Seeking Alpha
View as an RSS Feed

Poonam A. Arora  

View Poonam A. Arora's Comments BY TICKER:
Latest  |  Highest rated
  • Epizyme: Shares Oversold On Mixed Data From Early Studies [View article]
    Not a problem Lilly. Happy New Year!
    Jan 1, 2015. 01:29 AM | Likes Like |Link to Comment
  • Epizyme: Shares Oversold On Mixed Data From Early Studies [View article]
    Keep in mind that 5676 is being developed specifically to treat MLL-r. So if the drug is effective, it will definitely be used to treat MLL-r and be insulated from competition. However, if the agent is only moderately effective and has safety concerns (appears unlikely) then physicians might consider broad based AML/ALL therapies that are very effective to treat the condition. That is why I included a remark on SGEN’s drug in my note.

    There are some pipeline drugs being tested in AML but a majority of these belong to private companies. JUNO is clinically active in AML, ALL, and NHL. However, the trials are still in early stages with results still a year or more away. BLUE has a partnership with CELG for developing treatments for hematological cancers but that too appears in very early stages. KITE is developing a therapy for ALL and anticipates initiating a pivotal study in 2015 (not sure how that works out because it is still in pre-IND stage for clinical development). I believe in regards to competition for EPZM, you should be more concerned about 6438, as there is significant ongoing public company developmental activity in NHL.

    So to your query on the impact of immuno-oncology drugs on the commercial prospects for 5676, it depends totally on the effectiveness of 5676 and the immuno-oncology drugs. With respect to timing, all agents mentioned above appear close enough in developmental timeline (except maybe the KITE drug), with EPZM a little ahead.
    Dec 31, 2014. 11:44 AM | 3 Likes Like |Link to Comment
  • Epizyme: Shares Oversold On Mixed Data From Early Studies [View article]
    Not a problem Lilly. Glad I could help.
    Dec 31, 2014. 03:25 AM | Likes Like |Link to Comment
  • Puma Biotechnology: Legacy Wyeth Study Provides The Back Story On Neratinib - Adjuvant Approval Appears Unlikely [View article]
    Please check clinicaltrials.gov for the ExteNET final data collection date for primary outcome measure as November 2012 and study completion date as November 2013. Check also that ExteNET is a PBYI sponsored study.

    http://1.usa.gov/1z5boxK

    Not presenting ExteNET complete data at SABCS 2014 is a long delay.
    Oct 24, 2014. 04:16 PM | 1 Like Like |Link to Comment
  • Puma Biotechnology: Legacy Wyeth Study Provides The Back Story On Neratinib - Adjuvant Approval Appears Unlikely [View article]
    I was asked for an update given the price action. Here it is.

    I’d mentioned above that PBYI will delay the process to FDA decision at every step, from reporting ExteNET top line results, to announcing complete results, to filing the NDA, in order to buy as much time as possible to sell the company before the FDA decision. This is exactly how it is playing out. Based on tweets published last week, ExteNET complete data will not be presented at SABCS 2014 because the academic steering committee did not submit the results. What? Moreover, even if the tweets were rumors, ExteNET final data collection date for primary outcome measure was November 2012 and study completion date was November 2013. I think that’s delay enough in reporting complete results.
    Oct 23, 2014. 01:03 PM | 1 Like Like |Link to Comment
  • Puma Biotechnology: Legacy Wyeth Study Provides The Back Story On Neratinib - Adjuvant Approval Appears Unlikely [View article]
    I published my first short thesis on PBYI on March 12 with a Price Target of $86.27/share, when the stock opened at $106.35/share. My Price Target was reached on April 7, and shares traded mostly in-line with my subsequent Price Targets (even as low as $53.63/share) over the next several months until July 23.

    In the above article, I have provided 10 charts and linked roughly 23 statements to support my thesis. Based on my data driven analysis, it would be uncharacteristic for the FDA to approve Neratinib on 2 years of follow-up data. No near-term take out is likely to happen because no company is going to buy PBYI without data that assures adjuvant approval. Given the dynamics in the adjuvant space, with 2 years follow-up data PBYI cannot provide that assurance.
    Oct 15, 2014. 10:09 AM | 1 Like Like |Link to Comment
  • Puma Biotechnology: Legacy Wyeth Study Provides The Back Story On Neratinib - Adjuvant Approval Appears Unlikely [View article]
    In my article, I have said that the FDA is not going to approve Neratinib with 2 years of follow-up mentioned in the ExteNET protocol. So the contention by a commenter asking to move on to the Phase III data, the Wyeth data is Phase II, is inaccurate. The ExteNET study with its 2 years of follow-up has been considered and deemed insufficient for approval on basis of 4 factors including the Wyeth study results. The results which showed that at 96 weeks all patients on study including the adjuvant patients had progressed. The FDA is not going to approve Neratinib as adjuvant therapy based on 104 weeks (2 years) follow-up data from ExteNET. They are going to demand at least 5 years of follow-up data.

    The Wyeth data is only one point of four I have used to argue that Neratinib will not be approved on basis of the ExteNET study. There are 3 more, including that adjuvant treatments are developed to prevent recurrence over the long-term (most of the patients in the adjuvant setting are not sick) and so require long-term outcomes data, that all relevant adjuvant setting studies have follow-ups of at least 5 years, and that 2 years of Herceptin showed a benefit over 1 year of Herceptin in the initial years but the advantage disappeared with additional follow-up in the HERA study and the same could happen with adjuvant Neratinib.

    In addition, the survival data that a commenter mentioned can come later, cannot come later because according to clinicaltrials.gov the ExteNET study is complete and the overall survival timeframe is indicated as 2 years. So there is no 5 year follow-up for disease free survival or overall survival per the ExteNET protocol.

    Most of the indications a commenter keeps talking about are already accounted for in the stock and the rest can’t be as they are still pipeline dreams – only Phase I and above assets are represented in valuations.
    Oct 10, 2014. 11:02 AM | 1 Like Like |Link to Comment
  • Puma Biotechnology: Legacy Wyeth Study Provides The Back Story On Neratinib - Adjuvant Approval Appears Unlikely [View article]
    I agree with John Chow. Future pipeline drugs are not accounted for in 1-year Price Targets. Valuations consist only of pipeline drugs which are at least in Phase I development. My Price Target of $49.22/share is valuing on a per share basis Neratinib in 5 indications.

    In my Price Target, I have given Neratinib credit for treatment of metastatic HER2+ breast cancer in patients that failed 2 HER2 targeted therapies. This is despite the outstanding CLEOPATRA results because enrollment in the NALA study is still ongoing and patients that have failed Perjeta + Herceptin + chemotherapy can still be enrolled.

    In addition, I also have neo-adjuvant revenues in my Price Target as it is possible that a Phase III study testing Neratinib in the neo-adjuvant setting might contain a regimen of Neratinib + Perjeta + Herceptin + chemotherapy against Perjeta + Herceptin + chemotherapy.
    Oct 4, 2014. 09:02 AM | 1 Like Like |Link to Comment
  • Puma Biotechnology: Legacy Wyeth Study Provides The Back Story On Neratinib - Adjuvant Approval Appears Unlikely [View article]
    John - I believe the first priority for PBYI is getting bought out. However, they have guided to possible data releases from a few studies this year, including the ExteNet study (complete results).
    Sep 29, 2014. 04:09 PM | Likes Like |Link to Comment
  • Puma Biotechnology: Legacy Wyeth Study Provides The Back Story On Neratinib - Adjuvant Approval Appears Unlikely [View article]
    I have been on Seeking Alpha long enough to know that comments can be edited after publishing - you changed your comment after I responded to you. Not a shred of data or scientific literature in your arguments, only unsubstantiated rhetoric. Logging in as proxy with the sole objective of influencing market dynamics through disingenuous accusations. Talking from both sides of your mouth. You would wish that I can’t see your intentions but I do. Hence my accurately belligerent tone towards you. Seeking Alpha needs to verify the identities of commenters as they do for contributors.

    The only person that is unconscionable is you, in your attempts to use a blanket term “ADVANCED” when on a specific level the study clearly breaks down the patient population between NEO-ADJUVANT, ADJUVANT, and METASTATIC and mentions that several times. I described the patient population multiple times in my article. In my response to a comment, I copied and pasted sentences from the study that showed that the trial included NEO-ADJUVANT, ADJUVANT, and ADJUVANT patients. Readers can see that in the study themselves. And like I mentioned in my article, all patients including the ADJUVANT patients in the Herceptin experienced group had had progressed by week 96. I repeat, all patients including the adjuvant patients HAD PROGRESSED by week 96. Here is the quote from my article “Third, the only available follow-up data on Neratinib in the adjuvant setting (Wyeth study) show that in a mixed population of Herceptin pretreated patients that included 23% adjuvant and neo-adjuvant patients, progression free survival at 48 weeks was only 20% and at 96 weeks was a total of 0%. Although, I recognize that the group was small and contained only Herceptin failures, the fact that all patients, including those with adjuvant disease had progressed by week 96 is compelling, and I believe prognostic of the efficacy profile of the drug over the longer term.” End of quote. So you are outright lying. My conclusions are substantiated by none other than PBYI itself, which decided to change the follow-up (based on results of this study) to 2 years from the 5 years planned by Wyeth and Pfizer, because they knew Neratinib could not withstand 5 years of scrutiny.

    PBYI knew the past history of the FDA in requesting long-term data in the 2nd year adjuvant setting, but still decided to change the follow-up to 2 years from 5 years planned under Wyeth and Pfizer, and decided to forgo 5x in revenues for 1x, because it was only at 2 years follow-up that the drug had any, if dismal, chance of getting approved in the adjuvant setting. That was in 2011. Since then results from 2 adjuvant studies have shown that early efficacy in the drug arm disappears over the long-term. The likelihood of the FDA approving adjuvant Neratinib without 5 years follow-up is almost zero. That was why Pfizer decided to divest Neratinib. They didn’t want to sink good money after bad.

    When it comes to a PBYI buyout, companies are going to request to see data showing at least trends that the drug will be effective over the long-term (5 years and upwards). Since, a majority of PBYI’s revenues were expected from the adjuvant setting, no company is going to contemplate buying PBYI without that data. Potential acquirers don’t need to wear blinkers and hope and pray that the FDA approves adjuvant Neratinib with 2 years follow-up. They can move on to the next asset.

    In my opinion, the PBYI strategy was to change the follow-up to 2 years with the hope that someone would buy the company on that data and the adjuvant issues would become the problem of the acquirer. In that respect, delaying the process at every step, from reporting ExteNET top line results, to reporting final results, to filing the NDA, is all part of the strategy, to have as long a time as possible to facilitate a buyout before the FDA decision on adjuvant Neratinib.

    I have seen Werber’s notes on PBYI, there is no analysis in them, mostly pumping the company’s line. Which is fine, given that he and his company have a lot to gain if PBYI is sold (with them as bankers) for a valuation in multiples of that which it deserves, after all, the higher the transaction value of a sale, the higher the commissions.
    Sep 29, 2014. 12:31 PM | 1 Like Like |Link to Comment
  • Puma Biotechnology: Legacy Wyeth Study Provides The Back Story On Neratinib - Adjuvant Approval Appears Unlikely [View article]
    The CLEOPATRA results at ESMO 2014 bolster the argument I have been making since my first article on PBYI, that treatment with Herceptin + Perjeta is not the same as treatment with Herceptin. We saw that with NeoSphere and now with CLEOPATRA. We will likely see that with the APHINITY study. Neratinib needs to be tested after 1 year of Herceptin + Perjeta and show statistically significant DFS over placebo at upwards of 5 years of follow-up to be relevant in the adjuvant HER2+ breast cancer setting.

    Just to be clear on today’s announcement of Neratinib’s favorable results in HER2+ NSCLC. I have not seen the results, but want to point out that potential revenues from the NSCLC indication are in my model, and accounted for in my Price Target of $49.22/share.
    Sep 29, 2014. 08:13 AM | 2 Likes Like |Link to Comment
  • Puma Biotechnology: Legacy Wyeth Study Provides The Back Story On Neratinib - Adjuvant Approval Appears Unlikely [View article]
    Beyond the legacy study likely behind PBYI’s decision to change the follow-up for adjuvant Neratinib to 2 years from the 5 years planned by Wyeth and Pfizer, the pertinent issue now is whether the FDA will approve the drug on 2 years of follow-up. Based on results from the HERA and ALTTO studies, as well as the FDA’s 2012 draft guidance on the use of pCR as surrogate end-point in the neo-adjuvant setting, and its implications on the adjuvant setting, it appears highly unlikely that the agency will approve Neratinib on 2 years of follow-up.

    In regards to a buy-out, no company is likely to acquire PBYI (in the current scenario) without data that almost guarantees FDA approval in the adjuvant setting. Given that it is highly improbable that the FDA will approve the drug for adjuvant disease on 2 years of follow-up, that assurance appears difficult. Clear trends towards 5 years of adjuvant efficacy will likely be required. Therefore, a potential take out of PBYI at the present time looks tough.
    Sep 28, 2014. 02:41 PM | 1 Like Like |Link to Comment
  • Puma Biotechnology: Legacy Wyeth Study Provides The Back Story On Neratinib - Adjuvant Approval Appears Unlikely [View article]
    You've lost me on this one. I have no idea what you are talking about. Probably some more of your trickery.
    Sep 27, 2014. 03:21 PM | 1 Like Like |Link to Comment
  • Puma Biotechnology: Legacy Wyeth Study Provides The Back Story On Neratinib - Adjuvant Approval Appears Unlikely [View article]
    It has not gone past me that you have 3 comments and all 3 comments are on my article. In addition, my very systematic response by providing examples seems "unjustified and roundabout" to you. Moreover, my article which provides trial data at every step to substantiate my opinions appears as “impossible to follow leaps that don’t stand up to precedence”. Not only have I provided figures with clinical data at every step, I have provided the websites where I got my data as links embedded in my article. Sell-side analysts don’t provide even 1/10th of the data and links to information I have provided.

    So yes, considering your lack of history as a Seeking Alpha commenter combined with baseless repeated commentary regarding my abilities are indicative enough of your end goal. A goal to disrupt the conversation – a conversation about PBYI’s doubts about the longer term efficacy of Neratinib in the adjuvant setting. The doubts that made PBYI change the follow-up to 2 years from the planned 5 years under Wyeth and Pfizer. The doubts that made PBYI pick a 1 year regimen for adjuvant Neratinib, when it could be given for 5 years under the patent. The data I am referencing is the reason behind the change from the 5 years of follow-up to 2 years of follow-up, it is the reason for picking a 1 year regimen over a possible 5 year regimen.

    I don’t need you to approve my analysis. I believe my readers are savvy enough to evaluate all conversations on PBYI whether it’s mine or another analyst’s. I don’t feel the need to attack another analyst's ability the way you are doing mine to influence the conversation. Your intentions are crystal clear.
    Sep 27, 2014. 03:06 PM | 2 Likes Like |Link to Comment
  • Puma Biotechnology: Legacy Wyeth Study Provides The Back Story On Neratinib - Adjuvant Approval Appears Unlikely [View article]
    I see that you replaced your yesterday’s comment. I don’t consider indications that are not yet in the clinic in my valuation. Only pipeline drugs that are at least in Phase I are accounted for in my Price Target. In that regards, 2 indications you have mentioned, the HER2 mutant breast and lung cancer are already in my valuation.
    Sep 26, 2014. 05:24 PM | Likes Like |Link to Comment
COMMENTS STATS
98 Comments
88 Likes