- By Alberto Abaterusso
Amgen Inc. (AMGN) announced July 17 it has received a response from the U.S. Food and Drug Administration in regard to its Biologics License Application (BLA) for Evenity.
In its letter, the FDA asked the biopharmaceutical company to integrate the data from the phase three trial of the Frame study on postmenopausal women affected by osteoporosis with the data from the phase three active-comparator ARCH study and the phase three BRIDGE study. The latter assessed Evenity in men with osteoporosis. The data from both studies refers to the safety and efficacy of romosozumab, which was assessed on patients affected with osteoporosis.
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The intrinsic value of AMGN
Evenity is the brand name under which Amgen will commercialize romosozumab once it has obtained approval from the FDA.
Since the drug is able to inhibit osteoblastic activity induced by osteocytes - the most abundant cells in the bone tissue and contained in spaces of lenticular form such gaps or osteoplasts - romosozumab increases bone formation and, therefore, reduces the risk of fractures.
The FDA, however, is not expected to give its approval for Evenity before the end of fiscal 2017.
Romosozumab was originally discovered by UCB (UCB.BR), a biopharmaceutical company formerly known as Celltech. In 2014, Amgen collaborated with UCB to develop the investigational monoclonal antibody.
Amgen is trading at $177.71 per share, up 58 cents or 0.33% from the previous trading day with a price-sales (P/S) ratio of 5.70, a price-earnings (P/E) ratio of 16.88, a price-book (P/B) ratio of 4.28 and a forward P/E ratio of 13.97.
Amgen has an average target price of $182.41 per share, which represents a 2.64% upside from the current share price. The recommendation rating is 2.4 out of 5.
GuruFocus gives Amgen a financial strength rating of 6 out of 10 and a profitability and growth rating of 9 out of 10.
The company distributes an annual dividend of $4.60 through quarterly payments of $1.15 per share, for a dividend yield of 2.6% according to the most recent share price.
Disclosure: I have no positions in any stock mentioned in this article.
This article first appeared on GuruFocus.
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The intrinsic value of AMGN