60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60P”
or the “Company”), a pharmaceutical company focused on developing
new medicines for infectious diseases, announced today it has
appointed Kristen Landon to the newly created role of Chief
Commercial Officer, effective immediately. Ms. Landon is an
accomplished commercial leader with over 26 years’ experience
launching, building, and transforming commercial teams and brands
in the pharmaceutical industry.
“We screened hundreds of applicants during the second half of
2023 and Kristen’s vision and directly relevant experience made her
the ideal match for the position,” said Geoff Dow, PhD., 60 Degrees
Pharma Chief Executive Officer. “With this hire and last month’s
financing, management and the Board are excited about the
milestones we aim to achieve in the coming quarters.”
“I am impressed by the vision and track record that the 60
Degrees team has demonstrated by the achievement of FDA approval
for ARAKODA, a successful IPO and recent FDA support of a clinical
babesiosis program,” said Ms. Landon. “We have had extensive
discussions about our commercial path and I’m confident in this
team’s ability to grow the business based on smart planning and
focused execution.”
Most recently, Ms Landon served as Senior Vice President of
Marketing and Communications at TherapeuticsMD. Previous commercial
leadership roles include Vice President of Marketing at Radius
Health, Vice President of Marketing at Sprout, and Executive
Director of Women’s Health Global Brands at Actavis. Earlier in her
career, Ms. Landon held roles of increasing responsibility in sales
and marketing leadership at Abbott Labs and Novartis. Ms. Landon
holds an MBA from Silberman College of Business at Fairleigh
Dickinson University, and a Bachelor’s degree from Kean
University.
Tafenoquine is approved for malaria prophylaxis
in patients aged 18 years and older 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 FDA for such an indication.
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.
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.
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; or
- 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, Inc. at 1- 888-834-0225 or the
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The full prescribing
information of ARAKODA® is located 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. 60 Degrees
Pharmaceuticals achieved FDA approval of its lead product, ARAKODA®
(tafenoquine), for malaria prevention in 2018. 60
Degrees Pharmaceuticals also collaborates with prominent research
organizations in the U.S., Australia and Singapore. The 60 Degrees
Pharmaceutical mission has been supported through in-kind funding
from the DOD and private institutional investors including Knight
Therapeutics Inc., a Canadian-based pan-American specialty
pharmaceutical company. 60 Degrees Pharmaceuticals is headquartered
in Washington D.C., with a majority-owned subsidiary in Australia.
Learn more at www.60degreespharma.com.
Disclaimer & Cautionary
Note Regarding Forward-Looking Statements The
statements made about our tafenoquine-babesiosis clinical trial in
this press release are based on both written correspondence from
the FDA ahead of the Company’s Type C meeting on January 17, 2024,
and the Company’s minutes from the meeting. The Company has not
received the FDA’s formal minutes from the meeting and will not do
so until 30 days following January 17, 2024. Any information
released by us about the protocol on clinicaltrials.gov, our
website or elsewhere should be considered out of date as of the
date of this press release. The Company has not yet rewritten its
clinical protocol in light of FDA comments and there is no
guarantee it will receive Institutional Review Board or FDA
approval when resubmitted. The protocol will be resubmitted under
our malaria Investigational New Drug Application, and is not
subject to the minimum 30-day holding period required for a new
Investigational New Drug Application. However, the FDA can at its
discretion require changes to protocols at any time.
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 the information contained in the
final prospectus to our Registration Statement on Form S-1 (File
No.: 333-269483), as amended, initially filed with the SEC on
January 31, 2023 relating to our initial public offering, and our
subsequent Quarterly Report on Form 10-Q for the period ended June
30, 2023 and 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
60 Degrees Pharmaceuticals (NASDAQ:SXTP)
Historical Stock Chart
From Aug 2024 to Sep 2024
60 Degrees Pharmaceuticals (NASDAQ:SXTP)
Historical Stock Chart
From Sep 2023 to Sep 2024