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UPLYSO(TM) (alfataliglicerase) Approved in Brazil by ANVISA for the Treatment of Gaucher Disease



UPLYSO(TM) (alfataliglicerase) Approved in Brazil by ANVISA for the Treatment
of Gaucher Disease

NEW YORK and CARMIEL, Israel, March 18, 2013 (GLOBE NEWSWIRE) -- Pfizer Inc.
(NYSE:PFE) and Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX)
announced today that the Brazilian National Health Surveillance Agency
(ANVISA, Agencia Nacional de Vigilancia Sanitaria) has granted regulatory
approval to UPLYSO™ (alfataliglicerase) for the long-term enzyme replacement
therapy for adults with a confirmed diagnosis of Type I Gaucher disease.
Gaucher disease is a rare lysosomal storage disorder that affects
approximately 10,000 people worldwide.

UPLYSO is known as ELELYSO™ (taliglucerase alfa) outside of Latin America.
ELELYSO was approved by the United States Food and Drug Administration in May
2012 and by Israel's Ministry of Health in September 2012 for the long-term
enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type
I Gaucher disease. The ANVISA approval comes after the approval of UPLYSO by
the Ministry of Public Health in Uruguay in November 2012.

"ANVISA's approval of UPLYSO demonstrates Pfizer's ability to successfully
bring therapies for rare diseases to the marketplace," said Diem Nguyen,
Ph.D., MBA, general manager, Pfizer Biosimilars. "We are committed to the
Gaucher community and look forward to continuing to work closely with our
partner Protalix toward our goal of bringing UPLYSO to those living with
Gaucher throughout Latin America."

UPLYSO is the first plant cell-based ERT for the treatment of Gaucher disease.
It is also the first approved plant cell-expressed drug that is derived from
ProCellEx^®, Protalix's proprietary plant cell-based protein manufacturing
system, using genetically engineered carrot cells. UPLYSO is a form of the
human lysosomal enzyme, glucocerebrosidase, used to treat Gaucher disease.

"The approval of UPLYSO provides an important treatment option for those in
Brazil using enzyme replacement therapy to manage their Gaucher disease and
demonstrates the potential of our plant cell manufacturing technology," said
David Aviezer, Ph.D., MBA, president and chief executive officer of Protalix
BioTherapeutics.

On November 30, 2009, Protalix entered into an agreement with Pfizer to
develop and commercialize taliglucerase alfa/alfataliglicerase. Under the
terms of the agreement, Protalix retained the exclusive commercialization
rights in Israel, while Pfizer received exclusive licensing rights for
commercialization in all other markets.

Indication for UPLYSO in Brazil

UPLYSO (alfataliglicerase) is indicated for long-term enzyme replacement
therapy for adults with a confirmed diagnosis of Type I Gaucher disease. The
manifestations of Gaucher disease may include one or more of the following:
splenomegaly, hepatomegaly, anemia, thrombocytopenia, bone disease.

Important Safety Information for UPLYSO in Brazil

As with any intravenous protein medicine, like enzyme replacement therapy
(ERT), UPLYSO may cause infusion-related reactions (i.e., occurring during or
shortly after infusion) and hypersensitivity reactions. If a severe allergic
reaction occurs, immediate discontinuation of the alfataliglicerase infusion
is recommended. Patients who experience reactions of hypersensitivity or
related to the infusion, can however be managed successfully. The therapy can
be continued by slowing the infusion rate, treating with medicinal products
such as antihistamines, antipyretics and/or corticosteroids, and/or stopping
and resuming treatment with decreased infusion rate. Pre-treatment with
antihistamines and/or corticosteroids may prevent subsequent reactions.

The most commonly observed infusion reactions were headache, hypersensitivity
(allergic reaction), dizziness, flushing (redness), throat irritation, nausea
(qualm), pruritus (itch), erythema (redness), rash, bone pain, back pain,
arthralgia (joint pain), among others.

Also, there is a possibility of developing antibodies to UPLYSO. However, it
is currently unclear whether this has an impact on the clinical response or
adverse reactions. Patients with an immune response to other ERTs who are
switching to UPLYSO should continue to be monitored for antibodies. Patients
who have developed infusion or immune reactions with UPLYSO or with another
ERT should be monitored for antidrug antibodies when being treated with
UPLYSO.

If you are pregnant, or plan to become pregnant, you should talk to your
doctor about potential benefits and risks.

Indication for ELELYSO in the U.S.

ELELYSO™ (taliglucerase alfa) for injection is a hydrolytic lysosomal
glucocerebroside-specific enzyme indicated for long-term enzyme replacement
therapy (ERT) for adults with a confirmed diagnosis of Type 1 Gaucher disease.

Important Safety Information for ELELYSO in the U.S.

As with any intravenous protein medicine, like enzyme replacement therapy
(ERT), severe allergic reactions (including anaphylaxis) have been observed in
patients treated with ELELYSO. If this occurs, ELELYSO should be immediately
discontinued, and appropriate medical treatment should be initiated. Patients
who have experienced anaphylaxis to ELELYSO or another ERT should proceed with
caution upon retreatment.

In addition, infusion reactions (including allergic reactions)—defined as a
reaction occurring within 24 hours of the infusion—were the most commonly
observed reactions to ELELYSO. The most commonly observed infusion reactions
were headache, chest pain or discomfort, weakness, fatigue, hives, abnormal
redness of the skin, increased blood pressure, back or joint pain, and
flushing. Other infusion or allergic reactions included swelling of the face,
mouth, and/or throat; wheezing; shortness of breath; skin color turning blue;
coughing; and low blood pressure. Most of these reactions were mild and did
not require treatment.

Management of infusion reactions is based on the type and severity of the
reaction. Your doctor may manage infusion reactions by temporarily stopping
the infusion, slowing the infusion rate, or treating with medications such as
an antihistamine and/or a fever reducer. Treatment with antihistamines and/or
corticosteroids prior to infusion with ELELYSO may prevent these reactions.

Other common adverse reactions observed were upper respiratory tract
infections, throat infection, flu, urinary tract infection, and pain in
extremities.

As with all therapeutic proteins, including ERTs, there is a possibility of
developing antibodies to ELELYSO. However, it is currently unclear whether
this has an impact on the clinical response or adverse reactions. Patients
with an immune response to other ERTs who are switching to ELELYSO should
continue to be monitored for antibodies. Comparison of the frequency of
antibodies across ERTs may be misleading. Patients who have developed infusion
or immune reactions with ELELYSO or with another ERT should be monitored for
antidrug antibodies when being treated with ELELYSO.

If you are pregnant, or plan to become pregnant, you should talk to your
doctor about potential benefits and risks.

The health information contained herein is provided for educational purposes
only and is not intended to replace discussions with a health care provider.
All decisions regarding patient care must be made with a health care provider,
considering the unique characteristics of the patient.

This product information is intended only for residents of the United States.

You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About Gaucher Disease

Gaucher disease is an inherited lysosomal storage disorder in humans that
affects an estimated 10,000 people worldwide and can cause severe and
debilitating symptoms, including: enlargement of the liver and spleen, various
forms of bone disease, easy bruising and anemia (a low number of red blood
cells). Gaucher disease consists of varying degrees of severity; it has been
sub-divided into three subtypes—Types 1, 2 and 3—according to the presence or
absence of neurological involvement. Type 1, the most common, is found at a
higher frequency among individuals who are of Ashkenazi Jewish ancestry.

Pfizer Inc.: Working together for a healthier world™

At Pfizer, we apply science and our global resources to bring therapies to
people that extend and significantly improve their lives. We strive to set the
standard for quality, safety and value in the discovery, development and
manufacture of health care products. Our global portfolio includes medicines
and vaccines as well as many of the world's best-known consumer health care
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
one of the world's premier innovative biopharmaceutical companies, we
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, please visit us at www.pfizer.com.

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 protein expression system, ProCellEx®. Protalix's
unique expression system presents a proprietary method for developing
recombinant proteins in a cost-effective, industrial-scale manner. Protalix's
first product manufactured by ProCellEx, ELELYSO™ (taliglucerase alfa), was
approved for marketing by the U.S. Food and Drug Administration on May 1,
2012, by Israel's Ministry of Health in September 2012 and by ANVISA on March
18, 2013. It also has been approved in Uruguay. Protalix has partnered with
Pfizer Inc. for the worldwide development and commercialization of ELELYSO™,
excluding Israel, where Protalix retains full rights. Marketing applications
for taliglucerase alfa have been filed in additional markets. 

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 Brazil and other countries;
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; the risk that applicable regulatory authorities may refuse to
approve the marketing and sale of a drug product even after acceptance of an
application filed for the drug product; 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, 2012.

PFIZER DISCLOSURE NOTICE: The information contained in this release is as of
March 18, 2013. 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
(generic name: alfataliglicerase in Brazil, trade name: UPLYSO in Brazil) that
involve substantial risks and uncertainties. Such risks and uncertainties
include, among other things, the uncertainties regarding the commercial
success of UPLYSO in Brazil; decisions by regulatory authorities in various
other 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, 2012 and in
its reports on Form 10-Q and Form 8-K.

CONTACT: Pfizer Contacts:
        
         Sharon Castillo (Media)
         202-494-6769
         Sharon.J.Castillo@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
        
         Marcy Beth Nanus (Investors)
         The Trout Group, LLC
         646-378-2927
         MNanus@troutgroup.com
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