Ovid Therapeutics Inc. (NASDAQ: OVID, hereinafter “Ovid”), a
biopharmaceutical company committed to developing medicines that
transform the lives of people with rare neurological diseases, and
Angelini Pharma S.p.A. (hereinafter “Angelini Pharma”), an Italian
family-owned pharmaceutical company committed to helping patients
with a constant and prevalent focus on Mental Health, Rare Diseases
and Consumer Health, announced an agreement in which Angelini
Pharma will be responsible to develop, manufacture and
commercialize OV101 (gaboxadol) for the potential treatment of
Angelman syndrome in the European Union and other countries in the
European Economic Area (Switzerland, Turkey and the United Kingdom)
and Russia. Angelini Pharma will execute the agreement through its
new affiliate Angelini Pharma Rare Diseases AG. OV101 is believed
to be the only delta (δ)-selective GABAA receptor agonist in
development and is currently being evaluated in the pivotal Phase 3
NEPTUNE trial in Angelman syndrome, with topline results expected
in the fourth quarter of 2020.
Under the terms of the agreement, Ovid will receive
an upfront payment of $20 million and is eligible to receive up to
an additional $212.5 million in payments upon the achievement of
development, manufacturing and sales milestones for the initial
indication (Angelman syndrome), as well as double-digit royalties
on net sales if OV101 is successfully commercialized. Ovid will
retain all U.S. and rest-of-world commercial rights to OV101.
“We are excited to enter into a strategic
collaboration with Angelini Pharma with the goal of bringing OV101,
if approved, to the Angelman community in Europe as quickly as
possible. Angelini Pharma is an ideal partner for Europe as they
have deep regional knowledge, an established infrastructure with a
history of successful product launches, and a commitment to
improving the quality of life of the patient communities they
serve,” said Jeremy Levin, DPhil, MB, BChir, Chairman and Chief
Executive Officer of Ovid Therapeutics. “Finding the right partners
to bring OV101 to the Angelman community as rapidly as possible is
a core part of our global strategy. We believe this partnership
with Angelini will help to maximize the potential commercial value
of OV101 and achieve our strategic objectives in this important
geography."
“Today is a day that we will remember. Through our
collaboration with Ovid Therapeutics, we are laying the foundation
to developing innovative health solutions for rare diseases, in
line with Angelini Pharma’s new strategy,” said Pierluigi
Antonelli, Angelini Pharma CEO. “The new business unit Angelini
Pharma Rare Diseases AG will contribute to the development,
registration, production and, if approved, commercialization in
Europe of OV101, Ovid Therapeutics’ very promising drug being
evaluated in a Phase 3 clinical trial for the treatment of Angelman
syndrome. As of now, there is no effective treatment for this rare
genetic disease, characterized by severe psychomotor disability,
which manifests itself from childhood. Delivering on our commitment
makes us proud both from a scientific and social impact
perspectives.”
"As shareholders and executives of Angelini Holding
we continue to invest in the pharma area, which today represents
half of our Group's turnover,” commented the executive vice
president Thea Paola Angelini and the CEO Sergio Marullo di
Condojanni. “Our global development and internationalization
strategy focuses on business areas with high growth potential.
Particularly, we look closely at all the opportunities that can
open up, not only in healthcare, but also in the consumer and
machinery sector."
Rothschild & Co acted as an advisor to Ovid on
the collaboration agreement.
About Angelman Syndrome Angelman
syndrome is a rare genetic condition that is characterized by a
variety of signs and symptoms. Characteristic features of this
condition include delayed development, intellectual disability,
severe speech impairment, problems with movement and balance,
seizures, sleep disorders and anxiety. The most common cause of
Angelman syndrome is the loss of function of the gene that codes
for ubiquitin protein ligase E3A (UBE3A), which plays a critical
role in nerve cell communication, resulting in impaired tonic
inhibition. Individuals with Angelman syndrome typically have
normal lifespans but are unable to live independently. Therefore,
they require constant support from a network of specialists and
caregivers. Angelman syndrome affects approximately 1 in 12,000 to
1 in 20,000 people globally.
There are no approved therapies by the U.S. Food
and Drug Administration (FDA), European Medicines Agency or
rest–of-world for Angelman syndrome, and treatment primarily
consists of behavioral interventions and pharmacologic management
of symptoms.
Angelman syndrome is associated with a reduction in
tonic inhibition, a function of the delta (δ)-selective GABAA
receptor that allows a human brain to decipher excitatory and
inhibitory neurological signals correctly without being overloaded.
If tonic inhibition is reduced, the brain becomes inundated with
signals and loses the ability to separate background noise from
critical information.
About OV101 (gaboxadol)OV101 is
believed to be the only delta (δ)-selective GABAA receptor agonist
in development and the first investigational drug to specifically
target the disruption of tonic inhibition, a central physiological
process of the brain that is thought to be the underlying cause of
certain neurodevelopmental disorders. OV101 has demonstrated in
laboratory studies and animal models to selectively activate the
δ-subunit of GABAA receptors, which are found in the extrasynaptic
space (outside of the synapse), and thereby impact neuronal
activity through modulation of tonic inhibition.
Ovid is developing OV101 for the treatment of
Angelman syndrome and Fragile X syndrome to potentially restore
tonic inhibition and thereby address several core symptoms of these
conditions. In both these syndromes, the underlying pathophysiology
includes disruption of tonic inhibition modulated through the
δ-subunit of GABAA receptors. In preclinical studies, it was
observed that OV101 improved symptoms of Angelman syndrome and
Fragile X syndrome. This compound has also previously been tested
in more than 4,000 patients (more than 1,000 patient-years of
exposure) and was observed to have favorable safety and
bioavailability profiles. Ovid is conducting a pivotal Phase 3
clinical trial with OV101 in Angelman syndrome (NEPTUNE) and has
completed a Phase 2 signal-finding clinical trial with OV101 in
Fragile X syndrome (ROCKET).
OV101 has received Rare Pediatric Disease
Designation from the FDA for the treatment of Angelman syndrome.
The FDA has also granted Orphan Drug and Fast Track designations
for OV101 for both the treatment of Angelman syndrome and Fragile X
syndrome. In addition, the European Commission (EC) has granted
orphan drug designation to OV101 for the treatment of Angelman
syndrome. The U.S. Patent and Trademark Office has granted Ovid
patents directed to methods of treating Angelman syndrome and
Fragile X syndrome using OV101. The issued patents expire in 2035
without regulatory extensions.
Ovid Conference Call and Webcast
InformationOvid Therapeutics will host a live conference
call and webcast today at 8:15 a.m. Eastern Time. The live webcast
can be accessed by visiting the Investors section of the Company’s
website at
https://investors.ovidrx.com/news-events/presentations-events.
Alternatively, please call 866-830-1640 (U.S.) or 210-874-7820
(international) to listen to the live conference call. The
conference ID number for the live call is 5579257. A replay of the
webcast will be available on the Company’s website following the
live conference call.
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.
Ovid has a broad pipeline of potential first-in-class medicines.
The Company’s most advanced investigational medicine, OV101
(gaboxadol), is currently in clinical development for the treatment
of Angelman syndrome and Fragile X syndrome. Ovid is also
developing OV935 (soticlestat) in collaboration with Takeda
Pharmaceutical Company Limited for the potential treatment of rare
developmental and epileptic encephalopathies (DEE). For more
information on Ovid, please visit www.ovidrx.com.
About Angelini PharmaAngelini
Pharma, owned by Angelini Holding, is a pharmaceutical Company
committed to helping patients with a constant and prevalent focus
on Mental Health, including Pain, Rare Diseases and Consumer
Health. Angelini Pharma has an extensive and recognized R&D
programs, "World Class" production plants and international
commercialization activities of active ingredients and
market-leading drugs. For further information, please visit
www.angelinipharma.com
About Angelini HoldingAngelini
Holding is the parent company of an international group operating
in the pharmaceutical and consumer goods sectors. Founded in Italy
in 1919, today Angelini group operates in 17
countries with a staff of 5,600 and a turnover
of €1,7 billion. In addition to
the Pharmaceutical sector, Angelini group operates in
Personal and Home Care business area through Fater, a joint
venture with Procter & Gamble, in
the Machinery field, again in joint venture with P&G,
with the group operating in automation and robotics for the
consumer goods industry Fameccanica, in Perfumery and Skincare and
Suncare with Angelini Beauty and in the Wine sector through
Bertani Domains. Angelini Holding has recently entered the Baby
food market as well through MadreNatura, a joint venture with Hero
Group, which offers 100% organic baby food products.
Ovid Therapeutics Forward-Looking
StatementsThis press release includes certain disclosures
that contain “forward-looking statements,” including, without
limitation, statements regarding: advancing development of and
commercializing OV101, the potential benefits and value of OV101;
the anticipated reporting schedule of clinical data for OV101; and
the potential benefits and outcome from this collaboration. 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, and 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.
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.
Ovid Therapeutics Contacts
Investors and Media:Ovid
Therapeutics Inc.Investor Relations & Public
Relationsirpr@ovidrx.com
Or
Investors: Steve KlassBurns
McClellan, Inc.sklass@burnsmc.com (212) 213-0006
Media: Katie Engleman 1AB
katie@1abmedia.com
Angelini Pharma Contact:Daniela
PoggioHead of Global Communications Angelini Pharma +39 348
6558882daniela.poggio@angelinipharma.com
Angelini Holding
Contact:Institutional & External Relations Director
Angelini Holding +39 348
6707240alessandra.favilli@angeliniholding.com
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