SOURCE: Amarillo Biosciences, Inc.

March 04, 2010 11:32 ET

Amarillo Biosciences and Intas Pharmaceuticals Sign License and Supply Agreement to Use Oral Interferon to Treat Influenza in India and Nepal

Intas Pharmaceutical to Launch Phase 3 Clinical Trial in India to Test Amarillo Biosciences' Oral Interferon Against Influenza

AMARILLO, TX--(Marketwire - March 4, 2010) - Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) today announced that it has executed a license and supply agreement with Intas Pharmaceuticals Limited (Intas), one of the top 20 pharmaceutical companies in India. Intas plans to launch a double-blind, placebo-controlled Phase 3 clinical trial of ABI's orally administered interferon-alpha lozenges in India by the end of March. The study will include up to 520 patients with clinical signs and symptoms of influenza. Intas will pay ABI a royalty on net sales in India and Nepal after marketing approval is obtained.

The H1N1 virus continues to circulate in India. The objective of the clinical trial planned in India is to determine the safety and efficacy of low dose oral interferon in reducing the severity of infection with influenza viruses such as H1N1. A Phase 2 clinical trial recently completed in Perth, Australia demonstrated that ABI's interferon-alpha lozenges were safe and beneficial when given as prevention against respiratory viruses, including influenza.

In the double-blind study that was conducted in Perth, 200 healthy volunteers were given ABI's low-dose interferon-alpha lozenges or placebo once daily for 16 weeks during the winter cold and flu season in Western Australia. Preliminary analysis has shown that interferon-alpha lozenges were free from adverse effects and led to a shift in symptom severity from moderate to mild. Importantly, prophylactic use of low-dose interferon-alpha lozenges significantly reduced the rate of influenza-like illness in study volunteers ages 55 years and older, who are generally considered to be at high risk for influenza. The company plans to release full study results when serology testing is completed.

"Influenza viruses mutate to evade the effects of anti-viral drugs. Influenza viruses do not mutate to evade interferon, but instead they have a strategy to sabotage the host interferon system. By giving people interferon orally, we believe we can overcome this viral strategy. It is my belief that low-dose oral interferon will be a beneficial therapy of all influenza viruses, not just the H1N1 strain," said Dr. Joseph M. Cummins, President and CEO of ABI.

About Amarillo Biosciences
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 6% of Amarillo Biosciences shares and has provided over $18 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including influenza, hepatitis C, chronic cough, and opportunistic infections in patients who are HIV positive. The Company has invested nearly $40 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the web at http://www.amarbio.com/.

About Intas Pharmaceuticals
Intas Pharmaceuticals Ltd. is an India based pharmaceutical company with three decades of experience in the healthcare industry and a global presence in 42 countries worldwide. The Company has a strong focus in the areas of CNS disorders, cardiovascular disease, diabetes, gastroenterology, urology, pain management, animal health care, oncology and biotechnology. In the domestic market, the Company is rated amongst the top 20 pharmaceuticals companies. The Company has a strong presence in the European, UK, US and Latin American pharmaceutical markets. The Company operates state-of-the-art manufacturing facilities and has expertise with a range of formulations from tablets to injectables. The Company has a fully integrated model encompassing formulation development, APIs and formulation manufacturing, and marketing. Total sales for 2008-2009 were 11.6 billion rupees (US$240 million). Additional information is available on the web at: http://www.intaspharma.com/.

Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company's other product candidates and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" and "Item 7A. Qualitative and Quantitative Disclosures About Market Risk" of the Company's Form 10-K for the fiscal year ended December 31, 2008. 

Contact Information

  • Investor Relations:
    Philippe Niemetz
    PAN Consultants, Ltd.
    e-mail:p.niemetz@panconsultants.com
    Tel: 800-477-7570
    212-344-6464
    Fax: 212-618-1276

    Joseph M. Cummins, DVM, PhD
    Amarillo Biosciences, Inc.
    e-mail:jcummins@amarbio.com
    Tel: 806-376-1741 x 13
    Fax: 806-376-9301