Replies to post #77942 on Biotech Values

[bladerunner1717]

SPPI turns profitable (for a quarter). This probably won't last, because the bottom line was given a big boost by FUSILEV sales which was used because leucovorin was in short supply. Leucovorin is no longer in such short supply.





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Spectrum Pharmaceuticals turns to profit in Q1 - Update
5/18/2009 8:44 AM ET





(RTTNews) - Cancer drug maker Spectrum Pharmaceuticals, Inc. (SPPI: News ), reported Monday a profit for the first quarter, as it generated revenues from sales of its two oncology proprietary drugs, Fusilev and Zevalin.

For the first quarter, net income was $0.62 million or $0.02 per share, compared to a net loss of $8.7 million or $0.28 per share in the previous year.

Spectrum reported revenues of $14.1 million in the quarter, compared to nil revenues in the year-ago period.

Rajesh Shrotriya, chairman, chief executive officer, and president of Spectrum Pharmaceuticals, said, "I am pleased to announce that 2009 is a transformative year for Spectrum, as we have fully transitioned into a diversified, commercial stage biotechnology company with two proprietary, oncology drugs on the market."

Net sales of Fusilev was $9.4 million, while net sales of Zevalin was $2.6 million. About $2.1 million was added to the topline as a result of amortization of the $41.5 million up-front payment received from Allergan, Inc. (AGN) last October.

Shrotriya, added, "Following our recent acquisition of full commercial rights to ZEVALIN, our goal is to stabilize ZEVALIN sales by year-end."

Research and development expenses decreased to $5.7 million from $6.4 million, primarily because of cost sharing in the development of apaziquone with Allergan.

Selling, general and administrative expenses increased year-over-year to $6.4 million from $2.6 million, mainly due to the commercialization of Zevalin and Fusilev.

SPPI closed Friday's regular trading session at $4.0 on the Nasdaq.



Bladerunner

[bladerunner1717]

Dew,

Why is SPPI issuing a PR about Satraplatin now? Of what use is this information now? Do the statistics about the correlation between PFS and OS have relevance for other prostate cancer drugs?

http://phx.corporate-ir.net/phoenix.zhtml?c=83249&p=irol-newsArticle&ID=1295063&highlight=




<< Back
New Data from Satraplatin Phase 3 Trial in Second-Line Castrate-Refractory Prostate Cancer Presented at 2009 ASCO Annual Meeting
SPARC Trial Analyses Demonstrate Pain At Baseline, Pain Progression And Progression-Free Survival At Three Months Are Predictive Of Overall Survival In Metastatic Castrate-Refractory Prostate Cancer Patients Previously Treated With Docetaxel Data From Several Other Trials Evaluating Satraplatin In Combination With Various Anti-Cancer Therapies Published In ASCO Proceedings
IRVINE, Calif.--(BUSINESS WIRE)--Jun. 2, 2009-- Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a commercial-stage biotechnology company with two proprietary, FDA-approved oncology drugs on the market, today announced that data from the double-blind, randomized satraplatin Phase 3 trial, the SPARC trial (Satraplatin and Prednisone Against Refractory Cancer) were presented at the 2009 American Society for Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida. The SPARC trial evaluated satraplatin plus prednisone versus placebo plus prednisone in 950 patients with castrate-refractory prostate cancer (CRPC) who had progressed after initial chemotherapy. The data presented are retrospective analyses of the SPARC trial evaluating correlations between overall survival (OS) and pain at baseline, pain progression, and progression-free survival (PFS) at three months.

One presentation (“Use of pain at baseline and pain progression to predict overall survival in patients with docetaxel pretreated metastatic castration-refractory prostate cancer: results from the SPARC trial,” Sartor et al, Abstract #5148), analyzed the docetaxel-pretreated population (n= 488) in two separate ways:

The first analysis compared OS in those patients who had no pain* (Present Pain Intensity (PPI) score < 1) vs. those with pain (PPI > 2) at time of entry to the trial; and
The second analysis compared OS in those patients who experienced pain progression versus progression by pre-specified measures other than pain (as judged by the blinded Independent Review Committee (IRC)).
Shorter OS time was observed in docetaxel-pretreated patients who had pain at baseline compared to those who did not. The median survival of patients with baseline pain (n=178) was 44 weeks versus 72 weeks for patients without baseline pain (n=287) [stratified hazard ratio: 0.59 (95% CI: 0.48-0.74), stratified log-rank p<0.0001]. The IRC found that 414 docetaxel-pretreated patients (84.8%) progressed as of the data cutoff date for the SPARC study. Of these, the median survival of patients showing pain progression (n=196) was 47 weeks, compared to 71 weeks for non-pain progressors (n=292) [stratified hazard ratio: 0.71 (95% CI: 0.57-0.87), stratified log-rank p=0.0022]. Thus, pain at baseline, as well as pain progression, were prognostic indicators of OS in the docetaxel-pretreated patient population.

A second presentation (“Correlation of progression-free survival and overall survival in men with metastatic castration-resistant prostate cancer who failed first-line chemotherapy: results from the SPARC trial,” Halabi et al, Abstract #5150) evaluated whether PFS at three months was predictive of OS and explored the statistical dependencies between PFS and OS. Of the 853 men alive at three months post-randomization, 477 (56%) had already progressed. The median survival for this group was 34.5 weeks versus 78.7 weeks in men who had not progressed at the same three month timepoint. [hazard ratio: 2.16 (95% CI =1.84-2.55), p-value <0.001]. The dependence between PFS and OS was 0.29 (95% confidence limits = 0.24-0.33, p-value < 0.00001). Thus PFS at three months predicts OS. Additional studies will be needed to assess the clinical relevance of the individual components of progression as defined in the SPARC trial to OS.

Data from other Phase I and Phase II clinical trials evaluating satraplatin in combination with other cancer therapeutic drugs were published in the 2009 ASCO Annual Meeting Proceedings.

Phase II trial of bevacizumab and oral satraplatin and prednisone in docetaxel pretreated metastatic castrate resistant prostate cancer – Vaishampayan et al (Abstract #e16028)
Dose finding study of the combination of satraplatin and gemcitabine in patients with advanced solid tumors – Di Paola et al (Abstract #e13534)
A phase I study investigating the combination of orally bioavailable platinum and nonparticle albumin-bound paclitaxel in advanced solid tumors – Deshpande et al (Abstract #e13501)



Bladerunner