- Mylan New Zealand and Mylan-owned Alphapharm in Australia have recalled a number of batches of Mylan's adrenaline auto-injector EpiPen, that expire April 2017. Other recalls of the batches have taken place in Japan and Europe, Mylan told BioPharma Dive.
- The injectors in the recalled batches may have a defective part that could result in the pen failing to activate or being more difficult to operate. These batches were manufactured by Meridian Medical Technologies in St. Louis, MO.
- The defects have been seen in two devices worldwide in a batch of around 80,000 devices; however, Mylan confirmed that none of these batches has been distributed to the U.S.
Mylan and its EpiPen have been dogged by controversy of late, and this voluntary recall isn't going to help the company any.
"Mylan has issued a voluntary recall for one lot of EpiPen Auto-Injectors (5FA665) distributed in Australia, New Zealand, Europe and Japan only. This lot was not distributed in the U.S.," said the company to BioPharma Dive in an email.
Mylan faced pushback over the rise in price of an EpiPen two-pack from less than $200 in 2007 to more than $600 last year; it responded by creating a half-price generic version and offering discounts to uninsured or underinsured patients, bringing the price down to about $300 for thw two-pack in both cases. The company also had to pay a $465 million settlement for overcharging the federal government for its EpiPens, and this drove a third-quarter 2016 loss.
EpiPen is used an emergency treatment for allergic reactions. It is often used by children or caregivers in emergency situations and needs to be easy to operate. One thing that has made the brand successful and allowed Mylan to keep competition at bay has been the reliability of the product and the trust that parents put in the brand. Any further erosion of that trust could mean a major hit to sales for Mylan—even if the recall is limited.
A safety recall sunk a similar product called Auvi-Q, that was marketed by Sanofi and Kaleo. The pair were forced to withdraw Auvi-Q for safety reasons and Sanofi dropped the partnership. Yet, Kaleo has recently relaunched Auvi-Q in the U.S., but is already facing scrutiny for suggestions it will cost payers and insurers $4,500 for a two-pack.
Impax Pharmaceuticals is also offering an EpiPen alternative, dubbed Adrenaclick, that can cost as little as $110 per two-pack with rebates and discounts.
Adamis Pharmaceuticals' pre-filled syringe, which is currently under review by the Food and Drug Administration, has a PDUFA date in June 2017. This could mean that it is only a few months off the market. Analysts at Maxim see Adamis' syringe as "a better, more user-friendly product (design wise) versus EpiPen, Adrenaclick and AuviQ. The market opportunity is large. Even with just moderate market share assumptions,the pre-filled syringe becomes a significant product," they said in a note to clients.