10th Oct 2007 11:00
GlaxoSmithKline (GSK) (LSE: GSK; NYSE: GSK) and SyntaPharmaceuticals Corp. (NASDAQ: SNTA) today announced the execution ofa global collaboration agreement for the joint development andcommercialization of STA-4783, a first-in-class, small-molecule,oxidative stress inducer that is entering Phase 3 clinical developmentfor the treatment of metastatic melanoma. £ Under the terms of the agreement, the companies will shareresponsibility for development and commercialization of STA-4783 inthe U.S. and GSK will have exclusive responsibility for developmentand commercialization of STA-4783 outside the U.S. Synta will receivean upfront cash payment of $80 million. Synta will also be eligible toreceive potential milestone payments of up to $135 million for eventsleading to approval of STA-4783 in metastatic melanoma, furtherdevelopment and regulatory milestones of up to $450 million acrossvarious indications and up to $300 million in potential commercialmilestone payments based on achieving certain net sales thresholds.Synta will continue to fund all development for metastatic melanoma inthe U.S. and the companies will share responsibility and costs fordevelopment of STA-4783 in other indications. Synta and GSK willjointly commercialize STA-4783 in the U.S. with Synta receiving atiered profit share based on levels of annual net sales. The partieswill share development costs outside of the U.S. and Synta willreceive double-digit tiered royalties on net sales. In addition, GSKmay, subject to Synta's agreement, purchase, up to $45 million ofSynta's common stock upon the future achievement of specifieddevelopment and regulatory milestones. £ The agreement is subject to antitrust clearance by the U.S.government under the Hart-Scott-Rodino Act. Common stock purchases maybe subject to approval of Synta's shareholders if required under therules and regulations of The Nasdaq Stock Market. £ "GSK is an established global leader in the pharmaceuticalindustry with a strong commitment to oncology as a franchise," saidSafi Bahcall, Ph.D., President and Chief Executive Officer, Synta."GSK and Synta have a shared vision for the development andcommercialization of STA-4783 in a range of potential indications,beginning with metastatic melanoma where a Phase 2b study withSTA-4783 in combination with paclitaxel has shown doubling ofprogression free survival compared to paclitaxel alone. We areconfident that this agreement will allow STA-4783 to achieve its fullpotential as a novel therapeutic option for treating cancer." £ "This agreement confirms GSK's growing status as a world leader inthe development of new oncology medicines for use in the treatment,prevention and supportive care of cancer patients. It furtherstrengthens our late stage oncology pipeline, which currently includesten Phase 3 programs, and also demonstrates our commitment toidentifying compounds that have the potential to deliver real benefitto patients," said Moncef Slaoui, Chairman R&D, GSK. "The data we haveseen from the Phase 2 trials conducted by Synta have given usconfidence in the potential of STA-4783 as a novel means of treatingmetastatic melanoma, a disease for which there is high unmet medicalneed." £ "We are pleased to establish this alliance with GSK, a companywith a long history of success in launching and marketing importantand innovative new drugs," said Martin Williams, Senior Vice Presidentand Chief Business Officer, Synta. "GSK shares our enthusiasm andcommitment to developing this first-in-class compound. Together weexpect to bring STA-4783 more quickly to more patients and to build aU.S. sales and marketing organization at Synta in collaboration with aworld leader." £ Conference Call £ Synta Pharmaceuticals management will conduct a conference call at10:30 a.m. (ET) today to discuss the collaboration. The conferencecall will be webcast live over the Internet and can be accessed bylogging on to the "Investors" section of the Synta Pharmaceuticalswebsite, 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 thelive 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 286and conference ID 258153. The webcast also will be archived on thecompany's website. £ About STA-4783 £ STA-4783 is a novel, injectable, investigational drug candidatethat kills cancer cells by elevating oxidative stress levels beyond abreaking point, triggering programmed cell death. In preclinicalmodels STA-4783 showed potent killing of a broad range of cancer celltypes at high doses, and an ability to strongly enhance the efficacyof certain chemotherapy agents, with minimal additional toxicity, atmoderate doses. £ In a recent 21-center, double-blind, randomized, controlled Phase2b clinical trial in 81 patients with metastatic melanoma, STA-4783 incombination with paclitaxel met the primary endpoint - doubling themedian time patients survived without their disease progressing -compared to paclitaxel alone (p=0.035). STA-4783 is now entering apivotal, confirmatory Phase 3 clinical trial in metastatic melanoma.Phase 2 trials in other indications, and in combination with otheragents, are planned. STA-4783 has received Fast Track designation fromthe FDA for development in metastatic melanoma. £ For more details on the Phase 2b trial please visit:http://www.syntapharma.com/Documents/STA4783_Overview.pdf. £ About Metastatic Melanoma £ Melanoma, the most deadly form of skin cancer, arises frommelanocytes, the pigment-producing cells of the skin. According to theAmerican Cancer Society, melanoma accounts for approximately fivepercent of all skin cancers but causes about 75% of all skincancer-related deaths. An estimated 60,000 people will be diagnosedand nearly 8,200 people will die from melanoma this year in the U.S.alone. If diagnosed and surgically removed while localized in theoutermost skin layer, melanoma is potentially curable; however, forpatients with metastatic disease the prognosis is poor, with limitedavailable treatments and an expected survival of only six to ninemonths. £ The incidence of melanoma has increased more rapidly than anyother cancer during the past ten years. The FDA has not approved anovel, small molecule drug for the treatment of metastatic melanoma inover 30 years. £ About Oxidative Stress and Apoptosis £ Oxidative stress in cells is the presence of elevated levels ofreactive oxygen species (ROS) such as oxygen radicals and hydrogenperoxide. ROS can be generated by many stimuli, including ordinarycell metabolism, exposure to heat or radiation, or attack by bacteriaor viruses. Normal cells have a strong anti-oxidant capacity thatregulates the levels of ROS. Cancer cells, however, typically operateat a much higher level of oxidative stress than normal cells and havea greatly diminished anti-oxidant capacity. This diminished capacityto clear ROS leaves them vulnerable to further increases in oxidativestress. When ROS levels exceed a critical threshold, continuedsurvival of the cell becomes unsustainable and programmed cell death(apoptosis) is initiated. £ In a series of in vitro and in vivo experiments, STA-4783 has beenshown to rapidly cause a dramatic increase in the level of ROS insidecancer cells and induce apoptosis. At similar doses and exposure,STA-4783 has little to no impact on non-cancer cells. £ Elevated oxidative stress induces apoptosis through themitochondrial pathway. In addition to potent induction of oxidativestress and apoptosis in cancer cells as a single agent, STA-4783 hasbeen shown to enhance the activity of other anti-cancer agents thatact through the mitochondrial pathway. These include commonly usedchemotherapies such as paclitaxel and docetaxel. £ Oxidative stress induction represents a novel anti-cancer strategy- a novel way of differentiating, and selectively killing, cancercells vs. normal cells. £ About GSK £ GlaxoSmithKline, one of the world's leading research-basedpharmaceutical and healthcare companies, is committed to improving thequality of human life by enabling people to do more, feel better andlive longer. For information about GSK visit the company website atwww.GSK.com. £ About Synta Pharmaceuticals £ Synta Pharmaceuticals Corp. is a biopharmaceutical company focusedon discovering, developing, and commercializing small molecule drugsto extend and enhance the lives of patients with severe medicalconditions, including cancer and chronic inflammatory diseases. Syntahas a unique chemical compound library, an integrated discoveryengine, and a diverse pipeline of clinical- and preclinical-stage drugcandidates with distinct mechanisms of action and novel chemicalstructures. All Synta drug candidates were discovered and developedinternally. For more information, please see www.syntapharma.com. £ GlaxoSmithKline Forward-Looking Statement £ Under the safe harbor provisions of the U.S. Private SecuritiesLitigation Reform Act of 1995, GSK cautions investors that anyforward-looking statements or projections made by GSK, including thosemade in this announcement, are subject to risks and uncertainties thatmay cause actual results to differ materially from those projected.Factors that may affect GSK's operations are described under 'RiskFactors' in the Business and Prospects in GSK's Annual Report on Form20-F for 2006. £ Synta Safe Harbor Statement £ This media release contains forward-looking statements includingstatements relating to the potential value of payments that may bereceived pursuant to the agreement with GSK, the potential equityinvestments by GSK, and the anticipated progress and development ofSTA-4783, including the timing of clinical trials. Suchforward-looking statements can be identified by the use offorward-looking terminology such as "will", "would", "should","expects", "anticipates", "intends", "plans", "believes", "may","estimates", "predicts", "projects", or similar expressions intendedto identify forward-looking statements. Such statements, reflect ourcurrent views with respect to future events and are based onassumptions and subject to risks and uncertainties that could causeactual results to differ materially from those expressed or implied bysuch forward-looking statements, including those described under "RiskFactors" in our Annual Report on Form 10-K for the year ended December31, 2006 as filed with the Securities and Exchange Commission. Syntaundertakes no obligation to publicly update forward-lookingstatements, whether because of new information, future events orotherwise, except as required by law. Copyright Business Wire 2007Related Shares:
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