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MANGOCEUTICALS TO INTRODUCE "PRIME", POWERED BY KYZATREX (CIII TESTOSTERONE UNDECANOATE CAPSULES), FOR AN FDA APPROVED ORAL TESTOSTERONE REPLACEMENT THERAPY (TRT) PRODUCT

MANGOCEUTICALS TO INTRODUCE "PRIME", POWERED BY KYZATREX (CIII TESTOSTERONE UNDECANOATE CAPSULES), FOR AN FDA APPROVED ORAL TESTOSTERONE REPLACEMENT THERAPY (TRT) PRODUCT

MANGOCEUTICALS將推出由KYZATREX(CIII 十一酸睾丸激素膠囊)提供動力的 “PRIME”,用於美國食品藥品管理局批准的口服睾丸激素替代療法(TRT)產品
GlobeNewswire ·  2023/12/13 07:30

The Dallas Based, Direct-to-Consumer Telemedicine Company Secures Marketing Agreement with Marius Pharmaceuticals Bringing KYZATREX to the Telehealth Market as 'Prime' by MangoRx

這家總部位於達拉斯的直接面向消費者的遠程醫療公司與Marius Pharmicals簽訂了營銷協議,將KYZATREX作爲MangorX的 “Prime” 引入遠程醫療市場

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.

德克薩斯州達拉斯和北卡羅來納州羅利,2023 年 12 月 13 日(GLOBE NEWSWIRE)——Mangoceuticals, Inc.(納斯達克股票代碼:MGRX)(“MangorX” 或 “公司”),一家專注於通過安全的遠程醫療平台開發、營銷和銷售各種男士健康和保健產品的公司,包括其獨特配方的生髮產品(“GROW”)和勃起功能障礙(ED)藥物(“Mango”)很高興地宣佈,它已與Marius Pharmicals(“Marius”)簽訂了營銷協議,以銷售經美國食品藥品管理局批准的創新口服睾丸激素KYZATREX該計劃下的替代療法(TRT)產品是MangorX的 “PRIME”。

PRIME will be available on MangoRx's telemedicine platform with an anticipated launch date of January 31, 2024.

PRIME將在MangorX的遠程醫療平台上線,預計發佈日期爲2024年1月31日。

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.

KYZATREX是一種處方藥,用於治療因某些疾病而睾丸激素水平低或不高的成年男性,是美國食品藥品管理局批准的僅有的三種口服TRT治療方法之一,而不是傳統的、侵入性的、不方便的注射給藥方案。KYZATREX 在軟膠囊中輸送睾酮,該膠囊主要通過淋巴系統吸收,從而避免肝臟毒性。

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.

睾丸激素缺乏症通常首先通過疲勞或精力不足、性慾減退、肌肉質量下降和許多其他不利的下游影響症狀來識別。由KYZATREX提供支持的PRIME可以幫助男性將睾丸激素恢復到正常水平並改善他們的感覺。在一項針對139名性腺功能減退患者的爲期6個月的開放標籤臨床研究中,服用KYZATREX的患者中有88%在第90天睾丸激素水平正常(最壞情況(WCS)療效計算,不包括位點104)。1在研究完成者中(n=127),96%的KYZATREX患者在第90.2天達到正常睾丸激素水平有了PRIME,MangorX將擴大廣泛消費者獲得這種創新療法的機會。

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.

傳統上,TRT 治療是通過肌肉注射針劑、皮下植入物或外用凝膠進行的。根據給藥方式的不同,這些應用存在不同的缺點,例如給藥疼痛、吸收不均勻、有轉移給他人的風險,以及人體自然日間節律受到干擾,從而在一天中的早些時候達到最佳表現。

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.

每天兩次口服 TRT 可無痛給藥,促進穩定的吸收,降低 SHGB 水平,增加遊離 T 水平以使身體更有用的睾丸激素,並適應人體的自然日間節律。口服軟膠囊也很方便、無混亂且不顯眼。

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."

Marius首席執行官沙林·沙阿分享說:“向遠程醫療的擴展標誌着睾丸激素缺乏患者護理邁出了重要的一步。睾丸激素缺乏症是一種嚴重的慢性病,前幾代產品尚未得到充分解決。KYZATREX標誌着治療模式的轉變,對於尋求恢復最佳睾丸激素水平的患者來說,這是一個有意義的機會。Marius很高興能與MangorX合作,成爲DTC市場的創新合作伙伴。我們期待芒果團隊提高人們對睾丸激素作爲一種代謝激素的重要性及其在低 T 男性最佳健康中的作用的認識。”

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.

MangorX的PRIME將通過該公司的遠程醫療平台爲48個州的患者提供KYZATREX,該平台經過優化,可提供順暢的醫療處方流程,包括血液檢查和與持牌處方醫生同步進行遠程醫療就診。訂單將經過審查,待批准後發貨,然後通過MangorX經URAC認證的郵購合作伙伴藥房謹慎地直接運送到患者家門口。

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."

MangorX聯合創始人兼首席執行官雅各布·科恩指出:“PRIME代表着向新的垂直領域的關鍵擴張,市場潛力巨大,消費者方面的競爭很少,同時我們作爲一家致力於提供新的和創新的製藥解決方案的公司的既定身份完全一致,致力於提供新的和創新的製藥解決方案,幫助男性在生活的各個領域實現最佳表現。我們非常幸運能與Marius合作,併成爲少數幾家能夠獲得這種創新產品的公司之一。有了我們成熟的營銷和遠程醫療基礎設施,我們已準備好在下個月開始爲全國有需要的患者提供PRIME。”

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

根據內分泌學會的數據,睾丸激素缺乏會影響大約十分之四的45歲以上的男性,30-50%的肥胖或2型糖尿病男性。3,4 全球有10%至40%的男性睾丸激素水平低。5

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