Saturday 1 October 2016

Pharma giant Mylan under fire despite generic EpiPen decision

Ankur Banerjee and Ransdell Pierson

Published 06/09/2016 | 02:30

Mylan has defended EpiPen's price, saying it had spent hundreds of millions of dollars to improve the product since acquiring it in 2007. Stock image
Mylan has defended EpiPen's price, saying it had spent hundreds of millions of dollars to improve the product since acquiring it in 2007. Stock image

Mylan is to launch the first generic version of its allergy auto-injector EpiPen for $300, half the price of the branded product, the drugmaker's latest bid to counter the backlash over the product's steep price.

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It cut the out-of-pocket costs of EpiPen for some patients recently, but kept the list price at about $600, a move that US politicians and Presidential candidate Hillary Clinton said was not enough. EpiPen cost about $100 in 2008.

Mylan says it expects to launch the generic product "in several weeks", an unusual move considering the branded bestseller is still patent protected and major rival treatments have failed to get clearances.

"Our decision to launch a generic alternative to EpiPen is an extraordinary commercial response," chief executive Heather Bresch said last week. "We determined that bypassing the brand system in this case and offering an additional alternative was the best option."

Mylan's price move failed to squelch criticism of the company's huge price increase for EpiPen since it acquired the product in 2007. The U.S. House Committee on Oversight and Government Reform sent a letter to Mylan's ceo last week seeking documents on EpiPen pricing, including those relating to revenue from EpiPen sales since 2007, manufacturing costs, and the amount of money the company receives from federal government healthcare programmes.

US consumer watchdog group Public Citizen claimed the move by Canonsburg, Pennsylvania-headquartered Mylan was another "convoluted mechanism to avoid plain talk".

"We would like the company to drop the price to $100 for two EpiPens," said Public Citizen spokeswoman Angela Bradbery, adding that was about the price charged in France.

She said her organisation has gathered petitions on the issue with various other consumer groups, including Consumers Union.

EpiPen has a 94pc market share for auto-injector devices, which jabs a dose of the drug epinephrine into the thigh to counter dangerous allergic reactions such as to peanuts, food allergies and bee stings. The biggest danger is an allergic reaction called anaphylaxis that could cause death if untreated.

Its only US competitor is Adrenaclick, a device sold by Impax Laboratories that has not caught on with patients and doctors. The product, which is assembled by hand and is not considered by regulators to be an exact copy of EpiPen, has a list price of more than $400.

Impax spokesman Mark Donohue declined to comment on whether the company would lower Adrenaclick's list price given the planned cheaper price of Mylan's generic injector.

Dr Howard Selinger, chairman of family medicine at Quinnipiac University, said he has only written two prescriptions for Adrenaclick because it's not much cheaper than EpiPen. Many other doctors do not know the product's name because of EpiPen's domination, he said.

Industry analysts said the biggest potential threat to EpiPen is a similar device being developed by rival generic drugmaker Teva Pharmaceutical Industries.

The US Food and Drug Administration declined to approve the product because of dosing problems. But some analysts believe Teva, after fixing the issue, could reapply for approval and have its product on the market as soon as next year.

Mylan has defended EpiPen's price, saying it had spent hundreds of millions of dollars to improve the product since acquiring it in 2007.

It has said it recoups less than half the list price as pharmacy benefit managers, which often require discounted prices or rebates from drugmakers, are involved, along with insurers and others. (Reuters)

Irish Independent

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