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Not priced in. Hardly. Think interchangeable Humera, impending copax approval, amphastar litigation (and held bond return), new partnerships, antiimflamatories etc. Market has been slow to understand impact of FDA position on interchangeables. Use of phrases like fingerprint identity very reflective of a refined strategy by management. bp
Look like Dr. Venkataraman exercised some options. bp
Dew, given the impending expiration of Humera patents. What do see as a reasonable timeline for a MNTA biointerchangable to be brought to market? Best wishes for a Happy New Year. bp
Dew, also don't you think Momenta's autoimmune programs are less (or not at all) encumbered by the looming IP/patent battles that have littered the landscape? bp
Jbog, Sure that case was totally bogus but the FTC is a government agency so I thought it might carry more weight and as Dew alludes to may also carry a political agenda. bp
Re FTC amicus brief: would we have seen this five years ago when the district court judgment was overturned? Is the a government entity actually siding with Ampha and is there validity to the claim of deception? This seems so far afield from what I have read from the courts in the past, it seems to be coming out of left field and I wondered what the general take was on the weight of this filing. Thanks, bp
Hear hear! Dew I have thanked you privately in the past and greatly value your insights and the detailed information you have provided this board. bp
So noted. Thank you mouton and flo for the update. Great cartoon by the way, I need a good laugh. bp
Flo, right but mouton's July post is worth a look since the schedule provided was so detailed. For that reason I think the article you reference may be incorrect re trial date. bp
Flo, Mouton's posting of July 6th indicated an Ampha trial date of Dec 4th or later 2017. Has this changed? bp
Another domino down...bp
Our Mylan partner has not been scoring points with Congress...Any thoughts as to how this public relations disaster could affect the ongoing partnership with Momenta? Also is there anyway to follow the Teva trial in real time or do we just wait for the ruling. Regards, bp
Dew, thanks for keeping me in the loop. Its not a home run but only an interim early analysis after three months of therapy. The study was not stopped and safety not an issue. Trends positive for stated endpoint analysis scheduled after another three months. MDS results said to parallel initial Mayo pilot (NEJM). Re: MF- low dose arm discontinued and those patients will cross to the higher dose arm with no further enrollment planned (90 patients total once cross over complete). Three more months of f/up in high dose MF arm (end stage JAK2 failures--life expectancy, well six months...) and six more months in low dose/crossed over arm to get to six months for this group. If patients still alive, primary endpoint of symptoms and spleen might take a back seat to survivorship. Regards, bp
Dew, looks like the dominos are starting to fall for copax 40. I noted in your RMF that the timeline for the enox district court trials may no longer be correct in light in the information kindly provided by mouton regarding an anticipated trial date of late 2017 for the Amphastar proceedings. . I know you are a stickler for details so I just wanted to mention this. Will continue to follow with anticipation and excitement. Thanks and best regards, bp
Driver of uptick probably anticipated FDA approval of 3x/ dosing. Why wouldn't MNTA resist a Mylan marriage until the dowry could include a nice piece of Watson? bp
Indigo, maybe most MNTA investors are giving no value to a potential settlement esp jbog. But MNTA and Sandoz clearly are with the investment of millions in legal expenses. MNTA went from about 300 M in income from the lovonox program to next to nothing with the Ampha debacle and Ampha did it apparently by violating patent protections. The courts so far seem to agree. While true, this has taken years and resolution is far off, the potential for substantial damages is far from zero. bp
Thanks, Mouton, wow, another 18 months before even going to trial, all to rehash many of the same arguments (with some additions), does it seem likely that they will settle before or is it in Momenta's best interest to go to trial? Regards, bp
Not so far fetched. Ampha market cap is about 750 M and is valued way less than the damage they caused. Momenta was making about a 1 M a day on lovonox before the Ampha debacle. bp
mouton, again thanks for the update. Looks the the noose is tightening: The court already ruled previously that the DBB patent is likely violated:
<<-7-Defendants’ statement that the amended contentions would “substantially” broaden the scope of the claims and present new issues of claim construction is unpersuasive. As the Court found when it considered Momenta’s prior motion to amend, the DBB test uses a different reference standard but is otherwise the same as the two 15-25% procedures identified in the initial set of infringement contentions.Accordingly, Momenta’s renewed motion to amend with respect to the DBB test will be allowed.>>
I wonder if there will only be a full more rounds before we see a TKO. Regards, bp
Thank you mouton, step by step. What happens next? bp
Thanks Dew, what about ballpark patient enrollment numbers and were the trials "completed" or were any stopped early due to efficacy? There were 81 patients in the single center trial and projected 200 in the multi center trial with an anticipated response of 20-30% based on the pilot findings, most responses were seen in a matter of weeks which is why my radar suggests possible early approval. In this current study there are two dosing arms and of course no control since they all failed Jakafi. If you haven't see the "before and after" bone marrow biopsies in the CR and PR patients, they are worth a look and are accessible via the Geron web site via various archived presentations. I know you were never too taken (with good reason) with this company from our previous (old) communications, but they have since divested the stem cell arm of the company and now have an attractive partnership with Janssen with two active studies in MF and MDS. Would the FDA approve before a presentation at a major heme meeting like ASH or likely wait until there has been scrutiny from the scientific community. Thanks and Regards, bp
Dew, can I draw on your encyclopedic memory to help me know if any FDA new drug approvals have occurred during ( or after) and phase II study and what the FDA requirements might look like for this? I ask specifically in the context of the ongoing Phase II Imetelstat study,(Janssen/Geron) for myelofibrosis in patients who have failed Jakafi. This study has 77 active sites with plans for 97 and will enroll 200 patients or be terminated by the sponsor early for presumed efficacy (or failure I suppose,) protocol detailed at ASCO in a poster presentation). A single center pilot study (Mayo Clinic/Dr. Ayelew Teferri,) demonstrated previously unprecedented CR and PR responses in perhaps 20% of patients with pretty amazing molecular responses and associated bone marrow reversion to normal histology. I wonder if you might look at the CT site to see if you think this is a trial that will go to completion or whether it is designed to stop early if efficacy met. I would think in this population of Jakafi failures, if the pilot findings are reproduced, an early approval could be warranted. (Also for those on the board not familiar with the CR PR and CI terminology in MF; CR=complete response, not complete remission, its confusing but CR is a higher bar, PR partial response and CI clinical improvement. ) Thanks for sharing your thoughts. bp
OT: response to Amphastar profiteering: Narcan, a narcotic antagonist has been around for a long time. I became familiar with it in the emergency rooms of Washington DC and Boston City Hospital some 40 years ago as a medical intern and resident, when drug ODs came in with apnea. The response of reversal was immediate and dramatic, that is if they weren't already dead. It was an IV drug. Most on this board are aware that Narcan is now available, or if not available soon to be available as a NASAL SPRAY OTC. On the shelves of your friendly pharmacy. The shameful need to have narcotic reversal agents available so when your friends OD you can give them a squirt of Narcan intranasally is apparent. So to the cost: if you can support your drug habit, you can afford Narcan. The scourge of drug addition has received some tacit societal accommodation by making this reversal agent available without a prescription. Houston there is a problem here. The irony to me is that the drug addicts driven to buy this agent and keep it around for their buds will eventually be supporting the large settlement that looms in the future of Amphastar and Momenta. Regards to all, bp
Is there potential for a small silver lining in that a future settlement would hopefully take into consideration accrued losses to date (perhaps subject to a treble damage award) that could not have been realized had the CAFC not been such tools? Its a stretch. No on #4 it is. bp
Thanks Mouton, may this be the first in a series of harsh spankings for Ampha. (it was about half of the requested amount...) keep us posted. Regards, bp
Thanks Boing, your contributions to this board are always appreciated. It was getting a little lonely here so a new post with new info is always welcome. bp
Mouton, thanks for keeping us posted. Ampha sure is good at delaying tactics. SC will reject of course. Regards, bp
Dew, are you buying at these levels? I am thinking about it and wanted to see what you were up to. Regards, bp
Dew, I think you meant 9/26/16 (not 9/26/15) for the 40 mg patent trial for copax. It is very rare indeed to find an error on RMF but I thought given your penchant for accuracy that I would mention this. Best regards, bp
marthambles, say the deal didn't fall through, its just coming down to the wire. Or even if it came through the first week in Jan, what would be the option play? I ask because I have no experience in this area. Thanks bp
Hi flo, well heparin induced thrombocytopenia is a real issue in un fractionated heparin that affects only a minority of patients and is reversible with discontinuation. Unrecognized it resulted in paradox thrombosis since the plates that were in circulation were more "sticky". It was antibody mediated. Seem to see way less with enox but still an issue. Yet another reason why NOACs might be ascendent. Wonder if this is the mechanism of what they are noticing? Don't know if an attempt was made to "design" this immune response out of the nec molecule. I realize there is cross talk between our anticoag discussions and the Nec molecule but there it is. Regards, bp
jbog, once MNTAs enox was introduced the system was saved tens of millions due to price reductions and competition. Ampha played dirty as far as I can see. All they managed to do was to decimate a market that was already destined to shrink (but I don't think anyone could know to what extent). Anyway we'll see what happens. Dew has said pressure to settle is strong so hopefully we will be spared more lengthy legal wrangling. bp
jog, you may be right about the timeline (unless there is a settlement) but I disagree about the damages part--MNTA certainly had serious material damage and the DC thought they would prevail when last checked. About the lawyers...sure they will do well. As the story goes a note was written from one lawyer to another in colonial times: "two fat geese, you pluck yours and I will pluck mine". Regards, bp
GrthzGd, well I understand your point, but the practical aspect is that much less enox is used today than when it was first released thanks to the advent of the NOACs (novel anticoagulants) which are oral. There is much less "bridging" therapy too as one transitioned on to coumadin as in the old days. My only point is the absolute market for enox seems way down in day to day usage. On the other hand when the rug was pulled out from under MNTA the income was fabulous so the real impact was early on and only in part related to the entrance of other competitors as the market was in the process of changing and MNTA paradoxically got hit at exactly the right moment to show the greatest damage! Regards, bp
GrthzGd, its all about damages and not about current market for enox. bp
Dew, I am going to disagree a little here. Getting this info out into the public domain might help prepare the mindset (even if subtly) of a prospective juror or even a judge. Lawyers work in funny ways on many levels when they fight, it would seem. It was interesting that this recent film clip did not emphasize Glactopa or other follow on biosimiliars or other major programs (IVG), but focued on enox. Its just an interesting conjecture, nothing more. Regards, bp
Hi Boing x2, thanks for the research you have been sharing. Saw the film clip of Wheeler. The only thing I could take away was his dropping that the first year of lovonox sales saw 1.5B of value. Otherwise the usual positive message. I think he was telegraphing especially given the timing of this clip something to Amphastar regarding just how much they are on the hook for. Regard, bp
mouton, it gets complicated and depends in part whether the patient is designated "inpatient" or "outpatient" as well as the length of hospital stay as to whether hospitals encourage use of own meds or not. Also if payment is itemized (private insurance) or bundled (like DRGs) may have an impact too. Not ideal. Also medical legal issues at hospital level by allowing some patients to administer their own medications or manage their own diseases which sometimes they understand very well like insulin dependent diabetics. Regards, bp
Dew, aside from the very convoluted course this case has taken, split decisions not withstanding, it seems to me after reading as much as I could that the district court and the solicitor general did their homework and the CAFC simply did not, they did not seek a deep understanding of the intent of the HW act until they put the SG on it, years into the case. The intent of HW is clear and the presentation of the SG finally brings clarity to the the obfuscation intentionally brought about by Ampha et al. I think there is a good likelihood that the DC will rule that there has been patent infringement when the case finally get the long overdue closure it deserves. Ok, but that aside and the issue of a multiplier for damages aside. If one were to look at only single damages, given that MNTA was making about 1 M/day from Lovonox before the sneak attack, how would damages be assessed? Even taking into consideration the dates of market entry for the NOACs it would seem that Amph/Watson/Activis/Teva are at great risk for a huge settlement for patent infringement. I realize there is much that would have to happen to bring things to this point but the damage potential must be huge and perhaps quantifiable by a famous "shesh/bek" analyst? regards, bp
Thanks Dew, mouton and Boing. So are we at a place where one might speculate that if MNTA wins the patent case in DC assuming the CAFC rules as they should, is the eventual assessment of treble damages a possibility? (this has been discussed priviously in the remote past on this board) If so it could be ironic that the total value to MNTA of the outcome of this mess might actually be in excess of what might have happened had there never been entry of Amphastar and the erosion of MNTAs market, not just from competitors Ampha and Teva but the oral NOACs (novel oral anticoagulants) currently used as front line therapy for DVT and Pulmonary embolus which would have certainly also eventually eroded the enox market. That would be justice indeed! Anyway, fun to speculate and thanks to all for answering my questions. Dew, have you added to your 27,000 shares? Regards, bp