AMGen (formerly Applied Molecular Genetics Inc.) is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California. Located in the Conejo Valley, AMGen is the world's largest independent biotechnology firm. In 2013, the company's largest selling product lines were Neulasta/Neupogen, two closely related drugs used to prevent infections in patients undergoing cancer chemotherapy; and Enbrel, a tumor necrosis factor blocker used in the treatment of rheumatoid arthritis and other autoimmune diseases. Other products include Epogen, Aranesp, Sensipar/Mimpara, Nplate, Vectibix, Prolia and XGEVA.
The word AMGen is a portmanteau of the company's original name, Applied Molecular Genetics, which became the official name of the company in 1983 (three years after incorporation and coincident with its initial public offering). The company's first chief executive officer, from 1980, was co-founder George B. Rathmann, followed by Gordon M. Binder in 1988, followed by Kevin W. Sharer in 2000. Robert A. Bradway became Amgen’s president and chief executive officer in May 2012 following Sharer's retirement.
The company has made at least five major corporate acquisitions.
- 1989. Amgen received approval for the first recombinant human erythropoetin product, Epogen, for the treatment of anemia associated with chronic kidney failure. Epogen (also marketed by Johnson and Johnson under the tradename Procrit) would later be approved for anemia due to cancer chemotherapy, anemia due to treatment with certain HIV drugs, and for the reduction of the need for transfusions associated with surgery.
- 1991. In February 1991, Amgen received FDA approval for Neupogen for the prevention of infections in patients whose immune systems are suppressed due to cancer chemotherapy. A 2002 meta-analysis found that Neupogen treatment reduced the risk of febrile neutropenia by 38%, reduced the risk of documented infection by 49%, and reduced the risk of infection-related mortality by 40%.
- 1998. In November 1998, Immunex, a future acquisition of Amgen, received approval for Enbrel (etanercept), the first rheumatoid arthritis drug targeting tumor necrosis factor alpha (TNF-alpha). A 2006 assessment by the National Institute of Clinical Excellence of the United Kingdom concluded that etanercept and related rheumatoid arthritis drugs later introduced by competitors "are effective treatments compared with placebo for RA patients who are not well controlled by conventional DMARDs, improving control of symptoms, improving physical function, and slowing radiographic changes in joints." A more recent study demonstrated that compared to traditional disease-modifying anti-rheumatic drugs, treatment with etanercept improved survival, reduced cardiovascular events and reduced the incidence of hematological cancers.
- 2010. On June 6, 2010 Amgen received FDA approval for Prolia, a protein drug for the treatment of post-menopausal osteoporosis. In clinical trials, Prolia reduced the rate of vertebral fractures by 61% and the risk of hip fractures by 40%.
- 2010 In November 2010 the FDA approved Xgeva for the prevention of complications of bone metastases in patients with solid tumors. The clinical trials primarily enrolled patients with breast or prostate cancer.
- 2012. Illegal marketing practices. The Los Angeles Times reported on December 18, 2012, that AMGEN pleaded guilty and agreed to pay $150 million in criminal penalty and $612 million to resolve 11 related whistleblower complaints. Federal prosecutors accused the company of pursuing profits while putting patients at risk. Larry Husten, a contributor at Forbes.com elaborates on AMGEN's illegal marketing practices in this case, namely that the "government accused Amgen of marketing Aranesp for indications not approved by the FDA and other illegal marketing practices". One of the drugs mentioned in the lawsuit had sales of $492 million in the third quarter of 2012, down 17% from the same quarter the previous year due to "reimbursement problems and label changes".
- 2012. Amgen paid $762 million after pleading guilty to criminal charges of improper promotion and sale of misbranded drugs.
- 2013. Lawmakers inserted text into the fiscal cliff bill that will allow the drugmaker to sell a class of drugs that includes Sensipar without government controls for an additional two years. The New York Times estimated that the paragraph in the fiscal cliff bill will cost taxpayers an estimated $500 million but other assessments concluded that the change would protect seniors in rural areas and reduce overall Medicare spending.
- 2015. In September the company announced it would acquire Dezima Pharma for more than $1.55 billion. The same day the company announced a collabaration with Xencor on 6 early stage immuno-oncology and inflammation programmes. As part of the deal Amgen will pay $45 million upfront, with the deal being worth up to another $1.7 billion.
- 1994 – Synergen, Inc.
- 2000 – Kinetix Pharmaceuticals, Inc.
- 2002 – Immunex Corporation
- 2004 – Tularik, Inc.
- 2006 – Abgenix, Inc.
- 2006 – Avidia, Inc.
- 2007 – Alantos Pharmaceuticals
- 2007 – Ilypsa, Inc.
- 2007 – Alantos Pharmaceuticals Holdings, Inc.
- 2011 – BioVex Group, Inc.
- 2011 – Laboratório Químico Farmacêutico Bergamo Ltda.
- 2012 – Micromet, Inc.
- 2012 – Mustafa Nevzat İlaç
- 2012 – KAI Pharmaceuticals
- 2012 – deCODE genetics
- 2013 – Onyx Pharmaceuticals Inc.
- 2015 – Dezima Pharma
- 2015 – Catherex
The following is an illustration of the company's mergers, acquisitions, spin-offs and historical predecessors:
As of December, 2013, Amgen had twelve approved drugs or therapeutic biologicals for seventeen conditions (conditions lists are highly generalized; see each article for more detail):
- Aranesp (darbepoetin alfa) (for anemia)
- Blincyto (Blinatumomab) (for the treatment of acute lymphoblastic leukemia).
- Enbrel (Etanercept) (for various forms of arthritis)
- Epogen (Epoetin) (also known as Procrit; for anemia)
- Neulasta (PEG Granulocyte-Colony Stimulating Factor or "Pegfilgrastim") (for neutropenia)
- Neupogen (Granulocyte-Colony Stimulating Factor) (for neutropenia)
- Nplate (Romiplostim) (for chronic immune thrombocytopenic purpura)
- Prolia (denosumab) (for postmenopausal osteoporosis)
- Sensipar/Mimpara (Cinacalcet) (for Primary & Secondary hyperparathyroidism, a mineral metabolism complication common in patients with kidney failure)
- Vectibix (Panitumumab) (for colon cancer)
- XGEVA (denosumab) (for the prevention of skeletal-related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone in adults with bone metastases from solid tumors)
Products developed and then sold off
- Kepivance (Palifermin) (for oral mucositis) (sold to Biovitrium, now Swedish Orphan Biovitrum, in December 2008)
- StemGen (Ancestim) (for use in combination with filgrastim for mobilizing peripheral hematopoietic stem cells) (sold to Biovitrium, now Swedish Orphan Biovitrum, in December 2008)
- Kineret (Anakinra) (for rheumatoid arthritis) (exclusively licensed to Biovitrium, now Swedish Orphan Biovitrum, in December 2008)
Pipeline & clinical trials
In November 2014 the company announced it was halting all trials of rilotumumab in advanced gastric cancer patients after one of the trials found more deaths in those who took the compound with chemotherapy, than those without. Later in the same week, the company (in conjunction with AstraZeneca) reported positive results for brodalumab in a phase III trial comparing the compound with ustekinumab and a placebo in treating psoriasis.
In March 2015, the company announced it would license its Phase II candidate drug AMG 714 to developer Celimmune who plan to develop the anti-IL-15 monoclonal antibody for treatment against diet nonresponsive celiac disease and refractory celiac disease.