Sources inform “Globes” that drug development company BiolineRX Ltd. (TASE:BLRX) is negotiating with US pharmaceutical giant Merck for the commercialization of one of its two leading drugs, BL 1020 for the treatment of schizophrenia. BioLineRX declined to comment on the report.
Senior representatives of Merck have already visited BioLine and have begun the due diligence process, and the two companies have already reached understandings regarding the commercialization conditions for the deal. Agreement is now dependent on the scientific due diligence that Merck is carrying out, during which the global pharmaceutical company will conduct its own trials. At the same time BioLine is also holding talks with others.
If and when a deal is signed, it will earn BioLineRX an initial payment of more than $10 million, full funding of development, and milestone payments worth several tens of millions of dollars, even before the product reaches the market. Subsequently, the company would receive royalties from sales so that the deal could be worth hundreds of millions of dollars. The drug is in Phase IIb clinical trials, with interim results expected in the third quarter of 2009.
In a presentation made by BioLine several weeks ago, the company said that it aimed to commercialize at least one of its two most advanced drugs by the end of 2009. The company’s second leading drug is BL 1040 for rebuilding heart tissue for heart attack sufferers. It is possible that both drugs will be commercialized by the end of the year.
There are many schizophrenia drugs on the market, both patented and without patents. But although the market is very competitive, there is no existing product which is thought to provide a fully successful solution to the problem. There are two families of effective medications, but each one has harsh side effects.
BioLine will be able to compete successfully on this market only if can present results, which are as effective as existing drugs, but with significantly less side effects. The IIa phase of the clinical trial, which involved 36 patients, showed outstanding statistical effectiveness and a small number of side effects. Previous safety trials were also completed with a small number of side effects.
BioLine shares rose 12% yesterday on the Tel Aviv Stock Exchange, and are up 4.55% in late morning trade today.
Published by Globes [online], Israel business news - www.globes-online.com - on January 8, 2009
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