Summary
- The company’s lead product is Doptelet (avatrombopag), an oral, thrombopoietin receptor agonist, which received FDA approval for treating refractory chronic idiopathic thrombocytopenia in adults.
- Doptelet is also FDA-approved for treating thrombocytopenia in adult patients with chronic liver disease planned to undergo a surgical procedure.
- Doptelet is also in a phase 3 trial in chemotherapy-induced thrombocytopenia, a common condition (data is expected in the first half of 2020), which will further expand its target market.
- Rating Dova's common stock a Buy with price target of $35 (2-3 years time frame).
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Dova Pharmaceuticals (DOVA) was founded in 2016, and is based in Durham, North Carolina. In this article, I will analyze Dova’s product pipeline and present my investment thesis for this company.
The company’s lead product is Doptelet (avatrombopag), an oral, thrombopoietin receptor agonist (TPO-RA), which received FDA approval for treating chronic idiopathic thrombocytopenia, ITP (low platelet count), in adults who had an inadequate response to previous therapy on June 27. Doptelet was earlier FDA-approved for treating thrombocytopenia in adult patients with chronic liver disease, CLD, who are scheduled to undergo a surgical procedure in May 2018. Last month, the company also received European marketing authorization for Doptelet in treating thrombocytopenia in adult patients with CLD, who are scheduled to undergo a surgical procedure. TPO-RA acts by stimulating the production of megakaryocytes and ultimately platelets in the bone marrow by binding to and activating the TPO receptor.
In the U.S., Dova has signed a deal to co-promote Doptelet in thrombocytopenia due to CLD to Salix Pharmaceuticals in the interventional radiology, hepatology, gastroenterology, colorectal surgery and proctology segments, which are specialties with a high volume of procedures. The division of net revenues from this deal will be 65% to Dova and 35% to Salix. This deal adds further conviction to Doptelet’s potential in this indication where platelet transfusions (whose efficacy lasts for a short time) have been the usual standard of care.
Chronic ITP indication is the crown jewel in Doptelet’s FDA-approved indications. Chronic ITP in adults is an autoimmune disease caused by the formation of auto-antibodies against platelets. Primary ITP is caused by autoantibody formation which is not associated with a secondary condition. Secondary ITP is associated with diseases like lupus (SLE), HIV, hepatitis C, chronic lymphocytic leukemia, CLL and more recently, with Zika virus infection. ITP is termed as chronic when it lasts more than 12 months after diagnosis. Severe ITP is the term used when the platelet count is below 20K/microL with bleeding symptoms and requires platelet transfusion.
The prevalence of chronic ITP was approximately 8 per 100,000 in children and 12 per 100,000 in adults in the U.S. In a case series, 52% of adults with chronic ITP had a platelet count below 20K/microL at some point in their disease course, thus requiring treatment. Bleeding due to thrombocytopenia was seen in two-third of chronic ITP patients, usually in the skin and mucous membranes (purpura and petechiae). Up to 57% of patients with chronic ITP may have serious bleeding manifestations like intracranial hemorrhage, gastrointestinal bleeding, severe menstrual bleeding or hematuria.
The first-line treatment for chronic ITP is glucocorticoids which are indicated in patients with platelet counts below 20K/microL, even in the absence of bleeding symptoms. Patients with platelet count higher than 20K/microL may also need glucocorticoid therapy if they have bleeding symptoms. Severe bleeding symptoms like gastrointestinal bleeding or intracranial hemorrhage require urgent platelet transfusion, IV immunoglobulin, and IV glucocorticoids. Patients who do not respond to these first-line agents may need second-line treatments like rituximab, oral TPO-RAs (Doptelet), splenectomy or immunosuppressants.
