March 12, 2008
Knobias Clip Report (03-11-2008)
By admin
Submitted By Knobias ClipReport
SPPI: Management Discusses FDA Approval of Levoleucovorin for Injection
Spectrum Pharmaceuticals, Inc. (SPPI) conducted a conference call after the bell on Monday to discuss the FDA’s approval of Levoleucovorin for Injection. It is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. The Company currently expects its commercial launch by June 2008.
The Chairman and CEO of Spectrum, Dr. Rajesh Shrotriya, stated in the conference call, “We believe this approval can be the springboard for the next phase of our company’s growth. Levoleucovorin can be the foundation for commercial success. This approval puts us in a differenct league, and this launch will be a transforming event for the company.”
Levoleucovorin has been available for more than ten years in Europe and Japan. The Company plans to file for a supplemental New Drug Application with the FDA for use of leucovorin in colorectal cancer in 5-fluorouracil containing regimens and an NDA amendment for an oral tablet formulation by mid-year 2008.
Dr. Shrotriya added, “We are expecting approval without the requirement of conducting any more clinical trials. It will be more of a matter of preparing the data for submission. Once the other indications for this drug have been approved, you are talking about a U.S. market of $100 million for levoleucovorin.”
“Although a final determination has not been made, we want to price this product as a branded drug that is premium to currently available generic drugs. Our sales and ramp-up will occur slowly until we get approval for all indications.”
Vice President of Marketing & Sales for Spectrum, George Uly added, “We have recently been in discussions with two potential partners for this drug. One has a market cap of over $20 billion, and the other is a private company with a sales force in place. When we get the colorectal indication approval, our target market will increase significantly. It would probably make more sense for a strategic partnership at that time, but we will make that decsisoon when appropriate and in the best interest of Spectrum. In the meantime, we have been busy building the infrastructure for launch.”
EOquin(R) is the Company’s synthetic Bio-reductive prodrug that is being investigated in the treatment of non-invasive bladder cancer, and began two Phase 3 studies in 2007. Spectrum also has three drugs in the Phase 2 stage of development: Ozarelix, for the treatment of prostate cancer and benign prostatic hypertrophy, Ortataxel, for the treatment of taxane-refractory tumors, and Satraplatin, a Phase 2 oral, anti-cancer drug, being investigated for non-small cell lung cancer (NSCLC).
The Company has three drugs in the Phase 1 stage of development: SPI-1620, an adjunct to chemotherapy, Elsamitrucin, which will target advanced solid tumors and Lucanthone, a chemotherapy sensitizer in the treatment of recurrent, malignant brain tumors. Other drugs in development include RenaZorb(TM), used in the treatment of hyperphosphotemia in end stage renal disease (ESRD), and SPI-205 for chemotherapy induced neuropathy.
In addition, the Company has the right to market authorized versions of sumatriptan injection, the generic version of GlaxoSmithKline’s Imitrex(R) Injection for migraine, which Spectrum will in the second half of 2008.
Dr. Shrotriya concluded, “It is important to remember that this company has only existed for five years. We currently have ten proprietary drugs in our pipeline. By the end of the year, our company should have two revenue producing drugs.”
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