Spectrum Pharmaceuticals to Present at the BMO Capital Markets 2009 Focus on Healthcare Conference:
Source: Spectrum Pharmaceuticals, Inc. On Monday August 3, 2009, 7:00 am EDT
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI - News), a commercial-stage biotechnology company with a focus in oncology, announced today that an overview of the Company’s business strategy will be presented at the BMO Capital Markets 2009 Focus on Healthcare Conference on August 5, 2009 at 3:00 p.m. Eastern Time. The Conference is being held at the Millennium Broadway Hotel in New York City.
We are a commercial-stage biotechnology company with a focus in oncology. Our strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit our website at www.spectrumpharm.com.
Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for our approved drugs, continuing to build our team, leveraging the expertise of partners around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.™, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
SPPI is trading up at $7.09 in the pre-market session after closing at $6.70 on Friday...Probably because the rumor mill is talking about this company is a buyout target from one of the big Pharma companies...
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Edits: VRTX (updated several items re reporting of Telaprevir data).
ABT – Certriad PFDUFA date early Apr 2010 (NDA submitted 6/5/09).
AZN – Certriad: see ABT.
ACAD - Pimavanserin for dementia in Parkinson's patients due Dec 2009 per clinicaltrials.org
ACHN – ACH-1095 (a.k.a. GS9525) HCV NS4A antagonist: GILD has decided not to take ACH-1095 into the clinic due to concerns about the “therapeutic index” of the compound; ACHN is apparently trying to restructure its licensing agreement with GILD so that it can take the compound into the clinic on its own. The two companies are apparently still working on backup NS4A antagonists, notwithstanding what is now apparently two failed attempts to develop one. ACHN – ACH-1625 HCV protease inhibitor: announced on 6/29/09 that dosing had begun in its Phase I European trial; ACHN expects to start US phase-1 trial 3Q09. (The split phase-1 trials are a new development; prior guidance for start of phase-1 was 1Q09.)
AGN – Botox for migraine: sBLA submission late 3Q09. AGN – Botox for spasticity: CR letter received 5/25/09; reply by AGN in 60-90 days.
AMGN – Denosumab: FDA panel 8/13/09; PDUFA date 10/19/09.
AMLN – Exenatide LAR: PDUFA date early Mar 2010 (NDA submitted 5/5/09 and accepted for review 7/7/09). AMLN – Byetta monotherapy NDA: AMLN/LLY reported on 12/8/08 that FDA action will slip to an unspecified date in 2009.
ANDS – ANA598 phase-2 trial: safety and RVR data from 200mg arm: end 2009; safety and RVR data from 400mg arm: 1H10; SVR data: 2H10.
Bayer – Xarelto: see JNJ.
DNDN – Resubmit Provenge BLA: 4Q09.
DORB - Orbec P3 confirmatory study in treatment of GVHD: expects to begin in 2H 09. DORB - Orbec P2 in prevention of GVHD ongoing.
DYAX – DX-88 for HAE: response to FDA’s CRL submitted 6/8/09.
ELN – AAB-001 phase-3: final data mid-2011 (est.). (First patient dosed 12/21/07.) ELN – ELND005 for AD phase-2: final data 1H10 (est.) (First patient dosed 12/21/07.)
FOLD - Amigal in SPA discussion: expecting phase 3 in Fabry to start 2Q 09. P2 extension data in 1Q 09. FOLD - Plicera P2 in Gaucher: results expected in 3Q 09.
GILD – GS9190 HCV polymerase inhibitor: fully enrolled; report data by end 2008. GILD – Elvitegravir phase-3 vs Isentress: 50% enrolled; complete enrollment 4Q09. GILD – ‘Quadro’ phase-2: complete enrollment (75 pnts) in May 2008; primary endpoint (24 weeks) by end 2008. GILD – GS9450 (caspase inhibitor to inhibit fibrosis): start phase-2b 2Q09; report phase-2a data at AASLD (the HCV study, not the NASH study)
HEB – Ampligen BLA: PDUFA date was 5/25/09 (originally 2/25/09), but FDA said it still needs more time.
HEPH - Triolex Phase I/II for ulcerative colitis: data were expected 2Q09.
HGSI – Submit Albuferon BLA/MAA fall 2009. (Data from 2nd phase-3 trial reported 3/9/09.)
INSM - NDGA phase II trial run by UCSF in prostate cancer started May 2008. Primary data: ? (was expected May 2009). INSM - Iplex in ROP phase II: no date known yet
ITMN – ITMN191: see Roche. ITMN – pirfenidone: NDA submission summer 2009; MAA submission late 2009. ITMN – ITMN-520 qD pirfenidone analog for IPF and other conditions: IND filing mid 2010.
JNJ – Xarelto: reply to FDA’s CRL 4Q09. JNJ – Stelara (ustekinumab) for psoriasis: FDA action expected Oct 2009 (FDA missed May 2009 PDUFA date). JNJ – PurTox: submit BLA calendar 4Q10 after completion of two ongoing phase-3 trials. (First phase-3 trial reported positive data 10/1/08.) JNJ – Telaprevir: see VRTX.
MRK – Isentress sNDA for qD dosing: submission 2011. (Phase-3 trial called QDMRK started 4Q08: Isentress BID + Truvada vs Isentress qD + Truvada in first-line setting.)
NVS – FTY720 FREEDOMS phase-3 trial: report data Jul 2009. (The FREEDOMS trial plus the TRANFORMS trial and the US subset from the FREEDOMS-2 trial will comprise the NDA package. TRANSFORMS, a 1-yr trial vs Avonex, hit its primary endpoint as reported on 12/12/08; FREEDOMS and FREEDOMS-2 have identical protocols with a 2-yr duration and a placebo control arm. Data from the US subset of FREEDOMS-2 will already be available and will be reported when FREEDOMS finishes.) NVS – Albuferon: see HGSI.
OREX - Contrave ph iii - per clinicaltrials.org should have finished in April 09
OXGN 2H 09 Initiate OXI4503 Phase 1 in AML OXGN 2H 09 Interim Zybrestat NSCLC Phase 2 data OXGN 2H 09 OXI4503 Phase 1 data (solid tumors)
PIP – Phase-1 Protexia results: ? (guidance was 2Q09).
REGN - Rilonacept in flare prevention upon initiation of allopurinol - results expected in 2010 REGN - Rilonacept in flare treatment - results expected in 2010 REGN - Aflibercept in 4 different ph iii's (total enrollment expected is ~4000). VELOUR (2nd line colorectal + chemo cocktail), VANILLA (1st line metastatic pancreatic + Gemcitibine), VITAL (2nd line NSCLC with docetaxel), VENICE (1st line HRPC with docetaxel + pred) REGN - VEGF Trap Eye - 3 ph iii's expecting results from some by end of 2010.
Roche – INFORM-1 trial in HCV: full data at AASLD 11/09 (interim data was presented at EASL). Roche – R7128: Report phase-2a EoT (28 days) data and start phase-2b trial: summer 2009.
RPRX – Androxal: P2b in fertility preservation results: 3Q09.
SGP – Boceprevir NDA: 2011-2012 (based on SGP’s Nov 2008 R&D Day).
TSPT – Intermezzo PDUFA date 10/31/09 (#msg-38604446).
VRTX – Telaprevir phase-3 ADVANCE and ILLUMINATE trials in 1st-line setting: SVR data 1H10. VRTX – Telaprevir phase-3 REALIZE trial in 2nd-line setting: SVR data mid 2010. VRTX – Telaprevir phase-2 ‘C208’ trial testing BID vs TID dosing: full presentation including SVR data 11/3/09 at AASLD. VRTX – Telaprevir ± VX-222 (formerly called VCH-222): start phase-2 study 4Q09. VRTX – Telaprevir: submit NDA 2H10.
VRUS – R7128 & INFORM-1 all-oral HCV cocktail: see Roche.
VVUS - Qnexa Pivotal trial data obesity (OB-302) Mid 2009 VVUS - Qnexa Pivotal trial data obesity (OB-3030 Mid 2009 VVUS - File NDA Qnexa obesity Late 2009
ZGEN - Atacicept 26 week Ph ii in RA TNF-naive patients 1H10 (but clinicaltrials.org expects in 2H09) ZGEN - Atacicept 26 week Ph ii in RA TNF inadequate-responders in 2H09 ZGEN - Atacicept small Ph ii in RA in combo with Rituxan. 25 week study with results expected per clinicaltrials.org in 2H10. ZGEN - Atacicept 48 week Ph ii in MS - clinicaltrials.org expects data 1H10
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