CAMBRIDGE, UK – 15 January 2024 – Cycle Pharmaceuticals Ltd (Cycle) and Inceptua Group (Inceptua) have announced a partnership to make NITYR® (nitisinone) Tablets available via a Free Goods Programme for eligible patients with Hereditary Tyrosinemia Type 1 (HT-1) and Alkaptonuria (AKU).

HT-1 and AKU are both ultra-rare diseases. HT-1 affects about 1 in 100,000 individuals worldwide,1 whilst AKU affects 1 in 250,000 to 1 million people worldwide.2

A Free Goods Programme is a compliant way for medicines that are not approved in their country of intended use to be made available for patients who either have no alternative treatment option or have exhausted all other treatment options available in their country of residence.

Cycle has an existing Free Goods Programme with patients with HT-1 in India, Bangladesh, Pakistan, and Sudan. Inceptua will support Cycle through the expansion of the Free Goods Programme to include further countries where NITYR is not commercially available, or where the local healthcare system is unable to afford this medication. Countries include Argentina, Bangladesh, Brazil, Chile, Colombia, Dominican Republic, Jordan, Mexico, Nigeria, Pakistan, Peru, Tunisia and Turkey.

Cycle is committed to supporting patients on the Free Goods Programme for the duration of their lifetime.

James Harrison, CEO of Cycle Pharmaceuticals said, “Right from the beginning of Cycle’s story in 2012, we made a commitment to provide a Free Goods Programme for rare disease patients that cannot otherwise access our medicines.  The whole Cycle team is extremely proud and humbled to be able to expand the NITYR Free Goods Programme. It really matters.”

Stuart Bell, Senior Vice President, Inceptua Early Access said, “Inceptua is proud to partner with Cycle in this Free Goods Programme to allow access to NITYR to a broader number of countries and patients. Cycle’s ethos around medicine provision aligns very closely to those of Inceptua’s, and we look forward to supporting patients with no other treatment options for these devastating diseases”.

Requests for access to NITYR must be made by a Healthcare Professional (HCP). HCPs can request access for a patient by contacting Inceptua at: access@inceptua.com or calling + 44 20 3910 7670.

About NITYR

NITYR (nitisinone) Tablets are a competitive inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase indicated for the treatment of adult and paediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. NITYR has been approved for use by the FDA, Health Canada, EMA, MHRA and TGA. Read the full prescribing information.

About Cycle

Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering drug treatments and product support to the underserved rare disease patient community. Cycle focuses on rare metabolic, immunological, and neurological genetic conditions. Within neurological conditions, we focus on multiple sclerosis. Cycle is headquartered in Cambridge, UK and has offices in Boston, Massachusetts. For more information, please visit www.cyclepharma.com and follow us on Twitter, LinkedIn and Facebook.

About Inceptua

Inceptua Early Access partners with pharma and biotech companies to provide truly global early access programs, which allow patients around the world access to potentially life-saving medicines. With offices in 8 countries, and a global warehousing and distribution network, Inceptua Early Ac-cess is the preferred partner for many companies in their efforts to bring promising medicines to patients as quickly as possible. Inceptua Early Access is a part of Inceptua Group – global service partner for pharma, delivering clinical trial services, early access programs and distribute medicines worldwide.

Cycle Media Contact:

marketing@cyclepharma.com

Website: www.cyclepharma.com

Inceptua Media Contact:

Morten Grøn

VP, Corporate Communication and Marketing

Telephone: +45 2556 4781

Email: morten.gron@inceptua.com

Website: www.inceptua.com

References:

  1. Medline Plus (2023) Available at: https://medlineplus.gov/genetics/condition/tyrosinemia/#frequency (Accessed 10 November 2023)
  2. Medline Plus (2023) Available at: https://medlineplus.gov/genetics/condition/alkaptonuria/#frequency (Accessed 14 November 2023)

–ENDS–

NITYR® is a registered trademark of Cycle Pharmaceuticals Limited in the United States.

©2023 Cycle Pharmaceuticals Limited. All rights reserved

GL-NIT-2300006 (Date of prep: November 2023)