Momenta Pharmaceuticals developed Glatopa, the first US generic version of Teva’s multiple sclerosis blockbuster drug Copaxone (glatiramer acetate), launched by Novartis offshoot Sandoz last June.
And while the firm announced it has received $43m (€38m) in product revenues since the launch, CEO Craig Wheeler said during a conference call last week Momenta and Sandoz have a long way to go in countering Teva’s defense tactics before Glatopa can take a significant share of the market.
“Teva has switched approximately 75% of once daily Copaxone 20mg patients to three times weekly Copaxone 40mg product [launched in January 2014], and Teva has aggressively defended the remaining 20mg share with implementation of a strong dispenses written campaign prior to and during Sandoz’s launch of Glatopa,” he told investors.
Furthermore, Teva “has made contracting difficult in some accounts because of their franchise rebating strategy, which appears to tie rebates on their three-times weekly product to continue the use of the 20mg product.”
For the full year 2015, Teva actually reported an increase of 4% year-on-year to $3.2bn for Copaxone sales, although fourth quarter sales dropped 9% to $760m.
“The challenge now is to define strategies to continue to increase Glatopa’s market penetration,” Wheeler said. “Sandoz and Novartis have the capabilities necessary and are focused on countering these tactics, but it will take time.”
The 40mg thrice-weekly reformulation is protected by three US Orange Book patents that expire in 2030, but Sandoz is legally challenging Teva’s patents, and an ANDA for a generic thrice-weekly Copaxone generic is currently under active review by the US Food and Drug Administration (FDA).
"From a competitive standpoint we are still the only company to have the API approved for the 20mg Copaxone [generic]. This is the same API as the 40mg version. We believe by having approved 20mg API we may be better positioned than others to gain approval for our three times per week application," said Wheeler.
“We have received a target action date and expect approval this year. We expect that accessing the market with this product will block many of Teva’s tactics and open up a much broader market for Glatopa.”