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EMA Orphan Approval Path Seems More Twisty After Pfizer/Protalix’s Elelyso Stumbles

This article was originally published in The Pink Sheet Daily

Executive Summary

The European Medicines Agency will not recommend Pfizer/Protalix’s Elelyso for type 1 Gaucher, maintaining that it is too similar to Shire’s Vpriv, despite the firms’ argument that their product offers better bone marrow data and alleviates shortage concerns.

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CDC panel recommends combined regimen of Pfizer’s Prevnar 13 and Merck’s Pneumovax 23 in immunocompromised adults; FDA issues “complete response” letters and completes review of compounded hydroxyprogesterone.

Pfizer/Protalix’s Elelyso Offers Gaucher Patients A Vegetarian Option

Gaucher disease enzyme-replacement therapy Elelyso is the first FDA-approved plant-cell based recombinant therapeutic protein, a biosimilar option that may eliminate the production-related problems Genzyme’s Cerezyme and Shire’s Vpriv face with animal cell-based processes. Pfizer is launching Elelyso at a 25% discount to Cerezyme and promising to maintain a two-year supply.

Pfizer Thinks Small: Partnership With Protalix On Gaucher Drug Eyes Cheaper Plant-Based Production

Pfizer's licensing deal with Protalix for global rights to the enzyme replacement therapy taliglucerase for the treatment of Gaucher disease, announced Dec. 1, signals the drug giant's interest in the orphan drug space. It also plays into the company's biosimilar strategy, given that taliglucerase will likely be positioned as a lower-cost alternative to Genzyme's Cerezyme (imiglucerase)


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