LONDON: Clinigen Group plc (AIM: CLIN, ‘Clinigen’), the global pharmaceutical Products and Services company, and Horizon Therapeutics Plc (‘Horizon’) announce that they have signed an agreement to implement a Managed Access Program, being referred to by Horizon as a Named Patient Use (NPU) Program, for UPLIZNA.
The UPLIZNA NPU Program is for adult patients with anti-aquaporin-4 (AQP4) antibody positive NMOSD in countries where UPLIZNA is not approved by the country’s local regulatory authority.
NMOSD is a unifying term for neuromyelitis optical (NMO) and related syndromes. NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that attacks the optic nerve, spinal cord and brain stem.1,2 Approximately 80 percent of all patients with NMOSD test positive for anti-AQP4 antibodies.
The program will provide an avenue for physicians – contingent on meeting all eligibility criteria and receiving local health approval – to potentially prescribe UPLIZNA for patients who live in certain countries where it is not commercially available. UPLIZNA is currently approved in the United States and Japan. In Japan, UPLIZNA is marketed by Mitsubishi Tanabe Pharma Corporation.
Pete Belden, Executive Vice President Services Division, Clinigen said: “We are pleased to be partnering with Horizon to make UPLINZA available for patients with this rare autoimmune condition, extending access to this valuable medicine where it is otherwise unavailable. This aligns with our mission to ensure the right patient gets the right medicine at the right time.”
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global, specialist pharmaceutical services and products platform focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time. The Group operates from sites in North America, Europe, Africa and the Asia Pacific.
Clinigen has more than 1,000 employees across five continents in 16 countries, with supply and distribution hubs and operational centres of excellence in key long-term growth regions. The Group works with 34 of the top 50 pharmaceutical companies; interacting with over 5,000 hospitals across more than 115 countries.
For more information on Clinigen, please visit http://www.clinigen.com