INDIANAPOLIS and CAMBRIDGE, Mass., April
4, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE:
LLY) and Sigilon Therapeutics today announced a global
collaboration to develop encapsulated cell therapies for the
potential treatment of type 1 diabetes. Sigilon is a privately-held
biopharmaceutical company that is focused on discovering and
developing "living therapeutics" with its Afibromer™ technology
product platform. Lilly is a global biopharmaceutical company and a
worldwide leader in diabetes care, offering a wide range of
therapies and a strong commitment to cutting-edge research.
Encapsulated cell therapy is an emerging area of
biopharmaceutical research that aims to unleash the therapeutic
potential of cells to treat serious diseases without the need for
immunosuppression. This approach holds promise to address chronic
conditions, such as type 1 diabetes. In type 1 diabetes, pancreatic
beta cells are destroyed by the immune system, leading to
hyperglycemia (high blood sugar) and long-term complications if
glucose levels are not managed effectively.
In the Lilly-Sigilon collaboration, Sigilon will create
proprietary products comprised of induced pluripotent stem cells, a
type of stem cell derived from adult cells, engineered into
differentiated insulin-producing pancreatic beta cells and
encapsulated using Sigilon's Afibromer technology. The goal of
these products will be to restore insulin production over sustained
periods, without triggering an immune reaction.
Research leading to the discovery of Afibromer biomaterials was
funded by grants from JDRF International and the Leona M. Helmsley
and Harry B. Helmsley Charitable Trust and conducted under the
leadership of Daniel Anderson,
Ph.D., and Robert Langer, Sc.D., of
the Massachusetts Institute of
Technology and Boston Children's Hospital.
"At Lilly, we endeavor to change the frontiers of what's
possible in medicine, both through our own scientific labs and in
collaboration with other leading researchers," said Daniel Skovronsky, M.D., Ph.D., senior vice
president for clinical and product development and incoming
president of Lilly Research Labs. "We are excited to be
collaborating with, and investing in, Sigilon as they seek to
develop encapsulated cell therapies, a potentially disruptive
technology that could result in meaningful clinical advancements
for chronic diseases such as type 1 diabetes."
"We are very pleased to partner with Lilly, a worldwide leader
in diabetes care, as we seek to apply Sigilon's game-changing
technology to the area of insulin-dependent diabetes," commented
Paul Wotton, Ph.D., Chief Executive
Officer of Sigilon Therapeutics. "At Sigilon, published studies
have shown the ability to overcome the immune foreign body response
with our proprietary Afibromer technology. This holds the promise
for the creation of state-of-the-art allogeneic cell factories to
be transplanted into patients, without the need for immune
suppression. Our cell engineering and delivery system-based
platform may allow us to program and control dynamic protein
delivery for the long-term treatment of debilitating diseases."
Under the terms of the agreement, Lilly will receive an
exclusive worldwide license to Sigilon's Afibromer technology for
islet cell encapsulation. Sigilon will receive an upfront payment
of $63 million and Lilly will make an
undisclosed equity investment in Sigilon. Sigilon is also eligible
to receive up to $410 million in
development and commercialization milestones, as well as single to
double digit tiered royalties on future product sales should the
collaboration yield a commercially successful product. Sigilon will
be responsible for all development activities and costs related to
the collaboration until submission of an investigational new drug
application (IND). After an IND is submitted, Lilly will be
responsible for all clinical development and commercialization
activities and costs related to the collaboration.
Sigilon was founded and created by Flagship Pioneering, a life
science innovation firm, which unveiled the company in 2017 with
$23.5 million in capital.
Doug Cole, Managing Partner at
Flagship Pioneering and Chairman of Sigilon's Board added, "We
believe that unprecedented innovation, such as that at Sigilon, is
necessary to uncover new solutions for patients. Sigilon's product
platform offers the possibility of realizing the full potential of
cell therapies, and we look forward to seeing the outcome of
Lilly's and Sigilon's collaboration for type 1 diabetes."
As a result of this transaction, Lilly will incur an acquired
in-process research and development charge to earnings of
approximately $0.05 per share in the
second quarter of 2018. The company's reported earnings per share
guidance for 2018 is expected to be reduced by the amount of the
charge. There will be no change to the company's non-GAAP earnings
per share guidance as a result of this transaction.
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
http://newsroom.lilly.com/social-channels.
About Sigilon Therapeutics
Founded and created by
Flagship Pioneering in conjunction with Daniel Anderson, Ph.D., and Robert Langer, Sc.D., of the Massachusetts Institute of Technology, Sigilon
Therapeutics is a biopharmaceutical company that discovers and
develops immune-privileged living therapeutic implants for the
treatment of chronic diseases. Treatments based on Sigilon
Therapeutics' Afibromer™ technology platform include cell implants
that act as responsive "living therapeutics," providing more
natural control for diseases that are currently treated with
intermittent injection or infusion. Initial areas of focus include
hematologic, enzyme deficiency, endocrine and metabolic disorders.
More natural control would restore health and free patients from
the need for therapies that are disruptive to quality of life. For
more information please visit www.sigilon.com or follow on Twitter
at https://twitter.com/Sigilon_Inc.
C-LLY
Lilly Forward-Looking Statement
This press release
contains forward-looking statements (as that term is defined in the
Private Securities Litigation Reform Act of 1995) about the
benefits of a collaboration between Lilly and Sigilon, and reflects
Lilly's current beliefs. However, as with any such
undertaking, there are substantial risks and uncertainties in the
process of drug development and commercialization. Among other
things, there can be no guarantee that Lilly will realize the
expected benefits of the collaboration, or that the collaboration
will yield commercially successful products. For a further
discussion of these and other risks and uncertainties that could
cause actual results to differ from Lilly's expectations, please
see Lilly's most recent Forms 10-K and 10-Q filed with the U.S.
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements.
Refer
to:
|
Mark Taylor;
mark.taylor@lilly.com; 317-276-5795 (Lilly Media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (Lilly
Investors)
|
|
David Schull;
david.schull@russopartnersllc.com; (212) 845-4271 (Sigilon Media
Contact)
|
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SOURCE Eli Lilly and Company