Player Avatar mdriver78 (61.05) Submitted: 2/16/2011 8:51:31 AM : Outperform Start Price: $3.37 SPPI Score: +86.24

Perhaps the FDA will approve Fusilev for mCRC on or before April 29, 2011.

With FDA approval and full reimbursement, it is believed that many doctors will gravitate towards Fusilev. Here's why:

Reliability - Fusilev supplies should be sufficient to meet future demands (excluding the ongoing, short-term Cangene plant closing).

Ready-to-Use - SPPI recently submitted a second sNDA for a Ready-to-Use version of Fusilev that will make it more convenient for end-users to administer the treatment to patients. That's good stuff.

Less Toxicity - Fusilev has been shown in some studies to be less toxic than its generic competitor. With annual sales of $200 million in the EU, it certainly appears that doctors overseas prefer the potentially less toxic levoleucovorin (Fusilev) over the generic.

Post FDA approval, Fusilev has $8 to $10 million / quarter potential. Coupled with continued growth of Zevalin sales, SPPI could generate $100 million+ in total revenue during FY 2011.

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Member Avatar mdriver78 (61.05) Submitted: 2/17/2011 10:49:23 AM
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Morre information is always better:
Spectrum has two FDA approved drugs in the cancer sector, Zevalin and Fusilev.

Zevalin is approved for the treatment of non-Hodgkins Lymphoma (NHL) and Fusilev for the treatment of Osteosarcoma. The combined revenue for the two products, according to this week's reports, accounted for over $30 million, a five hundred percent increase over sales for the same quarter of 2009.

Additionally, revenues for 2010 more than doubled over the revenues for 2009.

Two more pending developments for these products could add significant value and increased revenue potential.

It's expected that the FDA will rule on the approval of Fusileve for the indication of colorectal cancer by April, 2011. Spectrum had previously received a denial from the FDA for this indication, but the company has submitted additional data based on the European findings where the drug is approved and hopes to see a different outcome on this go-round.

Regarding Zevalin, the Spectrum is looking to have the bioscan removed from the criteria for treatment, and after recently filing some additional data with the FDA, the company hopes to receive word on this front by the end of 2011.

The bioscan removal would make Zevalin treatment less of a burden on both Doctors and patients, and the belief is that would incline the Doctors to recommend the treatment more.

Currently, it's Fusilev that is generating most of the sales revenue for Spectrum.

Spectrum also has Belinostat and Apaziquone in the late stages of development.

Belinostat data should be available later this year, which the company will use to file an NDA for the indication of T-Cell Lymphoma.

The bladder cancer treatment Apaziquone is a little further off, but an NDA is expected to be filed for that product in 2012.

There's even more in the pipeline than that, with multiple products still in earlier stages of development.

With a robust pipeline, growing revenue and multiple significant events expected over the course of the next couple of years, SPPI has the potential to greatly appreciate in value, far moreso than this run that has taken the stock to over seven dollars.

Member Avatar mdriver78 (61.05) Submitted: 3/11/2011 8:32:37 AM
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From AP, "The company reported $23 million in revenue from its drug Fusilev, which is used to treat the side effects of the chemotherapy drug methotrexate. It is approved for use in patients who are being treated for osteosarcoma, a type of bone cancer, and to reduce the toxicity of methotrexate. Sales of Fusilev totaled $100,000 in the year-ago quarter. Sales of Spectrum's lymphoma drug Zevalin rose to $8 million from $5.1 million. Spectrum also reported $3 million in licensing payments during the quarter.

The company lost $48.9 million, or 99 cents per share, for the year. In 2009 Spectrum lost $19 million, or 48 cents per share. Revenue increased 95 percent to $74.1 million from $38 million."

It appears all good.

Member Avatar mdriver78 (61.05) Submitted: 5/2/2011 8:03:31 AM
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The report on the wire this morning says "Co announces the FDA approved the use of FUSILEV in combination with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer. This new, expanded indication supplements the original 2008 FDA approval of FUSILEV. Co states FUSILEV sales exceeded $34mln in the First Quarter of 2011, resulting in a second consecutive profitable quarter. According to the American Cancer Society, colorectal cancer is the third most commonly diagnosed cancer and the third leading cause of cancer death in both men and women in the US, with approx 41,210 new cases and 49,380 deaths expected in 2011. Co comments: "...In the United States, more than 90% of its clinical use is for the treatment of patients with colorectal cancer. FUSILEV, under various trade names, has been available in Europe and Japan primarily by Wyeth, Sanofi-Aventis (SNY), and Takeda Pharmaceuticals (TKPYY). It is estimated that ex-U.S. sales of FUSILEV are in excess of $180 mln a year." With really good earning due out tomorrow it appears to be all green.

Member Avatar mdriver78 (61.05) Submitted: 12/21/2012 8:51:27 AM
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Can you imagine the information put out by HF and friends is false and misleading once again. The release this morning, "The Co announced surpassing the primary endpoint in the pivotal, registrational Phase 2 BELIEF trial of belinostat, a pan-histone deacetylase (HDAC) inhibitor. The BELIEF trial is evaluating the efficacy and safety of intravenous belinostat for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL).

- Trial surpassed an objective response rate (ORR) of at least 20% in Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) patients.

- The primary efficacy endpoint was established under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.

- The Company expects NDA filing by mid-2013, and an FDA decision in 2014.

- The complete safety evaluation has been accepted for presentation at the T- Cell Lymphoma Forum to be held in San Francisco, Jan 24-26, 2013. "

Well another drug in pipeline will move to next stage and it will be interesting to see what negative spin will be laid on this event.

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