GlaxoSmithKline and Synta Pharmaceuticals Announce Development and Commercialization Collaboration for STA-4783 in Oncology
Wednesday October 10, 6:00 am ET
LONDON & LEXINGTON, Mass.--(BUSINESS WIRE)--GlaxoSmithKline (GSK) (LSE: GSK - News; NYSE: GSK - News) and Synta Pharmaceuticals Corp. (NASDAQ: SNTA - News) today announced the execution of a global collaboration agreement for the joint development and commercialization of STA-4783, a first-in-class, small-molecule, oxidative stress inducer that is entering Phase 3 clinical development for the treatment of metastatic melanoma.
Source: Synta Pharmaceuticals Corp.
Under the terms of the agreement, the companies will share responsibility for development and commercialization of STA-4783 in the U.S. and GSK will have exclusive responsibility for development and commercialization of STA-4783 outside the U.S. Synta will receive an upfront cash payment of $80 million. Synta will also be eligible to receive potential milestone payments of up to $135 million for events leading to approval of STA-4783 in metastatic melanoma, further development and regulatory milestones of up to $450 million across various indications and up to $300 million in potential commercial milestone payments based on achieving certain net sales thresholds. Synta will continue to fund all development for metastatic melanoma in the U.S. and the companies will share responsibility and costs for development of STA-4783 in other indications. Synta and GSK will jointly commercialize STA-4783 in the U.S. with Synta receiving a tiered profit share based on levels of annual net sales. The parties will share development costs outside of the U.S. and Synta will receive double-digit tiered royalties on net sales. In addition, GSK may, subject to Synta's agreement, purchase, up to $45 million of Synta's common stock upon the future achievement of specified development and regulatory milestones.
The agreement is subject to antitrust clearance by the U.S. government under the Hart-Scott-Rodino Act. Common stock purchases may be subject to approval of Synta's shareholders if required under the rules and regulations of The Nasdaq Stock Market.
"GSK is an established global leader in the pharmaceutical industry with a strong commitment to oncology as a franchise," said Safi Bahcall, Ph.D., President and Chief Executive Officer, Synta. "GSK and Synta have a shared vision for the development and commercialization of STA-4783 in a range of potential indications, beginning with metastatic melanoma where a Phase 2b study with STA-4783 in combination with paclitaxel has shown doubling of progression free survival compared to paclitaxel alone. We are confident that this agreement will allow STA-4783 to achieve its full potential as a novel therapeutic option for treating cancer."
"This agreement confirms GSK's growing status as a world leader in the development of new oncology medicines for use in the treatment, prevention and supportive care of cancer patients. It further strengthens our late stage oncology pipeline, which currently includes ten Phase 3 programs, and also demonstrates our commitment to identifying compounds that have the potential to deliver real benefit to patients," said Moncef Slaoui, Chairman R&D, GSK. "The data we have seen from the Phase 2 trials conducted by Synta have given us confidence in the potential of STA-4783 as a novel means of treating metastatic melanoma, a disease for which there is high unmet medical need."
"We are pleased to establish this alliance with GSK, a company with a long history of success in launching and marketing important and innovative new drugs," said Martin Williams, Senior Vice President and Chief Business Officer, Synta. "GSK shares our enthusiasm and commitment to developing this first-in-class compound. Together we expect to bring STA-4783 more quickly to more patients and to build a U.S. sales and marketing organization at Synta in collaboration with a world leader."
Conference Call
Synta Pharmaceuticals management will conduct a conference call at 10:30 a.m. (ET) today to discuss the collaboration. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" section of the Synta Pharmaceuticals website, www.syntapharma.com, prior to the event.
The call also can be accessed by dialing (877) 407-8035 or (201) 689-8035 prior to the start of the call. For those unable to join the live conference call, a replay will be available from 2:00 p.m. (ET) today through midnight (ET) on October 17. To access the replay, dial (877) 660-6853 or (201) 612-7415 and refer to both account number 286 and conference ID 258153. The webcast also will be archived on the company's website.
About STA-4783
STA-4783 is a novel, injectable, investigational drug candidate that kills cancer cells by elevating oxidative stress levels beyond a breaking point, triggering programmed cell death. In preclinical models STA-4783 showed potent killing of a broad range of cancer cell types at high doses, and an ability to strongly enhance the efficacy of certain chemotherapy agents, with minimal additional toxicity, at moderate doses.
In a recent 21-center, double-blind, randomized, controlled Phase 2b clinical trial in 81 patients with metastatic melanoma, STA-4783 in combination with paclitaxel met the primary endpoint - doubling the median time patients survived without their disease progressing - compared to paclitaxel alone (p=0.035). STA-4783 is now entering a pivotal, confirmatory Phase 3 clinical trial in metastatic melanoma. Phase 2 trials in other indications, and in combination with other agents, are planned. STA-4783 has received Fast Track designation from the FDA for development in metastatic melanoma.
For more details on the Phase 2b trial please visit: syntapharma.com. |
