Dova Receives Approval For Doptelet In Europe, Stock Up
Zacks Investment Research | Jun 26, 2019 09:50PM ET
Shares of Dova Pharmaceuticals, Inc. (NASDAQ:DOVA) gained 3.3% on Jun 26 after the company’s lead drug, Doptelet, received marketing authorization from the European Commission for treating severe thrombocytopenia in adult patients with chronic liver disease (“CLD”) who are scheduled to undergo an invasive procedure. The authorization allows the company to market the drug in 28 countries constituting the European Union, plus Iceland, Norway, and Liechtenstein.
The company is currently seeking partnerships for commercialization of the drug in Europe. The drug has been available in the United States since last year. The company has a co-promotion agreement with the Salix division of Bausch Health Companies (NYSE:BHC) , for commercialization of Doptelet in the United States.
Shares of Dova have increased 39.8% so far this year compared with the industry ’s rise of 8.5%.
The approval of the drug in Europe was based on data from two phase III studies, which evaluated two doses of Doptelet — 40 mg and 60 mg — in patients with thrombocytopenia and CLD. Treatment with the drug increased the proportion of patients who did not require platelet transfusions or rescue procedures for bleeding up to seven days following a scheduled procedure. The increase in the number of patients was superior compared to a placebo. The drug also achieved superior results compared to placebo in increasing the proportion of patients with platelet count equal to or greater than 50,000/µL and increase in platelet count from baseline.
The drug has generated sales of $11.7 million since its approval in May 2018 in the United States. The recent approval in Europe is expected to increase the sales of the drug following a successful launch.
Dova is also developing Doptelet as a treatment for chronic immune thrombocytopenia (“ITP”) and chemotherapy-induced thrombocytopenia (“CIT”). A supplemental new drug application is under review in the United States seeking label expansion of the drug to include ITP patients. A decision is expected shortly. An approval will boost the prospects of the drug. A phase III study is evaluating the drug in CIT patients. Top-line data is expected in the first half of 2020.
Doptelet faces competition from Shionogi's Mulpleta (lusutrombopag) for its approved indication in the United States and Europe. Moreover, there are several drugs approved for treating ITP including Rigel Pharmaceuticals (NASDAQ:RIGL) Tavalisse, Novartis’ (NYSE:NVS) Promacta and Amgen’s Nplate. Several other companies including Bristol-Myers are developing their candidate for ITP indication.
There is no approved drug for the treatment of CIT. Amgen (NASDAQ:AMGN) is evaluating Nplate in a late-stage study in CIT patients.
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