Protalix has completed New Drug Application (NDA) submission with the FDA for Taliglucerase Alfa, a plant-cell expressed form of glucocerebrosidase (GCD) for the potential treatment of gaucher’s disease.
On December 1, 2009, Pfizer and Protalix entered into an agreement to develop and commercialise Taliglucerase Alfa for the treatment of gaucher’s disease. The agreement gives Pfizer exclusive worldwide licensing rights to commercialise Taliglucerase Alfa while Protalix retains commercialisation rights in Israel.
David Aviezer, president and CEO of Protalix, said: “With this submission, Protalix and Pfizer take a significant step forward in making a cost-effective treatment alternative available for gaucher’s disease patients. Our global plans include submitting additional regulatory applications for Taliglucerase Alfa in the near term.”
David Simmons, president and general manager of established products business unit at Pfizer, said: “Pfizer has assembled a team of experts with significant orphan and genetic disease experience dedicated to working with the worldwide gaucher’s disease community. Upon the receipt of regulatory approvals, we are poised to quickly make Taliglucerase Alfa available to patients suffering with gaucher’s disease who are in need of new treatment options.”
In addition, Protalix today announced the filing of its proposed pediatric investigation plan to the pediatric committee of the EMEA for a clinical study in patients between the ages of 2 and 18. This event triggers a milestone payment of $5m by Pfizer to Protalix according to the agreement between the parties. The terms of the agreement calls for $55m to be paid by Pfizer to Protalix in connection with certain regulatory milestones.
Taliglucerase Alfa has been granted orphan product designation and fast track development status by FDA. Taliglucerase Alfa is currently being provided to gaucher’s patients in the US under an expanded access protocol, as well as to patients in the EU under a compassionate use protocol.
On December 2, 2009, Protalix held a medical meeting with the principal investigators involved with the company’s Taliglucerase Alfa clinical trial program. At the event, the company shared the full Phase III trial results that were submitted to FDA in the company’s NDA filing.