SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--June 9, 2006--Hana Biosciences (Nasdaq:HNAB - News), a biopharmaceutical company focused on advancing cancer care, announced that the U.S. Food and Drug Administration has granted orphan drug designation for Ropidoxuridine (IPdR) for the treatment of malignant glioma, which makes up approximately half of all primary brain tumors. Ropidoxuridine is a novel, orally available, thymidine analogue and prodrug for IUdR, which demonstrated a survival advantage in Phase II studies in anaplastic astrocytoma, a type of brain tumor. Hana Biosciences also recently received orphan drug designation for Talotrexin for the treatment of acute lymphoblastic leukemia.
“This designation not only underscores the need for improved therapies in malignant glioma, it also reiterates the company’s development strategy in areas of unmet need. Hana Biosciences is committed to the clinical development of Ropidoxuridine in this disease,” commented Greg Berk, MD, Senior Vice President and Chief Medical Officer of Hana Biosciences.
About Orphan Drug Designation
The Orphan Drugs Act provides for economic incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the United States. Orphan drug designation entitles Hana Biosciences to seven years of market exclusivity for Ropidoxuridine in the treatment of malignant glioma. Additional incentives include tax credits related to clinical trial expenses, a possible exemption from the FDA-user fee, and assistance in clinical trial protocol design.
About Ropidoxuridine (IPdR)
Ropidoxuridine is a novel, orally available, thymidine analogue and prodrug for IUdR, which demonstrated a survival advantage in Phase II studies in anaplastic astrocytoma, a type of glioma. Preclinical studies have also demonstrated that Ropidoxuridine has dose responsive and synergistic effects when combined with radiation in human glioblastoma models. Ropidoxuridine has also shown reduced toxicity, with better tissue incorporation and improved anti-tumor activity when compared to IUdR in nonclinical models. Ropidoxuridine is currently in Phase I clinical trials in patients with colorectal, gastric, and pancreatic cancer, and other solid tumors. In addition, a Phase I/II clinical trial in malignant glioma is planned.
About Malignant Glioma
Gliomas are the most common malignant brain tumor in adults. Brain tumors are the second leading cause of cancer-related deaths in males ages 20-39 and the fifth leading cause of cancer-related deaths in women ages 20-39. Surgery is generally the first line of treatment, followed by radiation therapy and chemotherapy, either individually or in combination. Although primary treatment is often successful in temporarily stopping the progression of the tumor, gliomas almost always recur and survival rates remain low. Thus the disease remains a significant unmet clinical need in oncology.
About Hana Biosciences, Inc.
Hana Biosciences, Inc. (Nasdaq:HNAB - News) is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing innovative products to advance cancer care. The company is committed to creating value by building a world-class team, accelerating the development of lead product candidates, expanding its pipeline by being the alliance partner of choice, and nurturing a unique company culture. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that could cause Hana’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as “anticipates,” “expects,” “plans,” “believes,” “intends,” and similar words or phrases. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana’s development efforts relating to its product candidates will be successful. Other risks that may affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of Hana’s product candidates, the risk that the results of clinical trials may not support Hana’s claims, Hana’s reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2006 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.
Contact: Hana Biosciences, Inc. Remy Bernarda, 650-228-2769 (Investor Relations) fax: 650-588-2787 investor.relations@hanabiosciences.com
Source: Hana Biosciences
