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Financial Assistance Now Available for People with Acute Lymphoblastic Leukemia
Date:6/27/2011

GAITHERSBURG, Md., June 27, 2011 /PRNewswire-USNewswire/ -- Today, Sigma-Tau Pharmaceuticals, Inc. announced a vital new service for people with Acute Lymphoblastic Leukemia (ALL).  The Sigma-Tau Outreach Service (S.O.S.) will now refund eligible patients 100 percent of any co-pay associated with their prescription for Oncaspar®.  For more information on eligibility criteria, please call 1-800-490-3262, Monday through Friday, 9 a.m. to 5 p.m. ET.

"It is important to Sigma-Tau that families and patients accessing our medicines do not suffer financial distress," said Gregg Lapointe, Chief Executive Officer, Sigma-Tau Pharmaceuticals, Inc.  "This program is designed to ensure that patients and families battling ALL will not be burdened with co-pays tied to Oncaspar®, regardless of income."    

The S.O.S. resource provides patients, families and healthcare providers with the following free services:

Reimbursement Support:  Trained specialists will help patients understand how to effectively navigate their insurance coverage and address common issues, such as prior authorization or appeals.  Specialists also will work to identify additional benefit programs patients might be eligible to join.

Patient Assistance:  Sigma-Tau Pharmaceuticals, Inc. will provide eligible patients who cannot pay for Oncaspar® with the treatment at no charge.  

Oncaspar® Co-pay Assistance: Eligible patients will receive 100 percent reimbursement for all co-pays associated with the utilization of Oncaspar® with no limitations on family income or financial status.

"Today's insurance programs are complex.  The trained specialists available through the S.O.S. service can help people navigate insurance coverage and reimbursement concerns.  We're very proud to offer this service, so patients can focus on their treatment," said Lapointe.  

Patients and caregivers are encouraged to visit www.oncaspar.com for more information.

About Acute Lymphoblastic Leukemia (ALL):
Acute Lymphoblastic Leukemia (ALL) is a cancer of the white lymphoid blood cells, which, when normal, fight infections.  It causes the body to produce abnormal and immature white blood cells that cannot accomplish this purpose.  ALL is the most common form of leukemia found in children, representing 23 percent of cancer diagnoses in children under age 15.  It occurs in one of every 29,000 children in the United States each year.  While ALL is most common in children, people can be diagnosed with ALL at any age and the risk increases after age 45.  Over the past 35 years, the overall five year survival rate for children with ALL has greatly improved, going from less than 5 percent in the 1960s to about 85 percent today.

About Oncaspar® (pegaspargase):
While normal cells can produce asparagine, leukemic cells are unable to produce enough asparagine to survive on their own. L-asparaginase is given to ALL patients to ensure depletion of asparagine that is circulating in the blood.  Depletion (starving the leukemic cells) of asparagine ultimately results in leukemic cell death.

Oncaspar® (pegaspargase) is the only FDA-approved PEGylated formulation of L-asparaginase, the enzyme that depletes the amino acid asparagine.  For the last 25 years, L-asparaginase has been an important component in the treatment of ALL.  Oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of patients with ALL and for the treatment of patients with ALL and hypersensitivity to native forms of L-asparaginase.

Oncaspar® can be administered through intramuscular (IM) injection or intravenous (IV) infusion.  When utilized as a component of induction therapy for ALL, one dose of Oncaspar® achieved similar levels of asparagine depletion as six to nine doses of native L-asparaginase.

Oncaspar® allows patients to gain the full benefits of asparaginase therapy with less frequent dosing schedule compared with native L-asparaginase (nonPEGylated form).  Through the process of pegylation, the half-life of L-asparaginase is significantly increased and the L-asparaginase activity is sustained.  Oncaspar® is a registered trademark of Defiante Farmaceutica S.A.

Important Oncaspar® Safety Information:
Oncaspar® is contraindicated in patients with a history of serious allergic reactions to Oncaspar®, and in patients with a history of serious thrombosis, pancreatitis or serious hemorrhagic events with prior L-asparaginase therapy.

Oncaspar® should be discontinued in the case of anaphylaxis or serious allergic reactions, thrombosis or pancreatitis.  Glucose intolerance, in some cases irreversible, can occur. Coagulopathy can occur.  Perform appropriate monitoring.  The most common adverse reactions with Oncaspar® (> or = 2 percent) are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia and elevated transaminases.  

About Sigma-Tau Pharmaceuticals, Inc.:
Sigma-Tau Pharmaceuticals, Inc. is a U.S.-based, wholly owned subsidiary of the Sigma-Tau Group, and is dedicated solely to the global development and commercialization of medicines for patients with rare diseases.  Sigma-Tau Pharmaceuticals, Inc. is based in Gaithersburg, Md.  Since 1989, the company's products have been focused on rare diseases, including kidney disease, certain genetic disorders and cancers.  With more than 7,000 identified rare diseases that affect approximately 25 million patients in the United States, Sigma-Tau Pharmaceuticals, Inc. places its considerable scientific resources behind the development and commercialization of compounds that benefit the few.  The company has a substantial development program focused on transplants, cancer, inherited genetic disorders, malaria and other areas of unmet medical need.  For more information about the company, visit www.sigmatau.com.


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SOURCE Sigma-Tau Pharmaceuticals, Inc.
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