- Mylan N.V. on April 20 released more than 400 workers from its Morgantown, West Virginia plant, most of whom were production employees.
- Mylan confirmed the news, saying the plant needed to be "rightsized to be less complex," and that the layoffs are "consistent with discussions" it has been having with the Food and Drug Administration. The company added that the cuts are necessary "to position the site as best [it] can for continued operations."
- While Mylan is making efforts to develop new complex generic products, many of its follow-on biologic hopefuls likely won't be made at the West Virginia location as it exists today, given the plant's focus on oral medications.
Pricing pressure has hit generic drugmakers hard these past years, and though tax reform efforts may help some new facilities in the U.S. sprout up, legacy locations can't always benefit from measures to repatriate funds.
Mylan owns twelve manufacturing and distribution sites in the U.S., with five sites it characterizes as "significant sites" — one being the Morgantown location. And it is the only plant in the U.S. that the company identifies as a global "R&D center of excellence."
The company is riding on the hope that new copycat candidates for Humira (adalimumab) and Copaxone (glatiramer acetate) prove successful, and expects to launch a Neulasta (pegfilgrastim) biosimilar in June. It has 16 biosimilars and insulin analogs in development or on the market already, and more than half of its R&D investments are devoted to complex product development.
But the types of drugs made at the Morgantown plant are oral solids, and include both tablets and capsules, said Lauren Kashtan, head of North America communications at Mylan. The West Viriginia facility, then, might feature less heavily in the company's plans for complex injectable products.
"We remain committed to a U.S. manufacturing base and plan to continue making the majority of the medicines we supply to the U.S. in the U.S.," added Kashtan.
Meanwhile, the EpiPen drama is still following the company financially (although those products are not manufactured at the West Virginia site).
Sales of the EpiPen dropped by about $655 million in 2017 as a result of the impact of the launch of its authorized generic, higher rebates to the government stemming from a recent settlement and increased competition from other epinephrine auto-injector makers. To settle the Medicaid-based case, the company estimated it made payments of approximately $472.7 million by year-end 2017; a tough blow to Mylan.
The drop in EpiPen sales might have even been steeper had pharmacy benefit managers decided to favor another alternative to Mylan's offerings — but most of the big PBMs kept the preferred status for Mylan's product on its formularies, insulating the product from an even more drastic sales dip.