Cycle Pharmaceuticals Ltd. (Cycle) is pleased to announce that it has received marketing authorization from Saudi Food and Drug Authority (SFDA) for NITYR^® (nitisinone) Tablets indicated for the treatment of patients with Hereditary Tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

HT-1 is an ultra-rare genetic disease that can cause hepatic, renal and neurological complications. In most cases, if left untreated, the disease is fatal. The worldwide frequency of HT-1 is 1 patient in 100,000 individuals and it is estimated that the number of patients living with this condition in Saudi Arabia is approximately 50.

In Saudi Arabia, HT-1 is listed in the national new-born screening program however the screening is not yet implemented; treatment includes medication and a special diet which are funded by the Saudi’s government or through private acquisition.

Cycle has partnered with Mecapharma Offshore SAL (Mecapharma) with an exclusive agreement for the distribution of NITYR^® in the Kingdom of Saudi Arabia.

 

Cycle’s NITYR^® (nitisinone) Tablets are approved in the US, Europe, Canada and Australia, and are also being prescribed in many regions around the world such as Latin America, Middle East, North Africa, South Africa, and South East Asia.

Michel Yaacoub, Mecapharma’s CEO stated “We are very proud to be the exclusive distributors of NITYR^® and to bring to the Saudis the only nitisinone tablet formulation that can be kept at room temperature. For these patients, where temperatures are very high year-round, the availability of NITYR^® represents an improvement to their quality of life, providing extra peace of mind to patients, families and the healthcare provider community.”

Antonio Benedetti, Cycle’s CEO added “This approval is part of Cycle’s global roll-out plan for NITYR^® to ensure that HT-1 patients worldwide will have the opportunity to benefit from the unique characteristics of NITYR^®. We look forward to working with our local partner Mecapharma who are experts in ensuring access to medicines to patients in the Middle East and North Africa region”.

NITYR^® was developed after four years of research and development to find an alternative formulation to Orfadin* (nitisinone) capsules. NITYR® is room temperature stable, small tablet (baby aspirin sized) and has a long three (3) years shelf life.

NITYR^® Tablets are manufactured in Switzerland and the UK.

NITYR is a registered trademark of Cycle Pharmaceuticals Limited in the United States.

*Orfadin is a registered trademark of Swedish Orphan Biovitrum International AB (publ).

GL-0040 (Date of Preparation: May 2020)

About Cycle Pharmaceuticals

Cycle is a pioneering pharmaceutical company, reimagining how drugs can benefit patients to make their lives easier and improve their quality of life at every stage. Specifically, Cycle focuses on improving orphan drugs, which treat under-served rare disease patient community.

With headquarters in Cambridge, UK and offices in Boston, Mass. (USA), Cycle has developed unique partnerships with renowned universities around the world. For further information, please visit www.cyclepharma.com.

 About Mecapharma

Mecapharma is a regional pharmaceutical service provider with an established network of distributors in the MENA region. Mecapharma brings to market innovative lifesaving products meeting international quality standards by partnering with expert pharmaceutical companies from the US and EU.

In addition to making US and EU registered medicines available in MENA, Mecapharma also provides tailored regulatory, pharmacovigilance, medical information and quality services as well as commercial services including marketing and market access strategy design and local sales force capability.

For further information, please visit www.mecapharma.com