60 Degrees Pharmaceuticals Inc. (“60P” or the “Company”) (Nasdaq:
SXTP), a pharmaceutical company focused on developing new medicines
for infectious diseases, today announced that the Canadian
Intellectual Property Office (CIPO) has issued the Company a patent
covering the use of novel regimens of
tafenoquine
for the prevention of malaria in malaria-naive individuals.
Travelers from, and residents of, Canada and the United States, are
usually malaria naïve because they have not previously contracted
malaria and thus lack immunity to the disease.
Tafenoquine is the active molecule in the
Company’s U.S. Food and Drug Administration-approved regimen for
malaria prevention, ARAKODA®. ARAKODA, an oral tablet containing
100 mg of tafenoquine base, is an anti-malarial
indicated in the U.S. for the prophylaxis of malaria in individuals
aged 18 years and older. Travelers or individuals at risk of
contracting malaria are prescribed 2 x 100 mg tablets once per day
for three days (the loading phase) prior to travel, 2 x 100 mg
tablets weekly for up to six months during travel, then 2 x 100 mg
in the week following travel. ARAKODA is not approved by Health
Canada for the prevention of malaria.
The newly issued Canadian patent provides exclusive use of
tafenoquine for preventing malaria in
malaria-naive patients in Canada to December 2, 2035. The Company
was previously issued a U.S. patent covering the use of
tafenoquine for malaria prevention in
malaria-naïve individuals. The U.S. and Canadian patents cover the
ARAKODA dosing regimen approved in the U.S. for malaria
prevention.
Malaria is a life-threatening disease when contracted by
malaria-naïve individuals. There are no vaccines useful for
travelers that have been approved by Canadian or U.S. regulatory
authorities, so CDC and Health Canada recommend the use of malaria
chemoprophylactic drugs during travel. There were 1,823 symptomatic
malaria cases in the United States in 2018 and 489 cases were
reported to Health Canada in 2014, and the overall rate of cases is
increasing. In the U.S. 95% of malaria cases occurring in returning
travelers were in individuals who reported not taking or failing to
adhere to CDC-recommended malaria chemoprophylactic regimens. Local
malaria transmission is also an increasing problem in the southern
United States – Texas and Florida have reported eight such cases to
date in 2023, prompting a CDC health warning.
About ARAKODA® (tafenoquine)
Tafenoquine was discovered by Walter Reed Army
Institute of Research and approved for malaria prophylaxis in 2018
in the United States as ARAKODA (tafenoquine) 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. 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.
ARAKODA® (tafenoquine) Important Safety
Information
ARAKODA® is an antimalarial indicated for the prophylaxis of
malaria in patients aged 18 years of age and older.
Contraindications
ARAKODA® should not be administered to patients with:
Glucose-6-phosphate dehydrogenase (G6PD) deficiency or unknown
G6PD status
Lactating women who are 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
Patients with known hypersensitivity reactions to tafenoquine,
other 8-aminoquinolines, or any component of ARAKODA®.
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
greater than or equal to 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 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. 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 institutional investors including 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
Statements
This 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.
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 fact, 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 because 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
60 Degrees Pharmaceuticals (NASDAQ:SXTP)
過去 株価チャート
から 8 2024 まで 9 2024
60 Degrees Pharmaceuticals (NASDAQ:SXTP)
過去 株価チャート
から 9 2023 まで 9 2024