Shares of Adamis Pharmaceuticals Corp. (ADMP) are up over 36% year-to-date compared to a modest 10.83% rise in the iShares NASDAQ Biotech Index (ETF) during the same time frame.
Adamis Pharma is focused on developing products in the therapeutic areas of respiratory disease and allergy.
The most advanced product candidate in the Company’s pipeline is Epinephrine Pre-filled Syringe for the emergency treatment of anaphylaxis.
Anaphylaxis is a potentially life-threatening allergic reaction. Certain medications, especially penicillin, anesthesia and aspirin; insect stings, certain foods and latex can trigger anaphylaxis.
Anaphylaxis requires immediate medical treatment, including treatment with epinephrine, which is administered using a needle and syringe or an autoinjector like the well-known Mylan’s (MYL) EpiPen.
The autoinjectors are not only costly but they also have some potential administration issues related to delivering epinephrine. As you may know, much has been written about Mylan’s EpiPen price-gouging scandal.
Adamis Pharma’s Epinephrine Pre-filled Syringe, developed under 505(b)(2) regulatory pathway, is designed to be a more cost-effective alternative.
This is the third time that that the Company’s Epinephrine Pre-Filled Syringe is at the FDA altar. Epinephrine Pre-Filled Syringe was turned down by the U.S. regulatory agency in March of 2015 as well as in June 2016.
Addressing the issues raised by the FDA in the agency’s June 2016 Complete Response Letter, the Company resubmitted the NDA for Epinephrine Pre-filled Syringe on December 15, 2016. Although the PDUFA date has not been disclosed, we estimate that the decision is likely to be announced by June 15, 2017 based on the review timeline of 6 months for resubmissions.
The other products in Adamis Pharma’s pipeline are:
— Albuterol (APC-2000) and Fluticasone (APC-4000) dry powder inhaler products for the treatment of bronchospasm and asthma, respectively,
— Beclomethasone (APC-1000), a metered dose…