Threshold Pharmaceuticals, Inc., a biotechnology company, discovers and develops therapeutic agents that selectively target tumor cells for the treatment of patients living with cancer. TH-302 The company’s investigational small molecule, TH-302, is being evaluated in two pivotal Phase 3 clinical trials and multiple earlier-stage clinical trials. The company has a license and co-development agreement for TH-302 with Merck KGaA, with an option to co-commercialize in the United States. As a prodrug, TH-302 is designed to remain essentially inactive in normal tissues, but to activate under conditions of tumor hypoxia. Upon activation, TH-302 releases bromo isophosphoramide mustard (Br-IPM), a potent cytotoxin that kills cells by causing DNA to crosslink. Strategy The company focuses on building a fully integrated biopharmaceutical company that discovers, develops, and commercializes drugs for cancer based on targeting the tumor microenvironment. 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 TH-302 successfully; continue to broaden its pipeline by discovering and developing new compounds; and build on its expertise in targeting the tumor microenvironment. Agreement with Merck KGaA The company has entered into a license and co-development agreement for TH-302 with Merck KGaA, Darmstadt, Germany, with an option to co-commercialize in the United States. The company has a license agreement with Eleison Pharmaceuticals, Inc. for the development and commercialization of glufosfamide, which is used for the treatment of cancer in humans and animals. Patents and Proprietary Rights As of February 26, 2014, the company owned 80 U.S. and foreign patents and patent applications relating to TH-302 and its manufacture, formulation and use, each of which are either exclusively or co-exclusively licensed to Merck KGaA. These consisted of 6 issued U.S. patents expiring from 2024 to 2030 and 24 issued foreign patents expiring from 2024 to 2027, as well as 8 pending U.S., 4 pending Patent Cooperation Treaty and 38 pending foreign national patent applications. 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 also subject to regulation by the Occupational Safety and Health Administration, 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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