NITYR (nitisinone) Tablets for Tyrosinaemia Type 1 receives Marketing Authorization in New Zealand

March 15th 2021

NITYR (nitisinone) Tablets for Tyrosinaemia Type 1 receives Marketing Authorization in New Zealand

MELBOURNE, Australia, March 15th, 2021 –Cycle Pharmaceuticals Ltd. and Orpharma NZ Ltd. are pleased to announce that on 19th January 2021 they have received the Marketing Authorization for NITYR™ (nitisinone) Tablets by the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE). NITYR is indicated for the treatment of patients with Hereditary Tyrosinaemia 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 neurological complications. In most cases, if left untreated, the disease is fatal. The current number of patients with this condition in New Zealand is estimated at 3-4 patients.

New Zealand’s Pharmaceutical Management Agency (PHARMAC) Rare Disorders Subcommittee made a decision to recommend funding of nitisinone with a high priority in 2019. A final decision is yet to be made by New Zealand’s Pharmacology and Therapeutics Advisory Committee (PTAC).

“This approval is part of the successful global roll out plan for NITYRTM, to ensure that HT-1 patients worldwide will have the opportunity to benefit from its unique characteristics. We look forward to continuing the work we started with Orpharma in Australia and being able to bring NITYR™ to patients in New Zealand” says Antonio Benedetti, CEO of Cycle.

NITYR™ was developed by Cycle Pharmaceuticals  Ltd. after many years of research and development to find an alternative formulation to ORFADIN* (nitisinone) Capsules. NITYR™ is clinically proven to be bioequivalent to ORFADIN1; has an improved formulation allowing it to be stored at room temperature and administered with or without food. NITYR™ tablets are small and tasteless, allowing for ease of swallowing, and are available in 2, 5 and 10 mg strengths. NITYR™ can be disintegrated in water and administered using an oral syringe, the preparation can be stored for up to 24 hours, allowing NITYR™ to be used by patients of any age.

 

Please review the Product Information before prescribing. The Product information can be accessed at: http://www.orpharma.com/products/orphan  

 

1- Data on File: NIT/02/20.

NITYR is a registered trademark of Cycle Pharmaceuticals Limited in the United Kingdom, licensed by Orpharma Pty Ltd in Australia and New Zealand. – GL-0059 (March 2021)

*Orfadin is a registered trademark of Swedish Orphan Biovitrum International AB (publ).

 

About Cycle Pharmaceuticals

 

Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering best-in-class drug treatments and services to the under-served rare disease patient community. We focus on rare metabolic and neurological genetic conditions.  Cycle is headquartered in Cambridge, UK and has offices in Boston, Mass. (USA).  For more information, please visit www.cyclepharma.com and follow us on Twitter, LinkedIn, Facebook and Instagram.

About Orpharma

Orpharma is an Australian pharmaceutical company focused on the supply of orphan, paediatric and emerging therapeutics. Orpharma is Australia’s first and only one stop shop for metabolic products supplying a range of low protein food, medical nutrition and medicines. Orpharma is collaborating with global leaders in biotechnology and pharmaceuticals to deliver therapies to patients in need. The company’s current product portfolio includes innovative medicines targeting rare metabolic diseases and medical nutrition for various conditions. For more information about Orpharma visit www.orpharma.com

 

FOR FURTHER INFORMATION PLEASE CONTACT

Ahmed Moosa, Operations Manager, Orpharma NZ Ltd.
Phone: +61 498 017 868
E-mail: enquiries@orpharma.com