Mylan CEO Heather Bresch testifies before the House Oversight and Government Reform Committee during a 2016 hearing titled “Reviewing the rising price of EpiPens.”
EpiPens save lives. It’s a fact that many patients believe was exploited by Mylan after it acquired the anti-anaphylaxis franchise in 2007 and began jacking up prices in 2009.
Over the course of seven years, the specialty pharma company raised the price of its emergency epinephrine autoinjectors by 400 percent, from $124 to $609 for a pack of two.
Mylan and EpiPens became the face of ‘price gouging.’ Public outcry ensued, along with a dedicated hearing before the House Oversight and Government Reform Committee.
In 2017, the winds are finally shifting.
On Thursday, San Diego, California-based Adamis Pharmaceuticals received a nod from the FDA to begin marketing its version of the device. Shares of the NASDAQ-listed company spiked 50 percent following the news.
Via phone, Mark Flather, senior director of investor relations and corporate communications for Adamis, said the company won’t release a definitive price until the product launches in the second half of this year. The expectation is, however, that it will meet customers’ demand for a more affordable product.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“We expect to be cheaper than the other offerings on the market,” Flather stated.
Cost is one of three key advantages Adamis hopes to bring with its new product, dubbed Symjepi.
The second value proposition is ease-of-use. Symjepi is a prefilled syringe, not an autoinjector. While that sounds more complicated and hazardous, Flather said the opposite is true. The needle itself is the same size as the one found in an EpiPen. But there are fewer unknowns in the way.
“All the auto-injectors come with a training device, so they’re not that intuitive,” Flather said, adding that studies show even doctors misuse autoinjectors a significant amount of the time.
By comparison, people are familiar with injections; they’ve had vaccines, they’ve been to the dentist, they’ve seen people with diabetes inject insulin.
The third benefit Flather cites its Symjepi’s portability. The product is approximately four inches long (see image below) and fits in the palm of an adult hand. At the same time, Adamis has been preparing its NDA for an even smaller “junior” version of the device.
Adamis Pharmaceuticals’ newly approved prefilled epinephrine syringe Symjepi (Photo/Adamis)
For many observers, the last two benefits are a nice-to-have. What matters most is having an alternative to the high-cost EpiPen, first approved for use in the 1980s.
With no R&D expenses to hide behind, Mylan took a lot of heat for its pricing hikes. Jimmy Kimmel even had a dig in September 2016 while hosting the Emmy Awards, a sign of how mainstream the issue had become.
Mylan eventually launched its own generic version, which sold for 50 percent less than its brand-name brother. An alternative device named Adrenaclick was also launched by Impax Laboratories and is now sold through CVS pharmacy stores.
In October 2016, Mylan agreed to pay the federal government $465 million to settle questions of how the company’s EpiPen was classified under the Medicaid Drug Rebate Program.
It’s a good refund, but it also underscores how large the sales numbers grew.
A U.S. Government Report published just last month concluded that American taxpayers may have overpaid for Mylan’s EpiPen by $1.27 billion over the last 10 years.
Photo: Alex Wong, Getty Images
