60 Degrees Pharmaceuticals Awarded Contract with U.S. Army for ARAKODA® Supply Chain Upgrade Support
July 25 2024 - 8:02AM
60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the
“Company”), a pharmaceutical company focused on developing new
medicines for infectious diseases, announced today that it has been
awarded a fixed-price contract with the United States Army Medical
Materiel Development Activity to support commercial validation of
new bottle and replacement blister packaging of ARAKODA®
(
tafenoquine), the Company’s malaria prevention
product.
This follows the implementation of an increased tablet
compression batch size in Q1 2024, planned in anticipation of
increasing sales volume in 2024. Recently, 60 Degrees
Pharmaceuticals announced that Q1 2024 ARAKODA net sales revenues
increased 515% year-over-year to $105.7 thousand.
“Supply chain upgrade support from the United States Army
Medical Materiel Development Activity is most welcome and important
to our primary commercial goal of ensuring a sustainable supply of
ARAKODA for our civilian and military customers in the U.S.,” said
Chief Executive Officer of 60 Degrees Pharmaceuticals, Geoff Dow.
“We are very proud of our uninterrupted supply of ARAKODA to the
U.S. market, even in light of the earlier impact of the pandemic on
international travel. We anticipate that, increasingly and over
time, the U.S. healthcare provider community will recognize the
advantages of using ARAKODA for malaria prevention. Also, the
potential life-saving role the product may play in the treatment of
all forms of babesiosis in the future is certainly very
exciting.”
Babesiosis is a steadily emerging, tick-borne disease
transmitted through the bite of the black-legged (deer) tick, the
vector that spreads Lyme disease. An orphan disease, babesiosis may
be life-threatening in elderly and immunosuppressed patients.
ARAKODA is indicated for the prophylaxis of malaria in
patients aged 18 years and older. Tafenoquine is
approved for malaria prophylaxis in the United States under the
product name ARAKODA®. The safety of the approved regimen of
tafenoquine for malaria prophylaxis has been
assessed in five separate randomized, double-blind, active
comparator or placebo-controlled trials for durations of up to six
months. Tafenoquine has not been proven to be
effective for treatment or prevention of babesiosis and is not
approved by the U.S. Food and Drug Administration for such an
indication.
About ARAKODA® (tafenoquine)Tafenoquine was
discovered by Walter Reed Army Institute of Research with funding
from the United States Army Medical Materiel Development Activity.
Tafenoquine was approved for malaria prophylaxis in 2018 in the
United States as ARAKODA® and in Australia as KODATEF®. Both were
commercially launched in 2019 and are currently distributed through
pharmaceutical wholesaler networks in each respective country. They
are available at retail pharmacies as a prescription-only malaria
prevention drug.
About 60 Degrees Pharmaceuticals, Inc.60
Degrees Pharmaceuticals, Inc., founded in 2010, specializes in
developing and marketing new medicines for the treatment and
prevention of infectious diseases that affect the lives of millions
of people. 60 Degrees Pharmaceuticals, Inc. achieved FDA approval
of its lead product, ARAKODA® (tafenoquine), for
malaria prevention, in 2018. 60 Degrees Pharmaceuticals, Inc. also
collaborates with prominent research organizations in the U.S.,
Australia, and Singapore. The 60 Degrees Pharmaceuticals, Inc.
mission has been supported through in-kind funding from the U.S.
Department of Defense and private institutional investors including
Knight Therapeutics Inc., a Canadian-based pan-American specialty
pharmaceutical company. 60 Degrees Pharmaceuticals, Inc. is
headquartered in Washington D.C., with a majority-owned subsidiary
in Australia. Learn more at www.60degreespharma.com.
The statements contained herein may include prospects,
statements of future expectations and other forward-looking
statements that are based on management's current views and
assumptions and involve known and unknown risks and uncertainties.
Actual results, performance or events may differ materially from
those expressed or implied in such forward-looking statements. The
statements expressed herein are those of 60 Degrees
Pharmaceuticals, Inc. and do not necessarily represent those of the
U.S. Department of Defense.
Cautionary Note Regarding Forward-Looking
StatementsThis press release may contain “forward-looking
statements” within the meaning of the safe harbor provisions of the
U.S. Private Securities Litigation Reform Act of 1995.
Forward‐looking statements reflect the current view about future
events. When used in this press release, the words “anticipate,”
“believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the
negative of these terms and similar expressions, as they relate to
us or our management, identify forward‐looking statements.
Forward-looking statements are neither historical facts
nor assurances of future performance. Instead, they are based
only on our current beliefs, expectations and assumptions
regarding the future of our business, future plans and strategies,
projections, anticipated events and trends, the economy, activities
of regulators and future regulations and other future conditions.
Because forward-looking statements relate to the future, they are
subject to inherent uncertainties, risks and changes in
circumstances that are difficult to predict and many of which are
outside of our control. Our actual results and financial condition
may differ materially from those indicated in the forward-looking
statements. Therefore, you should not rely on any of these
forward-looking statements. Important factors that could cause our
actual results and financial condition to differ materially from
those indicated in the forward-looking statements include, among
others, the following: there is substantial doubt as to our ability
to continue on a going-concern basis; we might not be eligible for
Australian government research and development tax rebates; if we
are not able to successfully develop, obtain FDA approval for, and
provide for the commercialization of non-malaria prevention
indications for tafenoquine (ARAKODA® or other
regimen) or Celgosivir in a timely manner, we may not be able to
expand our business operations; we may not be able to successfully
conduct planned clinical trials; and we have no manufacturing
capacity which puts us at risk of lengthy and costly delays of
bringing our products to market. More detailed information
about the Company and the risk factors that may affect the
realization of forward-looking statements is set forth in the
Company’s filings with the Securities and Exchange
Commission (“SEC”), including the information contained in our
Annual Report on Form 10-K filed with the SEC on April 1, 2024, and
our subsequent SEC filings. Investors and security holders are
urged to read these documents free of charge on the SEC’s web site
at www.sec.gov. As a result of these matters, changes in
facts, assumptions not being realized or other circumstances, the
Company’s actual results may differ materially from the expected
results discussed in the forward-looking statements contained in
this press release. Any forward-looking statement made by us in
this press release is based only on information currently available
to us and speaks only as of the date on which it is made. We
undertake no obligation to publicly update any forward-looking
statement, whether written or oral, that may be made from time to
time, whether as a result of new information, future developments
or otherwise.
Media Contact:Sheila A.
BurkeSheilaBurke-consultant@60degreespharma.com(484) 667-6330
Investor Contact:Patrick
Gaynespatrickgaynes@60degreespharma.com(310) 989-5666
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