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Repatha and Kyprolis Will Likely Become Blockbuster Drugs

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Dec. 30 2015, Updated 8:06 a.m. ET

Regulatory approvals

In 2015, Amgen (AMGN) managed to launch six new products in the US market. The company expects its cardiovascular drug Repatha and its oncology drug Kyprolis to become blockbuster drugs in the coming quarters.

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Repatha

On November 24, 2015, Repatha managed to be included as the only PCSK9 inhibitor drug on CVS Caremark’s formulary. On October 6, 2015, Express Scripts announced that it included both Repatha and its competitor drug Sanofi (SNY). It also included Regeneron’s (REGN) PCSK9 inhibitor Praluent. Being included on the formularies of the two leading PBMs (pharmacy benefit managers) in the US, Repatha is expected to enjoy more access to patients compared to Praluent. This will lead to blockbuster sales. Amgen will have to give substantial pricing discounts to CVS Caremark. The latter only included Repatha in its formulary to negotiate for a better price from the company.

On September 11, 2015, Amgen submitted an application to the FDA (US Food and Drug Administration) seeking approval for a single dose monthly regimen for Repatha. If approved, the high efficacy of the drug combined with the increased ease of use is expected to drive the drug’s blockbuster sales. To learn more about Repatha and its launch in the US, read FDA Approves Repatha Last Week: Amgen Stock Rises 7.3%.

Amgen is also involved in reimbursement related to negotiations for Repatha with payers across the world. It expects to obtain approval for the drug in the Japanese market in 1H16.

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Kyprolis

Kyprolis was originally used as a third line of treatment for multiple myeloma. On July 24, 2015, the FDA approved Kyprolis in combination with Revlimid and dexamethasone—known as the “KRd regimen”—to treat patients who previously received one to three lines of therapy. With the KRd regimen being accepted more as a new standard of care for relapsed multiple myeloma, Amgen is expected to provide tough competition for other multiple myeloma players like Celgene (CELG) and Johnson & Johnson. To learn more about Kyprolis, read Kyprolis: Amgen’s Innovative Drug in Oncology Segment.

Other launches

Amgen’s Neulasta Onpro kit proved to be a commercial success. It managed to acquire 19% of the total Neulasta patient share in fiscal 3Q15. The device allows patient to avoid visiting a clinic the day after chemotherapy. Neulasta Onpro kit is attached to the patient on the day of chemotherapy. After 24 hours, the on-body device injects the drug into the patient’s body. The device witnessed strong uptake. It’s expected to continue in 4Q15. Since Onpro kit makes it more convenient to administer Neulasta, patients might prefer to continue with the drug even if cheaper biosimilars enter the market in 2016.

By end of fiscal 3Q15, Amgen’s rare disease oncology drug Blincyto managed to cover half of the total addressable population in the US. It continues to penetrate the market. To learn more about Blincyto, read Amgen’s Launches Blincyto Targeting Rare Disease.

Amgen continued to advance in the oncology market. The company developed the first oncolytic viral therapy called “Imlygic,” or talimogene laherparepvec, to be approved by the FDA as well as the European Commisson. To learn more about this therapy, read Amgen’s Research Pipeline in the Oncology Segment.

Corlanor was approved for congestive heart failure. It reached 1,300 prescribers by the end of fiscal 3Q15. It continues to add 100 new prescribers each week. To learn more about Corlanor, read Amgen Launches Corlanor, Chronic Heart Failure Drug.

Instead of directly investing in Amgen and being exposed to excessive company-specific risks, investors can invest in the VanEck Vectors Biotech ETF (BBH). Amgen accounts for 12.6% of BBH’s total holdings.

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