SPPI - Spectrum Pharmaceuticals, Inc (NASDAQ Stock)

[fz4fun]

Thread starter for most recent RU pick and some DD for everyone: Opening price at date of this thread was $6.50

Spectrum Pharmaceuticals, Inc. ( Spectrum) is a commercial stage biopharmaceutical company, engaged in developing and commercializing therapies with a focus primarily in the areas of hematology-oncology and urology. The Company's product is apaziquone (formerly EOquin), which is in two Phase 3 clinical trials for non-muscle invasive bladder cancer under a collaboration with Allergan Inc. Another drug, ozarelix is in a Phase 2 clinical trial for benign prostatic hypertrophy (BPH). On December 15, 2008, Spectrum and Cell Therapeutics, Inc. (CTI) partnered to form a joint venture, RIT Oncology, LLC (RIT), to develop Zevalin ([90Y]-ibritumomab tiuxetan) in the United States. Its subsidiaries include OncoRx Pharma Private Limited, Spectrum Pharmaceuticals GmbH, RIT Oncology, LLC and Spectrum Pharma Canada. During the year ended December 31, 2008, the Company dissolved NeoJB LLC.

[fz4fun]

Now for some informations regarding SPPI:

excerpted from Seeking Alpha article:

According to the American Cancer Society [ACS], non-Hodgkin lymphoma [also known as non-Hodgkin’s lymphoma, NHL, or sometimes just lymphoma] is a cancer that starts in cells of the lymph system, which is part of the body’s immune system. NHL is the fifth most common cancer in both men and women in the United States [not counting skin cancers]. In 2009, the ACS estimates that there will be nearly 66,000 new cases of NHL in the United States and that about 20,000 people will die from the disease. In general, the overall 5-year relative survival rate for people with NHL is 65%, and 10-year relative survival is 54%.

By 2003, the U.S. Food and Drug Administration [FDA] had approved two radioactive labeled monoclonal antibodies for the treatment of patients with “relapsed” or “refractory”, low-grade or follicular B-cell NHL. Refractory NHL is disease that never responded or has stopped responding to standard therapies. Relapsed NHL is disease that has returned after successful initial treatment.

Both products utilize monoclonal antibodies that target an antigen expressed by certain normal and malignant B-cell lymphocytes [CD20] combined with the killing power of radiation to eradicate tumor cells. Zevalin® [ibritumomab tiuxetan] by Spectrum Pharmaceuticals, Inc. (SPPI) in the United States and Bayer Schering Pharma ex-United States employs yttrium-90 as its therapeutic payload, while Bexxar® [tositumomab] by GlaxoSmithKline (GSK) uses iodine-131.... Unfortunately, despite the fact that both Zevalin and Bexxar have been demonstrated as safe and effective treatments for patients with relapsed or refractory NHL for years, it has been reported that fewer than 10% of patients who are candidates for the products ever receive them. Recall the aforementioned statistic regarding NHL relative survival rates, indicating that a significant number of patients experience relapsed or refractory NHL. According to Spectrum Pharmaceuticals, Zevalin’s annual sales in the United States were a mere $11.4 million in 2008.

Therefore, while an expanded indication for Zevalin is nice, the fact that the product has yet to penetrate the market indication afforded approximately five years ago implies that there are other obstacles to the product’s success. ...Spectrum Pharmaceuticals’ stock has been strong as of late – but perhaps more a result of Russell Investments adding Spectrum Pharmaceuticals to the Russell Global®, the Russell 3000® and the Russell 2000® Indexes. For investors, significantly improved sales of Zevalin in future quarters will be much more important to Spectrum Pharmaceuticals than near-term approval of the sBLA.

And a link to the entire article that the above info was obtained from:

Can Spectrum Pharmaceuticals Benefit from FDA Action on Zevalin? -- Seeking Alpha

[fz4fun]

Additional info regarding recent stock offering for SPPI:

Spectrum Pharmaceuticals Receives $50 Million from Institutional Investors at $7.55 Per Share
Monday, 21 September 2009 23:00


IRVINE, Calif.--Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a commercial-stage biotechnology company with a focus primarily in oncology, today announced that it has received 50 million from existing institutional investors in a previously announced registered direct offering. Spectrum received net proceeds of approximately $47.5 million after deducting placement agent fees and other offering expenses.

All of the securities were offered pursuant to an effective shelf registration statement. Proceeds from the transaction will be used for general corporate purposes.

After the offering, the company has 48,707,303 shares issued and outstanding.

A shelf registration statement relating to the shares of common stock and warrants issued in the offering (and the shares of common stock issuable upon exercise of the warrants) has been filed with the Securities and Exchange Commission (the “SEC”) and has been declared effective. A prospectus supplement relating to the offering was filed with the SEC. Copies of the prospectus supplement and accompanying prospectus may be obtained directly from the Company by contacting Spectrum Pharmaceuticals, Inc., 157 Technology Drive, Irvine, California 92618. This announcement is neither an offer to sell nor a solicitation of an offer to buy any of our shares of common stock or warrants. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.

Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc., (Nasdaq: RODM), acted as the exclusive placement agent for the transaction.

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology. The Company’s strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for its approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in its areas of focus; and, leveraging the expertise of partners around the world to assist it in the execution of its strategy. For more information, please visit our website at Spectrum Pharmaceuticals, Inc. - A Commercial-Stage Biotechnology Company with a Focus in Oncology.

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. ® is a registered trademark of Spectrum, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

[fz4fun]

and this info as well:

SPPI shares moving up on takeover rumors
Written by Staff and Wire Reports
Monday, 14 September 2009 07:20

Shares of Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) are shooting upwards on unconfirmed takeover speculation.

Earlier this month, Spectrum was granted an approval from the FDA for an expanded label for the treatment of patients with previously untreated follicular non-Hodgkin's lymphoma, or NHL, who achieve a partial or complete response to first-line chemotherapy. The company also has a pending FDA approval due early next month and a healthy pipeline of developmental drugs.

TradeTheNews and FlyOnTheWall are reporting Bayer as a potential buyer with price chatter in the mid-teens.

On Friday, BioMedReports reported related news about the company here:

Market opportunities for Spectrum's ZEVALIN may expand significantly - BioMedReports.com

[thegreatgate]

October 8th

The FDA accepted Spectrum Pharma's supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for injection on 3/26/09 in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The user fee goal (PDUFA) date for the sNDA is October 8 2009. The FDA Approved Fusilev on March 7, 2008 for rescue after high dose methotrexate therapy in osteosarcoma. Fusilev is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvetent overdosage of folic acid antagonists. In December 2008, the FUSILEV was listed in the National Comprehensive Cancer Network (NCCN) Drugs and Biologic Compendium to be used in combination with high dose methotrexate for the treatment of bone cancer (osteosarcoma and dedifferentiated chrondrosarcoma), and the NCCN Clinical Practice Guidelines in Oncology in Colon Cancer and Rectal Cancel were updated to reflect the Fusilev is available in the United States.

[Aufan 1983]

SPPI going to run today? Premarket is already going north... Does someone know the decision or is this just anticipation?

[PennyPicker]

Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) has announced that U.S. health regulators have declined to approve its supplementary marketing application for its advanced metastatic colorectal cancer drug Fusilev in its current form.

Spectrum, which received a label expansion approval for another cancer drug last month, said it plans to request a meeting with the U.S. Food and Drug Administration to discuss options for the approval of Fusilev.

Fusilev is currently approved by the FDA as a rescue after high dose of methotrexate therapy in patients with osteosarcoma, a type of bone cancer.

The drug is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonist, a type of chemotherapy.

The FDA stated in the Complete Response letter that the submission did not demonstrate that FUSILEV is non-inferior to leucovorin; and recommended that the Company meet with them to discuss options for continuing to seek approval of FUSILEV in advanced metastatic colorectal cancer. The Company plans to promptly request such meeting to discuss options for FUSILEV in this indication.

Spectrum shares were down in pre-market trading.

They closed previously at $6.21 on Thursday.

FDA Says No to Spectrum - BioMedReports.com

[johnpalley]

guys, should we get in on this dip? i dont know that much about this company.

[greencat]

SPPI with a W pattern. Bullish- Should at least fill the gap at $6.00

SPPI Chart

[greencat]

Whoops, I posted the wrong chart cause SPPI is a beauty and made a nice move.

SPPI Chart

Originally Posted by greencat

SPPI with a W pattern. Bullish- Should at least fill the gap at $6.00

SPPI Chart