Following the recent license and supply agreement signed between Amarillo Biosciences Inc. (ABI), a US biotechnology firm, and Intas Pharmaceuticals, Intas will soon market world’s first Interferon Lozenges (tablet form) in India.
Unlike vaccines, Lozenges (tablet form) has outstanding safety profile with minimal side effects at a much affordable price. Lozenges, being orally administered, offer treatment of Influenza which have unique advantages of less frequent visit to doctors and efficacy at low dose. In a breakthrough achievement, Australian scientists have also studied this drug that prepares the immune system to effectively resist flu infections. The drug contains interferon, a protein, which is produced by the body naturally to fight infections. When lozenge releases the protein, the immune system is stimulated to protect against infection caused by different viruses. Interferon placed in mouth binds to receptors in the mucosal lining and stimulates immune system to protect against viral invasion.
Elaborating on the development, Kirti Maheshwari, senior vice president, Corporate, Quality & Regulatory affairs, Intas, informed that after approval, Intas is planning to conduct clinical trial with Amarillo Biosciences’ patented orally administered interferon-alfa lozenges. This will be a multi-centre study on 500 patients and would take approximately three months to complete. Intas has submitted the required technical documents to Drug Controller General of India (DCGI) for authorisation of conducting clinical trials.
Intas will undertake clinical study which will be randomised and double blind in nature. It will conduct clinical trial on ambulatory patients who are clinically diagnosed with influenza. 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. Intas will pay ABI a royalty on net sales in India and Nepal after marketing approval is obtained
Dr Rajendra Rane, senior vice president (Medical Affairs), Intas, said, “Our collaboration with Amarillo Biosciences ensures that we have the best available technological expertise of oral Interferon that offers superior safety and efficacy profile than the conventional vaccines. If things work out as per plans, we will be producing the drug at our Ahmedabad facility.”
Giving further details about the launch, Maheshwari informed that if Government of India supports this low dose, cost effective drug with minimal side-effects in fast review and approves it, then they will be able to bring the product much sooner than expected. "We would be able to bring the product to Indian market before 2011," added Maheshwari.
Amarillo Biosciences has already completed preclinical studies in US and rest of the world and in a phase-II 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 experience in Australian clinical study is a well-timed development, which will help Intas deal with the next wave of swine flu or any other viral respiratory infections efficiently.
