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Post by figglebird on Oct 8, 2018 16:18:32 GMT -5
Of interest, assuming some of you may have noticed what appears to be an ongoing patent litigation settlement(also awaiting FTC approval8/18) between our new potential partner and Watson.
Of note, these details stick out.
-patent litigation started approx 3 years ago - Steady Med and Watson v UTHR - the former alleging right to produce the entire range of UTHR's pah portolio - Remodylin, Tyvasso etc. Three years later, UTHR has recently acquired Steady med and more recently settled remaining patent issue w/ Watson under terms that state Watson(a former public company/Generic heavy weight acquired I believe by Sandoz/NVs(could be wrong) has thr right to manufacture and distribute inhalable generic version of Tyvaso starting 1/26 - BUT date of entry could be EARLIER depending on whether or not undisclosed events transpire - this settlement, like ours, announced appro. two weeks prior to ours is still apparently awaiting FTC clearance... Settlement makes point of leaving all other pah meds off limits to Watson in terms of generic beyond tyavaso.
tyva-So, what if anything does this mean? IDK could be nothing or somethig... what I do recall is the following...
-While uthr has in press releases referred to TS TREPOSTINIL as new TYVASSO Mnkd has not(check for Matt on this). I wonder if this kind of point would accelerate Watson generic tyvasso entry to mkt and moreover how it may or may not relate to ongoing closure w FTC
-It's no secret UTHR is aggressive as can be in this space, in that they previously to this bought out a steady med - a co filer originally w Watson.
-The patent
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Post by figglebird on Oct 8, 2018 16:45:02 GMT -5
So again, everyone is EAGER for FTC clearance, as a shareholder I can understand BUT my belief is that any further wait beyond 10/31 if that were to occur would for numerous reasons(despite what a couple of uneasy posters claim) be met with another 8K that keeps DF at bay in extension until all is sorted - the story here for UTHR is as important and brings closer to surface certain interesting story points rer their efforts to defend their space... All of which is positive as far as mnkd is concerned imo... UTHR became a mid cap by claiming essential co-ownership of this space and they are doing0 what is necessary to defend it - 150m purchase of Steadymed represents to them about 10pct of what they so far intend to put aside on a partnership w mankind...
The first question to me is to what degree the Watson settlement re generic Tyvasso if at all is linked to our deal? if at all?
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Post by tomtabb on Oct 9, 2018 7:10:47 GMT -5
Along that line -- www.genengnews.com/gen-news-highlights/united-therapeutics-to-acquire-steadymed-for-up-to-216m/81255762:"However, in November 2017, the U.S. Court of Appeals affirmed a March 2017 ruling by the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office that invalidated U.S. Patent No. 8,497,393, owned by United Therapeutics. The patent related to a product made by a process intended to purify treprostinil—the active pharmaceutical ingredient used in both Remodulin and Trevyent—and other prostacyclin derivatives (United Therapeutics Corporation v. SteadyMed Ltd.). An appellate suit (Appeal No. 17-2121) was filed after the PTAB’s decision." Treyvent is produced by Correvio and was licensed to Steadymed. Now UTHR appears to have agreed to distribute treyvent as part of the deal acquiring Steadymed. It appears that treyvent is just Canadian treprostinil and you have to wonder why they would use treyvent versus their own treprostinil. The FDA rejected Steadymed's application last year due to insufficient data. The company claimed that a new NDA with sufficient data would be submitted by the end of this year, but there's been no NDA yet submitted. Without the NDA, the cost of acquiring Steadymed is only 114 million. They also wouldn't be needing to spend money to buy treyvent from Correvio. I wonder if it's possible UTHR simply elected to spend 114 million to protect its patent and has no further plans for treyvent.
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Post by tomtabb on Oct 9, 2018 7:13:23 GMT -5
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Post by figglebird on Oct 9, 2018 9:47:59 GMT -5
yup - that is exactly what I was referring to - both their settlement re Tyvasso and our deal re Tycasso have concluded and are now awaiting clearance from ftc - I was merely pointing out this additional information as potentially connected as far as the ftc is concerned - not suggesting in a negative way - but perhaps this move w mnkd allows watson earlier entry - just a Guess.
lets see
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Post by mango on Oct 9, 2018 11:52:37 GMT -5
Of interest, assuming some of you may have noticed what appears to be an ongoing patent litigation settlement(also awaiting FTC approval8/18) between our new potential partner and Watson. Of note, these details stick out. -patent litigation started approx 3 years ago - Steady Med and Watson v UTHR - the former alleging right to produce thie entire range of UTHR's pah portolio - Remodylin, Tyvasso etc. Three years later, UTHR has recently acquired Steady med and more recently settled remaining patent issue w/ Watson under terms that state Watson(a former public company/Generic heavy weight acquired I believe by Sandoz/NVs(could be wrong) has thr right to manufacture and distribute inhalable generic version of Tyvaso starting 1/26 - BUT date of entry could be EARLIER depending on whether or not undisclosed events transpire - this settlement, like ours, announced appro. two weeks prior to ours is still apparently awaiting FTC clearance... Settlement makes point of leaving all other pah meds off limits to Watson in terms of generic beyond tyavaso. tyva-So, what if anything does this mean? IDK could be nothing or somethig... what I do recall is the following... -While uthr has in press releases referred to TS TREPOSTINIL as new TYVASSO Mnkd has not(check for Matt on this). I wonder if this kind of point would accelerate Watson generic tyvasso entry to mkt and moreover how it may or may not relate to ongoing closure w FTC -It's no secret UTHR is aggressive as can be in this space, in that they previously to this bought out a steady med - a co filer originally w Watson. -The patent Can you post a link to the litigation por favor? Unless those fellas at Watson/Sandoz have a formulation/device combo that's equal to or greater than MannKind's, and in addition to that, unless they they have a reputation in the PAH space that's equal to or greater than United Therapeutics, then they offer no logical contribution for people w/ PAH, not a threat of competition & would be wasting their time, IMO.
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Post by mango on Oct 9, 2018 11:57:05 GMT -5
And I don't trust Sandoz anyway because of their involvement in the MKUltra programs manufacturing LSD for the military & CIA & used on innocent civilians & pyschological toture experiments with incarcerated individuals
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Post by figglebird on Oct 9, 2018 13:46:19 GMT -5
I hear you and agree - in fact, my follow up post regarding PTE's was in part due to a growing sense that WS and BP are mistakenly labeling Mnkd as some kind of reciprocated dpi - not really a new problem but one mnkd has to solve for its own benefit. Conversely, as the longstanding generic trend continues to grow, other bio techs, despite getting approval(such as Admp), for a generic(epi), are unable to translate, at least at the onset into a higher valuation(despite potential revenue) - it seems like the major distributors(teva, endp, myln) are the real value plays.
And speaking of Sandoz/nvs, I believe they are the partner on that epi w admp.
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Post by tomtabb on Oct 9, 2018 15:09:19 GMT -5
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Post by matt on Oct 11, 2018 8:04:52 GMT -5
The purpose of the HSR waiting period is for DOJ / FTC to assess the impact on competition in an industry sector. Most of the time the review centers on the Herfindahl-Hirschman index which measures the concentration of companies in a particular sector, essentially a measure of the market power controlled by the top few firms. If there are 20 competitors who each have 5% market share, combining two of them will barely move the HHI but if there are only 5 competitors and the top three control 80% of the market, any transaction involving the top companies will impermissibly increase the HHI.
A lot comes down to how DOJ want to define the sector. Normally in generic drugs there are low barriers to entry so there are minimal impacts on competition if the leader acquires a potential competitor that presently has 0% market share. However, in this case where UTHR has already scooped up SteadyMed taking another potential competitor (i.e. MNKD) out of the picture may leave too few viable competitors. A lot may rest on an evaluation of MNKD's ability to find a different partner or to commercialize a competitive product on its own. If DOJ thinks MNKD is a credible marketing threat to UTHR if the drug remains unpartnered, then they are more likely to object to the deal. If DOJ thinks MNKD is too weak to bring Tret to market on their own or if they don't think MNKD can attract another generics partner, they are less likely to object.
Remember too that this transaction will never be "approved". The HSR regulations give the government 30 days to register an objection, but if no objection is raised then the transaction can automatically move forward on day 31. In this case, no news is good news.
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Post by jlaw277 on Oct 11, 2018 8:48:43 GMT -5
The purpose of the HSR waiting period is for DOJ / FTC to assess the impact on competition in an industry sector. Most of the time the review centers on the Herfindahl-Hirschman index which measures the concentration of companies in a particular sector, essentially a measure of the market power controlled by the top few firms. If there are 20 competitors who each have 5% market share, combining two of them will barely move the HHI but if there are only 5 competitors and the top three control 80% of the market, any transaction involving the top companies will impermissibly increase the HHI. A lot comes down to how DOJ want to define the sector. Normally in generic drugs there are low barriers to entry so there are minimal impacts on competition if the leader acquires a potential competitor that presently has 0% market share. However, in this case where UTHR has already scooped up SteadyMed taking another potential competitor (i.e. MNKD) out of the picture may leave too few viable competitors. A lot may rest on an evaluation of MNKD's ability to find a different partner or to commercialize a competitive product on its own. If DOJ thinks MNKD is a credible marketing threat to UTHR if the drug remains unpartnered, then they are more likely to object to the deal. If DOJ thinks MNKD is too weak to bring Tret to market on their own or if they don't think MNKD can attract another generics partner, they are less likely to object. Remember too that this transaction will never be "approved". The HSR regulations give the government 30 days to register an objection, but if no objection is raised then the transaction can automatically move forward on day 31. In this case, no news is good news. To Matt's point, here from the 8-k: "The effectiveness of the License Agreement is conditioned upon expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act." Matt, would the "expiration" of the required waiting period constitute a reportable event on the parts of MNKD & UTHR, or could/would they keep it quiet until the release of the 10-Q? I would think that for the purpose of the warrants/stock price MNKD would want to trumpet it from the rooftops, but I guess UTHR is in control of the process at this point.
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Post by Deleted on Oct 11, 2018 8:50:10 GMT -5
The purpose of the HSR waiting period is for DOJ / FTC to assess the impact on competition in an industry sector. Most of the time the review centers on the Herfindahl-Hirschman index which measures the concentration of companies in a particular sector, essentially a measure of the market power controlled by the top few firms. If there are 20 competitors who each have 5% market share, combining two of them will barely move the HHI but if there are only 5 competitors and the top three control 80% of the market, any transaction involving the top companies will impermissibly increase the HHI. A lot comes down to how DOJ want to define the sector. Normally in generic drugs there are low barriers to entry so there are minimal impacts on competition if the leader acquires a potential competitor that presently has 0% market share. However, in this case where UTHR has already scooped up SteadyMed taking another potential competitor (i.e. MNKD) out of the picture may leave too few viable competitors. A lot may rest on an evaluation of MNKD's ability to find a different partner or to commercialize a competitive product on its own. If DOJ thinks MNKD is a credible marketing threat to UTHR if the drug remains unpartnered, then they are more likely to object to the deal. If DOJ thinks MNKD is too weak to bring Tret to market on their own or if they don't think MNKD can attract another generics partner, they are less likely to object. Remember too that this transaction will never be "approved". The HSR regulations give the government 30 days to register an objection, but if no objection is raised then the transaction can automatically move forward on day 31. In this case, no news is good news. 8 K filed 9-3-18. 30 business days? 9-3-18 was Monday, Labor Day. When is day 30 and if we hear nothing on day 30, 12:01am day 31 its a done deal?
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Post by casualinvestor on Oct 11, 2018 9:06:06 GMT -5
30 business days from 9/3/18 will be 10/15/18, aka monday
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Post by kite on Oct 11, 2018 9:10:33 GMT -5
30 business days from 9/3/18 will be 10/15/18, aka monday I'm ready for news!!!
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Post by jlaw277 on Oct 11, 2018 9:12:25 GMT -5
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