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BioCryst Pharmaceuticals and Presidio Pharmaceuticals to Merge
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New company to focus on oral drugs for hepatitis C and hereditary angioedema
RESEARCH TRIANGLE PARK, N.C. & SAN FRANCISCO, Oct 18, 2012 (BUSINESS WIRE) -- --Combined HCV portfolio includes three complementary viral targeting mechanisms
BioCryst Pharmaceuticals, Inc and privately held Presidio Pharmaceuticals, Inc. today 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.
Terms of the Transaction & Proposed Governance Structure
The merger is subject to customary closing conditions, including approval of the transaction by BioCryst shareholders, as well as completion of a minimum $60 million equity financing on commercially reasonable terms. Certain Presidio shareholders have provided definitive commitments to purchase $25 million of this minimum $60 million financing at the closing of the merger. BioCryst has received voting commitments from certain significant Presidio shareholders sufficient to ensure Presidio shareholder approval.
In total, subject to adjustment based on Presidio's working capital at closing and certain other factors, BioCryst will issue a total of 24.5 million shares of its common stock to Presidio's shareholders in exchange for all of the outstanding shares of Presidio and the $25 million of new cash financing committed by certain Presidio shareholders. The combined company will launch under a new name and will be headquartered in Durham, North Carolina, with facilities in San Francisco, California and Birmingham, Alabama.
The proposed Board of Directors of the new company will consist of three Presidio nominees and six BioCryst nominees. Mr. Stonehouse will be the Chief Executive Officer of the combined company and Mr. Kenneth Galbraith, current Chairman of Presidio, will be the non-executive Chairman of the Board.
Conference Call and Webcast
Executives from BioCryst and Presidio will host a conference call and webcast Thursday, October 18, 2012 at 8:30 a.m. Eastern Time, to discuss the proposed transaction. To participate in the conference call, please dial 1-877-303-8027 (United States) or 1-760-536-5165 (International). No passcode is needed for the call. The webcast can be accessed by logging onto www.BioCryst.com . Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary. The event and slide presentation will be available prior to the event and archived after in the Investor Relations section of www.BioCryst.com .
Advisors
J.P. Morgan Securities LLC is acting as exclusive financial advisor and Wachtell, Lipton, Rosen & Katz provided legal counsel to BioCryst in the transaction. Bank of America Merrill Lynch is acting as the exclusive financial advisor and Cooley LLP provided legal counsel to Presidio.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in infectious and inflammatory diseases. BioCryst currently has two late stage development programs: peramivir, a viral neuraminidase inhibitor for the treatment of influenza, and ulodesine (BCX4208), a purine nucleoside phosphorylase (PNP) inhibitor for the treatment of gout. In addition, BioCryst is advancing two preclinical programs towards IND filings: BCX5191, a nucleoside analog inhibitor of HCV RNA polymerase (NS5B) for hepatitis C, and BCX4161, an oral inhibitor of plasma kallikrein for hereditary angioedema. Utilizing state-of-the-art structure-guided drug design and crystallography, BioCryst continues to discover innovative compounds with the goal of addressing unmet medical needs of patients and physicians. For more information, please visit the Company's website at www.BioCryst.com .
About Presidio Pharmaceuticals
Presidio Pharmaceuticals, Inc. is a San Francisco-based clinical stage specialty pharmaceutical company dedicated to the discovery and development of small molecule antiviral therapeutics. The Presidio portfolio includes PPI-668, an oral, once-daily pan-genotypic NS5A with demonstrated antiviral efficacy and safety in a recently completed Phase 1b trial in HCV patients, and PPI-383, a pan-genotypic, non-nucleoside NS5B currently undergoing IND-enabling studies to support initiation of clinical trials alone and in combination with PPI-668 during 2013. For more information, please visit the Company's website: www.presidiopharma.com .
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