Osteoporosis Drug Meets Primary and Secondary Endpoints
- By Alberto Abaterusso
Amgen Inc. (AMGN) informed the stock market through the PRNewswire May 21 about the results of the ARCH clinical trial, Phase 3, with which Evenity (romosozumab) - an investigational monoclonal antibody that increases bone formation - was assessed in postmenopausal women affected with osteoporosis and who have a high risk of fracture. Evenity is aimed to prevent fractures in these patients.
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The intrinsic value of AMGN
Romosozumab is a monoclonal anti-sclerostin antibody and capable of enhancing bone formation by inhibiting osteoblastic activity induced by osteocytes.
Originally discovered by UCB - formerly Celltech - Romosozumab has been developed by UCB in collaboration with Amgen since 2004.
Osteoporosis is a condition characterized by the reduction of bone resistance, resulting in increased risk of fractures - i.e., bone breakage.
In women after menopause and the elderly, osteoporosis is the most common factor for fractures that mostly affect femur, spinal column, wrist, although in fact they may affect any bone. Some fractures cause permanent disabilities, especially those affecting the hip.
Osteoporosis evolves without giving any symptoms until it causes a fracture or collapse of one or more vertebrae. Vertebral collapse manifests itself with severe back pain, height decrease or column deformities with altered postures. Bones with osteoporosis may become so fragile that they can break spontaneously or following insignificant or even normal traumas such as those caused by bending, raising weight or even coughing. According to the experts, osteoporosis is a largely preventable condition.
According to the International Osteoporosis Foundation an estimated 200 million people in the world are living with osteoporosis and an estimated 9 million fractures are attributed to osteoporosis every year.
The company says that the study met both primary endpoints and the key secondary endpoint.
The primary analysis showed that, on the aforementioned patients who were treated with Evenity for a period of 12 months followed by a treatment based on alendronate, a bisphosphonate drug used to treat osteoporosis and sold by Merck (MRK) under the brand name Fosamax, the incidence of new fractures, compared to alendronate alone, was significantly reduced over a 24 months' period as well as that for clinical fractures and nonvertebral ones.
In the group treated with Evenity and Merck's Fosamax the researchers observed a higher rate of serious cardiovascular adverse events than in the group of patients treated only with alendronate: 2.5% versus 1.9%.
The applications made by Amgen to health authorities of the U.S., Canada and Japan with which the U.S. global health care company is seeking commercialization for Evenity in these countries are currently under review. The Food and Drug Administration's approval for Evenity is not expected by Amgen before the end of 2017 since the U.S. health care company has agreed with the Department of Health and Human Services' federal agency that data from ARCH should be contemplated in its review. The company is preparing the marketing application that will be submitted to the European health authority.
Amgen is trading at $153.16 per share, down $3.35 or minus 2.14% from the previous trading day with a price-sales (P/S) ratio of 4.91, a price-earnings (P/E) ratio of 14.55, a price-book (P/B) ratio of 3.68 and a forward P/E ratio of 12.07.
The health care stock has an average target price of $182.87 per share, which represents a 15.4% upside from the current share price. The recommendation rating is 2.4 out of 5.
Disclosure: I have no positions in any stock mentioned in this article.
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The intrinsic value of AMGN
