SAN DIEGO, Aug. 28, 2019 — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today provided a progress report and marketing update on the U.S. launch of SYMJEPITM (epinephrine) 0.3 mg and 0.15 mg Injections.
During this back-to-school season, there is a heightened awareness of the shortage for epinephrine auto injectors. Adamis, in collaboration with Sandoz, Inc., hopes to alleviate some of the demand with their recently launched both doses of SYMJEPI into the hospital and retail market. Due to their efforts to broaden access for patients, nearly 90% of commercially insured people in the U.S. now have access to SYMJEPI through National and Regional Payers.
To ensure access for U.S. military personnel, retirees, and their dependents, SYMJEPI has been added to the Department of Defense’s (“DOD”) Uniform Formulary for Tricare, now effective as of early August. Public records indicate the DOD’s budget for epinephrine in fiscal 2016 was more than $57 million.
SYMJEPI was featured in an online USA Today article on August 14 in USA Today, “How to protect your children from life-threatening allergies.” Other marketing efforts underway include public relations programs, product donations to underserved US patients, patient advocacy efforts, personal selling, and raising awareness through scientific and consumer journal advertising. For a more detailed list of recent SYMJEPI press and scientific articles, please visit Adamis’ website here.
Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, “We are excited to see the progress being made regarding the retail launch of SYMJEPI. Through our collaboration, we are increasing marketing efforts through several channels and these formulary additions should provide a broad foundation for growth of this product during a time of shortages of other products in this space. We look forward to seeing continued momentum through the end of the year and beyond.”
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.
Important Safety Information
WARNINGS AND PRECAUTIONS
- You should get emergency medical care right away after using the product.
- You may need to use a second SYMJEPI (epinephrine) injection if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.
- Symjepi should only be injected into the middle of your outer thigh (upper leg) with the needle facing downwards. Never inject into any other part of the body. If you accidentally inject SYMJEPI into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection. Symjepi can be injected through your clothing if needed.
- The needle cap on the SYMJEPI prefilled syringe helps to prevent needle sticks and accidental injection of epinephrine. Do not remove the needle cap until you are ready to use it.
- Never put your thumb, fingers, or hand over the exposed needle.
- If an accidental injection happens, get medical help right away.
- Do not drop the carrier case or SYMJEPI prefilled syringe. If the carrier case or prefilled syringe is dropped, check for damage and leakage. Dispose of the prefilled syringe and carrier case, and replace if damage or leakage is noticed or suspected.
- Do not place patient information or any other foreign objects in the carrier case with the prefilled syringe, as this may prevent you from removing the prefilled syringe for use.
- If you inject a young child with SYMJEPI, hold their leg firmly in place before and during the injection to prevent injuries. Ask your healthcare provider to show you how to properly hold the leg of a young child during injection.
- Before using SYMJEPI, tell your healthcare provider about all of your medical conditions, including if you:
- have heart problems or high blood pressure.
- have diabetes.
- have thyroid problems.
- have asthma.
- have a history of depression.
- have Parkinson’s disease.
- are pregnant or plan to become pregnant. It is not known if epinephrine will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if epinephrine passes into your breast milk.
Symjepi may cause serious side effects.
- Rarely, patients who have used SYMJEPI may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following at an injection site:
- redness that does not go away
- the area feels warm to the touch
- Cuts on the skin, bent needles, and needles that remain in the skin after the injection, have happened in young children who do not cooperate and kick or move during the injection.
- If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use your SYMJEPI. Talk to your healthcare provider about all your medical conditions.
Common side effects of SYMJEPI include:
- fast, irregular or “pounding” heartbeat
- feelings of over excitement, nervousness or anxiety
- nausea and vomiting
- breathing problems
These side effects may go away with rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of SYMJEPI. For more information, ask your healthcare provider or pharmacist.
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- Tell your healthcare provider of all known allergies.
- Especially tell your healthcare provider if you take certain asthma medicines.
- SYMJEPI and other medicines may affect each other, causing side effects. SYMJEPI may affect the way other medicines work, and other medicines may affect how SYMJEPI works.
- Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
For full prescribing and safety information, please click on this link.
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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 commercial success of its SYMJEPI products; the company’s beliefs concerning the marketing and commercialization efforts of Sandoz relating to the SYMJEPI products; the company’s ability to provide an adequate supply of product; the company’s beliefs concerning the resources and capabilities that are required to provide access to its SYMJEPI product; the company’s ability to commercialize its product and product candidates, itself or through commercialization partners; 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; guidance regarding future periods; 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 future commercial success of SYMJEPI. 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