- Sandoz has launched its epinephrine injection Symjepi, which the Swiss pharma argues will be an affordable alternative to existing epinephrine auto-injectors.
- A twinpack will have a wholesale acquisition cost (WAC) of $250, around 16.5% less than Mylan and Teva's generic EpiPens, Sandoz told BioPharma Dive in an email.
- In July 2018, Symjepi developer Adamis Pharmaceuticals inked an exclusive U.S. distribution and commercialization deal with Sandoz, a division of Novartis. Adamis shares shot up on the launch to $2.80 apiece Thursday — more than 14% higher than the prior day's closing share price. Adamis will share U.S. net profits with Sandoz.
When Adamis picked up Food and Drug Administration approval for Symjepi in June 2017, its share price was at $5.20. But by the end of 2018, it had almost halved to $2.25 apiece.
Though the route to market was slow, Symjepi's U.S. launch should bring some relief to Adamis as well as the parents and patients who have been worried about EpiPen supply issues.
"While Adamis shares since the partnership have been on a rollercoaster ride stemming from the apparent delay to the launch, the announcement today should clear baseless noise around the commercialization effort and shift attention from conjecture to launch execution," Elliot Wilbur, an analyst Raymond James, wrote in a Jan. 16 note.
Sandoz, in a statement to BioPharma Dive, said the initial launch for Symjepi will be in the institutional channel, as this is the market sector where the company is established and has " significant experience and knowledge."
The next steps will be the launch of Symjepi 0.3 mg injection into the U.S. retail market. The Sandoz spokesperson declined to share specific timing of the commercial launch, citing "competitive reasons."
Sandoz pitched the pricing for Symjepi below Mylan’s authorized generic EpiPen and Teva’s generic EpiPen, both of which are $300 for a twinpack. An additional competitive advantage for Sandoz could be availability, if the manufacturing issues at Pfizer subsidiary Meridian Medical Technologies continue to dog EpiPen availability.
According to the FDA's drug shortages site, the epinephrine auto injector from Impax Laboratories and Mylan's EpiPen remain in shortage. Kaléo's AUVI-Q is currently readily available.