biota provides update on barda contract for la

Biota Provides Update on BARDA Contract for Laninamivir Octanoate

ATLANTA, May 8, 2014 (GLOBE NEWSWIRE) -- Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) (the "Company") today announced that last night it received notice from the Department of Health and Human Services Office of Assistant Secretary for Preparedness and Response (ASPR) Biomedical Advanced Research and Development Authority (BARDA), advising the Company of its decision to terminate its contract, which was supporting the development of laninamivir octanoate, for the convenience of the Government. The decision is a result of a recently concluded In-Process Review. No reasons for the termination for convenience were provided to the Company. The Company intends to immediately begin negotiating a final termination settlement with ASPR/BARDA with respect to the termination of the contract.

The Company is developing laninamivir octanoate, a long-acting neuraminidase inhibitor, administered by inhalation via the TwinCaps® dry powder inhaler, for the treatment of influenza A and B under an Investigational New Drug (IND) in the United States. Laninamivir octanoate (Inavir®) has been successfully developed in Japan by the Company's partner, Daiichi-Sankyo, where it was approved for the treatment and prevention of influenza A and B in 2010 and 2013, respectively. Since its launch in 2010, Inavir® has become the leading antiviral used to treat influenza in Japan.

Since the initiation of the contract with BARDA in April 2011, the Company has advanced the development of laninamivir octanoate under its IND as follows:

completed three Phase 1 clinical trials (ADME, Safety and Pharmacokinetics in Chronic Asthma Patients, and TQT);
completed the targeted enrollment in its Phase 2 IGLOO trial on a timely-basis, the top-line results of which are anticipated in the third quarter of 2014;
initiated enrollment in a Phase 1/2 trial in pediatric patients;
successfully completed required improvements to the TwinCaps® dry powder inhaler; and
made significant advancements in the process development and manufacturing facets of the program, such that the installation of a commercial scale filling and finishing line for the manufacture of TwinCaps® inhaler for laninamivir octanoate can be initiated.

"Given the commercial success of Inavir® in Japan over the past several years, the status of the program and with top-line data from the Phase 2 IGLOO trial anticipated in a matter of months, we are somewhat perplexed by this decision," stated Russell H. Plumb, President and CEO of Biota Pharmaceuticals, Inc. "Notwithstanding this action, we intend to complete the collection, analysis, and reporting of the data from the IGLOO trial, as well as the recently completed Phase 1 trials. Subject to the results of IGLOO trial, which we expect will be available in the third quarter, we will make a data-driven decision as to the next steps in the development of laninamivir octanoate."

About Biota

Biota Pharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery and development of products to prevent and treat serious and potentially life-threatening infectious diseases. The Company currently has two Phase 2 clinical-stage product candidates: laninamivir octanoate, which the Company is developing for the treatment of influenza A and B infections under an IND in the United States; and vapendavir, a potent, oral broad spectrum capsid inhibitor of enteroviruses, including human rhinovirus. In addition to these clinical-stage development programs, the Company has preclinical programs focused on developing treatments for respiratory syncytial virus. For additional information about the Company, please visit www.biotapharma.com.