- Japanese pharma Shionogi last week launched its drug for chronic liver disease patients, pricing it below U.S.-based Dova Pharmaceuticals' competing product.
- Shionogi priced Mulpleta at $8,500 for a seven-day fixed dose, lower than the price for Dova's Doptelet, which was set at $9,000 for the 40 mg dose and $14,500 for the 60 mg dose. That makes Doptelet about 6% and 70% more pricey than Mulpleta, respectively.
- At least one analyst saw the move as significant Tuesday, tweaking Dova's target price down over the increased threat of lower market share. The company saw its shares drop roughly 9% in the first hours of trading Tuesday morning.
While Doptelet was the first thrombopoietin receptor agonist for liver disease approved in the U.S., cheaper competition has now arrived, making marketing a key factor going forward in the race for market share. Mulpleta was the second in the class approved in the U.S.
Thrombocytopenia is the most common hematologic complication for chronic liver disease patients. It increases the risk of bleeding, which is where drugs like Mulpleta and Doptelet come in by boosting platelet production.
Mulpleta (lusutrombopag) and Doptelet (avatrombopag) received identical prescribing indications from the Food and Drug Administration "for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure."
Dova launched Doptelet in late May as its only product, putting a steep list price on the drug, one analyst noted at the time.
"Even in this indication, it is hard to predict how payers will react to a pre-treatment regimen whose cost is significantly higher, in my cases, than the procedure itself," Porges wrote in an Aug. 1 note.
Mulpleta got the FDA's OK on July 31 after previously getting approval in Japan in 2015. Shionogi said it expects the European Medicines Agency to recommend approval it for Europe in the first half of next year.
"As adult patients with CLD often undergo procedures that could put them at increased risk for bleeding, this treatment will offer physicians an option other than platelet transfusions," CEO Takayuki Yoshioka said in an Aug. 30 statement.
Leerink analyst Geoffrey Porges trimmed back the investment bank's target price for Dova from $32 to $31 on Tuesday, according to an investor's note. Porges characterized Mulpleta as a "direct competitor ... at a significant list price discount for Doptelet, and at least on a list price basis, the economics favor Mulpleta in patients with more severe thrombocytopenia."
The analyst continued by describing the drugs as "not substantially differentiated" for efficacy and safety, so "we believe promotion, pricing, and access will influence long-term market share."
The bank also lowered Dova's expected revenue down from $59.3 million to $58.2 million for 2019. In the second quarter of this year — Dova's first since launching its first drug — the company posted net product sales of just under $2 million and a quarterly net loss of $19.7 million.
In an SEC filing, the company disclosed it "does not expect product revenues [from Doptelet] to be sufficient to satisfy its operating needs for several years, if ever."
With Shionogi's launch and cheaper pricing, Dova's measured expectations for Doptelet appear to have become even truer this past month.