Pharm Exec's Brand of the Year
award is itself a brand with staying power—our first recipient was Merck's Gardasil papillomavirus vaccine, which eight years
later is still going strong as one of the company's 10 top-selling products. This year's winner, Teva's Copaxone, also pins
the needle on the long tail, at 17 years on the market with an equally durable safety profile against its nemesis, the elusive
autoimmune disease multiple sclerosis. But lest we be accused of being safely predictable, this year Pharm Exec decided to
focus, too, on clinical and marketing achievement for an orphan-status rare disease drug, calling out Bay area start-up Corcept
Therapeutics' initiative in repurposing an old drug, mifepristone, for a new indication as the first treatment for Cushing's
syndrome, a disabling metabolic disorder that is habitually underdiagnosed. Corcept's KORLYM carries larger potential as the
test launch for a new class of medicines to address how the "fight or flight" hormone, cortisol, works as a precursor to many
chronic life-threatening conditions that affect millions of patients outside the rare disease space. It's literally a new
way to think about disease. — William Looney, Editor-in-Chief
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.
Teva has continued to improve the Copaxone brand experience for patients over time, from a new injection device to engaging
patients online and off. The company hosted an early online MS patient community—http://MSWatch.com/—"long before the term 'social media' was coined," says Hassler. Shared Solutions, now a part of Teva, made nurses available
to patients around the clock beginning in 1997, when Copaxone launched. Shared Solutions, a gold standard in the category,
is open to all MS patients, regardless of therapy.
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.