) PCSK9 inhibitor, evolocumab (AMG 145), is one of the most
promising and interesting candidates in the company's pipeline.
Evolocumab works by inhibiting PCSK9, a protein that reduces the
liver's ability to remove "bad" cholesterol from the blood.
Amgen recently presented new data on evolocumab from an
open-label extension study. Results from the long-term controlled
52-week safety and efficacy Open Label Study of Long TERm
Evaluation Against LDL-C (OSLER), showed that monthly treatment
with evolocumab was not associated with a major increase in
adverse events (AEs) compared to standard of care (SOC).
Moreover, mean LDL-C reductions of 52% were observed in high
cholesterol patients receiving evolocumab plus SOC.
The results are encouraging and indicate that evolocumab could
be a promising treatment option for hyperlipidemia in at-risk
patients. These results were presented at the American Heart
Association (AHA) Scientific Sessions 2013 and published in
Amgen is conducting four pivotal phase III studies with
evolocumab. Results are expected in the first quarter of 2014. We
believe evolocumab has huge market potential. Other companies
developing PSCK9 inhibitors include
) among others.
Meanwhile, Amgen presented encouraging data on another
pipeline candidate, talimogene laherparepvec, which is being
studied in patients with unresected stage IIIB, IIIC or IV
melanoma. Interim data from a phase III study comparing
talimogene laherparepvec to granulocyte-macrophage
colony-stimulating factor (GM-CSF) showed that median overall
survival (OS) was higher in the talimogene laherparepvec arm
(23.3 months versus 19.0 months). Mature OS data should be out in
the first half of 2014.
Amgen currently carries a Zacks Rank #2 (Buy). Other companies
that look well-positioned include
Vanda Pharmaceuticals, Inc.
), a Zacks Rank #1 (Strong Buy) stock.
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