By Peter Loftus
Swiss drug giant Novartis AG has bought the U.S. commercial rights to sell a potentially lower-cost alternative to Mylan NV's EpiPen, the emergency treatment for allergic reactions that has been dogged by pricing and supply challenges.
Novartis's Sandoz generic-drug unit acquired the U.S. commercial rights for an emergency shot called Symjepi from Adamis Pharmaceuticals Corp., the companies said late Sunday. The deal means Mylan will face competition from an industry heavyweight, though Symjepi isn't an exact copy of EpiPen so some patients may stick with the more familiar brand.
Symjepi contains the same active ingredient, epinephrine, as EpiPen, which is used to treat anaphylaxis caused by insect bites and foods, among other allergic reactions. Symjepi comes in a prefilled syringe, which Adamis says could make it cheaper than EpiPen, which comes in an auto-injector device that conceals the needle.
U.S. regulators approved Symjepi in June 2017 but Adamis, a San Diego startup, never launched the product and instead hired an investment banker to find a commercial partner for it. Sandoz, one of the biggest generic-drug makers, plans to begin selling it in the U.S.
Mylan came under criticism in 2016 for boosting the list price for an EpiPen two-pack to more than $600, up 550% since acquiring the product in 2007. The company has since started selling a generic version for about $300.
Mylan also has experienced supply shortages for EpiPen this year because of problems at a Pfizer Inc. manufacturing plant that makes the product.
Under the exclusive agreement for Symjepi, Sandoz will pay an upfront fee and make potential performance-based milestone payments for the rights, the companies said in press releases Sunday night. Net profits generated from U.S. sales of Symjepi will be shared equally by Adamis and Sandoz. The companies didn't divulge the exact terms.
Sandoz didn't say when it planned to begin distributing Symjepi in the U.S., or how much it would cost. Carol Lynch, president of Sandoz, called the product "an affordable alternative treatment for patients who are at increased risk for anaphylaxis."
Adamis hopes Symjepi will be a "cheaper alternative" to Mylan's generic version of EpiPen, Adamis spokesman Mark Flather said.
Adamis said it would retain the rights to commercialize Symjepi outside the U.S. but has granted Sandoz the first right of negotiation for such markets. Also, Adamis may continue to develop its Symject injection platform for additional product candidates, including a previously announced naloxone product candidate that is being developed to treat opioid overdoses, the company said.
Adamis said the agreement with Sandoz would also cover a lower-dose version of Symjepi if it receives regulatory approval.
"We believe the financial terms of this agreement have the potential to bring meaningful recurring revenue to Adamis and we look forward to growing, and possibly expanding, this partnership with Sandoz based on the future success of Symjepi in the market," said Dennis J. Carlo, Adamis's chief executive, in the statement.
In February, he acknowledged the search for a commercial partner for a U.S. rollout of Symjepi was taking longer than the company had expected. "I know many investors have become frustrated with the time that this process has taken," Dr. Carlo said in a statement to MarketWatch.
Adamis shares jumped 50% to $4.80 on Monday.
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