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Zalicus Inc. Message Board

scistats 194 posts  |  Last Activity: Apr 13, 2014 2:43 AM Member since: Apr 5, 2009
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  • Reply to

    Two Questions

    by nom_de_plune Feb 19, 2014 9:09 PM
    scistats scistats Feb 19, 2014 9:41 PM Flag

    Probably by June or July, but since the next myelofibrosis phase 2 must recruit patients based on markers that actually correlated with efficacy, we need to extract as much info from the Mayo trial and Dr. Tefferi as possible. We do not need to rush this one. Get the markers right, and everything falls into place.

    Sentiment: Strong Buy

  • Tefferi is the man to link markers with imetelstat success.

    Leukemia. 2014 Feb 5. doi: 10.1038/leu.2014.57. [Epub ahead of print]

    CALR and ASXL1 mutations-based molecular prognostication in primary myelofibrosis: an international study of 570 patients.

    Tefferi A, Guglielmelli P, Lasho TL1, Rotunno G, Finke C, Mannarelli C, Belachew AA, Pancrazzi A, Wassie EA, Ketterling RP, Hanson CA, Pardanani A, Vannucchi AM.

    Current prognostication in primary myelofibrosis (PMF) is based on the dynamic international prognostic scoring system (DIPSS)-plus, which employs clinical and cytogenetic variables. We recently reported DIPSS-plus independent prognostic significance for CALR (favorable) and ASXL1 (unfavorable) mutations. In the current study, 570 PMF patients were recruited for derivation (n=277) and validation (n=293) of a molecular prognostic model based on these two mutations. Survival was the longest in CALR+ASXL1- (median 10.4 years) and shortest in CALR-ASXL1+ patients (median 2.3 years; HR 5.9, 95% CI 3.5-10.0). CALR+ASXL1+ and CALR-ASXL1- patients had similar survival and were grouped together in an intermediate risk category (median survival 5.8 years; HR 2.5, 95% CI 1.5-4.0). The CALRsolASXL1 mutations-based prognostic model was DIPSS-plus independent (P 65 years vs 2.7 for unfavorable karyotype. These observations signify immediate clinical relevance and warrant i) CALR and ASXL1 mutation screening in all patients with PMF and ii) molecular revision of DIPSS-plus.

    Sentiment: Strong Buy

  • scistats scistats Feb 19, 2014 6:08 PM Flag

    Yes, true it is a poster rather than oral presentation, but the nerds (triumphing) are tinkering with the system which is always a good thing.

    Sentiment: Strong Buy

  • BioPearl, come on, looks like fundamental research and improvement to me.

    Abstract Number: 2743
    Presentation Title: Telomere transcripts improve synthetic inhibitors of telomerase
    Presentation Time: Monday, Apr 07, 2014, 1:00 PM - 5:00 PM
    Location: Hall A-E, Poster Section 34
    Poster Board Number: 14
    Author Block: Sandra Sampl1, Doris Mejri1, Christian Stern1, Hui Wang2, Klaus Holzmann1. 1Medical Univ. of Vienna, Vienna, Austria; 2Geron Corporation, Menlo Park, CA

    Sentiment: Strong Buy

  • scistats scistats Feb 19, 2014 2:37 PM Flag

    I am not an Incyte investor, but they have a pill that relieves symptoms and increases survival for the majority of cases while we have a drug that requires infusion and is effective for a minority of cases.

    I am talking about Geron more than doubling its PPS from here, regardless of having failed for breast and lung cancer and with absolutely zero proof of efficacy for solid tumors.

    I think it is a fair valuation when you consider the facts and take the speculation off the table about possible solid tumor success when there is none so far, and also consider that the pancreatic cancer cells did stabilize following a brief response to imetelstat.

    If imetelstat holds for myelofibrosis, it is worth in the ballpark of 10 PPS with orphaned status.

    Sentiment: Strong Buy

  • scistats scistats Feb 19, 2014 1:10 AM Flag

    Trailblazer, for now, imetelstat combined with paclitaxel failed for breast cancer in phase 2 and the non-small cell lung cancer phase 2 trial failed as well. As for pancreatic cancer, " a potential pitfall that could limit the clinical value of GRN163L (imetelstat) in pancreatic cancer will be the stabilization of telomeres seen after the initial rapid shortening and the long delays incurred before cells succumb to crisis."

    Yes, there may be ways around these problems, but its not going to happen any time soon. It is also not going to happen on a Geron sized budget.

    So, I reiterate 10 to 15 PPS estimate as it sits right now. That's it. Nothing more that this. This is a no conjecture, no BS, price estimate.

    Remember Jakafi keeps the majority of myelofibrosis patients as well, 60%+. This is the reality.

    Sentiment: Strong Buy

  • scistats scistats Feb 18, 2014 11:08 PM Flag

    I think so Vette.
    If the final Mayo data looks good, we will get some strong bites on the line. Chip just has to set the hook.

    Sentiment: Strong Buy

  • scistats scistats Feb 18, 2014 11:04 PM Flag

    I think Incyte believes that Jakafi will be used in combination, and myelofibrosis is just the tip of the iceberg for them in terms of indications for this oral drug. Take a look at their pipeline.

    Sentiment: Strong Buy

  • scistats scistats Feb 18, 2014 11:02 PM Flag

    25% is a conservative estimate, assuming that the 41% may not hold or the duration may be lackluster for some.

    Jakafi does a great job in reducing spleen size. Furthermore, there are survival benefits:

    NEW ORLEANS--(BUSINESS WIRE)--Dec. 9, 2013-- Incyte Corporation (Nasdaq: INCY) announced today that more than 35 analyses from clinical studies of Jakafi® (ruxolitinib) were presented at the 2013 American Society of Hematology (ASH) Annual Meeting from Dec. 7 to 10 in New Orleans. Jakafi, an oral JAK1/JAK2 inhibitor, is FDA-approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF).

    “Myelofibrosis is a debilitating, life-threatening blood cancer with limited treatment options. It is, therefore, rewarding to see that the expanding body of clinical data for Jakafi shows durable reductions in spleen volume and clinically meaningful improvements in health-related quality of life measures and supports a survival benefit for patients,” stated Paul A. Friedman, M.D., Incyte’s Chief Executive Officer and President.

    Ruben Mesa, M.D., Deputy Director, Mayo Clinic Cancer Center; Chair, Division of Hematology and Medical Oncology, Mayo Clinic in Arizona; and creator of the Myelofibrosis Symptom Assessment Form, an evidence-based tool used in the COMFORT trials to measure quality of life and symptomatic response to treatment, stated, “Given the growing evidence of a potential survival benefit for Jakafi-treated patients, it’s important to note that data from COMFORT-I suggest that dose titration and close monitoring of blood counts early in the course of Jakafi treatment are more likely to help patients remain on drug therapy, achieve and maintain improvements in spleen volume and symptoms, and improve survival.”

    Sentiment: Strong Buy

  • scistats scistats Feb 18, 2014 9:51 PM Flag

    A phase 2 solid tumor trial for pediatric cases is underway, but Geron will be long sold before these trial results see the light of day.

    Sentiment: Strong Buy

  • scistats scistats Feb 18, 2014 9:49 PM Flag

    Jakafi is being given to ALL myelofibrosis patients whereas Ayalew Tefferi, MD has clearly stated that imetelstat is a personalized medicine effective for, at most, 40% of myelofibrosis patients.

    Furthermore, Jakafi has a deep list of other indications viable for an oral drug whereas imetelstat is given IV and will likely never have the same viability because of this.

    We are looking at a narrow slice of the pie that I value somewhere between 10 and 15 PPS for the foreseeable future. Other indications and combination approaches are pie in the sky.

    I have already addressed the estimated number of patients which is well documented, i.e. known.

    Unless you plan on sticking around for 20 years and diluting to zero, a sell out is going to happen in the range of 10 to 15 PPS.

    Sentiment: Strong Buy

  • scistats scistats Feb 18, 2014 8:48 PM Flag

    "Its leading drug Imetelstat is targeting a $4 billion market of Essential Thrombocythemia and Myelofibrosis."

    Essential Thrombocythemia is not a viable market and imetelstat only captures ~25% of the Myelofibrosis market due to patients specific efficacy.

    "It is estimated that ~100,000 patients are afflicted with primary myelofibrosis, polycythaemia vera (PV) and essential thrombocythaemia (ET) in the United States alone2. Ruxolitinib (Jakafi; Incyte/Novartis), an oral Janus kinase inhibitor, is the first drug to be approved specifically to treat patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-PV myelofibrosis and post-ET myelofibrosis. It is launching with a fairly broad label into a disease area with a high unmet need and with plenty of opportunity to grow. Initial perceptions of physicians on efficacy and/or safety are also likely to change with the release of additional long-term safety data and survival data, which — if favourable — could contribute to increased uptake. Potential barriers to its adoption include its high cost; Incyte states that ruxolitinib will cost US$7,000 a month, or $84,000 per year, for insured patients. Novartis holds the rights to ruxolitinib outside the United States, and its experience with imatinib (Gleevec) for chronic myeloid leukaemia is expected to be valuable in establishing a launch platform. Additional Phase II studies are currently underway with ruxolitinib for PV and ET, and other potential indications include rheumatoid arthritis. Analysts' projections for ruxolitinib sales reflect its promising clinical profile; sales estimates range from $56 million to $67 million in 2012, with projected worldwide peak sales of more than $1 billion by 2015 (Wei, T. et al. Jefferies Equity Research Report. 7 Nov 2011; Schmidt, E. & Bishop, N. Cowen & Company Biotechnology Report. 8 Dec 2011)."

    $1 billion * .25 = $250,000,000

    787.54M/250M = 3x peak sales
    Double this = 10 PPS buyout price

    Sentiment: Strong Buy

  • scistats scistats Feb 18, 2014 6:23 PM Flag

    Come on Main, give us a lesson in valuation.
    Quit hiding behind cheese impacted assertions of foolish pseudo-psychiatric conjecture.

    "The difference in valuation is wide between these two industries, as the drug industry trades at 2.9 times sales while biotechnology is at six times sales. Typically, with companies in biotech either having greater growth or no sales, valuations are higher relative to fundamentals. Therefore, six times "current" sales becomes a healthy valuation while 2.9 times peak sales shows that all upside is priced into a stock."

    GERN is selling at 3X what I think the peak sales will be. I think 12 PPS factors in all the unknowns at this point in time concerning solid tumors and other indications with possible merit but not solid data as of yet.

    Sentiment: Strong Buy

  • Current Geron Mkt Cap is 787.54M at PPS of 5.2
    Imetelstat for myelofibrosis for 1 in 500,000 world-wide.

    Assume, imetelstat for orphaned disease designation achieved.

    Average $500,000 per treatment course over a lifetime???

    Buyout at ~12 PPS as it sits in the parking lot with no further modifications using BioMarin's estimated Vimizim's peak market potential of $1 billon with similar patients numbers? $250,000,000 peak annual market potential for imetelstat. Assuming PR, CR, and durability hold up and we capture at least 25% to 30% of the patients with markers that give imetelstat the green light for likely efficacy.

    Yes, I say we are worth ~12 PPS immediately after orphaned disease designation, with this value climbing substantially if indications expand beyond myelofibrosis or more data become even more solid.

    Sentiment: Strong Buy

  • Reply to

    When is the next big news?

    by joenlipinski Feb 18, 2014 1:31 PM
    scistats scistats Feb 18, 2014 2:51 PM Flag

    "Big news" is personal and subjective and otherwise called an exit strategy, which everyone should certainly have.

    By stating that your exit strategy will eventually arrive, but hasn't yet, can I deduce that you imply that there will be a buyout, bankruptcy, a successful phase 2, a successful phase 3, or a successful FDA approval and marketing of imetelstat for myelofibrosis, or a successful phase 3 with a pending solid tumor indication, possibly all without a buyout or partnership?

    I doubt that we are all waiting on the same big news nor will we all agree if or when it has arrived unless that news is bankruptcy or a buyout and delisting in which cases one cannot refute that it is over.

    Sentiment: Strong Buy

  • scistats scistats Feb 18, 2014 9:59 AM Flag

    Ayalew Tefferi, MD should be getting closer to defining which patients imetelstat will work for by correlating the trial successes (CRemission and PRemission) with these markers.

    Sentiment: Strong Buy

  • NeoGenomics is the First Laboratory to Offer Calreticulin (CALR) Mutation Testing for the Diagnosis and Classification of Myeloproliferative Neoplasms
    FT. MYERS, Fla., Jan. 7, 2014 /PRNewswire/ -- NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of cancer-focused genetic testing services, announced today that it has validated and launched a new test for the detection of mutations in the calreticulin (CALR) gene. The CALR gene is a novel biomarker that was reported to be specific for myeloproliferative neoplasms (MPN) for the first time at the annual meeting of the American Society of Hematology (ASH) last month. Since then, findings on the CALR gene have been published in the three articles referenced below.

    Based on data contained in the referenced papers and on its own retrospective validation data, NeoGenomics believes the presence of CALR mutation is pathogenic and pathognomonic for myelofibrosis and essential thrombocythemia, and is detected in a majority of cases that lack JAK2/MPL mutations. These findings suggest that patients suspected of having MPN should be tested for CALR mutation if they lack JAK2/MPL mutations. The company believes that CALR testing is not only important for the diagnosis and classification of MPN, but also for prognosis.

    Doug VanOort, the company's Chairman and CEO, said "NeoGenomics is proud to be the first laboratory in the United States to offer CALR testing on a clinical basis. This effort to quickly develop and offer important new tests to Physicians across the country demonstrates our commitment to be a leader in molecular oncology."

    Dr. Maher Albitar, the Company's Chief Medical Officer and Director of Research and Development, commented, "Offering CALR mutation testing compliments our comprehensive testing for patients with MPN. We now offer the most comprehensive, clinically relevant testing for MPN, including JAK2, MPL, CALR, CBL, PTPN11, CSF3R, TET2, ASXL1, and SF3B.

    Sentiment: Strong Buy

  • Interesting.

    Sentiment: Strong Buy

  • scistats scistats Feb 17, 2014 4:51 PM Flag

    I would have to agree that selling is the prudent option for imetelstat/Geron given the facts of this highly specialized orphaned indication. The pie simply cannot be sliced into any more pieces for myelofibrosis, and waiting on other trials that may/may not identify other indications is only going to burn cash that the company does not have. They also cannot afford to dilute given the market potential of what works (myelofibrosis). This is a no brainer. A buyout it will be, IF imetelstat delivers the numbers.

    Sentiment: Strong Buy

  • scistats scistats Feb 17, 2014 4:41 PM Flag

    A buyout ***IF*** durability and CRemission/PRemission numbers hold.
    Only IF imetelstat delivers the numbers.

    Sentiment: Strong Buy

1.21-0.14(-10.37%)Apr 17 3:59 PMEDT

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