There’s potential good news for those with serious allergies: Adamis Pharmaceutical’s Symjepi, an EpiPen alternative, has been granted FDA approval. Pricing information has yet to be released to the public, but the company anticipates Symjepi will be priced well below Mylan’s outrageously over-priced EpiPen.
Symjepi comes in the form of two 0.3mg pre-filled syringes of epinephrine. Its intended use is the same as that of the EpiPen: treatment of serious allergic reactions (including anaphylaxis) to insect bites/stings, foods, exercise-induced anaphylaxis, and other drugs. Adamis is aiming for a product launch in the second half of 2017 and is already preparing a second New Drug Application (NDA) involving a “junior” version of Symjepi, according to CEO Dr. Dennis Carlo.
The company issued a statement saying, “We are very excited by this approval, and at the same time, are already preparing to submit our second NDA to the FDA. This second submission is for the junior version of Symjepi. We are committed to helping patients by providing them with additional therapeutic choices. With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail (patient) and non-retail (professional) sectors of the epinephrine market. We are currently in the process of exploring all of our commercialization options and in discussions with potential partners in order to facilitate broad patient access to this new epinephrine treatment option and to maximize the value of our important asset. In the interim, we expect to build inventory levels in preparation for an anticipated launch in the second half of this year.”
Despite the fact that Mylan’s EpiPen commands the majority of the epinephrine market certain analysts believe that Symjepi has the potential to outperform the Mylan product as well as other alternatives, such as Kaléo Pharma’s Auvi-Q and Impax Laboratories’ Adrenaclick.
Maxim Group’s Jason Kolbert wrote that, “We believe [Symjepi] may actually be a better, more user-friendly product (design wise) versus EpiPen, Adrenaclick and AuviQ. The market opportunity is large. Even with just moderate market share assumptions, [Symjepi] becomes a significant product.”
This is especially true given the massive price hikes Mylan instituted. There has been significant public and Congressional upset over what has been seen as price gouging, in addition to a recall in the U.S., Europe, Australia, Japan and New Zealand.
Symjepi’s one major drawback, according to analysts, is the fact that the product is administered via traditional syringe as opposed to other product’s auto-injection systems. This could be problematic, especially given that the majority of epinephrine patients are children. Experts say that there is significant data showing that patients are more likely to prefer easy-to-use medications. However, epinephrine is a life-saving drug and Symjepi’s anticipated lower price may make this a non-issue.
Speaking of pricing, Symjepi’s competition is as follows:
- Mylan’s EpiPen – name-brand = $608, generic = $300;
- Kaléo Pharma’s Auvi-Q = $4,500 out of pocket, which drops to $360 for families with an annual income less than $100,000;
- Impax Laboratories’ Adrenaclick = $365, but can be purchased through CVS for around $110. However, Maxim Group’s analysts believe that Adrenaclick is an “inferior product” and unlikely to affect Symjepi’s pricing strategy.
San Diego, California-based Adamis has seen great benefits to its bottom line at the introduction of its first drug. Following the June 15 announcement, the company’s stock price jumped by almost 50%, closing the day at $5.75 per share.