Ovid Therapeutics Announces Closing of Agreement with Takeda for Global Development and Commercialization of Soticlestat
March 30 2021 - 8:00AM
Ovid Therapeutics Inc. (NASDAQ: OVID) (“Ovid”), a biopharmaceutical
company committed to developing medicines that transform the lives
of people with rare neurological diseases, today announced the
closing of the Royalty, License and Termination agreement (the
“Agreement”) under which Takeda Pharmaceutical secured global
rights from Ovid to develop and commercialize the investigational
medicine soticlestat (TAK-935/OV935) for the treatment of
developmental and epileptic encephalopathies, including Dravet
syndrome and Lennox-Gastaut syndrome.
At closing, Ovid received an upfront payment of
$196 million and is eligible to receive up to an additional $660
million upon achieving development, regulatory and sales
milestones. In addition, Ovid will receive tiered double-digit
royalties, up to 20 percent on sales of soticlestat, if approved
and commercialized. Takeda has assumed sole responsibility for
further worldwide development and commercialization, and Ovid no
longer has any financial obligation to Takeda under the original
collaboration agreement, including for milestone payments or any
future development and commercialization costs.
About Soticlestat
(TAK-935/OV935)Soticlestat is a potent, highly selective,
first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase
(CH24H), with the potential to reduce seizure susceptibility and
improve seizure control. CH24H is predominantly expressed in the
brain, where it converts cholesterol into 24S-hydroxycholesterol
(24HC) to adjust the homeostatic balance of brain cholesterol. 24HC
is a positive allosteric modulator of the NMDA receptor and
modulates glutamatergic signaling associated with epilepsy.
Glutamate is one of the main neurotransmitters in the brain and has
been shown to play a role in the initiation and spread of seizure
activity. Recent literature indicates that CH24H is involved in
over-activation of the glutamatergic pathway through modulation of
the NMDA channel and that increased expression of CH24H can disrupt
the reuptake of glutamate by astrocytes, resulting in
epileptogenesis and neurotoxicity. Inhibition of CH24H by
soticlestat reduces the neuronal levels of 24HC and may improve
distorted excitatory/inhibitory balance in the brain.
About Ovid TherapeuticsOvid
Therapeutics Inc. is a New York-based biopharmaceutical
company using its BoldMedicine® approach to develop medicines that
transform the lives of patients with rare neurological
disorders. We believe these disorders represent an attractive
area for drug development as the understanding of the underlying
biology has grown meaningfully over the last few years and today
represents a substantial opportunity medically and commercially.
Based on recent scientific advances in genetics and the biological
pathways of the brain, we aim to identify, discover and acquire
novel compounds for the treatment of rare neurological disorders.
We have built a deep knowledge of such disorders, how to treat them
and how to develop the clinically meaningful endpoints required for
development of a compound in these disorders. We continue to
execute on our strategy to build this pipeline by discovering,
in-licensing and collaborating with leading biopharmaceutical
companies and academic institutions. These pipeline programs
include programs targeting rare epilepsies, Angelman syndrome and
Fragile X syndrome, as well as early-stage programs into other
monogenetic disorders. Ovid’s emerging pipeline programs include
OV329, a small molecule GABA aminotransferase inhibitor for
seizures associated with Tuberous Sclerosis Complex and
Infantile Spasms; OV882, a short hairpin RNA therapy approach for
Angelman syndrome; OV815, a genetic therapy approach for KIF1A
associated neurological disorder; and other non-disclosed research
targets. Additionally, Ovid maintains a financial interest in OV935
which is now being developed by Takeda. For more information
on Ovid, please visit www.ovidrx.com.
Ovid Forward-Looking
StatementsThis press release includes certain disclosures
that contain “forward-looking statements,” including, without
limitation, statements regarding the potential benefits, clinical
and regulatory development and commercialization of soticlestat and
Ovid’s programs and the potential value, benefits, and outcome of
the Royalty, License and Termination Agreement with Takeda. You can
identify forward-looking statements because they contain words such
as “will,” “appears,” “believes” and “expects.” Forward-looking
statements are based on Ovid’s current expectations and
assumptions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that may differ materially from those
contemplated by the forward-looking statements, which are neither
statements of historical fact nor guarantees or assurances of
future performance. Important factors that could cause actual
results to differ materially from those in the forward-looking
statements include uncertainties in the development and regulatory
approval processes, the fact that initial data from clinical trials
may not be indicative, and are not guarantees, of the final results
of the clinical trials and are subject to the risk that one or more
of the clinical outcomes may materially change as patient
enrollment continues and/or more patient data become available, and
the ability to commercialize soticlestat. Additional risks that
could cause actual results to differ materially from those in the
forward-looking statements are set forth in Ovid’s filings with the
Securities and Exchange Commission under the caption “Risk
Factors.” Such risks may be amplified by the COVID-19 pandemic and
its potential impact on Ovid’s business and the global economy.
Ovid assumes no obligation to update any forward-looking statements
contained herein to reflect any change in expectations, even as new
information becomes available.
Contacts
Investors and Media:Ovid
Therapeutics Inc.Investor Relations & Public
Relationsirpr@ovidrx.com
OR
Investors:Argot PartnersDawn
Schottlandt212-600-1902ovid@argotpartners.com
Media:Dan
Budwick1ABdan@1abmedia.com
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