The Dallas Based, Direct-to-Consumer Telemedicine Company Secures Marketing Agreement with Marius Pharmaceuticals Bringing KYZATREX to the Telehealth Market as ‘Prime’ by MangoRx
Dallas, Texas & Raleigh, NC, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing, and selling a variety of men’s health and wellness products via a secure telemedicine platform, including its uniquely formulated hair growth product (‘GROW’) and erectile dysfunction (ED) drug (‘Mango’), is excited to announce that it has entered into a Marketing Agreement with Marius Pharmaceuticals ("Marius") to market and sell KYZATREX®️, an innovative FDA-approved oral Testosterone Replacement Therapy (TRT) product, under the program, 'PRIME' by MangoRx.
PRIME will be available on MangoRx’s telemedicine platform with an anticipated launch date of January 31, 2024.
KYZATREX, a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions, is one of only three FDA approved TRT treatments that is delivered orally--as opposed to the traditional, invasive, and inconvenient injection-based drug delivery protocol. KYZATREX delivers testosterone in a softgel capsule that is absorbed primarily via the lymphatic system, avoiding liver toxicity.
Testosterone deficiency is often first recognized through symptoms of fatigue or low energy, decreased sex drive, lower muscle mass and many other negative downstream impacts. PRIME, powered by KYZATREX, can help men restore Testosterone to normal levels and improve how they feel. In a 6-month open-label clinical study of 139 hypogonadal patients, 88% of patients taking KYZATREX had normal testosterone levels at Day 90 (worst case scenario (WCS) efficacy calculation, excluding Site 104).1 Among study completers (n=127), 96% of KYZATREX patients achieved normal testosterone levels at Day 90.2 With PRIME, MangoRx will expand broad-based consumer access to this innovative therapy.
TRT treatments have traditionally been delivered through intramuscular needle injection, a subcutaneous implant, or a topical gel. These applications have suffered from different drawbacks depending on the delivery method, such as painful administration, uneven absorption, risk of transfer to others, and disruptions to the body's natural diurnal rhythm allowing for peak performance early in the day.
Twice daily oral TRTs offer painless administration, promote steady absorption, lower SHGB levels, increase free T levels to give the body more usable testosterone, and work with the body's natural diurnal rhythm. Oral softgels are also convenient, mess-free, and discreet.
Shalin Shah, CEO of Marius, shared, “This expansion into telehealth marks an important step in the care of Testosterone Deficient patients. Testosterone Deficiency is a serious chronic disease and has been inadequately addressed by previous generations of products. KYZATREX marks a shift in the treatment paradigm and a meaningful opportunity for patients seeking to restore optimal testosterone levels. Marius is excited to partner with MangoRx as an innovative partner in the DTC marketplace. We look forward to the Mango team bringing more awareness around the significance of Testosterone as a metabolic hormone and its role in optimal health for men with Low T.”
PRIME by MangoRx will bring KYZATREX to patients spanning 48 states through the Company’s telemedicine platform, which is optimized to deliver a smooth medical prescription process, including blood work and synchronous telehealth visits with a fully licensed prescribing physician. Orders will be reviewed and, pending approval, fulfilled, then discreetly shipped via MangoRx’s URAC accredited mail order partner pharmacy directly to the patient’s doorstep.
Jacob Cohen, MangoRx’s Co-Founder and CEO, noted, “PRIME represents a critical expansion into a new vertical with massive market potential and very little competition on the consumer side, while remaining completely consistent with our established identity as a company committed to providing new and innovative pharmaceutical based solutions helping men achieve optimal performance in all areas of life. We are extremely fortunate to be working with Marius and to be one of only a few companies with access to this innovative product. With our established marketing and telemedicine infrastructure in place, we are ready to hit the ground running and take PRIME to patients in need across the country next month."
Testosterone deficiency affects approximately four in ten men older than 45 years and 30-50% of men with obesity or type 2 diabetes, according to the Endocrine Society.3,4 Between 10% and 40% of men worldwide suffer from low testosterone levels.5
About MangoRx
MangoRx is focused on developing a variety of men's health and wellness products and services via a secure telemedicine platform. To date, the Company has identified men's wellness telemedicine services and products as a growing sector and especially related to the area of erectile dysfunction (ED) and hair growth. Interested consumers can use MangoRx’s telemedicine platform for a smooth experience. Prescription requests will be reviewed by a physician and, if approved, fulfilled and discreetly shipped through MangoRx’s partner compounding pharmacy and right to the patient’s doorstep.
To learn more about MangoRx’s mission and other products, please visit www.MangoRx.com or on social media @Mango.Rx.
About Marius Pharmaceuticals
Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company's vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.
About KYZATREX® (testosterone undecanoate)
KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) and indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in symptoms of low testosterone, including quality of life, energy/fatigue, erectile function, sexual intercourse, and mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established.
Favorable response from exhibitors, preview audiences and cross-promotional partners has encouraged indie distributor Hannover House, Inc. (OTC: HHSE) to significantly expand the theatrical release for its first fully-facilitated feature production, "WILDFIRE: The Legend of the Cherokee Ghost Horse." The family-appeal movie was inspired by the # 1 worldwide hit song by Michael Martin Murphey, and features the final big-screen performance for the late Anne Heche.
The film was originally slated for a key market theatrical release on Jan. 26, 2024. However, competitive factors and positive audience response have created the opportunity for a wider theatrical break. The release date of April 19 will provide Hannover House with another three-months of pre-release marketing, as well as place the title in a rare calendar window in which no other family appeal releases are scheduled as competition. There are two other wide release films set for April 19: the Guy Ritchie World War II action film, "The Ministry of Ungentlemanly Warfare" from Lionsgate and "Abigail" a horror-thriller from Universal. There are no live-action family features in the weeks leading up to and following April 19, with only two animated releases set as potential competition for family viewers: Disney's "Luca" on March 22, and Viva's "Dragonkeeper" on April 5.
In addition to traditional in-theatre promotions, Hannover House will also be working with a large assortment of local, regional and national cross-promotional sponsors, ranging from rodeo and horse-riding groups to a major, national retail clothing chain. "Murphey's 'WILDFIRE' song is so iconic and beloved," said Eric Parkinson. "We have seen how cross-generations react to this movie and to the story of a young girl who befriends a mysterious, wild horse. It's got a great message and is a wholesome, family-appeal movie that leaves you with a smile. The opportunity to fit the movie's release into a window in which there are no competitive family titles was a blessing for the movie and for families that love inspirational films," he continued.
Chevel Shepherd, winner of NBC's "The Voice" competition portrays Samantha Nichols, a young girl who is struggling to deal with the sudden loss of her parents. Michael Martin Murphey portrays Pastor Micah, and Mo Brings Plenty ("Yellowstone") plays Udeli, a Cherokee Spiritual Advisor. The parents are played by Adrian Paul ("Highlander") and Cara Jade Myers ("Killers of the Flower Moon"). Other notable cast members include Olivia Slatton-Fite as Joyce, Thesa Loving as Grandma Bette, Major Dodge Senior as Fred and the late, screen legend Anne Heche as the rodeo trainer.
The film was produced by Snowy Morning, Inc., and shot primarily in eastern Oklahoma, with creative guidance and advisors from the United Keetowah Band of Cherokee Indians. Financing was provided through private investors and through facilitation loans made by Hannover House, in consideration for sales representation rights. Eric Parkinson and Mike Snyder wrote the screenplay and Parkinson directed the film.
In addition to the film's national theatrical release on April 19, 2024 Hannover House is working with Cinemark Theatres for a series of "sneak-peek" / word-of-mouth events to occur on February 28 in selected markets.
TITLE LISTING INFORMATION
Title: WILDFIRE: The Legend of the Cherokee Ghost Horse
Genre: Family / Horses / Live-Action
Writers: Written by ERIC PARKINSON and MIKE SNYDER, based on the hit song by MICHAEL MARTIN MURPHEY
Director: ERIC PARKINSON
Producers: CHRIS LARGE, KYLE MARTENS, ERIC PARKINSON
Stars: CHEVEL SHEPHERD, ANNE HECHE, ADRIAN PAULMICHAEL MARTIN MURPHEY, MO BRINGS PLENTY,OLIVIA SLATTON-FITE, THESA LOVING, MAJOR DODGE, SNR., CASSIE SELF and CARA JADE MYERS.
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