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Bendamustine HCl Granted Orphan Drug Status
Orphan drug status is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases affecting less than 200,000 Americans annually. The orphan drug designation would entitle Cephalon to a seven-year period of marketing exclusivity in the United States for TREANDA, if approved by FDA for the treatment of CLL.
In the third quarter of 2007, Cephalon plans to submit a new drug application to the FDA for TREANDA for the treatment of patients with CLL. The company also is studying TREANDA for the treatment of patients with indolent (or slowly-progressing) non-Hodgkin's lymphoma (iNHL), who are refractory to the monoclonal antibody rituximab.
Cephalon is committed to advancing medications for orphan diseases. The company's first product, PROVIGIL(R) (modafinil) Tablets [C-IV], was launched with an orphan drug designation for narcolepsy in 1999. Other Cephalon therapies with orphan drug designation include TRISENOX(R) (arsenic trioxide) injection and CEP-701 (lestaurtinib), which is in development.
TREANDA is the first rationally designed purine analog / alkylator hybrid, combining the moieties of an antimetabolite and an alkylator. Preclinical data show that TREANDA induces rapid, sustained single- and double-strand DNA damage, which results in apoptosis, or programmed cell death in the tumor. TREANDA also induces mitotic checkpoint inhibition, which results in non-apoptotic cell death. These novel dual-action, anti-tumor effects of TREANDA may be attributed to its unique chemical design.