Adamis Pharmaceuticals Corp. (ADMP, Financial) announced June 15 its epinephrine injection had been approved by the U.S. Food and Drug Administration, giving EpiPen manufacturer Mylan NV (MYL, Financial) a run for its money.
Like Mylan’s EpiPen, Adamis’ prefilled single-dose syringe is used to treat allergic reactions in emergency situations. The product will be sold under the name Symjepi.
Dr. Dennis J. Carlo, Adamis president and CEO, said the company is very excited about the approval and is preparing to submit a new drug application to the FDA for a junior version of the treatment.
“With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail (patient) and nonretail (professional) sectors of the epinephrine market,” Carlo said in a statement. “We are currently in the process of exploring all of our commercialization options and in discussions with potential partners in order to facilitate broad patient access to this new epinephrine treatment option and to maximize the value of our important asset.”
Mylan has faced pressure over the past year as it has been scrutinized for its pricing practices and overcharging U.S. taxpayers by as much as $1.27 billion between 2006 and 2016. The company agreed to settle with the U.S. government for $465 million in October 2016, but could face further penalties.
While California-based Adamis did not disclose the price for a set of two Symjepi syringes, they are expected to cost less than a pair of EpiPens, which sell for around $600. In response to the pricing backlash, Mylan announced in December 2016 it would release a generic version of the drug, which costs $300 for a two-pack.
Adamis shares jumped more than 50% after the announcement to $5.75. Mylan shares were down 2.4% at $36.98. With a market cap of $158.5 million, Adamis trades with a price-book (P/B) ratio of 6.3 and a price-sales (P/S) ratio of 11.9.
The company said Symjepi is expected to launch later this year.
Disclosure: I do not own any stocks mentioned in the article.
