Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 258)

[VaJo]

Spectrum Pharma's Date With FDA
6/25/2009 10:29 AM ET

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(RTTNews) - The decision date for FDA approval of Spectrum Pharmaceuticals Inc.'s (SPPI: News ) cancer therapy Zevalin for an additional indication is drawing near. The regulatory agency is expected to decide whether or not to approve Zevalin as first-line consolidation therapy for non-Hodgkin's Lymphoma on July 2.

Consolidation therapy is a treatment regimen given after a patient responds to initial first-line induction therapy (e.g. chemotherapy). The aim of consolidation therapy is to rapidly improve the quality of a patient's response, thereby extending the response duration.

Zevalin was initially approved by the FDA in February 2002, when it was then owned by Idec Pharmaceuticals, as a treatment for patients with B-cell non-Hodgkin's lymphoma who have failed other treatments like standard chemotherapy. Non-Hodgkin's Lymphoma, or NHL, is a cancer of the lymphatic system. Roche's Rituxan is the standard of care for the treatment of non-Hodgkin's lymphoma.

Zevalin is approved in over 40 countries for the treatment of B-cell non-Hodgkin's lymphoma. In April 2008, Zevalin won the EU approval for expanded indication as first-line consolidation treatment.

According to reports, the estimated new cases of non-Hodgkin's lymphoma in the U.S. in 2009 are 65,980 and the number of deaths from this disease is expected to be 19,500.
In clinical studies, Zevalin when used as a first-line consolidation therapy for patients with follicular non-Hodgkin's lymphoma, significantly improved the median progression-free survival time from 13 months (control arm) to 37 months (Zevalin arm).

Zevalin is a radio immunotherapy drug that has two parts - a monoclonal antibody and a radioactive substance, Indium-111 or Yttrium-90 to kill cancer cells. Zevalin is administered as an injection in the veins and when the drug enters the bloodstream, the monoclonal antibody portion of the drug recognizes and attaches to the CD20 protein found on the surface of lymphoma cells. Radiation is then released from the yttrium or indium radioisotope, damaging or killing the B-cells. Even though Zevalin attacks both normal and malignant B-cell lymphocytes, the body quickly replaces any normal white blood cells that are damaged. Zevalin is usually administered along with Rituxan.

Spectrum Pharma is the fourth company to own Zevalin since the drug was launched. When Zevalin was commercially launched in 2002, it was then owned by Idec Pharmaceuticals. The drug then came under Biogen Idec Inc.'s (BIIB) fold, following the merger of Idec and Biogen in 2003. Biogen Idec sold the U.S. rights to the drug to Cell Therapeutics Inc. (CTIC) in August 2007 for about $30 million. The drug continues to be sold outside the United States by Bayer Schering under an agreement between Biogen Idec and Bayer Schering.

(RTTNews) - Last November, Cell Therapeutics teamed up with Spectrum Pharma to form a 50:50 joint venture -- RIT Oncology, to develop and commercialize Zevalin. Cell Therapeutics received an initial cash payment of $7.5 million and an additional $7.5 million in early January of 2009 pursuant to the formation of the joint venture.

Cell Therapeutics, which came close to the brink of financial ruin in February, sold its remaining 50% stake in Zevalin to Spectrum Pharma for $18 million.

Zevalin logged $11.4 million in sales in 2008 and about $2.6 million in the first-quarter of fiscal 2009. Zevalin, like GlaxoSmithKline's (GSK) Bexxar, which is also a radioactive drug, is not used widely despite being as good as other treatments. The complexities in administering and reimbursement concerns have been blamed for the lackluster sales of the radioimmunotherapies. All radioactive handling precautions have to be followed while administering Zevalin and Bexxar, making them a bit complex. (Bexxar was approved by the FDA for use in patients with non-Hodgkins lymphoma in 2003).

Spectrum is working to establish reimbursement standards in concert with Centers for Medicare and Medicaid Services by early 2010.

If approved, Zevalin would be the first therapeutic available to patients in the U.S. as first-line consolidation therapy to treat non-Hodgkin's lymphoma. The addressable patient population of Zevalin is projected to increase by approximately 18,000, following the anticipated FDA approval. The approval in first-line consolidation treatment will also help Spectrum to further exploit the potential of Zevalin and ramp up its sales.
Yet other drug of Spectrum whose fate will be decided by the FDA in the coming months is Fusilev (levoleucovorin). The company is seeking FDA approval of Fusilev for expanded indication in the treatment of advanced metastatic colorectal cancer in combination with 5-FU containing regimens. The regulatory agency is expected to make a decision on Fusilev on October 8.

Fusilev was approved as a rescue therapy by the FDA in March 2008 for use in patients with osteosarcoma who are treated with high-dose of folic acid antagonist methotrexate, which is a type of chemotherapy. The drug is also approved to diminish the toxicity of methotrexate. Currently Fusilev serves a relatively smaller market because osteosarcoma, a rare form of bone cancer, is diagnosed in fewer than 3,000 individuals per year in the U.S.

The drug has been on the market in Europe and Japan for more than ten years, where it is marketed by Takeda, Wyeth and Sanofi-Aventis (SNY) among others. The drug fetches sales of approximately $200 million outside the U.S., according to Spectrum.

(RTTNews) - According to a clinical alert issued by the American Society of Clinical Oncology, Fusilev is often used off-label to treat colorectal cancer. Fusilev fetched net sales of $7.7 million in *2008 and approximately $9.4 million in the recent first-quarter of fiscal 2009. (*Fusilev was launched in August 2008).

Unlike osteosarcoma, the market for colorectal cancer is much larger. Colorectal cancer is the third most common cancer in the U.S., affecting about 5% of the population, with up to 150,000 new cases reported each year, according to reports.

In addition to two drugs, which are at the altar awaiting FDA decision, Spectrum has one drug under phase III study and three drugs each under phase II and phase I development.

EOquin (apaziquone), which is under phase III testing, is being investigated in the treatment of non-invasive bladder cancer. The first patient was enrolled in May 2007. Spectrum expects to complete enrollment of patients in the ongoing phase 3 registrational trials by the end of 2009. The primary endpoint will be a statistically significant difference in the rate of tumor recurrence between the two treatment groups by year two. Results from the phase III trial are expected in 2012.

The company has an agreement in place with Allergan, Inc. (AGN: News ) for the development and commercialization of apaziquone. Under the terms of the agreement, Allergan paid Spectrum $41.5 million last November and will make additional payments of up to $304 million based on the achievement of certain development, regulatory and commercialization milestones.

Spectrum has exclusive rights to apaziquone in Asia, including Japan and China, while Allergan has exclusive rights to apaziquone for the treatment of bladder cancer in the rest of the world, including the United States, Canada and Europe. In the U.S., Allergan and Spectrum will co-promote apaziquone and share in its profits and expenses. Allergan will also pay Spectrum royalties on all of its apaziquone sales outside of the United States.
Spectrum's drugs under phase II testing include Ozarelix, for the treatment of prostate cancer and benign prostatic hypertrophy; Ortataxel, for the treatment of taxane-refractory tumors, and Satraplatin for non-small cell lung cancer.

The company also has two drugs under preclinical development -- RenaZorb used in the treatment of hyperphosphotemia in end stage renal disease and SPI-205 for chemotherapy induced neuropathy.

Spectrum's cumulative losses, since inception in 1987 through March 31, 2009, are approximately $260 million. For the first-quarter ended March 31, 2009, the company posted net income of approximately $0.6 million or $0.02 per share, compared to a net loss of approximately $8.7 million or $0.28 per share in the year-ago period.

(RTTNews) - Revenues, which included product sales and license and contract revenue, totaled $14.1 million. Product sales (sales from Zevalin and Fusilev) were $12 million, while license and contract revenue was $2.1 million in the first quarter of fiscal 2009. The company did not record any revenue in the comparable year-ago quarter.

As of March 31, 2009, the company had approximately $64 million in cash, cash equivalents, marketable securities and funds in escrow.

On May 26, Spectrum was awarded nearly $4.3 million by an arbitrator in its dispute with Cell Therapeutics related to the joint venture between the two companies. On May 29, Spectrum received a $20 million cash infusion from three institutional investors in a previously announced registered direct offering and as recently as June 18, the company received yet another $10 million from two existing institutional investors.

As a reminder, the company was formerly known as NeoTherapeutics Inc. and changed its name to Spectrum Pharmaceuticals Inc. in December 2002. The company went public in September 1996 pricing its IPO at $7.60 per share.
Spectrum shares have thus far hit a 52-week low of $0.55 and a 52-week high of $6.35. The stock is currently trading at $5.94, up 1.54% on a volume of 248,140 shares.

With an FDA announcement expected in the next few days, it is worth keeping an eye on Spectrum Pharma. Will Zevalin cross the final hurdle in its journey from research to clinical treatment for an additional indication? ...Stay tuned.

by RTT

[VaJo]

Nachbörslich 6,20 Dollar
Mit ein wenig Glück wird Ville heute bedient

[Ville7]

Antwort auf Beitrag Nr.: 37.459.480 von blb am 24.06.09 17:09:43

Shit, das sind ja 2% mehr als ich.

[blb]

Antwort auf Beitrag Nr.: 37.459.420 von blb am 24.06.09 17:04:54

Gab ne Meldung, Shrotriya hält jetzt 7,8 prozent der Aktien.

[blb]

Antwort auf Beitrag Nr.: 37.453.642 von larsuwe am 23.06.09 22:24:29

Und ab geht die Post!

[larsuwe]

Da gebe ich dir recht,damit habe ich heute auch nicht gerechnet.Trozdem glaube ich, das wir bis zum ende der Woche noch die Marke von 7,00Dollar sehen werden.Also immer schoen ruhig bleiben.Ciao Lars!

[future_trader]

ist schon ein heftiger Rückfall!

[future_trader]

Antwort auf Beitrag Nr.: 37.451.622 von blb am 23.06.09 18:29:50

*lach* ich bin dabei.

[blb]

Antwort auf Beitrag Nr.: 37.451.416 von Magnetfeldfredy am 23.06.09 18:07:20

So sieht es aus. Ich seh schon, wir müssen mal nen Spectrum-Stammtisch machen. Zwischen Ville und Vajo können wir ja ne Trennwand einbauen, die bei Bedarf hochgefahren wird.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 37.451.164 von Ville7 am 23.06.09 17:39:34

Mit das Wichtigste ist, daß man nie den Humor verliert, Aktien hin oder her!