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EMA Adopts Opinion on Taliglucerase Alfa Marketing Authorization Application
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Jun
22
Despite the positive risk-benefit assessment, the Committee could not recommend Marketing Authorization due to Shire's velaglucerase alfa, which received prior Marketing Authorization with orphan drug designation for the same condition. Therefore, Shire's treatment has orphan market exclusivity in the
"While we are disappointed by the CHMP's recommendation, we are encouraged that the Committee gave a positive risk-benefit assessment. The recommendation was based solely on orphan market exclusivity and not the safety and efficacy profile of taliglucerase alfa," said
Pfizer and Protalix are dedicated to the treatment of Gaucher disease worldwide and continue to move forward with other global regulatory filings for taliglucerase alfa. Taliglucerase alfa (ELELYSO™) was approved by the
On
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments visit www.pfizer.com.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell based expression system, ProCellEx(R). Protalix's unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix's first approved product manufactured by ProCellEx, ELELYSO™ (taliglucerase alfa), an enzyme replacement therapy for the treatment of Gaucher disease, was approved for marketing by the
This release contains forward-looking statements about ELELYSO that involve substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties related to the timing of a commercial launch and market acceptance in
PFIZER DISCLOSURE NOTICE: The information contained in this release is as of
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended Protalix Forward-Looking Statement Disclaimer
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The statements in this release are valid only as of the date hereof and Protalix disclaims any obligation to update this information. These and other risks and uncertainties are detailed under the heading "Risk Factors" in Protalix's Annual Report on Form 10-K for the year ended CONTACT: Pfizer Contacts: |