Copaxone: Built To Last
The first prescriptions for Teva's Copaxone were written in the spring of 1997, with peak sales estimated at $250 million. Seventeen years and many billions of dollars later, Teva has returned for an encore with the approval of a newly-formulated Copaxone touting fewer injections, just in time to upstage the potential entrance of generic competition this summer.By Ben Comer
Specialty drugs for the treatment of chronic disease, along with orphan drugs for rare conditions, are the two most popular areas of biopharmaceutical R&D activity for one obvious reason—optimal return on investment. In the case of chronic diseases, companies turn patients into walking annuities toting a prescription that needs to be filled and refilled perpetually, with a caveat: it's hard to know how a drug will perform for patients 10 or 20 years later, in the real world. Products age along with the patients who take them, sometimes with unexpected results.
Copaxone (glatiramer acetate injection), Israel-based Teva's multiple sclerosis drug and a once unlikely blockbuster, was chosen by Pharm Exec as one of this year's two Brand of the Year awards for its consistent success in this context. Copaxone has been on the market for 17 years, with virtually no serious side effects emerging during that time. According to John Hassler, Teva's VP of marketing for neuroscience, Copaxone is the "market leading therapy for relapsing-remitting forms of multiple sclerosis, with over 40% more total prescription volume than the next closest competitor."
About 35% of all patients taking a drug for MS take Copaxone, or roughly 85,000 patients, adds Mike Derkacz, VP and general manager of Teva's CNS unit. Derkacz held the same title at Cephalon prior to Teva's acquisition of that company in 2011.
In January, Teva received approval for a new 40mg version of Copaxone that reduces the number of injections from seven a week, to three. Despite the recent Supreme Court decision on Copaxone's patent—which opens the door to potential generic competition as soon as this month—Teva has already recorded strong results from the newly-formulated 40mg version. Seven weeks into the launch, Copaxone 40mg became the most prescribed treatment in terms of new prescriptions for patients with relapsing-remitting MS, the most common form of the disease, and has remained at the top since then, the company says.
Despite competing with at least a half-dozen newer disease-modifying agents for the treatment of MS, some of them oral formulations, Copaxone still managed to lead the category in 2013, with global sales topping $4.3 billion.