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news.BioDelivery Sciences International, a specialty pharmaceutical company, has signed a research collaboration and licensing agreement with the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit foundation focused on the development of new drugs and new formulations of existing drugs for patients suffering from some of the most neglected communicable diseases.
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Drugs for Neglected Diseases initiative (DNDi) will collaborate with BDSI on a non-exclusive basis in the design and conduct of a research and clinical development program to assess the efficacy and safety of Bioral Amphotericin B for the treatment of neglected diseases like leishmaniasis and Chagas disease.
Bioral Amphotericin B utilizes BioDelivery Sciences’s (BDSI) patented Bioral drug delivery technology, which encapsulates a drug in a lipid covering to potentially facilitate the oral administration of drugs otherwise given by intravenous administration.
Under the terms of the agreement, DNDi will execute a mutually agreed upon clinical development plan for Bioral Amphotericin B and seek regulatory approvals and distribution outside the US and Europe for the diseases specified.
The agreement covers many of the poor and marginalized countries of the world. BDSI will be responsible for manufacturing and providing clinical trial materials. All costs incurred will be the responsibility of DNDi.
The data generated through the collaborative development program is expected to also assist BDSI in furthering the development of Bioral Amphotericin B for broader use in treating a variety of common systemic fungal infections which are not covered by the DNDi agreement, such as esophageal candidiasis. The first Phase I trial of Bioral Amphotericin B was completed in December 2008 and results are expected to be announced within the next several weeks.