Adamis Pharmaceuticals (NASDAQ:ADMP) shares tumbled as much as 30% this month, prompting plenty of inquiries from investors.
Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, said, “We have been receiving a considerable amount of inquiries from investors, and although it is our policy not to comment on stock price activity, we believe that now is a good time to provide an update on Symjepi™ and to reiterate several factors that we believe will deliver shareholder value going forward.”
SYMJEPI (epinephrine) Injection 0.30mg
Adamis remains excited about the potential for our FDA approved Symjepi Injection 0.30mg to be an affordable alternative treatment for patients who are at increased risk of anaphylaxis. We believe that we have selected an excellent collaborator, Sandoz, to take on the challenges within this market. As a division of the Novartis Group, Sandoz has the proper resources and expertise to support broad patient access to this important product. We have been monitoring the development efforts of the generic version of EpiPen® for the last two years and have anticipated an eventual approval. Symjepi is not an auto-injector like the EpiPen or its generic equivalent. It is a small, pre-filled syringe containing epinephrine. Symjepi remains a simple, intuitive, easy-to-use product that has displayed several positive attributes as discussed in our published human factors studies comparing Symjepi to EpiPen.
As for the timing of the launch for Symjepi, we are working closely with Sandoz to prepare a successful launch.
SYMJEPI (epinephrine) Injection 0.15mg
Our low dose Symjepi product candidate is still under review with the US Food and Drug Administration (FDA). The agency has provided the company with a PDUFA date of September 27, 2018. If approved, Sandoz has the rights to commercialize this product in the US. The approval has no effect on the timing of the launch of the high dose product.
Some of the company’s future milestones include the following:
- Commercial launch for Symjepi in U.S.
- FDA approval of lower dose (0.15mg) Symjepi
- Announcement of ex-U.S. strategy for Symjepi
- Filing of NDA for naloxone injection
- Filing of NDA for the sublingual tadalafil (Cialis®) product
- Commencement of Phase 3 studies for beclomethasone
- Growing net revenue of outsourcing facility by 30% over 2017
Dr. Carlo added, “With all of the reported shortages of epinephrine products, we believe that there is a great opportunity for a simple, easy-to-use device like Symjepi within the anaphylaxis market. With several upcoming milestones in our pipeline, a strengthened cash position, and a solid commercialization partner for Symjepi, we believe that Adamis is poised for substantial growth for the foreseeable future.”
Upcoming Conference Presentation
Adamis will present at the 20th Annual Global Investment Conference sponsored by HC Wainwright & Co. at the St. Regis New York Hotel on September 5, 2018. The presentation time is scheduled for 4:15pm Eastern Time.
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