After last week’s FDA rejection for Sandoz’s generic Advair, Novartis’ copycat arm needed a win. And it got a key one Tuesday with the approval of generic 40-mg Copaxone.
After manufacturing delays, Sandoz has nabbed an FDA green light for Glatopa, a fully substitutable version of the long-acting formula of Teva’s multiple sclerosis star. And Sandoz will back up that launch with a copay support program that gives new patients a chance to try the formula with no charge at the pharmacy. It's also offering personalized injection training, 24-hour nurse access and a free starter kit that includes its Glatopaject injection device.
Novartis, which won its approval for 20mg Glatopa in 2015, hit a stumbling block with the 40-mg formulation last February, when U.S. regulators handed Pfizer a warning letter over the McPherson, Kansas-based plant the Swiss drugmaker was using to finish the product.
The legacy Hospira site had already suffered repeated issues, and this one ended up costing Novartis close to a year of Glatopa sales.
Pfizer signaled good news ahead last month, however, with an announcement that the FDA had upgraded the plant’s compliance status. And it’s good news Sandoz needed, particularly now that the FDA has refused to OK the drugmaker’s version of GlaxoSmithKline respiratory giant Advair.
In the meantime, though, Mylan has moved in with the market’s first 40-mg Copaxone approval, which the company snagged in October after its own fair share of delays. Since then, it’s gone on to snap up a sizable piece of the market, with Credit Suisse analyst Vamil Divan last month crediting Mylan with 10% of total Copaxone prescriptions.
On the other side of the coin, more competition is a negative for Teva, although dramatically lowered expectations for the troubled company mean the situation with Copaxone doesn’t look as dire as it once did. Market watchers are already expecting the sales drop.
“We already model steep erosion of U.S. Copaxone sales,” Divan wrote Tuesday, predicting a 60% decline—to $1.2 billion from $3 billion—this year. “Based on recent conversations, most investors appear to be assuming similar erosion rates,” he added.
Teva, whose new CEO Kåre Schultz queued up 14,000 layoffs immediately upon taking the reins, is working its way back from serious debt and hobbling generics pricing pressure. But Divan, for one, likes what he sees so far. He recently upgraded the company’s shares, pointing to “early signs of execution” on the restructuring plan.
And he predicts the dim generic situation will come around, too.
“We expect the focus on healthcare spending and, in particular, increased drug spending, to lead to greater utilization of generic drugs both in the U.S. and outside of the U.S., and this is something that should ultimately be a positive for Teva and other large generic manufacturers,” he wrote.