Amgen's Prolia Approved in U.S. - Analyst Blog

(

) is on a roll with its key pipeline candidate, Prolia, receiving back to back approval in both the EU and the US. While Prolia 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.

The FDA approval, which came more than a month before the action date of July 25, is a major boost for Amgen. Prolia has been competitively priced at $825 per 60 mg injection, and will be available from next week along with a Risk Evaluation and Mitigation Strategy (REMS).

Although treatments for the postmenopausal osteoarthritis (

) indication are currently available, Prolia could have an advantage over existing treatment options due to its convenient dosing regimen. Prolia needs to be injected only twice a year as opposed to other treatments, which require more frequent dosing.

Prolia’s approval is a major positive for Amgen. Based on encouraging phase III results, we believe the product has the potential to capture a major share of the osteoporosis market once launched. We believe the drug has blockbuster potential.

Amgen is also looking to get the drug approved for the delay of skeletal-related events in patients with advanced cancer. A biologics license application (BLA), with data from several studies including three pivotal phase III studies comparing Prolia with

(

) Zometa was submitted recently.

While Amgen has a collaboration and licensing agreement for Prolia with Daiichi-Sankyo for Japan, the company has a collaboration agreement with

(

) for Prolia for the postmenopausal osteoporosis indication in Europe, Australia, New Zealand and Mexico.

With all the key products expected to lose patent protection in the next few years, Prolia’s approval is an important event for Amgen. We expect investor focus to remain on the successful launch and commercialization of the product. Prolia will compete primarily with

(

) Fosamax, GlaxoSmithKline’s Boniva,

(

) Evista and Forteo for a share of the osteoporosis market. We currently have a Neutral recommendation on Amgen.