INDIANAPOLIS, March 19, 2015 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Hanmi Pharmaceutical Co., Ltd. (Hanmi)
today announced they have entered into an exclusive license and
collaboration agreement for the development and commercialization
of Hanmi's oral Bruton's tyrosine kinase (BTK) inhibitor, HM71224,
for the treatment of autoimmune and other diseases. The
agreement is subject to clearance under the Hart-Scott-Rodino
Antitrust Improvements Act, similar requirements outside the U.S.,
and other customary closing conditions.
This small molecule is ready to enter Phase II and the parties
plan to investigate the molecule for the potential treatment of
rheumatoid arthritis, lupus, lupus nephritis, Sjögren's syndrome,
and other related conditions.
"Significant unmet medical need exists in many prevalent
autoimmune diseases where individual patient needs are not
adequately being met with available treatments," said Thomas Bumol, Ph.D., senior vice president,
biotechnology and immunology research at Lilly. "Lilly is committed
to changing patient expectations in some of the world's most
debilitating disease areas, and we're building a portfolio of
potential advances in immunology through our own research and key
collaborations such as with Hanmi. We're highly encouraged by the
potential of HM71224 to deliver an innovative, first-in-class
treatment option."
"HM71224 is a potent and effective BTK inhibitor and has
successfully demonstrated proof of mechanism in preclinical studies
and a Phase I study in Europe," said Dr. Gwan Sun Lee, CEO/President of Hanmi
Pharmaceutical. He continued, "We are very pleased to be
collaborating with Lilly on HM71224, and through this agreement and
R&D collaborations, we are excited to drive the joint project
forward with the ultimate aim to offer new medical treatment
options to patients with autoimmune disorders and related
conditions."
Under the terms of the agreement, Lilly will receive worldwide
rights to the molecule for all indications excluding China, Hong
Kong, Taiwan, and Korea.
Lilly will take development, regulatory, manufacturing, and
commercial leadership for the molecule in the Lilly territories.
Hanmi will receive an initial payment of $50
million and is eligible for up to $640 million in potential development,
regulatory, and sales milestones. If the BTK inhibitor is
successfully commercialized, Hanmi would also be eligible for
tiered double-digit royalty payments.
About Eli Lilly and Company External
Innovation
Our long-term commitment to scientific excellence
at Lilly is the foundation for our success in identifying,
accessing and shaping external innovation.
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 Hanmi Pharmaceutical Co., Ltd.
Hanmi
Pharmaceutical is a Korea-based global pharmaceutical company
focused on the development and commercialization of new
pharmaceutical products. The Company is fully integrated from
R&D through manufacturing, marketing and sales with an
established presence in Korea as well as China. The Company invests over 20 percent of
its sales in R&D and has over 20 programs in clinical
development in three main areas: 1) novel long-acting biologics
based on the Company's LAPSCOVERY™ platform including weekly
insulin, weekly to monthly GLP-1, and their combinations (Quantum
Project) in diabetes and obesity; 2) novel targeted agents against
cancer and autoimmune disorders; and 3) fixed-dose combination
programs. More information on Hanmi is available at
www.hanmipharm.com.
This press release contains forward-looking statements about
the development and commercialization collaboration between Hanmi
Pharmaceutical Co., Ltd. and Eli Lilly and Company and reflects
Lilly's current beliefs. However, there are substantial risks and
uncertainties in the process of drug research, development, and
commercialization. There is no guarantee that the collaboration
will yield successful results, that HM71224 will be approved for
autoimmune diseases or any other indication, or that either company
will achieve the anticipated benefits. For further discussion of
these and other risks and uncertainties, see Lilly's most recent
10-K and 10-Q filings with the United States Securities and
Exchange Commission. Lilly undertakes no duty to update
forward-looking statements.
C-LLY
Refer to: +1-317-433-9100; Karen
Glowacki; kglowacki@lilly.com
+1-317-277-6524; Lauren Zierke;
lauren_zierke@lilly.com
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SOURCE Eli Lilly and Company; Hanmi Pharmaceutical Co., Ltd.