60 Degrees Pharmaceuticals (“60P”) (Nasdaq: SXTP), specialists in
developing and marketing medicines for infectious diseases, today
announced that the United States Patent and Trademark Office
(USPTO) has awarded 60P a patent covering the use of
tafenoquine for prevention of Plasmodium
falciparum malaria.
Tafenoquine is the active
molecule in ARAKODA
®, the Company’s FDA-approved
drug for malaria prevention in individuals aged 18 years and older
for up to six months of continuous dosing.
Travelers from and residents of the United States are usually
malaria naïve, that is, they have not previously contracted malaria
and thus lack immunity to the disease. When contracted by these
individuals, malaria can be a life-threatening disease.
“Securing this patent is important for 60P,” said Chief
Executive Officer, Geoff Dow. “It ensures that 60P can continue to
maintain a long-term competitive position for the regimen of
tafenoquine known as ARAKODA in the U.S.
marketplace. Tafenoquine is effective against all
species and stages of malaria. Furthermore, physicians can
administer it weekly during travel. The current market leading
malaria drugs do not kill latent vivax liver stages and must be
given daily. We are pleased to have secured this additional patent
on tafenoquine.”
There were 1,823 symptomatic malaria cases in the United States
in 2018 and the overall rate of cases is increasing. In the U.S.,
95 percent of malaria cases occurring in returning travelers were
in individuals who reported not taking, or failing to adhere to,
CDC-recommended malaria chemoprophylactic regimens.
No useful vaccine against malaria is approved in the U.S.
Therefore, the CDC recommends the use of malaria chemoprophylactic
drugs during travel. Local malaria transmission has become an
increasing problem in the United States; Texas, Maryland and
Florida have reported a total of nine such cases to date in 2023,
prompting a Centers for Disease Control and Prevention (CDC) health
warning. The Maryland case involved the parasite Plasmodium
falciparum, according to the Maryland Department of Health.
60P initially received a U.S. patent in 2019 for
tafenoquine for the prevention of P. falciparum
malaria in naïve individuals aged 18 years of age or older. The
current patent award is a continuation of the application for that
original patent.
About ARAKODA®
(tafenoquine)
Tafenoquine was discovered by Walter Reed Army
Institute of Research and the current study was funded by 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.
According to the Centers for Disease Control and Prevention, the
long terminal half-life of tafenoquine, which is
approximately 16 days, may offer potential advantages in
less-frequent dosing for prophylaxis for malaria.
ARAKODA is not suitable for everyone and patients
and prescribers should review the Important Safety Information
below.
Individuals at risk of contracting malaria are prescribed
ARAKODA 2 x 100 mg tablets once per day for three days (the loading
phase) prior to travel to an area of the world where malaria is
endemic, 2 x 100 mg tablets weekly for up to six months during
travel, then 2 x 100 mg in the week following travel.
ARAKODA® (tafenoquine)
Important Safety Information
ARAKODA is an antimalarial indicated for the
prophylaxis of malaria in patients aged 18 years of age and
older.
Important Safety Information
Contraindications
ARAKODA should not be administered to:
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency or unknown
G6PD status
- Breastfeeding by a lactating woman when the infant is found to
be G6PD deficient or if G6PD status is unknown
- Patients with a history of psychotic disorders or current
psychotic symptoms
- Known hypersensitivity reactions to
tafenoquine, other 8-aminoquinolines, or any
component of ARAKODA Warnings and Precautions
Warnings and Precautions
- Hemolytic Anemia: G6PD testing must be
performed before prescribing ARAKODA due to the
risk of hemolytic anemia. Monitor patients for signs or symptoms of
hemolysis.
- G6PD Deficiency in Pregnancy or Lactation:
ARAKODA may cause fetal harm when administered to
a pregnant woman with a G6PD-deficient fetus.
ARAKODA is not recommended during pregnancy. A
G6PD-deficient infant may be at risk for hemolytic anemia from
exposure to ARAKODA through breast milk. Check infant’s G6PD status
before breastfeeding begins.
- Methemoglobinemia: Asymptomatic elevations in
blood methemoglobin have been observed. Initiate appropriate
therapy if signs or symptoms of methemoglobinemia occur.
- Psychiatric Effects: Serious psychotic adverse
reactions have been observed in patients with a history of
psychosis or schizophrenia, at doses different from the approved
dose. If psychotic symptoms (hallucinations, delusions, or grossly
disorganized thinking or behavior) occur, consider discontinuation
of ARAKODA therapy and evaluation by a mental
health professional as soon as possible.
- Hypersensitivity Reactions: Serious
hypersensitivity reactions have been observed with administration
of ARAKODA. If hypersensitivity reactions occur,
institute appropriate therapy.
- Delayed Adverse Reactions: Due to the long
half-life of ARAKODA, (approximately 17 days),
psychiatric effects, hemolytic anemia, methemoglobinemia, and
hypersensitivity reactions may be delayed in onset and/or
duration.
Adverse Reactions The most common adverse
reactions (incidence ≥1 percent) were: headache, dizziness, back
pain, diarrhea, nausea, vomiting, increased alanine
aminotransferase (ALT), motion sickness, insomnia, depression,
abnormal dreams, and anxiety.
Drug Interactions Avoid co-administration with
drugs that are substrates of organic cation transporter-2 (OCT2) or
multidrug and toxin extrusion (MATE) transporters.
Use in Specific Populations Lactation: Advise
women not to breastfeed a G6PD-deficient infant or infant with
unknown G6PD status during treatment and for 3 months after the
last dose of ARAKODA.
To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees
Pharmaceuticals at 1-888-834-0225 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch. ARAKODA full prescribing
information is here.
About 60 Degree 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. 60P achieved FDA approval of its lead product, ARAKODA ®
(tafenoquine), for malaria prevention, in 2018. 60P also
collaborates with prominent research organizations in the U.S.,
Australia and Singapore. 60P’s mission has been supported through
in-kind funding from the United States Department of Defense and
private investment from Knight Therapeutics Inc., a Canadian-based
pan American specialty pharmaceutical company. 60P is headquartered
in Washington D.C., with a majority-owned subsidiary in Australia.
Learn more at www.60degreespharma.com.
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 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 our final prospectus to our Form S-1 (File No.:
333-269483) filed with the SEC on July 13, 2023, and our subsequent
annual reports on Form 10-K and our quarterly reports on Form 10-Q
filed with the SEC. 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.com484-667-6330
Investor Contact:Patrick
Gaynespatrickgaynes@60degreespharma.com(310) 989-5666
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