Protalix BioTherapeutics, Inc.
) 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
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
) 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
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
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,
), a Zacks Rank #2 stock, looks well-positioned.
NOVO-NORDISK AS (NVO): Free Stock Analysis
PFIZER INC (PFE): Free Stock Analysis Report
PROTALIX BIOTHR (PLX): Free Stock Analysis
SHIRE PLC-ADR (SHPG): Free Stock Analysis
To read this article on Zacks.com click here.