Santhera Grants Exclusive North America License for Vamorolone to
Catalyst Pharmaceuticals in Deal Valued at up to USD 231 Million
Plus Royalties
Ad hoc announcement pursuant to Art. 53 LR
A conference call will be held today at 14:30 CEST / 13:30 BST /
08:30 EDT. Details are at the end of this news release.
- Santhera
will receive USD 90 million
upfront at
closing
(USD 75 million in
cash and USD 15 million
equity
investment),
an additional
USD 10
million upon U.S. FDA
approval of vamorolone in Duchenne
muscular dystrophy (DMD)
plus USD 26 million to pay
approval related regulatory milestones to
third parties, and
potential sales milestones of up to
USD 105
million
-
Agreement covers commercialization of vamorolone in
DMD and rights to all potential
future indications in North America
(NA)
-
Catalyst will pay
Santhera up to low-teen percentage
royalties and will
assume corresponding
third-party royalty obligations
on vamorolone
sales in NA
-
Santhera will continue
to focus on European
commercialization of vamorolone
in DMD, and
further development of its
clinical pipeline
- Santhera
and Catalyst intend
to collaborate on joint
clinical development and funding of
vamorolone for additional
indications beyond DMD
- Proceeds
allow for repayment of all short-term
debt with Highbridge and an overall
strengthening of the balance sheet
Pratteln, Switzerland,
June 20,
2023 – Santhera
Pharmaceuticals (SIX: SANN) announces that it has
signed an exclusive
license and collaboration
agreement for vamorolone in North
America (NA) with
Catalyst Pharmaceuticals, Inc.
(NASDAQ:
CPRX), a commercial-stage
biopharmaceutical company focused on novel medicines for patients
living with rare diseases. Total
consideration to Santhera
is up to
USD 231
million (including equity
investment), plus royalty
payments from product sales,
with near-term cash
proceeds for Santhera
of
USD 126
million.
Under the terms of the agreement, Santhera will
grant Catalyst exclusive commercialization rights to vamorolone in
North America, comprising the U.S., Canada and Mexico. At closing,
Santhera will receive an upfront cash payment of USD 75
million. In addition, Catalyst will make an equity investment of
USD 15 million through the purchase of 14,146,882 treasury
shares at a price of CHF 0.9477 per share which corresponds to
the ten-day volume-weighted average price ending two days prior to
signing of the agreement, subject to a six-month post-closing
lock-up and standstill. Use of proceeds from the equity investment
will support Phase 4 studies in DMD and joint development of
additional indications. Upon U.S. FDA approval of vamorolone in
DMD, a decision expected on October 26, 2023 (PDUFA date),
Santhera would receive an additional USD 36 million from
Catalyst, of which Santhera would pay contractually agreed
third-party regulatory milestone obligations (USD 26 million).
Furthermore, Catalyst may pay Santhera sales-based milestones of up
to USD 105 million as well as up to low-teen percentage
royalties and will assume corresponding third-party royalty
obligations of Santhera on vamorolone sales in all indications in
NA.
Dario Eklund, Chief Executive Officer of
Santhera, commented: “Duchenne muscular dystrophy is a
devastating condition. Everyone at Santhera has been working
diligently to advance vamorolone in order to make this important
treatment option available to patients. We believe Catalyst is well
placed to maximize the value of vamorolone and, subject to
regulatory approval, ensure patients in North America receive this
transformational therapy as quickly as possible. Catalyst has a
track record of success in the rare disease and neuromuscular space
and is our commercial partner of choice for North America with an
established infrastructure and commitment to patients. With our new
partner, we also look forward to jointly address the benefits of
vamorolone in additional indications. As part of this agreement,
Santhera benefits from upfront, milestone and royalty payments
which allows us to focus on the commercial roll-out of vamorolone
in DMD and future other indications in Europe.”
In Europe, Santhera plans to commercialize
vamorolone in key geographies (including Germany, France, UK,
Italy, Spain, Benelux), and will seek partners for
commercialization in all other countries. Market access, the
build-up of a core organization and stakeholder engagement
activities in these priority countries are ongoing. Already ahead
of the European approval decisions expected at year-end, the early
access programs submitted in the UK and France could allow
treatment of first DMD patients with vamorolone. For certain
countries, where Santhera chooses not to market vamorolone
directly, including certain European countries and Japan, it has
granted Catalyst a right of first negotiation in partnering
discussions.
The new drug application (NDA) for vamorolone in
DMD is under review in the U.S. by FDA, which has set
October 26, 2023 as the Prescription Drug User Fee Act (PDUFA)
date for its regulatory decision on approval. In Europe, the review
of the marketing authorization application (MAA) for vamorolone by
the European Medicines Agency (EMA) is ongoing. An opinion from the
Committee for Medicinal Products for Human Use (CHMP) is expected
in Q3-2023, followed by an approval decision by the European
Commission (EC) in late 2023. In the UK, a corresponding MAA is
under review by the Medicines and Healthcare products Regulatory
Agency (MHRA). Subject to approvals, vamorolone could be launched
in both the first EU countries and the U.S. in late 2023 and early
in the first quarter 2024, respectively.
For indications in addition to DMD, Santhera and
Catalyst will establish a joint steering committee (JSC) to
undertake the joint clinical development of vamorolone for global
indications, in which both parties would participate in the
development process and funding.
The closing of the transaction is expected to
occur early in the third quarter 2023, subject to customary
conditions and regulatory clearances in the United States.
Funding
OutlookThe near-term proceeds from the agreement
with Catalyst amount to USD 100 million (cash inflows of USD
126 million net of regulatory approval milestone obligation to
third parties of USD 26 million). This substantial infusion of
funds significantly extends the Company’s cash reach into Q1-2025,
providing a strong financial foundation for future endeavors
including advancing development of vamorolone and European
commercialization. In addition, funds will also be allocated
towards the repayment of the exchangeable notes facility to
Highbridge, resulting in a substantial reduction in debt and
strengthening the Company’s financial position.
AdvisorsCenterview Partners and
H.C. Wainwright & Co. acted as financial advisors to
Santhera.
Conference CallSanthera will
host a conference call on June 20, 2023, at 14:30 CEST / 13:30
BST / 08:30 EDT to discuss the agreement on vamorolone.
Participants are invited to call one of the following numbers (no
dial-in code is required):
Switzerland/Europe: +41 58 310 50 00United
Kingdom: +44 207 107 06
13USA:
+1 631 570 56 13
A replay will be accessible at
https://www.santhera.com/ad-hoc-news from about two hours after the
call has ended.
About Vamorolone Vamorolone is
an investigational drug candidate with a mode of action based on
binding to the same receptor as glucocorticoids but modifying its
downstream activity and as such is considered a dissociative
anti-inflammatory drug [2-5]. This mechanism has shown the
potential to ‘dissociate’ efficacy from steroid safety concerns and
therefore vamorolone could emerge as an alternative to existing
corticosteroids, the current standard of care in children and
adolescent subjects with DMD. In the pivotal VISION-DMD study,
vamorolone 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]. The most
commonly reported adverse events versus placebo from the VISION-DMD
study were cushingoid features, vomiting and vitamin D deficiency.
Adverse events were generally of mild to moderate severity.
Vamorolone has been granted Orphan Drug status
for DMD in the U.S. and in Europe and has received Fast Track and
Rare Pediatric Disease designations by the U.S. FDA and Promising
Innovative Medicine (PIM) status from the UK MHRA for DMD.
Vamorolone is an investigational medicine and is currently not
approved for use by any health authority.
References:[1]
Guglieri M et al
(2022). JAMA Neurol. 2022;79(10):1005-1014.
doi:10.1001/jamaneurol.2022.2480.
Link.[2] Mah JK et
al (2022). JAMA Netw Open. 2022;5(1):e2144178.
doi:10.1001/jamanetworkopen.2021.44178. Link.[3]
Guglieri M et al
(2022) JAMA. doi:10.1001/jama.2022.4315[4]
Heier CR et al
(2019). Life Science Alliance DOI: 10.26508[5]
Liu X et al (2020).
Proc Natl Acad Sci USA 117:24285-24293
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 Catalyst
PharmaceuticalsWith exceptional patient focus, Catalyst is
committed to developing and commercializing innovative
first-in-class medicines that address rare neurological and
epileptic diseases. Catalyst's flagship U.S. commercial product is
FIRDAPSE® (amifampridine) Tablets 10 mg, approved for the treatment
of Lambert-Eaton myasthenic syndrome ("LEMS") for adults and for
children ages six and up. In January 2023, Catalyst acquired the
U.S. commercial rights to FYCOMPA® (perampanel) CIII, a
prescription medicine approved in people with epilepsy aged four
and older alone or with other medicines to treat partial-onset
seizures with or without secondarily generalized seizures and with
other medicines to treat primary generalized tonic-clonic seizures
for people with epilepsy aged 12 and older. Further, Canada's
national healthcare regulatory agency, Health Canada, has approved
the use of FIRDAPSE® for the treatment of adult patients in Canada
with LEMS. For additional information about the Company, please
visit www.catalystpharma.com.
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
for all indications worldwide to 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. For vamorolone in the
treatment of DMD, Santhera has a new drug application (NDA) under
review by the U.S. FDA, a marketing authorization application (MAA)
under review by the European Medicines Agency (EMA) and an MAA
submitted to the UK Medicines and Healthcare products Regulatory
Agency (MHRA). The clinical stage pipeline also includes
lonodelestat to treat cystic fibrosis (CF) and other neutrophilic
pulmonary diseases. Santhera out-licensed rights to its first
approved product, Raxone® (idebenone), outside North America and
France for the treatment of Leber's hereditary optic neuropathy
(LHON) to Chiesi Group. For further information, please visit
www.santhera.com.
Raxone® is a trademark of Santhera
Pharmaceuticals.
For further information please
contact: public-relations@santhera.com orEva Kalias, Head
Investor Relations & CommunicationsPhone: +41 79 875 27
80eva.kalias@santhera.com
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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