Biotech and Pharma

Pfizer under pressure to resolve shortage of life-saving EpiPen

David Crow
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Mylan, the company behind the EpiPen allergy injector, is pressing its manufacturing partner Pfizer to do more to tackle shortages of the life-saving medicine in a sign of its growing frustration with the Big Pharma company.

Although Mylan owns the rights to the EpiPen — which can stave off deadly anaphylactic shock — it subcontracts manufacturing of the auto-injector to Meridian Medical, a division of Pfizer.

However, Pfizer has struggled to meet demand for the allergy injector, resulting in some patients having difficulties finding the product in their local pharmacies. The US Food and Drug Administration put the medicine on its official shortages list earlier this month.

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If not resolved, the shortages could become more severe in the third quarter when demand tends to soar as children with severe allergies return to school.

Mylan has responded to the shortage by sending a team of its own managers to try to fix problems at a Pfizer factory in St Louis, Missouri — which makes all the EpiPens in the US — according to people familiar with the situation.

The factory in St Louis has been struggling to maintain production following an inspection that resulted in a scathing warning letter in September from the FDA, which ordered it to fix several quality control issues.

Mylan sent its team to the plant in part because its managers sensed a lack of urgency among their counterparts at Pfizer, which is dealing with shortages of hundreds of drugs, one person said.

While the EpiPen is but one among the hundreds of products in short supply, it has outsize importance for Mylan because it is the company's best-known drug.

In a joint statement, Pfizer and Mylan said: "Both companies are fully aware of the life-saving importance of EpiPen and we are working together, as we have throughout our long collaboration, to increase production and expedite shipments as rapidly as possible."

They said their partnership had "always included frequent interactions such as visits to each other's sites".

The shortage of EpiPens is particularly irksome for Mylan as it tries to move on from controversy over the cost of the medicine. The company had priced a two-pack of EpiPens at roughly $600 until 2016, when a political and public backlash forced it to introduce a cheaper generic version.

"Mylan's management has never been shy to show how they feel about business issues," said Ronny Gal, analyst at Bernstein, who added that the company had several "fair arguments" against Pfizer.

"This is actually a life-saving, mission-critical product and it is Pfizer's fault — but it is casting Mylan in a bad light when they already have a reputation problem."

He added: "And this product has had decades of manufacturing issues that Pfizer has never fixed."

The EpiPen shortage comes as Pfizer races to resolve shortages caused by manufacturing problems at several of its factories, many of them acquired when it took over Hospira, a maker of injectable drugs, for $16bn in 2015.

A rival allergy injector known as Adrenaclick, which is marketed by Amneal Pharmaceuticals, is also in short supply because of issues at a Pfizer plant in McPherson, Kansas, which makes the crucial ingredient.

A spokesperson for Amneal said the company was "not pleased by the shortages" and that it was "trying to resolve them by working with the manufacturer and the FDA".

Mr. Gal said that Pfizer should try to "prioritise life-saving drugs like Adrenaclick and EpiPen" as it works through the problems at its plants.

A Pfizer spokesperson said: "We are currently shipping product and our shipments have been increasing over the last few months, with April shipments exceeding projections."

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