Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a
company focused on developing, marketing, and selling a variety of
men’s health and wellness products via a secure telemedicine
platform, including its uniquely formulated hair growth product
(‘GROW’) and erectile dysfunction (ED) drug (‘Mango’), is excited
to announce that it has entered into a Marketing Agreement with
Marius Pharmaceuticals ("Marius") to market and sell KYZATREX®️, an
innovative FDA-approved oral Testosterone Replacement Therapy (TRT)
product, under the program, 'PRIME' by MangoRx.
PRIME will be available on MangoRx’s
telemedicine platform with an anticipated launch date of January
31, 2024.
KYZATREX, a prescription drug that is used to
treat adult men who have low or no testosterone levels due to
certain medical conditions, is one of only three FDA approved TRT
treatments that is delivered orally--as opposed to the traditional,
invasive, and inconvenient injection-based drug delivery protocol.
KYZATREX delivers testosterone in a softgel capsule that is
absorbed primarily via the lymphatic system, avoiding liver
toxicity.
Testosterone deficiency is often first
recognized through symptoms of fatigue or low energy, decreased sex
drive, lower muscle mass and many other negative downstream
impacts. PRIME, powered by KYZATREX, can help men restore
Testosterone to normal levels and improve how they feel. In a
6-month open-label clinical study of 139 hypogonadal patients, 88%
of patients taking KYZATREX had normal testosterone levels at Day
90 (worst case scenario (WCS) efficacy calculation, excluding Site
104).1 Among study completers (n=127), 96% of KYZATREX patients
achieved normal testosterone levels at Day 90.2 With PRIME, MangoRx
will expand broad-based consumer access to this innovative
therapy.
TRT treatments have traditionally been delivered
through intramuscular needle injection, a subcutaneous implant, or
a topical gel. These applications have suffered from different
drawbacks depending on the delivery method, such as painful
administration, uneven absorption, risk of transfer to others, and
disruptions to the body's natural diurnal rhythm allowing for peak
performance early in the day.
Twice daily oral TRTs offer painless
administration, promote steady absorption, lower SHGB levels,
increase free T levels to give the body more usable testosterone,
and work with the body's natural diurnal rhythm. Oral softgels are
also convenient, mess-free, and discreet.
Shalin Shah, CEO of Marius, shared, “This
expansion into telehealth marks an important step in the care of
Testosterone Deficient patients. Testosterone Deficiency is a
serious chronic disease and has been inadequately addressed by
previous generations of products. KYZATREX marks a shift in the
treatment paradigm and a meaningful opportunity for patients
seeking to restore optimal testosterone levels. Marius is excited
to partner with MangoRx as an innovative partner in the DTC
marketplace. We look forward to the Mango team bringing more
awareness around the significance of Testosterone as a metabolic
hormone and its role in optimal health for men with Low T.”
PRIME by MangoRx will bring KYZATREX to patients
spanning 48 states through the Company’s telemedicine platform,
which is optimized to deliver a smooth medical prescription
process, including blood work and synchronous telehealth visits
with a fully licensed prescribing physician. Orders will be
reviewed and, pending approval, fulfilled, then discreetly shipped
via MangoRx’s URAC accredited mail order partner pharmacy directly
to the patient’s doorstep.
Jacob Cohen, MangoRx’s Co-Founder and CEO,
noted, “PRIME represents a critical expansion into a new vertical
with massive market potential and very little competition on the
consumer side, while remaining completely consistent with our
established identity as a company committed to providing new and
innovative pharmaceutical based solutions helping men achieve
optimal performance in all areas of life. We are extremely
fortunate to be working with Marius and to be one of only a few
companies with access to this innovative product. With our
established marketing and telemedicine infrastructure in place, we
are ready to hit the ground running and take PRIME to patients in
need across the country next month."
Testosterone deficiency affects approximately
four in ten men older than 45 years and 30-50% of men with obesity
or type 2 diabetes, according to the Endocrine Society.3,4 Between
10% and 40% of men worldwide suffer from low testosterone
levels.5
About MangoRx
MangoRx is focused on developing a variety of
men's health and wellness products and services via a secure
telemedicine platform. To date, the Company has identified men's
wellness telemedicine services and products as a growing sector and
especially related to the area of erectile dysfunction (ED) and
hair growth. Interested consumers can use MangoRx’s telemedicine
platform for a smooth experience. Prescription requests will be
reviewed by a physician and, if approved, fulfilled and discreetly
shipped through MangoRx’s partner compounding pharmacy and right to
the patient’s doorstep.
To learn more about MangoRx’s mission and other
products, please visit www.MangoRx.com or on social media
@Mango.Rx.
About Marius
Pharmaceuticals
Marius Pharmaceuticals strives to better the
lives of patients by focusing on therapies designed for
hypogonadism or Testosterone Deficiency. The company's vision is to
holistically improve metabolic health and mitigate significant
unnecessary costs to the global healthcare system. For more
information, please visit www.mariuspharma.com.
About
KYZATREX® (testosterone
undecanoate)
KYZATREX is a proprietary softgel oral
formulation absorbed primarily via the lymphatic system (meaning it
is not toxic to the liver) and indicated in adult males for
conditions associated with a deficiency or absence of endogenous
testosterone. The safety and efficacy of KYZATREX was demonstrated
in a phase 3, multi-center, open-label, six-month study in 155
hypogonadal males between 18 and 65 years of age with documented
hypogonadism, as defined by a below normal serum testosterone level
(≤281 ng/dL) and at least one sign or symptom of testosterone
deficiency. In the efficacy population (n=139), 88 percent of
hypogonadal men treated with KYZATREX achieved a mean plasma total
testosterone concentration (Cavg) over 24 hours within the normal
range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of
the study at Day 90 (primary endpoint). Based on exploratory
endpoints, patients who received KYZATREX reported improvements in
symptoms of low testosterone, including quality of life,
energy/fatigue, erectile function, sexual intercourse, and mood.
The most common side effect reported in ≥2 percent of KYZATREX
patients was increased blood pressure (2.6%). The safety and
efficacy of KYZATREX in males less than 18 years old have not been
established.
Please see additional Important Safety
Information for KYZATREX below, including Boxed Warning for
potential increased blood pressure, or visit www.kyzatrex.com.
Important Safety Information for
KYZATREX® (testosterone
undecanoate capsules)
UseKYZATREX® (testosterone
undecanoate) is a prescription drug that is used to treat adult men
who have low or no testosterone levels due to certain medical
conditions.
KYZATREX is a controlled substance (CIII)
because it contains testosterone. It is not known if KYZATREX is
safe or effective in males younger than 18 years old. Improper use
may affect bone growth in children. KYZATREX is not meant for use
by women.
Important Safety Information for
KYZATREX®
KYZATREX can increase blood
pressure, which can increase the risk of having a heart
attack or stroke and can increase risk of death due to a heart
attack or stroke. Your risk may be greater if you have already had
a heart attack or stroke or if you have other risk factors for
heart attack or stroke.
- If your blood pressure increases
while on KYZATREX, blood pressure medicines may need to be started.
If you are currently taking blood pressure medicines, they may need
to be changed or new blood pressure medicines may need to be added
to control your blood pressure.
- If your blood pressure cannot be
controlled, KYZATREX may need to be stopped.
- Your healthcare provider will
monitor your blood pressure while you are being treated with
KYZATREX.
Do not take KYZATREX if you:
have breast cancer; have or might have prostate cancer; are a woman
who is pregnant (KYZATREX may harm your unborn baby); are allergic
to KYZATREX or any of its ingredients; or have low testosterone
without certain medical conditions (e.g., do not take KYZATREX if
you have low testosterone due to age).
Before you take KYZATREX, tell your
healthcare provider about all of your medical conditions, including
if you: have high blood pressure or are treated for high
blood pressure; have a history of diabetes; have heart problems;
have high red blood cell count (hematocrit) or high hemoglobin
laboratory value; have urinary problems due to an enlarged
prostate; have liver or kidney problems; or have problems breathing
while you sleep (sleep apnea).
Tell your healthcare provider about all
the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Taking
KYZATREX with certain other medicines can affect each other.
Especially, tell your healthcare provider if you
take: insulin; medicines that decrease blood clotting
(blood thinners); corticosteroids; or medicines that increase blood
pressure, such as some cold medicine and pain medicines.
KYZATREX may cause other serious side
effects including:
- Increase in red blood cell
count (hematocrit) or hemoglobin, which
can increase the risk of blood clots, strokes, and heart attacks.
You may need to stop KYZATREX if your red blood cell count
increases.
- If
you already have
an enlarged
prostate, your
signs and
symptoms may
worsen while
taking KYZATREX. These may
include: increased urination at night; trouble starting your urine
stream; urinating many times during the day; urge to go to the
bathroom right away; a urine accident; inability to pass urine or
weak urine flow.
- Increased risk of prostate
cancer.
- Blood
clots in the
legs or lungs.
Signs and symptoms of a blood clot in your leg can include pain,
swelling or redness. Signs and symptoms of a blood clot in your
lungs can include difficulty breathing or chest pain.
- Abuse.
Testosterone can be abused when taken at higher than prescribed
doses and when used with other anabolic androgenic steroids. Abuse
can cause serious heart and psychological side effects.
- In large doses, KYZATREX
may lower your sperm count.
- Liver
problems. Symptoms of liver problems may include:
nausea or vomiting; yellowing of your skin or whites of your eyes;
dark urine; pain on the right side of your stomach area (abdominal
pain).
- Swelling of your ankles,
feet, or body (edema), with or without heart
failure.
- Enlarged or
painful breasts.
- Breathing problems while
you sleep (sleep apnea).
Call your healthcare provider right away
if you have any of the serious side effects listed
above.
The most common side effect of KYZATREX
is high blood pressure. Other side effects may include:
headache, joint or back pain, diarrhea, increased red blood cell
count, anxiety, constipation, swelling of the legs, and increased
prostate specific antigen (PSA) levels.
These are not all the possible side effects of
KYZATREX. For more information, ask your healthcare provider or
pharmacist.
You are encouraged to report negative side
effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report
side effects to Marius by visiting www.mariuspharma.com.
Keep KYZATREX and all medicines out of
the reach of children.
See Full Prescribing
Information and Medication
Guide for KYZATREX.
References:
-
KYZATREX [prescribing information]. Raleigh, NC: Marius
Pharmaceuticals.
-
Data on File. Raleigh, NC: Marius Pharmaceuticals, 2020.
-
Mulligan T, Frick MF, Zuraw QC, et al. Prevalence of hypogonadism
in males aged at least 45 years: the HIM study. Int J Clin
Pract. 2006 Jul 1; 60(7): 762–769.
doi: 10.1111/j.1742-1241.2006.00992.x
-
“Hypogonadism in Men.” Endocrine Society, Endocrine Society, 31
Mar. 2022,
www.endocrine.org/patient-engagement/endocrine-library/hypogonadism.
-
Anaissie, James et al. “Testosterone deficiency in adults and
corresponding treatment patterns across the globe.” Translational
andrology and urology vol. 6,2 (2017): 183-191.
doi:10.21037/tau.2016.11.16
Cautionary Note Regarding
Forward-Looking Statements
Certain statements made in this press release
contain forward-looking information within the meaning of
applicable securities laws, including within the meaning of the
Private Securities Litigation Reform Act of 1995 ("forward-looking
statements"). These forward-looking statements represent the
Company's current expectations or beliefs concerning future events
and can generally be identified using statements that include words
such as "estimate," "expects," "project," "believe," "anticipate,"
"intend," "plan," "foresee," "forecast," "likely," "will," "target"
or similar words or phrases. These forward-looking statements are
subject to risks, uncertainties and other factors, many of which
are outside of the Company's control which could cause actual
results to differ materially from the results expressed or implied
in the forward-looking statements, including, but not limited to;
our ability to obtain additional funding and generate revenues to
support our operations; risks associated with our ED product which
have not been, and will not be, approved by the U.S. Food and Drug
Administration ("FDA") and have not had the benefit of the FDA's
clinical trial protocol which seeks to prevent the possibility of
serious patient injury and death; risks that the FDA may determine
that the compounding of our planned products does not fall within
the exemption from the Federal Food, Drug, and Cosmetic Act ("FFDCA
Act") provided by Section 503A; risks associated with related party
relationships and agreements; the effect of data security breaches,
malicious code and/or hackers; competition and our ability to
create a well-known brand name; changes in consumer tastes and
preferences; material changes and/or terminations of our
relationships with key parties; significant product returns from
customers, product liability, recalls and litigation associated
with tainted products or products found to cause health issues; our
ability to innovate, expand our offerings and compete against
competitors which may have greater resources; our significant
reliance on related party transactions; the projected size of the
potential market for our technologies and products; risks related
to the fact that our Chairman and Chief Executive Officer, Jacob D.
Cohen and President, Jonathan Arango, combined have majority voting
control over the Company; risks related to the significant number
of shares in the public float, our share volume, the effect of
sales of a significant number of shares in the marketplace, and the
fact that the majority of our shareholders paid less for their
shares than the public offering price of our common stock in our
recent initial public offering; the fact that we have a significant
number of outstanding warrants to purchase shares of common stock
at $1.00 per share, the resale of which underlying shares have been
registered under the Securities Act of 1933, as amended; our
ability to build and maintain our brand; cybersecurity, information
systems and fraud risks and problems with our websites; changes in,
and our compliance with, rules and regulations affecting our
operations, sales, marketing and/or our products; shipping,
production or manufacturing delays; regulations we are required to
comply with in connection with our operations, manufacturing,
labeling and shipping; our dependency on third-parties to prescribe
and compound our ED product; our ability to establish or maintain
relations and/or relationships with third-parties; potential safety
risks associated with our Mango ED product, including the use of
ingredients, combination of such ingredients and the dosages
thereof; the effects of high inflation, increasing interest rates
and economic downturns, including potential recessions, as well as
macroeconomic, geopolitical, health and industry trends, pandemics,
acts of war (including the ongoing Ukraine/Russian conflict) and
other large-scale crises; our ability to protect intellectual
property rights; our ability to attract and retain key personnel to
manage our business effectively; our ability to maintain the
listing of our common stock on the Nasdaq Capital Market; overhang
which may reduce the value of our common stock; volatility in the
trading price of our common stock; and general consumer sentiment
and economic conditions that may affect levels of discretionary
customer purchases of the Company's products, including potential
recessions and global economic slowdowns. Although we believe that
our plans, intentions and expectations reflected in or suggested by
the forward-looking statements we make in this release are
reasonable, we provide no assurance that these plans, intentions or
expectations will be achieved. Consequently, you should not
consider any such list to be a complete set of all potential risks
and uncertainties.
More information on potential factors that could
affect the Company's financial results is included from time to
time in the "Cautionary Note Regarding Forward-Looking Statements,"
"Risk Factors" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations" sections of the
Company's filings with the SEC, including the Company’s Quarterly
Report on Form 10-Q for the Quarter ended September 30, 2023. These
filings are available at www.sec.gov and at our website
at https://www.mangoceuticals.com/sec-filings. All subsequent
written and oral forward-looking statements attributable to the
Company or any person acting on behalf of the Company are expressly
qualified in their entirety by the cautionary statements referenced
above. Other unknown or unpredictable factors also could have
material adverse effects on the Company's future results. The
forward-looking statements included in this press release are made
only as of the date hereof. The Company cannot guarantee future
results, levels of activity, performance or achievements.
Accordingly, you should not place undue reliance on these
forward-looking statements. Finally, the Company undertakes no
obligation to update these statements after the date of this
release, except as required by law, and takes no obligation to
update or correct information prepared by third parties that are
not paid for by the Company. If we update one or more
forward-looking statements, no inference should be drawn that we
will make additional updates with respect to those or other
forward-looking statements.
Follow Mangoceuticals and MangoRx on social media:
https://www.instagram.com/mango.rx
https://twitter.com/Mangoceuticals
https://www.facebook.com/MangoRxOfficial
FOR PUBLIC RELATIONSLucky Break Public RelationsSahra
SimpsonSahra@luckybreakpr.com (323) 602-0091 ext. 704
FOR INVESTOR RELATIONSMangoceuticals Investor RelationsEmail:
investors@mangorx.com
MEDIA CONTACTPHOENIX MGMT Marketing &
Consultinginfo@phoenix-mediamarketing.com
SOURCE: Mangoceuticals Inc.
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