Pratteln, Switzerland, September 10, 2024 –
Santhera Pharmaceuticals (SIX: SANN) announces the signing of an
exclusive distribution agreement with GENESIS Pharma for AGAMREE®
(vamorolone) for the treatment of Duchenne muscular dystrophy (DMD)
in 20 markets in Central and Eastern Europe.
Santhera Pharmaceuticals and GENESIS Pharma have
signed a distribution agreement for 20 markets in Central and
Eastern Europe. This strategic collaboration aims to address unmet
medical needs by allowing GENESIS Pharma to commercialize AGAMREE
in Greece, Cyprus, Malta, Romania, Bulgaria, Slovenia, Croatia,
Poland, Czech Republic, Hungary, Slovakia, Lithuania, Latvia,
Estonia, Serbia, North Macedonia, Bosnia & Herzegovina,
Montenegro, Albania, and Kosovo.
“This distribution agreement with GENESIS Pharma
marks a significant achievement for Santhera as we expand the
global availability of AGAMREE. By partnering with expert
organizations with a strong understanding of specialist markets, we
ensure optimal patient access,” said Geert Jan van Daal,
MD, PhD, Chief Commercial Officer of Santhera. “This is a
further step in our strategy to allow focus on key European markets
with dedicated Santhera teams while partnering with the best
companies for non-core European markets.”
Constantinos Evripides, Managing
Director of GENESIS Pharma, stated: “Our company has a
strong focus on rare diseases and an established expertise of more
than twenty years in the commercialization of orphan therapies. We
are delighted that Santhera has trusted our capabilities across the
CEE region, giving us the opportunity to add Vamorolone to our
broad and robust orphans’ portfolio. We will work closely and
diligently with Santhera to ensure a smooth and unhindered access
to all patients that can benefit from this innovative
treatment.”
The European Commission approved AGAMREE for the
treatment of DMD, in patients 4 years of age and older, in December
2023. This was based on data from the positive pivotal DMD study
and three open-label studies. Patients treated with AGAMREE or
placebo showed normal and similar growth while growth stunting was
observed in children treated with prednisone. In addition, patients
who switched from a standard of care corticosteroid to AGAMREE
maintained the efficacy benefit while recovering their growth and
bone health.
About AGAMREE® (vamorolone)
AGAMREE is a novel drug with a mode of action based on binding to
the same receptor as glucocorticoids but modifying its downstream
activity. Moreover, it is not a substrate for the
11-β-hydroxysteroid dehydrogenase (11β-HSD) enzymes that may be
responsible for local drug amplification and
corticosteroid-associated toxicity in local tissues [1-4]. This
mechanism has shown the potential to ‘dissociate’ efficacy from
steroid safety concerns and therefore AGAMREE is positioned as a
dissociative anti-inflammatory drug and an alternative to existing
corticosteroids, the current standard of care in children and
adolescent patients with DMD [1-4].
In the pivotal VISION-DMD study, AGAMREE met the
primary endpoint Time to Stand (TTSTAND) velocity versus placebo
(p=0.002) at 24 weeks of treatment and showed a good safety and
tolerability profile [1, 4]. The most commonly reported side
effects were cushingoid features, vomiting, weight increase and
irritability. Side effects were generally of mild to moderate
severity.
Currently available data show that AGAMREE,
unlike corticosteroids, has no restriction of growth [5] and no
negative effects on bone metabolism as demonstrated by normal bone
formation and bone resorption serum markers [6].
AGAMREE (vamorolone), an orphan medicinal
product, is approved for use in the United States (Prescribing
Information), the European Union (Summary of Product
Characteristics) and the United Kingdom.
References:[1] Dang
UJ et al. (2024) Neurology 2024;102:e208112.
doi.org/10.1212/WNL.0000000000208112. Link.[2]
Guglieri M et al
(2022). JAMA Neurol. 2022;79(10):1005-1014.
doi:10.1001/jamaneurol.2022.2480. Link.[3]
Liu X et al (2020).
Proc Natl Acad Sci USA 117:24285-24293[4]
Heier CR et al
(2019). Life Science Alliance DOI: 10.26508[5]
Ward et al., WMS
2022, FP.27 - Poster 71.
Link.[6] Hasham et
al., MDA 2022 Poster presentation. Link.
About Duchenne Muscular
Dystrophy Duchenne muscular dystrophy (DMD) is a rare
inherited X-chromosome-linked disease, which almost exclusively
affects males. DMD is characterized by inflammation which is
present at birth or shortly thereafter. Inflammation leads to
fibrosis of muscle and is clinically manifested by progressive
muscle degeneration and weakness. Major milestones in the disease
are the loss of ambulation, the loss of self-feeding, the start of
assisted ventilation, and the development of cardiomyopathy. DMD
reduces life expectancy to before the fourth decade due to
respiratory and/or cardiac failure. Corticosteroids are the current
standard of care for the treatment of DMD.
About SantheraSanthera
Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical
company focused on the development and commercialization of
innovative medicines for rare neuromuscular and pulmonary diseases
with high unmet medical need. The Company has an exclusive license
from ReveraGen for all indications worldwide to AGAMREE®
(vamorolone), a dissociative steroid with novel mode of action,
which was investigated in a pivotal study in patients with Duchenne
muscular dystrophy (DMD) as an alternative to standard
corticosteroids. AGAMREE for the treatment of DMD is approved in
the U.S. by the Food and Drug Administration (FDA), in the EU by
the European Medicines Agency (EMA), and in the UK by the Medicines
and Healthcare products Regulatory Agency (MHRA). Santhera has
out-licensed rights to vamorolone for North America to Catalyst
Pharmaceuticals and for China to Sperogenix Therapeutics. For
further information, please visit www.santhera.com.
AGAMREE® is a trademark of Santhera
Pharmaceuticals.
About GENESIS PharmaGENESIS
Pharma is a regional biopharma company focused on the
commercialization of innovative biopharmaceutical products
targeting severe and rare diseases in Central and Eastern Europe.
Established in 1997, GENESIS Pharma was among the first
pharmaceutical companies in Europe to specialize in the marketing,
sales and distribution of biopharmaceutical products. GENESIS
Pharma maintains a strong portfolio in therapeutic areas with high
unmet medical need through long standing strategic alliances with
some of the leading global biopharma companies. For more
information, please visit www.genesispharmagroup.com.
For further information please
contact: public-relations@santhera.com orEva Kalias, Head
Investor Relations & CommunicationsPhone: +41 79 875 27
80eva.kalias@santhera.com
For more information about GENESIS
Pharma, please contact:Natalia Karahaliou, Communications
Manager nkarahaliou@genesispharma.comPhone: +30 210 87 71 605
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.
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