- A high-stakes trial pitting Novartis' and Teva Pharmaceuticals' top-selling multiple sclerosis drugs head to head found the Swiss pharma's treatment to hold an efficacy edge.
- Novartis released topline data for the Phase 3b study Wednesday, showing its drug Gilenya beat Teva's Copaxone 20 mg at reducing the rate of relapses in patients with relapsing remitting MS, the most common form of the central nervous system disease.
- However, Gilenya only reached statistical significance with the higher 0.5 mg dosing level against 20 mg injections of Copaxone, touting a 41% relative reduction in the relapse rate at that dosage. The 0.25 mg dose did not lower the relapse rate in a statistically meaningful way.
While Novartis likely would have preferred to hit on both dosage levels, it played the study results off as a win for Gilenya (fingolimod).
"The ASSESS data add to the robust body of evidence which show that Gilenya is a highly efficacious, cornerstone therapy in relapsing MS," Danny Bar-Zohar, Novartis' global head of neuroscience development, said in an Oct. 10 statement.
The data could be useful in helping Gilenya hold its market share. Yet the MS market is highly competitive, with new entrants like Roche's Ocrevus (ocrelizumab) putting pressure on incumbents.
First is the fact that both marketed doses of Copaxone (glatiramer acetate) have now gone generic. Copycat treatments to the higher 40 mg dose of the drug have been on the market for roughly a year and will put fresh competitive pressures on Teva. Even if Gilenya is seen as more effective than Copaxone in treating relapsing MS, a cheaper price could factor into physician and patient decision-making.
And the price of MS drugs matters. A little more than a year ago, two congressional members opened an investigation into why drugmakers have steadily increased the cost of such treatments in recent years.
In a letter, Reps. Elijah Cummings, D-Md., and Peter Welch, D-Vt., noted that the price of Gilenya has soared from roughly $51,000 in 2010 to $92,000 in 2017.
The 20 mg version of Copaxone was originally approved in 1996 with a price of $8,300. It was up to $91,400 last year. The 40 mg version tracked up from $63,700 in 2014 to $80,100 in 2017.
Beyond generic and pricing concerns, Roche's Ocrevus has proven itself a major competitor since winning approval last year for both relapsing remitting and primary progressive MS.
Already, Ocrevus is on track to break $2 billion in sales for 2018 after posting roughly $1 billion over the first six months.
Ocrevus sales still lag behind Gilenya and Copaxone, which posted respective 2017 sales of $3.2 billion and $4.4 billion, but Ocrevus is rapidly gaining ground. On its last earnings call, Roche CEO Daniel O'Day said roughly one in three MS patients new to treatment or switching from another treatment received Ocrevus.
Novartis said it plans on publishing full study results and presenting them at upcoming medical meetings once it finishes its review of the data.