Israel’s biomed industry can celebrate today along with Protalix. For the first time in years, a drug, Uplyso, developed by a company founded in Israel and active here has succeeded in Phase III trials, the last hurdle before registration of the drug for sale with the US Food and Drug Administration (FDA). This means that within a few months the company can start selling its Gaucher’s Disease treatment. More than that, this is vindication of the company’s unique technology for genetic engineering of drugs in plant cells.
Protalix’s chairman is a very well-known figure in the industry Eli Hurvitz, chairman of Teva, invested in the company via his Pontifax fund. Protalix is also called “the little Teva” or “the next Teva” among its fans. This is because it main activity is in producing biological drugs from plants that are identical to drugs already on the market, without infringing the patents on those drugs, and much more cheaply.
Clinical trials are usually something of a lottery, but in the case of Protalix there were already several indicators that the results would be good. The rise in the company’s share price today was therefore not all that dramatic. “We aren’t very surprised, but naturally we are happy and relived to see the results before our eyes, in tables in the FDA filing documents,” Protalix CEO Dr. David Aviezer said today.
Despite the lack of tension Aviezer describes, the fact that an Israeli-developed drug is inches from market launch is a real milestone. At present there are only two drugs on the US market that were brought there an Israeli company Copaxone and Azilect, both from Teva.
Three other drugs, Rebif, Exelon, and Doxil, were developed in Israel but commercialized by foreign companies. Circadin, developed by Neurim Pharmaceuticals, is for the time being sold only in Europe. That pretty much sums up 30 years of drug development activity in Israel.
Protalix’s drug is however a little different from the others. It is biologically identical to an existing drug, Genzyme’s Cerezyme. The difference is that it is produced from plants. Protalix’s trial was designed to be identical to the trial Genzyme carried out on its own drug. The results demonstrate that Protalix’s product is in no way inferior, either in efficacy or in safety.
Although the drug is identical to an existing one, it still represents real innovation. It is the first drug in the world to be produced by genetic engineering of plants, a field expected to develop considerably in the coming years. “This is innovative technology. The trial results very much strengthen our faith in our ability to use the same method for other products. Uplyso is just the tip of the iceberg,” Aviezer says.
Protalix will compete directly with Genzyme and with another company, Shire, which is about to launch a similar product. Protalix’s success will mainly depend on how much market share it can take from Cerezyme, which has annual sales of $1.3 billion. Much will depend on Protalix’s marketing capacity, which will be based on partnerships with established companies. According to Aviezer, talks with potential partners are already underway. He says Protalix is ready for production, and can currently supply 20% of the market (1,000 patients), and that within a year it will be able to supply 50% of total demand.
Jefferies recently estimated that sales of Protalix’s product would be $153 million in the first year, and $381 million annually by 2015.
Protalix Biotherapeutics Ltd. came into the world at the beginning of the 1990s under the name Metabogal. It was founded Professor Yossi Shaltiel in the Meitav technology incubator in Kiryat Shemona, when the incubator itself was just setting out and a long way from privatization.
Shaltiel’s technology remains the basis of the company’s activity to this day:
Published by Globes [online], Israel business news - www.globes-online.com - on October 15, 2009
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