Novartis takes $10-mn equity in BioLineRx

GLOBAL pharmaceutical company Novartis Pharma AG and BioLineRx Ltd., a clinical-stage biopharmaceutical company, have entered into a multi-year strategic collaboration agreement designed to facilitate development and commercialization of Israeli-sourced drug candidates.

The companies intend to co-develop a number of pre-clinical and early clinical therapeutic projects through clinical proof-of-concept. As part of the agreement, Novartis has made an initial equity investment in BioLineRx of $10 million for 12.8% of BioLineRx’s current shares outstanding.

Jerusalem-based BioLineRX in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

Under the collaboration, Novartis will evaluate projects identified and presented by BioLineRx for co-development and potential future licensing.

Dr. Kinneret Savitsky, CEO of BioLineRx, said the transformative collaboration with the global leader for innovative therapeutics is a further validation of the BioLine RX drug development capabilities, business model, and strong track record of selecting the most promising innovative therapeutic programs stemming from Israel’s leading research institutions and biotech start-ups, and developing them towards commercialization.

“Working closely with Novartis at relatively early stages of project development will enable us to tailor our development processes to meet their needs and expectations, helping to ensure agreed upon clinical goals are met successfully,” said Dr. Savitsky.

Novartis and BioLineRx will jointly evaluate both clinical and pre-clinical stage projects presented by BioLineRx via a Joint Steering Committee, which will determine which projects to advance further in development and on what terms. Projects at or reaching the clinical stage will be eligible for selection by Novartis.

Upon selection of a project, Novartis will pay BioLineRx an option fee of $5 million, as well as fund 50% of the anticipated remaining development costs associated with establishing clinical proof-of-concept, in the form of an additional equity investment in BioLineRx.

Novartis will have an exclusive right of first negotiation to license from BioLineRx each selected project upon establishment of clinical proof-of-concept. The companies intend to develop up to three programs pursuant to this collaboration.

BioLineRx’s current portfolio consists of a variety of clinical and pre-clinical projects, including: BL-1040 for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Bellerophon BCM (f/k/a Ikaria) and is in the midst of a pivotal CE-Mark registration trial; BL-8040, a cancer therapy platform, which is in the midst of a Phase 2 study for acute myeloid leukemia (AML) as well as a Phase 1 study for stem cell mobilization; and BL-7010 for celiac disease, which has completed a Phase 1/2 study.