Amgen (AMGN) recently received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Xgeva (denosumab).
Xgeva is currently under review in the EU for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors.
The CHMP also said that Xgeva should be granted an additional year of data and market exclusivity in the EU given the significantly new indication for Xgeva and the clinical benefit demonstrated by the candidate compared to existing therapies. The CHMP’s positive opinion was based on data from three pivotal phase III head-to-head studies which compared Xgeva to Novartis’ (NVS) Zometa.
Xgeva is already approved in the US for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva, which gained US Food and Drug Administration (FDA) approval on November 18, 2010, is off to a strong start with first quarter 2011 sales coming in at $42 million, up from the $8 million reported in the fourth quarter of 2010. Amgen said that Xgeva is seeing usage among both oncologists and urologists.
Amgen is currently seeking approval in other territories including Australia, Mexico, Russia, Japan and Switzerland. While Daiichi Sankyo is Amgen’s licensing partner in Japan, Amgen has a collaboration agreement with GlaxoSmithKline (GSK) in countries where it does not have a commercial presence.
Denosumab is also available under the trade name Prolia for the treatment of osteoporosis in postmenopausal women at increased risk of fractures or patients who have failed or are intolerant to other osteoporosis treatments.
Neutral on Amgen
We currently have a Neutral recommendation on Amgen, which carries a Zacks #3 Rank (short-term Hold rating). We expect EU approval for Xgeva in the next 2-3 months. We expect investor focus to remain on the successful commercialization of Prolia/Xgeva.
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