Mylan's EpiPen Added to FDA List of Medications in Short Supply

(Bloomberg) -- Mylan NV said that the U.S. Food and Drug Administration posted a supply notification about its EpiPen device, after patients and pharmacists reported difficulties finding the lifesaving shot.

On Tuesday, Bloomberg reported more than 400 patients in 45 states said they were having trouble tracking down the EpiPen and other similar epinephrine injectors. Most patients told patient-advocacy group Food Allergy Research & Education that they haven’t been able to obtain the devices at all, while others said they have had to wait several weeks to get one.

“There are intermittent supply constraints; however, product is available and Mylan is currently receiving continual supply from its manufacturing partner Meridian Medical Technologies, a Pfizer company,” Mylan said in a statement on Wednesday. EpiPen is manufactured by Pfizer Inc. and sold by Mylan.

The FDA said on its website that Mylan “is receiving continual supply from MMT and expediting shipment to wholesalers.”

Steve Danehy, a Pfizer spokesman, didn’t immediately return a request for comment Wednesday morning.

Mylan shares rose about 1 percent in premarket trading to $35.70 at 8:31 a.m. in New York.

Weaker Sales

Weaker sales of EpiPen contributed to a dropoff in Mylan’s sales in North America during the first quarter, the company said in a separate statement on Wednesday.

The drugmaker said that first-quarter sales in North America dropped 19 percent from a year earlier to $985.3 million. Overall revenue in the quarter was $2.68 billion, the company said, missing analysts’ expectations for $2.74 billion.

Mylan, the second-biggest generic drug manufacturer by sales, is faced with an industry-wide pattern of depressed sales of U.S. generic drugs and headwinds from competitive pricing. The drugmaker has 2,500 products in its pipeline and has turned to developing complex generic products and biosimilars, or copycat versions of biotechnology medicines, to make up for weakness in other parts of its portfolio.

“Our diversity and durability are what allow us to absorb evolving industry dynamics and natural market volatility, while at the same time accelerate our mission of providing access to high quality medicine,” Heather Bresch, Mylan’s chief executive officer, said in the statement.

Mylan’s North American sales were pressured by a $108.7 million combined decrease in the sales of branded products, including EpiPen, the company said, in addition to the loss of exclusivity on blood-pressure drug olmesartan.

Wednesday’s report marked the fifth consecutive quarter Mylan has missed Wall Street’s revenue expectations. First-quarter earnings per share of 96 cents met expectations, as analysts adjusted their estimates after Mylan executives said the year’s profits might be weighted in the second half of 2018.

©2018 Bloomberg L.P.

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