FDA's generic competition push hits Valeant's Isuprel, a price-hike poster child

Commissioner Scott Gottlieb said his FDA would speed generics to market, and that effort has claimed an early branded victim. Valeant’s heart medication Isuprel, whose controversial hike helped touch off a still-raging debate, faces a newly FDA-approved copycat from Nexus Pharmaceuticals.

Nexus won a green light for its Isuprel generic last week, according to Drugs@FDA, threatening a Valeant drug that pulled in $150 million last year. Along with Nitropress, Isuprel is a hospital-administered heart med Valeant purchased from Marathon Pharmaceuticals back in 2015. The drugs would later be the focus of a Congressional pricing investigation and a part of the pricing firestorm that continues today.

According to Wells Fargo analyst David Maris, Valeant had expected to lose Isuprel exclusivity next quarter. The analyst previously predicted the Canadian drugmaker would be hit hard by the FDA’s new campaign to introduce more competition to the drug market by prioritizing some generic reviews and introducing other measures.

After picking up the pair of heart meds from Marathon, Valeant jacked up their prices by several hundred percent—Isuprel went up by more than 300%, to $881 per vial—leading Congressional pharma critics Rep. Elijah Cummings and Sen. Bernie Sanders to demand answers from then-CEO J. Michael Pearson. As part of their inquiry, the lawmakers wanted to see sales and expense figures for the drugs, profit projections and more.

Since then, as industry watchers know, things have taken a turn for the worse at Valeant as a series of problems came to light at the company, prompting new investigations and a variety of lawsuits. Valeant’s share price has cratered more than 90% since the summer of 2015.

After he was sworn in earlier this year, Gottlieb unveiled a plan to combat some of the industry’s pricing tactics. At a congressional budget hearing, Gottlieb said the FDA under his direction will publish and regularly update a list of medications that are off patent and have no competition and work to improve generic review times. The agency will also seek to "curtail gaming" of regulations; companies have used such workarounds to extend patent monopolies.

Isuprel first won approval way back in 1956, according to Drugs@FDA. It has no remaining active patents, according to the agency’s Orange Book. Nexus' chief commercial officer Omair Ahmed told FiercePharma the company's generic should be available within the month.

Writing on the approval, Maris said Nexus "believes they have no capacity constraints for the U.S. market, and is to command the lion's share of the market as their product is made in the U.S. (including the active pharmaceutical ingredient), and has 24-month stability vs. what they state is 18 months for Valeant."

At Valeant, meanwhile, hedge fund billionaire John Paulson has taken up a board position, just after another high profile investor, Bill Ackman, called it quits on the embattled drugmaker. The company reports second-quarter results Tuesday.