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Cycle Pharmaceuticals (“Cycle”) has selected Cardinal Health Inc. (“Cardinal”) as the importer and distributor of its nitisinone tablets Nityr™ to Diplomat Pharmacy, Inc. Cycle and Cardinal have entered an agreement where Cardinal is the exclusive U.S. logistic provider.
Nityr™ has recently been approved by the U.S. Food and Drug Administration (FDA) for the treatment of Hereditary Tyrosinemia type-1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Bioequivalent to the current nitisinone capsule, Nityr™ is the first treatment for HT-1 that does not require refrigeration and can be administered with or without food. Nityr™ provides treatment for patients from infancy to adulthood and is available as an easy to swallow small tablet. Nityr™ can also be disintegrated and administered in an oral syringe – ideal for paediatric patients.
“Cardinal Health is a leading wholesaler, distributor and logistic operator in the U.S.. This partnership is consistent with our view of excellence of services and will strengthen the supply chain of Nityr™, securing the availability of our product for the HT-1 community,” said Philippe Di Ruzza, Director North America, 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-lamp examination 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.
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.
Cardinal Health, Inc (NYSE: CAH) is a global, integrated healthcare services and products company, providing customised solutions for hospitals, health systems, pharmacies, ambulatory centres, clinical laboratories and physician offices worldwide. The company provides clinically-proven medical products and pharmaceuticals and cost-effective solutions that enhance supply chain efficiency from hospital to home. Cardinal Health connects patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. For more information, visit www.cardinalhealth.com.
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