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Pfizer Inc. announced today that they are partnering with The Victor Center for the Prevention of Jewish Genetic Diseases at Einstein Medical Center Philadelphia, to support a new program called Screen for Nineteen. Through this new nationwide initiative, The Victor Center is enlisting American rabbis at synagogues, third-party organizations and college campuses across the country to help raise awareness of the importance of screening, pre-conception, for Jewish genetic diseases. One in 4 Jewish people is a carrier for at least one of 19 Jewish genetic diseases, and while the disease does not affect carriers themselves, two carriers of the same disease have a 25 percent chance with each pregnancy of having an affected child. Pre-conception screening provides people with helpful information about their status as a carrier of a Jewish genetic disease.Gaucher disease is the most common of the 19 rare, life-altering Jewish genetic diseases, for which as many as 1 in 15 people of Ashkenazi Jewish descent are carriers. In May 2012, Pfizer together with Israel-based Protalix BioTherapeutics, introduced a treatment option for the adult Type 1 Gaucher community. ELELYSOTM (taliglucerase alfa) for injection is the first plant cell-based enzyme replacement therapy for the treatment of Gaucher disease; it is manufactured in Carmiel, Israel and was approved by the U.S. Food and Drug Administration (FDA) in May 2012, and the Israeli Ministry of Health in September 2012.“We are proud to be working on this innovative program with The Victor Center and continuing our efforts to help address the unmet medical needs of people faced with rare genetic diseases, such as Gaucher disease,” said Miyeon Kim, Vice President, Established Products North America, Pfizer.The target age for pre-conception screening is 18-44 years of age. It is important for people to update their screening prior to each pregnancy, as new diseases may have become available for testing.
“The Victor Center’s aspiration is for all 18-44 year old people of Jewish heritage or partial Jewish heritage to seek genetic counseling and screening,” said Adele Schneider, M.D., Medical Director, Victor Center for the Prevention of Jewish Genetic Diseases. “Our clergy educate the community in many different ways, including premarital counseling. We believe that the support of rabbis, chaplains and cantors nationwide is instrumental in spreading the word about the importance of screening, before pregnancy, to help ensure people know their carrier status for Jewish genetic diseases.” As part of the Screen for Nineteen program, resource kits will be distributed to approximately 3,000 synagogues in the United States. The kits will include tips and talking points on how clergy can educate their congregants, brochures, pocket cards on screening for young couples, posters, a step-by-step guide to help navigate the screening process, information about “Gene Screen” (the first app for Jewish genetic diseases), as well as additional resources. Pfizer is committed to helping patients with life-altering diseases and has created a specialized program for people living with Gaucher disease called Gaucher Personal Support (GPS). GPS staffs a dedicated team of health care specialists who are available 24/7 to help Gaucher disease patients and their families with reimbursement assistance, facilitate locating infusion services, and provide ongoing pharmacy support. For more information on Pfizer’s commitment to Gaucher disease, please visit www.PfizerGaucherCommitment.com. About Jewish Genetic DiseasesThere are a number of serious rare autosomal recessive genetic diseases for which persons of Jewish heritage are more likely to be carriers than the general population. These diseases include: Bloom’s Syndrome, Canavan Disease, Cystic Fibrosis, Familial Dysautonomia, Familial Hyperinsulinism, Fanconi Anemia Type C, Gaucher Disease Type 1, Glycogen Storage Disorder Type1A, Joubert Syndrome Type 2, Lipoamide Dehydrogenase Deficiency (E3), Maple Syrup Urine Disease, Mucolipidosis Type 4, Nemaline Myopathy, Niemann-Pick Disease Type A, Spinal Muscular Atrophy, Tay-Sachs Disease, Usher Syndrome Type 3, Usher Syndrome Type 1, and Walker Warbug Syndrome. 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.INDICATIONELELYSO™ (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 INFORMATIONAs 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. Please see ELELYSO full Prescribing Information here.Pfizer Inc.: Working together for a healthier world™ At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer 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 the world’s leading biopharmaceutical company, we also 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 about our commitments visit www.pfizer.com. About the Victor Center for the Prevention of Jewish Genetic DiseasesOne in 4 Jews is a carrier for at least 1 of 19 preventable Jewish genetic diseases. The Victor Center offers genetic counseling and pre-conception screenings for these 19 diseases. On a national level, the Victor Center works in partnership with healthcare professionals, clergy and the community to create awareness about the need to be screened. There are currently Victor Centers in Philadelphia, Boston, Miami and Pittsburgh and community partnerships in Atlanta, Birmingham, and Dallas. The National Victor Center at Einstein Medical Center in Philadelphia was founded by Lois Victor.