Santhera Receives Rare Pediatric Disease Designation from FDA for Idebenone for the Treatment of Duchenne Muscular Dystrophy
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Santhera Pharmaceuticals Holding AG /
Santhera Receives Rare Pediatric Disease Designation from FDA for Idebenone for
the Treatment of Duchenne Muscular Dystrophy
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Liestal, Switzerland, August 19, 2015 - Santhera Pharmaceuticals (SIX: SANN)
announces that the U.S. Food and Drug Administration (FDA) has granted rare
pediatric disease designation for Santhera's lead orphan drug candidate,
idebenone, for the treatment of Duchenne Muscular Dystrophy (DMD). The rare
pediatric disease designation supplements the orphan drug designation granted by
the FDA for idebenone to treat DMD in February 2007.
"We are pleased that the FDA has granted our request to designate idebenone for
the treatment of DMD as a drug for a rare pediatric disease," said Thomas Meier,
PhD, Chief Executive Officer of Santhera. "We already have Fast Track
designation for idebenone in DMD and, on this basis, will be requesting priority
review when we file the planned NDA. The potential to obtain a Rare Pediatric
Disease Priority Review Voucher from the FDA, which we could retain for a future
clinical development program of our own or sell, could provide additional value
for the company in the future."
About Rare Pediatric Disease Designation
The FDA defines a "rare pediatric disease" as a disease that affects fewer than
200,000 individuals in the U.S. primarily aged from birth to 18 years. Under the
FDA's Rare Pediatric Disease Priority Review Voucher program, a sponsor who
receives an approval of a new drug application (NDA) or biologics license
application (BLA) for a rare pediatric disease may be eligible for a voucher
which can be redeemed to obtain priority review for a subsequent marketing
application for a different product. The Priority Review Voucher may be sold or
transferred an unlimited number of times.
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 develops Raxone(®)/Catena(®) as treatment for patients with Leber's
Hereditary Optic Neuropathy (LHON), Duchenne Muscular Dystrophy (DMD) and
primary progressive Multiple Sclerosis (ppMS) and omigapil for Congenital
Muscular Dystrophy (CMD), all areas of high unmet medical need. In June 2015,
the Committee for Medicinal Products for Human Use (CHMP) recommended granting a
marketing authorization in Europe for Raxone(®) for the treatment of LHON. For
further information, please visit the Company's website www.santhera.com.
Raxone(®) and Catena(®) are trademarks 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, Deanne Eagle, Planet Communications
LLC
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 RPD designation:
http://hugin.info/137261/R/1946358/706188.pdf
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Santhera Pharmaceuticals Holding AG via GlobeNewswire
[HUG#1946358]
Unternehmensinformation / Kurzprofil:
Datum: 19.08.2015 - 07:00 Uhr
Sprache: Deutsch
News-ID 414577
Anzahl Zeichen: 5294
contact information:
Town:
Liestal
Kategorie:
Business News
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