INDIANAPOLIS and THOUSAND OAKS, Calif., Sept. 17, 2020 /PRNewswire/ -- Eli Lilly and
Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global
antibody manufacturing collaboration to significantly increase the
supply capacity available for Lilly's potential COVID-19 therapies.
Lilly is currently studying several potential neutralizing
antibodies for the prevention and/or treatment of COVID-19 as
either monotherapy or in combination. Through this collaboration,
the two companies will have the ability to quickly scale up
production and serve many more patients around the world should one
or more of Lilly's antibody therapies prove successful in clinical
testing and receive regulatory approval.
"Based on our initial clinical studies, we believe that virus
neutralizing antibodies, including LY-CoV-555, could play an
important role in the fight against COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief
scientific officer and president of Lilly Research Laboratories.
"Increasing the manufacturing capacity for our neutralizing
antibodies through this collaboration with Amgen is a crucial next
step, and together we hope to be able to produce many millions of
doses even next year."
"We are impressed with Lilly's data, in particular the reduction
in hospitalizations, and are enthusiastic about the potential for
these neutralizing antibodies as a therapeutic for COVID-19," said
David M. Reese, M.D., executive vice
president of research and development at Amgen. Esteban Santos, executive vice president of
Operations at Amgen, added "we are proud to partner with Lilly and
leverage our deep technical expertise in antibody development and,
in particular, our strong capabilities in the scale up and
manufacturing of complex biologics. This is yet another example of
the ways our industry is closely collaborating to combat this
devastating disease and help patients around the world access new
therapies."
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the world's leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
About Eli Lilly and Company
Lilly is a global
health care leader that unites caring with discovery to create
medicines that 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
lilly.com and lilly.com/news. C-LLY
Amgen Forward Looking Statements
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including any statements on the
outcome, benefits and synergies of collaborations, or potential
collaborations, with any other company, including BeiGene, Ltd. or
any collaboration or potential collaboration in pursuit of
therapeutic antibodies against COVID-19 (including statements
regarding such collaboration's, or our own, ability to discover and
develop fully-human neutralizing antibodies targeting SARS-CoV-2 or
antibodies against targets other than the SARS-CoV-2 receptor
binding domain, and/or to produce any such antibodies to
potentially prevent or treat COVID-19), or the Otezla®
(apremilast) acquisition (including anticipated Otezla sales growth
and the timing of non-GAAP EPS accretion), as well as estimates of
revenues, operating margins, capital expenditures, cash, other
financial metrics, expected legal, arbitration, political,
regulatory or clinical results or practices, customer and
prescriber patterns or practices, reimbursement activities and
outcomes, effects of pandemics or other widespread health problems
such as the ongoing COVID-19 pandemic on our business, outcomes,
progress, or effects relating to studies of Otezla as a potential
treatment for COVID-19, and other such estimates and
results. Forward-looking statements involve significant risks
and uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission reports filed
by Amgen, including our most recent annual report on Form 10-K and
any subsequent periodic reports on Form 10-Q and current reports on
Form 8-K. Unless otherwise noted, Amgen is providing this
information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Our results
may be affected by our ability to successfully market both new and
existing products domestically and internationally, clinical and
regulatory developments involving current and future products,
sales growth of recently launched products, competition from other
products including biosimilars, difficulties or delays in
manufacturing our products and global economic conditions. In
addition, sales of our products are affected by pricing pressure,
political and public scrutiny and reimbursement policies imposed by
third-party payers, including governments, private insurance plans
and managed care providers and may be affected by regulatory,
clinical and guideline developments and domestic and international
trends toward managed care and healthcare cost containment.
Furthermore, our research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and
foreign government regulatory authorities. We or others could
identify safety, side effects or manufacturing problems with our
products, including our devices, after they are on the market. Our
business may be impacted by government investigations, litigation
and product liability claims. In addition, our business may be
impacted by the adoption of new tax legislation or exposure to
additional tax liabilities. If we fail to meet the compliance
obligations in the corporate integrity agreement between us and the
U.S. government, we could become subject to significant sanctions.
Further, while we routinely obtain patents for our products and
technology, the protection offered by our patents and patent
applications may be challenged, invalidated or circumvented by our
competitors, or we may fail to prevail in present and future
intellectual property litigation. We perform a substantial amount
of our commercial manufacturing activities at a few key facilities,
including in Puerto Rico, and also
depend on third parties for a portion of our manufacturing
activities, and limits on supply may constrain sales of certain of
our current products and product candidate development. An outbreak
of disease or similar public health threat, such as COVID-19, and
the public and governmental effort to mitigate against the spread
of such disease, could have a significant adverse effect on the
supply of materials for our manufacturing activities, the
distribution of our products, the commercialization of our product
candidates, and our clinical trial operations, and any such events
may have a material adverse effect on our product development,
product sales, business and results of operations. We rely on
collaborations with third parties for the development of some of
our product candidates and for the commercialization and sales of
some of our commercial products. In addition, we compete with other
companies with respect to many of our marketed products as well as
for the discovery and development of new products. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, some raw materials, medical
devices and component parts for our products are supplied by sole
third-party suppliers. Certain of our distributors, customers and
payers have substantial purchasing leverage in their dealings with
us. The discovery of significant problems with a product similar to
one of our products that implicate an entire class of products
could have a material adverse effect on sales of the affected
products and on our business and results of operations. Our efforts
to collaborate with or acquire other companies, products or
technology, and to integrate the operations of companies or to
support the products or technology we have acquired, may not be
successful. A breakdown, cyberattack or information security breach
could compromise the confidentiality, integrity and availability of
our systems and our data. Our stock price is volatile and may be
affected by a number of events. Our business performance could
affect or limit the ability of our Board of Directors to declare a
dividend or our ability to pay a dividend or repurchase our common
stock. We may not be able to access the capital and credit markets
on terms that are favorable to us, or at all.
Lilly Forward Looking Statements
This press release
contains forward-looking statements about the supply and use of
Lilly antibodies to treat or prevent COVID-19 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 antibodies will prove to be safe and
effective to treat or prevent COVID-19, that any Lilly antibody
will receive regulatory approval, or that we can provide an
adequate supply of Lilly antibodies. 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 (Media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; (317) 277-1838 (Investors)
|
|
Trish Rowland;
plange@amgen.com; (805) 447-5631 (Media)
|
|
Arvind Sood;
arvinds@amgen.com; (805) 447-1060 (Investors)
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/lilly-and-amgen-announce-manufacturing-collaboration-for-covid-19-antibody-therapies-301132807.html
SOURCE Eli Lilly and Company