Cycle Pharmaceuticals’ NITYR (nitisinone) tablets receives marketing authorization in Chile

NOVEMBER 22, 2018

Cycle Pharmaceuticals Ltd. (Cycle) and its licensee Axon Pharma S.P.A. (Axon) are pleased to announce the approval of NITYR™ (nitisinone) tablets by the Chilean Institute of Public Health (Ministry of Health, MINSAL). 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 current patient population with this condition in Chile is estimated at 13 patients.

In Chile, the diagnosis and treatment of HT-1 are financially supported by the Ricarte Soto Law (Ley Ricarte Soto) which provides universal coverage for a group of high cost pathologies including rare diseases.

“This timely approval represents the first in our Latin American regulatory strategy for NTIYR™. We are proud to have partnered with Axon in Chile for NITYR™ as their support and regional knowledge has been key to this successful outcome.” said Paula Bekinschtein, Latin America Director, Cycle.

Cycle’s nitisinone tablets were recently approved by the European Medicines Agency (EMA) in Europe and it is already being prescribed in key countries and regions around the world such as U.S. and Canada, Latin America, Middle East and North Africa, South Africa, Australia, South East Asia.

“This approval is part of a global roll-out plan to make sure that HT-1 patients will have the opportunity to benefit from the unique characteristics of NITYR™. We look forward to working with Axon and Chilean physicians and caregivers” Said Antonio Benedetti, CEO, 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.

 

*Orfadin is a registered trademark of Swedish Orphan Biovitrum International AB (publ).
GL-0010 (Date of Preparation: November 2018)