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Longer shelf life for NITYR (nitisinone) tablets for HT-1 in the U.S. granted by the FDA

November 19, 2018

BOSTON--(BUSINESS WIRE)--Nov 19, 2018--Cycle Pharmaceuticals (Cycle) is pleased to announce that it has obtained the required stability data to extend the shelf life of NITYR™ (nitisinone) tablets from 24 to 36 months at room temperature.

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Longer shelf life for NITYR (nitisinone) tablets for HT-1 in the U.S. granted by the FDA (Photo: Business Wire)

NITYR™ is 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 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.

“For the last 20 years patients taking nitisinone had to store their medication in the fridge bringing extra complications and worries for families travelling, dealing with hot weather seasons or with potential power cuts that could take place on regular basis. From the beginning of the development work of NITYR™, one of our improvement targets was to produce a stable formulation with minimum formation of impurities, that could be kept outside of the fridge and not just for a few weeks. 36 months of shelf life at room temperature means that the NITYR is extremely stable, and caregivers can keep this medication for longer and even using it to keep emergency stock in schools or at the grandparents’ house for peace of mind. This is a great advancement in the quality of life of those managing the day to day of patients with HT-1” said Brian Sergenian, Director North America, Cycle

NITYR™ is a small and tasteless tablet (baby aspirin sized) for all ages. For patients, including pediatric patients who have difficulty swallowing, the tablets can also be disintegrated in water and administered using an oral syringe. Also, NITYR™ can be tried for three weeks by U.S. patients through a Free Trial Program, at the end of which they can freely decide to stay on NITYR™ or to go back to their previous treatment, without any kind of obligation.

“Following the great news last week for NITYR™ regarding the simplification of the infant administration, we are proud to announce another milestone in the development of NITYR™ that will further reassure families and physicians about the stability profile of this unique nitisinone formulation, providing them with a product that can contribute to alleviate their daily burden.” said Antonio Benedetti, CEO, Cycle.

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

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 on NITYR™, please visit www.nityr.us/PI.

About Cycle Pharmaceuticals, the commitment to HT-1 and NITYR ™

Cycle Pharmaceuticals is committed to changing the way that HT-1 is treated and managed around the world. Cycle Pharmaceuticals has worked for years with the FDA, physicians and patient groups to reduce the impact that HT-1 treatment has on patients’ lives. NITYR™ is the first and only nitisinone tablet in the world that does not require refrigeration (removing the need for cold chain transportation and storage) and can be taken with or without food; which may represent a significant improvement on previous treatments for patients and caregivers. NTIYR™ has a shelf life of 3 years stored at room temperature. NITYR™ can be tried for free and has a unique Diet and Low Protein Food Program.

Cycle Pharmaceuticals Ltd is registered in England. No. 7933058

View source version on businesswire.com:https://www.businesswire.com/news/home/20181119005482/en/

CONTACT: FOR FURTHER INFORMATION PLEASE CONTACT

Paula Bekinschtein, Global Marketing Manager

Cycle Pharmaceuticals

Tel: +44 1223 803 636 (GMT)

Email:info@cyclepharma.com

Company’s website:www.cyclepharma.com

US-0114 – Date of Preparation: November 2018

KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY PHARMACEUTICAL FDA MEDICAL SUPPLIES

SOURCE: Cycle Pharmaceuticals

Copyright Business Wire 2018.

PUB: 11/19/2018 10:10 AM/DISC: 11/19/2018 10:11 AM

http://www.businesswire.com/news/home/20181119005482/en

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