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Brazil Approves Pfizer-Protalix Gaucher Drug

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Pfizer Inc. (PFE) and Protalix BioTherapeutics, Inc. (PLX) recently announced the approval of their Gaucher drug, Uplyso (taliglucerase alfa), in Brazil. Uplyso has gained approval as a long-term enzyme replacement therapy for adults with a confirmed diagnosis of type I Gaucher disease.

We note that Uplyso is already approved in countries like the US, Israel and Uruguay. However, in Nov 2012, Pfizer and Protalix had announced that the European Commission issued a decision refusing the Marketing Authorization for taliglucerase alfa for the treatment of Gaucher disease.

Earlier in 2012, the European Medicines Agency (:EMA)'s Committee for Medicinal Products for Human Use (CHMP) had expressed its inability to recommend marketing authorization for taliglucerase alfa.

Although the CHMP had given a positive opinion regarding the risk-benefit profile of the enzyme replacement therapy for the treatment of Gaucher disease, the Committee said that it could not recommend marketing approval due to the presence of Shire’s (SHPG) Vpriv (velaglucerase alfa) in the market.

Vpriv, which gained EU approval in Aug 2010, has 10 years marketing exclusivity given its orphan drug status for Gaucher disease.

Pfizer and Protalix’ association dates back to late 2009 when the companies entered into a commercialization agreement. Per the terms of the agreement, Pfizer has exclusive worldwide rights for the commercialization of taliglucerase alfa in all territories excluding Israel. Uplyso is known as Elelyso in countries outside Latin America.

While Pfizer is a Zacks Rank #3 (Hold) stock, Protalix is a Zacks Rank #4 (Sell) stock. Shire, a Zacks Rank #2 (Buy) stock, looks more attractive at present. Among large-cap pharma stocks, Novo Nordisk (NVO), a Zacks Rank #2 stock, looks well-positioned.

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