SIGA Technologies Awarded BARDA Contract for TPOXX®
September 10 2018 - 5:50PM
- Contract Valued at Up to $629 Million
–
SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company focused on the health security market, today
announced that it has signed a multi-year contract with the
Biomedical Advanced Research and Development Authority (BARDA), a
division of the U.S. Department of Health and Human Services’
Office of the Assistant Secretary for Preparedness and Response,
for the delivery of oral and intravenous (IV) formulations of
TPOXX® to the Strategic National Stockpile. The contract also
covers advanced development of the IV formulation and
post-marketing activities for the oral formulation of TPOXX. The
contract (HHSO100201800019C) is valued at up to $629 million, and
consists of a five-year base period of performance and a total
contract period of performance (base period plus option exercises)
of up to ten years (if necessary). The contract contains base
period activities and a series of options, and is designed to
maintain a stockpile of 1.7 million courses of antiviral treatment
for smallpox.
On July 13, 2018, the U.S. Food and Drug Administration (FDA)
approved oral TPOXX® (tecovirimat) for the treatment of smallpox to
mitigate the impact of a potential outbreak. TPOXX, a
small-molecule antiviral treatment for smallpox, is the first
therapy specifically approved for this indication.
”This contract builds on the strong foundation of the SIGA and
BARDA partnership and we look forward to working closely with BARDA
to ensure the current U.S. stockpile is adequately maintained,”
said Phil Gomez, CEO of SIGA Technologies. “The contract provides
excellent value to the U.S. Government for the mitigation of the
risks of a smallpox outbreak, outlines a roadmap for sustaining the
current stockpile, and adds the IV formulation of TPOXX as an
available alternative treatment option.”
Under contract HHSO100201800019C, base period activities are
valued at approximately $52 million and include:
- Development activities for the IV formulation of TPOXX (IV
TPOXX).
- Delivery to the Strategic National Stockpile (SNS) of a limited
number of courses (approximately 35,700 courses) of the oral
formulation of TPOXX (oral TPOXX) for an approximate value of $11
million; such courses being readily-available for delivery or will
be manufactured using currently-held active pharmaceutical
ingredient.
- Delivery of bulk drug substance to be used for the manufacture
of IV TPOXX and the use of such bulk drug substance to manufacture
20,000 courses of final drug product of IV TPOXX, with such
activities having a total value of $8 million for 7-day (14-vial)
courses; additionally, SIGA will be paid for the storage, if
applicable, and delivery of final drug product of IV TPOXX.
With options valued at approximately $577 million in total (if
all options are fully exercised), contract HHSO100201800019C is
primarily comprised of options that are exercisable at the sole
discretion of BARDA.
Options within the contract include:
- Series of options to procure up to approximately 1,452,300
courses in total of oral TPOXX (exclusive of the courses to be
purchased for base period activities), with such options having a
total value of up to approximately $450 million.
- Series of options to procure up to 192,000 courses in total
(exclusive of the courses to be purchased for base period
activities) of final drug product of IV TPOXX, with such options
having a cumulative total value of up to approximately $77 million
for the combination of bulk drug substance and final drug product
manufacturing; or alternatively, to procure up to 192,000
equivalent courses in total (exclusive of the equivalent courses to
be purchased for base period activities) of bulk drug substance
that could be used in the future for the manufacture of final drug
product of IV TPOXX, with such alternative having a value of up to
approximately $31 million.
- Series of options for vendor-managed storage of either bulk
drug substance that would be used in the manufacture of the IV
TPOXX or final drug product of IV TPOXX (total option value of
approximately $6 million).
- Separate options to cumulatively provide up to approximately
$44 million of funding for post-marketing activities for oral TPOXX
and IV TPOXX.
This BARDA contract (HHSO100201800019C) becomes the third active
contract between the Company and BARDA. Under contract
HHSO100201100001C, BARDA funded late-stage development of oral
TPOXX for the treatment of smallpox, which culminated in the U.S.
Food and Drug Administration (FDA) approval on July 13, 2018,
and the acquisition of 2 million courses of oral TPOXX which the
Company has delivered. Under contract HHSO100201100023C, the
Company receives funding from BARDA for the development of the IV
formulation of TPOXX to provide a treatment option for patients who
are too sick or unable to swallow oral capsules. It is anticipated
that patients taking the IV formulation would eventually
“step-down” to the oral formulation, once they are able to swallow
capsules. To accommodate this dosing regimen, contract
HHSO100201800019C includes an initial order and options for the
purchase of up to 212,000 treatment courses (in total) of IV
therapy, and each treatment course is expected to cover seven (7)
days (14 vials) of treatment. Oral TPOXX approval and procurement
is based upon 14 total days of therapy.
This contract will be funded in whole or in part with Federal
funds from the Office of the Assistant Secretary for Preparedness
and Response, Biomedical Advanced Research and Development
Authority, under Contract No HHS0100201800019C.
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 Food and Drug Administration (FDA) for the
treatment of smallpox on July 13, 2018. 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. No cure or treatment for smallpox exists. A vaccine
can prevent smallpox, but the risk of the 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, including statements relating to the future
exercise of options by BARDA for procurement of TPOXX®. 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.
Contact:
Investors and MediaDavid Carey
212-867-1768dcarey@lazarpartners.com
_______________________
1 http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
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