BOSTON, Mass. August 5th 2020 – Cycle Pharmaceuticals (Cycle) is pleased to announce the launch of a new Wellbeing Program1 created to further support eligible U.S. patients with Hereditary Tyrosinemia Type 1 (HT-1) undergoing treatment with NITYR® (nitisinone) Tablets, during the COVID-19 pandemic.
NITYR® was approved in July 2017 by the US Food and Drug Administration (FDA) for the treatment of 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 peripheral nerve damage. In most cases, if left untreated, the disease is fatal. It is estimated that there are approximately 200 patients in the U.S. A carefully tailored low-protein diet combined with a proper regular exercise program, are especially important elements of a complete treatment plan for HT-1 patients.
Given the unprecedented COVID-19 lockdown that shuts down patient access to wellbeing facilities that may seriously impact the health of HT-1 patients, Cycle has developed this COVID-19 response for a limited period of time and only for eligible HT-1 patients.
“At Cycle we understand that lockdown restrictions during a pandemic may impose extra health challenges for patients with HT-1. These programs were created specifically to facilitate the access to proper medical foods and to benefit from important fitness programs when it is not possible to leave home.” said Peter Myrenfors, M.D., Chief Medical Officer at Cycle.
“We are pleased to be partnering with first-class organizations such as Cambrooke, My Gym and Fit Factory. We also look forward to continuing the cooperation with physicians, dietitians and the larger HT-1 Community to make sure that they can benefit from these initiatives and other patient support services during these difficult, unprecedented times” said Renata Tate, Head of US Patient Liaison Services at Cycle.
The newly launched program includes a Low-protein Diet Food Program1 and an Online Fitness Program1.
The Low-Protein Diet Food program has been created in partnership with Ajinomoto Cambrooke (Cambrooke) that eligible HT-1 patients can redeem against medical nutrition for all products available at Cambrooke’s website.
The Online Fitness Program has been created in partnership with the leading fitness organizations My Gym and Fit Factory, to provide eligible HT-1 patients of all ages with an on-line live program that they can join to support a healthy exercise routine from home, while most groups classes and gyms are closed across the country.
Cycle has also extended their existing Free NITYR® Program2 from 21 to 30 days, where patients can try the product for free and without interruptions in the delivery of their current medication.
In clinical trials, NITYR® tablets have an established safety profile with warnings and precautions as follows: 1. Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques. 2. Leukopenia and Severe Thrombocytopenia. There are no contraindications for NITYR® tablets, however, patients should consult their Doctor prior to taking this medication. For full prescribing information and important safety information, please visit www.nityr.us/PI.
References: 1. Wellbeing Program (Low-Protein Food Program and Online Fitness Program): Subject to terms and conditions and eligibility criteria. This program is for eligible commercially insured patients only. Not available for government-insured patients and subject to other federal and state law. Terms, Conditions and eligibility criteria is available at www.nityr.us/offerstcs. 2. Free NITYR Program: Patients can try NTIYR for 30 days, one time, for free, as long as their doctor prescribes it. Subject to terms and conditions, eligibility criteria, and other federal and state law. Terms and Conditions and eligibility criteria are available at www.nityr.us/offerstcs.
US-0296 – Date of Preparation: July 2020