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2016-09-06

Santhera Pharmaceuticals Holding AG: Santhera Announces Financial Results for the First Half Year 2016 and Reports Solid Sales Growth - Company Starts to Build

Santhera Pharmaceuticals Holding AG / Santhera Announces Financial Results for
the First Half Year 2016 and ReportsSolid Sales Growth - Company Starts to
Build US Operations and Strengthens Board of Directors. Processed and
transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible
for the content of this announcement.
Liestal, Switzerland, September 6, 2016 - Santhera Pharmaceuticals (SIX: SANN)
announces its financial results for the first half year 2016 and reports
solid sales growth. By end of the reporting period sales of Raxone
®
for Leber's hereditary optic neuropathy (LHON) had reached CHF 7.2 million,
recorded primarily in Germany and France with an increasing sales
contribution from additional mid-sized markets. Santhera has filed a
Marketing Authorization Application (MAA) in Europe for Raxone for the
treatment of Duchenne muscular dystrophy (DMD) in patients not taking
glucocorticoids. The MAA was submitted as Type II variation of the existing
marketing authorization for LHON and is currently under review by the
Committee for Medicinal Products for Human Use (CHMP). Santhera will shortly
start a randomized, double-blind, placebo-controlled phase III (SIDEROS)
trial to assess the efficacy of Raxone in DMD patients receiving concomitant
glucocorticoids. If successful, data from this trial will be used to support
a label extension to include all DMD patients irrespective of their
glucocorticoid use status. Santhera will also approach the US Food and Drug
Administration (FDA) with the intent to re-engage in further discussions on
the accelerated approval pathway for the glucocorticoid non-using patients,
in whom clinically relevant benefit with Raxone has already been
demonstrated.

Santhera also reports that it has started to build US operations under the
leadership of Todd Bazemore, who was appointed as Chief Operating Officer of
Santhera Pharmaceuticals (USA) Inc. and member of Santhera's Executive
Management Team. In addition, the Company announces the nomination of Patrick
Vink, MD to Santhera's Board of Directors. Patrick Vink is a senior life
science executive with a track-record in building global pharmaceutical
businesses.

Thomas Meier
, PhD, Chief Executive Officer of Santhera, commented on the first six months
of 2016: "The highlights in the first half year were the solid growth of
Raxone sales for LHON in initial markets in Europe and the submission of our
MAA for DMD. The sales uptake has been somewhat slower than originally
expected due to the complex pricing and reimbursement processes in which we
are currently engaged in several EU markets. As such decisions are expected
in the coming months, we anticipate further growth of Raxone sales in the
second half of 2016. Whilst we await the outcome of the ongoing review of our
MAA for DMD, we are already actively preparing for market entry."

Building US Operations - Appointment of Todd Bazemore as Chief Operating
Officer of Santhera Pharmaceuticals U.S. and Member of Santhera's Executive
Management Team

Santhera is establishing US operations in the Greater Boston Area under the
leadership ofTodd Bazemore
appointed today as Chief Operating Officer of Santhera Pharmaceuticals (USA)
Inc. He joins Santhera as a biopharmaceutical executive with 22 years of
experience in launching and building brands and has been instrumental in the
success of a number of drugs across multiple therapeutic areas, spanning from
ultra-rare diseases to large primary care conditions. Prior to joining
Santhera Todd Bazemore served as EVP&Chief Commercial Officer at Dyax Corp.
where he was responsible for global commercial strategy and oversaw all
commercial functions. Dyax was acquired by Shire plc in January of this year.
The US operations will initially be staffed to focus on regulatory and
clinical operations support, medical affairs, patient advocacy liaison and
commercial strategy.

"The US market is a key driver of Santhera's long-term valuation,"
commentedThomas Meier
. "I am very pleased that we establish our US operations now as we plan to
engage the FDA in further discussions about accelerated approval for Raxone
in DMD. Todd's strong track record of strategic leadership, operational
execution and launching and building brands will be highly valuable as we
develop our commercial strategy for the US market. In this important role,
Todd will join our Executive Management Team."

Extending Board of Directors

Santhera plans to extend its Board of Directors with the nomination of Patrick
Vink, MD and senior life science executive with a track-record of
successfully managing global businesses. As a former member of company
executive teams, he adds extensive experience in interacting with key
stakeholders like investors, the financial community and government officials
both from European and US perspectives. In his most recent operational role
he was Executive Vice President and Chief Operating Officer at Cubist
Pharmaceuticals. Patrick Vink acts as Advisor to the Board of Directors with
immediate effect and is designated for election as a new member of the Board
of Directors at the Company's 2017 Annual Shareholder Meeting.

On the extension of the Board of DirectorsMartin Gertsch
, Chairman of Santhera's Board of Directors commented: "I am very delighted
about the nomination of Patrick Vink to our Board of Directors. Patrick's
strong track record of growing global life science businesses and his
strategic leadership nicely complements the expertise of the current members
of the Board of Directors."

Key Financials in the First Half Year

* Increasing sales for Raxone drove topline growth

In the first six months of 2016, Raxone generated net sales of CHF 7.2 million
(1H 2015: CHF 1.5 million; 2H 2015: CHF 2.8 million), mainly driven by
increased Raxone sales to LHON patients in Germany and France.

* Intensified commercial and clinical activities increased operating expenses

Operating expenses in the first half-year were CHF 22.6 million (1H 2015: CHF
7.5 million). Preparation of regulatory filings for DMD in Europe and the US
and the implementation of late stage clinical trials led to higher
development expenses of CHF 8.1 million (1H 2015: CHF 2.9 million). Marketing
and sales expenses rose to CHF 8.9 million (1H 2015: CHF 1.5 million) and
general and administrative expenses (G&A) to CHF 5.5 million (1H 2015: CHF
3.1 million). These increases reflect the expansion of Santhera's operations,
especially the commercial activities, the ongoing roll-out of Raxone for LHON
across Europe and market entry preparations for Raxone for DMD. In summary,
the operating loss amounted to CHF 17.2 million (1H 2015: CHF -6.2 million)
leading to a net result of CHF -18.0 million (1H 2015: CHF -6.4 million).

* Sound financial basis to advance commercial and development strategies as
planned

As of June 30, 2016, Santhera had cash and cash equivalents of CHF 63.6
million (December 31, 2015: CHF 76.9 million). Net change in cash and cash
equivalents in the first half year of 2016 was CHF -13.3 million.

Company Highlights

* Solid uptake of Raxone for LHON in Europe

By end of the reporting period Raxone sales were recorded primarily in Germany
and France with an increasing sales contribution from additional mid-sized
markets. Santhera expects reimbursement decisions by a number of European
Authorities in the second half 2016 and early 2017.

* Relevance of pulmonary benefits for patients with DMD reconfirmed at first
"Duchenne Pulmonary Outcomes Workshop"

In April 2016, Santhera participated in the "Duchenne Pulmonary Outcomes
Workshop," organized by Parent Project Muscular Dystrophy (PPMD), the leading
U.S. advocacy organization working to end Duchenne. The workshop convened
experts in the research and clinical care of DMD patients who examined
current and future assessments of pulmonary function. Santhera presented data
from its phase III DELOS trial, which demonstrated clinically relevant
efficacy of Raxone (idebenone) in preserving respiratory function, a key
objective for DMD therapy. Previously, a patient and caregiver survey
conducted by PPMD clearly demonstrated that the DMD community highly values
treatment options for pulmonary complications.

* Marketing Authorization Application (MAA) filed in Europe for Raxone for
DMD

In May 2016, Santhera submitted a MAA to the European Medicines Agency (EMA)
for Raxone for the treatment of DMD in patients with respiratory function
decline and not taking concomitant glucocorticoids. The new indication was
submitted as Type II variation of the Company's existing marketing
authorization for Raxone which was granted last year. Shortly thereafter, on
June 21, the EMA validated Santhera's application thereby confirming that the
submission is complete and the review process by the Committee for Medicinal
Products for Human Use (CHMP) has begun.

* Update on US filing strategy for DMD

In July 2016, Santhera reported that the FDA commented on the proposed subpart
H approval pathway and requested that a second phase III trial be completed
providing additional data to support NDA filing for Raxone in all DMD
patients, irrespective of their glucocorticoid use status. The FDA confirmed
that a positive outcome of the planned SIDEROS trial has the potential to
provide the supplementary efficacy data to support NDA filing in all DMD
patients whether they use glucocorticoid or not. Santhera will work closely
with the DMD patient community and clinical experts with the intent to engage
the FDA in further discussions on an accelerated pathway to approval in the
glucocorticoid non-using patients, in whom clinically relevant benefit has
already been demonstrated.

* Publication on bronchopulmonary benefits of Raxone in DMD inNeuromuscular
Disorders

In June, additional data from the pivotal phase III trial (DELOS) were
published inNeuromuscular Disorders
, the official journal of the World Muscle Society (McDonald et al.,
Neuromuscular Disorders 2016, 26: 473-480). These data show that DMD patients
treated with Raxone have a reduced risk of bronchopulmonary complications
including fewer hospitalizations caused by such complications and a reduced
need for systemic antibiotic treatment compared to patients receiving
placebo.

* Received US fast-track designation for omigapil - CALLISTO study on track

In May, Santhera received Fast Track Designation from the FDA for omigapil for
the treatment of congenital muscular dystrophy (CMD). Previously, omigapil
was granted Orphan Drug Designation for CMD in both the EU and the US.
Santhera, in collaboration with the US National Institutes of Health (NIH),
is currently conducting a clinical phase I study (CALLISTO) with omigapil in
CMD patients. CALLISTO assesses the pharmacokinetics, safety, and...

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