St. Louis area manufacturer of EpiPens to produce Mylan's new generic version


By:  Samantha Liss
St. Louis Post-Dispatch

Drugmaker Mylan NV will produce a generic version of the EpiPen after receiving unrelenting criticism over its high prices for the life-saving drug that stops allergic reactions.

The company said Monday the generic version would result in cost savings of up to 50 percent, or a list price of $300 as opposed to the $600 price that caused a backlash from consumers, including parents who must buy the injectable drug for their school-age children.

The money-saving generic version will be produced in the same St. Louis area facilities where the EpiPen is made.

Meridian Medical Technologies, a Pfizer subsidiary with facilities in Brentwood and Maryland Heights, is the sole firm that manufactures the EpiPen for Mylan, and it will also produce the new generic version, Rachel Hooper, a Pfizer spokeswoman, told the Post-Dispatch on Monday.

Meridian’s profile is likely to rise as controversy continues to build about the price of the allergy auto-injector device.

On Monday, U.S. Reps. Jason Chaffetz and Elijah Cummings of the House Committee on Oversight and Government Reform sent a letter to Mylan Chief Executive Heather Bresch asking for documents and communications related to EpiPen price, including how much it costs to make.

Chaffetz and Cummings, the committee’s chairman and ranking member respectively, are seeking documents related to Mylan’s revenue from sales of EpiPens since 2007 and manufacturing costs, as well as the amount the company receives from federal health care programs.

EpiPens are used in emergencies to treat severe allergies to insect bites and foods such as nuts and eggs that can lead to anaphylactic shock. People usually keep EpiPens handy at home, school or work. The syringes, prefilled with the hormone epinephrine, expire after a year.

Consumers and politicians have accused Mylan of price-gouging, because the list price for a pair of EpiPens has climbed repeatedly from around $94 in 2007, when the Dutch company acquired the product.

Sen. Claire McCaskill, D-Missouri, weighed in on on the controversy by sending Mylan’s CEO a letter calling for more information about the company’s decision to raise prices.

She also commented on the issue at an unrelated event on Monday, saying that drug prices “were raised unconscionably."

"Companies shouldn’t be able to use a de facto monopoly to jack up prices," the senator said. "We’ve seen these companies scraping every last dollar from consumers, and they’ve been getting away with it. But I’m confident that public pressure from Congress and others is having an effect here. No one is eager to create restrictions on the free market, but we can’t stand by when something like this happens.”

Mylan has defended the price increases by claiming 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 because pharmacy benefit managers, or PBMs, such as north St. Louis County-based Express Scripts are involved, along with insurers and others.

PBMs often get discounts off a drug’s list price, and patient out-of-pocket costs can vary by plan. For instance, Express Scripts customers pay $73.50 on average, a price the company has kept fairly stable for a couple of years.

Mylan said that last year, nearly 80 percent of its patients with commercial insurance paid nothing out of pocket for an EpiPen prescription due to its savings card.

But faced with mounting criticism, Mylan last week announced it would expand programs that help people pay for EpiPens. It doubled the limit for eligibility for its patient assistance program, so a family of four making up to $97,200 would pay nothing out of pocket. It also said it will offer $300 co-pay cards, up from the current $100 per-prescription savings.

And on Monday, Mylan announced it was adding the generic alternative, a move Bresch characterized as “an extraordinary commercial response.”

However, consumer watchdog group Public Citizen called the company’s latest move another “convoluted mechanism to avoid plain talk, admit to price-gouging and just cut the price of EpiPen.”

“The weirdness of a generic drug company offering a generic version of its own branded but off-patent product is a signal that something is wrong,” said Robert Weissman, president of the consumer organization.

The St. Louis connection

The story of how Mylan’s controversial product came to be produced in St. Louis by the subsidiary of a competitor stretches back more than a decade and is the result of several corporate mergers and acquisitions, according to Food and Drug Administration and Securities and Exchange Commission records.

Today, Meridian’s Brentwood facility formulates the EpiPen, and then it’s assembled, stored and shipped out of its Maryland Heights facility, according to Carl Williams, a business representative with Teamsters Local 688, who says he represents more than 375 union workers at the facilities.

The Maryland Heights facility formerly housed the former Jones Pharma Inc. manufacturing plant. Jones Pharma previously manufactured specialty pharmaceuticals and was acquired in 2000. Dennis M. Jones was the founder of Jones Pharma.

Although it’s not clear exactly when Meridian began manufacturing the EpiPen in the St. Louis area, the Columbia, Md.-based company has long produced the drug for various pharmaceutical companies.

Since at least 2001, Meridian has been the manufacturer of the EpiPen, according to previous labeling information with the FDA. That year, the company was making it for Dey, a U.S. subsidiary of Merck KGaA. When Mylan acquired Dey in 2007, it also acquired EpiPen.

Meanwhile, Meridian Medical Technologies also went through a series of its own acquisitions. The firm was purchased by King Pharmaceuticals in 2003; King was acquired by Pfizer in 2011.

And that’s how a Pfizer company came to be the contract manufacturer of the EpiPen for Mylan.

In 2013, Meridian garnered headlines after it suspended manufacture of its antidote to sarin nerve gas at the local plants because of quality-control issues.

Sarin is a poisonous gas and the Pentagon had contracts with Meridian to supply the antidote. But company officials acknowledged that in certain cases, the pre-filled syringes were not adequately filled.

The Associated Press and Reuters contributed to this report.