Monday, 3 December 2012

SPA Directory Part 3: L-R

Here is the 3rd portion of the SPA Directory for companies L-R.  As always I welcome your comments on any SPA agreements that are not shown here, especially active ongoing studies.

LCILannettC-TopicalLocal anesthesiahttp://www.streetinsider.com/Corporate+News/Lannett+(LCI),+FDA+Reach+Agreement+Over+SPA+for+C-Topical+Phase+III/7054155.htmlYESn/an/a
nilLantheusFlurpiridaz F18Myocardial perfusion imaginghttp://www.lantheus.com/News-Press-2011-0311.htmlYeshttp://www.clinicaltrials.gov/ct2/show/NCT01347710?term=Flurpiridaz+F18&rank=1Dec-12
CSE:VELO LifeCycle PharmaLCP-TacroKidney Transplanthttp://www.news-medical.net/news/20100812/FDA-grants-LifeCycle-Pharma-SPA-for-LCP-Tacro-pivotal-Phase-3-study-in-de-novo-kidney-transplant-patients.aspxYeshttp://www.clinicaltrials.gov/ct2/show/NCT01187953?term=LCP-tacro&rank=8Mar-13
nilMacrocureCureXcellChronic diabetic ulcershttps://sos.cision.com/node/499686Yeshttp://www.clinicaltrials.gov/ct2/show/NCT01421966?term=macrocure&rank=3Feb-15
TSE:4508Mitsubishi Tanabe Pharma CoCollategeneAdvanced PADhttp://www.anges-mg.com/en/news/pdf/20121024.pdfYesn/an/a
nilNanotherapeuticsRamoplaninC Diffhttp://www.nanotherapeutics.com/products_pipeline_ramoplanin.phpYesn/an/a
NLNKNew Link GeneticsHyperAcute immunotherapyPancreatic cancerhttp://www.linkp.com/products/hyperacute-pancreas.htmlYeshttp://www.clinicaltrials.gov/ct2/show/NCT01072981?term=hyperacute+pancreas&rank=1Jan-14
nilNovaRxLucanixAdvanced NSCLChttp://www.prnewswire.com/news-releases/novarx-completes-enrollment-in-lucanix-pivitol-phase-iii-therapeutic-vaccine-trial-for-post-frontline-maintenace-therapy-in-non-small-cell-lung-cancer-159688685.htmlYeshttp://www.clinicaltrials.gov/ct2/show/NCT00676507?term=NovaRx&rank=2Oct-12
OXGIOncogenixCustirsenCancer pain in mCRPChttp://oncogenex.com/physicians/custirsen-ogx-011Yeshttp://www.clinicaltrials.gov/ct2/show/NCT01188187?term=Custirsen&rank=6Dec-13
nilOnconovaEstybonMyelodysplastic Syndromes http://www.eurekalert.org/pub_releases/2010-10/poc-oaf100410.phpYeshttp://www.clinicaltrials.gov/ct2/show/NCT01241500?term=onconova&rank=13Oct-13Interim analysis
ONXXOnyx PharmaCarfilzomib2L MM +lenolidomidehttp://www.onyx.com/view.cfm/626/onyx-pharmaceuticals-receives-fda-accelerated-approval-of-kyprolis-carfilzomib-for-injection-Yeshttp://www.clinicaltrials.gov/ct2/show/NCT01568866?term=carfilzomib&phase=2&rank=1Jan-15
OREXOrexigenContraveObesityhttp://ir.orexigen.com/phoenix.zhtml?c=207034&p=irol-newsArticle&id=1656731Yeshttp://www.clinicaltrials.gov/ct2/show/NCT01601704?term=orexigen&rank=1Sep-13
OXGNOxigeneZybrestat Anaplastic Thyroid Cancerhttp://investor.oxigene.com/releasedetail.cfm?ReleaseID=707372Yeshttp://www.clinicaltrials.gov/ct2/show/NCT01701349?term=oxigene&rank=5Dec-16
nilParatekOmadacyclineABSSSIhttp://www.paratekpharm.com/press/032812_SPA_ECCMID_release.pdfYesn/an/a
nilParatekOmadacyclineCABPhttp://www.paratekpharm.com/press/032812_SPA_ECCMID_release.pdfYesn/an/a
n/aPervasisVascugelFistula/Graft failure preventionhttp://www.prnewswire.com/news-releases/pervasis-receives-fda-fast-track-status-for-vascugel-to-prevent-arteriovenous-access-failure-in-patients-undergoing-hemodialysis-115553949.htmlYesn/an/a
PXSLPharmaxisBronchitolBronchiectasishttp://www.prnewswire.com/news-releases/pharmaxis-concludes-special-protocol-assessment-with-fda-for-bronchitol-phase-3-trial-57511597.htmlYeshttp://www.clinicaltrials.gov/ct2/show/NCT00669331?term=pharmaxis&phase=2&rank=4Jun-13
nilPolaris GroupADI-PEG 20Advanced HCChttp://www.prnewswire.com/news-releases/fda-approves-special-protocol-assessment-for-phase-3-trial-of-polaris-groups-cancer-therapeutic-adi-peg-20-in-the-treatment-of-hepatocellular-carcinoma-118979494.htmlYeshttp://www.clinicaltrials.gov/ct2/show/NCT01287585?term=Polaris+group&rank=1&submit_fld_opt=Jun-13
PVCTProvectusRose BengalMelanomahttp://www.pvct.com/pressrelease.html?article=20121002pendingn/an/a
RPTPRaptorDR CysteamineNephropathic Cystinosishttp://ir.raptorpharma.com/releasedetail.cfm?releaseid=633905Yeshttp://www.clinicaltrials.gov/ct2/show/NCT01000961?term=raptor&rank=11Jun-11
RPRXReprosAndroxalHypogonadismhttp://www.reprosrx.com/pr_20120912_repros_updates_androxal_phase_3.phpYeshttp://www.clinicaltrials.gov/ct2/show/NCT01534208?term=REPROS&rank=30Jul-13

1 comment:

  1. Oncothyreon has a SPA on the Stimuvax trial. Results due early 1st qtr 2013.

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