Santhera's Raxone® designated Promising Innovative Medicine and suitable candidate for further evaluation under UK Early Access to Medicines Scheme (EAMS) for treatment in Duchenne muscular dystrophy
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Santhera Pharmaceuticals Holding AG /
Santhera's Raxone® designated Promising Innovative Medicine and suitable
candidate for further evaluation under UK Early Access to Medicines Scheme
(EAMS) for treatment in Duchenne muscular dystrophy
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The issuer is solely responsible for the content of this announcement.
Liestal, Switzerland, December 23, 2016 - Santhera Pharmaceuticals (SIX: SANN)
announces that it has been informed that the UK's Medicines and Healthcare
Products Regulatory Agency (MHRA) designated Raxone(®) (idebenone) for the
treatment of Duchenne muscular dystrophy (DMD) in patients with respiratory
function decline not taking concomitant glucocorticoids as Promising Innovative
Medicine (PIM) and as a suitable candidate for entry into Step II of the EAMS
process.
In the UK the Early Access to Medicines Scheme aims to give patients with life
threatening or seriously debilitating conditions access to medicines that do not
yet have a marketing authorization when there is a clear unmet medical need.
"We are delighted about MHRA's decision designating Raxone as a candidate for
further consideration under the Early Access to Medicines Scheme as this
underscores the high unmet medical need in DMD and acknowledges the innovative
treatment approach of Raxone," said Thomas Meier, PhD, CEO of Santhera.
Nic Bungay, Director of Campaigns, Care and Information at Muscular Dystrophy
UK, commented: "We welcome this very encouraging news that Raxone has been
considered suitable for the second step of the EAMS process, especially as this
is the first muscular dystrophy drug to reach this stage. This demonstrates that
the introduction of the EAMS, which Muscular Dystrophy UK had called for, could
help to fast track emerging treatments. We urge the Government to continue to
support the use of EAMS by pharmaceutical companies to bring through potentially
promising treatments."
The European Medicines Agency (EMA) and Swissmedic (the Swiss Agency for
Therapeutic Products) are currently reviewing marketing authorization
applications for Raxone for DMD patients in whom respiratory function has
started to decline and who are not taking concomitant glucocorticoids. This
indication would include patients who were previously treated with
glucocorticoids or in whom glucocorticoid treatment is not desired, not
tolerated or is contraindicated.
About the UK Early Access to Medicines Scheme (EAMS)
The UK's industry-sponsored EAMS aims to give patients with life threatening or
seriously debilitating conditions access to medicines that do not yet have a
marketing authorization when there is a clear unmet medical need. The EAMS is a
two-step process:
Step I is the Designation as a Promising Innovation Medicine (PIM). The PIM
designation is an early indication that a medicinal product is a promising
candidate for EAMS and gives reassurance that its clinical development is on
track by having an early review of its data by the medicines regulator.
Step II is the Scientific Opinion by the Medicines and Healthcare products
Regulatory Agency (MHRA, UK regulatory agency). The Scientific Opinion describes
the benefits and risks of the medicine and supports the prescriber and patient
to make a decision on using the medicine before its license is approved.
About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company
focused on the development and commercialization of innovative pharmaceutical
products for the treatment of orphan mitochondrial and neuromuscular diseases.
Santhera's lead product Raxone is authorized in the European Union, Norway,
Iceland and Liechtenstein for the treatment of Leber's hereditary optic
neuropathy (LHON). For Duchenne muscular dystrophy (DMD), the second indication
for Raxone, Santhera has filed a Marketing Authorization Application (MAA) in
the European Union and Switzerland. In collaboration with the US National
Institute of Neurological Disorders and Stroke (NINDS) Santhera is developing
Raxone in a third indication, primary progressive multiple sclerosis (PPMS), and
omigapil for congenital muscular dystrophy (CMD), all areas of high unmet
medical need. For further information, please visit the Company's website
www.santhera.com.
Raxone(®) is a trademark of Santhera Pharmaceuticals.
For further information, contact:
Thomas Meier, PhD, Chief Executive Christoph Rentsch, Chief Financial
Officer Officer
Phone +41 61 906 89 64 Phone +41 61 906 89 65
thomas.meier(at)santhera.com christoph.rentsch(at)santhera.com
US investor contact: US Public Relations contact:
Hans Vitzthum, LifeSci Advisors, LLC Deanne Eagle, Planet Communications
Phone +1 212 915 2568 Phone +1 917 837 5866
hans(at)lifesciadvisors.com deanne(at)planetcommunications.nyc
Disclaimer / Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for
or purchase any securities of Santhera Pharmaceuticals Holding AG. This
publication may contain certain forward-looking statements concerning the
Company and its business. Such statements involve certain risks, uncertainties
and other factors which could cause the actual results, financial condition,
performance or achievements of the Company to be materially different from those
expressed or implied by such statements. Readers should therefore not place
undue reliance on these statements, particularly not in connection with any
contract or investment decision. The Company disclaims any obligation to update
these forward-looking statements.
# # #
News Release EAMS:
http://hugin.info/137261/R/2067591/776337.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Santhera Pharmaceuticals Holding AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 23.12.2016 - 07:00 Uhr
Sprache: Deutsch
News-ID 514651
Anzahl Zeichen: 6957
contact information:
Town:
Liestal
Kategorie:
Business News
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