: Media Contact

Pfizer And Protalix BioTherapeutics Announce

FDA Approval Of Pediatric Indication For ELELYSO (taliglucerase alfa) For Injection, For Intravenous Use For The Treatment

Of Type 1 Gaucher Disease

NEW YORK, N.Y., & CARMIEL, Israel, August 28 - Pfizer

Inc. (NYSE:PFE) and Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX, TASE:PLX) announced today that the U.S. Food and Drug Administration

(FDA) approved ELELYSO (taliglucerase alfa) for injection for pediatric patients. ELELYSO is therefore now indicated for

long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.

"The approval of ELELYSO to treat pediatric patients with

Type 1 Gaucher disease provides physicians another treatment option for this rare and potentially debilitating disease,"

said Rory O'Connor, Senior Vice President, Global Medical Affairs, Global Innovative Pharma Business, Pfizer Inc. "This

pediatric indication, along with the recent announcement that ELELYSO received kosher certification by the Orthodox Union (OU),

reinforces the ongoing commitment of Pfizer to addressing the needs of the Gaucher community."

The safety and efficacy of ELELYSO were assessed in fourteen

pediatric patients with Type 1 Gaucher disease in two clinical trials. The first trial consisted of nine patients in a 12-month,

multi-center, double-blind, randomized study in treatment-na ve patients aged two to 13 years. At the end of the 12-month

study, therapeutic efficacy of ELELYSO was demonstrated, as measured by a decrease in spleen and liver volume and an increase in

platelet count. A second trial consisted of 5 pediatric patients aged 6 to 16 years who were switched from imiglucerase to ELELYSO.

The trial was a 9-month, multi-center, open-label, single-arm study in patients who had been receiving treatment with imiglucerase

at dosages ranging from 9.5 units/kg to 60 units/kg every other week for a minimum of 2 years. ELELYSO was administered for 9 months

at the same dose as each patient's previous imiglucerase dose. If needed, adjustment of dosage was allowed during the study

in order to maintain stability of clinical parameters. Mean spleen and liver volume, platelet count and hemoglobin value remained

stable through 9 months of ELELYSO treatment.

The recommended dosage of ELELSYO for treatment-na ve adult

and pediatric patients four years of age and older is 60 units per kg of body weight administered every other week as a 60 to 120

minute intravenous infusion.

Patients previously treated on a stable dosage of imiglucerase

are recommended to begin treatment with ELELYSO at that same dosage when they switch from imiglucerase to ELELYSO. Dosage adjustments

can be made based on achievement and maintenance of each patient's therapeutic goals.

Serious hypersensitivity reactions, including anaphylaxis, have

occurred in some patients treated with ELELYSO. The most common adverse reactions for ELELYSO in clinical trials were itching,

flushing, headache, joint pain, pain in extremity, abdominal pain, vomiting, fatigue, back pain, dizziness, nausea and rash. Vomiting

occurred more often in pediatric patients than adults.

"While Type 1 Gaucher disease can manifest in childhood

or adulthood, the disease more often presents during childhood," said Paige Kaplan, MB, BCh, Section of Biochemical Genetics

(Metabolic Diseases), Children's Hospital of Philadelphia. "It is important that children with this disease have access to

a range of FDA-approved treatment options that are effective."

As part of its ongoing commitment to helping address the unmet

medical needs of people with rare diseases, Pfizer also offers a specialized support program -- called Gaucher Personal Support

(GPS) -- for people living with Gaucher disease. Pfizer GPS is a one-stop resource for personalized patient support and specialty

pharmacy services for patients and healthcare professionals. Pfizer GPS employs a dedicated and caring team of healthcare specialists

who are available to help patients with Gaucher disease and their caregivers with reimbursement assistance, coordinating and locating

infusion services and ongoing pharmacy support. Using Pfizer GPS, patients and healthcare professionals can access all support

services 24/7 using one toll-free phone number, 1-855-ELELYSO (1-855-353-5976).

ELELYSO for injection is supplied as 200 units per vial and

is available by prescription only.

For more information about Gaucher disease, please visit www.ELELYSO.com.

ELELYSO is indicated for long-term enzyme replacement

therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.

IMPORTANT SAFETY INFORMATION

Serious hypersensitivity reactions including anaphylaxis have

occurred in some patients treated with ELELYSO (taliglucerase alfa) for injection, for intravenous use. When treated with ELELYSO

your doctor should monitor you before and after infusion for reactions.

Medical support should be readily available when ELELYSO is

given. Discontinue ELELYSO immediately if you show signs or symptoms of anaphylaxis during infusion and get immediate medical care.

Signs and symptoms of anaphylaxis included hives, low blood pressure, flushing, wheezing, chest tightness, nausea, vomiting and

Signs and symptoms of hypersensitivity included itching, swelling

under the skin, flushing, redness, rash, nausea, vomiting, cough, chest tightness and throat irritation. These reactions occurred

up to 3 hours after the start of infusion

Management of hypersensitivity reactions is based on the severity

of the reaction. Your doctor may manage the reactions by slowing or temporarily stopping the infusion, and/or treating with medications

such as an antihistamine, a fever reducer and/or corticosteroids for mild reactions. Treatment with antihistamines and/or corticosteroids

prior to infusion with ELELYSO may prevent these reactions from reoccurring. If severe hypersensitivity reactions occur, immediately

stop the infusion of ELELYSO and get immediate medical care.

You should be carefully re-evaluated for treatment with ELELYSO

if serious or hypersensitivity reactions including anaphylaxis occur.

The most common adverse reactions for ELELYSO are itching, flushing,

headache, joint pain, pain in extremity, abdominal pain, vomiting, fatigue, back pain, dizziness, nausea and rash. Vomiting occurred

more often in children than adults.

The recommended dosage of ELELYSO for adults and children who

are 4 years of age and older and not taking another ERT is 60 units per kg of body weight given every other week as a 60 to 120

minute intravenous infusion.

As with all therapeutic proteins, including (enzyme replacement

therapy) ERTs, there is a possibility of developing antibodies to ELELYSO. The relationship between developing antibodies and hypersensitivity

reactions is not clear. Your doctor should monitor you for antibodies to ELELYSO if you have developed antibodies or if you have

experienced hypersensitivity reactions to ELELYSO or other ERTs.

If you are pregnant, or plan to become pregnant, you should

talk to your doctor about potential benefits and risks.

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.

For full prescribing information click here.

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.

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 and Rare Diseases

Rare diseases are among the most serious of all illnesses and

impact millions of patients worldwide, representing an opportunity to apply our knowledge and expertise to help make a significant

impact in addressing unmet medical needs. The Pfizer focus on rare diseases builds on more than a decade of experience and a global

portfolio of 22 medicines approved worldwide that treat rare diseases in the areas of hematology, neuroscience, inherited metabolic

disorders, pulmonology, and oncology.

Pfizer Inc.: Working together for a healthier world

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