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Zalicus AŞ Message Board

scistats 226 posts  |  Last Activity: 15 hours ago Member since: Apr 5, 2009
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  • Reply to

    May 1, 2014

    by dchance75702 May 4, 2016 10:23 AM
    scistats scistats May 4, 2016 10:35 AM Flag

    Pancreatic cancer is rare, and enrollment of patients in the many phase 2 and phase 3 pancreatic clinical trials is subtracting from Onivyde's eligible paying patient base.

    A combination of USA and EU Onivyde sales is needed to make money with economies of scale across the entire Merrimack antibody directed nanotherapeutic (ADN) business. This requires a buyout and is especially true with checkpoint inhibitors arriving.

    Either Baxalta/Shire can do it or someone else. Proven candidates are in the pipeline. This is a mathematical certainty.

    Sentiment: Strong Buy

  • Reply to

    mgmt

    by dcorm05 May 3, 2016 10:27 PM
    scistats scistats May 4, 2016 10:02 AM Flag

    Selling is a mathematical certainty.

    "We have never been profitable and, as of March 31, 2016, we had an accumulated deficit of $840.7 million." (Reference below)

    CEO Robert Mulroy may point to a vision of Merrimack as a Genentech-like member of a big pharma, but there is no denying even he has accepted that selling must happen. There is no way that Onivyde can be profitable without Europe. CEO Mulroy now understands that there is competition for eligible patients with many ongoing phase 2 and phase 3 pancreatic cancer clinical trials, and this number will get larger and more aggressive.

    The bottom line is: Merrimack has kept itself as intact as possible following the end of the MM-121 Sanofi deal. They have not diluted pipeline candidates among partners like many other small biotechs. Onivyde, which Merrimack acquired form Hermes BioSciences in 2009, is maintained in the United States by Merrimack, but Baxalta/Shire's EU share of Onivyde and the entire lineup of antibody directed nanotherapeutics (ADN) at MACK is needed to be profitable in tomorrow's immune checkpoint inhibitor world.

    CEO Robert Mulroy now understands this as the Onivyde numbers sink in relative to their deficit, likely with the help of Dr. Al-Wakeel and the board.

    Merrimack can be sold as a package deal including: antibody directed nanotherapeutics (ADN), antibodies, therapeutic manufacturing, diagnostic imaging, and molecular companion testing (with Leica), and their patient assistance program called Provyde. The MM-141 and MM-310 and MM-302 and MM-121 data look great. It is just a matter of when at this point.

    As dcorm05 said, more insider buying will serve to validate the buyout argument. Dr. Al-Wakeel is helping to orchestrate this process as seen by conversion of notes to shares. Additional validation on multiple fronts will seal the deal.

    Reference:
    MERRIMACK PHARMACEUTICALS INC
    FORM 10-Q
    (Quarterly Report)
    Filed 05/02/16 for the Period Ending 03/31/16

    Sentiment: Strong Buy

  • Reply to

    Onivyde is approve in 1L PC...

    by italian30_2000 May 3, 2016 11:50 AM
    scistats scistats May 3, 2016 6:53 PM Flag

    Italian, the numbers for Q1 are outstanding considering the large number of pancreatic cancer trials currently ongoing out there which compete directly with Onivyde for the same patients. Clinical trials are big competition for patients.

    Merrimack needs to go ahead and sell out to Baxalta/Shire so that they can achieve the economies of scale required for the nanoliposome platform. Stemcentrx pulled the trigger early for the same reason. The writing is on the wall, and maybe Al-Wakeel is positioning them for this. The sooner the better.

    Sentiment: Strong Buy

  • Jup, its a tough "row" to hoe, as in cotton...
    You are right about it being hard to hoe though, but the question is why?

    Let face it, Onivyde knocked it out of the ballpark if you ask me considering the competition.

    Pancreatic cancer is a small population disease.

    Just quickly looking, there are some combined 268 open phase 2 and 3 interventional studies for pancreatic cancer. The vast majority of these are recruiting. Many of these studies are enrolling hundreds of patients. This would account for many "post-gemcitabine" patients who will not show up for the Onivyde end of quarter roll call.

    Merrimack's largest competitor is a free experimental pill known as "Clinical Trial Sulfate".

    Sentiment: Strong Buy

  • scistats scistats May 3, 2016 6:53 AM Flag

    Cut MM-141?
    Did you see the MM-141 (Istiratumab) + Taxol or Doxil in-vivo tumor growth data?

    Sentiment: Strong Buy

  • scistats scistats May 3, 2016 6:43 AM Flag

    MM-310 is Onivyde loaded with docetaxel pro-drug topped with EphA2 antibody.
    It is an already proven nanoliposome chassis carrying a proven prodrug version of docetaxel.
    The EphA2 antibody topping is a no-brainer.
    Big partnership coming soon.

    Sentiment: Strong Buy

  • 1. Yasir did a great job of explaining the cost savings rationale behind the conversion, and he seems to be in control of getting the books in order. He is a major asset to Merrimack.

    2. It is now abundantly clear that Merrimack is promoting MM-310 to be partnered. Since Celgene makes ABRAXANE®, they would be an ideal partner since "a newly engineered chemical entity of docetaxel as a prodrug" is being used....something is up here.

    3. Next catalysts will be Baxalta EU Onivyde approval milestone payment and MM-310 partnership.

    About MM-310:

    MM-310 is an antibody directed nanotherapeutic (ADN) targeting the EphA2 receptor, which tumor surveys suggest is present in 50-100% of major tumor types including prostate, ovarian, bladder, gastric and lung cancers

    MM-310's novel ADN design was developed to maximize the delivery and local activation of a newly engineered chemical entity of docetaxel as a prodrug

    MM-310 had superior antitumor activity compared to traditional docetaxel (100 days versus 40 days of full tumor regression) while significantly decreasing drug-related side effects in preclinical models

    Sentiment: Strong Buy

  • 1. What do MM-161 & MM-436 target?

    2. When will the EU approve Onivdye? CHMP meeting dates are:
    23-26 May
    20-23 June
    18-21 July

    3. Is $422.2 million remaining in the Baxalta deal? How much for EU Onivyde approval & Onivyde sales milestones?

    4. Is the Allergan agreement to use MACK's nanoliposomal platform still active? Are there any new nanoliposome or antibody manufacturing contracts? If not, is large-scale manufacturing still viable for MACK at its current 100+ employee burn rate?

    5. Are MM-302 and MM-310 going to be partnered with Baxalta/Shire as Antibody Directed Nanotherapeutic (ADN) extensions of Onivyde? Can we expect needed upfront cash soon?

    6. Will MM-141 (istiratumab) or MM-121 or any other MACK candidate be partnered with a checkpoint inhibitor + chemo?

    7. MM-302 and MM-310 antibody directed nanotherapeutic (ADN) are similar in principle to Stemcentrx's Rova-T. Will MACK target DLL3 (delta like protein 3) with its ADN platform for small cell lung cancer (SCLC)?

    8. The MM-310 preclinical data looks great! What is the docetaxel prodrug being used to target EphA2, and how significant is MM-310's achievement of pre-clinical 100 days vs. 40 days full tumor regression with low toxicity?

    9. Silvercreek appears to be circling the drain. Is there any news about this "asset" or new spin-offs?

    10. Merrimack is localizing cancer using imaging technology as described in clinical trial NCT01770353 which is in Expansion Phase for advanced metastatic breast cancer. Is Merrimack imaging to support MACK therapeutics only or is imaging for diagnosis & monitoring going to be marketed for any therapeutic?

    11. Is the Leica diagnostic deal exclusively for pairing Merrimack therapeutics with the right patients, or a is it a stand-alone business unit for pairing patients with any available therapy targeting the same protein?

    12. Is PROVYDE™ (ONIVYDE® Access Services) only for MACK therapeutics, or is it a new stand-alone business for broader patient services?

    Sentiment: Strong Buy

  • Reply to

    The AbbVie-Stemcentrx deal bodes well for MACK

    by scistats Apr 30, 2016 10:10 PM
    scistats scistats May 1, 2016 2:42 PM Flag

    It is a stretch at 30PPS maybe, but Merrimack has an approved drug that can likely achieve the same thing as Rova-T.

    In Stemcentrx's data, I see 31% of small cell lung cancer patients had the best case of disease stabilization using Rova-T but no shrinkage mentioned in what I read.

    Small cell lung cancer is certainly an under-served cancer, but because of this, we need to see a full phase 3 study to really know what is going on here because there is considerable variation among patients as it is.

    I do not think AbbVie can patent DLL3 as a target itself, so Merrimack can simply target Onivyde to delta-like 3 (DLL3) using its own antibody. Right? Just like many companies are going after HER3.

    Then, it will be Onivyde vs. antobody-linker-tesirine

    "Rova-T is an antibody drug conjugate (ADC) consisting of three components:
    1. an antibody, 2. a linker and 3. the active chemotherapy"

    "Rovalpituzumab tesirine consists of a monoclonal antibody against DLL3 linked to the cytotoxic agent tesirine, a DNA-damaging pyrrolobenzodiazepine dimer toxin."

    “Of the 48 tumour samples we were able to analyse, 33 were positive for DLL3. Among the 29 DLL3+ patients we could treat at the maximum tolerated dose of Rova-T, ten (34%) had a partial response and nine (31%) had disease stabilisation. The duration of response among these patients was more than 178 days, with no cases of disease progression,” Dr Pietanza will say.

    Rova-T is an antibody drug conjugate (ADC) consisting of three components – an antibody, a linker and the active chemotherapy, or cytotoxic payload. The antibody portion of an ADC can recognise cell surface receptors specific to and that are over-expressed in cancer cells, allowing the delivery of the chemotherapy directly to the tumour. This means the treatment is more effective, and also minimises its exposure to normal cells, with a consequent reduction in toxicity."

    Sentiment: Strong Buy

  • Stemcentrx was a smaller parallel of MACK and AbbVie was willing to pay for it.

    MACK has a Mkt cap of 863.19M.
    One could see a buyout at 20 PPS to 30 PPS if the Onivyde ramp continues to be robust and that value of MM-141 is understood.

    Sentiment: Strong Buy

  • scistats by scistats Apr 30, 2016 9:48 AM Flag

    Diethylstilbestrol inhibits telomerase activity and gene expression of prostate cancer cells.
    Prostate. 2010 Sep 1;70(12):1307-12

    Combining imetelstat + diethylstilbestrol [or its pro-drug Honvan] might act in synergy for cancers.

    You have to wonder if Janssen is gong through the conventional list of telomerase inhibitors and telomerase vaccines to combine with imetelstat in their pre-clinical labs?

    Sentiment: Strong Buy

  • Reply to

    SNY...huh

    by innsbrooklad Apr 28, 2016 11:08 AM
    scistats scistats Apr 29, 2016 10:30 PM Flag

    I said I am against the laws proposed by the candidates to mandate drug prices, and I am pro-market with the caveat that the market can, for some time, side with Madoff, Enron, ZYTIGA®, and Xtandi until it no longer does. I like the fact that you can run but not hide from the market. Heil innovation and true blockbusters that make biotech great and enhance and prolong life.

    Sentiment: Strong Buy

  • Reply to

    SNY...huh

    by innsbrooklad Apr 28, 2016 11:08 AM
    scistats scistats Apr 29, 2016 8:43 PM Flag

    I am pro capitalism for biotech and pharma and anti-Hillary, Bernie, and Trump when it comes to thoughtless, across-the-board drug pricing mandates and caps. These kill incentive and the industry as whole. We know this.

    But, I am also against billion dollar frauds like Madoff and Enron and promoting billion dollar drugs that are no better than generics. Only give credit where credit is due. Ibrutinib is one such drug. Now that is a molecule that earned its keep.

    Every time the public is fed lies about a drug, it only harms the industry.

    Sentiment: Strong Buy

  • scistats scistats Apr 29, 2016 1:09 PM Flag

    Looking forward to the MM-161 and MM-436 unveil.

    Sentiment: Strong Buy

  • Reply to

    Q1 Sales estimates

    by biofellowtraveler Apr 29, 2016 10:14 AM
    scistats scistats Apr 29, 2016 12:50 PM Flag

    We need EU approval and milestones to beat out R&D cash burn. Without this, Merrimack is a flaming tiramisu. A Roche/Genentech buyout makes sense. Mulroy keeping no strings attached with multiple Sanofi dilution collaborations make this a real possibility. With MACK, the whole enchilada is available.

    Sentiment: Strong Buy

  • Reply to

    Q1 Sales estimates

    by biofellowtraveler Apr 29, 2016 10:14 AM
    scistats scistats Apr 29, 2016 10:28 AM Flag

    Thanks for the sales information.
    Any news about Baxalta's progress obtaining EU Onivyde approval and the expected milestone payment?

    Sentiment: Strong Buy

  • Reply to

    SNY...huh

    by innsbrooklad Apr 28, 2016 11:08 AM
    scistats scistats Apr 29, 2016 9:14 AM Flag

    For the longest time, JNJ has the following on their webpage:

    "For the abiraterone phase 3, the median overall survival for was 35.3 months for the group of men who received ZYTIGA® (abiraterone) plus prednisone, compared to 30.1 months for the group of men who received placebo plus prednisone. This difference, however, did not meet statistical significance."

    Well, I guess they finally got the data they wanted because this has been removed I believe. Xtandi is the same. Both are expensive false bills of goods in my opinion.

    "New" does not mean better. I used to think like Inns and reject conventional approaches for "cutting edge". I too believed old always meant, as he says, "stale" until I saw the results. Biology does not know old and new, and believe me estramustine works.

    Zytiga and Xtandi are expensive and would never be put head-to-head with estramustine because estramustine is cheap, generic, and would probably perform better.

    Estramustine side effects you are probably thinking, ha!

    Zytiga and Xtandi are no better when you consider what else you have to take. What Zytiga and Xtandi do most effectively is drain your bank account and run up our healthcare cost. If they were truly better, I would go along with, but they are not. PSA flare means its working my foot.

    Again, a few years ago, I would have agreed with Inns 100%. Not any more.

    For this and other reasons, I am not a Sanofi fan beyond their vaccine program. For oncology, Merrimack needs to partner with the likes of Roche/Genentech. I hope they do. Or get bought by them.

    Sentiment: Strong Buy

  • scistats scistats Apr 28, 2016 2:32 PM Flag

    I do not know what to make of this exactly.

    The European Medicines Agency (EMA) website refers to the sponsor here as Baxter, but the Sponsor’s contact details are Baxalta Innovations GmbH.

    EMA does state that: "The sponsorship was transferred to Baxter Innovations GmbH, Austria, in December 2014."

    So, sponsorship has not changed from Baxter to Baxalta even thought they have "ONIVYDE (MM-398)– Gastric - phase 3" on Baxalta (Shire) website?

    Maybe they are holding Onivyde in Europe hostage for a hostile takeover of MACK?

    Sentiment: Strong Buy

  • Reply to

    SNY...huh

    by innsbrooklad Apr 28, 2016 11:08 AM
    scistats scistats Apr 28, 2016 11:19 AM Flag

    Xtandi and Zytiga are garbage.
    Estramustine and diethylstilbestrol work better and are essentially free.
    Sanofi would be a horrible partner.

    Sentiment: Strong Buy

  • Reply to

    Sellers appear to be dryin up...

    by italian30_2000 Apr 28, 2016 10:15 AM
    scistats scistats Apr 28, 2016 11:09 AM Flag

    Onivyde is a nanoliposome abmassador currently touring Europe.
    Attach antibodies for targeting and package with whatever you like.
    By the way, MACK manufactures too.

    Sentiment: Strong Buy

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