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™.

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 to 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 that 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 focussed 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 access to KYZATREX. 

Find out more

Marius Pharmaceuticals
Lilly Washburn
+1 (336) 404-9622
[email protected]

Smartway Pharmaceuticals
Robert Donnell, Executive Vice President - Medicines Access
+44 20 4551 5884
[email protected]
Anna Vassova, Marketing Manager
[email protected]

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 Smartway Pharmaceuticals 

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.

If you need help with Early Access Programs, don't hesitate to contact our experts by emailing [email protected]

For more information on how we design, implement and manage EAPs worldwide, please click below: 

Smartway EAP