SIGA Announces Exercise of Option for the Purchase of Raw Materials for Oral TPOXX® Manufacturing Totaling $11 Million
May 20 2019 - 4:30PM
SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company focused on the health security market, today
announced the exercise of an option under BARDA contract
HHSO100201800019C (“2018 BARDA Contract”) worth a total of
approximately $11 million for the purchase of raw materials in
sufficient quantity to support the manufacture of at least 363,070
courses of oral TPOXX. The option exercise occurs
simultaneously with a modification to the 2018 BARDA Contract, in
which optional procurement Contract Line Item Number (CLIN) 0009
(“Optional CLIN 0009") was replaced with four new
procurement-related options. One of the four new
procurement-related options, the aforementioned $11 million option
(“Optional CLIN 0009a"), has been exercised. Each of the
other three new options, optional CLINs 0009b-d, individually
specify the delivery of approximately 121,000 courses of oral TPOXX
worth approximately $34 million. In total, optional CLINs
0009a (exercised), 0009b, 0009c and 0009d provide for the
manufacturing and delivery of 363,070 courses of oral TPOXX with a
total value of approximately $112.5 million. The modification
does not change the overall total potential value of the 2018 BARDA
Contract, nor does it change the total amount to be paid in
connection with the delivery of oral TPOXX courses originally
specified in Optional CLIN 0009.
“The execution of this option is an important
step in the timely maintenance of the oral TPOXX stockpile for the
US Government,” said Phil Gomez, CEO of SIGA Technologies.
“It provides meaningful cash funding to SIGA prior to delivery of
final product, and reflects a shared focus on ensuring timely
production of TPOXX to support stockpile maintenance.” Dr.
Gomez further noted that “TPOXX deliveries to the Strategic
National Stockpile began in 2013, and the FDA approval of oral
TPOXX in July of 2018 included a 7-year shelf life. In the
Request For Proposal ('RFP') for the BARDA contract awarded to SIGA
in 2018, BARDA indicated that part of the intent of that RFP was to
maintain a stockpile of 1.7 million courses of TPOXX. SIGA is
committed to working with BARDA to achieve this goal and provide
flexibility where necessary to ensure timely manufacture and
delivery of TPOXX.”
In its Form 10-K filed on March 5, 2019, SIGA
also disclosed that BARDA has exercised CLIN 0007 to support the
post-marketing commitments required by the U.S. Food and Drug
Administration (“FDA”) for oral TPOXX. The total value of
this cost plus fixed-fee option (CLIN 0007) is approximately $12
million, and will support on-going activities required by FDA
post-approval for oral TPOXX.
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 approximately
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,
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 212-867-1768dcarey@lazarpartners.com
MediaStephanie Seiler206-713-0124sseiler@lazarpartners.com
_________________________1
http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
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