Pfizer, Protalix near Elelyso supply deal in Brazil
Pfizer ($PFE) and Protalix ($PLX) are near a coup for their new Gaucher disease drug Elelyso. According to Globes, the Israel-based company and its behemoth partner are negotiating a supply deal with the Brazilian government. If the deal is signed within a few days, as Globes' sources say, it would be worth "hundreds of millions" to the companies.
It's not clear how many years' worth of supply that those "hundreds of millions" would represent. Sanofi's ($SNY) Gaucher treatment, Cerezyme, racked up €163 million ($207.5 million) in worldwide sales for the third quarter alone, but it has dominated the market for years, supply problems notwithstanding. And Gaucher disease is a rare disorder, with an estimated 10,000 patients worldwide, according to Pfizer.
But then again, as a rare-disease remedy, Elelyso sells at a premium. When FDA approved the drug in May, Pfizer said it would be priced at a 25% discount to Cerezyme in the U.S., but that's still $150,000.
The Brazilian deal would be a welcome victory for Elelyso. Earlier this month, the European Commission officially rejected the drug, after a recommendation to that effect from the Committee for Medicinal Products for Human Use (CHMP). The decision wasn't based on safety or efficacy, but on Europe's orphan-drug framework. Shire's Gaucher treatment Vpriv is the designated Gaucher orphan drug, with 10 years of exclusivity. Pfizer was unable to persuade European officials to countermand that rule.
- read the Globes news
Protalix scores $25M milestone from Pfizer
Pfizer aims at Genzyme with Gaucher drug approval
FDA OK for Gaucher drug opens new market for Pfizer, Protalix
Genzyme wins key FDA approval for new plant