Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a
biopharmaceutical company with a pipeline of clinical-stage assets
designed to modulate immunological pathways that are implicated
across a spectrum of diseases, today announced that the company
will host a virtual Rilonacept Analyst Day on Monday, September
28th, 2020 from 8:00 a.m. to 9:30 a.m. Eastern Daylight Time.
The event will feature presentations from the Kiniksa management
team on the market opportunity for rilonacept in recurrent
pericarditis as well as the company’s continued commercial
preparations and launch strategy. Additionally, guest speaker Paul
Cremer, MD, Cardiovascular Medicine, Cleveland Clinic, will review
the burden of recurrent pericarditis, the current treatment
landscape, and the unmet need.
Rilonacept was discovered and developed by Regeneron
Pharmaceuticals, Inc. (Regeneron) and is approved by the U.S.
Food and Drug Administration (FDA) under the brand name
ARCALYST® for the treatment of Cryopyrin-Associated Periodic
Syndromes (CAPS). Kiniksa licensed rilonacept from Regeneron in
2017 for evaluation in diseases believed to be mediated by both
interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β),
including recurrent pericarditis. The FDA granted Breakthrough
Therapy designation to rilonacept for recurrent pericarditis in
2019 and Orphan Drug designation to rilonacept for pericarditis in
2020. Based on highly statistically significant Phase 3 data in
recurrent pericarditis, the Biologic License Application (BLA) for
CAPS will transfer to Kiniksa, and the company plans to submit a
supplemental Biologic License Application (sBLA) in recurrent
pericarditis to the FDA this year. Upon receipt of FDA
approval for rilonacept in recurrent pericarditis, Kiniksa will
assume the sales and distribution of rilonacept for the approved
indications in the United States and evenly split profits
on sales with Regeneron.Webcast and
Conference Call InformationKiniksa will
host a webcast and conference call at 8:00 a.m. Eastern Daylight
Time on Monday, September 28th, 2020. The presentation will be
accessible through this link as well as through the Investors &
Media section of the company's website. Individuals can also
participate by dialing (866) 614-0636 (U.S. and Canada) or (409)
231-2053 (international) using conference ID number 3890078. The
archived webcast will be available on Kiniksa’s website for 14 days
beginning approximately one hour after the conclusion of the
event.
About Recurrent PericarditisRecurrent
pericarditis is a painful and debilitating autoinflammatory
cardiovascular disease that typically presents with chest pain and
is often associated with changes in electrical conduction and
sometimes buildup of fluid around the heart, called pericardial
effusion. Patients with pericarditis are deemed recurrent if they
have an additional episode after a symptom-free period of 4-6
weeks, and chronic if symptoms from any one episode last longer
than three months. Recurrent pericarditis symptoms impair qualify
of life, limit physical activities, and lead to frequent emergency
department visits and hospitalizations. There are currently no
FDA-approved treatments for recurrent pericarditis.
About the
Rilonacept License Agreement with
RegeneronIn 2017, Regeneron granted Kiniksa an exclusive
license to develop and commercialize rilonacept worldwide, aside
from Israel, Egypt, Turkey and select countries in the Middle East
and North Africa. In the United States and Japan, Kiniksa’s license
is initially for all indications other than those involving local
administration to the eye or ear, oncology, deficiency of the
interleukin1 receptor antagonist (DIRA) and CAPS. If Kiniksa is
successful in receiving marketing approval for rilonacept in the
United States for a new indication, the scope of the license
granted to Kiniksa will automatically expand to include DIRA and
CAPS in the United States and Japan, and Kiniksa will assume the
sales and distribution of rilonacept in these additional
indications. Outside the United States and Japan, Kiniksa’s license
is for all indications other than local application to the eye or
ear, oncology, CAPS, DIRA and certain periodic fever syndromes.
Kiniksa made an upfront payment of $5.0 million to Regeneron and is
obligated to make regulatory milestone payments of up to $27.5
million in the aggregate. Thereafter, Kiniksa and Regeneron will
evenly split profits on sales of rilonacept after deducting certain
commercialization expenses subject to specified limits.
About RilonaceptRilonacept is a weekly,
subcutaneously-injected, recombinant fusion protein that blocks
IL-1α and IL-1β. Rilonacept was discovered and developed by
Regeneron and is approved by the FDA under the brand name ARCALYST®
for the treatment of CAPS, specifically Familial Cold
Autoinflammatory Syndrome and Muckle-Wells Syndrome. Rilonacept for
the treatment of DIRA is currently pending FDA approval following
the submission of an sBLA in June 2020. Rilonacept in
recurrent pericarditis is an investigational drug. The FDA granted
Breakthrough Therapy designation to rilonacept for recurrent
pericarditis in 2019 and Orphan Drug designation to rilonacept for
pericarditis in 2020.
Important information about ARCALYST® (rilonacept)
Injection IL-1 blockade may interfere with immune response
to infections. Serious, life-threatening infections have been
reported in patients taking ARCALYST. ARCALYST should be
discontinued if a patient develops a serious infection. Taking
ARCALYST with TNF inhibitors is not recommended because this may
increase the risk of serious infections.Patients should not receive
a live vaccine while taking ARCALYST. It is recommended that prior
to initiation of therapy with ARCALYST patients receive all
recommended vaccinations, as appropriate, including pneumococcal
vaccine and inactivated influenza vaccine. In the initial
development program for ARCALYST, six serious adverse reactions
were reported by four patients: Mycobacterium intracellular
infection, gastrointestinal bleeding and colitis, sinusitis and
bronchitis and Streptococcus pneumoniae meningitis. The most
commonly reported adverse reactions associated with ARCALYST were
injection site reaction and upper respiratory tract infection.
Patients should be monitored for changes in their lipid profiles
and provided with medical treatment if warranted. Treatment with
immunosuppressants, including ARCALYST, may result in an increase
in risk of malignancies. Hypersensitivity reactions associated with
ARCALYST administration in clinical studies have been rare. If a
hypersensitivity reaction occurs, administration of ARCALYST should
be discontinued and appropriate therapy initiated.
About KiniksaKiniksa is a
biopharmaceutical company focused on discovering, acquiring,
developing and commercializing therapeutic medicines for patients
suffering from debilitating diseases with significant unmet medical
need. Kiniksa’s clinical-stage product candidates, rilonacept,
mavrilimumab, vixarelimab and KPL-404, are based on strong biologic
rationale or validated mechanisms, target underserved conditions
and offer the potential for differentiation. These pipeline assets
are designed to modulate immunological pathways that are implicated
across a spectrum of diseases. For more information, please
visit www.kiniksa.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. In some cases,
you can identify forward looking statements by terms such as “may,”
“will,” “should,” “expect,” “plan,” “anticipate,” “could,”
“intend,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “potential” or “continue” or the negative of
these terms or other similar expressions, although not all
forwardlooking statements contain these identifying words. All
statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements, including without limitation, statements regarding: our
expectation with respect to the BLA for CAPs transferring to
Kiniksa; our timing for submitting an sBLA to the FDA; and the
potential for all of our clinical stage product candidates to offer
differentiation.
These forward-looking statements are based on management’s
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including without limitation, the
following: the potential impact of the COVID-19 pandemic and
measures taken in response to the pandemic; changes in our
operating plan and funding requirements; existing or new
competition; and our ability to attract and retain qualified
personnel.
These and other important factors discussed under the caption
“Risk Factors” in our Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission (“SEC”)
on August 4, 2020 and our other reports subsequently
filed with the SEC could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release. Any such forward-looking statements
represent management’s estimates as of the date of this press
release. While we may elect to update such forward-looking
statements at some point in the future, we disclaim any obligation
to do so, even if subsequent events cause our views to change.
These forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
ARCALYST® is a registered trademark of Regeneron
Pharmaceuticals, Inc.
Every Second Counts!™
Kiniksa Investor and Media
ContactMark Ragosa(781) 430-8289mragosa@kiniksa.com
Kiniksa Pharmaceuticals (NASDAQ:KNSA)
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