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Marius Pharmaceuticals Announces Pilot Study Exploring the Effect of Its Oral Testosterone Therapy, KYZATREX® (CIII testosterone undecanoate capsules), on Male Fertility
Raleigh, N.C., (January 9, 2023) – Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, today announced it has initiated a pilot study to better understand the effect of oral testosterone replacement therapy, KYZATREX® (testosterone undecanoate), on spermatogenesis in adult males. KYZATREX is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
While it is generally accepted that TRT in males decreases spermatogenesis, which occurs through suppression of the hypothalamic-pituitary-gonadal axis, most data are derived from traditional routes of administration of TRT (eg, injections, patches, gels, implantable pellets, etc.). This study will be the first of its kind to specifically examine the effects of an oral TRT, like KYZATREX, on spermatogenesis. Importantly, the American Urological Association currently recommends that physicians prescribing TRT inform their patients of the risks of the therapy on fertility.
“We are eager to begin this new pilot study, as finding an option of TRT that does not reduce fertility in men would be a significant milestone in the field of andrology and society as a whole,” said Andrew Sun, M.D., Director at the Center for Men’s Health at Urology Partners of North Texas and Chief Medical Advisor for Marius Pharmaceuticals. “Too many men are suffering in silence from the effects of testosterone deficiency, and the results from this study could help us better understand the effects of oral TRT on spermatogenesis, which might potentially benefit a subset of men; those who are looking to start a family while still treating
their low T.”
Led by principal investigator Dr. Mohit Khera, Director of the Laboratory for Andrology Research Baylor College of Medicine, the study will enroll 20 male patients, ages 18-49 years old, who meet the American Urological Association’s criteria for hypogonadism and who have not previously used TRT. “Historically, testosterone products have been known to impair sperm production. Thus, many
young hypogonadal men planning to achieve a pregnancy are unable to use testosterone due to an increased risk of suppressing their sperm production,” said Dr. Khera. “Identifying testosterone therapy that could potentially not suppress sperm production would be a significant advancement in the way we treat these hypogonadal men.”
Participating patients will receive 200-400mg of KYZATREX BID for three months. Two semen analyses will be performed at baseline, one month, and three months, to assess any changes in each patient’s sperm count. Blood draws will also be taken at each of these timepoints to measure testosterone, hormones, lipids, and hematocrit. There will also be an additional blood draw two weeks after starting the therapy to support drug titration to reach therapeutic levels. Additionally, patients will receive the IIEF, PHQ-9, and SF36 questionnaires at baseline and at the conclusion of the study to assess symptoms of low testosterone.
This pilot study is part of Marius Pharmaceuticals’ comprehensive effort to develop innovative therapies for testosterone deficiency. To learn more about KYZATREX, visit https://www.kyzatrex.com. To learn more about Marius Pharmaceuticals, visit https://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) 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 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 of 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.
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:
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.
Media Contact:
5W Public Relations
kyzatrex@5wpr.com
212-999-5585
Media Contact:
5W Public Relations
kyzatrex@5wpr.com
212-999-5585
Marius Pharmaceuticals Announces KYZATREX® (CIII testosterone undecanoate capsules) HERO Campaign, Empowering Men To ‘Be the Hero of Your Life Again’
Raleigh, N.C., (December 6th, 2023) – 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)).⁴,⁵Mean 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 (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 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 of 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.
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:
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.
Marius Pharmaceuticals Expands Access of KYZATREX™ (testosterone undecanoate) to Department of Veterans Affairs (VA), Pledging Support for Proper Hormonal Balance Among Military Personnel
RALEIGH, N.C., Sept. 19th, 2023 – Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, is proud to announce the expansion of access to its FDA-approved oral testosterone therapy, KYZATREX™, to the
Department of Veteran Affairs (VA). This initiative is a significant milestone in Marius Pharmaceutical’s ongoing mission to provide accessible and life-enhancing therapies to focused communities.
Military personnel face an array of physical and psychological health challenges, including but not limited to stress, insomnia, emotional distress, and physical injuries. Veterans often endure unresolved health implications, including mental health conditions, that are frequently linked to low testosterone. A lack of awareness about the impacts of military service on both hormone health and symptom stigma makes it difficult for veterans to confront low testosterone.
Studies have shown that the stress associated with intense military field training can result in up to a 47% decrease in testosterone levels. With increased education and awareness about this connection, veteran mental and physical health can be addressed. Marius Pharmaceuticals is committed to offering a safe and accessible oral solution with KYZATREX™. By providing a trusted therapy like KYZATREX™, Marius aims to not only enhance the long-term quality of life for these individuals but also contribute to the savings to the U.S. Healthcare system.
“At Marius Pharmaceuticals, we are proud to offer a treatment option to our veterans who have suffered from the physical and mental conditions associated with Low T, while bringing awareness of their plight to countless others who might not have realized the connection. Early
diagnosis and treatment can reduce or eliminate downstream expenses freeing up budget dollars to help more veterans obtain the help they deserve,” shared Rich Callaghan, SVP, Operations at Marius Pharmaceuticals.
As part of its comprehensive effort to raise awareness about testosterone deficiency or hypogonadism, Marius Pharmaceuticals has launched the ReThink Testosterone disease state awareness initiative and website. ReThink Testosterone 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 will continue to expand its content and resources to provide valuable information on this critical topic.
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 strives to better the lives of men and women by focusing on therapies designed for hypogonadism or Testosterone Deficiency. Their 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 ReThink Testosterone:
ReThink Testosterone is a disease state awareness campaign that aims to transform lives through education and support for individuals affected by low testosterone or Low T (male hypogonadism). Its mission is to enhance understanding of the symptoms, impact, and available treatment options for this condition, empowering men to make informed decisions about their health and well-being. For more information, please visit www.rethinktestosterone.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 medicines 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™.
Media Contact:
Lilly Washburn
336-404-9622
lilly@mariuspharma.com
Marius Pharmaceuticals Partners with Smartway to Design and Manage the Global Early Access Program for KYZATREX™ (testosterone undecanoate)
RALEIGH, N.C., August 10, 2023 – 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 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™.
Marius Pharmaceuticals Announces Launch of ReThink Testosterone, Disease-State Awareness Initiative for Patients
RALEIGH, N.C. July 24, 2023 – Marius Pharmaceuticals, a patient-centric healthcare company specializing in therapies for hypogonadism or Testosterone Deficiency, is proud to announce the launch of their disease state awareness website, ReThink Testosterone. With the aim of changing the narrative surrounding testosterone and testosterone therapy, ReThink Testosterone seeks to empower men dealing with Low T to advocate for their health by providing valuable education and debunking long-standing myths.
Low testosterone, also known as male hypogonadism, affects millions of men worldwide, often impacting their overall health and well-being. However, misconceptions and stigma have created barriers to understanding and seeking appropriate treatment. ReThink Testosterone is a comprehensive online resource designed to address this gap, equipping men with knowledge to make informed decisions about their health.
“At Marius Pharmaceuticals, we believe in empowering individuals to take control of their health,” said Shalin Shah, CEO of Marius Pharmaceuticals. “Our goal with the launch of ReThink Testosterone is to provide a platform where men with low testosterone can better understand the symptoms, impacts, and treatment options available to them.”
ReThink Testosterone offers a wealth of information and resources, including informative videos, insightful podcasts, and relevant studies, all focused on testosterone and testosterone therapy. By debunking prevalent myths and misconceptions, the website aims to alleviate confusion and provide clarity on the benefits and potential risks associated with testosterone therapy. Additionally, visitors can access information about symptoms, diagnosis, and various treatment options.
The website goes beyond just discussing low testosterone itself. It aims to educate visitors about the relationship between Low T and various comorbidities, such as type 2 diabetes, obesity, cardiovascular disease, and more. By highlighting the potential links between low testosterone and these conditions, ReThink Testosterone provides a holistic view of hormonal health and its impact on overall well-being.
ReThink Testosterone caters to men who are experiencing low testosterone or those who have an interest in understanding testosterone and its implications. The website serves as a valuable resource to facilitate open conversations between patients and healthcare providers, promoting proactive engagement in managing hormonal health.
Dispelling common myths is a key focus of ReThink Testosterone. Misconceptions such as testosterone therapy causing serious adverse cardiovascular events, being solely a hormone for sexual and muscular purposes, or leading to aggression will be addressed through evidence-based information and expert insights. Other myths, including claims that testosterone therapy causes prostate cancer, will also be refuted, ensuring that visitors have accurate and reliable information at their fingertips.
By visiting ReThink Testosterone at www.rethinktestosterone.com or following on Instagram (@rethinktestosterone), individuals can embark on a journey of understanding and empowerment. The website will serve as a trusted resource, enabling men to recognize the symptoms of Low T, take proactive steps towards diagnosis and treatment, and ultimately improve their overall quality of life.
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.
About ReThink Testosterone:
ReThink Testosterone is a disease state awareness campaign that aims to transform lives through education and support for individuals affected by low testosterone or Low-T (male hypogonadism). Its mission is to enhance understanding of the symptoms, impact, and available treatment options for this condition, empowering men to make informed decisions about their health and well-being.
Media Contact:
Lilly Washburn
336-404-9622
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 – 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
Marius Pharmaceuticals Announces Two Key Patents Related to KYZATREX™ in FDA Orange Book
RALEIGH, N.C., June 9, 2023 – Marius Pharmaceuticals, a patient-centric healthcare company focused on therapies designed for hypogonadism or testosterone deficiency, announced that its U.S. patents related to KYZATREX™ (testosterone undecanoate), No. 11590146B2 and No. 11617758B2, are now listed in the U.S. Food and Drug Administration (FDA) publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”
These patents represent significant milestones for Marius Pharmaceuticals as they underpin the broad coverage of KYZATREX’s™ advanced delivery system. This unique system has played a pivotal role in driving and generating robust safety and efficacy outcomes during the drug’s Phase 3 clinical trials.
The Orange Book lists patents for FDA-approved drugs that have been determined to be safe and effective for public use. Being included in this publication allows drug manufacturers to better monitor the introduction of potential generic drugs that may enter the U.S. market and potentially infringe on their patents.
“We are glad to announce the listing of these two pivotal patents related to KYZATREX™ in the FDA Orange Book,” said Shalin Shah, CEO of Marius Pharmaceuticals. “This recognition highlights the significant advancements we have made in developing a groundbreaking drug delivery system for Testosterone. These patents reinforce our commitment to providing patients with safe, effective, and innovative treatment options.”
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
RALEIGH, N.C., Oct. 18, 2022 (GLOBE NEWSWIRE) — Base Healthcare today announced the official launch of its subscription-based men’s virtual health platform, which focuses on foundational health and hormone optimization using oral testosterone therapy. The digital-forward platform will offer a convenient way for men to access Adequate Testosterone Therapy (ATT)™, certified-clinicians, and patient-centered health coaching.
Individuals can now visit https://basehealthcare.com/ where they can sign up to get a comprehensive metabolic blood panel, be diagnosed by a certified-clinician and prescribed an FDA-approved oral testosterone treatment that can be delivered directly to them. Base Healthcare is initially focused on the treatment of hypogonadism or low testosterone and will offer additional services and supplements for men in early 2023.
Base Healthcare chose the focus of low testosterone because it is one of the biggest blind spots in medicine today. There are over 20 million men in the U.S. suffering from hypogonadism or low testosterone today and almost 90% are unaware of it due to a lack of testing. Base believes every man over the age of 40 should have their testosterone levels routinely or annually checked. In addition to symptomatic men suffering from day-to-day quality of life loss, the downstream impact of low testosterone is significant and often co-related with obesity, Type 2 diabetes, cardiovascular disease and neurocognitive issues.
“We are excited to be launching this platform in a post-pandemic world when it’s imperative to be looking at foundational and preventive health measures, and adequate testosterone is just that. We are able to combine hormone expertise with a leading digital platform to offer men not just convenience, but expert guidance on their journey to better living,” said Amit Patel, Medical Director at Base Healthcare.
Launching alongside the platform is the Base Healthcare App, which includes many industry firsts. Patients will be able to utilize their smartphone to track important vitals, such as blood pressure, heart rate variability and stress indexes. Additionally, the app has integrated body composition analysis which is accurate to within 1% of a more traditional DEXA scan. “Building this platform from the ground up has allowed Base to incorporate technologies that will ultimately benefit members and we see substantially better patient adherence to treatment with this technological leadership,” said Abhi Muthiyan, Chief Technology Officer at Base Healthcare.
Base Healthcare is a men’s virtual health platform focusing on foundational health and hormone optimization using testosterone therapy and patient-centered health coaching. Base utilizes an FDA-approved oral testosterone therapy and comprehensive blood work to target ideal optimal ranges for an individual. Its patient-centered health coaching program will focus on the core tenants of stress, nutrition, exercise, and sleep to drive important physiological processes that can serve as a base for better functional living.
Hypogonadism, often referred to as low testosterone, is a condition that occurs when the body does not produce adequate levels of testosterone. In addition to testosterone’s widely accepted role in sexual and reproductive function, it also has important roles in numerous other metabolic and inflammatory processes. Hypogonadism is also the most common cause of secondary osteoporosis in men. Beyond these diseases, hypogonadism is a common comorbidity in a broader set of conditions from Type 2 diabetes to Non-Alcoholic Steatohepatitis (NASH).
Marius Pharmaceuticals, a specialty pharmaceutical company, today announced positive preliminary data for their Phase 3 clinical trial evaluating SOV-2012-F1 in men suffering from hypogonadism. SOV-2012-F1 is Marius’ proprietary oral testosterone replacement therapy (TRT) uniquely utilizing phytosterols to enhance absorption through the lymphatic system. The predictable pharmacokinetics of Marius’ formulation should provide the framework for improved therapeutic effect in clinical practice, better patient compliance, and a reduction in adverse events associated with poor therapeutic control. Together, these advantages should result in true symptom relief for the millions suffering from this chronic condition globally.
“We are extremely pleased with the results of the trial thus far,” said Om Dhingra, Chief Executive Officer for Marius Pharmaceuticals. “This positive preliminary data supports our belief that, if approved, SOV-2012-F1 may offer a safe, effective, and convenient oral treatment for men suffering from hypogonadism.”
Affecting an estimated 22 million men (7% of the population) of all ages in the US alone, with corresponding higher global impact, hypogonadism is characterized by inadequate testosterone production due to issues with the testes or pituitary gland. Although widely recognized as important for sexual health, testosterone also has roles in neurological, musculoskeletal, cardiovascular, and pulmonary health. Patients afflicted with this under-researched endocrine condition experience symptoms such as fatigue and low libido, with an increased risk for type 2 diabetes, anemia, and decreased bone density. Men with low testosterone often suffer from the co-morbidities of obesity, diabetes, osteoporosis, or asthma.
Current treatment paradigms for hypogonadism focus on restoring testosterone levels using TRT, primarily administered either by injection or topical application. In 2018, an estimated 1.8 million men are on active TRT treatment. However, current treatments are burdensome, provide inconsistent daily relief, and in the case of topical (transdermal) products, have a black box warning due to the risk of transfer to partners and/or children. TRT intramuscular options currently on the market often result in prolonged peaks and troughs of testosterone levels. This pattern produces emotional highs and depressive lows for many patients. As a result, many eligible patients do not start treatment. Of those who do begin treatment, one third of patients discontinue within 12 months, primarily due to a lack of symptom improvement
Marius Pharmaceuticals’ novel and proprietary SOV-2012-F1 oral formulation of testosterone undecanoate seeks to address these concerns. Its innovative formulation enhances absorption and provides convenient oral dosing, which in turn should increase compliance, reduce adverse events, and provide consistent and predictable symptom relief, as supported by preliminary Quality of Life data. SOV-2012-F1 provides higher levels of free testosterone and is the only product under development containing phytosterol esters for improved absorption and tolerability. In addition to providing stable testosterone levels, its convenient oral administration removes the burden of repeated injections or topical applications. Based on the 90-day efficacy set of patient-reported outcomes, SOV-2012-F1 performed better than the leading topical gel in most key male quality of life measures, with patients seeing a greater improvement in emotional well-being, energy levels, sexual desire, erectile function, and prostate symptom scores.
“For the first time, oral TRT products are coming to the market, representing a paradigm shift that is greatly needed for men suffering from hypogonadism” said Shalin Y. Shah, Chief Financial Officer for Marius Pharmaceuticals. “We believe that the novel characteristics of SOV-2012-F1 will make it an ideal solution to this largely unmet medical need.”
RALEIGH, N.C., May 21, 2020 (GLOBE NEWSWIRE) — Marius Pharmaceuticals announced today that the United States Patent and Trademark Office (USPTO) has issued two key patents related to its lead asset, Kyzatrex®*. Kyzatrex® is an oral Testosterone Replacement Therapy (TRT) that uses an innovative formulation to improve effectiveness and safety.
These allowed claims will provide strong IP protection to December 2030, over 8 years of potential commercial runway. They supplement Marius Pharmaceuticals’ already robust global patent portfolio for Kyzatrex®, which includes granted patents in the European Union, Canada, China, Taiwan, Japan, New Zealand and other key markets, and pending applications in India, and US. Marius Pharmaceuticals’ patent portfolio includes filings that extend protection to 2033, with the potential to extend protection out to 2040.
The allowed claims protect Kyzatrex®, an innovative formulation designed to increase bioavailability and provide a favorable pharmacokinetic (PK) profile compared to other therapeutic alternatives. Om Dhingra, Chief Executive Officer of Marius commented “This innovation is truly exceptional as we have created a formulation with a unique PK profile which we believe drives important clinical significance.”
Marius Pharmaceuticals’ Chief Financial Officer Shalin Shah said “We are very pleased to strengthen the intellectual property portfolio for Kyzatrex® and excited that it has tremendous potential to be differentiated and unique option in the TRT space. We are also drawing a line in the sand between a new treatment paradigm and old testosterone therapies.”
Marius Pharmaceuticals has recently completed its pivotal Phase 3 study for Kyzatrex® and intends to submit its New Drug Application (NDA) to the Food & Drug Administration (FDA).
Kyzatrex® is an experimental therapy for the treatment of primary and secondary hypogonadism (congenital or acquired). Testosterone is a crucial hormone that plays key roles in human growth and development and a wide range of other functions including metabolic and cardiovascular. Sources estimate that 15 million men in the United States suffer from hypogonadism, but only approximately 10% are currently treated. The co-morbidities of men suffering from hypogonadism are also a significant burden on patients and the healthcare system, these include Type 2 Diabetes and other serious chronic conditions.
Current marketed treatments are dominated by painful injections and messy topical applications with transference risk. Kyzatrex® is an orally administered therapy, which avoids those drawbacks. Market research points to 93% of patients indicating they would ask their physician about Kyzatrex® and more than half would consider a switch from their current regimen.
Marius pharmaceuticals is a cutting-edge biopharma company focusing on treating widespread conditions that have been triggered primarily through Androgen deficiency. Our pipeline consists of assets focused on inflammation while our commercial arm is at the forefront of data science technologies core to our commercialization of our lead asset Kyzatrex®.
*Kyzatrex is a tentative Tradename currently under review with the FDA
Shalin Shah
Raleigh, N.C., Jan. 5, 2021 — Marius Pharmaceuticals, a specialty pharmaceutical company focusing on treating conditions that are primarily associated with testosterone deficiency, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of KYZATREX®, its novel oral testosterone undecanoate soft gelatin capsule for the treatment of primary and secondary hypogonadism in adult men.
KYZATREX® has generated strong results in both safety and efficacy studies for KYZATREX® for treatment of primary and secondary hypogonadism in men. Due to the robust results, especially regarding safety, Marius has requested a Priority Review that, if granted, would result in an anticipated six-month review period.
“Submission of our first NDA is an important milestone, which is the culmination of over a decade of meticulous research and dedication and is just the beginning for Marius, as our pipeline will continue to advance research and development in this important therapeutic area that has a multitude of effects on our health system,” said Himanshu H. Shah, Founder and Executive Chairman of Marius.
The NDA submission is based on efficacy and safety data from its pivotal study (NCT04467697) in which KYZATREX® generated the most comprehensive ABPM data in its class. KYZATREX® was well tolerated by participants, with greater than 96% of those subjects completing 90 days of treatment achieving average testosterone levels in the normal range in the pivotal Phase 3 study. The most common treatment-related treatment-emergent adverse event (TEAE) in the pooled Phase 3 studies was hypertension, while there were no serious TEAEs across the Phase 3 trials deemed related to the study drug.
“We are extremely proud to have generated compelling efficacy and safety data in our Phase 3 trials,” commented Dr. Om Dhingra, Co-Founder and CEO of Marius. “We look forward to continuing to work collaboratively with the FDA on the review of our application, and if approved, KYZATREX® has the potential to become the standard of care (SOC) for the treatment of primary and secondary hypogonadism globally.”
Marius also intends to file a marketing authorization application (MAA) with the European Medicines Agency in the first half of 2022. For more information about Marius Pharmaceuticals and KYZATREX®, visit mariuspharma.com.
Hypogonadism, often referred to as testosterone deficiency, is a condition that occurs when the body does not produce adequate levels of testosterone. In addition to testosterone’s widely accepted role in sexual and reproductive function, it also has important roles in numerous other metabolic and inflammatory processes. In the U.S. there are at least six million symptomatic men suffering from hypogonadism, and over 100 million men globally. The resulting medical costs associated with men with untreated hypogonadism and related comorbidities are more than $25 billion in the U.S. alone.
Hypogonadism is also the most common cause of secondary osteoporosis in men. Beyond these diseases, hypogonadism is a common comorbidity in a broader set of conditions from Type-2 diabetes to Non-Alcoholic Steatohepatitis (NASH).
KYZATREX® if approved, will represent a novel oral testosterone replacement therapy option for adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
The ReTUNE™ study was a multi-center, 12-month study across the U.S. that studied the safety and efficacy of KYZATREX® in hypogonadal subjects (total testosterone ≤ 281 ng/dL). Efficacy was determined by number of subjects in the normal, eugonadal range after 90 days of treatment, including dose titrations, while safety was monitored for a further 9 months while on a steady dose. In addition to testosterone parameters, the study collected Patient Reported Outcomes (PROs), which showed statistically significant results both from baseline and against its comparator. A pivotal six-month Phase 3 study was conducted, in which subjects were monitored using ABPM, now considered the standard BP assessment by the FDA and clinical experts. An improved dose regimen was also used in the pivotal six-month Phase 3 study. The results of the Phase 3 studies will be published in leading medical journals and presented at national conferences during 2021.
The FDA has conditionally accepted KYZATREX® as the trade name for this investigational drug. The safety and efficacy have not been fully evaluated by any regulatory authority.
Marius is a specialty pharmaceutical company focusing on treating conditions that are primarily associated with hypogonadism, commonly referred to as testosterone deficiency. The company’s mission is to improve the functional lives of patients and reduce the risks of the downstream effects of endocrine imbalance by ensuring appropriate level of testosterone. For more information, please visit www.mariuspharma.com .
RALEIGH, N.C., January 28, 2021 – Marius Pharmaceuticals, a specialty pharmaceutical company focusing on treating conditions that are primarily associated with testosterone deficiency, today announced that it has appointed Himanshu H. Shah and Shalin Shah as co-CEOs to drive the next phase of growth as the company looks to a potential launch of KYZATREX® in Q4 2021 and further the development of Marius’ deep clinical pipeline.
Himanshu H. Shah brings over 30 years of experience across global capital markets and will continue his role as chairman of the board in addition to co-CEO. He has advised numerous public and private companies over the past decades to help them unlock substantial shareholder value and execute both innovative and pragmatic business strategies.
“I am proud to continue serving Marius and work on developing the best treatment options for men with hypogonadism, a common but not widely discussed disease among patients and prescribers,” said Himanshu H. Shah, chairman and co-CEO of Marius Pharmaceuticals. “Misconceptions about hypogonadism are having a huge impact on the health of millions of men globally and costing the U.S. healthcare system alone billions of dollars annually. There is a huge opportunity for Marius to address these issues and drastically alter the testosterone therapy landscape.”
Shalin Shah will also step into the role of co-CEO from chief financial officer and executive vice president of strategy for Marius. Shalin has been integral in driving overall strategy at Marius for the past four years and will oversee the growth of the team and execution of innovative models as it expands both clinically and commercially to become a leading pharmaceutical company.
“I am excited for the opportunity to serve Marius in this new capacity, especially at a time when the world is seeing technology and healthcare intersect more than ever, truly helping patients,” said Shalin Shah, co-CEO of Marius Pharmaceuticals. “I am confident in Marius’ mission to better the lives of patients by ensuring adequate levels of testosterone and enhance patient care through disruptive technologies and personalization.”
Om Dhingra, Ph.D., led the company from initial development of the lead compound through two successful Phase 3 clinical trials and will move into the role of vice chairman. He will help guide the company’s clinical development plan and ensure KYZATREX® and its differentiating safety and efficacy data is well known in the medical world.
“It has been my great pleasure serving the company as CEO. I am very proud of the data we have generated, which we believe will position KYZATREX® as the standard of care for patients suffering from hypogonadism globally,” said Dr. Om Dhingra, vice chairman of Marius Pharmaceuticals.
If approved by the FDA, KYZATREX® has the potential to become the new standard of care for treating patients with hypogonadism. Testosterone is a crucial hormone that is essential to sexual and reproductive health, but also has important functions in metabolic, inflammatory, cardiovascular and neurological health. In the U.S. there are at least six million symptomatic men suffering from hypogonadism, and over 100 million men globally. The resulting medical costs associated with men with untreated hypogonadism and related comorbidities are more than $25 billion in the U.S. alone. Current treatments on the market are dominated by therapies with unappealing administration methods, including auto-injections, in-office infusions and topical gels and creams that have a high transference risk. KYZATREX® is an orally administered treatment that avoids the drawbacks that keep men from continuing treatment on available testosterone therapies.
KYZATREX® if approved, will represent a novel oral testosterone replacement therapy option for adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
The ReTUNE™ study was a multi-center, 12-month study across the U.S. that studied the safety and efficacy of KYZATREX® in hypogonadal subjects (total testosterone ≤ 281 ng/dL). Efficacy was determined by number of subjects in the normal, eugonadal range after 90 days of treatment, including dose titrations, while safety was monitored for a further 9 months while on a steady dose. In addition to testosterone parameters, the study collected Patient Reported Outcomes (PROs), which showed statistically significant results both from baseline and against its comparator. A pivotal six-month Phase 3 study was conducted, in which subjects were monitored using ABPM, now considered the standard BP assessment by the FDA and clinical experts. An improved dose regimen was also used in the pivotal six-month Phase 3 study. The results of the Phase 3 studies will be published in leading medical journals and presented at national conferences in 2021.
The FDA has conditionally accepted KYZATREX® as the trade name for this investigational drug. The safety and efficacy have not been fully evaluated by any regulatory authority.
Marius is a specialty pharmaceutical company focusing on treating conditions that are primarily associated with hypogonadism, commonly referred to as testosterone deficiency. The company’s mission is to improve the functional lives of patients and reduce the risks of the downstream effects of endocrine imbalance by ensuring appropriate level of testosterone. For more information, please visit www.mariuspharma.com .
RALEIGH, N.C., March 11, 2021 – Marius Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 31, 2021 for the review of the KYZATREX® New Drug Application (NDA) for primary and secondary male hypogonadism. KYZATREX®, an oral testosterone undecanoate softgel, had one of the most comprehensive Phase 3 trials in the testosterone space and if approved, has the potential to be the only first-action approval oral testosterone product on the market. The company plans to launch immediately following product approval.
Hypogonadism, commonly referred to as testosterone deficiency, occurs when the body does not produce sufficient testosterone levels on its own. While testosterone’s role in sexual and reproductive function is widely known, it is also vital to numerous other metabolic and inflammatory processes. In the U.S., there are at least six million symptomatic men suffering from hypogonadism, and over 100 million men globally.
Evidence supports the need for research initiatives to examine hormonal imbalance and the benefits of testosterone therapy in reducing risk factors related to cardiometabolic diseases. Marius also supports broader testosterone testing protocols for those experiencing fatigue, decreased libido, depression, obesity, and Type 2 diabetes. To profess these initiatives, Marius is evaluating expansion of its research program to further explore the positive role of adequate levels of testosterone in the body.
The resulting medical costs associated with men with untreated hypogonadism and related comorbidities are approximately $25 billion in the U.S. alone. Hypogonadism is also the most common cause of secondary osteoporosis in men and related to a broader set of conditions ranging from Type 2 diabetes to non-alcoholic steatohepatitis, a type of fatty-liver disease.
KYZATREX® if approved, will represent a novel oral testosterone replacement therapy option for adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
The ReTUNE™ study was a multi-center, 12-month study across the U.S. that studied the safety and efficacy of KYZATREX® in hypogonadal subjects (total testosterone ≤ 281 ng/dL). Efficacy was determined by number of subjects in the normal, eugonadal range after 90 days of treatment, including dose titrations, while safety was monitored for a further nine months while on a steady dose. In addition to testosterone parameters, the study collected Patient Reported Outcomes (PROs), which showed statistically significant results both from baseline and against its comparator. A pivotal six-month Phase 3 study was conducted, in which subjects were monitored using ABPM, now considered the standard BP assessment by the FDA and clinical experts. An improved dose regimen was also used in the pivotal six-month Phase 3 study. The results of the Phase 3 studies will be published in leading medical journals and presented at national conferences in 2021.
The FDA has conditionally acceptedKYZATREX® as the trade name for this investigational drug. The safety and efficacy have not been fully evaluated by any regulatory authority.
RALEIGH, N.C., June 11, 2021 —Marius Pharmaceuticals, a patient-centric healthcare company focusing on therapies designed for hypogonadism, more commonly known as testosterone deficiency, today announced the publication of a study on the effects of oral testosterone undecanoate KYZATREX™ on ambulatory blood pressure in hypogonadal men in The Journal of Clinical Hypertension.
“Effects of Oral Testosterone Undecanoate KYZATREX™ on Ambulatory Blood Pressure in Hypogonadal Men”was published by William B. White, M.D., Professor, Cardiology Center, University of Connecticut School of Medicine, Farmington, and former President of the Hypertension Society of North America, Roger Rittmaster, MD, an endocrinologist in Camden, Maine, and Om Dhingra and James Bernstein from Marius. This newly published study shows small increases in ambulatory BP following 120 days on the oral testosterone undecanoate with a plateau and no further changes at 180 days. Changes in ambulatory BP were minimal in patients not taking antihypertensive therapies.
The publication of these results marks a significant milestone in the field of testosterone therapy as ambulatory blood pressure monitoring (ABPM) is the most accurate means to detect small BP changes in clinical trials and practice. Lead author William B. White, M.D. commented, “The changes in ambulatory BP were quite minimal in our study and of no clinical significance in normotensive men, a first in the testosterone space.” As testosterone therapy evolves past injections and gels towards the oral formulations, it is important to determine off-target effects on BP and to be able to compare these effects across the various therapies. Shalin Shah, Co-CEO of Marius commented, “We are extremely proud of the blood pressure data produced across all patient groups. If approved by the FDA, KYZATREX™ has the potential to provide greater clarity to both the physician and patient community on expected blood pressure changes.”
KYZATREX™, if approved, will represent a novel oral testosterone replacement therapy option for adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
The ReTUNE™ study was a multi-center, 12-month study across the U.S. that studied the safety and efficacy of KYZATREX™ in hypogonadal subjects (total testosterone ≤ 281 ng/dL). Efficacy was determined by number of subjects in the normal, eugonadal range after 90 days of treatment, including dose, titrations, while safety was monitored for a further 9 months while on a steady dose. In addition to testosterone parameters, the study collected Patient Reported Outcomes (PROs), which showed statistically significant results both from baseline and against its comparator. A pivotal six-month Phase 3 study was conducted, in which subjects were monitored using ABPM, now considered the standard BP assessment by the FDA and clinical experts. An improved dose regimen was also used in the pivotal six-month Phase 3 study. The results of the Phase 3 studies will be published in leading medical journals and presented at national conferences during 2021.
The FDA has conditionally accepted KYZATREX™ as the trade name for this investigational drug. The safety and efficacy have not been fully evaluated by any regulatory authority.
Hypogonadism, often referred to as testosterone deficiency, is a condition that occurs when the body does not produce adequate levels of testosterone. In addition to testosterone’s widely accepted role in sexual and reproductive function, it also has important roles in numerous other metabolic and inflammatory processes. In the U.S. there are at least six million symptomatic men suffering from hypogonadism, and over 100 million men globally. The resulting medical costs associated with men with untreated hypogonadism and related comorbidities are more than $25 billion in the U.S. alone.
Hypogonadism is also the most common cause of secondary osteoporosis in men. Beyond these diseases, hypogonadism is a common comorbidity in a broader set of conditions from Type-2 diabetes to Non-Alcoholic Steatohepatitis (NASH).
Marius 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 increased inflammation and fatigue. For more information, please visit www.mariuspharma.com
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This policy is effective as of 19 May 2020.