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Nektar Therapeutics (NKTR) Message Board

feeling_hijacked 43 posts  |  Last Activity: Mar 28, 2015 6:45 PM Member since: Jan 2, 2006
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  • Reply to

    Balance sheet

    by tlcjam1 Mar 26, 2015 10:35 PM
    feeling_hijacked feeling_hijacked Mar 28, 2015 6:45 PM Flag

    Tic, I have no great concern about dilution at this point, although it's inconceivable that HR would ever let NKTR's cash position run down to less than 12-months of cash. There is also the 125M senior note which comes due in July 2017. My reinvestment decision took into account the possibility that HR could engage in 1 more fundraising ($100 - 150M) after receipt of the AZN $100M for the US launch and prior to 102's approval to create additional cash cushion.

    However, a cash raise may not be needed. IMO, 102 can be partnered today for its combo potential with a parp inhibitor, and AZN and HR should be on the phone by now or in the near future exploring a deal to combine Olaparib and 102. In the Q4 call, HR indicated that NKTR had data for 102 with other parp inhibitors. If the mouse data with Olaparib is decent, I think that NKTR could obtain a $100M + upfront from AZN for exclusive access to 102 for trial purposes and to the safety and efficacy data from Beacon. An ex-US marketing deal could also be struck, but that could also await FDA approval to remove any deal discount for the contingency that 102 does not receive approval this time around.

  • Reply to

    FDA docket and NKTR

    by classshopper Mar 27, 2015 9:32 AM
    feeling_hijacked feeling_hijacked Mar 28, 2015 6:22 PM Flag

    The CT/gov listings show estimated completion dates for the 2 Respire trials in March and August of 2016. The 2 Inhale trials for inhaled amikacin have estimated completion dates of January 2016. My guess is that the topline results from the Inhale trials should be reported no later than 1-year from now. Bayer last updated the listings for all of these trials this month, so the estimated completion dates should be accurate. I believe there are SPAs for the Inhale trials, which means that FDA approval of inhaled amikacin could be quite rapid if the trials hit their endpoints.

  • Reply to

    HR Q&A

    by hoyas012 Mar 26, 2015 7:11 AM
    feeling_hijacked feeling_hijacked Mar 26, 2015 9:08 AM Flag

    Hoyas, first of all, thanks for the welcome back, but it feels like I never left. If six months ago someone had told me that I would be reinvesting after Beacon failed its primary and 2 secondary efficacy endpoints, my response would have been that I must have crushed and mainlined 10 of Klaus's blue pills before making that decision. But I am reinvesting and am confident it will be highly rewarding over the next year.

    I agree with DCX that NKTR needs lots of cash, but I also agree with you that HR will figure out a non-dilutive way to raise it. My guess as to how: a deal with AZN to pair 102 with Olaparib, AZN's parp inhibitor. Once 102 is approved, any pharma with a parp inhibitor could start trials of a combo, but HR now can offer a 1-year head start by providing pre-approval exclusive access to 102. This exclusive access could also be coupled with an ex-US marketing deal for 102, with a large upfront plus big milestone on FDA approval. HR has been great at extracting cash from AZN. The deal would be a winner for both AZN and NKTR. While it's also possible that AZN might try to buy all of NKTR, I think AZN's co-marketing deal with Daiichi Sankyo lessens the buyout odds considerably. This indicates to me that AZN will remain focused on its core R&D plans, which do not include CNS drugs such as 181 and the other pain drugs NKTR is seeking to develop. I predict an AZN 102 deal by ASCO. Whatever happens (or not on the deal front), the next year will be interesting, and likely a roller-coaster ride, especially if biotech continues to correct.

  • Reply to

    Beacon TPC choices and then some

    by kklausbeckerman Mar 24, 2015 9:47 PM
    feeling_hijacked feeling_hijacked Mar 25, 2015 9:27 AM Flag

    Ofjames, you can read Klaus's musings, or you can review the Q4 and Q3 earnings call transcripts for Sunesis (SNSS) on Seeking Alpha, which provide an ongoing case study on the regulatory process with a close-miss P3 trial highly similar to the Beacon trial miss. I suggest beginning with the Q4 transcript -- it is better edited -- and then going back to the Q3 transcript for additional flavor. Reviewing the SNSS PRs since September will also fill in details.

    By the way, I have bought back about 1/3rd of the max position I have held in NKTR (prior to the 181 P2 trial failure). I plan to continue adding over the coming weeks until I am once again at that max number of shares.

  • Reply to

    Nature of the market

    by hoyas012 Mar 20, 2015 7:30 AM
    feeling_hijacked feeling_hijacked Mar 20, 2015 11:53 AM Flag

    "I am skeptical that nktr could pull this off since I am not familiar with any case in which a drug was approved based on a post-hoc inferiority finding, and since they would have to stretch to argue that this is a case that fits within the contours of FDA's guidance on acceptable non-inferiority trials."

    Hoyas, I have been pressed for time the past 2 days and have not had a chance to provide a full follow-up on the significance of the Olaparib AA. Here's a summary: The AA was based upon ORR data mined from a subgroup of ovarian patients in a P2 trial which had ORR as its primary endpoint. AZN submitted the data after ODAC voted firmly against approval based on the registration trial results. For more info on the approval, google: FDA approves Lynparza to treat advanced ovarian cancer. Well worth reading, especially by our biggest skeptic, DCX.

    IMO, a full approval is quite possible since the data NKTR can rely on are gold standard OS data (not to mention the potential for biomarker analysis NKTR can now presumably prepare).

  • feeling_hijacked feeling_hijacked Mar 18, 2015 7:06 PM Flag

    Hoyas, you may have also missed my post on the approval of AZN's Olaparib back on 12/21. Search this board for "jq1234", who spotted the uniqueness of the approval on the IHUB BV board, and I reposted his BV post. In some respects, I consider this an even stronger proof than the Farydak approval of the FDA's new willingness to approve oncology drugs based on what many would regard as "data-dredged" data. I will have more to say about the Olaparib approval at a later time.

  • Reply to

    I am now fully out.

    by mcmanus157 Mar 18, 2015 11:27 AM
    feeling_hijacked feeling_hijacked Mar 18, 2015 11:58 AM Flag

    I am in the process of buying back in, and the potential of an AZN buyout is my principal reason for beginning the buyback (and probably accelerating it over the next few weeks instead of over the next few months as originally planned). AZN has compelling reasons for buying NKTR, as you point out.

  • Reply to

    ASCO, Pazdur, Biomarkers, Matsuoka

    by hoyas012 Mar 17, 2015 6:44 PM
    feeling_hijacked feeling_hijacked Mar 18, 2015 10:47 AM Flag

    Maybe "crossover" was the incorrect term to use, but patients on 102 were allowed to switch over to any of the single agents used in the TPC, and patients in the TPC arm were allowed to switch to any of the other TPC treatments, which presumably could occur at the time of progression on the initial treatment (whether 102 or TPC). In describing the Beacon design in a 2012 poster on the trial (from the IPAKT conference), the following was said about data collection for subsequent treatments:

    Data will be collected on subsequent anticancer therapies in both
    treatment arms from the time patients come off the study treatment
    until the time of primary data analysis for OS.

  • After Sunesis's P3 trial (VALOR) of vosaroxin in combo with cytarabine for the treatment of relapsed/refractory acute myeloid leukemia failed -- its stock tanked 80% after the topline results were released -- its management announced that it would pursue approval in the US and EU. The overall p value for VALOR was .06, even closer than Beacon's .08. DCX advised that we follow SNSS for clues as to what might happen if Beacon was a close miss. Good advice. Here is what has transpired thus far (from the S/A transcript of SNSS's 4Q call earlier this month):

    As Dan stated, the regulatory process in Europe and the US is now underway. In November, we announced submission of a European letter of intent. The letter initiates the process leading to the assignment of a Rapporteur and Co-Rapporteur, who are the two appointed members of the Committee for Human Medicinal Products or CHMP. Once the Rapporteurs are assigned, we intend to meet with them as early as possible to discuss our filing. We expect this interaction to take place in the second quarter and to submit the MAA filing in the second half of the year.

    In the U.S. we are in a constructive dialogue with the FDA. Our dialogue with the FDA is comprehensive and includes efficacy, safety and statistical considerations. We are engaged in an ongoing comprehensive data analysis of all of our four AML data set to identify the best population -- the patient population with the best benefit risk profile. We appreciate the FDA’s level of engagement to date and their underlying commitment to address the unmet medical need in AML. We look forward to gain further clarity by midyear with the hope that we can proceed to a rolling NDA submission in the second half.

  • Reply to

    ASCO, Pazdur, Biomarkers, Matsuoka

    by hoyas012 Mar 17, 2015 6:44 PM
    feeling_hijacked feeling_hijacked Mar 17, 2015 7:56 PM Flag

    Year end is my guess. NKTR will need to engage in a lot of data dredging, but I expect this will prove productive and enhance the chances for approval. The biomarker data pointed to by Hoyas, for example, may provide additional reasons for approval. I am also curious about the cross-over stats, which NKTR stated would be tracked during the trial.

  • Reply to

    ASCO, Pazdur, Biomarkers, Matsuoka

    by hoyas012 Mar 17, 2015 6:44 PM
    feeling_hijacked feeling_hijacked Mar 17, 2015 7:45 PM Flag

    I am surprised 102 missed on PFS and ORR. Based on the P2 results, I thought 102 would easily beat TPC on both of those secondary endpoints. However, the stat-sig OS results in patients with liver mets and stable brain mets, both of which were pre-specified subgroups, should suffice for approval IMO. I also believe that Pazdur will be a strong advocate for 102's approval. His influence at the FDA cannot be overemphasized, as seen in the FDA's recent AA of NVS's Farydak after ODAC voted against approval. The AA was based upon additional data from a 193-patient pre-specified subgroup submitted by NVS after the ODAC rejection. From the FDA PR on the AA:
    Farydak is the first HDAC inhibitor approved to treat multiple myeloma. It is intended for patients who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent. Farydak is to be used in combination with bortezomib, a type of chemotherapy, and dexamethasone, an anti-inflammatory medication.
    “Farydak has a new mechanism of action that distinguishes it from prior drugs approved to treat multiple myeloma, making it a potentially attractive candidate agent for the treatment of multiple myeloma,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Farydak’s approval is particularly important because it has been shown to slow the progression of multiple myeloma.”
    In November 2014, the FDA’s Oncologic Drugs Advisory Committee advised the agency that, based on the data reviewed, the drug’s benefits did not outweigh its risks for patients with relapsed multiple myeloma. After the meeting, the company submitted additional information supporting Farydak’s use for a different indication: patients with multiple myeloma who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent.

  • feeling_hijacked feeling_hijacked Mar 17, 2015 5:19 PM Flag

    Hey Teddy, why don't you imagine it's the summer of 1969 again, go find that bridge in Chappaquiddick, and have your date roll your wheelchair off the bridge (with you in it of course). Hopefully this time around, you will not bob to the surface and your date will survive. A much happier ending this time IMO.

  • I have not had a chance to read the PR closely, and I am now listening to HR drone on, but the results seem god enough to me for submission to the FDA. My guess is that the FDA with heavy influence from Pazdur, will approve. I would not have made my 50% prediction 6 months ago, but I now think approval is quite possible based on recent FDA approvals. I will elaborate on my reasons for optimism in the next day or so.

  • Reply to

    New miracle drug called nivolumab

    by corona_and_a_cigar Mar 16, 2015 8:59 PM
    feeling_hijacked feeling_hijacked Mar 17, 2015 9:36 AM Flag

    Response rates become almost irrelevant when a clear survival benefit is shown, although a 17% CR rate is impressive IMO. The second approval Opdivo recently received for squamous NSCLC is probably the fastest ever. Google "Opdivo's survival benefit inspired FDA to act fast on NSCLC approval: Pazdur" Some extracts from this article:

    "When Opdivo showed it could prolong the lives of lung cancer patients, Bristol-Myers Squibb ($BMY) quickly broadcast the data. And the pharma world was sufficiently impressed. But the FDA was so impressed with the survival data on the new immunotherapy, it was already working on a new approval for the drug.
    That's the news from Dr. Richard Pazdur, who heads up the agency's Office of Hematology and Oncology products. In an interview with The Cancer Letter, Pazdur said Opdivo's survival data came into the FDA Dec. 19, before the results were unblinded for Bristol-Myers. And the "magnitude of the survival effect" triggered quick action from the get-go, he said.
    "With regard to the impetus for this rapid action, we began working immediately on this review and submission strategy after being informed of the survival results. This was prior to BMS having been informed of the results since they were still blinded," Pazdur said to The Cancer Letter.
    The agency wanted to quickly get those findings into Opdivo's product label and open up approvals for second-line and third-line treatment of squamous non-small cell lung cancer. And it did--Bristol-Myers had only just announced that the agency accepted its app for expanded approval when the FDA turned around and announced the new indications.
    ***********
    "The FDA official also suggested that the bar for future approvals in squamous disease could be higher. Now that Opdivo has so decisively trounced the chemo med, docetaxel shouldn't be used as a comparator in future studies in squamous NSCLC, Pazdur suggests (as cited by Fernandez in his note)."

  • Reply to

    For what it's worth

    by bugsisdog Mar 10, 2015 3:08 PM
    feeling_hijacked feeling_hijacked Mar 10, 2015 7:20 PM Flag

    Decimal point. I think he has at least 1 comma in his number.

  • Reply to

    FDA Oncology NDA requirements.

    by kklausbeckerman Mar 9, 2015 12:15 PM
    feeling_hijacked feeling_hijacked Mar 9, 2015 1:38 PM Flag

    And search "FDA Approves Opdivo (nivolumab) for the Treatment of Patients with Previously Treated Metastatic Squamous Non-Small Cell Lung Cancer " for its PR from last week announcing the approval. Here is the first paragraph of the PR

    "[BMY] today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Opdivo is the first and only PD-1 (programmed death receptor-1) therapy to demonstrate overall survival in previously treated metastatic squamous NSCLC. Opdivo demonstrated significantly superior overall survival (OS) vs. docetaxel, with a 41% reduction in the risk of death (hazard ratio: 0.59 [95% CI: 0.44, 0.79; p=0.00025]), in a prespecified interim analysis of a Phase III clinical trial. The median OS was 9.2 months in the Opdivo arm (95% CI: 7.3, 13.3) and 6 months in the docetaxel arm (95% CI: 5.1, 7.3).

  • Reply to

    FDA Oncology NDA requirements.

    by kklausbeckerman Mar 9, 2015 12:15 PM
    feeling_hijacked feeling_hijacked Mar 9, 2015 1:33 PM Flag

    If 102 demonstrates a superior survival benefit, it could obtain rapid FDA review. But the OS benefit must be super superior (to use your words on the outlook for 102). See below on the FDA's rapid approval of Opdivo in NSCLC, which was a follow-on approval (and search "Opdivo's survival benefit inspired FDA to act fast on NSCLC approval: Pazdur" for full text of article):

    "When Opdivo showed it could prolong the lives of lung cancer patients, Bristol-Myers Squibb ($BMY) quickly broadcast the data. And the pharma world was sufficiently impressed. But the FDA was so impressed with the survival data on the new immunotherapy, it was already working on a new approval for the drug.
    That's the news from Dr. Richard Pazdur, who heads up the agency's Office of Hematology and Oncology products. In an interview with The Cancer Letter, Pazdur said Opdivo's survival data came into the FDA Dec. 19, before the results were unblinded for Bristol-Myers. And the "magnitude of the survival effect" triggered quick action from the get-go, he said.
    "With regard to the impetus for this rapid action, we began working immediately on this review and submission strategy after being informed of the survival results. This was prior to BMS having been informed of the results since they were still blinded," Pazdur said to The Cancer Letter.
    The agency wanted to quickly get those findings into Opdivo's product label and open up approvals for second-line and third-line treatment of squamous non-small cell lung cancer. And it did--Bristol-Myers had only just announced that the agency accepted its app for expanded approval when the FDA turned around and announced the new indications.
    The Checkmate-017 trial was the first to show a cancer immunotherapy beat another oncology drug--in this case docetaxel--on overall survival stats. And as Pazdur points out, that particular trial focused on patients with refractory squamous NSCLC, a group of patients with few treatment options."

  • Reply to

    Movantik prices are out...

    by bugsisdog Mar 4, 2015 4:32 PM
    feeling_hijacked feeling_hijacked Mar 4, 2015 5:32 PM Flag

    And it's competitively priced: 60 capsules of Amitiza, which must be taken 2x per day, ranges in cost from $315 to $335. Clinical trial results show that Movantik, taken once per day, has much greater efficacy than Amitiza

  • Reply to

    Can anyone explain ?

    by corona_and_a_cigar Mar 2, 2015 12:46 PM
    feeling_hijacked feeling_hijacked Mar 2, 2015 8:31 PM Flag

    One more point, and I downloaded and read this article when you referred to it a week or 2 ago: It was a good find.

    "Odd bit of reporting .. I believe this lady was part of PI
    Google: Iterative and prolonged remission in metastatic breast cancer using pegylated irinotecan"

    This patient was in the 14-day arm of the P2 trial after receiving 2 lines of chemo. I believe she demonstrated an impressive PFS of roughly 18 months while on 102, which included a significant period when she did not receive 102 because of toxicity yet showed a continuing tumor response during that period. She later resumed treatment with 102. When she finally progressed, she was sequenced into additional chemos, including eirbulin. A node biopsy showed that her cancer was HER2+. Her last reported treatment consisted of weekly paclitaxel plus Herceptin. This resulted in a CR.

  • Reply to

    Can anyone explain ?

    by corona_and_a_cigar Mar 2, 2015 12:46 PM
    feeling_hijacked feeling_hijacked Mar 2, 2015 8:14 PM Flag

    Corona, despite Klaus's recollection about P1 patients rolling over into P2, this was also prohibited under the protocol for the P2 trial. The CTgov listing for the P2 did not show this, but the poster presentation at the IMPAKT conference in May 2012 (available on NKTR's website) reporting the P2 results lists the eligibility criteria as follow (specifically excluding prior camptothecin treatment such as 102):

    "Key Eligibility Criteria
    • Male or female patients with advanced breast cancer following taxane therapy (adjuvant
    or metastatic)
    • Patients may also have received prior anthracycline or capecitabine
    • No prior camptothecin therapy
    • No more than two prior chemotherapy regimens given in the metastatic setting
    • Measurable disease as defined by RECIST version 1.0
    • ECOG PS: 0-1
    • Adequate renal, hepatic and marrow function
    • No known or suspected CNS metastases
    • No significant pre-existing acute/chronic GI disorder

NKTR
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