Approved! FDA gives Dova Pharma’s Doptelet a Thumbs Up

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Dova Pharmaceuticals, headquartered in Durham, North Carolina, announced that the U.S. Food and Drug Administration (FDA) approved its Doptelet (avatrombopag) to treat thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure.

Thrombocytopenia is a decrease in the number of blood platelets, and is a common complication of chronic liver disease (CLD) patients. There are about 70,000 patients with CLD whose platelet count is less than 50,000/mL. Generally, these patients require one to three invasive diagnostic and therapeutic procedures annually, each of which carries a bleeding risk.

Doptelet is a second generation, once daily, oral TPO receptor agonist. TPO is a regulator of platelet production, made in the liver, which stimulates bone marrow production of platelets. Doptelet mimics the effects of TPO.

The approval was based on two global Phase III clinical trials that hit all primary and secondary endpoints.

“We are delighted FDA has approved Doptelet, which represents a significant milestone for Dova, physicians, and most importantly, patients,” said Alex Sapir, Dova’s president and chief executive officer, in a statement. “Doptelet is the first orally administered treatment option for patients with CLD, allowing the majority of patients to avoid a platelet transfusion prior to a procedure by increasing platelet counts to the target level of greater or equal to 50,000 per microliter. Given our extensive preparations to date, we are positioned to launch Doptelet in June with our full complement of sales, marketing, and reimbursement support resources.”

Earlier this year, Dova made a secondary common stock offering, which followed an initial public offering last summer that brought in about $80 million. According to the Triangle Business Journal, the company has hired a full sales team, including former staffers from Salix, Bristol-Myers Squibb, Gilead and Intercept. When it launched its IPO, Dova had only nine employees. Currently it is at around 120 and expected to continue hiring.

In the second half of this year, Dova plans to file a supplementary New Drug Application (sNDA) with the FDA to expand the drug’s indication to include immune thrombocytopenic purpura. Kevin Laliberte, Dova’s vice president of product development, told the Triangle Business Journal, “As we file that sNDA and have success in that indication, we would have to expand that sales force probably toward the end of 2019.”

The company is also suggesting it plans to initiate a Phase III trial in patients with chemotherapy-induced thrombocytopenia by the second quarter of this year.

What is a bit puzzling is shares were trading down at the end of close yesterday and in premarket trading has basically remained steady so far. Terry Chrisomalis, who runs the Biotech Analysis Central investment research service on Seeking Alpha Marketplace, writing for Seeking Alpha, says, “The ability to go after thrombocytopenia patients regardless of disease etiology should be highly praised. The stock should not be trading lower on the FDA approval news. On the contrary, the expansion opportunities that can be achieved means that the stock should be climbing higher.”

Per its quarterly filing, the company had $126.9 million in cash and cash equivalents as of March 31, due to its stock raise and IPO. The company believes that’s plenty to cover the next 12 months. And once the drug goes on the market, revenue should be coming in.

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