THOUSAND OAKS, Calif. and
MELBOURNE, Australia, Dec. 22, 2020 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and Medicines Development for Global Health (MDGH), a
non-profit biopharmaceutical company, today announced that the
companies have entered into a license agreement for AMG 634, a
phosphodiesterase type 4 (PDE4) inhibitor being investigated for
the treatment of tuberculosis (TB) and erythema nodosum leprosum
(ENL), an inflammatory cutaneous and systemic complication of
leprosy. The compound is in Phase 2 development with studies
led by the Aurum Institute NPC (TB study) and The Leprosy Mission
Nepal (ENL study). Amgen had acquired AMG 634 (formerly CC-11050)
as part of its acquisition of Otezla® (apremilast)
from Celgene in 2019. Under the terms of the agreement, MDGH will
assume full responsibility for the further development and
commercialization of AMG 634.
"Since tuberculosis and erythema nodosum leprosum remain
challenging diseases in many countries around the world, Amgen
sought an organization that could support the development of AMG
634 to address the global health unmet need," said David M.
Reese, M.D., executive vice president of Research and Development
at Amgen. "MDGH's track record and experience in product
development, global health, and neglected infectious diseases makes
them an ideal company to further develop AMG 634 for the benefit of
patients."
Amgen will continue to support the two Phase 2 clinical trials
in ENL and TB set to begin in 2021 by providing study drug to both
studies and funding the ENL study. This support will help ensure a
seamless transition in development to MDGH.
"We are excited by the potential of AMG 634 for patients with
ENL and TB and are honored to take over the stewardship of this
compound from Amgen," said Mark
Sullivan, founder and managing director of MDGH. "MDGH is
dedicated to developing and delivering medicines for diseases that
disproportionally affect people in low- and middle-income
countries. We broke new ground as the first not-for-profit
biopharmaceutical company to achieve FDA approval for a treatment
for river blindness in 2018 and we will now undertake full
development of AMG 634 in hopes of bringing it to patients in need
of a treatment for their disease."
According to the World Health Organization (WHO), in 2019, an
estimated 10 million people were infected with TB, including over 1
million children, and 1.4 million people died of
TB.1 Leprosy, also known as Hansen's disease,
affects the skin, peripheral nerves mucosal surfaces of the upper
respiratory tract and the eyes.2 ENL is an autoimmune
complication that can occur many years after being cured of
leprosy, and can cause permanent nerve damage and
disability.3
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 Medicines Development for Global Health
MDGH is
an independent not-for-profit biopharmaceutical company
headquartered in Melbourne,
Australia. Established in 2005, this unique organization is
dedicated to the development of affordable medicines and vaccines
for infectious and neglected diseases prevalent in low- and
middle-income countries.
For additional information about MDGH, please
visit www.medicinesdevelopment.com.
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. 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, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for us
to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar
variability in the future. Even when clinical trials are
successful, regulatory authorities may question the sufficiency for
approval of the trial endpoints we have selected. We develop
product candidates internally and through licensing collaborations,
partnerships and joint ventures. Product candidates that are
derived from relationships may be subject to disputes between the
parties or may prove to be not as effective or as safe as we may
have believed at the time of entering into such relationship. Also,
we or others could identify safety, side effects or manufacturing
problems with our products, including our devices, after they are
on the market.
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. 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. 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.
The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and
Drug Administration, and no conclusions can or should be drawn
regarding the safety or effectiveness of the product candidates.
Further, any scientific information discussed in this news release
relating to new indications for our products is preliminary and
investigative and is not part of the labeling approved by
the U.S. Food and Drug Administration for the products.
The products are not approved for the investigational use(s)
discussed in this news release, and no conclusions can or should be
drawn regarding the safety or effectiveness of the products for
these uses.
CONTACT:
Amgen, Thousand Oaks
Megan Fox, 805-447-1423 (media)
Trish Rowland, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
MDGH, Melbourne, Australia
Mark Sullivan, +61 419 576575
(media)
Ranya Alkadamani, +61 434 664 589 (media)
1 World Health Organization website
https://www.who.int/tb/publications/factsheet_global.pdf?ua=1 (last
accessed Dec. 15, 2020)
2 World Health Organization website
https://www.who.int/health-topics/leprosy#tab=tab_1 (last accessed
Dec. 15, 2020)
3 Saunderson P, Gebre S, Byass P. ENL reactions in the
multi bacillary cases of the AMFES cohort in central Ethiopia: incidence and risk factors. Lepr
Rev (2000) 71, 3 1 8-324
View original content to download
multimedia:http://www.prnewswire.com/news-releases/amgen-licenses-amg-634-an-investigational-treatment-for-tuberculosis-and-leprosy-to-medicines-development-for-global-health-301197802.html
SOURCE Amgen