SANTHERA FULL YEAR RESULTS
Dario Eklund, CEO of Santhera
said: “The year 2024 marked
a transformational period for
Santhera, with the successful launch
of AGAMREE ® for the treatment
of Duchenne muscular dystrophy
in Germany and Austria, and in
the U.S. by our licensing partner
Catalyst Pharmaceuticals. Santhera
ended the year in a strong position,
having secured financing of up to
CHF 69 million. This will support
the Company’s growth and provide
liquidity to 2026, by which point we
expect to be cashflow break-even.

Looking ahead to the rest of 2025
and beyond, we will be focused on
the continued commercial rollout of
AGAMREE to drive revenue growth
and patient access. Alongside this
we will be strategically pursuing
complementary assets to expand
our product portfolio, which will
leverage our existing infrastructure.

Our aims are clear: building
Santhera into a leading specialty
pharmaceutical company in rare
diseases and creating long-term
value for shareholders.”
Operational Highlights
Successful launch progress in own
markets: AGAMREE was successfully
launched in Germany and Austria,
achieving strong early adoption.

By year-end, less than 12 months
post launch, over 300 patients
were on continuing treatment with
AGAMREE, representing almost
30% of those currently on steroid
treatment. This is a reflection of
AGAMREE’s positive impact on the
DMD community.

Other EU direct markets progressing
well: Following a positive
recommendation for AGAMREE
from the National Institute for
Health and Care Excellence in the
UK in December 2024, full launch
was achieved in Q2 2025. Launches
are expected to follow in other
major EU countries throughout
2025 and 2026.

Catalyst successfully launched in the
US: Catalyst launched AGAMREE in
the U.S. in March 2024 and reported
$46m revenue for the calendar year,
exceeding its upgraded guidance for
the year. Catalyst has provided sales
guidance in excess of $100m for
2025, which would trigger a further
milestone to Santhera in addition to
the ongoing royalty income.

Sperogenix partnership in China:
During the year Sperogenix
commenced an early access
program for AGAMREE. Following
the regulatory approval from
China’s National Medical Products
Administration in December
2024, Sperogenix is preparing for
commercial rollout mid-2025 on
a non-reimbursed basis, with full
pricing reimbursement expected
in early 2026. Santhera benefits
from royalties as well as milestone
payments. Rollout in other territories: Santhera
signed additional agreements during
the year to expand AGAMREE’s
access in non-direct European
markets, as well as Israel and Qatar.

A named patient supply agreement
with Clinigen was established
to cover territories where
AGAMREE is not yet commercially
available. Santhera remains active
in expanding territories through
additional partnerships.

Manufacturing expansion: To support
growing global demand, Santhera
and Catalyst are validating additional
manufacturing sites for the supply
of AGAMREE, including one in the
U.S., which will increase capacity,
streamline supply chain efficiencies,
and reduce production costs.

MORE LABELLING MACHINES FOR
KOHLPHARMA SUPPLIED BY HERMA
Small to very small batch sizes, with several thousands of items in a wide variety of packaging - and a constantly
changing product range at the same time: More than most, kohlpharma attaches great importance to being able to
apply labels with great flexibility.

And since the items are pharmaceuticals and medicinal products, extreme precision is also required. This is
the reason why kohlpharma operates well over 100 HERMA label applicators and labelling machines. The
company, based in Merzig in Saarland, Germany, has just ordered a further 22 type 452C S top labelling machines.

kohlpharma is the market leader in Germany and is still a rapidly growing parallel importer of pharmaceuticals.

12 CHP PACKER INTERNATIONAL update



SANOFI’S RESPIRATORY
PIPELINE ADVANCES WITH
NEW DATA IN ASTHMA AND
PLANS FOR NEW CLINICAL
STUDIES IN COPD
Sanofi share new
progress from its
mid-to late-stage
respiratory pipeline,
including preliminary
phase 2 results for
amlitelimab in adults
with moderate-to-severe
asthma. Amlitelimab: clinically meaningful efficacy in asthma
Preliminary results from the TIDE-
Asthma phase 2 study (clinical study
identifier: NCT05421598) show that
the primary endpoint of annualised
exacerbation rate at week 48 was
not met at the highest dose level,
leading to nominal significance at the
medium and low doses. However,
the study demonstrates amlitelimab’s
compelling efficacy in heterogeneous
inflammatory asthma, potentially
representing a breakthrough for this
underserved patient population if
observed in later studies.

Treatment with amlitelimab led to
nominally significant and clinically
meaningful reductions in asthma
exacerbations at the medium dose
tested and a numerically greater
reduction in exacerbations at the
high dose at week 60. The study
also demonstrated nominally
significant and clinically meaningful
improvement in secondary
endpoints of lung function and
asthma control. Notably, in a
patient sub-group defined by
biomarkers (eosinophils ≥300
cells/ml and elevated neutrophils),
amlitelimab showed nominally
significant and clinically meaningful
improvements in exacerbations
(with a reduction of more than
70%), lung function and asthma
control at week 60.

These results demonstrate that
amlitelimab has potential to
improve key disease outcomes in
asthma patients with continued
unmet need. The phase 3 program
is currently being planned.

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CHP PACKER INTERNATIONAL update 13