Why This Tiny SoCal Biopharma Could be a Real Threat to Mylan

Published: May 31, 2017

Why This Tiny SoCal Biopharma Could be a Real Threat to Mylan May 30, 2017
By Alex Keown, BioSpace.com Breaking News Staff

SAN DIEGO. – A new competitor has Mylan Pharmaceuticals in its sights.

Southern California-based Adamis Pharmaceuticals is awaiting a decision by the U.S. Food and Drug Administration (FDA) on its for its Epinephrine Pre-filled Syringe product for the treatment of anaphylaxis. After a stumble following the FDA’s issuing a Complete Response Letter last year, Adamis resubmitted its New Drug Application to the FDA in January. And Dennis Carlo, president and chief executive officer of Adamis couldn’t help but point out how a more economical solution to anaphylaxis is needed for patients, a clear reference to the pricing woes that faced Mylan over the high price tag for that company’s EpiPen Auto Injector.

“With all of the recent news regarding products in the anaphylaxis market, we believe our product, now so, more than ever, can be a part of the potential solution for patients and payors as there is an obvious need for a low-cost therapeutic alternative like our PFS,” Carlo said in a statement at the time the NDA was re-submitted.

Last year there was public outcry over the pricing of the injectable device that carries a $600 price tag. Since company acquisition of the EpiPen in 2007, the price has dramatically increased from $57 to nearly $500, a 400 percent increase. The EpiPen generated more than $1.2 billion in revenue for 2015, accounting for about 40 percent of Mylan’s overall earnings. EpiPen is now sold as a two-pack as opposed to a single autoinjector. Mylan has sought to quell some of the outrage over its pricing. The company said it will release a generic version of the EpiPen and also noted it distributed nearly 700,000 free EpiPens to more than 65,000 schools across the United States last year.

If Adamis is approved by the FDA, the company could take a bite out of Mylan’s earnings. At least, that’s the thinking of analyst David Liang. Writing in The Motley Fool, Liang said a low-cost epinephrine injector is in high demand given the number of people who are susceptible to allergic reactions requiring treatment. The company, Liang said, estimates about 8 percent of the American children has some form of food allergy and of that group, 38 percent are susceptible to severe allergic reactions. With a low-cost epinephrine injector, many consumers are likely to turn to Adamis and away from Mylan, Liang said. That would be good news for investors in the San Diego-based company.

Shares of Adamis are currently trading at $3.82 as of 10:45 a.m. With approval of the injector, Liang said the stock could gain multiples of its current share price” and rates it a buy.

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