Investors should find the resources in this article helpful to their research efforts on Spectrum Pharmaceuticals (Nasdaq: SPPI) regarding Zevalin®. <o:p> </o:p>
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As of March 16, 2009 , Zevalin® is now manufactured and sold in the <st1:country-region> <st1:place> US </st1:place> </st1:country-region> by Spectrum Pharmaceuticals (Nasdaq: SPPI ). Zevalin® is currently approved as a last resort treatment for refractory NHL. SPPI is seeking approval for Zevalin® as a first-line consolidation therapy for NHL. A FDA decision on Zevalin® is expected by <st1:date> September 8, 2009 </st1:date> . <o:p> </o:p>
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ZEVALIN® APPROVAL IS IMPORTANT FOR PATIENTS WITH NHL. <o:p> </o:p>
If Zevalin is approved under the first-line consolidation setting, the drug is more likely to have a better shot at becoming the standard of care for NHL. Some patients, who have received Zevalin® or a comparable radioimmunotherapeutic (RIT), Bexxar®, would likely argue that Zevalin deserves to be approved and made available for early-stage patients. The current standard of care is Rituxan® in combination with chemotherapy. Rituxan® is marketed by partners Roche (RHHBY.PK) and Biogen Idec (Nasdaq: BIIB). Bexxar® is marketed by GlaxoSmithKline (NYSE: GSK). <o:p> </o:p>
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For more details on SPPI, Zevalin®, and the company’s late-stage pipeline, including Fusilev® and Eoquin®, please refer to my previous articles . <o:p> </o:p>
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BETSY DE PARRY <o:p> </o:p>
Betsy de Parry’s story is one with a happy ending. Betsy is a NHL survivor, one of few patients in the <st1:country-region> <st1:place> US </st1:place> </st1:country-region> who has actually received a RIT for the treatment of her NHL. While Betsy’s story ended positively, more importantly it exemplifies why patients should be made aware of the Zevalin® option. Please make it a point to check out Betsy’s site . Investors should consider purchasing her book, The Roller Coaster Chronicles © , which is available for sale on her site.
MUST SEE VIDEO ON ZEVALIN® <o:p> </o:p>
Video: Zevalin and Bexxar
OTHER RESOURCES <o:p> </o:p>
New York Times article July, 14 2007 which also features Betsy de Parry as well as other NHL survivors. <o:p> </o:p>
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On July 16, 2007 , a blogger responds to the July 14 New York Times article, infra. Here, I found Betsy de Parry’s comments after the article more valuable than the article itself. <o:p> </o:p>
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New York Times article December 7, 2007 on Medicare reimbursement challenges. SPPI is working with the CMS to correct reimbursement issues. According to a recent presentation at JMP Securities Conference on May 20, 2009 , the company appears to be making headway on these issues. <o:p> </o:p>
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On April 28, 2008 , Zevalin® was approved in <st1:place> Europe </st1:place> as a first-line consolidation therapy for NHL. Bayer Schering markets Zevalin® in <st1:place> Europe </st1:place> as well as other countries except the <st1:country-region> <st1:place> US </st1:place> </st1:country-region> . <o:p> </o:p>
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Bexxar® versus Zevalin® , a factual comparison of the two RITs, Bexxar® and Zevalin®, approved for refractory NHL at Lymphomation.org <o:p> </o:p>
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CONCLUSION <o:p> </o:p>
From my view, these resources make the case – Zevalin® is an extraordinarily effective treatment for NHL. <o:p> </o:p>
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Regarding other issues: (1) SPPI is working closely with CMS (Medicare) to alleviate the reimbursement issue which has, in part, led to Zevalin’s disuse. (2) SPPI is also working with the FDA to modify the existing scanning requirements. <o:p> </o:p>
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If approved under the first-line setting, I believe Zevalin® sales will ramp up much faster than other analysts and commentators are expecting. In a recent article , I point out that SPPI’s leadership has the experience and know-how to make it happen for Zevalin®. I believe they will. <o:p> </o:p>
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As some have implied, I do not believe it is responsible to say the pending Zevalin® approval will NOT prove to be that important. For patients with NHL, Zevalin’s approval is important. Patients need to be aware of the Zevalin® option. Please do NOT take my word for it. Just ask Betsy de Parry . With the first-line approval, I expect more doctors will adopt the treatment and begin treating their patients with it. In time, I anticipate that Zevalin® will become the standard of care for NHL in addition to the current treatments. Under this same reasoning, I foresee sales of Zevalin® increasing over the next 12-18 months and maybe even beyond. <o:p> </o:p>
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Here, I think it is appropriate to quote a statement engraved on a paperweight that set atop President Ronald Reagan’s desk throughout the eight years he served in the White House, “It CAN Be Done.” <o:p> </o:p>
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Zevalin® should be made available to early-stage NHL patients. <o:p> </o:p>
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It’s the right thing to do.
This article is dedicated to my soon to be sister-in-law, Melissa, who was recently diagnosed with cancer one week ago on Friday, July 10, 2009.
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Disclosure: Long SPPI <o:p> </o:p>
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$5.55 (07/18/09)
