TIDMCLIN
Clinigen Group plc
29 November 2021
29 November 2021
Clinigen signs agreement with Nippon Shinyaku for
Viltolarsen Managed Access Program
Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global
pharmaceutical Services and Products company, announces it has
signed an exclusive agreement with Nippon Shinyaku Co., Ltd
('Nippon Shinyaku') to implement a Managed Access Program for
VILTEPSO(R) ( viltolarsen ) for patients with Duchenne muscular
dystrophy (DMD) who are amenable to exon 53 skipping therapy.
DMD is a progressive muscle disease that primarily occurs in
boys due to a genetic mutation in the dystrophin gene. This
prevents the production of normal dystrophin resulting in reduced
muscle strength/function that progressively continues to decline.
There are many types of genetic mutations that can cause DMD.
Viltolarsen skips exon 53; and therefore has the potential to
rescue the dystrophin protein for 8-10% of DMD patients.(1)
Following finalization, the Managed Access Program will enable
early access to VILTEPSO (R) for eligible patients in countries
where it is not commercially available. VILTEPSO (R) is currently
only approved in the US and Japan.
Under the terms of the agreement, Clinigen will manage key
elements of the program including regulatory oversight, logistics
and access management.
Pete Belden, Executive Vice President Services Division,
Clinigen, said:
"We are pleased to partner with Nippon Shinyaku to enable access
to a valuable new treatment option for DMD, a rare and progressive
disease for which there remains a clear unmet medical need. This
agreement underlines Clinigen's strength in partnering with
biotechnology companies to provide services that enable quicker and
broader access to new innovative therapies ."
Kazuchika Takagaki, Director, Head of R&D, Nippon Shinyaku,
said:
"We are delighted to help more DMD patients with critical unmet
medical needs around the world on this important access program in
partnership with Clinigen . We look forward to further contributing
to the well-being of patients and their families."
Healthcare professionals can obtain details about the
VILTEPSO(R) Program by calling the customer service team
at +44 1932 824001 or emailing medicineaccess@clinigengroup.com .
Patients seeking medical information should contact their
physician.
- Ends -
Contact details
Clinigen Group plc +44 (0) 1283 495010
Pete Belden, EVP Services Division investors@clinigengroup.com
Rob Fox, VP Investor Relations and Corporate
Development
Consilium Strategic Communications
Mary-Jane Elliott / Matthew Cole / Jessica Tel: +44 (0) 20 3709 5700
Hodgson Clinigen@consilium-comms.com
Nippon Shinyaku Co., Ltd.
Corporate Communications Dept. Fax: +81-75-321-9128
kouhou@mb.nippon-shinyaku.co.jp
Notes to Editors
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global, specialist
pharmaceutical services and products company 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
14 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 20,000 healthcare professionals across more than 120
countries.
For more information on Clinigen, please visit
http://www.clinigen.com
About Nippon Shinyaku
Nippon Shinyaku's mission is to help people lead healthier and
happier lives. Through creating unique medicines that will bring
hope to patients and families struggling with illness, we aim to be
an organization trusted by the community. Please visit their
website (http://www.nipponshinyaku.co.jp/english/) for products or
detailed information.
Duchenne Muscular Dystrophy (DMD)
The incidence of DMD is reported as being 10.7 to 27.8 per
100,000 live male births worldwide.(2) DMD is a progressive form of
muscular dystrophy that occurs primarily in males. DMD causes
progressive weakness and loss of skeletal, cardiac, and pulmonary
muscles. Early signs of DMD may include delayed ability to sit,
stand or walk. There is a progressive loss of mobility, and by
adolescence, patients with DMD may require the use of a wheelchair.
Cardiac and respiratory muscle problems begin in the teenage years
and lead to serious, life-threatening complications.
References
1. Komaki H, Takeshima Y, Matsumura T, Ozasa S, Funato M, Egawa
Y, et al. (n.d.). A Japanese Phase I/II study of NS-065/ NCNP-01
(Viltolarsen), Exon 53 skipping drug, in patients with Duchenne
muscular dystrophy-a dose-finding study. Mendoza: Poster presented
at the 23rd International Annual Congress of
the World Muscle Society; 2018.
2. Mah, J.K.; Korngut, L.; Dykeman, J.; Day, L.; Pringsheim, T.;
Jette, N. A systematic review and meta-analysis
on the epidemiology of Duchenne and Becker muscular dystrophy.
Neuromuscul. Disord. 2014, 24, 482-491.
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