Year Established: 1980
Revenues: $23,747 (+4%)
Net Income: $8,394 (NM)
R&D: $1,182 (+13%)
TOP SELLING DRUGS
|Neulasta||chemotherapy induced neutropenia||$4,475||-1%|
|Aranesp||chemotherapy induced anemia||$1,877||-9%|
While Amgen’s newer drugs Prolia, Xgeva, Blincyto, Kyprolis continue to drive growth, its mature flagship products are facing rising competition. Sales of Neulasta and Neupogen are declining due to biosimilar competition from several companies, including Mylan and Coherus BioSciences. Several others face generic competition as well, including Enbrel, Aranesp and Epogen. Meanwhile, sales of Amgen’s new migraine drug, Aimvoig, were unimpressive in the first quarter of 2019, and it’s up against strong competition from Lilly’s Emgality and Teva’s Ajovy.
Amgen is successfully advancing its pipeline with the approval of osteoporosis drug Evenity in April, and Kanjinti, a biosimilar of Roche’s breast cancer drug Herceptin, in June. This is the third biosimilar from Amgen’s portfolio to receive approval, providing the potential for long-term revenues. Amgen expects to launch additional biosimilars in 2019.
As part of an effort to bolster its R&D efforts, Amgen recently offered to acquire Nuevolution, a drug discovery platform biotech company based in Denmark, for approximately $167 million. The Nuevolution board has recommended accepting the offer and Amgen expects to settle by July 15. The two companies have collaborated since October 2016 for drugs targeting multiple indications including two cancer programs. Having Nuevolution’s discovery platform in-house may aid Amgen’s discovery efforts for small molecules against difficult-to-drug targets and make the process more efficient.
Additionally, to further enhance its manufacturing capabilities, Amgen is expanding its campus in West Greenwich, RI with a new $160 million next-gen biomanufacturing plant that will be the first of its kind in the U.S. It will manufacture products for the U.S. and global markets. Amgen plans to incorporate multiple innovative technologies into a single facility, which is expected to be built in half the construction time with approximately half of the operating cost required of a traditional plant. Next generation biomanufacturing plants require a smaller manufacturing footprint offering environmental benefits such as reduced water and energy consumption, and lower levels of carbon emissions.
Among its more significant approvals, Amgen and UCB gained FDA approval for EVENITY for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY is the first and only bone builder with a unique dual effect that both increases bone formation and to a lesser extent reduces bone resorption (or bone loss) to rapidly reduce the risk of fracture.
In October, the FDA approved the expanded indication for KYPROLIS to include a once-weekly dosing option in combination with dexamethasone for patients with relapsed or refractory multiple myeloma. The approval was based on Phase III data demonstrating that KYPROLIS achieved superior progression-free survival and overall response rates, with a comparable safety profile, versus twice-weekly. The FDA reviewed the application under its Real-Time Oncology Review and Assessment Aid pilot programs, which aim to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.
Also, Amgen’s BLINCYTO gained approval for relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) in Japan, and an expanded indication as a monotherapy to include adult patients with Philadelphia chromosome negative (Ph-) CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) by the European Commission. Developed by a joint venture between Amgen and Astellas Pharma Inc., BLINCYTO is the first-and-only bispecific T cell engager (BiTE) immunotherapy construct approved globally. It’s also the first approved immunotherapy from Amgen’s BiTE platform, an approach that helps the body’s immune system target cancer cells.
Amgen and its biosimilar partner Allergan, recently received approval from the FDA for Kanjinti, a biosimilar of Roche’s breast cancer drug, Herceptin, for all approved indications of the reference product, HER2 adjuvant and metastatic breast cancer, and HER2 metastatic gastric cancer or gastroesophageal junction adenocarcinoma. Since December of last year, the FDA approved four biosimilar versions of Herceptin including Kanjinti: Pfizer’s Trazimera, Merck/Samsung Bioepis’ Ontruzant, and Celltrion/Teva’s Herzuma).
Kanjinti is the third biosimilar from Amgen’s portfolio to receive approval in the U.S. and Europe, joining Amjevita (a biosimilar of Abbvie’s Humira) and Mvasi (a biosimilar of Roche’s cancer drug Avastin). Currently, Amgen has 10 biosimilar products in its portfolio and a biosimilar version of Johnson & Johnson/Merck’s Remicade (ABP 710) is under review in the U.S. and EU.
The collaboration with Allergan includes the development and commercialization of four oncology antibody biosimilars. A biosimilar version of Roche’s Rituxan is in late-stage development for non-Hodgkin’s lymphoma and rheumatoid arthritis.
Innovative oncology efforts are advancing as well. Amgen recently reported early data from a Phase I trial of AMG 510 showing promising activity in a study of 35 patients targeting one of the most commonly mutated genes in cancer. Analysts are suggesting it has the potential to be the next cancer blockbuster. Out of 10 lung cancer patients receiving Amgen’s AMG 510 in the early-stage study, five went into partial remission and another four saw their disease stabilize. One patient experienced a complete remission four months after treatment. Representing a 90% disease control rate which is quite remarkable for a Phase I trial.
MG 510 targets KRAS G12c mutation, which accounts for about 13% of non-small cell lung cancers and 3% to 5% of colorectal cancers, and has been the subject of research for decades. While Amgen’s results in colon cancer were less robust, it’s still too early to tell.
Furthermore, several interesting early research collaborations are underway. Most recently, a collaboration with Intermountain Health aims to rapidly develop new medicines. Amgen’s subsidiary deCODE genetics will have access to the genomes of 500,000 participants from a study carried out by Intermountain Healthcare. Amgen hopes to use this data to uncover new insights into specific diseases and develop new medicines that reach the right disease targets. The collaboration aims to improve success rates and reduce drug development cycle times. To date, Amgen has accelerated the development timeline from early preclinical work through clinical development with several of its molecules, including AMG 510, currently in Phase I.
In October, Amgen made an equity investment of $66 million in Oxford Nanopore Technologies, a UK-based company advancing a new generation of portable genetic sequencing technology to perform direct, real-time sequencing of DNA and RNA. deCODE Genetics uses Oxford’s sequencing technologies to conduct genome research, including the identification and validation of new targets. The investment aligns with Amgen’s strategic focus on using human genetics to develop new medicines.