Clinigen and Santhera Launch US Expanded Access Program with Idebenone for Patients with Duchenne Muscular Dystrophy
20 February 2018 - 8:00PM
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
idebenone@clinigengroup.com.
- Ends -
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
About Santhera
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20180220005231/en/
Clinigen Group plcShaun Chilton, Group Chief Executive
OfficerorJohn Lagus, Head of Managed AccessTel: +44 (0) 1283
495010orInstinctif Partners (media relations –
Clinigen)Melanie Toyne-Sewell / Alex Shaw / Deborah BellTel:
+44 (0) 20 7457 2020Email:clinigen@instinctif.com
Clinigen (LSE:CLIN)
Historical Stock Chart
From Apr 2024 to May 2024
Clinigen (LSE:CLIN)
Historical Stock Chart
From May 2023 to May 2024