SIGA Announces Priority Review Voucher Transaction Totaling $80 Million
November 01 2018 - 7:30AM
SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company focused on the health security market, today
announced that it has entered into an agreement to sell its medical
countermeasures priority review voucher (PRV) for a lump sum
payment of $80 million. SIGA was awarded the PRV in July 2018 upon
approval by the U.S. Food and Drug Administration (FDA) of oral
TPOXX® for the treatment of smallpox. The PRV was awarded by FDA
under a provision that encourages development of medical
countermeasures enacted as part of the 21st Century Cures Act
(Public Law 114-255).
“The opportunity to complete transactions like
this is an important incentive for the continued development of
products like TPOXX and will help us continue to drive value for
our partners in Health Security as well as our own business,” said
Dr. Phil Gomez, CEO of SIGA. “SIGA is proud to have worked
closely with BARDA, CDC, the FDA and other stakeholders to make
TPOXX the first FDA-approved countermeasure eligible under this
important program.”
Leerink Partners LLC acted as financial advisor
to SIGA and Covington & Burling LLP acted as legal advisor.
ABOUT SIGA TECHNOLOGIES, INC. and
TPOXX®
SIGA Technologies, Inc. is a commercial-stage
pharmaceutical company focused on the health security market.
Health security comprises countermeasures for biological, chemical,
radiological and nuclear attacks (biodefense market), vaccines and
therapies for emerging infectious diseases, and health
preparedness. Our lead product is TPOXX®, also known as tecovirimat
and ST-246®, an orally administered and IV formulation antiviral
drug for the treatment of human smallpox disease caused by variola
virus. TPOXX is a novel small-molecule drug of which 2 million oral
courses have been delivered to the Strategic National Stockpile
under Project BioShield. The oral formulation of TPOXX was approved
by the FDA for the treatment of smallpox on July 13, 2018. In
September 2018, SIGA signed a new contract with Biomedical Advanced
Research and Development Authority (BARDA) for additional
procurement and development related to both oral and intravenous
formulations of TPOXX. For more information about SIGA, please
visit www.siga.com.
About Smallpox1
Smallpox is a contagious, disfiguring and often
deadly disease that has affected humans for thousands of years.
Naturally-occurring smallpox was eradicated worldwide by 1980, the
result of an unprecedented global immunization campaign. Samples of
smallpox virus have been kept for research purposes. This has led
to concerns that smallpox could someday be used as a biological
warfare agent. A vaccine can prevent smallpox, but the risk of the
current vaccine's side effects is too high to justify routine
vaccination for people at low risk of exposure to the smallpox
virus.
FORWARD-LOOKING STATEMENTS
This press release contains certain
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended. Such
forward-looking statements are subject to various known and unknown
risks and uncertainties, and SIGA cautions you that any
forward-looking information provided by or on behalf of SIGA is not
a guarantee of future performance. More detailed information about
SIGA and risk factors that may affect the realization of
forward-looking statements, including the forward-looking
statements in this press release, is set forth in SIGA's filings
with the Securities and Exchange Commission, including SIGA's
Annual Report on Form 10-K for the fiscal year ended December 31,
2017, and in other documents that SIGA has filed with the SEC. SIGA
urges investors and security holders to read those documents free
of charge at the SEC's web site at http://www.sec.gov. Interested
parties may also obtain those documents free of charge from SIGA.
Forward-looking statements are current only as of the date on which
such statements were made, and except for our ongoing obligations
under the United States of America federal securities laws, we
undertake no obligation to update publicly any forward-looking
statements whether as a result of new information, future events,
or otherwise.
The information contained in this press release
does not necessarily reflect the position or the policy of the
Government and no official endorsement should be inferred.
Contacts:
InvestorsDavid Carey 212-867-1768dcarey@lazarpartners.com
MediaStephanie Seiler206-713-0124sseiler@lazarpartners.com
__________________________
1
http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
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