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Press Release

Cycle Pharmaceuticals Receives FDA Approval of NityrTM (nitisinone) Tablets for Treatment of HT-1

Cycle Pharmaceuticals
Posted on: 01 Aug 17

Cycle Pharmaceuticals is pleased to announce that Cycle’s nitisinone Tablets, NITYR, have been approved by the U.S. Food and Drug Administration for the treatment of 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.

Nityr, which is manufactured by Cycle Pharmaceuticals, was developed after four years of research to find an alternative to the current nitisinone capsule formulation.

The FDA approval of Nityr for HT-1, is an exciting new treatment option for patients in the United States,” said Jon Miller, President of the Network of Tyrosinemia Advocates (NOTA). “Since this new treatment is a small tablet and does not need refrigeration, it may offer convenience and a better quality of life to patients and families who struggle with the debilitating effects of HT-1. Cycle Pharmaceuticals has taken an innovative approach to help address unmet needs and I hope this will be an incentive for pharmaceutical companies to further invest and innovate in HT-1 treatments and support.”

Clinically proven to be bioequivalent to the current nitisinone capsule, Nityr is the first formulation of nitisinone treatment that does not require refrigeration. Nityr can be stored at room temperature and can be administered with or without food. Nityr tablets are small, so they may ease swallowing and may allow a more convenient daily administration, with a single tablet being only 20 percent of the volume of the current nitisinone capsules. Two single 10 mg tablets are only 40 percent of the volume of a single 20 mg nitisinone capsule.

Nityr tablets can serve HT-1 patients throughout their lives, from infancy to adulthood, as they can be disintegrated in water in an oral syringe, allowing easy administration and accurate dose delivery to paediatric patients.

"Cycle Pharmaceuticals has interpreted the modern health needs of HT-1 patients and caregivers, by developing a treatment that may improve their quality of life. Nityr is the first milestone in the long-term engagement of Cycle Pharmaceuticals with the HT-1 community. We look forward to working with physicians, caregivers and the patient community to help HT-1 patients benefit from the developments that Nityr brings," said Antonio Benedetti, CEO, Cycle Pharmaceuticals.

Available in three strengths, 2 mg, 5 mg and 10 mg, Nityr tablets are manufactured in Switzerland.

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: Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine, which at levels above 500 micromol/L can result in symptoms, intellectual disability and developmental delay or painful hyperkeratotic plaques on the soles and palms; do not adjust the dosage of Nityr in order to lower the plasma tyrosine concentration. Obtain slit-lampexamination prior to treatment and re-examination if symptoms develop. Assess plasma tyrosine levels in patients with an abrupt change in neurologic status.

2. Leukopenia and Severe Thrombocytopenia: Monitor platelet and white blood cell counts.

There are no contraindications for Nityr tablets, however, you should consult your Doctor prior to taking this medication. For full prescribing information on Nityr, please visit www.nityr.us.

About HT-1

Hereditary Tyrosinemia type-1 (HT-1) is a rare and serious inherited metabolic disease caused by the inability to metabolise the amino acid tyrosine. Left untreated, HT-1 can cause hepatic, renal and peripheral nerve damage. HT-1 affects at least 1 in 100,000 patients worldwide, with approximately 150 patients in the United States.

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 more than four years closely with physicians and patient groups to reduce the impact that HT-1 treatment has on patients’ lives. Nityr is the first formulation of nitisinone treatment that does not require refrigeration (removing 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 and caregivers.

Nityr should be taken in conjunction with a controlled diet and under the supervision of a healthcare professional.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170801005434/en/

Business Wire
www.businesswire.com

Last updated on: 01/08/2017

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