SIGA Completes Clinical Studies for IV Formulation of TPOXX®, NDA to be Submitted in 2020
October 03 2019 - 7:30AM
SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company focused on the health security market, today
announced that it has reached concurrence with the US Food and Drug
Administration (FDA) that no further clinical studies will be
required for the IV formulation of TPOXX (tecovirimat), and SIGA
anticipates filing the New Drug Application (NDA) for this
formulation in 2020. Given that the efficacy of TPOXX was
previously established in animal models used to support the
development and approval of the oral formulation, the FDA will not
require additional efficacy data to support the NDA for the IV
formulation.
The IV formulation of TPOXX is an important
option for the treatment of smallpox in those who may be too sick
or unable to swallow the oral capsule formulation. The
Biomedical Advanced Research and Development Authority (BARDA)
emphasized the importance of this option in the 2018 contract award
to SIGA, which specifies the delivery of 20,000 courses of the IV
formulation of TPOXX and contains options for the purchase of up to
an additional 192,000 courses of the formulation.
“We are pleased to reach this milestone with the
FDA in the development of the IV formulation of TPOXX,” said Phil
Gomez, CEO of SIGA Technologies. “We will now focus on finalizing
the commercial production capability for IV TPOXX and submitting
the NDA in 2020.” SIGA anticipates that the FDA will approve the IV
formulation of TPOXX in 2021.
On July 13, 2018, the FDA approved the oral
formulation of TPOXX (oral TPOXX) for the treatment of smallpox to
mitigate the impact of a potential outbreak or bioterror attack.
TPOXX, a small-molecule antiviral treatment for smallpox, is the
first therapy specifically approved for this indication, and was
developed through funding and collaboration with BARDA at the U.S.
Department of Health and Human Services, as well as early stage
development supported by the National Institutes of Health, U.S.
Centers for Disease Control and Prevention, and Department of
Defense.
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 and the US maintains a
stockpile of 1.7 million courses in 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,
2018, 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
212-867-1768david.carey@finnpartners.com
MediaStephanie
Seiler206-713-0124stephanie.seiler@finnpartners.com
____________1
http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
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