- Mylan's steep price increases for its epinephrine autoinjector EpiPen have led to accusations of price-gouging and set off a new round of outrage in the ongoing drug pricing debate.
- Competing products from Teva and Sanofi have either been sidelined or pulled off the market, leaving Mylan with a de facto monopoly.
- Adamis Pharmaceuticals has tried twice to win U.S. approval for its epinephrine pre-filled syringe, but regulators have rejected both applications. Adamis plans to resubmit to the Food and Drug Administration sometime in the second half of 2016, and hopes to win approval with a modified application.
Most people will never need an EpiPen. But for those that do, the epinephrine autoinjector, which carries the tagline ‘because every second counts,' is quite literally a lifesaver.
So, when generic company Mylan hiked the wholesale price of the anaphylaxis emergency product by over 400%, patients and lawmakers cried foul. EpiPens that once sold for around $100 are now price over $600, turning the product into a billion-dollar franchise.
At the moment, EpiPen has no competition. Sanofi’s Auvi-Q, which came to the market in 2012, was withdrawn because of dosage problems in 2015 and has now been dropped.
Teva is developing a generic version, but this is likely to be delayed until 2017, according to Bloomberg.
Adamis Pharmaceuticals hopes to change this. The San Diego-based specialty pharmaceuticals company has developed an epinephrine pre-filled syringe that could provide a lower-cost alternative.
The story so far: In March 2015, Adamis received a complete response letter (CRL) from the FDA in response to its new drug application for the product. As a result, the company sought feedback from users and made a number of changes, including making it more user-friendly and reducing the size of the carrying case.
Following an NDA resubmission, the FDA issued another further CRL in June 2016, citing Adamis' human factors study and reliability study.
Adamis believes it can resubmit in the second half of 2016, however, and quickly resolve the outstanding issues.
If the product reaches the market, a subsidiary of Allergan would distribute the product in the US in return for milestone payments of up to $35 million and double-digit royalties.
At a time when ‘price gouging’ has been hitting the headlines, from Turing Pharmaceuticals’ 5000% price hike of Daraprim to Valeant Pharmaceuticals' cost surges for Nitropress and Isuprel, patience (and budgets) are wearing thin for patients and payers alike.
A low-cost EpiPen-alike could make Adamis $50-$100 million in revenues and drive the value of the company’s stock, according the Maxim Group, a New York-based investment bank and wealth management firm.