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.
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