Sunesis Pharmaceuticals & Royalty Pharma Announce $25-Million Royalty Agreement
Sunesis Pharmaceuticals and Royalty Pharma recently announced that Royalty Pharma has agreed to pay Sunesis $25 million, under certain circumstances related to the successful development of Sunesis’ lead product candidate vosaroxin, to acquire a royalty on future worldwide net sales of vosaroxin.
Sunesis is evaluating vosaroxin in a pivotal Phase III, randomized, double-blind, placebo-controlled trial, the VALOR trial, in patients with first relapsed or refractory acute myeloid leukemia (AML). The VALOR trial employs an adaptive trial design that permits a one-time increase in sample size at the interim analysis by its Data and Safety Monitoring Board (DSMB). At the interim analysis, expected in the third quarter of 2012, the DSMB will examine pre-specified efficacy and safety data sets and decide whether to stop the study early for efficacy or futility, continue the study as planned, or implement a one-time sample size adjustment of 225 additional evaluable patients.
Under terms of the agreement, Royalty Pharma will invest $25 million immediately following VALOR’s interim analysis if: (a) the study stops early for efficacy, in exchange for a 3.6% participation payment on future net sales; or (b) the one-time sample size increase is being implemented, in exchange for a 6.75% participation payment on future net sales as well as two warrants. In the case when VALOR proceeds to its planned 450 patient enrollment, Royalty Pharma has the option to make a $25 million investment upon the unblinding of the study in exchange for a 3.6% participation payment on future net sales. The warrants issued to Royalty Pharma are exercisable if VALOR’s sample size is increased and are each to purchase 1,000,000 shares of Sunesis common stock at an exercise price of $3.48 and $4.64 per share, respectively. Sunesis currently holds all worldwide commercial rights to its vosaroxin product.
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, Vosaroxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit www.sunesis.com.
Royalty Pharma is an industry leader in acquiring royalty interests in marketed and late- stage biopharmaceutical products, with royalty interests in 30 approved products (including Abbott’s Humira, Johnson and Johnson’s Remicade, Merck’s Januvia, Gilead’s Atripla, Truvada, and Emtriva, Pfizer’s Lyrica, Amgen’s Neupogen and Neulasta, and Genentech’s Rituxan) valued at over $6 billion. Royalty Pharma has a 15-year history of providing value to holders of royalty interests.
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