GlaxoSmithKline (GSK) and Synta Pharmaceuticals Corp. jointly announced the execution of a global collaboration agreement for the joint development and commercialisation of STA-4783, a first-in-class, small-molecule, oxidative stress inducer that is entering phase III clinical development for the treatment of metastatic melanoma.
Under the terms of the agreement, the companies will share responsibility for development and commercialisation of STA-4783 in the US, and GSK will have exclusive responsibility for development and commercialisation of STA-4783 outside the US. 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 US and the companies will share responsibility and costs for development of STA-4783 in other indications. Synta and GSK will jointly commercialise STA-4783 in the US with Synta receiving a tiered profit share based on levels of annual net sales. The parties will share development costs outside of the US 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 US 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. GSK and Synta have a shared vision for the development and commercialisation 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," said Safi Bahcall, Ph.D., president and chief executive officer, Synta.
"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 III programmes, and also demonstrates our commitment to identifying compounds that have the potential to deliver real benefit to patients. The data we have seen from the phase II 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," said Moncef Slaoui, chairman R&D, GSK.
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 a recent 21-center, double-blind, randomised, 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 III clinical trial in metastatic melanoma. phase II 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.
Melanoma, the most deadly form of skin cancer, arises from melanocytes, the pigment-producing cells of the skin. According to the American Cancer Society, melanoma accounts for approximately five percent of all skin cancers but causes about 75 per cent of all skin cancer-related deaths. An estimated 60,000 people will be diagnosed and nearly 8,200 people will die from melanoma this year in the US alone. If diagnosed and surgically removed while localised in the outermost skin layer, melanoma is potentially curable; however, for patients with metastatic disease the prognosis is poor, with limited available treatments and an expected survival of only six to nine months.
Oxidative stress in cells is the presence of elevated levels of reactive oxygen species (ROS) such as oxygen radicals and hydrogen peroxide. ROS can be generated by many stimuli, including ordinary cell metabolism, exposure to heat or radiation, or attack by bacteria or viruses
Synta Pharmaceuticals Corp. is a biopharmaceutical company focused on discovering, developing, and commercialising small molecule drugs to extend and enhance the lives of patients with severe medical conditions, including cancer and chronic inflammatory diseases.