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biota pharmaceuticals inc (BOTA) Key Developments

Biota Pharmaceuticals, Inc. Announces Top-Line Data from Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Phase 2 Clinical Trial of Laninamivir Octanoate

Biota Pharmaceuticals, Inc. announced top-line data from a randomized, double-blind, placebo-controlled, parallel-arm Phase 2 clinical trial comparing the safety and efficacy of a 40 mg and 80 mg dose of laninamivir octanoate (LANI) to placebo. The trial, referred to as IGLOO, enrolled 639 patients across 12 countries in the Northern and Southern Hemisphere from June 2013 to April 2014. Of the 639 patients enrolled, 248, or 39%, had PCR confirmed influenza A or B virus and were included in the intent-to-treat efficacy analyses. Approximately 75% and 19% of the influenza-confirmed patients were infected with influenza A H1N1 2009 and H3N2, respectively, with 6% being infected with influenza B. As compared to placebo, neither the 40 mg or 80 mg cohort achieved a statistically significant reduction in the median time to alleviation of influenza symptoms as measured by the Flu-iiQ patient-recorded outcome questionnaire (p=0.248 and p=0.776, respectively), which was the primary endpoint of the study. The median time to alleviation of influenza symptoms was 102.3 hours for the 40 mg cohort and 103.2 hours for the 80 mg cohort, as compared to 104.1 hours for the placebo cohort. Patients in both the 40 mg (p<0.001) and 80 mg (p=0.070) cohorts demonstrated a statistically significant reduction in viral shedding on Day 3 of the study compared to placebo as quantified by qRT-PCR. In addition, a statistically significant proportion of patients in both the 40 mg (p=0.002) and 80 mg (p=0.020) cohorts were culture negative on Day 3 of the study as compared to placebo. Influenza-infected patients in the 40 mg cohort also demonstrated a statistically significant reduction in the incidence of secondary bacterial infections as compared to placebo (p=0.013). The nature and extent of adverse events were similar in the three cohorts, with diarrhea (3.1% vs. 0.9%), headache (1.4% vs. 0.5%), gastritis (1.4% vs. 0%), urinary tract infection (1.4% vs. 0%), and sinusitis (1.2% vs. 0.9%) being the most common adverse events that occurred more frequently in the treatment cohorts as compared to placebo. The incidence of serious adverse events was low and balanced across the three cohorts.

Biota Pharmaceuticals, Inc. Announces Restructuring Plan

Biota Pharmaceuticals, Inc. announced that following the completion of an operational review of the company, its Board of Directors has adopted a plan to restructure the company's operations. The adoption of the plan was the result of a recent decision by the Department of Health and Human Services Office of Assistant Secretary for Preparedness and Response (ASPR) Biomedical Advanced Research and Development Authority (BARDA) to terminate its contract with the company for the convenience of the U.S. Government. This contract was supporting the development of laninamivir octanoate, a long-acting neuraminidase inhibitor (LANI), for the treatment of uncomplicated influenza A and B. Immediate actions resulting from the adoption of this plan will involve a re-alignment of the company's operations and resources. Specifically, the company plans to reduce its workforce by approximately two-thirds over the next six to nine months and close its Melbourne, Australia facility by June 30, 2015. The company anticipates recording an estimated total charge of approximately $5.0 - $5.5 million over this and the next several quarters in association with this restructuring plan. Upon expected completion of the plan in the first half of 2015, the company estimates its annual, ongoing research and development and general and administrative overhead costs will be reduced by approximately $8.0 - $10.0 million from current annualized levels. In the near-term the company intends to focus its efforts on its late-stage clinical assets, namely LANI and vapendavir, as well as preclinical compounds being developed for the treatment of respiratory syncytial infections (RSV). The company anticipates data that will inform on the possible next steps in the development of each of these respective programs will be available in the third quarter. Further, the company anticipates exploring alternative business development and/or financing arrangements that could facilitate the continued development of LANI in later-stage clinical trials.

Biota Pharmaceuticals, Inc. Reports Earnings Results for the Third Quarter and Nine Months Ended March 31, 2014

Biota Pharmaceuticals, Inc. reported earnings results for the third quarter and nine months ended March 31, 2014. Net income for the third quarter was $3.2 million, or $0.09 per share, compared to $200,000, or $0.01 per share, for the same quarter ended March 31, 2013. Total revenue for the third quarter ended March 31, 2014 was $29.5 million, compared to $12.5 million for the same quarter ended March 31, 2013. Net loss for the nine months ended March 31, 2014 was $800,000, or $0.03 loss per share, compared to a net loss of $2.4 million, or $0.09 loss per share, for the same period ended March 31, 2013. Total revenue for the nine months ended March 31, 2014 was $60.3 million, compared to $24.3 million for the same period ended March 31, 2013.

Biota Pharmaceuticals, Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-02-2014 08:00 AM

Biota Pharmaceuticals, Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-02-2014 08:00 AM. Venue: Grand Hyatt, New York, New York, United States. Speakers: Joseph M. Patti, Executive Vice President of Corporate Development & Strategy and Assistant Secretary.

Biota Pharmaceuticals, Inc. Provides Update on BARDA Contract for Laninamivir Octanoate

Biota Pharmaceuticals, Inc. 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.

 

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