution is assumed to be about 60% of the total costs over the term of the OTA.
Under the OTA, BARDA and Basilea can jointly decide to move candidates into and out of the portfolio based on product performance, technical risk, and programmatic need.
“This flexibility results in significant time, effort, and cost savings for both partners,” according to the statement.
“The BARDA reimbursements will be reported under other revenue, resulting in increased total revenue and unchanged operating expenses. Also, additional deferred taxes are recognized due to the expected positive effect of the OTA on the company’s medium-term financial outlook.”
High morbidity
Fosmanogepix, available in both intravenous and oral forms, is a clinical-stage antifungal. It has received Fast Track and Orphan Drug designations from the US Food and Drug Administration for seven separate indications and is designated as a Qualified Infectious Disease Product (QIDP) for the treatment of four indications.
BAL2062 is an antifungal derived from a natural product and has demonstrated fungicidal activity against clinically important moulds. The drug candidate has QIDP, Orphan Drug and Fast Track designation for invasive aspergillosis.
Invasive aspergillosis and invasive infections with rare moulds are life-threatening infections that predominantly affect immunocompromised patients.
It also includes patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.