EMEA Grants Orphan Drug Status to Active Biotech's Cancer Treatment
Active Biotech AB (OMX Nordic:ACTI) today announced that ANYARA has been granted Orphan Drug Status by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA). Orphan Drug designation provides a variety of incentives, including market exclusivity for up to 10 years following approval.
ANYARA, one of Active Biotech's lead oncology candidate drugs, is currently in clinical Phase II/III trials for the indication Renal Cancer. "EMEA's decision to grant orphan drug status for the treatment of patients with Renal Cancer is an important step in the development of ANYARA," said Sven Andréasson, CEO of Active Biotech. "It provides us with important benefits, both in preparation for a marketing application and also commercially in the form of potential market exclusivity for our technology".
Lund, July 26, 2007
Active Biotech AB (publ)
Sven Andréasson President and CEO
About EMEA's Orphan Medicinal Product Designation 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.
About ANYARA Active Biotech's ANYARA* project develops a drug for use in cancer targeted therapy, primarily for the treatment of renal cancer. A Phase II/III study is ongoing since the end of 2006. It is a randomized study of ANYARA in combination with interferon-alpha, compared with only interferon-alpha, in patients with advanced renal cancer.
The primary clinical effect parameter for this study is survival and it will include approximately 500 patients at 45 clinics in Europe. Expected survival with conventional treatment for these patients is 10-15 months and the length of the study will depend on the patients' disease progression. An interim analysis based on approximately 200 patients is scheduled for mid-2008. *naptumomab estafenatox (rINN, Recommended International Non-proprietary Name)
About Renal cell carcinoma Renal cancer affects approximately 40,000 people annually in the US and 200,000 people worldwide. The usual age of onset of the disease is between 50 and 70, and it affects more men than women. Five-year survival for non-metastatic forms of the disease is approximately 64%. If the disease has metastasized to the lymphatic glands, five-year survival declines to 5-15%. The market for treatment of renal cancer is estimated at about USD 1 billion a year (Cowen & Co.).
About Active Biotech Active Biotech AB is a biotechnology company focusing on research and development of pharmaceuticals. Active Biotech has a strong R&D portfolio with pipeline products focused on autoimmune/inflammatory diseases and cancer. Most advanced projects are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, as well as ANYARA for use in cancer targeted therapy, the primary indication being renal cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer, 57-57 for SLE and RhuDex® for RA. In addition, the preclinical development of the I-3D project is conducted in cooperation with Chelsea Therapeutics.
Active Biotech AB P.O. Box 724, SE-220 07 Lund, Sweden Tel: +46 (0)46-19 20 00 Fax: +46 (0)46-19 20 50