electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a
commercial-stage bioelectronic medicine company, today announced it
has entered into an agreement with Teijin Limited (Teijin), a
global conglomerate based in Japan offering advanced solutions in
the fields including healthcare, material and information
technology, to license certain exclusive rights to its non-invasive
vagus nerve stimulation (nVNS) technology for commercialization in
Japan for a range of primary headache disorders.
Under the agreement, the Company will receive a non-refundable,
upfront payment for the licenses and rights granted to Teijin. The
financial terms contain milestone payments, payable upon the
decision by Teijin to commercialize the licensed product for
specific indications. The Company also will receive an annual
license fee commencing on the first anniversary of the agreement
and payable annually until the first commercial sale on any
approved indication. Upon favorable regulatory and payor coverage
decisions in Japan, the parties will enter into an exclusive
commercial supply agreement for gammaCore nVNS.
“We are delighted to enter into this exclusive license agreement
with Teijin, a multinational life sciences company,” mentioned
Joshua Lev, Chief Strategy Officer of the Company. “Teijin is an
ideal partner to drive commercialization of nVNS in Japan, and this
agreement provides another global milestone for our nVNS platform
technology, supporting a combined goal of improving the health and
lives of primary headache sufferers across the globe.”
The agreement contains customary terms and conditions, including
renewal and termination provisions, as well as minimum purchase
commitments once a commercial supply agreement is in place.
Furthermore, Teijin is responsible for all costs associated with
regulatory approval by the Pharmaceuticals and Medical Devices
Agency (PMDA), the Japanese FDA equivalent. As part of the
agreement, Teijin will have the right of first negotiation for a
license to additional indications in Japan.
About the Teijin GroupTeijin (TSE: 3401) is a
technology-driven global group offering advanced solutions in the
areas of environmental value; safety, security and disaster
mitigation; and demographic change and increased health
consciousness. Its main fields of operation are high-performance
fibers such as aramid, carbon fibers & composites, healthcare,
films, resin & plastic processing, polyester fibers, products
converting and IT. The group has over 170 companies and around
20,000 employees spread out over 20 countries worldwide. It posted
consolidated sales of JPY836.5 billion (USD 6.8 billion) and total
assets of JPY 1036.4 billion (USD 8.4 billion) in the fiscal year
ending March 31, 2021.
For more information, please visit https://www.teijin.com/
About electroCore, Inc.electroCore, Inc. is a
commercial stage bioelectronic medicine company dedicated to
improving patient outcomes through its non-invasive vagus nerve
stimulation therapy platform, initially focused on the treatment of
multiple conditions in neurology. The company's current indications
are the preventive treatment of cluster headache and migraine, the
acute treatment of migraine and episodic cluster headache, the
acute and preventive treatment of migraines in adolescents, and
paroxysmal hemicrania and hemicrania continua in adults.
For more information, visit www.electrocore.com.
About gammaCore™gammaCore™ (nVNS) is the first
non-invasive, hand-held medical therapy applied at the neck to
treat migraine and cluster headache through the utilization of a
mild electrical stimulation to the vagus nerve that passes through
the skin. Designed as a portable, easy-to-use technology, gammaCore
is self-administered by patients, as needed, without the potential
side effects associated with commonly prescribed drugs. When placed
on a patient’s neck over the vagus nerve, gammaCore stimulates the
nerve’s afferent fibers, which may lead to a reduction of pain in
patients.
gammaCore (nVNS) is FDA cleared in the United States for
adjunctive use for the preventive treatment of cluster headache in
adult patients, the acute treatment of pain associated with
episodic cluster headache in adult patients, and the acute and
preventive treatment of migraine in adolescent (ages 12 and older)
and adult patients, and paroxysmal hemicrania and hemicrania
continua in adult patients. gammaCore is CE-marked in the European
Union for the acute and/or prophylactic treatment of primary
headache (Migraine, Cluster Headache, Trigeminal Autonomic
Cephalalgias and Hemicrania Continua) and Medication Overuse
Headache in adults.
gammaCore is contraindicated for patients if they:
- Have an active implantable medical device, such as a pacemaker,
hearing aid implant, or any implanted electronic device
- Have a metallic device, such as a stent, bone plate, or bone
screw, implanted at or near the neck
- Are using another device at the same time (e.g., TENS Unit,
muscle stimulator) or any portable electronic device (e.g., mobile
phone)
Safety and efficacy of gammaCore have not been evaluated in the
following patients:
- Adolescent patients with congenital cardiac issues
- Patients diagnosed with narrowing of the arteries (carotid
atherosclerosis)
- Patients who have had surgery to cut the vagus nerve in the
neck (cervical vagotomy)
- Pediatric patients (less than 12 years)
- Pregnant women
- Patients with clinically significant hypertension, hypotension,
bradycardia, or tachycardia
For more information, please visit gammaCore.com.
Forward-Looking StatementsThis press release
and other written and oral statements made by representatives of
electroCore may contain forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements include, but are not limited to,
statements about electroCore's business prospects and clinical and
product development plans (including with respect to enrollment in
ongoing studies); its pipeline or potential markets for its
technologies; the timing, outcome and impact of regulatory,
clinical and commercial developments including online, e-commerce,
direct-to-consumer channels, telehealth portal, and cash pay
initiatives including Japan and its license agreement with Teijin;
the issuance of U.S. and international patents providing expanded
IP coverage; the possibility of future business models and revenue
streams from the company’s potential use of nVNS for the acute
treatment of PTSD, stroke and hemorrhagic brain injury, the
potential of nVNS generally and gammaCore in particular and other
statements that are not historical in nature, particularly those
that utilize terminology such as "anticipates," "will," "expects,"
"believes," "intends," other words of similar meaning, derivations
of such words and the use of future dates. Actual results could
differ from those projected in any forward-looking statements due
to numerous factors. Such factors include, among others, the
ability to raise the additional funding needed to continue to
pursue electroCore’s business and product development plans, the
inherent uncertainties associated with developing new products or
technologies, the ability to commercialize gammaCore™, the
potential impact and effects of COVID-19 on the business of
electroCore, electroCore’s results of operations and financial
performance, and any measures electroCore has and may take in
response to COVID-19 and any expectations electroCore may have with
respect thereto, competition in the industry in which electroCore
operates and overall market conditions. Any forward-looking
statements are made as of the date of this press release, and
electroCore assumes no obligation to update the forward-looking
statements or to update the reasons why actual results could differ
from those projected in the forward-looking statements, except as
required by law. Investors should consult all of the information
set forth herein and should also refer to the risk factor
disclosure set forth in the reports and other documents electroCore
files with the SEC available at www.sec.gov.
Contact:Rich CockrellCG
Capital404-736-3838ecor@cg.capital
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