Protalix Announces Elelyso (TM) (taliglucerase alfa) Approved in Australia for the Treatment of Gaucher Disease in Both Adult and Pediatric Patients

Protalix Announces Elelyso (TM) (taliglucerase alfa) Approved in Australia for the Treatment of Gaucher Disease in Both Adult and Pediatric Patients

CARMIEL, Israel, May 22, 2014 (GLOBE NEWSWIRE) -- Protalix
BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that
the Australian Therapeutic Goods Administration (TGA) has granted
regulatory approval to ELELYSO(TM) (taliglucerase alfa) for long-term
enzyme replacement therapy for both adult and pediatric patients with a
confirmed diagnosis of Type 1 Gaucher disease associated with at least
one of the following: splenomegaly, hepatomegaly, anemia,
thrombocytopenia. ELELYSO will be marketed in Australia by Pfizer Inc.,
the Company's commercialization partner.

Taliglucerase alfa was approved by the U.S. Food and Drug
Administration in May 2012 for adults with Type 1 Gaucher disease. With
this TGA decision, the drug is now licensed in ten countries and
further regulatory filings are underway.

"Australia is the first country in which ELELYSO is indicated for both
adult and pediatric patients as the pediatric trials were completed
concurrently with the commencement of the TGA's review," said Dr. Einat
Brill Almon, Protalix's Senior Vice President, Product Development. "In
other countries where ELELYSO is currently approved, label expansions
are being filed to include pediatric patients as well."

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

"The Australian approval of ELELYSO is an important achievement and a
testament to our successful partnership with Pfizer," said Dr. David
Aviezer, Protalix's President and Chief Executive Officer. "We are
delighted that the TGA has approved ELELYSO for the treatment of
Gaucher disease, providing an alternative treatment option for these

Indication for ELELYSO in the United States

ELELYSO(TM) (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 United States

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

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

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

This product information is intended only for residents of the United

You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit, 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.

About Protalix

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 product manufactured by ProCellEx,
taliglucerase alfa, was approved for marketing by the U.S. Food and
Drug Administration (FDA) in May 2012, by Israel's Ministry of Health
in September 2012, by the Brazilian National Health Surveillance Agency
(ANVISA) in March 2013, by the Mexican Federal Commission for the
Protection against Sanitary Risk (COFEPRIS) in April 2013, by the
Australian Therapeutic Goods Administration (TGA) in May 2014 and by
the regulatory authorities of other countries. Marketing applications
for taliglucerase alfa have been filed in additional territories as
well. Protalix has partnered with Pfizer Inc. for the worldwide
development and commercialization of taliglucerase alfa, excluding
Israel and Brazil, where Protalix retains full rights. Protalix's
development pipeline includes the following product candidates:
PRX-102, a modified version of the recombinant human alpha-GAL-A
protein for the treatment of Fabry disease; PRX-112, an
orally-delivered glucocerebrosidase enzyme that is produced and
encapsulated within carrot cells, also for the treatment of Gaucher
disease; pr-antiTNF, a similar plant cell version of etanercept
(Enbrel(R)) for the treatment of certain immune and inflammatory
diseases, such as rheumatoid arthritis, Crohn's disease, colitis,
psoriasis and other autoimmune and inflammatory disorders; PRX-110 for
the treatment of Cystic Fibrosis; and others.

Forward Looking Statements

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 terms "anticipate," "believe,"
"estimate," "expect," "plan" and "intend" and other words or phrases of
similar import are intended to identify forward-looking statements.
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. These statements are
based on our current beliefs and expectations as to such future
outcomes. Drug discovery and development involve a high degree of risk.
Factors that might cause material differences include, among others:
risks and uncertainties related to the timing of a commercial launch
and market acceptance of taliglucerase alfa in Australia and other
countries; risks relating to the review process of other foreign
regulatory and other governmental bodies; risks relating to delays in
other foreign regulatory authorities' approval of any applications
filed for taliglucerase alfa or refusals to approve such filings, as
well as the decisions of such regulatory authorities regarding labeling
and other matters that could affect the availability of taliglucerase
alfa or its 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; the dependence on performance by third party providers of
services and supplies relating to the commercialization of
taliglucerase alfa in Australia; the inherent risks and uncertainties
in developing drug platforms and products of the type we are
developing; the impact of development of competing therapies and/or
technologies by other companies and institutions; potential product
liability risks, and risks of securing adequate levels of product
liability and other necessary insurance coverage; and other factors
described in our filings with the U.S. Securities and Exchange
Commission. The statements in this release are valid only as of the
date hereof and we disclaim any obligation to update this information.

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         The Trout Group, LLC
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         MacDougall Biomedical Communications
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