Cycle Pharmaceuticals’ NITYR (nitisinone) Tablets Receives Marketing Authorization in Israel

October 19th 2020

CAMBRIDGE, United Kingdom, 19 October 2020 – Cycle Pharmaceuticals Ltd. (Cycle) and its licensee TrueMed Therapeutics (TrueMed) are pleased to announce the approval of NITYR® (nitisinone) Tablets by the State of Israel’s Ministry of Health. NITYR® has been approved 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.

In Israel, the HT-1 disease is diagnosed by the national new-born screening program and treatment includes medication and a special diet which are funded by the Israeli Ministry of Health.

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

“This approval is part of the successful global rollout plan for NITYR®, to ensure that HT-1 patients worldwide will have the opportunity to benefit from its unique characteristics. We look forward to working with TrueMed, industry leaders in rare disease therapies in Israel” says Antonio Benedetti, CEO of Cycle.

NITYR® was developed after four years of research and development to find an alternative formulation to Orfadin* (nitisinone) capsules.

NITYR® Tablets are manufactured in Switzerland and the UK.

 

About Cycle Pharmaceuticals

Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering best-in-class drug treatments and services to the under-served rare disease patient community.  We focus on rare genetic metabolic disorders and neurological conditions.  Cycle is headquartered in Cambridge, UK and has offices in Boston, Mass. (USA).  For more information, please visit www.cyclepharma.com and follow us on Twitter, LinkedIn, Facebook and Instagram.

 About TrueMed Therapeutics

TrueMed is a prominent distribution partner in Israel for rare disease and niche specialty care therapies. The company offers a complete and fully tailored local solution for global innovators, with a unique business model and clear focus on the long-term well-being of our patients and their families. TrueMed delivers rare dedication to wellness.

Visit www.truemedtx.com for additional information.

 

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-0038 (Date of Preparation: October 2020)