Marius Pharmaceuticals Supports AXYS 2023 Virtual Family Conference, Spotlighting KYZATREX™ for XY Chromosome Variations, such as Klinefelter’s Syndrome

RALEIGH, N.C., June 20, 2023 (GLOBE NEWSWIRE) — Marius Pharmaceuticals, a patient-centric healthcare company specializing in therapies for hypogonadism or testosterone deficiency, announced today its sponsorship of the AXYS 2023 Virtual Family Conference. This conference serves as a significant platform for individuals and families affected by XY Chromosome Variations, including conditions such as Klinefelter’s Syndrome.

KYZATREX™ (testosterone undecanoate), an oral medication developed by Marius Pharmaceuticals, has emerged as a viable treatment option for those with Klinefelter’s Syndrome. As the XY Chromosome Variations community seeks oral alternatives for testosterone replacement therapy (TRT), Marius Pharmaceuticals recognizes the significance of KYZATREX™ in meeting this demand.

The AXYS Family Conference brings together individuals with these chromosome variations, their families, caregivers, and a diverse range of professionals including genetic counselors, geneticists, endocrinologists, and advocates. With nearly 1,000 attendees anticipated from the United States and around the world, the conference fosters an environment of education, support, and connection.

Klinefelter’s Syndrome, a genetic condition characterized by an additional X chromosome in males, presents various challenges such as low sperm count, small testicles, reduced sex drive, increased height, weakened bones, and diminished muscle mass. KYZATREX™, easily accessible and convenient, offers effective management of this condition. However, many patients struggle to access oral testosterone therapies due to insurance coverage limitations. Marius Pharmaceuticals is committed to addressing this issue and ensuring patients have access to the treatment they need with a cash-pay treatment.

“We are dedicated to providing individuals with XY Chromosome Variations, particularly those with Klinefelter’s Syndrome, with a therapy that is both effective and accessible,” stated Shalin Shah, CEO of Marius Pharmaceuticals. “Our sponsorship of the AXYS 2023 Virtual Family Conference underscores our commitment to improving the lives of these individuals and their families.”

Marius Pharmaceuticals remains at the forefront of research and development, striving to advance the field of testosterone replacement therapy and support patients in need. Through ongoing efforts and patient support programs, Marius Pharmaceuticals aims to address the challenges faced by individuals with XY Chromosome Variations and enhance their quality of life.

About KYZATREX™

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 (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 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 below, including Boxed Warning for potential increased blood pressure, for KYZATREX™ or visit www.kyzatrex.com.

About Marius Pharmaceuticals

Marius Pharmaceuticals is a patient-centric healthcare company focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company’s mission is to improve the functional lives of patients by reducing the downstream effects of Testosterone Deficiency, which include multiple comorbidities, such as type 2 diabetes and obesity. 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™.

Contact:

Lilly Washburn
336-404-9622
Lilly@mariuspharma.com