>>EMEA Grants Orphan Drug Designation to BioCryst's Fodosine(TM) for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
Tuesday February 6, 7:30 am ET
BIRMINGHAM, Ala., Feb. 6 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX - News) today announced that Fodosine(TM) has been granted orphan status for the treatment of cutaneous T-cell lymphoma (CTCL), by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA).
This is the second indication for which the EMEA has granted orphan drug status to Fodosine(TM) following regulatory submissions by Mundipharma, BioCryst's European Fodosine(TM) partner. In November 2006, the EMEA granted orphan drug designation to Fodosine(TM) for the treatment of T-cell acute lymphoblastic leukemia (ALL).
Fodosine(TM), BioCryst's lead oncology candidate, is currently being studied in clinical trials for indications including T-cell acute lymphoblastic leukemia (T-ALL), cutaneous T-cell lymphoma (CTCL), B-cell acute lymphoblastic leukemia (B-ALL) and chronic lymphocytic leukemia (CLL). In January 2007, BioCryst initiated a pivotal phase IIb clinical trial with Fodosine(TM) in the treatment of patients with relapsed or refractory T-cell leukemia/lymphoma.
The EMEA's "Orphan Medicinal Product Designation" is designed to promote the development of drugs, which may provide "significant benefit" to patients suffering from rare diseases identified as "life-threatening or very serious." Under EMEA guidelines, Orphan Medicinal Product Designation provides 10 years of potential market exclusivity if the product candidate is approved for marketing in the European Union. Orphan status also permits EMEA assistance in optimizing the candidate's clinical development through participation in designing the clinical protocol and preparing the marketing application. Additionally, a drug candidate designated by the EMEA as an Orphan Medicinal Product may qualify for a reduction in regulatory fees as well as a European Union-funded research grant.
"The EMEA's decision to grant Fodosine(TM) orphan drug designation for the treatment of patients with CTCL signifies another important step for BioCryst and Mundipharma in our development of Fodosine(TM)," said Jon P. Stonehouse, CEO of BioCryst. "This action by the EMEA reinforces our belief that Fodosine(TM) has worldwide potential to become an important treatment alternative for patients with this debilitating disease."
In 2005, the United States Food and Drug Administration (FDA) granted Orphan Drug designation to Fodosine(TM) for three indications: T-cell non- Hodgkin's lymphoma, including CTCL; CLL and related leukemias including T-cell prolymphocytic leukemia, adult T-cell leukemia, and hairy cell leukemia; and for the treatment of B-ALL. Additionally the FDA has granted "fast track" status to the development of Fodosine(TM) for the treatment of relapsed or refractory T-cell leukemia.
About Fodosine(TM)
Fodosine(TM) is a transition-state analog inhibitor of the target enzyme purine nucleoside phosphorylase (PNP). The drug is currently being studied in clinical trials for indications including T-cell acute lymphoblastic leukemia (T-ALL), cutaneous T-cell lymphoma (CTCL), B-cell acute lymphoblastic leukemia (B-ALL) and chronic lymphocytic leukemia (CLL).
In early 2006, BioCryst entered into a strategic collaboration with Mundipharma International Holdings Limited to develop and commercialize Fodosine(TM) in markets across Europe, Asia, Australia and certain neighboring countries for use in oncology.
About Mundipharma
Mundipharma is one of the Purdue/Mundipharma/Napp independent associated companies -- privately owned companies and joint ventures covering the world's pharmaceutical markets. The companies worldwide are dedicated to bringing to patients with severe and debilitating diseases the benefits of novel treatment options in fields such as severe pain, haemato-oncology and respiratory disease. For more information: www.mundipharma.co.uk <<
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