Buckle up, Mylan, another epinephrine injection is in town—and its sticker price is lower than your own generic EpiPen's cut-rate cost.
Adamis Pharmaceuticals and its commercial partner, Novartis’ Sandoz unit, announced Wednesday they had officially launched the 0.3 mg dose of Symjepi, a prefilled epinephrine syringe meant for the emergency treatment of allergic reactions.
Sandoz has set the wholesale acquisition cost for a Symjepi two-pack at $250, lower than the $300 price of Mylan’s authorized generic EpiPen and Teva’s generic version. And it's touting its injector design as a plus.
“The Symjepi device is small in size and fits into the palm of your hand, with the goal of a simple-to-use application and intuitive, user-friendly design,” Sandoz President Carol Lynch said in a statement.
Symjepi’s launch comes a year and half after Adamis won its FDA nod—and more than two years after its initial FDA rejection in mid-2016. When it was approved, Adamis CEO Dennis Carlo said the firm was looking for potential partners to “facilitate broad patient access to this new epinephrine treatment option and to maximize the value of our important asset.” Enter Sandoz, which earned exclusive U.S. commercialization rights to Symjepi in July 2018.
Sandoz is now rolling out Symjepi through a phased launch, the Novartis subsidiary said in a statement. First, it will focus on the institutional setting, “an established channel where Sandoz Inc. has significant experience and knowledge.” After the professional sector introduction, Sandoz will then expand to the patient-facing retail market.
In addition to the 0.3 mg injection intended for patients who weigh 30 kg (about 66 pounds) or more, the pair also snagged FDA backing last September for a 0.15 mg pediatric dose. Novartis is now “actively preparing” for the launch of that kid-friendly version, a Novartis spokesman told FiercePharma, but declined to provide a timeline for competitive reasons.
With Teva's generic already aiming to steal share and the new, even cheaper Symjepi hitting the market, Mylan sales are likely to take a hit. In the third quarter prior to Teva’s launch, Mylan suffered a 14% decrease in North American sales, which it attributed “primarily to lower volumes on existing products, including the EpiPen Auto-Injector.” Executives on the Q3 call in early November said the volume drop was simply the result of the timing of purchases; they said they expect EpiPen demand would “rebalance” itself in Q4 to the usual volume it has seen in the past. That remains to be seen, however, until the company unveils its 2018 results next month.
Now that Teva and Sandoz have both launched, there's a chance Mylan might never see EpiPen bounce back to its traditional size. But Mylan might not fret about the competition too much, because EpiPen has already shrunk to the point where the company no longer relies on it for a big chunk of sales. No single Mylan product accounts for more than 3% of its revenue, the company has said.