Full Press Release Details
| For Immediate Release: | Pfizer Contacts: | |
| March 18, 2013 | 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 |
UPLYSO (alfataliglicerase) Approved
in Brazil by ANVISA for the Treatment of Gaucher Disease
New York, NY and Carmiel, Israel - March 18, 2013
- 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
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
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.
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