Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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.

You may also be interested in...



Regulatory News, In Brief

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)

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS074450

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel