SIGMA-TAU PHARMACEUTICALS ANNOUNCES NEW ONCASPAR® PRICING
-- Company Invests $50 Million to Avert Drug Shortage for Patients with Acute Lymphoblastic Leukemia --
GAITHERSBURG, MD – September 30, 2011 – Sigma-Tau Pharmaceuticals, Inc. today announced that it will begin distributing its biologic oncology medicine ONCASPAR® (pegaspargase) manufactured with a new Active Pharmaceutical Ingredient (API) which was recently approved by the U.S. Food and Drug Administration (FDA). The active ingredient “L-asparaginase” was approved after a complex three-year effort to redevelop, transfer and secure FDA approval of a new production process and source, after the prior manufacturer decided to cease production. The project cost more than $50 million and averted a potentially dangerous drug shortage or discontinuation. In addition to the upfront investment, the ongoing cost to manufacture the ingredient has nearly doubled as a consequence of enhancing and modernizing the previous production process, which was originated more than thirty years ago. As a result of these new developments, the Wholesale Acquisition Cost (WAC) of ONCASPAR will increase from $2,625 to $5,670 per vial, effective October 1, 2011.
ONCASPAR is a first-line treatment for people with Acute Lymphoblastic Leukemia (ALL), a disease that can occur at any age but is most common in children. Approximately 5,000 new cases of ALL are diagnosed annually in the United States. In April 2011, Sigma-Tau received approval from the FDA for a new manufacturing process for L-asparaginase.
A message from our CEO regarding the new Oncaspar pricing
The total cost of treating a patient with ALL depends on certain risk stratification criteria, which define the number of doses (vials) of ONCASPAR for a course of therapy. At the new WAC, the cost of therapy will range from $5,670 to $39,960 per patient. However, Sigma-Tau will not realize the entire benefit of this price increase. For certain government programs, such as Medicaid, and hospitals purchasing under the 340B PHS government pricing program, the price Sigma-Tau receives for ONCASPAR will actually decrease significantly as a result of this new pricing model. Approximately 45% of Sigma-Tau’s sales of ONCASPAR are subject to the mandated discounts under these government pricing programs. For example, under the Medicaid program, Sigma-Tau will receive as little as $70 per vial of ONCASPAR, or $70 to $490 for a full course of therapy. This is significantly below Sigma-Tau’s cost to manufacture the medicine.
“We are extremely pleased that we were able to complete the complex transition of ONCASPAR to a new manufacturing facility and process, ensure patients with ALL will continue to have access to this important medicine, and avoid a drug shortage along the way. We are also grateful to the FDA for their valuable input and guidance during this difficult transition,” said Gregg Lapointe, Chief Executive Officer, Sigma-Tau Pharmaceuticals, Inc. “The price change will enable Sigma-Tau to absorb increased production costs, recoup our investment over time, and to continue to invest in our other development programs in rare diseases.”
Sigma-Tau’s patient assistance and co-pay program, the Sigma-Tau Outreach Service (S.O.S.), provides eligible patients with 100% reimbursement for all co-pays associated with ONCASPAR, with no limitations on family income or financial status. In addition, the S.O.S program provides ONCASPAR free of charge to eligible patients who do not have insurance coverage or the ability to pay.
Reimbursement support, patient assistance and co-pay assistance for ONCASPAR can be accessed by calling the Sigma-Tau Outreach Service (S.O.S.) at 800-490-3262. 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. This disease 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 from
less than 5 percent in the 1960s to approximately 85 percent today.
About ONCASPAR® (pegaspargase):
While normal cells can produce asparagine, many leukemic cells are unable to produce
enough asparagine to survive on their own. L-asparaginase is often administered along
with chemotherapy to to ALL patients to deplete asparagine that is circulating in
the blood. This depletion (starving the leukemic cells) of asparagine ultimately
results in cell death of many leukemia cells.
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 acute lymphoblastic leukemia. ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia 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 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 (≥2%) are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia and elevated transaminases.
Please see full Prescribing Information attached.
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, Maryland. 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 Unites States, Sigma-Tau Pharmaceuticals 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.
Company Contact:
Marc Tewey
Sigma-Tau Pharmaceuticals, Inc
VP Commercial Operations
Email: Marc.Tewey@sigmatau.com
Phone: 301-948-1041