BTA biota holdings limited

2015 Annual Report

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    Here's an excerpt from the 2015 10K statement/annual report.

    2016 due soon.

    How did they go, I wonder

    Our Strategy
       
    We are focused on the discovery and development of direct-acting antivirals to treat infections that affect a significant number of patients globally for which there are limited therapeutic options. In the near-term we intend to employ the following strategy:
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    Focus Our Resources on the Development of our Clinical Stage Antiviral Product Candidates . We plan to focus our resources on vapendavir, an oral treatment for HRV infections in moderate-to-severe asthmatics; BTA074, a novel topical treatment for genital warts caused by HPV types 6 & 11; and BTA585, an oral fusion inhibitor in development for the treatment of RSV infections.


    More specifically, over the next 12 months we intend to:

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    Initiate a Phase 2 clinical trial for BTA074 in patients with genital warts late 2015;

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    Complete and report top-line data from a Phase 1 single ascending dose clinical trial for BTA585 in healthy volunteers in the fourth quarter of 2015;

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    Complete and report top-line data from a Phase 1 multiple ascending dose clinical trial for BTA585 in healthy volunteers in the first quarter of 2016;

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    Complete the Phase 2b SPIRITUS trial of vapendavir in patients with moderate-to-severe asthma and report top-line data in mid-2016;

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    Initiate a Phase 2a RSV c hallenge study in healthy volunteers for BTA585 in the second quarter of 2016; and

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    Continue process development and formulation activities (adult and pediatric) for BTA585 and BTA074.

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    Evaluate our RSV preclinical candidates and select a lead candidate for IND-enabling studies . We intend to develop a series of potent RSV non-fusion inhibitors that we believe could be used as a stand-alone treatment or potentially in combination therapy. Our goal is to select a lead candidate from this series by mid-year 2016.


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    Seek to o ut-license LANI . We, in concert with Daiichi Sankyo, intend to pursue a license agreement, or other similar transaction, with larger third-party regional or global pharmaceutical or biopharmaceutical companies that have greater clinical development, manufacturing and commercialization capabilities than we do that we believe could advance the development and/or commercialization of LANI.

 
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