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Spectrum Pharmaceuticals, Inc. Message Board

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  • nohype88 nohype88 Nov 3, 2006 4:57 PM Flag

    Another Day - Another Dime (EOM)

    Yes, I will take the 11 cents as well. As far as your question, for those not aware of the issue, the following is from prior news:

    GlaxoSmithKline (GSK) has filed a patent infringement lawsuit in federal court against Spectrum Pharmaceuticals to prevent Spectrum from developing a generic version of GSK's migraine drug Imitrex.

    GSK filed suit in the U.S. District Court for the District of Delaware to meet the required 45-day window called for under the Hatch-Waxman Act. Under Hatch-Waxman, if an abbreviated new drug application (ANDA) applicant files a Paragraph IV certification and notifies the patent holder, the patent holder has 45 days to sue the applicant for infringement.

    Spectrum initiated a challenge to GSK's Imitrex (sumatriptan succinate) injection in 6 mg/0.5 mL doses when it filed an ANDA with a Paragraph IV certification in October 2004. The FDA notified Spectrum that it had received the Paragraph IV certification in January. GSK's patent on Imitrex is set to expire Feb. 6, 2009.

    Moving forward to you question, the Sumatriptan injection patent litigation trial with GlaxoSmithKline is set for November 13, 2006. According to investor relations, a successful ruling by the court could result in SPPI�s launch of a Sumatriptan injection with its partner, PAR Pharmaceutical, in the second half of 2007. I can tell you from personal experience, that very few civil suits go to trial, and even those that do, often settle before a trier of fact makes its findings. I will not be at all surprised to see news of a settlement any day. The costs of trial preparation can be very high. While both sides are likely using this fact to secure their negotiation positions, news in the next week or so is likely IMO. Read what you will into today's share price increase.

    The issues, as I see them, are (1) whether SPPI can negotiate a settlement that is well accepted by the market (or at least is able to put a very positive spin on any deal reached); and, the actual long-term value of the deal to share-holders. The obvious down-side is a loss at trial would do more harm that just the loss of potential additional revenue. Alternatively, a clear victory at trial should give us a good boost IMO. Have a nice weekend.

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    • Nohype -

      Thanks for the information. A favorable outcome (whatever form it takes) could help us substantially. I'll hope for good news.

      Have a good weekend as well.

    • Nohype,

      Thanks for the synopsis. Does anyone have any idea how strong or weak SPPI's position is RE: the patent infringement? I understood Raj to say it did not have any real material importance to the company in either event. i.e. it will help, but not of major strategic importance.

      Any feedback is appreciated.


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