Spectrum Pharmaceuticals Submits Supplemental New Drug Application (sNDA) For Ready-to-Use Formulation Of FUSILEV(R) In Colorectal Cancer
Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology
Article Date: 06 Jan 2011 - 1:00 PST
Spectrum Pharmaceuticals (Nasdaq: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection. This submission is in support of FUSILEV's use in colorectal cancer, which is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) action date of April 29 2011. FDA has up to 60 days to formally accept the submission.
"If approved, we believe a RTU formulation of FUSILEV, as the name implies, will be more convenient for the staff and easy to use. RTU formulation requires no reconstitution, and since it will also be of a higher strength than the currently available lyophilized formulation, the healthcare provider's time to administer FUSILEV to colorectal cancer patients will be considerably reduced," said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals. Continued
FUSILEV is currently FDA approved and marketed by Spectrum 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 inadvertent overdosage of folic acid antagonists.
About FUSILEV® (levoleucovorin) for Injection
FUSILEV, a novel folate analog, is available in vials as freeze-dried powder. FUSILEV rescue is indicated 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 inadvertent overdosage of folic acid antagonists. FUSILEV has been marketed outside the United States by Wyeth, Sanofi-Aventis, Takeda, and others for more than 10 years.
Important FUSILEV® (levoleucovorin) for Injection Safety Considerations
FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Due to calcium content, no more than 16-mL (160-mg) of levoleucovorin solution should be injected intravenously per minute. FUSILEV enhances the cyto-toxicity of fluorouracil. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a placebo-controlled study. Allergic reactions were reported in patients receiving FUSILEV.
Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy. FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.
Spectrum Pharmaceuticals: Website http://www.spectrumpharm.com/
Product Pipeline for Spectrum Pharmaceuticals
View drug information on Fusilev.
UPDATE: Spectrum Pharmaceuticals In Deal With Viropro For Cancer Drug
DOW JONES NEWSWIRES
Spectrum Pharmaceuticals Inc. (SPPI) signed a deal with Viropro Inc. (VPRO) to develop a biosimilar version of Swiss pharmaceutical giant Roche Holding AG's (RHHBY, ROG.VX) cancer drug rituximab ahead of its U.S. patent expiration in 2015.
The agreement comes as many patent expirations loom over large pharmaceutical companies. Rituximab, used in the treatment of many lymphomas, leukemias, transplant rejection and some autoimmune disorders, saw worldwide sales of about $5.6 billion in 2009.
Financial terms weren't disclosed.
Viropro, a biotech drug maker, said Spectrum will license the rights to certain technology and it should get milestone payments over 36 months and royalty payments from ensuing sales.
Biosimilar drugs are officially approved versions of biopharmaceutical products made by a different company as patent and exclusivity expire on the product.
Biotech company Spectrum, which has a focus on cancer treatment, has been focused on making another push to improve the weak sales of its leading drug Zevalin. In its most recent quarterly results, Spectrum swung to a loss as it spent more to market Zevalin and another drug, Fusilev, which treats a vitamin deficiency in patients who have been treated with chemotherapy for colorectal cancer.
Meanwhile, Roche, the world's biggest maker of cancer drugs, is facing pressure following the U.S. Food and Drug Administration December decision to revoke approval of blockbuster drug Avastin for the treatment of breast cancer. The company has said it will appeal.
Spectrum shares were up 4 cents at $6.92. The stock is up 49% over 12 months.
Spectrum Pharma (NASDAQ: SPPI) Posts Large Volume Increase, Hits $6.34
January 7th, 2011
Shares of Spectrum Pharma (NASDAQ: SPPI) saw unusually high trading volume on Friday. Approximately 1.492 million shares changed hands during mid-day trading. During the most recent quarter, the stock had an average daily volume of 540,149 shares. The stock last traded at $6.34.
On a related note, analysts at Zacks Investment Research reiterated a “neutral” rating on shares of Spectrum Pharma in a research note to investors on Wednesday, December 29th. Separately, analysts at Morgan Joseph raised their price target on shares of Spectrum Pharma from $8.00 to $10.00 in a research note to investors on Wednesday, December 8th. They now have a “buy” rating on the stock.
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 has a fully developed commercial infrastructure that markets and sells two drugs in the United States, Zevalin and Fusilev. The Company has several drug candidates in development, which include apaziquone (EOquin), which is being studied in two large Phase III clinical trials for non-muscle invasive bladder cancer (NMIBC) under a strategic collaboration with Allergan; and belinostat, a drug partnered with TopoTarget A/S to jointly develop. Belinostat is being studied in multiple indications, including a Phase II registrational trial for relapsed or refractory Peripheral T-Cell Lymphoma (PTCL).
Spectrum Pharma (NASDAQ: SPPI) traded down 6.45% during mid-day trading on Friday. The stock has a 52 week low of $3.67 and a 52 week high of $7.19. Its 50-day moving average is $5.70 and its 200-day moving average is $4.51. The company has a market cap of $322.1 million and a price-to-earnings ratio of N/A.