Marius Pharmaceuticals Announces KYZATREX® (CIII testosterone undecanoate capsules) HERO Campaign, Empowering Men To ‘Be the Hero of Your Life Again’

RALEIGH, N.C., Dec. 6, 2023 /PRNewswire/ -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, today announces the launch of its KYZATREX^® HERO campaign that aims to empower men to "Be the Hero of Your Life Again." KYZATREX is an oral prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. The advertising campaign seeks to educate patients who are appropriate candidates for treatment and their physicians on how KYZATREX can help men restore testosterone levels to reinvigorate their natural vitality.

The world is currently facing a men's health crisis: Men account for 69% of suicides, 10.8 million men globally are living with prostate cancer, and testicular cancer is the most common cancer among men aged 15-39.¹ Additionally, men's testosterone levels are declining, with testosterone deficiency having a prevalence of 20% among adolescent and young adult males.² Research also indicates that nearly 40% of men over the age of 45 suffer from low testosterone, yet men may not realize the effect it can have on their overall health.³

Through the HERO campaign, Marius Pharmaceuticals wants to help men reveal their inner hero. One of the ways they can do that is to prioritize their own health. Marius believes that every man should be asking their healthcare provider to check their testosterone levels – specifically total testosterone, free testosterone, and sex hormone binding globulin (SHBG), which all contribute to a full understanding of a man's comprehensive metabolic health. In a clinical efficacy study of 127 hypogonadal patients, 96% of patients taking KYZATREX had normal testosterone levels at Day 90. (Based on end of clinical study completers (n=127). Worst case scenario (WCS) was used as a basis for the assessment of primary efficacy endpoint per label. WCS efficacy calculation was 88%, excluding Site 104 (n=139)).^4,5 Mean free testosterone levels doubled in the same time period, while mean SHBG levels declined by 30%.⁵ The only adverse event seen in more than 2% of patients receiving KYZATREX in the clinical trials was hypertension (2.6% of patients).⁵

"We hope the HERO campaign will help raise awareness for what is possible with safe, effective, and convenient testosterone replacement therapy; how KYZATREX can help get hypogonadal men back to feeling like themselves again," said Shalin Shah, CEO of Marius Pharmaceuticals. "Too many men are silently suffering the daily effects of Testosterone Deficiency, and we want to change that narrative by empowering them to be their own HERO, realizing how the responsible use of testosterone therapy can drive clinically beneficial outcomes for men living with Low T."

The HERO campaign is a part of Marius Pharmaceuticals' ongoing comprehensive effort to raise awareness about testosterone deficiency or hypogonadism. The company is committed to educating individuals, including veterans and active-duty service members, about the impact of low testosterone on overall health and well-being. The initiative continues to expand its content and resources to provide valuable information on this critical topic.

To learn more about the KYZATREX, visit www.kyzatrex.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) 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 (C_avg) 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 quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive 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.

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.

Important Safety Information for KYZATREX^® (testosterone undecanoate)

Use
KYZATREX (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 calling 1-833-949-5040.

Keep KYZATREX and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX.

References:

1. Men's Health is in Crisis. Movember. Accessed November 30, 2023. https://us.movember.com/about/cause
2. Lokeshwar SD, Patel P, Fantus RJ, et al. Decline in Serum Testosterone Levels Among Adolescent and Young Men in the USA. Eur Urol Focus. 2021 Jul;7(4):886-889.doi: 10.1016/j.euf.2020.02.006.
3. 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
4. KYZATREX [prescribing information]. Raleigh, NC: Marius Pharmaceuticals.
5. Data on File. Raleigh, NC: Marius Pharmaceuticals, 2020.

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