Threshold Pharmaceuticals, Inc., a biotechnology company, engages in the discovery and development of therapeutic agents that selectively target tumor cells for the treatment of patients living with cancer. Evofosfamide The company’s main investigational small molecule, evofosfamide (formerly TH-302), is being evaluated in two pivotal Phase 3 clinical trials, one registrational Phase 2 clinical trial, and multiple earlier-stage clinical trials. The company has a license and co-development agreement for evofosfamide with Merck KGaA, Darmstadt, Germany, with an option to co-commercialize in the United States. As a prodrug, evofosfamide is designed to remain essentially inactive in normal tissues, but to activate under conditions of tumor hypoxia. Upon activation, evofosfamide releases bromo-isophosphoramide mustard (Br-IPM), a potent cytotoxin that kills cells by causing DNA to crosslink. TH-4000 The company also has licensed worldwide rights to a development program from the University of Auckland based on the clinical-stage oncology compound TH-4000 (formerly referred to as PR610 or Hypoxin), a hypoxia-targeted epidermal growth factor receptor, or EGFR, tyrosine kinase inhibitor. TH-4000 is designed to selectively release a potent, irreversible tyrosine kinase inhibitor in hypoxic tumors. Strategy The company focuses on prodrugs of known chemotherapeutic agents or related analogs that undergo relatively selective activation in the tumor microenvironment and potentially allow for an improved safety and efficacy profile for the drug. Main elements of its strategy are to: develop evofosfamide successfully; continue to broaden its pipeline by discovering and developing new compounds; and build on its expertise in targeting the tumor microenvironment. Research and Development As of December 31, 2014, the company spent $35.8 million on research and development, including product development, discovery research and contract manufacturing activities. Patents and Proprietary Rights As of February 25, 2015, the company owned 107 U.S. and foreign patents and patent applications relating to evofosfamide and its manufacture, formulation and use, each of which are either exclusively or co-exclusively licensed to and one of which is co-owned with Merck KGaA. These include 7 issued U.S. patents expiring from 2024 to 2031 and 28 issued foreign patents expiring from 2024 to 2027 (in each case, without including any regulatory-delay based patent term extension), as well as 13 pending U.S., 1 pending Patent Cooperation Treaty and 58 pending foreign national patent applications, which, if issued, would in each case expire from 2024 to 2035 (without including any regulatory- or patent office-delay based patent term extension). As of February 25, 2015, the company had rights to 39 U.S. and foreign patents and patent applications relating to TH-4000 and its manufacture, formulation and use, each of which are exclusively licensed by the company from Auckland Uniservices Ltd. These include 4 issued foreign patents expiring in 2030, as well as 3 pending U.S., and 32 pending foreign national patent applications, which, if issued, would in each case expire from 2030 to 2035 (without including any regulatory- or patent office-delay based patent term extension). Regulations The manufacturing and marketing of the company’s potential products, and its ongoing research and development activities are subject to regulation by the U.S. Food and Drug Administration and comparable regulatory agencies in state and local jurisdictions and in foreign countries. The company is subject to regulation by the Occupational Safety and Health Administration, or OSHA, the California and federal environmental protection agencies and to regulation under the Toxic Substances Control Act. History Threshold Pharmaceuticals, Inc. was founded in 2001. The company was incorporated in the state of Delaware in 2001.
170 Harbor Way
South San Francisco, CA 94080
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