http://ir.sunesis.com/...ol-newsArticle&ID=1678333&highlight=
Sunesis and Royalty Pharma Announce $25 Million Vosaroxin Royalty Agreement
Design and Execution of VALOR Trial Enable Innovative Financing
SOUTH SAN FRANCISCO, Calif., March 29, 2012 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals (Nasdaq:SNSS) and Royalty Pharma today 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.
Image: Sunesis Pharmaceuticals, Inc. Logo
Image: Royalty Pharma Logo
Sunesis is evaluating vosaroxin in a pivotal Phase 3, 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.
"Royalty Pharma has a strong track record of identifying significant commercial opportunities in the pharmaceutical sector. We believe this commitment by Royalty Pharma is a validation of vosaroxin's potential in AML and reflects the significant upside of a positive VALOR trial," stated Daniel Swisher, Chief Executive Officer of Sunesis.
"This innovative transaction will provide us with access to added capital that extends our runway beyond the unblinding of VALOR and enables our team to actively prepare for vosaroxin's regulatory filings and US commercial launch. It will also allow us to selectively expand our development program and enhance our strategic flexibility on the timing and terms of vosaroxin partnering arrangements outside the US," added Eric Bjerkholt, Executive Vice President, Corporate Development & Finance of Sunesis.
"Sunesis' use of an adaptive trial design offers us an opportunity to invest in this promising biopharmaceutical product candidate on terms that are a win-win for both Sunesis and Royalty Pharma: Sunesis gains access to a flexible, novel financing structure and we are able to invest in vosaroxin at a time when we believe its likelihood of commercial success will be high," said Pablo Legorreta, Chief Executive Officer of Royalty Pharma. "Based on our extensive due diligence, we are impressed with the Sunesis team, the robust preclinical and clinical dataset for vosaroxin, as well as the rigor of the VALOR trial design and implementation. We are pleased to be partnering with Sunesis in this transaction, and believe that this first-in-class compound has the potential to transform the treatment landscape for AML and potentially other cancers."
About VALOR
VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial is expected to enroll 450 evaluable patients at more than 110 leading sites in the U.S., Canada, Europe, Australia and New Zealand. The VALOR trial is currently enrolling patients, who are randomized one to one to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. Additionally, the VALOR trial employs an innovative, adaptive trial design that allows for a one-time sample size adjustment by the DSMB at the interim analysis to maintain adequate power across a broader range of survival outcomes. The trial's primary endpoint is overall survival. For more information on the VALOR trial, please visit www.valortrial.com.
About Vosaroxin
Vosaroxin is a first-in-class anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis..............................
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