Dova prepares for newly minted Doptelet launch, with Shionogi’s rival close behind

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FDA approved Dova Pharmaceuticals' Doptelet to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. (FDA)

On Monday, Dova Pharmaceuticals won the FDA approval it promised IPO investors last year in the form of a platelet booster with peak sales estimates as high as $600 million-plus. And with Doptelet's launch, patients with chronic liver disease can be spared the costly and cumbersome blood transfusions typically needed ahead of surgery.

Dova said it will announce pricing at launch time next month; some analysts are expecting $6,000 per treatment course and 2025 sales of $341 million, more if the drug wins the follow-up approvals Dova's angling for. But it could be a hard sell for a company that's never rolled out a new treatment before, and in a market where "every patient will need to be a new start," one analyst said.

But those logistical challenges could theoretically be balanced out by favorable payer coverage because Doptelet's inherent design would save money on more complicated treatment.

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“This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions,” said Richard Pazdur, M.D., acting director of the FDA’s Office of Hematology and Oncology Products.

Doptelet, an oral thrombopoietin receptor agonist previously known as avatrombopag, helped more clinical trial patients avoid platelet transfusions or any rescue therapy up to seven days after surgical procedures, compared with patients on a dummy treatment.

Dova, created by PBM Capital, obtained Doptelet rights through its 2016 buyout of AkaRx from Eisai, which itself acquired the Astellas spinoff in 2010. The Durham, North Carolina-based company went up on Nasdaq last year as it prepared for a positive decision from the FDA.

To support its June launch, Dova has recruited a salesforce with previous hepatology experience to detail doctors, support other marketing efforts and work with payers on access and coverage.

In a note to investors Tuesday, Leerink’s Geoffrey Porges said getting patients signed up for Doptelet might be a slow process, “with substantial education and payer preparation required,” which could be even more challenging for a company launching a drug for the first time. His team anticipates a $6,000 sticker price.

“This slow ramp is likely to be accentuated by the non-recurring nature of avatrombopag’s initial indication—every patient will need to be a new start,” Porges wrote in a note on May 10. Based on that, he’s projecting 2018 sales of $20.9 million, with the potential to grow to $341 million in 2025.

RELATED: Dova and Novartis-backed Aileron file for new IPOs as biotech offerings tick up

Dova is looking to global markets, too; it filed for approval with the European Medicines Agency last month, and recently inked a licensing agreement with Fosun Pharma for rights in China.

Dova aims to expand Doptelet's reach, with approvals to treat other thrombocytopenia patients, including those without liver disease. It expects to seek FDA approval in immune thrombocytopenia later this year and plans a clinical study in chemotherapy-induced bleeding disorder. Leerink’s forecasts don’t count those possible follow-up indications, but Porges noted that consensus expectations of $648 million in 2023 might include them.

Doptelet is the first FDA-approved drug to treat low platelet counts in chronic liver disease patients, but it might not be alone for long. Shionogi’s lusutrombopag, already launched in Japan, is also under FDA priority review in the same indication with a verdict slated on Aug. 26. And if Doptelet finally goes into immune thrombocytopenia, it will face a Big Pharma—Novartis, which markets Promacta in the U.S. (or Revolade in the EU).

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