INDIANAPOLIS, Sept. 6, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today it will present new data for
galcanezumab and lasmiditan, two investigational treatments for
migraine, at the 18th Congress of the International Headache
Society (IHC) taking place Sept. 7-10
in Vancouver.
Lilly will highlight new, long-term data from an open-label
study evaluating the safety and effectiveness of two doses of
galcanezumab (120 mg and 240 mg) for the prevention of migraine.
Galcanezumab is a once-monthly, subcutaneously injected calcitonin
gene-related peptide (CGRP) antibody under evaluation for the
prevention of episodic and chronic migraine and cluster
headache.
Lilly will also present new data from SPARTAN, a Phase 3 study
evaluating the safety and efficacy of lasmiditan for the acute
treatment of migraine. Lasmiditan is an investigational, oral,
first-in-class molecule that could represent the first
significant innovation for the acute treatment of migraine in more
than two decades.
"After more than 25 years of research in migraine, we are
thrilled to help introduce a new era of treatment innovation not
only for the prevention of migraine, but also the acute treatment
of this disabling disease," said Robert
Conley, M.D., Distinguished Lilly Scholar and Lilly global
development leader for migraine therapeutics. "We are excited to
have another opportunity this year to share new data for
galcanezumab and lasmiditan, which if approved, may provide
much-needed treatment options for the millions of Americans
struggling to effectively manage migraine."
Studies, as well as the dates and times of the data sessions,
are highlighted below.
Oral Presentations:
Friday,
Sept. 8, 2017 – 7:00-8:00 p.m.
PT
- PO-01-197: Phase 3 Studies (EVOLVE-1 & EVOLVE-2)
of Galcanezumab in Episodic Migraine: Results of 6-Month Treatment
Phase
-
- Presenter: Vlad Skljarevski,
M.D., senior medical fellow, Eli Lilly and Company, Indianapolis, IN
- PO-01-195: A Phase 3 Placebo-Controlled Study of
Galcanezumab in Patients with Chronic Migraine: Results from the
3-Month Double-Blind Treatment Phase of the REGAIN Study
-
- Presenter: Sheena Aurora, M.D.,
medical fellow and global launch leader, galcanezumab and
lasmiditan, Eli Lilly and Company, Indianapolis, IN
Poster Presentations:
Friday,
Sept. 8, 2017 – 11:00 a.m.-12:00 p.m.
PT
- PO-01-197: Phase 3 Studies (EVOLVE-1 & EVOLVE-2) of
Galcanezumab in Episodic Migraine: Results of 6-Month Treatment
Phase
-
- Presenter: Katie Selzler, Ph.D.,
Scientific Communications, Eli Lilly and Company, Indianapolis, IN
- PO-01-184: A Phase 3, Long-Term, Open-Label Safety Study of
Self-Administered Galcanezumab Injections in Patients with
Migraine
-
- Presenter: Qi Zhang, Ph.D., principal research scientist,
Global Statistical Sciences and Bio-Medicines, Eli Lilly and
Company, Indianapolis, IN
- PO-01-195: A Phase 3 Placebo-Controlled Study of
Galcanezumab in Patients with Chronic Migraine: Results from the
3-Month Double-Blind Treatment Phase of the REGAIN Study
-
- Presenter: Sheena Aurora, M.D.,
medical fellow and global launch leader, galcanezumab and
lasmiditan, Eli Lilly and Company, Indianapolis, IN
Saturday, Sept. 9, 2017 –
10:00-10:45 a.m. PT
- PO-02-0999: Cycling Through Migraine Prevention Treatments:
Implications to All-Cause Total Direct Costs
-
- Presenter: Janet Ford, Ph.D.,
M.P.H., consultant scientist, Global Patient Outcomes and Real
World Evidence, Bio-Medicines, Eli Lilly and Company, Indianapolis, IN
- PO-02-180: Phase 3 Study (SPARTAN) of Lasmiditan
Compared to Placebo for Acute Treatment of Migraine
-
- Presenter: Sheena Aurora, M.D.,
medical fellow and global launch leader, galcanezumab and
lasmiditan, Eli Lilly and Company, Indianapolis, IN
- PO-02-173: In Vitro Characterization of Agonist Binding and
Functional Activity at a Panel of Serotonin Receptor Subtypes for
Lasmiditan, Triptans and other 5-HT Receptor Ligands and Activity
Relationships for Contraction of Human Isolated Coronary
Artery
-
- Presenter: Eloísa Rubio-Beltrán, Division of Pharmacology,
Department of Internal Medicine, Erasmus
University Medical Center, Rotterdam, Netherlands
- PO-02-172: Lasmiditan Inhibits CGRP Release in the Mouse
Trigeminovasular System
-
- Presenter: Alejandro Labastida-Ramírez, Division of Vascular
Medicine and Pharmacology, Erasmus
University Medical Center, Rotterdam, Netherlands
About Migraine
Migraine is a disabling neurological
disease characterized by recurrent episodes of severe headache
accompanied by other symptoms including nausea, vomiting,
sensitivity to light and sound, and changes in
vision.1,2
More than 36 million Americans have migraine, with three times more
women affected by migraine compared to
men.3 According to the
Migraine Research Foundation, healthcare and lost productivity
costs associated with migraine are estimated to be as high as
$36 billion annually in the U.S., yet
it remains under-recognized and
under-treated.4
About Cluster Headache
Cluster headache, often
characterized as the most painful of all headaches, is a
neurological disease characterized by recurrent, severe headaches
on one side of the head, usually behind or around one
eye.1,5 Cluster headaches – commonly known as "attacks"
– typically last between 15 minutes to more than two hours and can
recur on the same day and occur daily to multiple times a day for
weeks or longer, followed by periods of time in which no attacks
occur.5 Cluster headache is classified as "chronic"
when attacks occur for more than one year without a remission
period, or with remission lasting less than one month.5
About Lilly in Migraine
For over 25 years, Lilly has
been committed to helping people suffering from migraine,
investigating more than a dozen different compounds for the
treatment of migraine and disabling headache disorders. These
research programs have accelerated understanding of this disease
and advanced the development of Lilly's comprehensive late-stage
development programs studying galcanezumab for prevention of
migraine and cluster headache, and lasmiditan for the acute
treatment of migraine. Our goal is to make life better for people
with migraine by offering comprehensive solutions to prevent or
stop this disabling disease. The combined clinical, academic and
professional experience of our experts helps us to build our
research portfolio, identify challenges for healthcare providers
and pinpoint the needs of patients living with migraine and cluster
headache.
About Galcanezumab
Galcanezumab is a monoclonal
antibody specifically designed to bind to and inhibit the activity
of calcitonin gene-related peptide (CGRP), which is believed to
play a role in migraine and cluster headache. Galcanezumab is an
investigational once-monthly, self-administered injection under
evaluation for the prevention of migraine and cluster headache.
About Lasmiditan
Lasmiditan is an
investigational, first-in-class molecule under evaluation for the
acute treatment of migraine. Lasmiditan selectively targets
5-HT1F receptors expressed in the trigeminal pathway,
and has been designed for the acute treatment of migraine without
the vasoconstrictor activity associated with some migraine
therapies. In March 2017, Lilly
completed the acquisition of CoLucid Pharmaceuticals, including
lasmiditan, which was originally discovered at Lilly.
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to make life
better for people around the world. We were founded more than a
century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
www.lilly.com/newsroom/social-channels.
P-LLY
This press release contains forward-looking
statements (as that term is defined in the Private Securities
Litigation Reform Act of 1995) about galcanezumab and lasmiditan as
potential treatments for patients with migraine, and reflects
Lilly's current belief. However, as with any pharmaceutical
product, there are substantial risks and uncertainties in the
process of development and commercialization. Among other things,
there can be no guarantee that future study results will be
consistent with the results to date, that galcanezumab or
lasmiditan will achieve their primary study endpoints or receive
regulatory approvals. For further discussion of these and other
risks and uncertainties, see Lilly's most recent Form 10-K and Form
10-Q filings with the United States Securities and Exchange
Commission. Except as required by law, Lilly undertakes no duty to
update forward-looking statements to reflect events after the date
of this release.
1 Headache disorders. World Health
Organization website.
http://www.who.int/mediacentre/factsheets/fs277/en/. Accessed
August 29, 2017.
2 Russo AF. Calcitonin gene-related peptide
(CGRP): a new target for migraine. Annual Review of Pharmacology
and Toxicology. 2015;55:533-552.
3 Identifying and treating migraine. American
Migraine Foundation website.
https://americanmigrainefoundation.org/understanding-migraine/identifying-treating-migraine/.
Last accessed August 29, 2017.
4 Migraine facts. Migraine Research
Foundation website.
http://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed August 29, 2017.
5 Treatment for cluster headache. American Migraine
Foundation website.
https://americanmigrainefoundation.org/understanding-migraine/treatment-of-cluster-headache/.
Accessed August 29, 2017.
Refer
to:
|
Jen Dial;
dial_jennifer_kay@lilly.com; 317-220-1172 (Lilly
Bio-Medicines)
|
|
Phil Johnson;
johnson_philip_l@lilly.com; 317-655-6874 (Investor
Relations)
|
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