INDIANAPOLIS, July 3, 2017
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte
Corporation (NASDAQ: INCY) announced today that Japan's Ministry of Health, Labor and Welfare
(MHLW) granted marketing approval for Olumiant®
(baricitinib) 2-mg and 4-mg tablets for the treatment of rheumatoid
arthritis (RA) (including the prevention of structural injury of
joints) in patients with inadequate response to standard-of-care
therapies.
The Olumiant approval is based on the results of the baricitinib
development program, which includes four phase 3 clinical trials
enrolling various populations of more than 3,000 moderate-to-severe
RA patients worldwide, including more than 500 Japanese patients.
In clinical studies, baricitinib has demonstrated significant
improvement in the signs and symptoms of RA compared to
standard-of-care therapies.
Despite clinical advances in the treatment of RA, some people do
not achieve optimal control of their disease or they discontinue
treatment due to lack of efficacy or side effects, which can lead
to long-term damage and disability. In Japan, an estimated 700,000-800,000 people
suffer from RA, and women are three times more likely to be
affected than men.i,ii
"Today is an important milestone for the RA community in
Japan. Olumiant has been shown to
provide effective relief of RA symptoms in people who do not
respond to standard treatments, as well as prevent the structural
damage to joints that makes RA a progressive, debilitating
disease," said Christi Shaw,
president of Lilly Bio-Medicines.
"The phase 3 clinical trial program of Olumiant consistently
showed significant improvement in clinical signs and symptoms of RA
in a wide range of RA patients with a diverse treatment history,"
said Steven Stein, M.D., chief
medical officer, Incyte Corporation. "We are pleased to have helped
develop this new treatment option for the RA community in
Japan."
The Japan marketing
authorization of Olumiant triggers a $15
million milestone payment from Lilly to Incyte, which Incyte
expects to recognize, in full, in the third quarter of
2017.
About Olumiant
Olumiant® (baricitinib) is a
once-daily oral JAK inhibitor currently in clinical studies for
inflammatory and autoimmune diseases. There are four known JAK
enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have
been implicated in the pathogenesis of a number of inflammatory and
autoimmune diseases, suggesting that JAK inhibitors may be useful
for the treatment of a broad range of inflammatory conditions,
including rheumatoid arthritis.
In December 2009, Lilly and Incyte
announced an exclusive worldwide license and collaboration
agreement for the development and commercialization of baricitinib
and certain follow-on compounds for patients with inflammatory and
autoimmune diseases. Baricitinib was submitted for regulatory
review seeking marketing approval for the treatment of rheumatoid
arthritis in the U.S., European Union and Japan in 2016. Olumiant was approved in the EU
in February 2017. In April 2017, the U.S. Food and Drug Administration
issued a Complete Response Letter on the New Drug Application for
Olumiant. Olumiant was also approved in Kuwait and Switzerland in June
2017 and approved in Japan
in July 2017 for the treatment of
RA.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA)
is an autoimmune disease characterized by inflammation and
progressive destruction of joints. More than 23 million people
worldwide suffer from RA.iii Approximately three times
as many women as men have the disease.ii Current
treatment of RA includes the use of non-steroidal anti-inflammatory
drugs (NSAIDs), oral conventional disease-modifying antirheumatic
drugs (cDMARDs) – such as methotrexate, the current standard of
care, and injectable and intravenous biological disease-modifying
antirheumatic drugs (bDMARDs) that target selected mediators
implicated in the pathogenesis of RA.iv Despite current
treatment options, many patients do not reach their therapeutic
goals or are not able to achieve sustained remission.v
There remains an important need to provide additional treatment
options to improve overall patient care.
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
newsroom.lilly.com/social-channels.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization
of proprietary therapeutics. For additional information on Incyte,
please visit the Company's web site at
www.incyte.com.
Follow @Incyte on Twitter
at https://twitter.com/Incyte.
(P-LLY)
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about baricitinib as a potential treatment for patients with
rheumatoid arthritis, and reflects Lilly's and Incyte'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 baricitinib will receive additional
regulatory approvals, or be commercially successful. For further
discussion of these and other risks and uncertainties, see Lilly's
and Incyte'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 and Incyte undertake no duty to update
forward-looking statements to reflect events after the date of this
release.
i Report from Study Committee on Rheumatoid
Arthritis and Allergy
http://www.mhlw.go.jp/stf/houdou/2r9852000001nfao-att/2r9852000001nfdx.pdf
(Accessed on June 13, 2017)
ii Arthritis Foundation, What is Rheumatoid Arthritis?,
http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php
(Accessed: May, 16, 2017)
iii WHO Global Burden of Disease Report, (table 7, page
32) 2004,
http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf
(Accessed: May, 16, 2017)
iv Arthritis Foundation, Rheumatoid Arthritis Treatment,
http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php
(Accessed: May, 16, 2017)
v McWilliams DF, Kiely PDW, Young A, Walsh DA. Baseline
factors predicting change from the initial DMARD treatment during
the first 2 years of rheumatoid arthritis: experience in the ERAN
inception cohort. BMC Musculoskeletal Disorders.
2013;14:1-7.
Refer to: Danielle
Neveles; danielle.neveles@lilly.com; +1-317-796-4564 (Lilly
media)
Phil
Johnson; johnson_philip_l@lilly.com; +1-317-655-6874 (Lilly
investors)
Catalina Loveman;
cloveman@incyte.com; +1-302-498-6171 (Incyte media)
Michael Booth, DPhil;
mbooth@incyte.com; +1-302-498-5914 (Incyte investors)
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/japan-ministry-of-health-labor-and-welfare-mhlw-grants-marketing-approval-for-olumiant-baricitinib-for-the-treatment-of-rheumatoid-arthritis-300482898.html
SOURCE Eli Lilly and Company