− Ovid eligible to receive up to $856M in payments, including
a $196M upfront payment, regulatory and commercial milestone
payments and tiered double-digit royalties on product sales
− Potential first-in-class therapy reduced seizure frequency
in children with Dravet syndrome and Lennox-Gastaut syndrome in
Phase 2 ELEKTRA study
− Original 2017 collaboration between Ovid and Takeda to
conclude; Ovid will have no further development or milestone
obligations
− Takeda plans to initiate Phase 3 studies in children and
adults with Dravet syndrome and Lennox-Gastaut syndrome in calendar
year Q2 2021
− Ovid will hold a conference call and webcast today at 8:30
a.m. EST
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK)
(“Takeda”) and 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 that Takeda has entered into an exclusive agreement
under which Takeda will secure global rights at closing from Ovid
to develop and commercialize the investigational medicine
soticlestat (TAK-935/OV935) for the treatment of developmental and
epileptic encephalopathies, including Dravet syndrome (DS) and
Lennox-Gastaut syndrome (LGS).
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20210303005167/en/
Discovered at Takeda’s Shonan, Japan research center,
soticlestat is a potent, highly selective, first-in-class inhibitor
of the enzyme cholesterol 24-hydroxylase (CH24H). Under the new
exclusive agreement, all global rights to soticlestat have been
secured by Takeda from Ovid. Takeda will assume sole responsibility
for further worldwide development and commercialization, and Ovid
will no longer have any financial obligation to Takeda under the
original collaboration agreement, including for milestone payments
or any future development and commercialization costs. Ovid will
receive an upfront payment of $196 million at closing and is
eligible to receive up to an additional $660 million upon achieving
development, regulatory and sales milestones. In addition, Ovid
will receive tiered royalties beginning in the low double-digits
and up to 20 percent on sales of soticlestat, if approved and
commercialized. The new agreement is expected to close by end of
March 2021, subject to the satisfaction of customary closing
conditions, including review by the appropriate regulatory agencies
under the Hart-Scott-Rodino Act.
“I would like to thank Ovid for their thoughtful and productive
collaboration. Together we generated positive Phase 2 ELEKTRA study
data, and as a result, soticlestat is poised to enter two pivotal
trials,” said Andy Plump, M.D., Ph.D., President of Research and
Development at Takeda. “Our work together demonstrates the strength
of Takeda’s partnership model and our commitment to delivering
transformative medicines to patients with neurological
diseases.”
Under the 2017 collaboration agreement, Takeda received equity
in Ovid and was eligible to receive up to $85 million in payments
for regulatory milestones, including the initiation of Phase 3
clinical trials. Ovid led global development of soticlestat through
the successful demonstration of proof-of-concept in multiple rare
epilepsies.
“This new agreement is a positive outcome for patients, for Ovid
and for Takeda. Jointly, we have set the stage, optimized the
program and enabled it to accelerate,” said Jeremy Levin, DPhil,
MB, BChir, Chairman and Chief Executive Officer of Ovid
Therapeutics. “Ovid may benefit significantly, but without the
obligation to commit the substantial capital needed over the coming
years as soticlestat completes pivotal trials and, if successful,
enters the global market. Importantly, with the resources this
agreement delivers, Ovid is strategically and financially
positioned well into the future. We will advance and enrich our
pipeline while continuing to build a leading company in rare
diseases of the brain. We would like to thank Takeda, who has been
a superb partner, and we look forward to further successes for this
program in the future.”
“Soticlestat has emerged as an important late-stage molecule in
our portfolio, which focuses predominantly on rare neurological and
neuromuscular diseases with great unmet need,” said Sarah Sheikh,
M.D., M.Sc., MRCP, Head, Neuroscience Therapeutic Area Unit at
Takeda. “We are working diligently and expediently to initiate and
execute upon the Phase 3 studies in children and young adults with
DS and LGS. Our goal is to one day bring new treatment options that
provide greater seizure control, tolerability and function to DS
and LGS patients around the world.”
Advancing New Treatment Options for DS and LGS
Patients
Takeda and Ovid reported results from the Phase 2 ELEKTRA study
in August 2020, in which soticlestat met its primary endpoint of
reducing seizure frequency in pediatric patients with DS or LGS.
Takeda intends to initiate Phase 3 studies of soticlestat in
children and young adults with DS and LGS in calendar year Q2
2021.
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 Dravet Syndrome and Lennox-Gastaut Syndrome
Dravet syndrome and Lennox-Gastaut syndrome are types of
developmental and epileptic encephalopathies (DEEs), a
heterogeneous group of rare epilepsy syndromes. Dravet and
Lennox-Gastaut syndrome typically become apparent during infancy or
early childhood and are highly refractory to many antiseizure
medications.
Dravet syndrome is most commonly caused by a genetic mutation in
the SCN1A gene and affects approximately 1 in 15,000 to 1 in 21,000
people in the United States. Dravet syndrome is characterized by
prolonged focal seizures that can evolve to convulsive tonic-clonic
seizures. Children with Dravet syndrome experience developmental
disabilities as seizures increase. Other common symptoms include
changes in appetite, difficulty balancing and a crouched gait when
walking.
Lennox-Gastaut syndrome is estimated to affect approximately 1
in 11,000 people in the United States. Lennox-Gastaut syndrome is a
heterogeneous condition and characterized by several different
types of seizures, most commonly atonic (drop), tonic and atypical
absence seizures. Children with Lennox-Gastaut syndrome may also
develop cognitive dysfunction, delays in reaching developmental
milestones and behavioral problems. Lennox-Gastaut syndrome can be
caused by a variety of underlying conditions, but in some cases no
cause can be identified.
Ovid Conference Call and Webcast Information
Ovid Therapeutics will host a conference call beginning today,
March 3rd at 8:30 AM Eastern Time. The live event will be available
on the investor page of the Ovid Therapeutics website at
investors.ovidrx.com or by dialing (866) 830-1640 (domestic) or
(210) 874-7820 (international) and referencing conference ID number
6343028. A replay of the call will be available on the Ovid
Therapeutics website following the completion of the call and will
be archived for 30 days.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a
global, values-based, R&D-driven biopharmaceutical leader
headquartered in Japan, committed to discover and deliver
life-transforming treatments, guided by our commitment to patients,
our people and the planet. Takeda focuses its R&D efforts on
four therapeutic areas: Oncology, Rare Genetic and Hematology,
Neuroscience, and Gastroenterology (GI). We also make targeted
R&D investments in Plasma-Derived Therapies and Vaccines. We
are focusing on developing highly innovative medicines that
contribute to making a difference in people’s lives by advancing
the frontier of new treatment options and leveraging our enhanced
collaborative R&D engine and capabilities to create a robust,
modality-diverse pipeline. Our employees are committed to improving
quality of life for patients and to working with our partners in
healthcare in approximately 80 countries. For more information,
visit https://www.takeda.com.
Important Notice From Takeda
This press release and any materials distributed in connection
with this press release may contain forward-looking statements,
beliefs or opinions regarding Takeda’s future business, future
position and results of operations, including estimates, forecasts,
targets and plans for Takeda. Without limitation, forward-looking
statements often include words such as “targets”, “plans”,
“believes”, “hopes”, “continues”, “expects”, “aims”, “intends”,
“ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”,
“estimates”, “projects” or similar expressions or the negative
thereof. These forward-looking statements are based on assumptions
about many important factors, including the following, which could
cause actual results to differ materially from those expressed or
implied by the forward-looking statements: the economic
circumstances surrounding Takeda’s global business, including
general economic conditions in Japan and the United States;
competitive pressures and developments; changes to applicable laws
and regulations, including global health care reforms; challenges
inherent in new product development, including uncertainty of
clinical success and decisions of regulatory authorities and the
timing thereof; uncertainty of commercial success for new and
existing products; manufacturing difficulties or delays;
fluctuations in interest and currency exchange rates; claims or
concerns regarding the safety or efficacy of marketed products or
product candidates; the impact of health crises, like the novel
coronavirus pandemic, on Takeda and its customers and suppliers,
including foreign governments in countries in which Takeda
operates, or on other facets of its business; the timing and impact
of post-merger integration efforts with acquired companies; the
ability to divest assets that are not core to Takeda’s operations
and the timing of any such divestment(s); and other factors
identified in Takeda’s most recent Annual Report on Form 20-F and
Takeda’s other reports filed with the U.S. Securities and Exchange
Commission, available on Takeda’s website at:
https://www.takeda.com/investors/reports/sec-filings/ or at
www.sec.gov. Takeda does not undertake to update any of the
forward-looking statements contained in this press release or any
other forward-looking statements it may make, except as required by
law or stock exchange rule. Past performance is not an indicator of
future results and the results or statements of Takeda in this
press release may not be indicative of, and are not an estimate,
forecast, guarantee or projection of Takeda’s future results.
About Ovid Therapeutics
Ovid 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.
Ovid has a broad pipeline of potential first-in-class medicines.
These include programs targeting Angelman syndrome, Fragile X
syndrome, and rare epilepsies, as well as early-stage programs into
other monogenetic disorders. Ovid’s most advanced pipeline programs
include OV935 (soticlestat) in collaboration with Takeda and OV101
a δ-selective GABAA receptor agonist. 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
researched targets. For more information on Ovid, please visit
www.ovidrx.com.
Ovid Forward-Looking Statements
This 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 other programs, the closing of this 2021 Royalty, License
and Termination Agreement relating to the 2017 License and
Collaboration Agreement and the potential value, benefits, and
outcome of the collaboration 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210303005167/en/
Takeda Media Contacts: Japanese Media Kazumi Kobayashi
kazumi.kobayashi@takeda.com +81 (0) 3-3278-2095
Media outside Japan Chris Stamm chris.stamm@takeda.com +1 (617)
347-7726
Ovid Investors and Media: Ovid Therapeutics Inc. Investor
Relations & Public Relations irpr@ovidrx.com
Or
Ovid Investors: Argot Partners Maeve Conneighton/Dawn
Schottlandt 212-600-1902 Ovid@argotpartners.com
Ovid Media: Dan Budwick 1AB dan@1abmedia.com
Ovid Therapeutics (NASDAQ:OVID)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ovid Therapeutics (NASDAQ:OVID)
Historical Stock Chart
From Apr 2023 to Apr 2024