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Santhera Pharmaceuticals Holding AG: Santhera Receives Rare Pediatric Disease Designation from FDA for Idebenone for the Treatment of Duchenne Muscular Dystrop

Santhera Pharmaceuticals Holding AG / Santhera Receives Rare Pediatric Disease
Designation from FDA for Idebenone forthe Treatment of Duchenne Muscular
Dystrophy . Processed and transmitted by NASDAQ OMX Corporate Solutions.The
issuer is solely responsible for the content of this announcement.
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," saidThomas
, 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

Raxone®and Catena®are trademarks of Santhera Pharmaceuticals.

| For further information, contact: |
| Thomas Meier, PhD, Chief Executive Officer Christoph Rentsch, Chief Financial Officer |
| Phone +41 61 906 89 64 Phone +41 61 906 89 65 |
| |
| |
| 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 |
| |
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


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX 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


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