Biota wins U.S. drug development contract for Laninamivir

By Dr. Ananya Mandal, MDMar 31 2011

Australian biotechnology company Biota Holdings revealed its US subsidiary has won a five year $US231 million ($A224.36 million) contract from the US government to develop a long-acting, single-dose flu drug for sale in the US. Shares in the Melbourne-based drug development company jumped 66 cents to $1.66 at the market open today falling back to $1.43, 1pm (AEST).

Biota has been developing the drug, Laninamivir. Lainamivir is a unique treatment for influenza and has been approved for sale in Japan but not in other markets. Under the contract, Biota will establish US manufacturing of the drug and conduct clinical trials needed to apply for US Food and Drug Administration approval. Biota says the contract is fully funded over an estimated five year period and is designed to provide US based manufacturing and clinical data for the FDA.

According to Biota chief executive Peter Cook, “The award provides visible recognition of the potential medical value of Laninamivir to the world’s major market…The BARDA contract will be a major contributor to a timely introduction of the product and will create the opportunity to significantly develop Biota's business in the USA.” The US Office of Biomedical Advanced Research and Development Authority (BARDA) said in a statement the award was part of its national preparedness strategy for pandemic influenza. “This award represents another critical step forward in ensuring that safe and effective antiviral drugs are available for the treatment of influenza…The ability to treat influenza by delivering a single dose of medicine would provide real advantages to doctors and patients during an emergency and would be an important addition to our pandemic influenza arsenal,” BARDA director Dr Robin Robinson said.

BARDA said the antiviral requires only one dose for full treatment, as compared with 5 days of twice-daily dosing for oseltamivir and zanamivir. Like zanamivir, it is delivered with a powder inhaler.

Biota Holdings moved from a profit to a loss of almost $16 million in the six months to 31 December 2010. The drug was approved in Japan in September 2010. It is marketed there by Daiichi Sankyo Co. Ltd.