SPA Directory Part 4- S-Z

Here is the final installment of the SPA directory for companies S-Z below.

A few key findings from the whole dataset:

• 18/68 companies who actually secured a SPA agreement, never conducted the phase 3 study (reasons include lack of funding, lack of commercialization partner, ceasing operations). ~1/4 companies will never proceed beyond the SPA agreement phase
• 8/77 companies who put out active press about a SPA agreement, never actually secure an agreement. ~10% "noise" regarding SPA agreements in the public domain
• The most common therapeutic areas for SPA agreements
• Oncology (solid tumors and hematologic malignancies).
• Infections (ABSSSI, CABP, wound infection)
• SLE
• Spasticity
• Companies with drugs in development in the above areas conducting pivotal registration studies in the absence of a SPA are potentially likely to face heightened regulatory review hurdles

SNTS	Santarus	RUCONEST	HAE	http://ir.santarus.com/releasedetail.cfm?releaseid=596614	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01188564?term=recombinant+human+C1+inhibitor&rank=5	Sep-12	SPA from 08, trial not found
SCLN	SciClone	Thymalfasin	Advanced melanoma	http://investor.sciclone.com/releasedetail.cfm?ReleaseID=420381	Yes	n/a	n/a
nil	Spinal Restoration	Biostat system	Discogenic low back pain	http://www.spinalrestoration.com/newsroom/news_12-15-2009.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01011816?term=biostat+system&rank=1	Apr-13	Trial failed to meet primary end point
OTCQX SPHRY	StarPharma	VivaGel	Bacterial vaginosis	http://www.starpharma.com/vivagel	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01577537?term=vivagel&rank=1	12-Dec
SUN.BO	Sun Pharma	Baclofen GRS	Spasticity	http://smartinvestor.business-standard.com/company/direcrpt-27675-Sun_Pharma_Advanced_Research_Company_Ltd.htm	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01457352?term=baclofen+GRS&rank=1	Dec-13
TLON	Talon	Marquibo	2L ALL	http://ir.talontx.com/releasedetail.cfm?ReleaseID=601527	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01439347?term=HALLMARQ&rank=1	Dec-15
MDCO	The Medicines Company	Oritavancin	ABSSSI	http://www.dailyfinance.com/rtn/pr/the-medicines-company-reaches-agreement-with-fda-on-special-protocol-assessment-for-oritavancin-phase-3-trials/rfid391293110/	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01252732?term=Oritavancin&rank=2	Jun-13
THLD	Threshold	TH-302	Advanced soft tissue sarcoma	http://investor.thresholdpharm.com/releasedetail.cfm?ReleaseID=609818	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01440088?term=TH-302&rank=3	Jun-14
THLD	Threshold	TH-303	Advanced pancreatic cancer	http://investor.thresholdpharm.com/releasedetail.cfm?ReleaseID=713686	Yes	n/a	n/a
nil	Tioga	Asimadoline	IBS-D	http://www.prnewswire.com/news-releases/tioga-pharmaceuticals-begins-phase-3-trial-of-asimadoline-in-irritable-bowel-syndrome-95499844.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01100684?term=asimadoline&rank=4	May-13
nil	Tolera Therapeutics	TOL101	Organ rejection	http://www.prnewswire.com/news-releases/tolera-therapeutics-closes-series-b-3-financing-raises-55-million-to-submit-phase-3-special-protocol-assessment-for-its-immune-targeting-biologic-drug-in-kidney-transplantation-174443781.html	Pending	n/a	n/a
TSRX	Trius Therapeutics	torezolid phosphate	ABSSSI	http://www.triusrx.com/trius-therapeutics-news-100616.php	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01421511?term=Trius+Therapeutics&rank=1	Dec-12
nil	Upsher-Smith Labs	Intranasal midazolam	Epilepsy	http://www.prnewswire.com/news-releases/upsher-smith-laboratories-begins-phase-iii-study-of-intranasal-midazolam-for-rescue-treatment-of-seizure-clusters-in-epilepsy-patients-125739248.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01390220?term=Upsher-Smith+Labs&rank=2	Dec-13
nil	Vaccinogen	OncoVax	Colon cancer	http://www.vaccinogeninc.com/vaccinogen/index.cfm?LinkServID=70A8FD5C-9192-12E7-1532571A63255EA7	Yes	n/a	n/a
VICL	Vical	Allovectin	Advanced melanoma	http://www.vical.com/files/doc_presentations/101109_Allovectin_Rolland.pdf	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00395070?term=Allovectin&rank=1	Dec-12
VION	Vion Pharma	Laromustine	AML	http://www.highbeam.com/doc/1G1-217098067.html	Yes	n/a	n/a	Company filed for bankrupcy
XNPT	Xenoport	Arbaclofen	Spasticity	http://investor.xenoport.com/releasedetail.cfm?releaseid=708156	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01359566?term=Arbaclofen+AND+spasticity&rank=2	Sep-12	Last updated in 2011. Second confirmatory study set to complete 12/13
ZGEN	Zymogenetics	Atacicept	SLE	http://www.prnewswire.com/news-releases/zymogenetics-and-merck-serono-receive-fda-special-protocol-assessment-for-atacicept-pivotal-study-in-lupus-nephritis-58425412.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00573157?term=Atacicept&rank=8	n/a	Study terminated