Mylan's EpiPen Boosted as FDA Sees Holes in Teva Application

  • Teva expects its injection will be `significantly delayed'
  • Israel drugmaker will submit response to U.S. agency

Mylan NV may be able to curtail a decline in future sales of its EpiPen allergy-reaction injector after the U.S. Food and Drug Administration identified “major deficiencies” in an application for a competing generic version from Teva Pharmaceutical Industries Ltd.

Teva intends to submit a response to the FDA, but expects the launch of its epinephrine injection to be “significantly delayed” until at least 2017, the company said in a filing to the Tel Aviv stock exchange Tuesday.

That may boost Mylan’s 2017 earnings by 20 cents a share, Evercore ISI analyst Umer Raffat wrote in a note to clients. “If there is a longer delay, outer year estimates may need more meaningful revision.”

The setback to Teva’s launch could provide a lift to Mylan’s specialty division as EpiPen is the unit’s main product. Analysts had forecast erosion of $200 million in EpiPen sales in 2017, Raffat said. 

Revenue from Mylan’s specialty division rose about 1 percent to $1.2 billion in 2015, or 13 percent of total sales. The product got a boost in October after a rival version made by Sanofi was recalled because there was a chance that the device wasn’t delivering the drug.

Mylan shares rose less than 1 percent to $45.39 at 9:49 a.m. in New York. Teva dropped 1.4 percent to 217.40 shekels in Tel Aviv.

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