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Only real news from GS conference is potential partner for Humera by end of the year. Feels like Baxter redux but might move up timeline for payments. Wheeler is thinking 50-50 partnership like with Mylan programs. bp
Looks like CHRS got a CRL from the FDA re Neulasta biosimilar EOM bp
Dew, yes, at one point MNTA was logging about a million dollars a day from enox if I remember correctly, for at least more than a year if memory serves. That is why, although many here (not you) discount it, the potential for damages is substantial and the reason MNTA/Sandoz have kept the legal heat on. bp
Eh mouton? Could you speak up sonny? Now where did I put that gul dang ear trumpet? I would love attend but assume the sessions will be recorded. Will we have a ruling within 90 days or does Bleak House continue. Also what do you make of the yet to come (maybe) anti trust trial, a Hail Mary if ever there was one. Regards, bp
If I understood Wheeler correctly, there are planned releases of new products every year starting in 2020 or 2021. At least 70 patents stand between market release of biosimilar Humera. There are multiple products in development. Other than milestone payments and partnership payments, income from enox (negligible--unless there are damages from Ampha), dilution, and copox income are the drivers for the next three or four years (not including new partnerships). Does anyone see this differently? There is plenty of money in the bank at lease for the next two years. If Mylan receives approval along with Sandoz then an authorized generic from Teva looks like a given. Here we go again. Still trying to be optimistic. The autoimmune program looks very promising but with a long term horizon. Are there any other short term value creating events coming? Regards, bp
But but this is not the damages suit we were expecting to be tried at the district court level. I assume this means the antitrust suit would precede an additional suit for damages? Its all starting to look pretty moot since I will probably be in assisted living by then. Ah, Golden Acres beckons...Thanks, bp
Dew, is the update re lovonox litigation date (2019) in RMF correct? Thanks, bp
Dew, I hope you are right of course. If copax 40 gets approved there should be no need to "tell Momenta's story" to anyone. bp
Hi flo, the need for a communications manager to "tell momenta's story" just makes my heart sink. Its more like having an on the payroll spin doctor to explain the "Momentous" market failures. Success tells its own story and we could use a little of that now. The need to fill this position suggests we have a substantial wait. I don't mean to say there haven't been great successes in the lab and in the establishment of substantial IP and a good position re the regulatory environment but it would be nice to see some translation to stock value. Ten years and holding. Regards, bp
Thanks Dew, I can't imagine management would want us voting our shares until some clarity can be provided on the current fill/finish issue. bp
Anyone think the yearly shareholders meeting has not yet been announced (with shareholder voting and public comments) to try to allow for some stopgap solution for the current debacle to be put in place? bp
Jbog, True enough, I have never been in a pharma production facility. It would seem that if Pfizer began to address the FDAs objections in May that they should certainly be pretty far along in the process at the Kansas plant. Should there not be some optimism that Pfizer has successfully addressed these problem at this point? The timing of the FDA letter probably reflects the glacial turn around time from the original inspection. bp
mouton, it's interesting the center one link does not even list the Kansas facility! bp
The smart thing would be to shut down the vanco line and move it to Kalamazoo. Put as much distance between the offender and the copax line. They could shut down and isolate the offending geography within the plant. (Built the wall!!). Since the 20 mg production line seems to be operating without a problem they could focus on modifications to make the 40 mg production line acceptable where it is. bp
Given that Dr. Wheeler and Co received the warning letter one week ago, I do think it is reasonable at this point for the company to inform us as to what the scope of the current problems are. There is nothing on the FDA web site despite Dr. Wheeler's suggestion that the letter might be posted within a day or so of the announcement. That of course is the FDAs responsibility. I do think Momenta has a responsibility to its shareholders to make public the issues at hand and what remedies are planned. Maybe they will invoke confidentiality for competitive reasons. That Sandoz chose a plant with so many apparent red flags for such an important production assignment is baffling. With all the disclaimers listed by Momenta about how they can't take responsibility for their partners actions it seems unlikely that shareholders will have any recourse. At the very least we should be able to review the FDA warning letter, redactions and all. bp
Ok I got it. In that case self insurance sounds like no insurance. bp
Jbog, could you please clarify what "self insurance" looks like in this situation? Clearly partners and subcontractors would do best not to be suing each other. Are you suggesting a mechanism is probably in place contractually to protect MNTA against an event such as this? Since there are no historical market sales to value how would such a compensatory mechanism look? Dew touched on this previously but I think true and accurate compensation would involve a large chunk of change even over the short term. How would a self insured FUBAR like this be valued? bp
Dew, are protections usually written into these intercompany agreeements that contract out production or fill and finish responsibilities much the same as builders have liabilities as to timeslines structural standards that protect a client? Could an agreement be in place that would compensate a contractor from a failure to maintain a previously agreed upon standard of quality? I am loath to think about legal squabbles and wonder if simple prearranged contractual arrangement might blunt some of the lost income to MNTA tia bp
Jog, what are you talking about? You said<<This isn't a parental drug so the sterility is somewhat relaxed. >> Of course its a parenteral drug (e.g. not administered by the alimentary tract). To suggest there are two standards of sterility is also not correct. Its like saying someone is a little bit pregnant. Its either sterile or not. This is not going to be a small easily correctable problem in my opinion. It makes them look like a bunch of amateurs with so much at stake. This can't be their first rodeo. Teams that anticipate FDAs every evaluation have to have gone over all this stuff first and yet we have a fail. Shameful. It will be an interesting conference call.. Lets hope we are not entering a world of alternative facts. bp
Considering the alacrity that accompanied the approval of 20mg Glatopa after the FDA did their exhaustive confirmation of composition, manufacture, delivery etc as well as the successful prosecution of all of the legal issues that preceded almost immediate approval as I recall; it seems odd that we do not yet have approval of 40 mg copax. given the parallels that have gone before. Not withstanding the calm anticipation brought forth during the Leerink conference I really wonder if there is a major glitch that we don't know about. This can't be business as usual for the FDA. bp
jbog, well, if TEVA has copax income of over 3 B, its roughly 10M a day. If a competitor prices at 80% and they share the market (you don't think TEVA will lower to compete?) then I get savings in the millions, without multiple entrants. . bp
alternatepatel, well, last week the FDA approved new generics every day (except Friday), assuming they were working that day I am speculating that Friday was the day they chose to cross t's and dot i's for glatopa. This suggests to me approval Monday or Tuesday. Its interesting that this fairly short delay has already cost the system millions in lost savings. Anyone care to speculate the short term high once approval is obtained? I am thinking 25. Regards, bp
Have been checking FDA web site. No listing yet new drug approvals for today (as of 5:15 EST). bp
Not tonight dear, the FDA has (another) headache... EOM bp
Dew and Flo, thanks for answering my questions. It seems a little disconcerting that the FDA has delayed (granted so far this is a minor delay) but one would think they would be ready to "push the button" after all the court cases, biosimiliar guidance issuance etc. I wonder if they are still dealing with the "interchangeable" issue for the non MNTA applicants that presumably may not have fingerprint likeness (or maybe they do?). This seems unlikely given what we know. Any speculation as to why we don't have approval or is this just the unfathomable FDA being the FDA. Regards, bp
Does the FDA ordinarily take pains to avoid making approval announcements during the day out of fairness? In other words, were they to announce, would it always be before the market opens or after it closes on GPs? Or does it matter to them at all. Thanks, just curious, bp
Mouton, I echo Flo, I am still following this closely and greatly appreciate the updates. bp
Either way the later of the two dates is next Tuesday Feb 7th. bp
Or maybe that's when the last patent expired. I would be interested in knowing the exact date of HW expiration. Thanks, bp
Jbog, pretty sure it was up on Jan 28th. bp
Except that Sandoz might not share the same motivation for a patent related settlement and may not share the warm fuzzy feeling toward Mylan that Momenta probably does--esp since Mylan is a serious potential future MNTA suitor. The FDAs apparant delay in approval thus far literally translates into millions per day of lost profits to MNTA/Sandoz. bp
Those numbers aint hay and should be readily achievable. This next earnings call should be interesting, with some recent additions to the books. Thanks Dew, bp
Dew, is the milestone amount that will be triggered upon release known? bp
In 2015 the sequence that preceded launch of 20 mg copax was FDA approval in April 2015, followed by CAFC ruling on June 18th followed immediately by launch the same day, June 18th. In this case FDA approval preceded the court ruling, clearly not the case here but if MNTA/SANDOZ follows this pattern they probably will release the same day as the FDA approves. After all the legal falderal and time the FDA has had to evaluate one would think approval is imminent. Best wishes to all, bp
Flo, I may have to upgrade my ihub status (and I might be able to afford it now). Thanks for your response. bp
Dew, do you think (tentative) FDA approval is priced into to the current value or there is more short term upside once FDA grants approval? Last Friday I bought some Feb 17th calls (I haven't done anything like that for years and always lost money when I did) and am looking for advice re when to exit. Still holding long term also. Your long term guidance on MNTA has been spot on, many thanks, bp
Flo, many thanks for your kind updates. We go back many years, some with not such good news. Looks like that's about to change! Regards, bp
Flo, have found nary a news release for MNTA or Mylan have you? Hoping its just MNTA. Regards, bp
Hi Flo, seems a little odd to release this on a Sunday. I think they want to look good in case something interesting happens before the open. bp
Given that we are now 120 days (almost to the day) of the initiation of the Copax District Court case, is it not reasonable to expect a decision 90 days from the conclusion of the case? If such a decision is rendered would the FDA respond in a timely way with approval? Waiting with interest. Best Wishes, bp