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  • Competitor - Spectrum Pharmaceutical s - Irvine, CA US - 10-K - 2008: We are a commercial stage biopharmaceuti cal company committed to developing and commercializin g innovative therapies with a focus primarily in the areas of hematology-onc ology and urology. We have a fully developed commercial infrastructure that is responsible for the sales and marketing of two drugs in the United States, namely Fusilev and Zevalin. Our lead developmental drug is apaziquone (formerly EOquin), which is presently being studied in two large Phase 3 clinical trials for non-muscle invasive bladder cancer under a strategic collaboration with Allergan Inc. Another drug, ozarelix is in a Phase 2 clinical trial for benign prostatic hypertrophy (BPH).
  • Competitor - Molecular Insight - Cambridge, MA US - 10-K - 2008: The Hatch-Waxman Act provides a five-year period of non-patent marketing exclusivity to the first applicant to gain approval of a New Drug Application, or NDA, for a new chemical entity. A drug can be classified as a new chemical entity if the FDA has not previously approved any other new drug containing the same active agent. During the exclusivity period, the FDA may not accept for review an abbreviated new drug application, or ANDA, or a 505(b)(2) NDA submitted by another company for another version of such drug, where the applicant does not own or have a legal right of reference to all the data required for approval. Protection under the Hatch-Waxman Act will not prevent the filing or approval of another full NDA, but the applicant could be required to conduct its own adequate and well-controlle d clinical trials to demonstrate safety and effectiveness.
  • Competitor - CEL-SCI Corporation - Vienna, VA US - 10-K - 2008: CEL-SCI's lead product, Multikine(R), has been cleared for a global Phase III clinical trial in advanced primary (previously untreated) head and neck cancer patients. Multikine is being developed for the treatment of cancer. It is the first of a new class of cancer immunotherapy drugs called Immune SIMULATORs. It simulates the activities of a healthy person's immune system, which battles cancer every day. Multikine is multi-targeted ; it is the only cancer immunotherapy that both kills cancer cells in a targeted fashion and activates the general immune system to destroy the cancer. We believe Multikine is the first immunotherapeu tic agent being developed as a first-line standard of care treatment for cancer.
  • Competitor - Arqule - Woburn MA US - 10-K - 2008: We are a clinical-stage biotechnology company organized as a Delaware corporation in 1993 and engaged in the research and development of innovative cancer therapeutics directed toward molecular targets that we believe play critical roles in the development of human cancers. Our mission is to discover and develop novel products that target multiple tumor types, act selectively against cancer cells and are well tolerated by patients. We believe our clinical stage products represent potential best-in-class or first-in-class small molecule candidates with differentiated mechanisms of action.

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