Year Established: 1980
Revenues: $22,991 (+6%)
Net Income: $7,722 (+11%)
R&D: $3,840 (-6%)
TOP SELLING DRUGS
|Neulasta||chemotherapy induced neutropenia||$4,648||-1%|
|Aranesp||chemotherapy induced anemia||$2,093||7%|
|Neupogen||chemotherapy induced neutropenia||$765||-27%|
After nearly 40 years, Amgen remains among the world’s largest biopharma companies with a market cap of $114 billion. In 2016, Amgen’s portfolio of top sellers boasted seven blockbuster drugs (classified as $1 billion or more in annual sales). Of these, five are still growing, Enbrel, Aranesp, Prolia, Sensipar and Xgeva. Osteoporosis drug Prolia, has shown the strongest gains (25%) over the last year. However, biosimilar competition in today’s market is fierce and Amgen’s products are among the prime targets.
Enbrel sales soared 11% in 2016, just shy of $6 billion, while sales of Neulasta, a treatment for chemotherapy induced neutropenia, were pretty much flat at $4.6 billion due to increased competition in this space and patent expirations. Sales of Amgen’s original flagship blockbusters, Epogen and Neupogen (the industry’s first victim of biosimilar competition), have fallen dramatically in recent years, down a third since 2014.
Kyprolis, Blincyto and Repatha are Amgen’s fastest growing drugs but they have a way to go to compensate for the decline of core products.
Despite increased competition and patent expirations, 10 out of Amgen’s 13 products grew in 2016. Not unlike many of its competitors, advancing its pipeline assets is essential to maintaining growth. Amgevita and Erenumab look to be the most promising sources of revenue for the company in the near term.
Safety issues surrounding Evenity and less than impressive Repatha results are among the company’s most recent road blocks. Osteoporosis drug Evenity was close to gaining FDA approval, but a recent study showed an increased risk of heart-related side effects. It’s not likely to be approved this year and its future is in question. Also, Repatha, a new cholesterol reducing drug, showed positive results in a recent study but not enough to impress investors or outstrip the competition, and as a result, it could face tougher payer reimbursement.
In the way of positive news, Amgen submitted a Biologics License Application to the FDA for its new migraine drug Erenumab, which demonstrated positive Phase III results from pivotal studies in more than 2,600 patients with episodic and chronic migraine.
Amgen and development partner, Novartis, recently expanded their collaboration for erenumab, a fully human monoclonal antibody specifically designed to target and block the Calcitonin Gene-Related Peptide (CGRP) receptor, believed to have a critical role in mediating migraine pain. The companies have agreed to combine capabilities to co-commercialize erenumab in the U.S. Amgen retains exclusive rights in Japan and Novartis gains exclusive rights in Canada, retaining its existing rights in rest of the world.
Amgevita, Amgen’s biosimilar to AbbVie’s $16 billion top-seller Humira, was approved by the FDA and the EU, but ongoing litigation could significantly delay launch. Amjevita is the first Humira biosimilar to be approved in the U.S.
AbbVie filed a lawsuit seeking to block Amgen from selling a copy of the arthritis medicine, and according to AbbVie, Amgen’s proposed biosimilar would infringe at least 10 patents, and AbbVie has reserved the right to assert as many as 51 other patents. Unfortunately for Amgen, the trial is not expected to begin until November 2019, and Amgen is not alone in its pursuit for a Humira biosimilar. Samsung Bioepsis’ Imraldi was recently recommended for approval by the EMA. The EMA also recently accepted an application for review from Sandoz, and Boehringer Ingelheim’s recent Phase III study confirmed its biosimilar candidate has similar efficacy, safety and immunogenicity to Humira—just to name a few...
Moreover, with respect to the Sandoz v. Amgen dispute, on June 12, the U.S. Supreme Court released a highly anticipated decision relating to patent disputes between the developers of new biologics and the manufacturers of “biosimilar” copies.
Sandoz received approval from the European Commission for Erelzi, its biosimilar to Amgen’s Enbrel to treat inflammatory diseases such as rheumatoid arthritis, psoriasis, and psoriatic arthritis.
On one issue, Sandoz won. As a result of the court’s ruling, biosimilar companies will generally be able to launch their products as soon as the data exclusivity on the innovative product expires. On the second issue, however, the outcome was a bit murky. Amgen lost the immediate dispute presented to the Supreme Court, but the litigation is not over, and there are still key questions to be resolved concerning not only federal but also state law, namely California.
With respect to innovation efforts, two early stage R&D investments aim to target cancer. Amgen and Immatics Biotechnologies entered a research collaboration and exclusive license agreement to develop next-gen T-cell engaging bispecific immunotherapies targeting multiple cancers. Amgen paid $30 million upfront and Immatics is eligible to receive more than $500 million in development, regulatory and commercial milestones, as well as royalties on sales.
Additionally, Amgen acquired global rights from Boehringer Ingelheim for BI 836908 (AMG 420), a bispecific T cell engager (BiTE) that targets B-cell maturation antigen, a potential target for multiple myeloma. The drug is currently in Phase I studies. The companies will work together on clinical development, transfer of manufacturing, and global regulatory activity.
Among assets closer to fruition, Amgen will sponsor a clinical trial collaboration and supply agreement with Janssen Biotech that will evaluate the efficacy and safety of CD38-directed immunotherapy Darzalex, in combination with Amgen’s proteasome inhibitor Kyprolis and dexamethasone, to treat cancer. The first Phase III study will determine if this combination improves survival compared to Kyprolis and dexamethasone alone in multiple myeloma in patients who have received prior therapies.
Also, Amgen and Daiichi Sankyo Co. entered an exclusive agreement to commercialize nine biosimilars in Japan. The deal includes several biosimilars in late-stage development, including biosimilars of Humira, Avastin and Herceptin. Amgen is responsible for the development and manufacturing of the biosimilars and Daiichi Sankyo will file for marketing approval and be responsible for distribution and commercialization in Japan.
Despite current challenges, Amgen’s strong foundation as a biologics pioneer should prevail. Near term assets and strong revenue streams for top sellers should offset any losses for flagship products—for now.