- As Mylan and manufacturer Pfizer struggle with producing a steady supply of EpiPen auto-injectors, Novartis' Sandoz unit said Tuesday it would launch a rival treatment more broadly in the U.S. market.
- Sandoz is partnered with Adamis Pharmaceuticals on Symjepi, an epinephrine injection for emergency allergic reactions. Earlier this year, the companies launched the pre-filled syringe and device combo in the hospital setting. Now, both adult and pediatric dose strengths of the drug will be available in pharmacies, which accounts for most of the epinephrine market.
- Amid the shortage for branded EpiPen, Pfizer and Mylan last month worked with the Food and Drug Administration to extend the expiration dates on EpiPens by four months. That extension came after a review of product stability data and does not apply to the lower dose intended for children.
In May 2018, the FDA first flagged shortage concerns due to manufacturing issues for epinephrine.
While it's been more than a year since the shortage began, manufacturers are still dealing with production challenges. In a June update, Pfizer and Mylan said manufacturing issues continue to limit supply. In its EpiPen partnership with Mylan, Pfizer handles manufacturing through its subsidiary Meridian Medical Technologies.
"These challenges are expected to result in tighter supplies and greater variability in pharmacy-level access and will potentially continue through the summer months as seasonal demand increases," the manufacturers stated last month.
Given the inconsistent product availability for patients, generic drugmaker Sandoz sees an opportunity for Symjepi.
"Patients and health care professionals are trying to navigate this critical shortage of self-injectable epinephrine products, which is why Sandoz is immediately making Symjepi available in adult and pediatric doses to patients at their local pharmacies," Sandoz president Carol Lynch said in a statement.
The retail launch comes at the beginning of peak prescribing season for epinephrine, wrote Raymond James analyst Elliot Wilbur in a July 9 research note. July, August and September account for one-third of all prescriptions for the drug, noted Wilbur.
Even with an expanded launch, Wilbur estimates Symjepi will make up only 7.5% of the epinephrine market at peak by 2024.
Sandoz is grappling with its own issues to establish Symjepi, particularly given the difference between auto-injections and pre-filled syringes.
That distinction has put Sandoz on a lobbying campaign to rewrite federal and state laws to amend the definition of auto-injector. The company said a narrow definition does not include Symjepi and is focused on revising laws in 18 states.
Sandoz sales representatives have also been focused on getting doctors to write prescriptions for an "epinephrine injection" instead of an "epinephrine auto-injector," the company said.
EpiPen and Symjepi aren't the only competitors in the epinephrine space. Teva and Amneal Pharmaceuticals both sell generics of the auto-injector, and the private drugmaker Kaleo offers its own branded injection called Auvi-Q.
Between the branded EpiPen and their authorized generic, Mylan and Pfizer make up about half of the epinephrine market, according to recent prescription data cited by SVB Leerink.