BURTON ON TRENT, England--(BUSINESS WIRE)--Clinigen Group plc (AIM:CLIN, ‘Clinigen’), the global pharmaceutical and services company, has initiated an Expanded Access Program (‘EAP’) in the US with Santhera Pharmaceuticals (SIX:SANN, ‘Santhera’) for idebenone in patients with Duchenne Muscular Dystrophy (‘DMD’) who are in respiratory decline.
The EAP (also known as a Managed Access Program), referred to as BreatheDMD, provides a mechanism through which eligible patients in the US with DMD can obtain access to investigational idebenone, through a network of research centres across the US.
EAPs such as BreatheDMD allow eligible patients with serious or life-threatening conditions to access an investigational medicinal product, upon physician request, before it is approved by regulatory authorities where there is no suitable alternative treatment for the medical condition.
Idebenone is a medicine that is currently under investigation for the treatment of DMD in patients who are in respiratory decline.
John Lagus, Head of Managed Access, Clinigen, said:
“There is a huge unmet clinical need for patients with DMD and we are pleased to be working in partnership with Santhera to help eligible patients in the US gain access to this important medicine.
“This partnership aligns with our mission of getting the right medicines to the right patient at the right time.”
Thomas Meier, PhD, CEO, Santhera, said:
“Santhera’s mission remains to develop and bring new treatment options for patients with DMD. Feedback from the DMD patient community highlights the need for access to additional treatment options. Santhera is proud to be launching this EAP, allowing eligible patients to obtain access to investigational idebenone.”
Details regarding this EAP program, including eligibility requirements, can be obtained by visiting the website www.breatheDMD.com.
Healthcare professionals can obtain details about the idebenone EAP by calling Clinigen at
Tel: +1 877 768 4303, or emailing email@example.com.
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Notes to Editors
About Clinigen Group
Clinigen Group plc (AIM:CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time through three areas of global medicine supply; clinical trial, unlicensed and licensed medicines. Clinigen acquired Quantum Pharma in November 2017.
For more information, please visit www.clinigengroup.com
Santhera Pharmaceuticals (SIX:SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for orphan and other diseases with high unmet medical needs. The portfolio comprises clinical stage and marketed treatments for neuro-ophthalmologic, neuromuscular and pulmonary diseases. Santhera's lead product Raxone® (idebenone) is authorized in the European Union, Norway, Iceland, Liechtenstein and Israel for the treatment of Leber's hereditary optic neuropathy (LHON) and currently commercialized in 20 countries. Santhera is currently conducting the Phase III SIDEROS trial with idebenone in patients with Duchenne muscular dystrophy (DMD) in respiratory function decline and using concomitant glucocorticoids. In collaboration with the U.S. National Institute of Neurological Disorders and Stroke (NINDS) Santhera is developing idebenone in a third indication, primary progressive multiple sclerosis (PPMS), and another product – omigapil – for congenital muscular dystrophy (CMD), both also areas of high unmet medical need. For further information, please visit the Company's website: www.santhera.com.
For information about Duchenne Muscular Dystrophy and Idebenone in Duchenne Muscular Dystrophy, please visit Clinigen’s website.