FDA Grants Orphan Drug Designation for XTL's rHuEPO Treatment for Multiple Myeloma

Jun 01, 2011, 08:03 ET from XTL Biopharmaceuticals Ltd

HERZLIYA, Israel, June 1, 2011 /PRNewswire-FirstCall/ -- On May 29, 2011 XTL has announced that its rHuEPO (recombinant human erythropoietin) drug which is currently in preparations for phase 2 clinical trial, has been granted an Orphan-drug designation by the US Food and Drug Administration (FDA) for treatment of Multiple Myeloma blood cancer.

An orphan drug is defined as a drug treatment for an illness that affects a relatively small number of people in the population. In the US, an orphan drug designation is limited in connection with illnesses that affect less than 200,000 people a year.

In order to encourage the development of treatments to these diseases, regulatory authorities provide benefits and incentives for the developers. The standard benefit available for orphan drugs in the US is the right of sole exclusivity of marketing the drug for a period of 7 years from the day of FDA approval. Additional benefits include local tax credit in the US on research and development expenses, and exemption from payment of commissions to the FDA, a sub-unit of the US Department of Health & Human Services.

About XTL Biopharmaceuticals

XTL Biopharmaceuticals, Ltd., a biopharmaceutical company, focuses on the acquisition, development, and commercialization of pharmaceutical products. The Company is focused on developing a drug for the treatment of multiple myeloma and Hepatitis C. The Company has a unique treatment for multiple myeloma cancer patients based on rHuEPO, a genetically engineered version of a natural hormone produced by the kidneys. The drug has been approved for marketing by the FDA and has for many years been sold for billions of dollars across the world for the treatment of severe anemia. Additionally, the Company has an agreement with Presidio Pharmaceuticals, Inc., to develop a drug for the treatment of Hepatitis C based on the Company's DOS technology.

XTL is a public company traded on the Tel Aviv Stock Exchange (TASE: XTL) and its ADRs are quoted in the US on the Pink Sheets (Pink Sheets: XTLBY).

For further details, please contact:

XTL Investor Relations, Tel: +972-9-955-7080 or email: ir@xtlbio.com

SOURCE XTL Biopharmaceuticals Ltd