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 reporton 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.
“It’s a pretty critical drug for them,” Conover said, referring to Suvorexant. “It’s tricky to know the exact potential, but the insomnia market is a $2 billion industry. This is a big market and there’s an opportunity.”
Adding to its turbulent ride, a federal jury in Manhattan last week ordered Merck pay a woman $285,000 in a lawsuit for her injuries after taking its osteoporosis medication, Fosomax. More than 4,000 similar lawsuits remain — Merck has so far won five and lost two — including nearly 850 in federal court in New Jersey, alleging the drug caused femur injuries.
While other insomnia drugs affect the brain on a broader scale, experts said Suvorexant works on the specific chemicals called orexins within the brain, which is associated with sleep disruption.
Joseph Herring, Merck’s executive director for clinical neuroscience, said patients in two clinical trials — about 1,000 participated in each — “saw improvements in sleep maintenance, their ability to fall asleep faster and stay asleep longer.”
Herring, who oversees the clinical development for Suvorexant, called the results “overall, very good.”
In high dosages of Suvorexant, about 10 percent of patients experienced headaches, while about 7 percent experienced next-day sleepiness. But in the overall study population, there was no statistical next-day side effects between the patients given Suvorexant and those given placebos, according to the results.
But because of Merck’s recent setbacks in several pipeline drugs, Conover of MorningStar Research said analysts and investors will be closely watching Suvorexant’s progress. The drug, which could be launched in December if Merck receives FDA approval in the fall, could have an impact in 2014, he said.
Its approval, he said, will be a step in the right direction. “That’s going to be key.”
SOURCE: The Star-Ledger