Adamis wins U.S. approval to sell EpiPen rival, shares soar

[June 16, 2017] By Bill Berkrot

(Reuters) - Adamis Pharmaceuticals Corp said on Thursday it received U.S. approval for its emergency epinephrine syringes to treat severe allergic reactions that it intends to be a lower cost rival to Mylan NV's widely used EpiPen, sending its shares up more than 50 percent.

The company said it was looking for a marketing partner and would set a price for the product before its launch sometime in the second half of this year.

Adamis said its pre-filled epinephrine syringes would be sold under the brand name Symjepi.

Mylan has faced severe criticism and congressional and legal investigations after it doubled the cost for a pair of EpiPens to around $600, enraging consumers and putting it in the center of the ongoing debate over the high cost of prescription medicines in the United States. It has since offered its own generic version for about $300 in response to the furor.

"We plan to position the product as a lower cost alternative," Mark Flather, senior director for investor relations and corporate communications for Adamis, told Reuters. "We want to be part of the solution."

Epinephrine is the life-saving recommended treatment for severe allergic reactions, such as to bee stings, exposure to peanuts or medications.

Mylan has for years owned more than 90 percent of the market for emergency epinephrine injectors and its own authorized generic has recently surpassed sales of the branded version.

"With an anticipated lower cost and attractive design, we believe Symjepi will be a meaningful competitor to EpiPen," Wells Fargo Securities analyst David Maris said in a research note.

Other rival products are available. Impax Laboratories Inc's Adrenaclick device is being sold through CVS Health Corp's drugstore chain for about $110 a pair.

Privately held Kaleo earlier this year began selling its Auvi-Q epinephrine auto-injector that it reacquired from Sanofi SA under an unusual pricing strategy but with little success so far. The company said it would make the product available at no cost to many consumers but charge insurers $4,500.

Sanofi in April sued Mylan, accusing it of engaging in illegal practices to squash EpiPen competition when the French drugmaker held the Auvi-Q rights.

Adamis shares soared 53.3 percent to close at $5.75 on the Nasdaq and further rose to $6.00 in extended trading. Mylan shares closed down 2.4 percent at $36.98.

(Reporting by Bill Berkrot in New York; editing by Andrew Hay and Matthew Lewis)

[© 2017 Thomson Reuters. All rights reserved.]

Copyright 2017 Reuters. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.