RALEIGH, N.C., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals (Marius) and Smartway Pharmaceuticals (Smartway) are pleased to announce their strategic partnership, aimed at addressing the pressing global issue of hypogonadism through the launch of a comprehensive Early Access Program for KYZATREX™ (testosterone undecanoate).
Hypogonadism, a prevalent medical condition affecting millions of men worldwide, is characterized by low testosterone levels, which can lead to a range of comorbidities, including obesity, type 2 diabetes, depression, and cardiovascular disease. Recognizing the critical need for innovative solutions to alleviate the burden of this condition, the collaboration between Marius and Smartway marks a significant milestone in expanding access to KYZATREX™, a groundbreaking therapeutic option already demonstrating promise in improving the lives of men across the United States.
Smartway Pharmaceuticals, a specialist in the provision of early access, compassionate use, and named patient supply of new therapeutics, is appointed the exclusive Early Access Provider for KYZATREX™ in all countries outside of the USA. Smartway has hubs across the globe including in the UK, EU, Middle East, USA, and India.
Josh Cocklin, Chief Executive of Smartway, expressed his enthusiasm for the collaboration, stating, “KYZATREX™ is already making a difference in the lives of men across the USA. With this agreement, we will extend access to KYZATREX™ to patients across the world. We believe that there will be significant interest in KYZATREX™ from healthcare specialists globally.”
This latest agreement extends the portfolio of Early Access Programs Smartway is managing and continues their journey as one of the most rapidly expanding EAP providers in the industry, being trusted by large and small biotech companies and manufacturers.
Shalin Shah, CEO of Marius Pharmaceuticals, emphasized the significance of the partnership, stating, “We have seen the difference KYZATREX™ has made to patients’ lives in the USA and are excited that this agreement will expand access. Marius is focused on the US market, so we needed a patient-centric partner with deep expertise. Smartway has the capability to provide access to KYZATREX™ on a global basis while meeting the strict regulatory standards. Smartway matches our desire to help patients and has the expertise combined with a global network to get KYZATREX™ to patients. We view this as a strategic long-term partnership.”
As the world grapples with the escalating burden of hypogonadism and its associated comorbidities, the collaboration between Marius Pharmaceuticals and Smartway Pharmaceuticals represents a united effort to bring KYZATREX™ to the forefront of the global battle against this pervasive medical condition. Through this innovative Early Access Program, the partners seek to empower healthcare professionals worldwide with a transformative therapeutic solution that can positively impact the lives of millions of men suffering from low testosterone and its related health challenges.
About Smartway Pharmaceuticals (www.smartwaypharma.com)
Smartway Pharmaceuticals designs, implements, and manages global Early / Expanded Access Programs, intended to empower access to medicines on a global level and help transform lives. We partner with pharma and biotechs who trust Smartway as a leader in the provision of Expanded Access, Early Access, Compassionate Use and Named Patient Programs across 98 countries.
Over the last 20 years, we’ve gained the experience it takes to strategically advise, design, initiate and manage global or regional programs with biotechs and pharma. As part of its specialist offering, Smartway provide end-to-end solutions to manage complex EAPs, whatever the size and scale, Smartway are committed to empowering patient access to the right therapy. https://www.smartwaypharma.co.uk/how-we-help/eap
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. KYZATREX™ is only licensed in the USA.
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, obesity, cardiovascular disease, and depression. For more information, please visit www.mariuspharma.com.
Smartway Pharmaceuticals
Robert Donnell, Executive Vice President- Medicines Access
+44 20 4551 5884 eap@smartwaypharma.com
Anna Vassova, Marketing Manager
marketing@smartwaypharma.com
Marius Pharmaceuticals
Lilly Washburn
+1 (336) 404-9622
lilly@mariuspharma.com
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 visiting www.mariuspharma.com.
Keep KYZATREX™ and all medicines out of the reach of children.
See Full Prescribing Information and Medication Guide for KYZATREX™.
