Can tiny Dova take on Novartis? With its 2nd Doptelet nod and a price cut, maybe so

In what one analyst team called Dova Pharmaceuticals’ "biggest catalyst to date," the company won a second FDA nod for its platelet-boosting drug Doptelet, setting the stage for direct competition against Novartis and its still-growing blockbuster Promacta.

Doptelet, Dova’s first commercial product, racked up a go-ahead Thursday in chronic immune thrombocytopenia (ITP), after an initial approval last May to help replace platelet transfusion in certain patients with chronic liver disease. 

And to cope with the upcoming Promacta fight, Dova dramatically lowered the drug’s list price to $297 per 20-mg tablet, CEO David Zaccardelli said on a conference call Thursday. Previously, the list cost for a five-day course stood at $9,000 for the 40-mg daily dose and $13,500 for the 60-mg dose—or $900 per tablet.

Chief Commercial Officer Jason Hoitt said the new price stacks up to other drugs in its class of thrombopoietin receptor agonists for ITP. The price is similar to Promacta's at the most recommended dose, Evercore ISI analysts Jon Miller and Umer Raffat noted in a July 1 memo to clients.

Miller and Raffat called the ITP green light Dova’s "biggest catalyst to date and likely will be the biggest in the near future as well." Of the $1 billion U.S. market for its class in ITP, the Evercore analysts expect Dova could take $200 million to $250 million.

And Dova's investors seemed to agree, sending its stock up about 30% in Thursday's trading.

Doptelet does boast several advantages over existing drugs. With Amgen's Nplate, patients must be injected by a healthcare provider every week, while Doptelet is a daily pill. Novartis’ Promacta is also an oral drug, but it bears a black-box warning for risks to the liver and requires liver function monitoring during treatment.

The other details of Doptelet's new approval were more favorable than Jefferies had expected, though Miller and Raffat figure "the practical results of these differences are likely small."

For example, Promacta’s label specifies a list of prior treatments that should come before the Novartis drug, while Doptelet patients must simply fail on "a previous treatment." Corticosteroids, immunoglobulins and spleen removal are the common first-line treatments for ITP. Plus, Promacta can only be used in patients with increased bleeding risks, while Doptelet doesn’t have that restriction.

One potential threat to Doptelet sales is the patent cliff for its nearest competitor Promacta, which brought in $1.17 billion last year, up 35% over 2017. Zaccardelli said the Novartis drug has a lock on branded sales through 2023, but he figures it can hang onto its exclusivity till 2027. About half of Promacta's 2018 sales came in the U.S.

To focus on the bigger ITP launch, Dova is practically offloading its marketing rights in liver disease to Bausch Health’s Salix Pharmaceuticals. The two first inked a U.S. co-promotion deal last September, and now Dova has expanded the partnership to cover hepatology and interventional radiology, which Dova expects to be the most important to Doptelet's sales in liver disease.

The company has also increased its sales footprint to about 60 territories with an initial focus on hematology and oncology specialists, Hoitt said on the call. Some of its new sales recruits come from major players in these spaces, including Novartis, Amgen, Celgene and Genentech, he said.

Next up, Dova is looking to expand into chemotherapy-induced thrombocytopenia, with top-line results from a phase 3 trial expected in the first half of 2020. In Europe, Doptelet earned its first approval in liver disease on Tuesday, and Zaccardelli said the company is "under active conversations with potential partners in EU." As for ITP, it now plans to meet with the EMA in the third quarter to discuss a filing, the CEO said.