- Teva's multiple sclerosis drug, Copaxone, has long been the Israeli company's highest grossing drug. Last quarter, the drug raised over $1.1 billion in revenues and accounted for 49% of the company's $148 million profit growth during the second quarter.
- The company suffered a setback last year, however, when Novartis' Sandoz launched a generic version - dubbed Glatopa - of the drug's daily treatment. In response, Teva pushed to transition patients to a cheaper, long-acting but still patent-protected version of the treatment.
- While Teva's total market share in the MS field dropped 6.7% since the launch of Glatopa, U.S. sales of Copaxone have increased by 9.8% due largely to a 19.7% increase in prescriptions of the long-acting version during the same period.
Teva's long-acting version is protected by five orange book patents, according to the company, but is facing anti-patent litigation that is unlikely to conclude before 2018. Trials on the first four patents are expected to begin in September.
To date, the only FDA-approved generic for Copaxone is Novartis' Glatopa, which launched June 2015, and is a daily (30 doses of a 20mg injection) treatment.
Generics companies like Novartis' Sandoz and Mylan have long been trying to break into Teva's MS market as early as 2014, with limited success. Meanwhile Novartis developed a short-acting version of the treatment, Mylan submitted a New Drug Application for a version of Teva's long-acting (12 doses of a 40mg injection) Copaxone two years ago.
Various court cases would delay the launch of these products for at least another year, however, as the Supreme Court validated patents in January 2015. Following this decision, Teva's patent for its short-acting version was set to expire in September 2015, although an appeals court later allowed Novartis to market Glatopa earlier.
Meanwhile, the company asserts that despite ongoing litigation, "any generic launch prior to a final non-appealable court ruling on all five patents, which is not expected before second half of 2018, would be at risk," said Teva CEO Erez Vigodman during the company's second quarter earnings call.
The extended protection for the long-acting treatment has allowed Teva to retain market share despite increased competition.
"So on the Copaxone share, I think we're very, very pleased with the fact that 40mg is about 83% the U.S. market," said Vigodman. "And I think of equal importance is the fact that the EU remains on track with the U.S. We're quickly approaching a 60% conversion in Germany. We lead with new patients for Copaxone. And I think this just speaks to the support by payers, by patients, by physicians around the long-proven track record of safety and efficacy of the product and a tribute to the team's great work here."
Due to the expected release of Glatopa, Teva used pricing incentives to push patients to take the patent-protected long-acting version over the short-acting version. According to GoodRx, the 40mg treatment costs $5,652 at a CVS Pharmacy, compared to the $6,893 cost of a 20mg treatment. Meanwhile, the 20mg generic Glatopa treatment costs $4,552.
Last quarter, Teva reported Copaxone held 29.1% of the MS market according to data from IMS Health.