Synergy Pharmaceuticals’ Subsidiary Files Form 10 for Planned Spin-Off of
NEW YORK -- August 8, 2013
Synergy Pharmaceuticals Inc. (Nasdaq: SGYP), a developer of new drugs to treat
gastrointestinal diseases and disorders, today announced the planned spin-off
of its FV-100 assets into a separate publicly traded company. Synergy’s newly
formed subsidiary, ContraVir Pharmaceuticals, Inc., the company which will
hold the FV-100 assets (“ContraVir”), has filed a Form 10 Registration
Statement (“Form 10”) with the U.S. Securities and Exchange Commission.The
separation contemplates a 100% distribution of the ContraVir shares of common
stock, now held by Synergy, to Synergy’s stockholders on a pro-rata basis.
"The filing of the Form 10 by ContraVir is an important step in the process of
developing and establishing our FV-100 assets as a new, stand-alone company
with its own strategic focus and priorities," said Dr. Gary S. Jacob, Chief
Executive Officer of Synergy and Chief Executive Officer of ContraVir.“As two
distinct businesses, Synergy and ContraVir will be better positioned to
capitalize on significant growth opportunities and provide greater focus on
their respective businesses and strategic priorities."
ContraVir expects to look for a new chief executive officer upon completion of
the separation from Synergy. Furthermore, ContraVir expects to apply to have
its shares quoted for trading on the Over-the-Counter Bulletin Board in the
Completion of the transaction is subject to a number of conditions, including
effectiveness of the registration statement filed with the SEC and other
customary conditions. The transaction also remains subject to final approval
by the Synergy Board of Directors. Synergy notes that there can be no
assurance that any separation transaction will ultimately occur, or, if one
does occur, its terms or timing.
The Form 10 contains important information about ContraVir and the separation,
including an overview of the business which ContraVir will operate and of the
company's competitive strengths, strategies and risk factors.
A copy of the Form 10 is available at www.sec.gov. Additionally, the Form 10
can be found in the Investor Relations section of Synergy’s website at
About ContraVir Pharmaceuticals, Inc.
ContraVir is a biopharmaceutical company focused primarily on the development
of drugs to treat herpes zoster, or shingles, which is an infection caused by
the reactivation of varicella zoster virus or VZV. Our lead candidate is
FV-100 is an orally available nucleoside analogue prodrug of CF-1743 that we
are developing for the treatment of shingles. Published preclinical studies
demonstrate that FV-100 is significantly more potent against VZV than
acyclovir, valacyclovir, and famciclovir, the FDA-approved drugs used for the
treatment of shingles. Preclinical studies further demonstrate that FV-100 has
a more rapid onset of antiviral activity, and may fully inhibit the
replication of VZV more rapidly than these drugs at significantly lower
concentration levels. In addition, pharmacokinetic data from completed phase 1
and 2 clinical trials suggest that FV-100 has the potential to demonstrate
antiviral activity when dosed orally once-a-day at significantly lower levels
than valacyclovir, acyclovir, and famciclovir.
About Synergy Pharmaceuticals Inc.
Synergy Pharmaceuticals is a biopharmaceutical company focused on the
development of new drugs to treat patients with gastrointestinal (GI) diseases
and disorders. Synergy's lead drug, plecanatide, and next-generation
candidate, SP-333, are proprietary analogs of the natural human GI hormone,
uroguanylin, and members of the new class of guanylate cyclase-C ("GC-C")
agonists. Plecanatide is currently in development for the treatment of chronic
idiopathic constipation (CIC) and irritable bowel syndrome with constipation
(IBS-C). Synergy has successfully completed a positive phase 2a trial and a
large multicenter clinical trial of plecanatide in patients with CIC. The
Company is currently enrolling IBS-C patients for its ongoing plecanatide
phase 2b trial. SP-333 is in development to treat patients with inflammatory
bowel disease and other GI conditions.
Certain statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements may be identified by the use of forward- looking words such as
"anticipate," "planned," "believe," "forecast," "estimated," "expected," and
"intend," among others. These forward-looking statements are based on
Synergy's current expectations and actual results could differ materially.
There are a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements. These
factors include, but are not limited to, changes in market conditions;
unanticipated developments that prevent, delay, alter the terms of, or
otherwise negatively affect the planned spin-off of ContraVir Pharmaceuticals,
Inc., and other risk factors that ContraVir identifies in its Form 10
registration statement or that we identify in periodic reports filed with the
Securities and Exchange Commission. While the list of factors presented here
is considered representative, no such list should be considered to be a
complete statement of all potential risks and uncertainties. Unlisted factors
may present significant additional obstacles to the realization of
forward-looking statements. Forward-looking statements included herein are
made as of the date hereof, and Synergy does not undertake any obligation to
update publicly such statements to reflect subsequent events or circumstances.
Synergy Pharmaceuticals Inc.
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