The flawed bear thesis on TSRX

Please check out my first collaboration with Jason Napodano, CFA on Trius Therapeutics.  Trius is currently developing tedizolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI). They should be reporting results for their phase 3 pivotal study which has been conducted pursuant to a SPA agreement, in 1H 2013.  I hold a long position in this stock.  Anyone with an interest in this market should also look at Durata Therapeutics Dalbavancin. DRTX is set to report results for their second pivotal study (also conducted under a SPA agreement) in Q113.

Here is a link to the full article on PropThink.

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

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.

LCI	Lannett	C-Topical	Local anesthesia	http://www.streetinsider.com/Corporate+News/Lannett+(LCI),+FDA+Reach+Agreement+Over+SPA+for+C-Topical+Phase+III/7054155.html	YES	n/a	n/a
nil	Lantheus	Flurpiridaz F18	Myocardial perfusion imaging	http://www.lantheus.com/News-Press-2011-0311.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01347710?term=Flurpiridaz+F18&rank=1	Dec-12
CSE:VELO	LifeCycle Pharma	LCP-Tacro	Kidney Transplant	http://www.news-medical.net/news/20100812/FDA-grants-LifeCycle-Pharma-SPA-for-LCP-Tacro-pivotal-Phase-3-study-in-de-novo-kidney-transplant-patients.aspx	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01187953?term=LCP-tacro&rank=8	Mar-13
nil	Macrocure	CureXcell	Chronic diabetic ulcers	https://sos.cision.com/node/499686	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01421966?term=macrocure&rank=3	Feb-15
TSE:4508	Mitsubishi Tanabe Pharma Co	Collategene	Advanced PAD	http://www.anges-mg.com/en/news/pdf/20121024.pdf	Yes	n/a	n/a
nil	Nanotherapeutics	Ramoplanin	C Diff	http://www.nanotherapeutics.com/products_pipeline_ramoplanin.php	Yes	n/a	n/a
NLNK	New Link Genetics	HyperAcute immunotherapy	Pancreatic cancer	http://www.linkp.com/products/hyperacute-pancreas.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01072981?term=hyperacute+pancreas&rank=1	Jan-14
nil	NovaRx	Lucanix	Advanced NSCLC	http://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.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00676507?term=NovaRx&rank=2	Oct-12
OXGI	Oncogenix	Custirsen	Cancer pain in mCRPC	http://oncogenex.com/physicians/custirsen-ogx-011	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01188187?term=Custirsen&rank=6	Dec-13
nil	Onconova	Estybon	Myelodysplastic Syndromes	http://www.eurekalert.org/pub_releases/2010-10/poc-oaf100410.php	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01241500?term=onconova&rank=13	Oct-13	Interim analysis
ONXX	Onyx Pharma	Carfilzomib	2L MM +lenolidomide	http://www.onyx.com/view.cfm/626/onyx-pharmaceuticals-receives-fda-accelerated-approval-of-kyprolis-carfilzomib-for-injection-	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01568866?term=carfilzomib&phase=2&rank=1	Jan-15
OREX	Orexigen	Contrave	Obesity	http://ir.orexigen.com/phoenix.zhtml?c=207034&p=irol-newsArticle&id=1656731	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01601704?term=orexigen&rank=1	Sep-13
OXGN	Oxigene	Zybrestat	Anaplastic Thyroid Cancer	http://investor.oxigene.com/releasedetail.cfm?ReleaseID=707372	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01701349?term=oxigene&rank=5	Dec-16
nil	Paratek	Omadacycline	ABSSSI	http://www.paratekpharm.com/press/032812_SPA_ECCMID_release.pdf	Yes	n/a	n/a
nil	Paratek	Omadacycline	CABP	http://www.paratekpharm.com/press/032812_SPA_ECCMID_release.pdf	Yes	n/a	n/a
n/a	Pervasis	Vascugel	Fistula/Graft failure prevention	http://www.prnewswire.com/news-releases/pervasis-receives-fda-fast-track-status-for-vascugel-to-prevent-arteriovenous-access-failure-in-patients-undergoing-hemodialysis-115553949.html	Yes	n/a	n/a
PXSL	Pharmaxis	Bronchitol	Bronchiectasis	http://www.prnewswire.com/news-releases/pharmaxis-concludes-special-protocol-assessment-with-fda-for-bronchitol-phase-3-trial-57511597.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00669331?term=pharmaxis&phase=2&rank=4	Jun-13
nil	Polaris Group	ADI-PEG 20	Advanced HCC	http://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.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01287585?term=Polaris+group&rank=1&submit_fld_opt=	Jun-13
PVCT	Provectus	Rose Bengal	Melanoma	http://www.pvct.com/pressrelease.html?article=20121002	pending	n/a	n/a
RPTP	Raptor	DR Cysteamine	Nephropathic Cystinosis	http://ir.raptorpharma.com/releasedetail.cfm?releaseid=633905	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01000961?term=raptor&rank=11	Jun-11
RPRX	Repros	Androxal	Hypogonadism	http://www.reprosrx.com/pr_20120912_repros_updates_androxal_phase_3.php	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01534208?term=REPROS&rank=30	Jul-13

SPA Directory Part 2

Thank-you to everyone who has taken the time to review my last posting.  Below is an update to the directory for companies D-K.

TASE:DPRM	D-Pharm	DP-b99	Acute Ischemic Stroke	http://www.dpharm.com/News.asp?mode=1&type=0&id=133&Year=2011	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00893867?term=D-Pharm&rank=3	Feb-13	Futility analysis
ENDP	Endo Pharma	Urocidin	Bladder ca	http://bioniche.com/news_item.cfm?id=2215		http://www.clinicaltrials.gov/ct2/show/NCT01284205?term=bioniche&rank=5&submit_fld_opt=	n/a	Study withdrawn
EPCT	Epicept	Ceplene	AML	http://investor.epicept.com/releasedetail.cfm?ReleaseID=604432	Pending	n/a	n/a
EPCT	Epicept	Amiket	CIPN	http://investor.epicept.com/releasedetail.cfm?ReleaseID=641427	Pending	n/a	n/a
nil	Essentialis	Diazoxide Choline CR	VHTG's	http://essentialistherapeutics.com/media/Essentialis%20SPA%20Press%20Release%2010-25-10.pdf	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00973271?term=Essentialis&rank=5	Jun-14	My estimate
GALE	Galena	NeuVax	Early stage node+ low-expression HER2 breast cancer	http://www.galenabiopharma.com/pipeline	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01479244?term=NeuVax&rank=1	May-15
GNBT	Generex	AE37	Breast Cancer	http://www.prnewswire.com/news-releases/generex-provides-update-on-company-initiatives-including-the-ae37-breast-cancer-vaccine-program-179098191.html	Pending	n/a	n/a
nil	Helsinn	Netupitant and Palonosetron	CINV	http://www.prnewswire.co.uk/news-releases/fda-agrees-to-special-protocol-assessment-spa-to-evaluate-the-safety-and-efficacy-of-a-fixed-dose-combination-fdc-of-netupitant-and-palonosetron-in-the-prevention-of-cinv-156836265.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01376297?term=Netupitant&rank=1	Sep-12
nil	Hyperion Therapeutics	HPN-100	Urea Cycle Disorders	http://files.shareholder.com/downloads/AMDA-1412CE/0x0x585109/0f970e6e-64cd-430e-9796-995fcab86980/HPTX_News_2012_7_7_General_Releases.pdf	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00992459?term=HPN-100&rank=3	Aug-10
LSE:IMM	Immupharma	Lupuzor	SLE	http://www.immupharma.org/lupuzor	Yes	n/a	n/a
nil	Innocoll	Cogenzia	Wound infections	http://innocollinc.com/cogenzia.html	Yes	n/a	n/a
INSV	InSite Vision	Dexasite/Azasite	Blepharitis	http://phx.corporate-ir.net/phoenix.zhtml?c=86061&p=irol-newsArticle&ID=1631034&highlight=	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01408082?term=Insite+vision&rank=5&submit_fld_opt=	Dec-12
ISA.TO	Isotechnika Pharma	Voclosporin	Kidney Transplant	http://www.isotechnika.com/dnn/LinkClick.aspx?fileticket=UrRyyein3D8%3D&tabid=92&mid=671	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01586845?term=voclosporin&rank=1	Mar-15
nil	ISTA Pharma/B&L	Remura	Dry Eye Syndrome	http://www.prnewswire.com/news-releases/ista-pharmaceuticals-initiates-phase-3-clinical-program-for-remura-in-dry-eye-disease-103037129.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01212471?term=ISTA+bromfenac&rank=4	Dec-11
KERX	Keryx	Zerenex	Hyperphosphatemia in ESRD	http://www.keryx.com/page.cfm?hmid=20&smid=0&pg=4b	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01191255?term=zerenex&rank=2	Dec-12