Promising Insomnia Pill From Merck & Co., Inc. Remains "Critical" to Future Amid Recent Setbacks

The disappointing earnings report Merck recently announced could have prompted restless nights among investors and analysts. The pharmaceutical manufacturer predicted smaller profits for 2013, and said another setback in its drug pipeline and a significant revenue drop from a popular allergy medication that lost patent protection. Now, the Whitehouse Station-based drugmaker is hoping its new insomnia medication, which is under federal review but has shown promising results in clinical trials, may make everyone sleep a little easier. Analysts say it is a critical piece to the company getting back on track. According to Merck, late-stage trials of the drug, Suvorexant, showed it improved a person’s ability to fall asleep and stay asleep, made them less drowsy the next day and had no significant withdrawal symptoms. Suvorexant was filed with the Food and Drug Administration for review in November — the Drug Enforcement Administration will also review it — and a decision is expected in the fall. It was also filed with regulators in Japan. During a question-and-answer session with analysts following the earnings report on Feb. 1, Merck’s president of global human health, Adam Schechter, cited statistics showing 30 percent of the population has sleep issues and 30 percent are chronically treated. Suvorexant "could really have a significant impact and be an important product for these many patients that are suffering from the inability to sleep," he said. With the company’s recent string of otherwise disappointing news, Suvorexant has taken on greater importance at Merck, said Damien Conover, director of pharmaceutical research for MorningStar Research. He noted the world’s third-largest drugmaker had delayed submitting for review its highly touted osteoporosis medicine, Odanacatib; suspended worldwide sales of its cholesterol medicine, Tredaptive; and saw a $480 million decline in revenue last quarter from its top-selling allergy treatment, Singulair, which lost patent protection in August.