ROCKVILLE, MD -- (Marketwire) -- 02/12/13 -- Biota Pharmaceuticals, Inc. (NASDAQ: BOTA)
•LANI Influenza Program Advancing Toward Phase 2 Clinical Development
•Merger between Nabi Biopharmaceuticals and Biota Holdings Limited Successfully Completed
Biota Pharmaceuticals, Inc. (NASDAQ: BOTA) today announced its financial results for the three month period ended December 31, 2012 and recent corporate developments. The Company's fiscal year end is June 30.
"We are pleased with the progress of the LANI program such that we anticipate initiating a large, global Phase 2 clinical trial in patients with influenza in mid-2013," stated Russell H. Plumb, President and CEO of Biota Pharmaceuticals, Inc. "With the merger behind us and our balance sheet strengthened with the related net cash proceeds, we are now focused on integrating operations and completing an in-depth strategic, operational and financial review of our development programs, which we expect to complete by the end of this quarter."
Recent Corporate Developments
Merger between Nabi Biopharmaceuticals and Biota Holdings Limited - On November 8, 2012, the Company announced the completion of the merger between Nabi and Biota Holdings Limited, resulting in the formation of Biota Pharmaceuticals, Inc. Former Biota Holdings Limited shareholders retained approximately 83% of the Company's shares of common stock, while former Nabi shareholders retained approximately 17% as consideration for Nabi's net assets, which consisted primarily of $27 million in net cash on the date of the merger. The merger has been accounted for as a reverse merger, such that Biota Holdings Limited is considered the accounting acquirer for financial reporting purposes even though Nabi was the legal acquirer.
Reverse Stock Split - Concurrent with the completion of the merger, a reverse stock split of Nabi common stock occurred, resulting in each six shares of Nabi common stock issued and outstanding immediately prior to the reverse split being automatically combined into one share of Nabi common stock. As a result of the reverse split, the per share exercise price of, and the number of shares of common stock underlying all stock options outstanding immediately prior to the reverse split were automatically proportionally adjusted based on the 1:6 ratio in accordance with the terms of such options.
Laninamivir Octanoate (LANI) - Laninamivir octanoate is marketed in Japan by Daiichi Sankyo as Inavir® for the treatment of influenza A and B in adults and children. In November 2012, Daiichi Sankyo submitted an application for a label change in Japan to manufacture and market the influenza antiviral product Inavir® for the prevention of influenza A and B.
Under the contract the Company has with the U.S. Office of Biomedical Advanced Research and Development Authority ("BARDA"), in January 2013 the Company initiated a Phase 1 clinical trial designed to assess the pharmacokinetics and metabolite profile of laninamivir octanoate following an inhaled dose administered via TwinCaps®. This study is a single center, single dose, open-label study in six healthy male subjects. The Company anticipates that top-line results from this study will be available in mid-2013. Further, the Company anticipates initiating a 636-patient, randomized, placebo-controlled Phase 2 clinical trial of laninamivir octanoate in mid-2013. The primary objective of the study is to evaluate the safety and efficacy of two doses of inhaled laninamivir octanoate (40 and 80 mg) delivered via TwinCaps® in adults with symptomatic presumptive influenza A or B infection. The primary endpoint for this study is time to alleviation of influenza symptoms and fever for ≥ 24 hours.
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