Adamis Pharmaceuticals announced it is reacquiring from Sandoz Inc. the rights to its Symjepi (epinephrine) injection 0.3mg, Symjepi (epinephrine) injection 0.15mg products currently marketed and available in the United States.
Adamis has simultaneously entered into an exclusive distribution and commercialization agreement with US WorldMeds, LLC for the United States commercial rights for the Symjepi products, as well as its Zimhi (naloxone HCI injection, USP) 5mg/0.5mL product candidate.
Adamis and Sandoz have entered into an agreement providing for the mutually agreed return to Adamis of the marketing, promotion, and distribution rights of the Symjepi products, and the termination of the commercialization agreement between Adamis and Sandoz, following a transition period, supported by a transition services agreement that is currently being negotiated. As part of the termination agreement, Sandoz will continue to support the products in the US under the existing commercialization agreement through the end of the transition period to help minimize any potential impact to patients and customers.
Under the terms of the Adamis/US WorldMeds agreement, US WorldMeds obtained US rights to commercialize and distribute the Symjepi products, upon the termination of Sandoz’ commercial rights, and ZIMHI, if approved by the US Food and Drug Administration, in exchange for an upfront payment and potential regulatory and commercial milestones totaling up to US$ 26 million. Additionally, after deducting the supply price and certain other deductions, including an allocation for US WorldMeds sales and distribution expenses from net sales of the products, Adamis and US WorldMeds will share equally in the net profits, as defined in the agreement.
Adamis will be responsible for supplying the products to US WorldMeds at a supply price based on Adamis’ direct product costs. Adamis will retain rights to commercialize the products outside the US and may also continue to develop its injection platform for additional product candidates. Additional information concerning the agreement and the transaction is contained in a report on Form 8-K to be filed by the company with the Securities and Exchange Commission.
Dr. Dennis J. Carlo, president and CEO of Adamis, stated, “We are pleased Sandoz is willing to assist us through this transition and we are very excited about working with US WorldMeds. They have a proven track-record of commercializing pharmaceutical products and have a First-in-Class and only FDA-approved product, Lucemyra (lofexidine), for the treatment of withdrawal symptoms associated with abrupt opioid discontinuation. We believe US WorldMeds’ existing infrastructure and current sales force positions it well to take over the marketing and distribution of our Symjepi products and, after receiving FDA approval, quickly and effectively launching our Zimhi product. We view this partnership as a synergistic fit that has the potential to maximize the value of the products and create immediate lasting value to both shareholders and patients.”
P. Breckinridge Jones, Sr., CEO of US WorldMeds, added, “We are very excited to begin commercializing Adamis’ Symjepi epinephrine products, and look forward to launching Zimhi (naloxone) following its approval. We believe Symjepi represents a meaningful new alternative in the epinephrine market that will benefit from our enhanced focus. Our strong presence in the opioid dependence market made us keenly aware of the growing need for repeat dosing of the currently approved naloxone products to combat the more powerful opioids in the market today. So, when we learned Adamis was developing a higher dose naloxone product, we knew it would be a perfect companion product for Lucemyra. We are confident we can leverage our existing commercial infrastructure to speed the uptake and maximize the impact of Zimhi. I consider Zimhi and Lucemyra a one-two punch that can strike a powerful blow in the fight against opioid overdoses and the management of withdrawal symptoms, and ultimately make a positive impact on the overall opioid epidemic. US WorldMeds expects to be in position to launch ZIMHI shortly after approval and delivery of product from Adamis.”
Symjepi (epinephrine) Injection 0.3mg and Symjepi (epinephrine) injection 0.15mg products are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. In July 2018, Adamis announced that it had licensed commercial rights for the US to Sandoz.
Zimhi is a high-dose naloxone injection product candidate that is intended for the emergency treatment of opioid overdose, as manifested by respiratory and/or central nervous system depression in adults and pediatric patients. It is intended for immediate administration in settings where opioids may be present and is not a substitute for emergency medical care. Naloxone is an opioid antagonist, which is generally considered the drug of choice for immediate administration for opioid overdose, and works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness. Drug overdoses are now the leading cause of death for Americans under 50, and more powerful synthetic opioids, like fentanyl and its analogues, are responsible for the largest number of deaths from opioid overdoses.