Zacks_Analysts' Blog : Priority Review for Amgen Drug - Analyst Blog

Amgen (AMGN) recently announced that it has received priority review status from the US Food and Drug Administration ("FDA") for its Biologics License Application ("BLA") for denosumab. Amgen is looking to get denosumab approved for delaying skeletal related events in patients with advanced cancer.  

 

The BLA was filed by Amgen in mid-May 2010. Given the priority review status, a final response from the FDA on the candidate’s approvability should be out within 6 months from the filing date (FDA action date: November 18, 2010).

 

The BLA includes data from several studies including three pivotal phase III studies that compared denosumab with Novartis’ (NVS) Zometa. Amgen is seeking approval for this indication in other territories as well including the European Union, Switzerland, Canada, and Australia. Amgen and partner Daiichi-Sankyo are looking to file for approval in Japan as well.

 

Denosumab a Potential Blockbuster

 

Denosumab (trade name: Prolia) is currently approved in the EU and the US.  While denosumab gained approval in the EU for the treatment of osteoporosis in postmenopausal women at increased risk of fractures and the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, the US Food and Drug Administration (FDA) approved the product 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.

 

Although treatments for the postmenopausal osteoarthritis ("PMO") indication are currently available, denosumab could have an advantage over existing treatment options due to its convenient dosing regimen. Denosumab needs to be injected only twice a year as opposed to other treatments, which require more frequent dosing.

 

 Denosumab’s approval for the PMO indication is a major positive for Amgen and we believe approval for additional indications will help the drug achieve blockbuster status. Amgen has a collaboration agreement with GlaxoSmithKline (GSK) for denosumab for the postmenopausal osteoporosis indication in Europe, Australia, New Zealand and Mexico.

 

Our Take

 

We currently have a Neutral recommendation on Amgen which is supported by the Zacks Rank #3 (Hold). The recent approval of denosumab for the PMO indication is a major boost for the company. However, we note that the PMO market is highly competitive. Denosumab will compete primarily with established products like Merck’s (MRK) Fosamax, GlaxoSmithKline’s Boniva, Eli Lilly’s (LLY) Evista and Forteo for a share of the osteoporosis market.