- Adamis Pharmaceuticals has struck a deal with Novartis' generics unit Sandoz to commercialize its epinephrine autoinjector in the U.S.
- Sandoz will pay an undisclosed upfront fee, as well as milestone payments to Adamis for the U.S. rights to already-approved Symjepi injection 0.3 mg and to the 0.15 mg dosage if the latter is approved by the Food and Drug Administration.
- Adamis retains the right to commercialize the drug outside the U.S. and gives Sandoz the first right of refusal to partner in those territories. The two companies will equally split net profits in the U.S.
Watch out Mylan, a new competitive force is coming to threaten the EpiPen franchise.
Although Adamis won approval for its EpiPen alternative last June, the company chose not to launch the emergency allergy treatment Symjepi while it searched for a partner to help commercialize the drug-device combo. The small biotech had only about $14 million in cash and other short-term assets as of March 31.
At the time of the Symjepi launch, analysts speculated the product could be a major threat to EpiPen because of its easier usage.
The deal with Sandoz likely gives Adamis a much-needed cash injection, and provides a large pharma commercialization partner that can easily handle marketing the EpiPen alternative.
Once Mylan's crown jewel, the EpiPen franchise has been on the decline of late. Sales of the drug were down $655 million year over year in North America in 2017. Following pushback over EpiPen's pricing, Mylan launched an authorized generic costing half the price of the original, which has cut into higher-margin branded revenues. Other competition has also dented sales.
In 2016, Mylan had a monopoly on the emergency allergy market and boasted strong customer loyalty to the brand. But that quickly eroded after price hikes related to the product came to light.
Mylan has since battled a public relations quagmire after it was sharply criticized for charging $600 for a pair of the auto-injectors. The company also had to pay $465 million to settle a False Claims Act suit related to EpiPen pricing.
Further adding to Mylan's EpiPen woes have been shortages around the world related to manufacturing issues. The drug-device combo is manufactured by a plant run by a Pfizer subsidiary.