BIOCEO15: BioLineRx Ltd. CEO Touts New Celiac Drug, Fleshes Out Novartis AG Partnership Terms

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February 10, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Israeli clinical stage biopharma BioLineRx will be rolling out a new strategy for Celiac disease and has added new color to its recently inked partnership with Swiss behemoth Novartis, Chief Executive Officer Kinneret Savitsky told a conference panel in New York on Tuesday.

Savitsky made the comments as part of a panel at the 17th Annual BIO CEO and Investor Conference at the Waldorf-Astoria in New York City. Last year, BIO CEO, a well-known annual schmooze-fest for the biotech community, had more than 1,400 attendees from 26 different countries, with around 750 investors and around 1,820 partnering meetings scheduled, according to event organizers.

BIOCEO15: BioLine CEO Touts New Celiac Drug, Fleshes Out Novartis AG Partnership Terms

Savitsky specifically outline the way BioLine’s experimental drug BL-7010 targets gluten in an effort to help patients who have Celiac disease, a rare and extremely painful reaction to an inability to digest gluten (see images). She and Chief Financial and Operating Officer Philip Serlin also outlined the progress of its other two flagship drugs (see images) and provided and update on the nearly two-month-old partnership with Novartis.

BioLineRx’s is perhaps best known for its experimental heart drug, BL-1040, a therapy designed to prevent pathological cardiac remodeling following a myocardial infarction. That drug has already been out-licensed to Bellerophon BCM (f/k/a Ikaria) and is in the midst of a pivotal CE-Mark registration trial. BioLineRx has also seen some success with cancer drug BL-8040, 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.

BIOCEO15: BioLine CEO Touts New Celiac Drug, Fleshes Out Novartis AG Partnership Terms

The world of Israeli biotech is celebrated the major deal in December, after Novartis said it would take a 12.8 percent stake in Jerusalem-based clinical stage biopharma BioLineRx Ltd. for $10 million. The two companies said that under the terms of the deal, they will enter into a multi-year strategic collaboration agreement for pre-clinical and early clinical therapeutic projects through clinical proof-of-concept.

The deal is a significant move toward establishing a larger global footprint in the region for international pharmaceutical companies looking to get a piece of the development and commercialization of Israeli-sourced drug candidates.

Locally, BioLineRx is a good fit for any global company looking to make inroads to Israel’s vast technological resources and skilled life sciences workforce. The company is well known in the biotech and medical communities in Israel, and has what it described as “close and long-lasting ties” with academic institutions, hospitals and biomedical companies in Israel, as well as rumored collaboration with the massive Israeli military complex.

BIOCEO15: BioLine CEO Touts New Celiac Drug, Fleshes Out Novartis AG Partnership Terms

The new partnership is a good fit for the company, said Savitsky in a statement.

“This is a transformative collaboration for BioLineRx. Recognition by Novartis, the global leader for innovative therapeutics, is a further validation of our drug development capabilities, our business model, and our 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,” she said.

“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.”

BIOCEO15: BioLine CEO Touts New Celiac Drug, Fleshes Out Novartis AG Partnership Terms

Under the terms of the agreement, Novartis acquired an initial 5,000,000 American Depositary Shares of BioLineRx in a private transaction at a price of $2 per share. Under the terms of the agreement, Novartis and BioLineRx will cooperate together on clinical and pre-clinical stage projects presented by BioLineRx presented via a Joint Steering Committee.

Projects at or reaching the clinical stage will be eligible for selection by Novartis, at which point Novartis will pay BioLineRx an option fee of $5 million, as well as fund 50 percent 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,” said the company in a statement, adding that currently the two firms intend to develop up to three programs pursuant to this collaboration.


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