J&J Sees 10 Products Submitted for Approval by 2017Shannon Pettypiece and Michelle Fay Cortez
Johnson & Johnson, the world’s biggest maker of health-care products, anticipates submitting more than 10 new medicines for approval by regulators worldwide by 2017, including a modified version of a decades-old anesthetic that has been misused as a date-rape drug.
There also are plans to improve more than 25 current drugs during the same period, the New Brunswick, New Jersey-based company said today in a statement. The wave of new therapies developed in-house and acquired from outside may keep J&J in its position as the fastest growing drugmaker in 2012 among the largest pharmaceutical companies.
J&J’s drug unit, which accounts for 38 percent of the company’s annual sales, was the main driver of growth in 2011 and 2012, said Michael Weinstein, an analyst at JPMorgan Chase & Co. in New York. J&J has started selling eight new products since 2011 that generated $4.4 billion in sales last year, including the prostate cancer drug Zytiga, the diabetes medicine Invokana and the blood thinner Xarelto.
“By focusing on transformational innovation we can make a difference in the world and also build a sustainable, growing business for the future,” said Paul Stoffels, J&J’s chief scientific officer and worldwide chairman of pharmaceuticals. “With a steadfast focus on the most serious unmet medical needs, our approach is to identify the best science, internal and external, to deliver new options and solutions to patients.”
J&J, which released its pharmaceutical plans today at a meeting with analysts at its headquarters, fell less than 1 percent to $87.21 at the close in New York. The shares gained 38 percent in the past 12 months.
J&J is targeting some of the biggest markets and diseases that currently have few treatment options in its growth plan. The company plans to file for approval by 2017 of medicines including simeprevir for hepatitis C, ibrutinib and daratumumab for blood cancers, sirukumab and guselkumab for diseases of the immune system and vaccines for influenza, rabies and polio.
The company is also studying for depression an altered formulation of the human and animal anesthetic called ketamine, which the Department of Health and Human Services says is one of the most commonly used drugs in date rape. J&J said its altered formulation, called esketamine, is designed to be safer than the older drug, which can cause hallucination and delirium, and would be less prone to abuse.
J&J’s drug is one-twelfth the dosage used in anesthesia and would be administered nasally, said Husseini Manji, head of neuroscience at J&J. The company said the product is in the second of three stages of testing required to get U.S. regulatory approval and didn’t provide an estimated time for when it may reach the market.
For patients with major depression, J&J hopes the drug will be more effective than current treatments while providing faster results, Manji said. Existing depression drugs can take weeks to start working, requiring suicidal patients to be institutionalized, sometimes for months, until the drugs take affect. In a study, patients taking ketamine saw a benefit in a few hours, Manji said.
The pharmaceutical market is expected to grow about 4.5 percent each year to $1.2 trillion by 2017, the company said, citing statistics from industry-data tracker IMS Health. J&J said it’s focused on expanding business in emerging markets such as China, Brazil and India, which accounted for almost 20 percent of sales in the first quarter.
“The outlook for J&J’s pharma business appears bright,” Weinstein wrote in a May 13 note to clients that estimated sales growth of 7.5 percent in 2013 and 5 percent to 7 percent through 2016. “It’s a combination of base business products that continue to perform well coupled with new product launches layering on additional growth.”
New medicines are expected to account for almost half of the company’s pharmaceutical sales by 2017.