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  • Ampio Pharmaceuticals Drives To "First And Goal" With Four Potential Blockbusters 1 comment
    Mar 21, 2013 7:16 PM | about stocks: AMPE

     

     

    about:AMPE includes:NVS, PCYC, REGN

    With Mike Macaluso calling the plays for Ampio Pharmaceuticals' (NYSEMKT:AMPE) winning team, the company has executed a perfect drive to tee up 3 drugs for pivotal trials and a revolutionary diagnostic that can all lead to FDA and foreign approvals within only 12 to 18 months. This is extreme record fast time and extreme record low cost compared to industry standards. All three drugs and the diagnostic are potential blockbusters with each one of them capable of selling billions of dollars per year. And all three of these drugs are low risk of failure for FDA approval because they are all either repurposed drugs that have already been approved by the FDA for safety, or a biologic that is viewed as being very safe by the FDA because it is already present in the human body and has demonstrated a safe history over 50 years of use.

    (click to enlarge)

    Imminent Zertane Licensing Deal

    Ampio's recent announcement that the FDA accepted their critical Patient Outcome for Premature Ejaculation serves notice that the company is likely to announce a major licensing deal with a big pharma partner for Zertane. The company admitted to being in discussions with a major pharma partner for several months and has also stated that they took a big pharma partner to the FDA meeting last year. This strongly implies that an announcement of major proportions could be imminent. As much as 25% of the male population is estimated to suffer from this disorder. According to Macaluso, in his January 2013 presentation to Noble Financial, the only thing standing in the way of the final deal was the FDA's acceptance of the Patient Outcome Premature Ejaculation Questionnaire.

    Now that the questionnaire has been officially approved by the FDA, Ampio is rumored on Stocktwits to be within 2 to 4 weeks of announcing a major deal that will bring in loads of cash and large royalty payments. The company will also be relieved of the financial responsibility for the Zertane trials because as Macaluso said, "the partner has agreed to pay for them". Just the Zertane deal all by itself is enough to send shares of this small cap company soaring to record highs.

    If Approved, Optina May Make Lucentis and Eylea Obsolete

    Then there is Optina for Diabetic Macular Edema that if approved, will compete with the $1.7 billion Lucentis owned by Novartis (NYSE:NVS) and Roche (OTCQX:RHHBY) and Regeneron's (NASDAQ:REGN) $800 million Eylea. Optina is in a pill form as opposed to Lucentis and Eylea that are both brutal injections directly into the eyeball. Optina is also expected to be cheaper. If approved, Optina will very likely make both Lucentis and Eylea obsolete almost overnight. The impact to Novartis will not be nearly as severe as it will be to Regeneron who relies entirely on Eyelea to generate over 90% of their revenues. The impact of an approval to Ampio will be immense considering the huge sales potential to such a small market cap today.

    (click to enlarge)

    (click to enlarge)

    (click to enlarge)

    Optina's IND was accepted by the FDA and its pivotal trial has already begun. The trial is considered low risk because Optina has already demonstrated efficacy with no adverse side effects, and was actually structured under the guidance of the FDA last year. Optina is repurposed Danazol that has already passed FDA safety requirements and therefore has removed a great deal of the risk normally associated with pivotal clinical trials. This trial will be very short in that it is expected to be completed in only 12 weeks. There may or may not be news in the interim, but either way, 12 weeks is very fast and could send shares soaring even further than the Zertane deal expected imminently.

    Ampion Anti-Inflammatory

    Ampion is the company's lead drug that is an anti-inflammatory that has shownremarkable efficacy and an unheard of absence of side effects that are commonly associated with all anti-inflammatory drugs. The anti-inflammatory market is over$60 billion and just imagine how large it would be if there was an anti-inflammatory that worked well and that had zero side effects. If approved, Ampion has the potential to be a mega blockbuster breaking well over $5 billion in sales.

    The FDA recently responded to Ampio's IND for its pivotal phase III trial of Ampion by requesting an additional run in study of 320 patients to be included where they are given a dose of 10 ml in addition to the 4 ml dose as used in prior trials. According to Mike Macaluso, "The FDA has been very helpful by recommending a single run-In study to begin our Phase III pivotal trial that will provide us deeper understanding of the treatment effect and an optimized dose that may well reduce the patient requirement, and the associated time and costs as the number of combined patients in the run-in/phase III study may be significantly less than the 1600 patients planned for the two, phase III studies in the original IND application."

    The Ampion phase III trials are expected to require only 12 weeks and are expected to commence in less than 60 days. If approved, Ampion has the potential to create unprecedented excitement and enthusiasm that it is difficult to imagine how much higher the shares will trade beyond Zertane and Optina news.

    Oxidation Reduction Potential Diagnostic

    The company also announced plans to spin off its Oxidation Reduction Potential,"ORP", blockbuster diagnostic through a new entity called Luoxis diagnostics that will be 80% owned by Ampio Pharmaceuticals and 20% sold to new investors in an IPO. The company has concluded a 5,000 patient trial for ORP and is preparing to submit a 510k application to the FDA for a relatively fast approval this year.

    NCE001 Phophatase Activator Cancer Treatment Drug

    NCE001 is a promising novel new class of drugs for cancer treatment that are called phosphatase activators. They act similarly to the kinase inhibitors being developed by Pharmacyclics (NASDAQ:PCYC) and they appear to have remarkable results at halting proliferation on a broad line of cancers. The company is advancing NCE001 very quickly and very quietly. Pharmacyclics does not have the pipeline that Ampio has and yet it has moved up from just over $5 to over $90 in the past two years because of its kinase inhibitor, Ibrutinib.

    (click to enlarge)

    Ampio Pharmaceuticals Has a Steady Stream of News to Come

    The company has a large stack of news releases about four potential blockbusters that most pharma companies and their shareholders can only dream of.

    Risk

    There is always risk of failure associated with any clinical trial for drug approval by the FDA and also the risk of inadequate financing to achieve the company goals but Ampio has done an excellent job at reducing risk, cost and time. The company appears to be adequately funded through early 2014 and management is to be commended for unprecedented victories in such a short time.

    Strong Buy Recommendation

    The company has a record 3.6 million share short interest that must be getting very nervous now because the company is in the final stages of completing and announcing a major licensing deal for Zertane with a big pharma partner that will send shares spiking to new highs. Very soon, Ampio is also expected to begin releasing a steady flow of a large number of positive press releases on over 4 blockbuster products that will drive shares even higher.

    Given the small float, the short position, the low valuation and the magnitude and amount of news to come, my target price is between $10 to $15 in the next 90 days and over $40 by year end.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

    This article is tagged with: Long Ideas

     

     

    about:AMPE includes:NVS, PCYC, REGN

    With Mike Macaluso calling the plays for Ampio Pharmaceuticals' (AMPE) winning team, the company has executed a perfect drive to tee up 3 drugs for pivotal trials and a revolutionary diagnostic that can all lead to FDA and foreign approvals within only 12 to 18 months. This is extreme record fast time and extreme record low cost compared to industry standards. All three drugs and the diagnostic are potential blockbusters with each one of them capable of selling billions of dollars per year. And all three of these drugs are low risk of failure for FDA approval because they are all either repurposed drugs that have already been approved by the FDA for safety, or a biologic that is viewed as being very safe by the FDA because it is already present in the human body and has demonstrated a safe history over 50 years of use.

    (click to enlarge)

    Imminent Zertane Licensing Deal

    Ampio's recent announcement that the FDA accepted their critical Patient Outcome for Premature Ejaculation serves notice that the company is likely to announce a major licensing deal with a big pharma partner for Zertane. The company admitted to being in discussions with a major pharma partner for several months and has also stated that they took a big pharma partner to the FDA meeting last year. This strongly implies that an announcement of major proportions could be imminent. As much as 25% of the male population is estimated to suffer from this disorder. According to Macaluso, in his January 2013 presentation to Noble Financial, the only thing standing in the way of the final deal was the FDA's acceptance of the Patient Outcome Premature Ejaculation Questionnaire.

    Now that the questionnaire has been officially approved by the FDA, Ampio is rumored on Stocktwits to be within 2 to 4 weeks of announcing a major deal that will bring in loads of cash and large royalty payments. The company will also be relieved of the financial responsibility for the Zertane trials because as Macaluso said, "the partner has agreed to pay for them". Just the Zertane deal all by itself is enough to send shares of this small cap company soaring to record highs.

    If Approved, Optina May Make Lucentis and Eylea Obsolete

    Then there is Optina for Diabetic Macular Edema that if approved, will compete with the $1.7 billion Lucentis owned by Novartis (NVS) and Roche (OTCQX:RHHBY) and Regeneron's (REGN) $800 million Eylea. Optina is in a pill form as opposed to Lucentis and Eylea that are both brutal injections directly into the eyeball. Optina is also expected to be cheaper. If approved, Optina will very likely make both Lucentis and Eylea obsolete almost overnight. The impact to Novartis will not be nearly as severe as it will be to Regeneron who relies entirely on Eyelea to generate over 90% of their revenues. The impact of an approval to Ampio will be immense considering the huge sales potential to such a small market cap today.

    (click to enlarge)

    (click to enlarge)

    (click to enlarge)

    Optina's IND was accepted by the FDA and its pivotal trial has already begun. The trial is considered low risk because Optina has already demonstrated efficacy with no adverse side effects, and was actually structured under the guidance of the FDA last year. Optina is repurposed Danazol that has already passed FDA safety requirements and therefore has removed a great deal of the risk normally associated with pivotal clinical trials. This trial will be very short in that it is expected to be completed in only 12 weeks. There may or may not be news in the interim, but either way, 12 weeks is very fast and could send shares soaring even further than the Zertane deal expected imminently.

    Ampion Anti-Inflammatory

    Ampion is the company's lead drug that is an anti-inflammatory that has shownremarkable efficacy and an unheard of absence of side effects that are commonly associated with all anti-inflammatory drugs. The anti-inflammatory market is over$60 billion and just imagine how large it would be if there was an anti-inflammatory that worked well and that had zero side effects. If approved, Ampion has the potential to be a mega blockbuster breaking well over $5 billion in sales.

    The FDA recently responded to Ampio's IND for its pivotal phase III trial of Ampion by requesting an additional run in study of 320 patients to be included where they are given a dose of 10 ml in addition to the 4 ml dose as used in prior trials. According to Mike Macaluso, "The FDA has been very helpful by recommending a single run-In study to begin our Phase III pivotal trial that will provide us deeper understanding of the treatment effect and an optimized dose that may well reduce the patient requirement, and the associated time and costs as the number of combined patients in the run-in/phase III study may be significantly less than the 1600 patients planned for the two, phase III studies in the original IND application."

    The Ampion phase III trials are expected to require only 12 weeks and are expected to commence in less than 60 days. If approved, Ampion has the potential to create unprecedented excitement and enthusiasm that it is difficult to imagine how much higher the shares will trade beyond Zertane and Optina news.

    Oxidation Reduction Potential Diagnostic

    The company also announced plans to spin off its Oxidation Reduction Potential,"ORP", blockbuster diagnostic through a new entity called Luoxis diagnostics that will be 80% owned by Ampio Pharmaceuticals and 20% sold to new investors in an IPO. The company has concluded a 5,000 patient trial for ORP and is preparing to submit a 510k application to the FDA for a relatively fast approval this year.

    NCE001 Phophatase Activator Cancer Treatment Drug

    NCE001 is a promising novel new class of drugs for cancer treatment that are called phosphatase activators. They act similarly to the kinase inhibitors being developed by Pharmacyclics (PCYC) and they appear to have remarkable results at halting proliferation on a broad line of cancers. The company is advancing NCE001 very quickly and very quietly. Pharmacyclics does not have the pipeline that Ampio has and yet it has moved up from just over $5 to over $90 in the past two years because of its kinase inhibitor, Ibrutinib.

    (click to enlarge)

    Ampio Pharmaceuticals Has a Steady Stream of News to Come

    The company has a large stack of news releases about four potential blockbusters that most pharma companies and their shareholders can only dream of.

    Risk

    There is always risk of failure associated with any clinical trial for drug approval by the FDA and also the risk of inadequate financing to achieve the company goals but Ampio has done an excellent job at reducing risk, cost and time. The company appears to be adequately funded through early 2014 and management is to be commended for unprecedented victories in such a short time.

    Strong Buy Recommendation

    The company has a record 3.6 million share short interest that must be getting very nervous now because the company is in the final stages of completing and announcing a major licensing deal for Zertane with a big pharma partner that will send shares spiking to new highs. Very soon, Ampio is also expected to begin releasing a steady flow of a large number of positive press releases on over 4 blockbuster products that will drive shares even higher.

    Given the small float, the short position, the low valuation and the magnitude and amount of news to come, my target price is between $10 to $15 in the next 90 days and over $40 by year end.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

    This article is tagged with: Long Ideas
    Stocks: AMPE
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  • Michel D'Anges
    , contributor
    Comments (10) | Send Message
     
    Great article, Russ. Thanks.
    23 Mar 2013, 02:16 PM Reply Like
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