SAN DIEGO, Aug. 27, 2018 — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today provided a business update.
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.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including respiratory disease and allergy. The company’s Symjepi (epinephrine) Injection 0.30mg, was approved for use in the emergency treatment of acute allergic reactions, including anaphylaxis, and its Symjepi (epinephrine) Injection 0.15mg product is undergoing FDA review. Adamis recently announced a distribution and commercialization agreement with Sandoz, a division of Novartis Group, to market Symjepi in the U.S. Adamis is developing a sublingual tadalafil product candidate as well as additional product candidates, using its approved injection device, a metered dose inhaler and dry powder inhaler devices. The company’s subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs, and certain nonsterile drugs for human and veterinary use, to patients, physician clinics, hospitals, surgery centers and other clients throughout most of the United States.
Adamis Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to future events or future results of operations, including, but not limited to the following statements: the company’s beliefs concerning anticipated commencement and completion dates for clinical trials; the company’s beliefs concerning the timing and outcome of launch and commercialization arrangements and activities for its Symjepi (epinephrine) Injection 0.3mg product; the company’s beliefs concerning achievement of goals or milestones during the 2018 year; the company’s beliefs concerning the timing of commencement of and outcome of the FDA’s review of the company’s supplemental New Drug Application (sNDA) relating to the lower dose Symjepi (epinephrine) Injection 0.15mg product candidate, any Investigational New Drug Application that the company may file in the future relating to its sublingual tadalafil product candidate or other product candidates, or other regulatory filings relating to the company’s product candidates; the timing and outcome of any further studies or trials relating to the company’s product candidates; statements about strategies, objectives and our future goals and achievements; the company’s ability to commercialize its product and product candidates; the company’s beliefs concerning the ability of its products and product candidates to compete successfully in the market; the company’s beliefs concerning the safety and effectiveness of its products and product candidates; expectations and goals for future growth; current or planned clinical trials or research and development activities; product development timelines; anticipated dates for commercial introduction of products; guidance regarding future periods; the company’s beliefs concerning the safety and effectiveness of its products and product candidates; and other statements concerning our future operations and activities. There can be no assurances regarding the timing of outcome of the FDA’s review of our sNDA. In addition, product development time is subject to a number of risks and uncertainties which can delay the actual development time beyond our expectations. The timing of any NDA filing relating to any of our products candidates could be affected by a number of factors, including, without limitation, the availability of adequate funding, the presence or absence of unexpected regulatory issues or delays, negotiation of any required agreements with third parties, the time period required to enroll a sufficient number of patients in studies, results of trials or studies, the time required to complete and analyze the results of the studies, and FDA guidance concerning the regulatory pathway for the product. As a result, there can be no assurances concerning the timing of completion of trials or the filing of NDAs relating to our product candidates. In addition, forward-looking statements concerning our anticipated future activities assume that we are able to obtain sufficient funding to support such activities and continue our operations and planned activities. As discussed in our filings with the Securities and Exchange Commission, there are no assurances that any required additional funding will be available. Any forward-looking statements in this press release are only predictions, are not guarantees, involve known and unknown risks, uncertainties and other factors, and concern matters that could subsequently differ materially from those described in this press release, which may cause Adamis’ actual results to be materially different from those contemplated by these forward-looking statements. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, we undertake no obligation to update or revise any forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks, and additional risks, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time with the SEC, including its annual report on Form 10-K for the year ended December 31, 2017, and quarterly reports filed with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC’s web site at http://www.sec.gov.
Senior Director, Investor Relations
& Corporate Communications
Adamis Pharmaceuticals Corporation