BioCryst Pharmaceuticals and Presidio Pharmaceuticals to Merge
New company to focus on oral drugs for hepatitis C and hereditary angioedema
Combined HCV portfolio includes three complementary viral targeting mechanisms
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
"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
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
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
The proposed Board of Directors of the new company will consist of three
Presidio nominees and six BioCryst nominees.
Conference Call and Webcast
Executives from BioCryst and Presidio will host a conference call and
webcast
Advisors
About
About
Important Additional Information and Where to Find It
BioCryst intends to file with the
This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities in the equity financing.
Participants in the Merger Solicitation
BioCryst and its directors, executive officers and other members of
management and employees may be deemed to be participants in the
solicitation of proxies from shareholders with respect to the
transactions contemplated by the merger agreement. Information regarding
BioCryst's directors and executive officers is contained in BioCryst's
2011 Annual Report on Form 10-K filed with the
BioCryst Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding future results, performance or achievements. These
statements involve known and unknown risks, uncertainties and other
factors which may cause BioCryst's actual results, performance or
achievements to be materially different from any future results,
performances or achievements expressed or implied by the forward-looking
statements. These statements reflect our current views with respect to
future events and are based on assumptions and subject to risks and
uncertainties. Given these uncertainties, you should not place undue
reliance on these forward-looking statements. Some of the factors that
could affect the forward-looking statements contained herein include:
that the merger might not be completed for any number of reasons, most
of which are outside of the control of BioCryst; that BioCryst may not
be able to obtain the requisite financing on commercially reasonable
terms or that or that the financing may be raised at prices below the
currently prevailing price for BioCryst common stock; that integration
of BioCryst and Presidio may prove more challenging than anticipated or
that anticipated benefits of the merger may not be achieved, or may be
achieved less rapidly than anticipated; the outcome of any legal
proceedings that may be instituted against BioCryst or Presidio; risks
relating to any unforeseen liabilities, future capital expenditures,
revenues, expenses, earnings, economic performance, indebtedness,
financial condition, losses and future prospects, business and
management strategies or the expansion and growth of Presidio's
operations; BioCryst's ability to integrate Presidio's business
successfully after the closing of the merger agreement; and the risk
that disruptions from the merger agreement will harm BioCryst's or
Presidio's businesses. There can be no assurance that the proposed
merger and financing will in fact be consummated. Other important
factors include: that there can be no assurance that BioCryst's or
Presidio's compounds will prove effective in clinical trials; that
development and commercialization of BioCryst's or Presidio's compounds
may not be successful; that BARDA/HHS may further condition, reduce or
eliminate future funding of the peramivir program; that BioCryst,
Presidio or licensees may not be able to enroll the required number of
subjects in planned clinical trials of its product candidates and that
such clinical trials may not be successfully completed; that the
companies or licensees may not commence as expected additional human
clinical trials with product candidates; that the
BCRXW
Investors:
or
Media:
WCG
Catherine Kyroulis,
212-301-7174
Source:
News Provided by Acquire Media