Amgen’s (AMGN) 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 Circulation as well.
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 Sanofi (SNY) and Pfizer (PFE) 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. (VNDA), a Zacks Rank #1 (Strong Buy) stock.