PARIS--(BUSINESS WIRE)--May 11, 2006--Diatos SA, a Paris-based international biopharmaceutical company focusing on the research and development and commercialization of targeted anti-cancer therapies, announced today an exclusive licensing agreement with Gilead Sciences, Inc. on the worldwide development and commercialization rights to DaunoXome. DaunoXome is a marketed liposomal formulation of daunorubicin, which has been approved for AIDS/HIV-related Kaposi's sarcoma and is sold by Gilead in more than 20 countries. DaunoXome has also been evaluated in clinical studies for potential efficacy and safety in acute myeloid leukemia (AML). Daunorubicin is a widely used chemotherapeutic agent used principally in hematological malignancies.
Under the terms of the agreement, Diatos was granted exclusive worldwide development and commercialization rights to DaunoXome in Kaposi's sarcoma as well as all other potential indications. In exchange, Gilead will receive upfront and milestone payments of up to $4.7 million, based on regulatory approval of new indications, and royalties on net sales.
On the basis of data derived from DaunoXome's commercial use and from various clinical studies in acute leukemic diseases, Diatos intends to seek approval from European regulatory authorities for the use of DaunoXome in acute leukemia. Acute myeloid leukaemia (AML) in particular is a common form of blood cancer affecting more than 12,000 new patients per year in Europe. Diatos intends to continue to market DaunoXome in Kaposi's sarcoma in Europe and Brazil.
John Tchelingerian, PhD, President and CEO of Diatos, commented: "The acquisition of DaunoXome is a significant milestone to accelerate Diatos' transformation into an integrated European cancer biopharmaceutical company with commercial capabilities." "We are very pleased to acquire DaunoXome and expand its therapeutic spectrum in acute leukemia, an area with high unmet medical needs", Dr Tchelingerian added.
Notes to Editors:
DaunoXome is a liposomal formulation of daunorubicin, a widely used oncology chemotherapeutic agent. Daunorubicin is a chemotherapeutic agent of the anthracycline class used to treat a large number of hematological cancers, among which acute leukemia. However, systemic administration of daunorubicin may lead to severe cardiotoxic and hematotoxic unwanted side effects, which drastically limit administered doses.
DaunoXome's liposomal formulation has been developed to improve the pharmacokinetic properties of daunorubicin. By enabling a sustained release of active daunorubicin, it allows for the administration of significantly higher doses of daunorubicin without triggering more severe side effects.
Since its initial clinical development in Kaposi's sarcoma, DaunoXome has undergone extensive clinical trials in leukemia patients, either sponsored by Gilead or by independent investigators. In these trials, DaunoXome may present a better pharmacokinetic profile as well as an improved tolerance versus the non liposomal form of daunorubicin currently used as a standard treatment, which has led to its off-label use for this patient group. In January 2006, Gilead together with independent investigator groups completed a Phase III clinical trial suggesting a better long term clinical outcome in elderly AML patients receiving DaunoXome compared to those receiving daunorubicin as first line treatment.
About Kaposi's Sarcoma
Kaposi's sarcoma is a virus-induced cancer in which tumor cells, as well as abnormal growth of blood vessels, form solid lesions in connective tissue. The dominant form is AIDS/HIV-related and it represents approximately 80% of all forms of this cancer.
About Acute Leukemia
Leukemia is cancer of the blood and the blood-forming bone marrow, characterized by an uncontrolled growth of bone marrow stem cells, whose DNA has sustained acquired genetic damage. Acute Myelogenous (or Myeloid) Leukemia, also called AML, is the most common type of acute leukemia in adults and can also occur in children. Anthracycline-based chemotherapy is the mainstay of treatment for the majority of leukemias.
About Diatos S.A.
Diatos is a product-driven biopharmaceutical company dedicated to the research, development and commercialization of novel anti-cancer therapies with enhanced tumor targeting or improved biodistribution. Diatos is expanding its portfolio of drug candidates with new compounds that utilize its Vectocell® delivery technology or its Tumor-Selective Prodrug (TSP) technology as well as with in-licensed candidate cancer therapies. Diatos is headquartered in Paris, France and operates subsidiaries in Belgium and the United States of America.
For more information on Diatos, please visit its website at www.diatos.com.
The Diatos logo and Vectocell® are trademarks of Diatos S.A.
About Gilead Sciences, Inc. (Nasdaq: GILD - News)
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
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Source: Diatos SA