Cycle Pharma Partners With Diplomat To Dispense Nityr In U.S.

CAMBRIDGE, England--(BUSINESS WIRE)--Cycle Pharmaceuticals (“Cycle”) has selected Diplomat Pharmacy, Inc. (“Diplomat”) to dispense its nitisinone tablets, Nityr^TM.

Cycle and Diplomat have entered into an agreement where Diplomat is the exclusive Specialty Pharmacy provider. Nityr^TM 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.

HT-1 patients treated with Nityr^TM will benefit from the services of Diplomat's Rare Disease Center of Excellence - a team of specialists who serve the unique needs of rare disease populations. Diplomat’s Rare Disease Center of Excellence will also manage Cycle’s custom-built Nityr^TM Patient Support Program.

Bioequivalent to the current nitisinone capsule, Nityr^TM is the first treatment for HT-1 that does not require refrigeration and can be administered with or without food. Nityr^TM can provide treatment for patients from infancy to adulthood. Nityr^TM is available as an easy to swallow, small tablet and can also be disintegrated and administered in an oral syringe, which is ideal for paediatric patients.

“Working with a top-class player like Diplomat is consistent with our view that HT-1 patients and caregivers should be provided with the best product and the best service. We look forward to working with Diplomat to deliver the benefits of Nityr^TM to the HT-1 community,” said Antonio Benedetti, CEO, Cycle Pharmaceuticals.

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

In clinical trials, Nityr^TM 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^TM 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^TM tablets, however, you should consult your Doctor prior to taking this medication. For full prescribing information on Nityr^TM, 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^TM

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

About Diplomat

Diplomat (NYSE: DPLO) is the nation’s largest independent provider of specialty pharmacy services - helping patients and providers in all 50 states. The company offers medication management programs for people with complex chronic diseases and delivers unique solutions for manufacturers, hospitals, payors, providers, and more. Diplomat opened its doors in 1975 as a neighborhood pharmacy with one essential tenet: “Take good care of patients and the rest falls into place.” Today, that tradition continues—always focused on improving patient care and clinical adherence. For more information, visit www.diplomat.is.