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Drug Roundup - December 18, 2012
There have been several noteworthy developments in the drug space recently, which will likely have a material impact on the companies in this sector and the markets they serve. Companies mentioned in this review include Pfizer Inc. (PFE - Free Pfizer Stock Report), Novartis AG (NVS), GlaxoSmithKline (GSK), and Teva Pharmaceutical (TEVA).
Pfizer Raises its Dividend
The world’s largest drugmaker recently announced a 9% increase in its common stock dividend from $0.22 a share, to $0.24. The quarterly dividend will be paid on March 5th to shareholders of record as of February 1st. Following the hike, shares of PFE will be yielding about 3.5%, more than one full percentage point above The Value Line Investment Survey median.
Novartis Gains Approval for Signifor
On December 14th, the Swiss-based drug giant announced that the U.S. FDA had approved its Signifor injection, used for the treatment of Cushing’s disease patients who cannot be helped through surgery (Cushing’s disease is caused by overproduction of cortisol, a hormone made by the adrenal glands). Although surgery tends to be the first line of therapy to treat Cushing’s disease, Signifor represents a new option for patients when surgery has not worked or is not viable. The safety and effectiveness of the drug was evaluated in a clinical trial involving 162 patients, with participants receiving a one- or two-dose level of Signifor over a six-month period. Results were positive as Signifor managed to decrease cortisol levels in as early as one month after starting the treatment. About 20% of patients in the trial were able to reduce cortisol levels back into the normal range. However, side effects included significant increases in blood sugar levels being detected in as little as two weeks. The FDA is still requiring three post-marketing studies for the drug, which includes a clinical trial to assess high blood sugar management, a long-term prospective observational cohort study of Cushing’s disease patients being treated with Signifor, and an analysis focused on safety monitoring for reports of serious hyperglycemia, acute liver injury, and adrenal insufficiency.
GlaxoSmithKline Wins Approval for New Flu Vaccine
On December 17th, the company announced it had gained U.S. FDA approval for Fluarix Quadrivalent to immunize children age 3 and older and adults against flu virus subtypes A and B contained in the vaccine. Fluarix Quadrivalent represents the first intramuscular vaccine to protect against four influenza strains, and GSK hopes to make it available in time for the 2013-2014 flu season. At present, the product is not approved or licensed in any country outside the United States.
Teva Establishes Joint Venture in South Korea
In a bid to expand business into increasingly attractive Asian markets, Teva Pharmaceutical announced it has teamed up with Handok Pharmaceuticals to sell and market its products in South Korea. Under the terms, Teva will own a 51% stake in the JV, and it will handle the manufacturing and supply, while Handok will deal with regulators, plus marketing and distribution of the products. In our view, this represents a promising opportunity for both companies, as South Korea is among the fastest-growing drug markets in the world today, with an estimated $14 billion in annual spending.
At the time of this article’s writing, the author did not have positions in any of the companies mentioned.