September 22, 2014 6:40 PM ET

Pharmaceuticals

Company Overview of Inviragen, Inc.

Company Overview

Inviragen, Inc. develops life-saving vaccines to protect against various infectious diseases in North America and internationally. It offers its products to protect against dengue viruses, as well as West Nile, swine-origin, chikungunya, plague/smallpox, and avian influenza diseases. The company's products also include INV21, a purified virus particle vaccine against hand, foot, and mouth disease. Inviragen, Inc. was founded in 2003 and is based in Fort Collins, Colorado with an additional office in Madison, Wisconsin. As of May 31, 2013, Inviragen, Inc. operates as a subsidiary of Takeda America Holdings, Inc.

2619 Midpoint Drive

Suite A

Fort Collins, CO 80525

United States

Founded in 2003

Phone:

970-672-4918

Fax:

970-372-0693

Key Executives for Inviragen, Inc.

Co-founder and Chief Executive Officer
Age: 60
Co-founder and Chief Scientific Officer
Chief Operating Officer
Chief Medical Officer
Regulatory Advisor
Compensation as of Fiscal Year 2014.

Inviragen, Inc. Key Developments

Inviragen, Inc. Advances DENVax into Second Stage of Ongoing Phase 2 Clinical Study

Inviragen, Inc. announced the initiation of the second stage of an ongoing Phase 2, randomized, double-blind, placebo-controlled study of DENVax(TM), the Company's investigational dengue vaccine. An independent data and safety monitoring board (DSMB) evaluated the preliminary safety data from the first stage of the Phase 2 trial, in which individuals in multiple age groups received either DENVax vaccine or placebo. Upon the review and the recommendation of the DSMB, Inviragen is advancing DENVax into the second stage of this clinical trial. In this second stage, DENVax will be tested for safety and immunogenicity in approximately 200 additional children aged 18 months to 11 years. The Phase 2 study is enrolling individuals in Puerto Rico, Colombia, Singapore and Thailand. The first stage evaluated the safety and immunogenicity of two doses of DENVax, administered three months apart. Approximately 150 individuals were enrolled in this first stage in four different age groups: adults (aged 21 and older), adolescents (aged 11 to 20 years), school-age children (aged 6 to 10 years) and pre-school children (aged 18 months to 5 years). Following the assessment of an independent monitoring board, the study was designed to enter its second stage, in which it will enroll approximately 200 children aged 18 months to 11 years to further test the safety and immunogenicity of the two-dose DENVax vaccine. It is expected that the full results of the first stage of the Phase 2 study will be presented at an appropriate meeting later this year.

Vabiotech Licenses Inviragen Technology for Japanese Encephalitis Vaccine Production

Vabiotech has licensed Inviragen's proprietary Japanese encephalitis (JE) technology to produce a cell-derived vaccine. Under the license, VABIOTECH is expected to develop and commercialize JE vaccine in Vietnam, Cambodia and Myanmar. In addition, VABIOTECH will provide certain development-based milestone payments to Inviragen.

Inviragen and the International Vaccine Institute Expand Partnership

Inviragen, Inc. announced under its existing Memorandum of Understanding, the company and the International Vaccine Institute (IVI) announced a collaboration to assess the total health burden of dengue cases in Colombia and Thailand. The Mahidol University Department of Tropical Pediatrics in Thailand and PECET (Programa de Estudio y Control de Enfermedades Tropicales) at Universidad de Antioquia in Medellin, Colombia will manage the studies, which aim to detail the burden of dengue disease from epidemiological, economic, behavioral and market-demand perspectives. The studies will follow thousands of children and adults in two distinct dengue endemic environments: in the Bang Phae district in Ratchaburi province, Thailand and the Santa Cruz Comuna in Medellin, Colombia. The purpose is to determine the incidence and epidemiology of dengue infection, the clinical profile of dengue, the utilization of healthcare services, the cost of illness and the potential willingness to pay for a preventative vaccine.

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