PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[genisi]

FDA tries to speed access to Protalix Gaucher drug

http://www.reuters.com/article/marketsNews/idINN0624836120090706?rpc=44

* FDA asks Protalix to speed access to Gaucher drug

* FDA says Protalix drug meets expanded access criteria

* FDA action to offset likely shortages of Genzyme drug

BOSTON, July 6 (Reuters) - Biotechnology company Protalix BioTherapeutics Inc (PLX.A: Quote, Profile, Research, Stock Buzz) said on Monday it has been approached by the U.S. Food and Drug Administration to expand access to its experimental drug for Gaucher disease to help offset likely shortages of an alternative drug make by Genzyme Corp (GENZ.O: Quote, Profile, Research, Stock Buzz).

Genzyme, which makes Cerezyme, the world's leading treatment for Gaucher disease, a rare but serious disorder, recently announced it would shut down its plant in Boston after a virus halted production of Cerezyme and Fabrazyme, its treatment for Fabry disease.

Protalix said the FDA has asked the company to consider submitting a treatment protocol that would allow use of its experimental treatment prGCD under an expanded access program. Under this program, a treatment protocol may be submitted for a drug that has not yet been approved but is in development for a serious disease for which no other therapy is available.

The company said it is discussing the parameters of a proposed treatment protocol which would allow an increased number of patients with Gaucher disease to have access to prGCD, which is in late-stage development.

Protalix said the FDA indicated it believes the company's development program for prGCD satisfies the regulatory criteria required to supply prGCD for expanded access.

Genzyme has said it expects its Boston plant will be on line in late July, with shortages of Cerezyme expected to hit in August. Shortages of Fabrazyme will likely start to be seen in September or October.

Cerezyme is Genzyme's biggest selling product and one of the world's most expensive drugs. Cerezyme and Fabrazyme represented about 37 percent of the company's 2008 revenue of $4.6 billion.