- The Food and Drug Administration has OK'd a second 40 mg generic version of Teva Pharmaceutical Industries Ltd.'s multiple sclerosis medicine Copaxone, clearing a copy developed by Novartis AG's Sandoz division.
- Approval of Sandoz' Glatopa 40 mg will ratchet up the competitive threat to Copaxone, putting further pressure on Teva as the Israeli drugmaker faces major challenges across its business lines.
- Manufacturing issues at the Pfizer Inc.-owned facility contracted by Novartis and its partner Momenta Pharmaceuticals Inc. to produce Glatopa 40 mg had delayed approval, costing the companies a chance at being first to market. Rival Mylan N.V. won an FDA OK for its version last October.
Approval of Sandoz's 40 mg per milliliter copy appears to have come earlier than Teva expected.
On an earnings call last week, Teva CFO Michael McLellan laid out the company's expectations for Copaxone, forecasting $1.8 billion in 2018 sales and assuming an April launch of a second 40 mg version.
While a couple months may not seem like much of a difference, entry of Novartis' copy will likely accelerate branded sales erosion and further bring down net prices in the market.
Teva has already felt the impact of Mylan launching its 40 mg generic earlier than expected. U.S. sales of Copaxone fell by 25% during the fourth quarter, dropping to $622 million from $829 million in the same period a year prior.
Global sales of the drug totaled $3.8 billion last year, making up a shade under 20% of Teva's overall revenue.
The decline in the fourth quarter was primarily due to higher rebates and lower volumes sold, Teva said. A price hike of 7.9% taken by the company for both the 20 mg and 40 mg versions in early 2017 partially offset those effects.
Generic copies to the 20 mg formulation of Copaxone have been available for several years, but Teva has had some success in staving off a crippling blow to the drug's revenues by marketing the larger 40 mg version.
With multiple copies now approved for both formulations, Copaxone sales look set for major declines. Cowen analyst Ken Cacciatore predicts that Teva revenues from the drug will eventually settle to between $400 million and $500 million per year, assuming 50% price discounts from the generic competitors.
Approval of Sandoz' Glatopa 40 mg was likely triggered by the FDA reclassifying the Pfizer Inc. plant contracted for production, indicating the violations initially flagged by the regulator had been largely addressed.