We reported back in June on the FDA’s approval of Adamis Pharmaceutical’s Symjepi™, an alternative epinephrine delivery mechanism to the standard auto-injector. Introduction of the device – a prefilled syringe with a fixed needle ready for immediate use – promised to lower the cost of emergency epinephrine by increasing competition in a thin market with few options. Then in November, we reported that a pediatric (jr) version of the device had been FDA approved for use with children.
At the time, all things looked “Go!” for Adamis, but Symjepi has yet to make its debut. What happened?
Looking at today’s press release, we finally have a window into the trouble that is plaguing the company. In the release, Dr Dennis J Carlo, President and CEO of Adamis, states:
As reflected in our previous statements, since receiving FDA approval last year we have engaged in a confidential process with the goal to maximize the value of this asset, including seeking a commercial partner to launch Symjepi in the U.S. I know many investors have become frustrated with the time that this process has taken. I too am frustrated that the process is taking longer than we initially expected. However, this process has been neither simple nor linear. We remain committed to bringing Symjepi to the market.”
“While the process is still ongoing, we are now in discussions with two potential partners. I am confident both groups are capable of producing value for Symjepi in the market. Each group is engaged in what we believe are later stages of diligence, which may include discussions with potential drug buyers, wholesalers and distributors, that we believe will help refine their commercial plans. Although of course no assurances are possible, my belief is that we are finally nearing the conclusion of this process, and I am hopeful that our next communication will be to announce a definitive agreement and provide information concerning when Symjepi may be available in the market.
All well and good, but the fact that Adamis does not have a partner already working to commercialize Symjepi and bring it to market implies that it will be many months before the device is ready for distribution. And that means a longer wait for the increased competition and lower prices we were all promised.