SIGA Technologies Announces First International Delivery of Oral TPOXX®
June 01 2020 - 9:01AM
SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company focused on the health security market, today
announced its first international delivery of TPOXX® (tecovirimat),
with 2,500 courses delivered to the Canadian Department of National
Defence (CDND). On April 3, 2020, the Company previously
announced that the CDND is expected to purchase up to 15,325
courses of oral TPOXX® over four years for a total value of $14.3
million. Remaining purchases of 12,825 courses, at the option of
the CDND, are expected to occur after regulatory approval of oral
TPOXX® by Health Canada. Meridian Medical Technologies,
Inc. (“Meridian”, a Pfizer Company), SIGA’s partner for
international promotion of TPOXX, is the counterparty to the
Canadian Contract and SIGA is responsible for the manufacture and
delivery of oral TPOXX.
In addition to the Canadian product delivery,
SIGA also expects to make deliveries of oral TPOXX to the U.S.
Government this month. As previously disclosed, SIGA expects
to deliver $101.3 million of oral TPOXX to the U.S. Government by
April 2021, with deliveries starting this month. These
deliveries will be in connection with the recent option exercises
under its 2018 Biomedical Advanced Research and Development
Authority (BARDA) contract (“19C BARDA Contract”). In addition to
the options recently exercised, SIGA’s full 19C BARDA Contract has
up to $414 million of procurement-related options remaining for
future exercise.
“We are pleased to be moving quickly to deliver
on our new U.S. and international orders of TPOXX and we look
forward to continuing to work with BARDA and CDND on future options
and deliveries,” said Dr. Phil Gomez, CEO of SIGA. “We are working
on the filing of our regulatory submission to Health Canada later
this year and delivery of additional courses to CDND under this
contract following product approval. Meridian’s ability to secure
this opportunity to support smallpox preparedness in Canada is
evidence of its leadership in international health security and of
TPOXX’s importance for international biodefense preparedness.
The COVID-19 pandemic has highlighted the importance for
governments around the world to quickly build robust stockpiles in
order to protect the health and economic well-being of the general
population from other biological threats, and we look forward to
working with Meridian to address the global need for TPOXX as a
critical component of robust smallpox preparedness strategies.”
Dr. Gomez added, “I would like to thank everyone
at SIGA, all of whom have been working hard with our supply chain
partners to ensure continued manufacturing and delivery of TPOXX
during the COVID-19 pandemic, demonstrating the resiliency our
U.S.-based supply chain during these difficult times.”
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 in 2018. The
full label is here:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fce826ab-4d6a-4139-a2ee-a304a913a253.
In September 2018, SIGA signed a contract potentially worth more
than $600 million with 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.
Recently, SIGA announced in April 2020 that
BARDA exercised an option under the 2018 Contract for delivery of
approximately 363,000 courses or oral TPOXX as SIGA continues to
replenish the US government’s stockpile of its smallpox antiviral
treatment.
ABOUT MERIDIAN MEDICAL TECHNOLOGIES,
INC.
Meridian Medical Technologies, Inc., a Pfizer
company, has been putting emergency care treatment options into the
hands of military and civilian defenders for more than 50 years.
Meridian is committed to help defend against critical,
time-sensitive, life-or-death situations by providing medical
countermeasures to the United States Department of Defense,
Emergency Medical Services, Homeland Security, and more than 30
nations around the world.
Meridian holds a federal SAFETY Act designation
and certification from the Department of Homeland Security for its
portfolio of auto-injectors. The SAFETY Act is intended to provide
critical incentives for the development and deployment of
anti-terrorism technologies by providing liability protections for
sellers of qualified anti-terrorism technologies.
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 year ended December 31, 2019, 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
SIGA Technologies (NASDAQ:SIGA)
Historical Stock Chart
From Aug 2024 to Sep 2024
SIGA Technologies (NASDAQ:SIGA)
Historical Stock Chart
From Sep 2023 to Sep 2024