Adamis Gets FDA Nod For Generic Version Of Mylan's EpiPen

Shares of Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) soared more than 50% on Thursday after the FDA approved the company’s Epinephrine injection, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) (PFS) which is the generic version of Mylan N.V.’s (NASDAQ:MYL) EpiPen- the best-selling but high-cost treatment for life-threatening allergies. Shares of Adamis were up on the news while the news was a blow for the shares of Mylan which went down about 2.38%.

Adamis Pharmaceuticals’ share price shows that the company has outperformed the Zacks classified Medical-Drugs industry year to date. The stock has surged 99.7% compared with the industry’s gain of 16.8%.

The FDA approved the trade name Symjepi for the pre filled syringe which will treat allergic reactions. Symjepi provides two single dose syringes. It is expected to hit the market in the second half of 2017.

Symjepi will be available at lower cost and will be available in smaller size when compared with EpiPen. EpiPen has been facing concerns over pricing in the past. Mylan has been under immense pressure since Aug 2016 when the company came under the spotlight for price increase of EpiPen since its acquisition of the drug in 2007, drawing immense flak from lawmakers, consumers and the common people alike.

As a result of the increased prices of EpiPen, Mylan launched the first authorized generic for EpiPen Auto-Injector in Dec 2016 at a wholesale acquisition cost (WAC) of $300 per epinephrine injection USP two-pack, which is more than 50% lower than the WAC of EpiPen 2-Pak Auto-Injectors.

Another leading drug store chain CVS Health Corp. (NYSE:CVS) announced in January this year that that it is now selling a cheaper alternative to EpiPen. The authorized generic treatment is called Adrenaclick, and is made by Impax Laboratories Inc. (NASDAQ:IPXL) , and is priced at $109.99 for a two-pack.
Coming back to the release, Adamis is in discussions with potential partners in order to facilitate access of the PFS to a broader patient group.

Zacks Rank

Adamis currently carries a Zacks Rank#3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.

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