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Spectrum Pharmaceuticals Submits Supplemental New Drug Application (sNDA) for Ready-to-Use Formulation of FUSILEV® in Colorectal Cancer

* FUSILEV® sNDA is Currently under Review by the FDA for Use in Advanced Metastatic Colorectal Cancer
o PDUFA Action Date – April 29, 2011

* Ready-to-Use Formulation (RTU) Submitted in Support of FUSILEV’s Use in Advanced Metastatic Colorectal Cancer
* FUSILEV is Currently FDA Approved and Marketed by Spectrum for:
o Rescue after High-Dose Methotrexate Therapy in Osteosarcoma;
o To Diminish the Toxicity and Counteract the Effects of Impaired Methotrexate Elimination, and of Inadvertent Overdosage of Folic Acid Antagonists

IRVINE, Calif. (AP) -- Drugmaker Spectrum Pharmaceuticals Inc. said Wednesday it will develop a biosimilar version of the cancer drug Rituxan through a new partnership with Viropro Inc.

Financial terms weren't disclosed.

Rituxan, or rituximab, is approved to treat non-Hodgkin's lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis. It is sold by the Genentech unit of Swiss drugmaker Roche Holding, and by Biogen Idec Inc. Spectrum said worldwide sales totaled $5.6 billion in 2009. The drug is sold under the name MabThera in other markets.

Biosimilars are copies of biotech-based drugs and are to biotech drugs what generic drugs are to traditional chemical-based pharmaceuticals. New regulations in the U.S. have set up a path for approval of biosimilars, and generics are poised to eventually break into that new market.

Spectrum makes the lymphoma drug Zevalin. It acquired the drug from Biogen Idec in 2007, and in a recent clinical trial, Spectrum said lymphoma patients who were treated with Zevalin following chemotherapy lived longer than patients who were treated with chemotherapy and Rituxan, or chemotherapy alone.

Spectrum and Viropro are both headquartered in Irvine, Calif.

IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGM:SPPI - News), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the target enrollment has been reached for the Phase 2 study of belinostat in Carcinoma of Unknown Primary (CUP). The study, which is being conducted and fully funded by Spectrum’s partner, Topotarget A/S, is an open-label, randomized, controlled Phase 2 study in which patients with previously untreated CUP, were randomized into one of two treatment arms: Belinostat + carboplatin and paclitaxel (BelCaP), or carboplatin and paclitaxel (CaP). The primary objective of the CUP study is to provide an estimate of the treatment effect of BelCaP compared to CaP in terms of progression-free survival, response rate, and overall survival in patients with CUP.

"We believe that belinostat is an HDAC inhibitor with the potential safety advantage that allows for full-dose combination with other chemotherapeutic regimens, including carboplatin and paclitaxel, which are considered mainstays of cancer treatment,” said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “We look forward to the results of this trial, which Topotarget believes will be available in the third quarter of 2011.”

The probability of FUSILEV approval for Advanced Metastatic Colorectal Cancer is very high


Despite early diagnosis and treatment, cancers involving the colon or rectum (colorectal cancer) can reappear at a later time, even if the cancer was entirely removed during the initial treatment. This reappearance of the colorectal cancer is referred to as a recurrence or a relapse.

A colorectal cancer recurrence can be either local (confined to the large intestine or nearby tissues) or at a distant site. When the recurrence develops at a site away from the colon or rectum, it is called a metastasis.

Cure is not possible for most patients with metastatic colorectal cancer, although some patients who have limited involvement (particularly restricted to the liver or lung) can be cured with surgery. For others, chemotherapy is the most appropriate option. Chemotherapy does not cure metastatic colorectal cancer, but it can improve symptoms and prolong life.

At the 2008 annual meeting of the American Society of Clinical Oncology, researchers announced that colorectal cancer patients that have a mutation in the KRAS gene do not respond to certain therapies, those that inhibit the epidermal growth factor receptor (EGFR)--namely Erbitux (cetuximab) and Vectibix (panitumumab). Following recommendations by ASCO, patients should now be tested for the KRAS gene mutation before being offered these EGFR-inhibiting drugs.

In July 2009, the US Food and Drug Administration (FDA) updated the labels of two anti-EGFR monoclonal antibody drugs (panitumumab (Vectibix) and cetuximab (Erbitux)) indicated for treatment of metastatic colorectal cancer to include information about KRAS mutations.

Disclosure: already have SPPI positions.

February 16, 2011 by BiotechInvest

Today I sold SPPI (small profit). Will wait next entry point.

April 28, 2011 by BiotechInvest

I'm in for PDUFA, short-term investment.

May 04, 2011 by BiotechInvest

I do have a déjà vu with SPPI. Indeed, it's a usual scenario for SPPI i.e. any good news = SPPI sell off. Zevalin approval in Sept. 2009 had same effect.

UPDATE 1-Spectrum Pharma Q1 results blow past expectations

"May 4 (Reuters) - Spectrum Pharmaceuticals' quarterly profit blew past Wall Street expectations as sales of its cancer drugs Fusilev and Zevalin rose.

First-quarter net income was $13 million, or 23 cents per share, compared with a loss of $39 million, or 80 cents per share, a year ago.

Revenue rose four-fold to $44 million. Revenue from Fusilev rose to $35 million, while Zevalin sales rose to $6 million.

Fusilev is used for treatment of patients with advanced metastatic colon cancer while Zevalin is used for treatment of lymphatic cancer.

Analysts on average had expected earnings of 8 cents a share, on revenue of $30.5 million, according to Thomson Reuters I/B/E/S."

But in spite of good news we have a massive SPPI sell of today.

As usually TheStreet and Adam F did everything to slander SPPI.

But look at last sentence at Adam F. lie:

"Spectrum has not provided financial guidance for 2011, including sales forecasts for Zevalin or Fusilev. The current analyst consensus has Spectrum losing a penny a share on total revenue of $95.98 million."

Should company with total revenue of $96M and recently approved by FDA drug  FUSILEV for Advanced Metastatic Colorectal Cancer has pps $8 and market cap $400M?

Next question is who is accumulate SPPI shares now at cheap?

Look at JAZZ:  this pumped company reported revenue of $50.9 million in Q1, 2011 and it has pps $31 and market cap  $1.24B.

someone said "never fight with market" but here we have an ugly and obvious manipulation with purpose to force small investors to sell SPPI shares cheap. Should we fight with it? Definitely yes. I'll keep SPPI during next year and will see the earning results of Q1, 2012.


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