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Somaxon Pharmaceuticals, Inc. Message Board

  • investrforever investrforever Mar 22, 2010 11:20 PM Flag

    From the 10K folks:

    "Silenor is an oral tablet formulation of doxepin at strengths of 3 mg and 6 mg. Doxepin has been marketed and used for over 35 years at dosages from 75 mg to 300 mg per day and is indicated for the treatment of depression and anxiety."

    What SOMX FAILS to acknowledge is that doxepin is and has also been used to treat insomnia.

    If you doubt it - do a simple google search!

    Two points: 1) nothing new; 2) questionable patent rights

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    • Son, giver a break

    • What are you doing here ? Join the FDA

    • More on the patents, and reference to the existence of "prior art" that may pose a significant challenge to the patents SOMX acquired from Pro-Com. "Prior art" simply means in lay person's terms, that it has been used before.

      "The principal patent protection that covers, or that we expect will cover, Silenor consists of method of use patents. This type of patent protects the product only when used or sold for the specified method. However, this type of patent does not limit a competitor from making and marketing a product that is identical to our product for an indication that is outside of the patented method. Moreover, physicians may prescribe such a competitive identical product for off-label indications that are covered by the applicable patents. Although such off-label prescriptions may induce or contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute.
      Because products with active ingredients identical to ours have been on the market for many years, there can be no assurance that these other products were never used off-label or studied in such a manner that such prior usage would not affect the validity of our method of use patents."

      • 3 Replies to investrforever
      • talk about misleading.... wow. all of the sections that you posted is all boiler plate stuff. have you ever read a 10K before?

        of course there may be lawsuits in the future. of course there might be a chance that patents may be invalidated. but as of today, there's no evidence that such events are in progress or are likely.

      • well good luck everyone slogging through that 10k.

        One thing I can tell you FOR SURE: NO pharma company touches SOMX/Silenor without an opinion from patent counsel.

        Even assuming a patent lawyer is willing to opine that the patents are good (which will is highly questionable in light of the prior use of doxepin for insomnia), the researching and issuing of such an opinion takes a LONG time.

    • Doctor's couldn't prescribe these for insomnia, they can now prescribe Silenor, which is based on Doxepin but with modifications, and they have a patent!

    • More from the 10K re: SOMX's alleged patent to doxepin for insomnia:

      "There is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries generally. If a third party claims that we or our collaborators infringe its intellectual property rights, we may face a number of issues, including but not limited to:
      • infringement and other intellectual property claims which, with or without merit, may be expensive and time-consuming to litigate and may divert our management’s attention from our core business;

      • substantial damages for infringement, including treble damages and attorneys’ fees, which we may be required to pay if a court decides that the product candidate at issue infringes on or violates the third party’s rights;

      • a court prohibiting us from selling or licensing the product candidate or using the proprietary technology unless the third party licenses its technology to us, which it is not required to do;

      • if a license is available from the third party, we may have to pay substantial royalties or fees or grant cross-licenses to our technology; and

      • redesigning our product candidates so they do not infringe, which may not be possible or may require substantial funds and time.
      No assurance can be given that patents issued to third-parties do not exist, have not been filed, or could not be filed or issued, which contain claims covering our products or product candidates or methods. Because of the number of patents issued and patent applications filed in our technical areas or fields, we believe there is a risk that third parties may allege that they have patent rights encompassing our products or product candidates or methods."

      I think a patent challenge here is an excellent bet, given the fact that doxepin has been used previously for insomnia.

    • Also from the 10K: SOMX acknowledges that anti-depressants are being prescribed for insomnia, and specifically mentions trazodone, but fails to mention that doxepin is already being prescribed off label by drs for insomnia. This is BS!

      "According to physicians that we surveyed in our market research, one of the primary reasons they prescribe sedating antidepressants for the treatment of insomnia is that they generally are not associated with the risk of dependency. As a result, they are not Schedule IV controlled substances, and they may be administered for long periods of time. As an example, it is estimated that the majority of trazodone prescriptions are prescribed off-label for the treatment of insomnia."

      • 2 Replies to investrforever
      • Incorrect. They discuss it directly and state that the off-label usage is estimated to be 0.1% in the available doses. Under the patent rights another company cannot manufacture the drug in the 3mg and 6 mg doses for insomnia. A company is unlikely to produce a generic form of doxepin in 3mg or 6mg while the patent is in place because (a) the FDA will not approve it with the patents in place and (b) it will have no therapeutic affect for depression, the only other plausible use. Doing so would be a clear attempt to violate the SOMX's patent, and if you were an attorney, you would know that court's will not reward form over substance. From the 10K:

        Silenor is an oral tablet formulation of doxepin at strengths of 3 mg and 6 mg. Doxepin belongs to a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. Doxepin was first approved by the FDA in 1969 and was originally marketed by Pfizer Inc. under the brand name Sinequan. Doxepin is currently available in oral capsule form for depression and anxiety at strengths ranging from 10 mg to 150 mg, and in solution form at a concentration of 10 mg/mL. Therapeutic dosages of doxepin for its indicated uses range from 75 mg to 300 mg daily, and at these dosages, doxepin exhibits potent sedative properties. However, the available strengths of doxepin are seldom used in the treatment of insomnia as they leave many patients reporting next-day residual effects and other undesirable side effects. According to IMS data, doxepin accounted for less than 0.1% of the insomnia prescriptions written during 2009. We believe that doxepin at low dosages does not exhibit the same pharmacologic effects as high-dose doxepin, and in our clinical development program we observed a low dropout rate, an adverse event profile comparable to placebo and no clinically meaningful next-day residual effects. It has been hypothesized that doxepin’s sleep promoting effects derive primarily from potent H1 histamine-blocking properties. It is believed that the drug does not work via any of the GABA receptors and, according to its FDA-approved labeling, does not appear to have any potential for dependency, addiction or abuse.

      • Incorrect. They discuss it directly and state that the off-label usage is estimated to be 0.1% in the available doses. Under the patent rights another company cannot manufacture the drug in the 3mg and 6 mg doses for insomnia. A company is unlikely to produce a generic form of doxepin in 3mg or 6mg while the patent is in place because (a) the FDA will not approve it with the patents in place and (b) it will have no therapeutic affect for depression, the only other plausible use. Doing so would be a clear attempt to violate the SOMX's patent, and if you were an attorney, you would know that court's will not reward form over substance. From the 10K:

        Silenor is an oral tablet formulation of doxepin at strengths of 3 mg and 6 mg. Doxepin belongs to a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. Doxepin was first approved by the FDA in 1969 and was originally marketed by Pfizer Inc. under the brand name Sinequan. Doxepin is currently available in oral capsule form for depression and anxiety at strengths ranging from 10 mg to 150 mg, and in solution form at a concentration of 10 mg/mL. Therapeutic dosages of doxepin for its indicated uses range from 75 mg to 300 mg daily, and at these dosages, doxepin exhibits potent sedative properties. However, the available strengths of doxepin are seldom used in the treatment of insomnia as they leave many patients reporting next-day residual effects and other undesirable side effects. According to IMS data, doxepin accounted for less than 0.1% of the insomnia prescriptions written during 2009. We believe that doxepin at low dosages does not exhibit the same pharmacologic effects as high-dose doxepin, and in our clinical development program we observed a low dropout rate, an adverse event profile comparable to placebo and no clinically meaningful next-day residual effects. It has been hypothesized that doxepin’s sleep promoting effects derive primarily from potent H1 histamine-blocking properties. It is believed that the drug does not work via any of the GABA receptors and, according to its FDA-approved labeling, does not appear to have any potential for dependency, addiction or abuse.

    • More from the 10k that shows that Silenor is the SAME THING as Sinequan. Also acknowledges that doxepin is prescribed for insomnia.

      All we are talking about here folks is a smaller pill.That's it.

      "Silenor is an oral tablet formulation of doxepin at strengths of 3 mg and 6 mg. Doxepin belongs to a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. Doxepin was first approved by the FDA in 1969 and was originally marketed by Pfizer Inc. under the brand name Sinequan. Doxepin is currently available in oral capsule form for depression and anxiety at strengths ranging from 10 mg to 150 mg, and in solution form at a concentration of 10 mg/mL. Therapeutic dosages of doxepin for its indicated uses range from 75 mg to 300 mg daily, and at these dosages, doxepin exhibits potent sedative properties. However, the available strengths of doxepin are seldom used in the treatment of insomnia as they leave many patients reporting next-day residual effects and other undesirable side effects. According to IMS data, doxepin accounted for less than 0.1% of the insomnia prescriptions written during 2009."

    • More BS .......... nothing about questionable patent rights. Nothing.

      You bashers are funny ....... you scream and holler it will never get approved. then it gets approved and you scream and holler about its patents not holding up.

      I can't wait (12 months) when it has $500 million in sales ............ then you will scream and hller that it is all just a Ponzi sceme.

      Have fun ...... I and other longs will make real money. The kind of money that puts a couplel of kids through college or pays of a house 20-years early.

      Go short this and bet you life savings ...........