Cycle Pharmaceutical’s Nitisinone Tablets becomes first HT-1 treatment to pass through INESSS’ rigorous evaluation satisfying all therapeutic value criteria.

JUNE 1, 2017

Patients in Quebec with the rare, life-threatening disease HT-1 (Hereditary Tyrosinemia type 1) received a boost today with the announcement that INESSS, the Institut National d’Excellence en Santé et Services Sociaux Quebec, is making its first ever recommendation for an HT-1 treatment, Nitisinone Tablets.

HT-1 is a rare genetic disease that is unusually common in Quebec, particularly in the Saguenay-Lac-Saint-Jean region, affecting children from birth. Untreated, it leads to serious health consequences that can include childhood liver transplants or early death.

Cycle Pharmaceutical’s Nitisinone Tablets, approved by Health Canada in November 2016, is the first HT-1 treatment to pass through INESSS’ rigorous evaluation. The INESSS’ Scientific Committee have agreed unanimously that Cycle’s Nitisinone Tables satisfies all therapeutic value criteria including the prevention of deaths and liver transplants, as well as neurological crises and hospitalizations. There is no approved HT-1 treatment currently on the Quebec List of Medications. This recommendation represents a significant step forward to provide a new level of treatment access for HT-1 patients

Cycle Pharmaceuticals’ Director of North America, Philippe Di Ruzza said: “To guarantee the long-term availability of Nitisinone Tablets for all HT-1 patients in Quebec, Cycle have followed the Quebec laws and regulatioPhilippe Di Ruzzans, and worked with INESSS to recognise the therapeutic value of the new treatment. This represents a very important milestone for patients and families. Cycle continues to work with the Ministry of Health to ensure fair pricing and access for all patients in Quebec”.

Gpaula.bekinschtein-2719_2lobal Marketing Manager of Cycle Pharmaceuticals, Paula Bekinschtein added: “We’re very proud to be the first medication for HT-1 to be successfully assessed by INESSS. Cycle Pharmaceuticals has a long-term commitment with the HT-1 community and we welcome the outcomes of this evaluation. We look forward to bringing the benefits of our medication to  patients and their caregivers”.

 

 

The full INESSS notice is available at http://bit.ly/2qHwnWg

About Cycle Pharmaceuticals, the commitment with HT-1 and Nitisinone Tablets
Cycle Pharmaceuticals is committed to change the way that HT-1 is treated and managed around the world. Cycle has worked for more than 4 years closely with physicians and patient groups to reduce the impact that HT-1 treatment has on patients’ lives. The innovative Nitisinone Tablets is the first treatment for this condition that can be stored at room temperature (avoiding the need of a cold chain transportation and storage) and can be taken with or without food, representing a significant improvement from previous treatments for patients, carers and the health economies.

Nitisinone Tablets should be taken in conjunction with a controlled diet and under healthcare professional supervision.