The Amgen Story

Transcription

The Amgen Story
The Amgen Story
Unlocking the Potential of Biology for Patients
1980s
1980
AMGen incorporates.
Left: Farmers herd sheep near the
Ventura Highway in this 1967
archival image. The Security Bank
building would become the future
site of Building 29 on Amgen’s
Thousand Oaks campus. Photo
courtesy of Ed Lawrence.
Right: Amgen has had three logos
in its history. This is the first logo.
AMGen (Applied Molecular
Genetics Inc.) is established in
Thousand Oaks, California, on
April 8, 1980, as the brainchild
of venture capitalists William K.
(Bill) Bowes and associates.
With a staff of three, the
Company occupies a shared
building, now called “Building 1.”
1980
Early experiments.
Amgen’s research in cloning genes
led to the Company’s production of
indigo in E coli in the early 1980s.
The discovery and subsequent
patent made the cover of Science
magazine in 1983.
In the first three years, AMGen
scientists attempt many things:
creating organisms to extract oil from
shale, growing chickens faster,
making specialty chemicals, cloning
luciferase (the light source for
fireflies) and creating a process for
producing indigo dye in E coli—an
achievement that garners the
prestigious cover of Science
magazine. The final direction for the
Company would be treating and
curing disease.
1980
George B. Rathmann is
named first CEO.
AMGen names its first CEO, scientist
and businessman George B.
Rathmann. Dubbed “Mr. Biotech” by
Red Herring magazine, Rathmann has
been called one of the great geniuses
of high-tech entrepreneurialism.
Working from a small trailer to free up
space for scientists, Rathmann quickly
establishes scientific goals and
secures funding to conduct grand
experiments in technology.
1983
Led by CFO Gordon Binder,
Amgen’s IPO on June 17,
1983, raises nearly
$40 million.
The Company officially
changes its name to Amgen.
A May 1983 article of The Wall
Street Journal announces
Amgen’s IPO.
1983
The clone that
launched a company.
Fu-Kuen Lin examines x-ray film to
identify gene coding for
erythropoietin. The black areas
show bacterial colonies containing
the gene.
A team led by a young researcher from
Taiwan named Fu-Kuen Lin is tasked
with finding and cloning the
erythropoietin gene. Their job is
staggering: finding a gene on a single
fragment of DNA among 1.5 million
fragments of the human genome. After
working tirelessly for two years, they
did it. This groundbreaking
achievement enables the creation of
one of the most successful drugs in
biotech history, EPOGEN® (epoetin alfa).
George Rathmann in one of the
Building 2 laboratory bays in 1982.
1984
Kirin and Amgen form
a joint venture,
Kirin-Amgen, for the
worldwide commercialization
of erythropoietin.
1985
A second discovery.
Research head Larry Souza led the
team in the creation of
NEUPOGEN®, Amgen’s second
blockbuster drug.
1988
While Lin was working on
erythropoietin, researcher Larry Souza
and his team are able to clone
granulocyte colony-stimulating factor
(G-CSF). This discovery would lead to
the development of Amgen’s second
blockbuster drug NEUPOGEN®
(filgrastim).
Gordon Binder is
appointed CEO.
Amgen had just received the first U.S.
patent for recombinant erythropoietin,
completed a 20,000-page filing to the
FDA for approval of EPOGEN® and
completed building a new 24,000
square foot manufacturing facility. At
this height, Rathmann announces that
he is ready to retire, explaining “I
figured that would be a great thing if
they got a running start by launching
EPOGEN® as the new management
team.” Gordon Binder is promoted from
CFO to CEO and ushers in a new and
promising era.
1989
On June 1, 1989, the F DA
approves EPOGEN®
(epoetin alfa).
EPOGEN® named
Product of the Year
by Fortune magazine.
Gordon Binder and Harry Hixson
during the Company’s transition
following George Rathmann’s
retirement.
1989
Amgen goes international.
1990s
1991
On February 21, 1991,
NEUPOGEN® (filgrastim) is
approved by the FDA.
NEUPOGEN® is named
Product of the Year by
Fortune magazine.
1992
A billion-dollar company.
Manufacturing staffers oversee a
filling machine to dispense final,
formulated product into vials ready
for distribution.
Amgen hits $1 billion in product sales
for EPOGEN® and NEUPOGEN®
combined. On January 2, 1992, Amgen
is added to the S&P 500 and months
later, the Company debuts on the
Fortune 500 list.
1993
Since 1993, Amgen has relied
heavily on its facility in Puerto Rico.
Amgen opens its Puerto Rico
facility, which would become
Amgen’s flagship
manufacturing site with over
1.7 million square feet of space.
Amgen establishes its European
headquarters in Lucerne,
Switzerland. Later, the European
headquarters will relocate to Zug,
also in Switzerland. Over the next
several years, Amgen would quickly
establish offices across Europe,
including a key manufacturing and
distribution center in Breda, the
Netherlands.
Aart Brouwer was the first head of
Amgen’s European office from
1989 to 2001.
1991
Giving back for good: the Amgen Foundation is formed.
Amgen establishes the Amgen Foundation as a way to
coordinate the various groups and individuals who were already
giving back to the community. Today, the Amgen Foundation
focuses on excellence in science education to inspire the next
generation of innovators, and invest in strengthening
communities where Amgen staff members live and work. By the
end of 2014, the Foundation had donated more than $200 million
in grants to local, regional and international nonprofit
organizations that reflect Amgen’s core values and impact lives
in inspiring and innovative ways.
Research director Frank Martin is just
one of the many Amgen staffers who
take their love of science to the
classroom. In this 1995 photo, Martin
guides students in an experiment at
Walnut Elementary School in
Thousand Oaks.
mid
1990s
Two important discoveries.
1994
Amgen researcher Steve Elliott
and his team add two sugar chains
to erythropoietin, causing the protein
to remain in the body longer. From
this discovery, Aranesp ®
(darbepoetin alfa) is created.
The top page of scientist Steve
Elliott’s lab notebook contains early
data from cells transformed with
pDEC321, the plasmid used to
construct the cell line that produces
Aranesp®. With this data, he knew
he’d found what he was seeking.
A time of scale and growth.
Staff numbers reach 3,396 globally, up
from only 344 when Binder was named
CEO in 1988. The Thousand Oaks
headquarters had grown, too—from
half a building in 1980 to a sprawling
campus with well over a million square
feet of space by 1992. Local
newspapers describe the area as
“perpetually under construction.”
Around the same time, Amgen
researcher Olaf Kinstler and his team
are experimenting with a longerlasting form of NEUPOGEN ®
(filgrastim). Amgen attaches the waxy,
water-soluble polymer polyethylene
glycol (PEG) to G-CSF, which expands
the molecule and greatly slows down
excretion. From this discovery,
Neulasta® (pegfilgrastim) is created.
1994
Amgen wins the National Medal of Technology.
Amgen becomes the first biotech company to receive the U.S.
Department of Commerce National Medal of Technology. This
award is considered by the U.S. government to be on par with the
Nobel Prize. Given that year by Vice President Al Gore and
Commerce Secretary Ron Brown, the award recognizes Amgen for
“its leadership in developing innovative and important cost-effective
therapeutics based on advances in the cellular and molecular
biology for delivery to critically ill patients throughout the world.”
1996
The Amgen Values launch.
Staffers help develop the principles
that guide the way Amgen conducts
business. This early mission
statement has evolved into the
current mission, aspiration, values
and leadership attributes.
In 1995, the Los Angeles Times
writes a glowing article about
Amgen’s relationship with the city
of Thousand Oaks, calling it “a
Match Made in Heaven.”
The Amgen Values were first
launched in 1996. Amgen could not
have accomplished what it did if not
for its commitment to building a
culture and social architecture that
embraces science and innovation—a
culture that continues to shape what
Amgen is today.
Vice President Al Gore presents
the 1994 National Medal of
Technology to CEO Gordon
Binder. The award is the highest
honor awarded by the President
of the United States to America’s
leading innovators.
1998
mid to late
On November 2, 1998,
the FDA approves
Enbrel® (etanercept).
1990s
Key discoveries.
Scientists at Amgen identify and clone osteoprotegerin
(OPG). Subsequent research showed that OPG functioned
as a decoy receptor for RANK ligand. These insights form
the scientific basis for denosumab.
2000s
2000
An original x-ray
from 1995.
A new CEO for a new century.
2001
Amgen’s Cambridge, Mass.,
research center opens.
Amgen becomes one of the early
pioneers in what would become a
biotechnology hotbed in Kendall
Square, opening a 285,000-squarefoot facility.
Kevin W. Sharer becomes Amgen’s
third CEO, following the retirement of
Gordon Binder. When Binder
stepped down, Amgen had grown to
become the fourteenth largest drug
company in the world, having
outstripped its early biotech rivals
years before. As Amgen’s former
President and COO, Sharer had split
many responsibilities with Binder.
Binder explained, “Like an athlete,
there comes a time for the CEO to
leave. We were about to launch
preparations for several new
products, and Kevin was ready to
take command.”
Kevin Sharer and Amgen’s
executive management team are
featured in the July 2001
Pharmaceutical Executive
magazine—the top trade journal in
the industry.
2001
2001
Amgen in space.
NASA guest badges identified
spectators at the liftoff.
Amgen and NASA team up to study
Amgen’s investigational treatment,
osteoprotegerin (OPG), on the space
shuttle Endeavour. The experiment
mimics the effects of the rapid bone
loss that astronauts experience due to
microgravity.
2002
On January 31, 2002,
Neulasta® (pegfilgrastim) is
approved by the FDA.
On September 17, 2001,
Aranesp® (darbepoetin alfa) is
approved by the FDA.
2002
Every patient, every time.
Amgen acquires Immunex, the
developer of Enbrel ® (etanercept),
along with a manufacturing plant in
Rhode Island that had not been used
since being built 10 years earlier.
Within a matter of months, Amgen
teams secure FDA approval, start
production and are now able to
manufacture enough ENBREL to
meet demand.
The Amgen Rhode Island
manufacturing facility starts
production with the creed: “We
make ENBREL so that no patient
goes without.”
2004
2004
Writing on a hood in one of Amgen’s small
molecule labs.
Amgen acquires Tularik,
adding five candidates to
Amgen’s pipeline and
establishing a strong
presence in South San
Francisco.
2005
Breakaway from Cancer®
Amgen founds Breakaway from Cancer, a national initiative to
increase awareness of important resources available to people
affected by cancer—from prevention through survivorship.
Breakaway from Cancer represents a partnership between
Amgen and four nonprofit organizations dedicated to empowering
patients with education, resources and hope, wherever they may
be in the cancer care continuum. Today, Breakaway from Cancer
has reached hundreds of thousands of people touched by cancer
with information about resources and services available to
people affected by cancer, and more than $4 million has been
donated to the Breakaway from Cancer nonprofit partners.
Actor and cancer patient advocate
Patrick Dempsey participates in a
Breakaway from Cancer® “Breakaway
Mile” through Thousand Oaks honoring
cancer survivors and their supporters
during the 2011 Amgen Tour of
California. Photo by Andy Tao.
On March 8, 2004, Sensipar®
(cinacalcet) is approved by
the FDA.
mid
2000s
Elucidating the biology of
PCSK9.
Scientists in Amgen’s labs in South
San Francisco play a critical role in
elucidating the function of PCSK9,
which lays the groundwork for
evolocumab.
2006
On September 27, 2006,
Vectibix® (panitumumab) is
approved by the FDA.
2006
Women’s Genome Health Study begins.
Amgen collaborates with Brigham and Women’s Hospital and
NIH’s National Heart, Lung, and Blood Institute on the Women’s
Genome Health Study (WGHS). The purpose: to identify genetic
variations that may underlie a range of serious illnesses including
heart disease, stroke, diabetes, breast cancer and osteoporosis.
A strand of DNA. The initiative
combs the DNA of 28,000
women, who donated their DNA
to the groundbreaking study, for
differences between those who
have developed serious illness
and those who have remained
healthy.
2007
Providing cutting-edge research experiences.
The Amgen Foundation, in collaboration with Massachusetts
Institute of Technology (MIT), launches the Amgen Scholars
program to provide undergraduates with access to research
experiences and exposure to biotechnology and drug discovery at
top institutions globally.
As an Amgen Scholar in 2013,
Maithreyi Raman has the
opportunity to conduct research
on Huntington’s disease in
Professor Franz-Ulrich Hartl’s
laboratory at LudwigMaximilians-Universität in
Germany.
A desktop in an Amgen lab in
South San Francisco.
2008
On August 22, 2008, Nplate®
(romiplostim) is approved by
the FDA.
2009
Nplate® (romiplostim) is
awarded “Best Biotechnology
Product” by Prix Galien.
Prix Galien is an international award
that recognizes outstanding
achievements in improving the human
condition through the development of
innovative therapies.
2011
Prolia® (denosumab) and
XGEVA® (denosumab) are
awarded “Best Biotechnology
Product” by Prix Galien.
Prix Galien is an international award
that recognizes outstanding
achievements in improving the human
condition through the development of
innovative therapies.
2011
Tapping Amgen’s biomanufacturing expertise to
create biosimilars.
Amgen and Actavis, Inc. announce that they will collaborate to
develop and commercialize, on a worldwide basis, several
oncology antibody biosimilar medicines. This collaboration
reflects the shared belief that the development and
commercialization of biosimilar products will not follow a pure
brand or generic model, and will require significant expertise,
infrastructure and investment to ensure safe, reliably supplied
therapies for patients. Learn more about Amgen’s
biomanufacturing expertise at BiotechnologybyAmgen.com.
2010s
2010
Prolia® (denosumab) and
XGEVA® (denosumab) are
approved by the FDA on
June 1, 2010, and November
18, 2010, respectively.
Prolia® wins Best New Drug
from Scrip, one of the
industry’s highest global
accolades.
2011
Amgen, CDC and CDC Foundation partner to
improve infection control for cancer patients.
Preventing Infections in Cancer Patients is a comprehensive public
health collaboration between the CDC, the CDC Foundation and
Amgen to help reduce infections by raising awareness among
patients, caregivers and healthcare providers about steps they can
take to protect themselves during chemotherapy treatment.
Program resources include a Basic Infection Control and
Prevention Plan for outpatient oncology clinics and an online
patient risk assessment tool, in addition to posters, fact sheets and
postcards. As of 2015, nearly 650,000 pieces of initiative materials
have been disseminated to the public.
2011
Manufacturing equipment in Rhode Island.
2011
A T cell.
Amgen acquires BioVex,
developers of talimogene
laherparepvec.
2012
Robert A. Bradway is appointed
as Amgen’s fourth CEO.
Robert A. Bradway
After more than a decade of leading
Amgen as the world’s largest
biotechnology company, Sharer
announces his retirement and that the
reins will be handed over to Bradway,
Amgen’s president and COO. Vance
Coffman, chairman of the board’s
governance and nominating
committee at that time, explains,
“During [Kevin’s tenure], Amgen grew
significantly in every dimension and is
well positioned for the future.”
Amgen acquires a
manufacturing facility near
Dublin, Ireland.
2011
Amgen expands in Brazil,
including the acquisition of
Bergamo, a privately held
Brazilian pharmaceutical
company.
2012
Strategic partners and
acquisitions.
Amgen acquires deCODE Genetics, a
global leader in human genetics. The
acquisition reflects a core tenet of
Amgen’s current R&D strategy: finding
and pursuing drug targets that are
validated by human genetics.
That same year, Amgen and
AstraZeneca agree to jointly develop
and commercialize five monoclonal
antibodies from Amgen’s inflammation
portfolio. Amgen also acquires Micromet
Inc., developers of what would later be
approved by the FDA as BLINCYTO ®
(blinatumomab); KAI Pharmaceuticals,
developers of AMG 416; and Mustafa
Nevzat, a leading privately held Turkish
pharmaceutical company.
2013
Amgen acquires Onyx
Pharmaceuticals, developers
of Kyprolis® (carfilzomib)
for Injection.
2014
On December 3, 2014,
BLINCYTO® (blinatumomab)
is approved by the FDA.
2012
Amgen Teach launches in Europe.
Amgen Teach launches in Europe to provide hundreds of science
educators with free training sessions that emphasize hands-on,
inquiry-based experiential learning for their students.
Science teacher Kirstie
McAdoo of Ireland shares
that participating in Amgen
Teach “has given me a huge
amount of confidence to use
inquiry-based learning in the
classroom.”
2013
Amgen Astellas BioPharma
K.K. alliance forms in Japan
and Amgen-Betta
Pharmaceuticals joint venture
is established in China.
2013
Through a collaboration with
Servier, Amgen obtains the
U.S. commercial rights to
ivabradine.
2014
Amgen’s Asia Research and Development Center
opens at ShanghaiTech University in China.
2014
The next generation of biomanufacturing.
Construction is completed on a state-of-the-art facility in Singapore.
The plant has the same capacity as a conventional plant, but in a
smaller space, using less water and less energy while producing
fewer solid wastes and fewer emissions.
The R&D Center’s opening ceremony.
2015
On March 2, 2015, the
Neulasta® (pegfilgrastim)
Delivery Kit, including the
On-body Injector, launches.
2015
The groundbreaking ceremony on June 3, 2013, for the Singapore manufacturing facility.
2015
Amgen turns 35.
Today, Amgen remains committed to
unlocking the potential of biology for
patients suffering from serious
illnesses by discovering, developing,
manufacturing and delivering
innovative human therapeutics. The
first 35 years were just the beginning.
In biotechnology and at Amgen—the
best is yet to come.
On April 15, 2015, Corlanor®
(ivabradine) is approved by
the FDA.
2015
On August 27, 2015, Repatha®
(evolocumab) is approved by
the FDA.
2015
On October 27, 2015, IMLYGIC™
(talimogene laherparepvec) is
approved by the FDA.
© 2016 Amgen Inc. All rights reserved. February 2016.