Pfizer and Protalix BioTherapeutics Announce Submission of taliglucerase alfa for European Marketing Authorization for the Treatment of Gaucher Disease

By Pfizer Inc., PRNE
Sunday, November 28, 2010

NEW YORK and CARMIEL, Israel, November 29, 2010 - Pfizer Inc. (NYSE: PFE) and Protalix BioTherapeutics, Inc. (NYSE-Amex:
PLX, TASE: PLX) today announced the submission of a Marketing Authorization
Application to the European Medicines Agency for taliglucerase alfa, a
plant-cell expressed form of glucocerebrosidase (GCD)for the treatment of
Gaucher disease. Taliglucerase alfa was granted Orphan Designation by the
European Commission for the treatment of Gaucher disease on March 23, 2010.

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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.

Taliglucerase alfa was granted orphan drug designation by the U.S. Food
and Drug Administration. A New Drug Application (NDA) for taliglucerase alfa
has been accepted by the FDA and assigned a Prescription Drug User Fee Act
(PDUFA) action date of February 25, 2011. Taliglucerase alfa is available to
patients with Gaucher disease in the United States under an Expanded Access
protocol as well as to patients in several member states of the European
Union, Israel and other countries under Named Patient provisions.

DISCLOSURE NOTICE: The information contained in this release is as of
November 29, 2010. Neither Pfizer nor Protalix BioTherapeutics assumes any
obligation to update forward-looking statements contained in this release as
the result of new information or future events or developments.

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. These forward-looking statements are subject to known and unknown risks
and uncertainties that may cause actual future experience and results to
differ materially from the statements made. Drug discovery and development
involve a high degree of risk. Factors that might cause material differences
include, among others, risks relating to: the review process of the U.S. Food
and Drug Administration (FDA), the European Medicines Agency (EMEA), other
foreign regulatory bodies and other governmental regulatory bodies, including
the risk that regulatory authorities may find that the data from Protalix
BioTherapeutics' clinical trials and other studies is insufficient for
regulatory approval; delays in the FDA's, the EMEA's or other health
regulatory authorities' approval of any applications Protalix BioTherapeutics
and/or Pfizer file or refusals to approve such filings, including the New
Drug Application (NDA) filed with the FDA and the Marketing Authorization
Application (MAA) submitted to the EMEA for taliglucerase alfa for the
treatment of Gaucher disease; refusals by such regulatory authorities to
approve the marketing and sale of a drug product even after acceptance of an
application filed for any such drug product; risks relating to the decisions
of the FDA, EMEA and other foreign regulatory authorities regarding labeling
and other matters that could affect the commercial availability or potential
of taliglucerase alfa; risks relating to competitive developments regarding
taliglucerase alfa; and other factors described in Pfizer's and Protalix
BioTherapeutics' filings with the Securities and Exchange Commission. Even if
favorable testing data is generated from clinical trials of drug products,
the FDA, EMEA or any other foreign regulatory authority may not accept or
approve an NDA or MAA, as applicable, filed by a pharmaceutical or
biotechnology company for such drug product.

Pfizer Contacts: Joan Campion (Media), +1-212-733-2798, Joan.Campion at, or Suzanne Harnett (Investors), +1-212-733-8009, Suzanne.Harnett at; In Europe: Lisa O'Neill, 44-1737-331536, Lisa.O'Neill at; Protalix Contacts: Marcy Nanus (Investors), The Trout Group, LLC, +1-646-378-2927, Mnanus at, or Kari Watson (Media), MacDougall Biomedical Communications, +1-781-235-3060, kwatson at

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