NEW YORK and ROME, July 13,
2020 /PRNewswire/ --
- Angelini Pharma obtains exclusive development, manufacturing
and commercialization rights to 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
- Ovid Therapeutics will receive an upfront payment of
$20 million and additional payments
of up to $212.5 million upon the
achievement of development, manufacturing and sales milestones, in
addition to double-digit royalties on net sales if successfully
commercialized
- Angelini Pharma will execute the agreement through its new
affiliate Angelini Pharma Rare Diseases AG
- Ovid to host conference call
and webcast today at 8:30 a.m.
EDT
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, other
countries in the European Economic Area, Switzerland, Turkey, 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.
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. 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 Pharma
Angelini 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
Holding
Angelini
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. www.angeliniholding.com
Ovid Therapeutics Forward-Looking Statements
This
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.
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