BioCryst Provides Update Regarding BCX5191 Development Plan Following Discussion With FDA
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
BioCryst
Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced the withdrawal
of its Investigational New Drug application (IND) for the antiviral
nucleoside, BCX5191,
following a discussion with the U.S. Food and Drug Administration (FDA).
The FDA indicated concerns regarding the preclinical toxicity profile of
BCX5191 at exposure levels that they believe are likely to be necessary
to reduce viral load in patients infected with the hepatitis C virus
(HCV). Patient safety remains BioCryst's highest priority. BioCryst
continues to believe that BCX5191 may be distinct from other Nucs in
exhibiting antiviral potency in man at significantly lower doses than
other Nucs in development based on preclinical results, and will
therefore conduct additional preclinical studies to determine if low
doses—i.e. doses that are not associated with toxicity in
animals—exhibit meaningful viral load reductions in HCV infected
animals. BioCryst will then determine whether to continue development of
BCX5191, based on the results of these studies.
BioCryst agrees with the FDA's cautious approach to the development of
nucleoside and nucleotide inhibitors for HCV. Further, BioCryst believes
that the recent occurrence of serious adverse events in HCV patients
treated with BMS-986094, a nucleotide prodrug previously under clinical
development by Bristol-Myers Squibb, has heightened safety concerns
regarding this class of HCV inhibitors. FDA has previously placed
clinical holds on other nucleotides under development.
About BCX5191
Discovered by BioCryst, BCX5191 is a novel, oral, pan-genotypic adenine
nucleoside analog targeting viral RNA polymerase for the potential
treatment of patients with HCV. BCX5191 inhibits the viral RNA
polymerase enzyme across genotypes 1-4 at sub-micromolar concentrations
and it is active in replicon cell assays. In human liver cells, BCX5191
rapidly and efficiently converts into its active triphosphate form. In
preclinical models, BCX5191 demonstrates high oral bioavailability and
is actively transported into the liver, without requiring prodrug
technology. PK modeling supports once-daily dosing in clinical studies
and predicts that low doses of BCX5191 will show antiviral activity.
About Hepatitis C
Hepatitis C is a contagious liver disease that results from infection
with the hepatitis C virus (HCV), which is the most common virus that
infects the liver and can lead to life-threatening liver problems, such
as liver damage, cirrhosis, liver failure or liver cancer. There are an
estimated 170 million individuals worldwide who are chronically infected
with HCV, and about 3 to 4 million people are infected annually. In the
United States, there are approximately 4 million people who have chronic
hepatitis C.
Conference Call and Webcast
BioCryst's leadership team will host a conference call and webcast
Wednesday, October 31, 2012 at 8:30 a.m. Eastern Time. 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.
About BioCryst
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: 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 the BioCryst-Presidio Merger
BioCryst and privately held Presidio
Pharmaceuticals, Inc. recently announced the signing of a definitive merger
agreement to create a focused, clinical stage biopharmaceutical
company with lead programs in high-value infectious and orphan disease
indications: specifically HCV and hereditary angioedema (HAE).
Important Additional Information and Where to Find It
BioCryst intends to file with the Securities and Exchange Commission
("SEC") a registration statement on Form S-4, which will also include a
proxy statement and prospectus with respect to its proposed acquisition
of Presidio. The final proxy statement/prospectus will be mailed to the
stockholders of BioCryst and Presidio. Investors and security holders
are urged to read the proxy statement/prospectus regarding the proposed
transaction carefully and in its entirety when it becomes available
because it will contain important information regarding BioCryst,
Presidio and the proposed merger. Investors will be able to obtain a
free copy of the proxy statement/prospectus, as well as other filings
containing information about BioCryst, without charge, at the SEC's
website (http://www.sec.gov/).
Investors may also obtain these documents, without charge, from
BioCryst's website at http://investor.shareholder.com/biocryst/sec.cfm.
This communication shall not constitute an offer to sell or the
solicitation of an offer to buy any securities in the equity financing
connected to the proposed acquisition of Presidio.
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 definitive merger agreement signed by
Presidio. Information regarding BioCryst's directors and executive
officers is contained in BioCryst's 2011 Annual Report on Form 10-K
filed with the SEC on March 6, 2012 and its definitive proxy statement
filed with the SEC on April 9, 2012 in connection with its 2012 meeting
of stockholders. Other information regarding the participants in the
proxy solicitation and a description of their direct and indirect
interests, by security holdings or otherwise, will be contained in the
proxy statement/prospectus and other relevant materials to be filed with
the SEC when they become available.
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 FDA may require additional studies beyond the studies planned
for product candidates or may not provide regulatory clearances (e.g.
BCX5191) which may result in delay of planned clinical trials, clinical
hold with respect to such product candidate or inability to move forward
with development or the lack of market approval for such product
candidate; that ongoing and future preclinical and clinical development
may not have positive results; that the company or licensees may not be
able to continue future development of current and future development
programs; that such development programs may never result in future
product, license or royalty payments being received; that the company
may not be able to retain its current pharmaceutical and biotechnology
partners for further development of its product candidates or may not
reach favorable agreements with potential pharmaceutical and
biotechnology partners for further development of product candidates;
that actual cash burn rate may not be consistent with expectations; that
the peramivir interim analysis may not be favorable or that BARDA/HHS
may further condition, reduce or eliminate future funding of the
peramivir program; that the planned merger with Presidio 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 to complete the planned merger with Presidio 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 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 2012 operating expenses and cash usage
will be within management's expected ranges; that BioCryst or Presidio
may not have sufficient cash to continue funding the development,
manufacturing, marketing or distribution of products and that additional
funding, if necessary, may not be available at all or on terms
acceptable to BioCryst or Presidio. Please refer to the documents
BioCryst files periodically with the Securities and Exchange Commission,
specifically BioCryst's most recent Annual Report on Form 10-K,
Quarterly Reports on Form 10-Q, and current reports on Form 8-K, all of
which identify important factors that could cause the actual results to
differ materially from those contained in BioCryst's projections and
forward-looking statements.
BCRXW
BioCryst Pharmaceuticals Robert Bennett, 919-859-7910 (investors) or WCG Catherine
Kyroulis, 212-301-7174 (Media)
