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I wonder if ENTA is now a "buy" for Baird again now that it's under $41. Hmmmmm
Appreciate the math to support what I thought was the case (I actually hadn't added it up yet! :))
Looks like the sell siders are grasping for straws as the pile on the "downgrades." Pretty convenient they don't have a new PT.
And what does ABBV pursuing SHPG have to do with ENTA?
While annoying, it's just planned selling for tax purposes which is pretty neutral if anything imo.
Well that's about a weak as a "downgrade" as there is :P
I tend to agree especially since ENTA is sitting on some nucs as well despite sell-siders completely ignoring them.
I think would be disappointed (but not devastated of course :)) with anything below $1.5b. Considering what MRK paid for IDIX's nukes as well as what seems like a real interest by NVS in advancing ENTAs compound, I would like to think $1.5b would be the minimum someone would have to pay.
I was hoping they forgot a zero ($108)! :)
I'd imagine this is a misprint considering there is an outperform rating.
Considering ENTA's expertise and success thus far in this space, my inclincation is that their nukes are in fact viable. In lieu of the MRK/IDIX deal, I would contend that ENTA's program is considerably undervalued if not completely overlooked considering the current market cap.
Ah I thought you were referring more to the MNTA side and a PR.
MYL's original guidance called for a Q2 launch which they obviously recently had to back off something MNTA has never done. Perhaps boast wasn't the best word, but you know what I meant.
Not sure what you mean jbog?
Any chance that third party was Sandoz/MNTA or probably not since why would they remain hidden?
I don't think so unless it's approved or TEVA got a letter from the courts about approval. MNTA doesn't have an obligation to say anything since unlike MYL they didn't boast about a May 24 approval date.
Actavis is indemnified from this case. It's all on Amphastar
They also announced they plan to aggressively build up inventory starting May 24. Unless they're bluffing (don't see the purpose in that), why would they announce that unless launching was their intention?
What's interesting (I guess) is that basically every firm has gone from thinking that MYL doesn't have the goods to thinking MYL has the goods even though MYL's Gx Copax rhetoric has remained the same for years.
I think the only firm predicting MNTA solo entry still is Maxim, whoever they are.
Amphastar has filed for an IPO up to $100m.
TEVA and the 24 notice before Gx approval approval.So if approved, I guess this means we won't see a stock halt in MNTA or MYL or will that still be the case? Will TEVA then be the first to know then?
Any comments on the bolded statement below (emphasis added)
District Court Rejects Teva Lawsuit Seeking to Block Generics of Copaxone
2014-05-15 16:03:37.899 GMT
District Court Rejects Teva Lawsuit Seeking to Block Generics of
Copaxone
By Dana Elfin
Litigation Over Copaxone Dismissed
Development: Court dismisses Teva suit against the FDA over
potential Copaxone generics, finding the suit isn't ripe.
Impending Generics? The patent protection for Copaxone is
scheduled to expire May 24.
May 15 (BNA) -- In a loss for Teva Pharmaceutical Industries
Ltd., a federal district court May 14 dismissed the company's
suit seeking to preliminarily enjoin the Food and Drug
Administration from approving generic versions of its multiple
sclerosis drug Copaxone (glatiramer acetate injection), finding
the suit wasn't ripe (Teva Pharm. Industries, Ltd. v. Sebelius,
D.D.C., No. 1:14-cv-00786-ESH, order 5/14/14).
Judge Ellen S. Huvelle of the U.S. District Court for the
District of Columbia said the court had no jurisdiction to hear
the suit, which she dismissed without prejudice.
In a brief order, Huvelle said, “the Court concludes that
the case is not ripe and therefore the Court lacks jurisdiction.”
Accordingly, the court granted the government's motion to
dismiss for lack of ripeness and denied as moot Israel-based
Teva's motion for a preliminary injunction.
Teva Reacts
Denise Bradley, Teva's vice president of global corporate
reputation, told Bloomberg BNA May 15 that the company is
“pleased that the judge has requested 24-hour notification of
final action from FDA” as to approval of abbreviated new drug
applications (generics) and the company continues “to evaluate
our options.”
“Teva remains committed to advocating for the development of
safe and efficacious products for the public—both generic and
branded,” she added.
Meanwhile, Pittsburgh-based Mylan Inc., one of Teva's
potential competitors in the generic Copaxone market, praised the
court's decision to dismiss.
In a May 15 statement, Mylan's chief executive officer
Heather Bresch called Teva's suit “a desperate, last minute
tactic, among others, to delay access to more affordable generic
versions of Copaxone for patients in the U.S.”
Bresch added, “Following the Court's decision against Teva,
we continue to see no barrier to FDA approval of Mylan's generic
Copaxone following patent expiry, and we look forward to being
able to launch this very important first generic product for
multiple sclerosis at market formation.” Mylan intervened in the
suit on the side of the FDA.
Heather also said unequivocally they would be approved on May 24 exactly and they've already back tracked on that. I'll repeat for the last time, MYL has no knowledge of what is going on with MNTA's application with the FDA.
That's just not true. The FDA deals with each application individually and does not share what it is doing either others. I'm not saying there isn't a chance that they both are approved at the same time, but I am saying MYL has no knowledge of what is going on with MNTA's application. There is nothing one can infer regarding MNTA's application from MYL.
MYL and MNTA's are completely different applications. MYL has no way of knowing about what's going on with MNTA's.
I guess this shows the current mentality of MNTA in that the drop yesterday was because of this suit which apparantly the market thought had a chance of success
Makes sense. Do you think TEVA's tactics will work at all?
I concur. It's still rather baffling TEVA decided to file this suit before there was an approval (counter to what SNY did). Like I mentioned in PMs, perhaps MNTA stockpiling copax has something to do with it, but the more I think about it I don't think that's it.
Also of note is that they feel they have enough inventory for a May 24 launch if that was in the cards:
"But we believe we have sufficient launch inventory just by using our validation batches to at least make in-roads into the market."
I just don't understand how they can sue for something that hasn't happened yet?
Curious TEVA is suing before any Gx is actually approved, no?
Teva Sues FDA to Block Generic Copaxone
Teva Sues FDA to Block Generic Copaxone
2014-05-09 18:18:20.585 GMT
By Courtney Dentch
May 9 (Bloomberg) -- Teva claims FDA fails to respond to
request for generic trials; patent protection for Copaxone
expires on May 24.
Curious as to why some firms are lowering their PT. Is it because MNTA is setting their potential copax revenue aside? If so that would seem to be a silly reason.
Mouton will probably provide a better idea of this, but I'll give it my best.
During the CAFC review the panel unanimously (all 3 judges) found the 2015 patent invalid. TEVA then asked for an en banc review which was denied. Usually in these kinds of cases that should do it, but alas that did not happen as we all know.
Moving on there was a recent 6-4 en banc hearing regarding a case called Lightning Ballast that had to do with de novo review of claims construction where the CAFC hears the case from scratch. Lightning upheld the de novo of the CAFC, but since it was a close decision apparently SCOTUS felt that they should get involved and it just happened that the MNTA/TEVA case tackled the same subject matter at the same time so they took it.
So basically this case is about the CAFCs ability to rule on the district court's claims constructions, which as you can imagine was quite the blind side to MNTA/NVS.
MNTA believes it very unlikely that SCOTUS will consider the CAFC ruling invalid and that this is really about procedure more than anything else, but there is still that possibility that SCOTUS rules the CAFC invalid which is why MNTA set up the ATM and plans to sideline copax revs. MYL has come out and said that they don't even consider a launch to be "at-risk" to show their confidence on what will happen.
Hopefully Mouton chimes in to give a better picture!
That $75m ATM is still future dillution. Shea hinted that they intended to use it at a higher post m-copax price which is fine I guess so long as they stick to that. The likely scenario on the SCOTUS case is they come out okay one way or another, but how many times have we been here with MNTA in that regard where the unlikely and negative scenario prevails. I think that uncertainty and the fact they won't touch copax revenues added to the dip.I agree with your assessment that M-copax approval is a near term event.
MNTA didn't and has never said anything about a May 24 approval. However, they strongly implied that the FDA has a very strong incentive to approve around then and reiterated that their application is in approvable form. If there is any hold-up in MNTA's application that would delay it, it would have been relayed by PR which obviously it has not at this point. My guess is whatever is holding up MYL has no bearing on MNTA.
MNTA won't realize revenues from Copax early on as they will need to contribute 50% of the legal risk after the launch hence the $75m ATM to "bridge the gap." But all indications are they will launch at-risk
CW just confirmed what I said FWIW
I think that sounds more like protection in case the SCOTUS judge goes against them and the 808 gets validated. I don't think one can infer they won't at-risk launch from it.
NVS hasn't included Gx Copax revenues like MYL has so I don't think the onus is on them to reveal anything.