SAN DIEGO, Oct. 01, 2019 — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced today that it has entered into an exclusive distribution and commercialization agreement with Emerge Health Pty (“Emerge”) to register and commercialize Adamis’ SYMJEPI® (epinephrine) Injection products in Australia and New Zealand.
Under the terms of the agreement, Adamis will provide technical support to Emerge during the registration process, which could take more than a year. If successful, Adamis will begin supplying product to Emerge. Emerge will be responsible for the full registration, reimbursement, sales, marketing and distribution of SYMJEPI® in Australia and New Zealand (the “Territory”). Once commercially launched, Adamis and Emerge will equally share net profits (as defined in the agreement) generated from sales of SYMJEPI® in the Territory. Based on its experience with the registration process in the Territory, Emerge does not anticipate that a commercial launch could occur before 2021.
Adamis hopes that Emerge will find a ready market for SYMJEPI® as Australia has among the highest allergy rates in the world. A study published in 2017 in the Journal of Allergy and Clinical Immunology indicates that, in Australia, 1 in 10 infants and 1 in 20 children aged 10-14 years have food allergies. High rates of allergies typically result in higher incidences of anaphylaxis, and Australian hospital admissions for anaphylaxis have increased five-fold in the last 20 years. According to the Murdoch Children’s Research Institute in Victoria, Australia has one of the highest rates of hospital admissions for anaphylaxis in the developed world.
David J. Marguglio, Chief Business Officer of Adamis, stated, “We are very excited to be working with a great company like Emerge and see this as another important step toward our goal of making SYMJEPI® available to patients and caregivers around the world. We are also pleased that our first commercial partnership for SYMJEPI® outside the United States is for a territory we feel has a heightened need of a ready supply of epinephrine injection products.”
Chris Rossidis, Co-Founder and Head of Emerge’s Commercial Operations added, “The prevalence of allergies and inconsistent availability of epinephrine injection products have combined to create a public health crisis in Australia. We hope that through our partnership with Adamis we may be able to ensure all patients have access to this important and potentially life-saving product.”
Anaphylaxis is a serious, sometimes life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medications and latex. Anaphylaxis requires immediate medical treatment, including an injection of epinephrine. The use of epinephrine injection products has grown as the risk of anaphylaxis and allergic reactions have become more widely understood.
About Emerge Health Pty
Emerge is an innovative, specialized pharmaceutical company focused on the marketing and sales of high quality medicines in Australia and New Zealand. Emerge is dedicated to providing exceptional products and support to ensure they meet their customers’ and partners’ needs and priorities.
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, allergy and opioid overdose. The company’s SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection 0.15mg products were approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis, and both were fully launched in the U.S. in July 2019. Please refer to www.SYMJEPI.com for additional product information. Adamis is developing additional products, including a naloxone injection product candidate, ZIMHI, for the treatment of opioid overdose, and a metered dose inhaler and dry powder inhaler product candidates for the treatment of asthma and COPD. The company’s subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs, and certain nonsterile drugs for patients, animals, hospitals, clinics and surgery centers 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. These statements relate to future events or future results of operations, including, but not limited to the following statements: the company’s beliefs concerning the timing and outcome of the regulatory process in Australia and New Zealand concerning registration and approval of SYMJEPI in the Territory; the date of any commercial launch of SYMJEPI in the Territory; the ability of Emerge to successfully commercialize SYMJEPI in the Territory; the prevalence and severity of allergies in the Territory and the availability of epinephrine injection products in the Territory; 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; and other statements concerning our future operations and activities. 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 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. There can be no assurances regarding the timing or the outcome of the regulatory review process regarding SYMJEPI in Australia or New Zealand or that SYMJEPI will be registered and approved for marketing and sale in the Territory. There can be no assurances regarding the timing of any commercial launch of SYMJEPI in the Territory, the commercial success or any such launch or the amount of net profit payments that the company could receive following any such launch. The dates of regulatory approval, if obtained, and commercial introduction of SYMJEPI in the Territory could be delayed beyond our expectations. 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, we may require additional funding, and there are no assurances that such funding will be available if required. 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 release publicly the results of any revisions to these 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, 2018, and our subsequent filings 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