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BioCryst Pharmaceuticals and Presidio Pharmaceuticals to Merge

Published: Tuesday, October 23, 2012
Last Updated: Tuesday, October 23, 2012
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New company to focus on oral drugs for hepatitis C and hereditary angioedema. Combined HCV portfolio includes three complementary viral targeting mechanisms.

BioCryst Pharmaceuticals, Inc. and privately held Presidio Pharmaceuticals, Inc. announced that the companies have signed a definitive merger agreement for Presidio to be acquired by BioCryst in an all-stock transaction. The transaction has been approved by the Boards of both companies. The transaction values Presidio at approximately $101 million, based on yesterday's closing BioCryst share price of $4.11 per share. The transaction is expected to close in the first quarter of 2013, and is subject to customary conditions, including approval by BioCryst shareholders.

The merger creates a focused, clinical stage biopharmaceutical company with lead programs in high-value infectious and orphan disease indications: hepatitis C (HCV) and hereditary angioedema (HAE). This new entity would own a unique portfolio of three oral, pan-genotypic antivirals that are suitable either for development in combination with each other or in combination with other direct acting antivirals (DAAs) to treat patients with HCV infection.

"We're creating this new company to pursue the development and commercialization of antiviral and orphan drugs. Presidio brings exciting HCV assets to the new company, and a highly experienced scientific team with a proven track record in antiviral drug discovery and development," said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst. "Each of our HCV antivirals works via a different targeting mechanism and each is suitable for development in combination regimens with other classes of HCV inhibitors. The diversity of our HCV portfolio reduces our clinical development risk and defines this new company as a serious competitor in the development of orally administered, safe and effective combination therapies for hepatitis C."

"The Presidio team looks forward to joining forces with BioCryst in the pursuit of groundbreaking oral therapies for HCV and other important diseases such as hereditary angioedema," said Richard Colonno, Ph.D., Chief Scientific Officer of Presidio. "Our initial focus will be on commencing HCV curative Phase 2a combination trials with our NS5A inhibitor PPI-668, while advancing both our nucleoside and non-nucleoside inhibitors through Phase 1 proof-of-concept trials next year."

Presidio is a clinical stage pharmaceutical company that is developing small-molecule antiviral therapeutics for the treatment of chronic hepatitis C virus infection. Its lead HCV candidate, PPI-668, is an oral, once-daily, pan-genotypic HCV inhibitor targeting the viral NS5A protein, and is ready to enter Phase 2 clinical development. In a Phase 1b trial in patients with HCV genotype 1a and 1b, PPI-668 dosed once-daily at 40 mg to 240 mg produced mean maximal viral RNA load reductions of 3.5-3.7 log10 during three days of treatment at optimal dose levels. Presidio is also advancing PPI-383, a pan-genotypic, non-nucleoside inhibitor of the viral NS5B polymerase as a second, complementary HCV antiviral candidate. PPI-383 is currently undergoing IND-enabling studies to support initiation of clinical studies alone and in combination with PPI-668 during 2013.

BioCryst's portfolio includes the potent HCV NS5B-targeted nucleoside analog BCX5191, which has completed IND-enabling safety studies and is expected to enter Phase 1 trials before the end of 2012. BioCryst has also completed IND-enabling studies for BCX4161, an inhibitor of plasma kallikrein, a validated target for the treatment of HAE. Phase 1 trials of BCX4161 are also expected to begin before the end of 2012. In addition to BCX5191 and BCX4161, BioCryst's drug development portfolio includes peramivir, a viral neuraminidase inhibitor for the treatment of influenza in Phase 3 development, and ulodesine, a Phase 3 ready purine nucleoside phosphorylase (PNP) inhibitor for the treatment of gout. BioCryst plans to announce the outcome of a planned interim analysis reevaluating the sample size required for the primary efficacy analysis of the peramivir study before the end of 2012.

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