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SAN DIEGO, June 27, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today provided an update on the litigation with kaléo Inc. regarding kaléo’s claims of patent infringement relating to Adamis’ higher dose naloxone injection product (ZIMHITM), as well as, new claims brought by Adamis against kaléo regarding its use of Adamis’ SYMJEPITM trademark.
On Friday, June 21st, the company filed two motions in the United States District Court for the District of Delaware in response to kaléo’s patent infringement lawsuit relating to ZIMHI. The first was a motion to disqualify Cooley LLP as counsel to kaléo based on, among other things, conflicts of interest and violation of applicable ethical rules. The second was a motion to dismiss the entire lawsuit for lack of subject matter jurisdiction. Adamis filed an amendment to its original new drug application (“NDA”) removing any reference to kaléo’s EVZIO® product, which Adamis contends prevents kaléo from claiming infringement under the Hatch-Waxman Act.
On the same day, Adamis filed a separate lawsuit in the United States District Court for the Eastern District of Virginia against kaléo, Inc. for cybersquatting under 15 U.S.C. § 1125(d), unfair competition under 15 U.S.C. § 1125(a), and common law unfair competition and trademark infringement for kaléo’s use of Adamis’ SYMJEPI trademark. With this lawsuit, Adamis is seeking injunctive relief to prevent kaléo from using Adamis’ SYMJEPI trademark and damages for kaléo’s past use of Adamis’ SYMJEPI trademark in commerce.
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 TM (epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection 0.15mg products are FDA approved for use in the emergency treatment of acute allergic reactions, including anaphylaxis. Adamis is developing additional products, including a naloxone injection product candidate 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 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. These statements relate to future events or future results of operations, including, but not limited to the following statements: the outcome of the patent infringement lawsuit filed by kaléo and the trademark infringement lawsuit filed by the company against kaléo; the company’s ability to successfully enforce and defend its intellectual property rights; the potential costs associated with the patent and trademark infringement lawsuits; any future actions of the FDA arising from the patent infringement lawsuit; any action that kaléo Inc. may take in response to the company’s amended NDA filing, including the removal of EVZIO® as a Reference Listed Drug and withdrawal of the associated paragraph IV certification; the impact of the patent and trademark infringement lawsuits on our business, results of operations and financial position. 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 are no assurances concerning the outcome of the patent lawsuit filed by kaléo nor the trademark lawsuit filed against kaléo. The lawsuits could require material financial resources and consume significant management time to resolve, regardless of the outcome of the proceedings. The lawsuits, or an adverse outcome in the litigation, could have a material adverse effect on our naloxone product candidate and the company’s business, financial conditions and results of operations. In addition, there can be no assurances that the FDA will approve our NDA relating to our naloxone product candidate or will give final approval to our proposed brand name for the product, concerning the timing of any such approval, that the product will be commercially successful if approved and introduced, or concerning the outcome of any discussions with third parties concerning commercialization of the product. The FDA review process is subject to a number of uncertainties. The FDA could request additional or different submissions or request additional data, information, materials or clinical trials or studies, all of which could affect the timing and outcome of the review process. As a result, there can be no assurances regarding the timing or the outcome of the FDA’s review process. 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. 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 exceptas 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 most recent annual report on Form 10-K 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