Protalix's New Drug Likely to Win FDA Approval

Jul. 06, 2009 4:30 PM ETPLX, TEVA, SNY
Mike Huckman profile picture
Mike Huckman
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Could a carrot-chomping Bugs Bunny become a drug pitchman? Well, maybe, if the small Israeli company Protalix BioTherapeutics (PLX) could pay Warner Brothers enough money for Bugs' services. PLX also needs to first win FDA approval of its drug for the rare, genetic Gaucher disease. And today that's looking like it could happen sooner rather than later.

Protalix announced this morning that the FDA has approached the company about possibly making the late-stage experimental drug available to certain patients under a special expanded access program before it's even formally approved. The agency is reacting to the recent setback suffered by biotech giant Genzyme (GENZ), which is having manufacturing issues at the plant that makes GENZ's very expensive, but widely used blockbuster Gaucher drug, Cerezyme. Apparently the agency is trying to avoid the impact of a potential shortage of treatments.

So, what's up with Bugs? Well, Protalix's drug is made with carrot proteins. No, it doesn't have a kibbutz (a communal farm) that grows the vegetable and a bunch of juicers churning 24/7 in its labs. It's all done with a proprietary technology the company owns to possibly make drugs with plant cell-based proteins from carrots and tobacco, too. Israel's Teva Pharmaceutical (TEVA), the world's biggest generic drug company, has partnered with Protalix on a couple of things based on the technology.

Shares of PLX are up nearly 200 percent so far this year and are rallying again today to a new intra-day high on the FDA news. And the volume is relatively huge. On an average day, only around 67,000 PLX shares change hands. As I write this more than a million shares have been traded. GENZ shares are getting dinged a little again.

This article was written by

Mike Huckman profile picture
211 Followers
Mike Huckman is CNBC’s Pharmaceutical Reporter covering the drug, biotechnology and medical device industries. Huckman is based at the network’s global headquarters in Englewood Cliffs, N.J. Huckman joined CNBC in September 2000 after nine years at WXYZ-TV in Detroit where he was one of the station’s lead reporters. Prior to WXYZ-TV, he served as a general assignment reporter at KGUN-TV in Tucson, Ariz., KBCI-TV in Boise, Idaho, and as an anchor/producer for the Montana Television Network. Huckman has won numerous awards for his reporting, including three Michigan News Emmys, one for Business and Financial reporting, as well as a first place News Series Award from the Michigan Association of Broadcasters. Huckman earned a Bachelor of Arts degree in journalism from the University of Southern California.

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