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Spectrum Pharmaceuticals Expands Manufacturing Capacity and Builds Inventory Reserves for FUSILEV

Mon, 04/23/2012 - 3:45am
The Associated Press

HENDERSON, Nev.--(BUSINESS WIRE)--Apr 23, 2012-- Spectrum Pharmaceuticals (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that in order to meet the needs of cancer patients in the United States, the Company has substantially increased its manufacturing capacity of FUSILEV(R) (levoleucovorin) for injection, since its approval for use in advanced metastatic colorectal cancer. Spectrum has qualified and maintains multiple third-party manufacturing facilities approved by the U.S.

Food & Drug Administration (FDA) for the Company's oncology drug, FUSILEV, which was approved in 2011 for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.

"Spectrum's mission - to serve the needs of the cancer community - is exemplified by our commitment to those with colorectal cancer, a terrible disease inflicting approximately 400 new patients every day in the U.S," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "It is our goal to provide sufficient quantities of FUSILEV so no patient goes untreated.

To this end, Spectrum embarked on a manufacturing plan to expand capacity that can supply the demand of the entire patient population.

Access to multiple manufacturing facilities approved by the FDA greatly reduces the risk of supply interruptions, giving physicians and patients the strong reassurance of availability they need.

Spectrum provides FUSILEV free of charge through its Spectrum Therapy Access Resources(R) (STAR) program to eligible patients who cannot otherwise afford their medication." "We have taken steps to expand our manufacturing capabilities as we are currently experiencing increasing demand for FUSILEV, which we anticipate to continue throughout 2012 and beyond," concluded Dr.

Shrotriya.

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 U.S., with approximately 141,210 new cases and 49,380 deaths reported in 2011.

About FUSILEV (R) (levoleucovorin) for injection FUSILEV, a novel folate analog, is approved as a ready-to-use solution (FUSILEV Injection), and as freeze-dried powder (FUSILEV for Injection). FUSILEV is indicated for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer. FUSILEV is also indicated 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. FUSILEV, under various trade names, is marketed outside the United States by Pfizer, Sanofi-Aventis, and Takeda.

Important FUSILEV (R) (levoleucovorin) Safety Considerations FUSILEV is dosed at one-half the usual dose of racemic d,l-leucovorin.

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 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. The most common adverse reactions (> 50 in patients with advanced colorectal cancer receiving FUSILEV in combination with 5-fluorouracil were diarrhea, nausea and stomatitis. FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.

Full prescribing information can be found at www.FUSILEV.com.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV(R) and ZEVALIN(R). In addition, Spectrum has two drugs, apaziquone and belinostat, in late stage development. Spectrum also has a diversified pipeline of novel drug candidates. Spectrum's strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. Spectrum has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics and data management. Spectrum also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit Spectrum's website at www.sppirx.com.

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 are based on management's current beliefs and expectations. These statements include but are not limited to statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, 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 applications to the FDA may not receive approval, 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 sustained revenue history, 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. (R) , ZEVALIN (R) , FUSILEV (R) , Spectrum Therapy Access Resources (R) , and STAR (R) are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

5/8 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

CONTACT: Spectrum Pharmaceuticals Shiv Kapoor Vice President, Strategic Planning & Investor Relations 702-835-6300 InvestorRelations@sppirx.com KEYWORD: UNITED STATES NORTH AMERICA NEVADA INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY ONCOLOGY PHARMACEUTICAL MANUFACTURING OTHER MANUFACTURING FDA SOURCE: Spectrum Pharmaceuticals Copyright Business Wire 2012 PUB: 04/23/2012 07:00 AM/DISC: 04/23/2012 07:00 AM http://www.businesswire.com/news/home/20120423005512/

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