For Immediate Release
PHARMION CORPORATION LAUNCHES VIDAZA (AZACITIDINE FOR INJECTABLE SUSPENSION
Tuesday, July 6, 2004
BOULDER, CO -- Pharmion Corporation today announced that it commenced its U.S. commercial launch of Vidaza on July 1 with the shipment of initial supplies of the recently- approved drug.
"We are pleased to make Vidaza available to physicians and the patients who can benefit from its use," said Patrick J. Mahaffy, president and chief executive officer of Pharmion. "We believe Vidaza represents an important new option for patients being treated for Myelodysplastic Syndromes, who, until now, have had no approved therapies available for the treatment of this very serious and life-threatening disease."
Pharmion received full approval from the U.S. Food and Drug Administration (FDA) to market Vidaza for the treatment of all five subtypes of Myelodysplastic Syndromes ( MDS ) on May 19, 2004 . These subtypes include: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS)(if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
Pharmion recently expanded its field organization to 75 people to support the launch of the drug. This field organization includes sales representatives, field-based management, medical science liaisons and payer reimbursement specialists.
Pharmion expects it will submit its application with the European Medicines Evaluation Agency (EMEA) for the use of Vidaza to treat patients with MDS during the second half of 2004. The Company also continues to enroll patients in its Phase III /IV clinical trial comparing the effect of Vidaza to conventional care options on survival in patients with high-risk MDS . The study, which will examine survival outcomes as well as secondary endpoints, will recruit more than 350 patients at treatment centers across Europe , Australia and the U.S. , and is one of the largest studies to date in this disease.
Important Safety Information
Vidaza is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol and in patients with advanced malignant hepatic tumors.
In clinical studies, the most commonly occurring adverse reactions were nausea (70.5%), anemia (69.5%), thrombocytopenia (65.5%), vomiting (54.1%), pyrexia (51.8%), leukopenia (48.2%), diarrhea (36.4%), fatigue (35.9%), injection site erythema (35.0%), constipation (33.6%), neutropenia (32.3%) and ecchymosis (30.5%). Other adverse reactions included dizziness (18.6%), chest pain (16.4%), febrile neutropenia (16.4%), myalgia (15.9%), injection site reaction (13.6%), aggravated fatigue (12.7%) and malaise (10.9%).
Because treatment with Vidaza is associated with neutropenia and thrombocytopenia, complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle.
Because Vidaza is potentially hepatotoxic in patients with pre-existing hepatic impairment, caution is needed in patients with liver disease. In addition, the active ingredient in Vidaza -- azacitidine -- and its metabolites are substantially excreted by the kidneys and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.
Vidaza may cause fetal harm. While receiving treatment with Vidaza, women of childbearing potential should avoid becoming pregnant, and men should avoid fathering a child. In addition, women treated with Vidaza should not nurse.
About MDS
MDS is a bone marrow disorder characterized by the production of abnormally functioning, immature blood cells. The highest prevalence of MDS is in patients over 60 years of age. According to the American Cancer Society and the Aplastic Anemia and MDS International Foundation, there are an estimated 10,000-30,000 new cases of MDS in the United States each year. Survival ranges from six months to many years for the different subtypes of MDS . MDS can result in death from bleeding and infection in the majority of patients, and transformation to acute myelogenous leukemia ( AML ) occurs in up to 40 percent of patients. The prognosis for patients transforming to AML is exceptionally poor.
About Pharmion
Pharmion is a pharmaceutical company focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the U.S. , Europe and additional international markets. For additional information about Pharmion, please visit the company's website at http://www.pharmion.com.
For more information or complete prescribing information about Vidaza, please call 1-866-PHARMION.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Pharmion's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include the status and timing or regulatory approvals for Thalidomide Pharmion 50mg and Vidaza; the impact of competition from other products under development by Pharmion's competitors; the regulatory environment and changes in the health policies and structure of various countries; acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of products newly launched, currently being sold or in development; Pharmion's ability to successfully acquire rights to, develop and commercialize additional pharmaceutical products; fluctuations in currency exchange rates, and other factors that are discussed in Pharmion's filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and Pharmion undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
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