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Clinigen Group to Manage International Named Patient Program for Abiogen Pharma’s Nerixia®
Clinigen GAP will supply the drug to countries within the European Union (EU), except for in Italy where the drug is currently licensed and commercially available. Nerixia, an aminobisphosphonate, is indicated for the treatment of OI, a congenital disorder characterized by brittle bones that are prone to fracture, which is estimated to affect 1-9 people per 100,000 worldwide1. No other bisphosphonate is currently licensed for the condition in Europe.
Nerixia is not licensed outside of Italy but under the Named Patient Program, Healthcare Professionals in the EU will be able to request the drug for individual patients suffering from OI who have no other approved therapeutic option.
Dr. Massimo Di Martino, President and CEO of Abiogen said, “Securing a trusted, specialist partner to manage access for Nerixia is key. Our collaboration with Clinigen GAP will ensure responsive, efficient supply of the drug to those patients who need it until we can make Nerixia commercially available. Clinigen GAP has extensive experience in the design and management of access programs on a global scale and we look forward to working with the team.”
Mark Corbett, Senior Vice President, Clinigen GAP said, “Nerixia has the potential to make a huge difference to the lives of individual patients and we are very pleased to be able to implement an access program for this important therapy. With an expanding client base of international pharmaceutical companies and over thirty access programs ongoing we have the expertise, capabilities and regulatory know-how to deliver this bespoke program.”
1 Orphanet portal for rare disease and orphan drugs www.orpha.net
Search: Osteogenesis Imperfecta
Accessed on 10 March 2014
Notes to Editors
About Nerixia® (neridronic acid)
Nerixia® is an aminobisphosphonate discovered, developed and owned by Abiogen Pharma, Pisa. The Anti-resorptive activity leads to decrease in bone turnover, which is the basis for use of this drug in Osteogenesis imperfecta. Nerixia is the only bisphosphonate approved for use in infants, children and adults. The product obtained first registration in Italy in 2002. Nerixia is the only drug officially approved for the treatment of Osteogenesis imperfecta.
About Osteogenesis imperfecta
Osteogenesis imperfecta (OI) is a genetic disorder caused by mutation of the COL1 A1 or A2 genes, characterized by fragile bones that break easily and low bone mass which lead to associated deformities and pain. The disease is also known as brittle bone disease, glass bone disease, China doll etc. OI patients typically manifest blue sclera, brittle teeth (Dentinogenesis imperfecta) and presence of wormian bones on skull radiographs. OI is a recognized rare disease.
About Named Patient Programs
Named Patient Programs provide controlled, pre-approved access to unapproved medicines in response to requests from Healthcare Professionals on behalf of specific or ‘named’ patients before those medicines are licensed in the patients’ home country.
About Clinigen Group
The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group, dedicated to delivering ‘the right drug, to the right patient at the right time’, has three operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). Clinigen GAP develops and implements global access programs for biotechnology and pharmaceutical companies and has provided access to unlicensed, licensed and end-of-lifecycle products to thousands of patients. Clinigen has experience in the implementation of more than 30 access programs worldwide.
For more information, please visit www.clinigengroup.com
About Abiogen Pharma
Abiogen Pharma is a privately owned specialist pharmaceutical company focused on bone metabolism and some rare diseases. The Company was founded in 1997 as a spin-off of Istituto Gentili. Abiogen employs about 330 people with its head quarter in Pisa, Italy. The team of R&D of Abiogen Pharma had developed and continues to develop several bisphosphonates, including ethidronate, alendronate, clodronate and neridronate.
For more information, please visit www.abiogen.it
Instinctif Partners (Clinigen media relations)