Novartis, Adamis keep swinging at EpiPen with Symjepi pediatric dose

Novartis headquarters
Novartis' Sandoz struck a marketing deal with Adamis in July for both doses of Symjepi. (Wikimedia Commons / Andrew / Flickr)

Novartis’ Sandoz is getting ready to stir things up in the adult epinephrine market—and as of Thursday, it has a green light to stir things up in the pediatric epinephrine market, too.

The generics giant’s partner, Adamis, has snagged an FDA approval for a .15 mg dose of Symjepi, a prefilled syringe used for emergency treatment of severe allergic reactions. The smaller dose, which is half the volume of the .3 mg dose the agency OK’d last June, is meant for children who weigh between 33 and 65 pounds.

RELATED: Look out, EpiPen. With Adamis deal, Novartis is gunning for your sales

Sponsored by Lubrizol Life Science

[Webinar] Cannabinoid Formulation - from Farm to Pharma

Wednesday, June 24, 2020 | 12pm ET / 9am PT

A handful of cannabinoid-based pharmaceutical products are on the market today, and an ever-growing number are in the global development pipeline. This webinar will explore key considerations in developing cannabinoid-based pharmaceutical products, including an overview of global pharmaceutical cannabinoid usage today, common challenges formulating with CBD and other cannabinoids, and more.

Sandoz, which is gravitating toward more complex products as pricing pressure hurts easy-to-make generic pills, will market the pediatric offering in the U.S., thanks to a July deal it struck with San Diego-based Adamis. The pact between the two also handed Sandoz distribution and commercialization rights for the larger dose.

For decades, Mylan’s Epi-Pen has dominated the epinephrine market, but in recent years, pricing scandals have opened the doors for low-cost competition. Adamis, which snagged the FDA’s favor after an initial rejection, last year pledged to position the not-yet-launched .3 mg version “as a low-cost alternative to the other current offerings in the anaphylaxis market,” an Adamis spokesman told FiercePharma via email.

The pediatric offering will also represent “an affordable alternative to current treatment offerings at a time when patients need access to this medicine most,” Sandoz President Carol Lynch said in a statement, adding that, “We are committed to reimagining their care by bringing this valuable, life-saving medicine in a prefilled epinephrine syringe to the U.S. market as soon as possible.” 

RELATED: With EpiPen competitors bearing down, can Mylan maintain its lead?

That’s not to say grabbing market share will be an easy task. Lower-dose Symjepi will go up against not only a .15 mg dose of EpiPen, but a .15 mg dose of its generic, which Teva cleared with the FDA last month. Rival Auvi-Q from Kaléo also boasts a .15 mg dose, as well as the market’s only .1 mg dose for infants and toddlers. And it’ll be looking to keep patients who start on Auvi-Q as young children on the brand as they advance to the .15 mg dose.

Meanwhile, the competitive onslaught is coming at bad time for Mylan, whose EpiPen manufacturing woes have spurred a shortage and hurt shares. In response, the copycat drugmaker is conducting a strategic review, weighing options that could include a sale, execs have said.

Suggested Articles

About 76% remdesivir patients had at least one point of clinical improvement on a 7-point scale at day 11, versus 66% of patients on standard care.

Alexion and Amgen reached a deal to put off a biosimilar challenger to Alexion's blockbuster rare disease med Soliris until March 2025.

A top adviser for the Trump administration is calling on Congress to push for more manufacturing in Puerto Rico.