Intas Pharma to study Amarillo’s oral interferon-alpha lozenges in Indian flu patients

Intas Pharmaceuticals, a mid-size generic firm from India, will conduct late phase clinical studies of Amarillo Biosciences’ oral interferon-alpha lozenges in India.

Amarillo Biosciences, Inc has forged a license and supply agreement with Intas Pharmaceuticals Limited to start phase 3 clinical trials to test oral interferon-alpha lozenges in treating influenza.

Intas plans to launch a double-blind, placebo-controlled Phase 3 clinical trial of Amarillo’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.

The objective of the Indian clinical trial  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.

The Perth study in 200 healthy volunteers were given Amarillo’s low-dose interferon-alpha lozenges or placebo once daily for 16 weeks during the winter cold and flu season in Western Australia.

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, preliminary analysis has shown.

Amarillo 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, this viral strategy can be overcome, experts said.

Intas will pay Amarillo a royalty on net sales in India and Nepal after marketing approval is obtained.

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 focuses on 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.

Intas Pharmaceuticals Ltd has 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, Intas 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.

Intas’ total sales for 2008-2009 were 11.6 billion rupees (US$240 million).