European Commission Issues Decision on Taliglucerase Alfa Marketing Authorization Application
November 01 2012 - 10:33AM
Pfizer Inc. (NYSE:PFE) and Protalix BioTherapeutics, Inc.
(NYSE-MKT:PLX, TASE:PLX) today announced that the European
Commission (EC) has issued a Commission Decision refusing the
Marketing Authorization for taliglucerase alfa, an enzyme
replacement therapy (ERT) for the treatment of Gaucher disease. The
EC has endorsed the European Medicines Agency (EMA)'s Committee for
Medicinal Products for Human Use (CHMP) recommendation not to issue
a Marketing Authorization for taliglucerase alfa in the European
Union. The CHMP recommendation was not related to the safety,
quality or efficacy of taliglucerase alfa, but solely to the
specific requirements of the European Union (EU) Orphan Drug
Regulation.
As first disclosed on June 22, 2012, the CHMP issued its Opinion
on taliglucerase alfa and gave a positive risk-benefit assessment
concluding that the benefits of the medicine outweighed its risks
in the treatment of Type 1 Gaucher disease. Despite the positive
risk-benefit assessment, the CHMP could not recommend Marketing
Authorization due to the fact that Shire plc (Shire)'s
velaglucerase alfa had received prior Marketing Authorization with
orphan drug designation for the same condition. Therefore, Shire's
treatment has orphan market exclusivity in the EU for a ten-year
period commencing on its authorization in August 2010. Pfizer
pursued a request for derogation from Shire's orphan market
exclusivity based on a number of factors but the request was
denied.
"We are disappointed by the EC's decision on taliglucerase alfa
and believe it is important, given the history of past shortages,
for the Gaucher disease community in the EU to have a third
treatment option available," said Diem Nguyen, General Manager,
Pfizer Biosimilars. "We will continue to work closely with our
partner, Protalix, to make taliglucerase alfa available to the
Gaucher disease community in other countries."
Pfizer and Protalix are dedicated to the treatment of Gaucher
disease and continue to move forward with regulatory filings in
other countries for taliglucerase alfa. Taliglucerase alfa
(ELELYSO™) was approved by the U.S. Food and Drug Administration in
May 2012 for the long-term enzyme replacement therapy (ERT) of
adults with a confirmed diagnosis of Type 1 Gaucher disease and was
approved by Israel's Ministry of Health in September 2012.
On November 30, 2009, Pfizer and Protalix BioTherapeutics, Inc.
entered into an agreement to develop and commercialize
taliglucerase alfa. Under the terms of the agreement, Pfizer
received exclusive worldwide licensing rights for the
commercialization of taliglucerase alfa, while Protalix retained
the exclusive commercialization rights in Israel.
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Protalix BioTherapeutics, Inc.
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
U.S. Food and Drug Administration in May 2012 and by Israel's
Ministry of Health in September 2012. Additional marketing
applications for taliglucerase alfa have been filed in other
countries.
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. Forward-looking
statements involve substantial risks and uncertainties. Such risks
and uncertainties include, among other things, the uncertainties
related to the timing of a commercial launch in Israel; decisions
by regulatory authorities in various countries regarding whether
and when to approve drug applications that have been or may be
filed for taliglucerase alfa in such countries as well as their
decisions regarding labeling and other matters that could affect
its availability or commercial potential; risks related to the
European Commission's decisions not to grant a market authorization
for taliglucerase alfa; and risks related to competitive
developments. 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 December 31, 2011 and
Quarterly Report on Form 10-Q for the quarter ended March 31,
2012.
PFIZER DISCLOSURE NOTICE: The information contained in this
release is as of November 1, 2012. Pfizer assumes no obligation to
update forward-looking statements contained in this release as the
result of new information or future events or developments.
This release contains forward-looking statements about
taliglucerase alfa (trade name ELELYSO in the United States) that
involves substantial risks and uncertainties. Such risks and
uncertainties include, among other things, decisions by regulatory
authorities in various countries regarding whether and when to
approve drug applications that have been or may be filed for
taliglucerase alfa in such countries as well as their decisions
regarding labeling and other matters that could affect its
availability or commercial potential; and competitive
developments. A further description of risks and uncertainties
can be found in Pfizer's Annual Report on Form 10-K for the fiscal
year ended December 31, 2011 and in its reports on Form 10-Q and
Form 8-K.
CONTACT: Pfizer Contacts:
Joan Campion (Media - US)
212-733-2798
Joan.Campion@Pfizer.com
Suzanne Harnett (Investors)
212-733-8009
Suzanne.Harnett@Pfizer.com
Protalix Contacts:
Kari Watson (Media)
MacDougall Biomedical Communications
781-235-3060
kwatson@macbiocom.com
Tricia Swanson (Investors)
The Trout Group, LLC
646-378-2953
TSwanson@troutgroup.com