2010 a crucial year for biomed

Israeli companies await trial results and FDA approval.

2009 saw many impressive achievements for Israel's biomed sector, and 2010 will be a crucial year for many of the sector's companies. Several pharmaceutical companies, for example, expect their clinical trial results.

These include Biocancell Therapeutics Ltd. (TASE:BICL), which reported that its intermediary results for a Phase II clinical trial for its treatment for bladder cancer are expected before the end of 2009. In actual fact the results will probably be received in the coming months.

NasVax Ltd. (TASE:NSVX) announced six weeks ago that it has complete patient recruitment for its clinical trial and the results will be received in several months. Nasvax is conducting a Phase II trial for an improved flu vaccination for adults.

Quark Pharmaceuticals Ltd. announced that by 2010 one of its products will reach Phase III clinical trials, and it is not referring to its AMD lung disease product that it is developing with Pfizer Inc. (NYSE: PFE; LSE: PFZ), which will only end trials in 2011. The company has three additional products in trial - two for protection against kidney damage and the other for protecting nerve cells in the eye from degenerative diseases, such as glaucoma.

Prolor Biotech Inc. (Bulletin Board: PBTH) (formerly Modigene) has entered Phase I clinical trials on a long-life growth hormone, and the company has said in the past that it hopes to complete this trial by 2010.

Other companies such as D-Pharm Ltd. (TASE: DPRM), Clal Biotechnology Industries Ltd. (TASE: CBI) portfolio company Andromeda Biotech Ltd. and stem cell therapy company Gamida Cell Ltd. are all expected to complete clinic trials by 2011, although intermediary results may be reported in 2010. Molecular imaging company Aposense Ltd. will also complete a Phase II clinical trial in 2010.

Waiting for answers from the FDA

A number of Israeli companies are awaiting a response about their products from the Us Food and Drug Administration (FDA). Kamada Ltd. (TASE:KMDA), for example, is waiting for FDA approval for ATT for the treatment of multiple sclerosis through stimulation. The company is also likely to receive trial results during 2010 on the efficacy for the same product using inhalation.

Protalix Biotherapeutics Inc. (AMEX:PLX) is also awaiting FDA approval for its product for treating Gaucher's disease, which should be received very soon.

Several companies are already gearing up for major deals, and some of them are in advanced stages of negotiations. BiolineRX Ltd. (TASE:BLRX) hope to commercialize its BL 1020 drug for treating schizophrenia in the first half of 2010.

Can-Fite BioPharma Ltd. (TASE:CFBI) is looking for a partner for its advanced trial for a psoriasis treatment, and such an agreement if reached is likely to be in the first half of 2010. The company also has a number of Phase II clinical trials in various stages of progress.

Another CBI portfolio company Polyheal Ltd., which recently received good results in its clinical trial for treating chronic wounds, is also conducting negotiations with a foreign company.

Medigus Ltd. (TASE:MDGS) also expects to conclude a partnership agreement with a foreign company, in its case the Japanese firm Hoya. At the same time, Medigus expects to receive FDA approval for its non-invasive treatment for heartburn.

On top of all this in March the tender will close for the government's biomed fund, an event which may well cause a political storm in the coming months.

Published by Globes [online], Israel business news - www.globes-online.com - on January 4, 2010

© Copyright of Globes Publisher Itonut (1983) Ltd. 2010

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