Portola Pharma (PTLA) Enters Expanded AndexXa Development Agreement iwth Daiichi Sankyo

November 1, 2016 8:02 AM EDT

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Portola Pharmaceuticals Inc.® (Nasdaq: PTLA) announced that it has expanded its existing clinical collaboration agreement with Daiichi Sankyo to develop AndexXa™ (andexanet alfa) as an antidote for edoxaban, Daiichi Sankyo’s Factor Xa inhibitor. AndexXa is currently under EMA review for reversal of Factor Xa inhibition in patients experiencing a life-threatening or uncontrolled bleed and for patients requiring urgent or emergency surgery. As part of the updated agreement, Portola will expand the ongoing ANNEXA-4 study in bleeding patients in Germany.

“As an industry, we need to address the significant unmet medical need for managing Factor Xa inhibitor-related major bleeding by bringing to market an antidote that specifically reverses anti-Factor Xa activity, the anticoagulant mechanism of these agents. With this support from Daiichi Sankyo, we will be able to improve our ability to gather data on AndexXa as a reversal agent for edoxaban. Germany is the second largest market for Factor Xa inhibitors and one where edoxaban has experienced significant growth,” said Tao Fu, chief commercial and business officer of Portola. “Our long-standing collaboration with Daiichi Sankyo, as well as all of the other manufacturers of Factor Xa inhibitors, demonstrates the confidence these companies have in the AndexXa program.”

Under the terms of the non-exclusive agreement with Daiichi Sankyo, Portola will receive a $15 million upfront payment and is eligible to receive up to an additional $10 million upon meeting site initiation and enrollment targets. Upon AndexXa’s approval, Daiichi Sankyo will be eligible to receive a low single-digit royalty on AndexXa sales up to a total of $8 million.

Portola previously entered into nine separate non-exclusive clinical collaboration agreements with Daiichi Sankyo, BMS, Pfizer, Bayer and Janssen to support Phase 2 and registrational studies of AndexXa in the United States, Europe and Japan. Portola retains all rights, including full commercial and financial rights, for AndexXa outside of Japan.

The Urgent Need for a Factor Xa Inhibitor Antidote Annually, 1 to 4 percent of patients treated with Factor Xa inhibitors may experience major bleeding, and an additional 1 percent may require emergency surgery. Commensurate with the increase in the use of Factor Xa inhibitors -- for stroke prevention in atrial fibrillation; treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism; and prevention of DVT following knee or hip replacement surgery -- the number of hospital admissions due to bleeding associated with these agents continues to grow. In large randomized trials of Factor Xa inhibitors in patients with atrial fibrillation, the 30-day mortality rate in patients with intracranial hemorrhage (ICH) exceeded 40 percent. Based on the current adoption of all three Factor Xa inhibitors in the United States, this results in an estimated 300 deaths per month due to ICH related bleeding.

According to IMS Health, worldwide sales of oral Factor Xa inhibitors were $9.5 billion in the 12 months ending June 2016, a 52 percent growth over the same period of last year. In the EU5, an estimated 73,000 oral Factor Xa inhibitor-treated patients will be hospitalized this year due to major bleeding or will require urgent surgery, with half of those patients in Germany.i

ANNEXA-4 Study Design ANNEXA-4 is a global, single-arm, open-label clinical trial designed to evaluate AndexXa (andexanet alfa), a U.S. Food and Drug Administration (FDA)-designated Breakthrough Therapy, in patients who present with an acute major bleed while receiving apixaban, edoxaban, enoxaparin or rivaroxaban. For ethical reasons, this multi-center, prospective cohort study is not randomized and all participants receive AndexXa given as a bolus dose over 30 minutes followed by a two-hour infusion. Patients receive a low or high dose depending on which Factor Xa inhibitor they have received and the time they received it. Patients are evaluated for 30 days following AndexXa administration. The co-primary efficacy endpoints are the percent change in anti-Factor Xa activity at two hours and assessment of hemostasis over 12 hours following the infusion. Hemostatic efficacy is assessed by an independent endpoint adjudication committee as either excellent, good or poor/none. To date, ANNEXA-4 has enrolled more than 150 patients with life-threatening bleeds.

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