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I don't think there is a correlation is MNTA's and Synthon's versions are completely different.
Unlikely. I think it's more to do with this: Synthon will host a call to discuss data from its EU comparative trial for its generic Copaxone on Mar.27 [via MS]
I assume the drop is because of this nugget. "Synthon will host a call to discuss data from its EU comparative trial for its generic Copaxone on Mar.27 [via MS]"
Tks JBog. Not trying to be a smart-ass, but went through his filings in 2013 and didn't see him any exercise and hold I don't think (could be wrong of course as could have missed it).
I agree with you on MNTA executives persistent selling regardless that it's part of the plan. Hopefully the other execs take note and follow Ganesh's example.
When was the last time Ganesh exercised and held options?
Let's hope so, but considering the small amount of options exercised I'm not especially convinced it means one thing or the other. Hopefully, we see some more of these type transactions over the next few days.
Ganesh exercised and 31200 shares on Friday FWIW. They are pretty close to the expiration date 4/7/14, but I guess it's better than seeing 10b5-1 selling :P
http://ir.momentapharma.com/secfiling.cfm?filingID=1179110-14-5739&CIK=1235010
Why do I get the feeling you're baiting me JMK? :)
My answer is the MNTA story is not an easy one to understand. There is a lot of moving parts,court proceedings (that have burnt many investors) and lots of general uncertainty beyond the company's control. The lack of an actionable date for the ANDA has always been difficult cloud hovering over it. I would assume a lot of investors don't want to get tied up in that uncertainty which is understandable. Look at yesterday, it was down nearly 10% because TEVA is going to refile its patent which is basically a non-news event. For me, the upside of M-Copax approval is to tasty to ignore which is why I am invested.
considering mnta went up about 135% at one point after enox approval let's sure hope for a repeat :)
Curious it would take TEVA this long to do this...why not do it right after the CAFC decision?
Did he mention they'd be refiled? I agree it smells like a last ditch effort so curious the steep drop. I assume at this point if something changed MNTA/NVS would launch at risk assuming approval before the 2014 patents.
More color on this. Anyone care to weigh in?
Teva Copaxone Patent Reissue Yet Another Defense Strategy
2014-03-20 17:28:17.312 GMT
BI LITI NOAM LITI
Teva asked the U.S. Patent and Trademark Office to consider
reissuing the '808 patent that was invalidated in the Copaxone
litigation against Sandoz, Momenta, Mylan and Natco. Teva has
submitted new claims, amending the indefinite language objected
to by the Federal Circuit. If the patent authorities concur, the
reissue will have the same September 2015 expiry as the original
'808 patent. Teva can then file new litigation against generic
challengers.
I think thrice weekly is more the culprit for that drop. I think today's drop is correlated to that 808 stuff, but not sure I understand why.
For whatever reason, I assume this is why
Teva Copaxone Patent Reissue May Push Generics to ’15: Bernstein
Thursday, March 20, 2014 06:24 AM
by Sasha Damouni and Clyde Eltzroth
March 20 (Bloomberg) -- Teva is looking to have patent ’808 reissued, possibly delaying generic debut to 2015, Bernstein analyst Aaron Gal said in note.
Copaxone has two manufacturing patents (’808 and ’898) expiring September 2015 that aren’t listed in orange book
Bernstein and the market assumed “issue was over” and that from IP perspective, generics could enter market when the Copaxone formulation patents expire in May 2014
TEVA looking to add definition of molecular weight range as ’peak’ molecular weight
Copaxone is TEVA’s number 1 selling drug; 2014 estimates $3.31b (3 ests), falling to $2.64b (2 ests) in 2015: Bloomberg data
NOTE: On Nov. 23, TEVA sought to keep Copaxone patent coverage until 2015, challenged ruling that ends coverage in May
I'm not convinced they didn't (and my guess is they did, to throw wild guesses out there) considering the volume and the selling pressure above $40 (as mentioned before they never sell under $38). But I guess we'll know for sure early next week.
What would you say the other part is? I think this info is the primary driver today. Even though it's only 1 week, it supports the increasing evidence that the market is waiting for the ABBV/ENTA combo to be approved. The momentum may have finally switched in ABBV/ENTAs favor, but it will take another few weeks to know for sure.
From my understanding the payers aren't exactly happy with TEVA and are eagerly awaiting the generic. Knowing Sandoz, I'm sure pricing has already been discussed/decided.
At a $1.05B market cap, IDIX is extremely overvalued even with a significant royalty on Sovaldi sales IMO.
Klarman is off his rocker on this one.
Hats off. The TEVA machine is quite impressive. I still don't see them holding those thrice weekly patients if and when a generic comes on the market.
My guess is GILD NRx has more to do with it. Considering the volume, wouldn't surprise if TVM has in fact been selling into this.
GILD: Sovaldi Trx @ 6,835 and NRx slipped a little to 3,974.
Some action in the Ampha Patent case. I'll copy/paste the conclusion:
B. Conclusion
Because the Court finds that Amphastar’s motion is not ripe
for consideration and declines to exercise jurisdiction in any
event, it forgoes the issue of whether Momenta is entitled to
additional discovery before it can be required to file a
responsive pleading. Momenta’s motion to defer consideration
will be allowed and Amphastar’s motion to enforce liability on
the bonds will be denied without prejudice. Amphastar may renew
its motion after the Federal Circuit resolves Momenta’s appeal
from this Court’s entry of final judgment.
III. Amphastar’s request for an additional bond
In a subsequent “renewed motion” to enforce Momenta’s
liability on the bonds, Amphastar requests that the Court order
Momenta to post an additional security “to account for the lost
-15-
interest and delay damages” that continue to accrue. The Court
declines to do so, because:
1) Local Rule 62.2 is inapplicable in that the bond has yet
to be reduced to a money judgment and
2) modification of the bond or security pursuant to Local
Rules 67.1(h) and 67.1(i) is unwarranted. The Court concludes
that requiring an additional bond would not be in keeping with
the purpose of Fed. R. Civ. P. 65(c) to “provide the plaintiff
with notice of the maximum extent of its potential liability.”
Global NAPs, 489 F.3d at 21 (citing Continuum, 873 F.2d at 803).
ORDER
In accordance with the foregoing,
1) Defendants’ motion to enforce liability on bonds for
damages arising from wrongfully-issued TRO and
preliminary injunction (Docket No. 521) is DENIED
WITHOUT PREJUDICE;
2) Plaintiffs’ motion to defer consideration of motion to
enforce liability on the bonds (Docket No. 530) is
ALLOWED; and
3) Defendants’ renewed motion to enforce liability on the
bonds (Docket No. 594) is DENIED.
A little color on SAC. So is this good news or bad news that they now own MNTA. LOL.
http://dealbook.nytimes.com/2014/03/11/a-new-name-for-sac-capital-point72/?_php=true&_type=blogs&smid=tw-dealbook&seid=auto&_r=0
I see the SEC filing, but it won't open for whatever reason.
"Lucky" them to get in at such an opportunistic price.
Isn't there a boatload more of options executives get if they have copax approved before a certain date?
Teva Copaxone Appeal Decision Delayed by U.S. Supreme Court
2014-03-10 16:56:47.13 GMT
By Greg Stohr
March 10 (Bloomberg) -- The U.S. Supreme Court deferred a
decision on whether to hear an appeal by Teva Pharmaceutical
Industries Ltd. that aims to delay generic competition to its
top-selling Copaxone multiple-sclerosis drug.
The justices took no action today on Teva’s bid for a
hearing and are now scheduled to consider the case at their
March 21 private conference, according to the court’s public
docket.
Teva is seeking to revive a patent that would protect
Copaxone from generic rivals until September 2015. Without that
patent, Teva will lose legal protection this May on Copaxone,
which brings in $3.2 billion in annual U.S. sales and accounts
for more than half the company’s profit.
Teva is battling drugmakers that are planning to offer
generic versions in May: Momenta Pharmaceuticals Inc., which has
developed a version with Novartis AG’s Sandoz, and Mylan Inc.
The court issued a list of orders today from its March 7
conference. The Teva case was originally scheduled for
consideration at that conference. The court, which often defers
decisions on pending appeals, is scheduled to issue its next set
of orders on March 24.
A ruling last year by the U.S. Court of Appeals for the
Federal Circuit upheld four Teva patents that expire in May
while invalidating a separate patent that would have blocked
generic competition until September 2015.
In November, Chief Justice John Roberts refused to put the
Federal Circuit ruling on hold while the high court decided
whether to take up Teva’s appeal.
The case is Teva v. Sandoz, 13-854.
I have serious doubts the thrice weekly patents would hold up in court.
We can cross that bridge when we get there of course as a generic copax still has to be approved.
Correct me if I'm wrong, but it seems all of TVM's selling appears to be above the $38 price mark, no?
I think once the generic hits the market that many those switched to thrice weekly will go to the generic because of cost.
Also, if TEVA were to hit that 50% mark with thrice weekly with a generic approved, what would stop the company with the generic from going for the thrice weekly generic?
I'm with genisi in attributing the sharp decline to thrice-weekly. The sell-siders also jumped on this. However, I do think it will scale back some once the generic hits and would be surprised if it ever hits the 30% mark.
GL and looks like we're in this together (ENTA and MNTA) :)
Jbog: Just curious if you've pulled the trigger?
New filing out and more selling from that firm as expected.
http://ir.enanta.com/phoenix.zhtml?c=147990&p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTk0NDY0NjYmRFNFUT0wJlNFUT0wJlNRREVTQz1TRUNUSU9OX0VOVElSRSZzdWJzaWQ9NTc%3d
DD: considering the high volume selling of this director, can we infer that this was a big part of him leaving/being force out of the BOD?
LOL. Don't jinx us!!!! :)
All the best.
Interesting points.
Also perhaps worthy of mentioning is the last 2 times MNTA has tanked (Amphastar approval and lifting of the injunction by the CAFC wackos) there was absolutely no premonitions of it happening.
Hepatitis C Cases Fall 16% in U.S., CDC Survey Finds
http://www.bloomberg.com/news/2014-03-03/hepatitis-c-cases-fall-165-in-u-s-cdc-survey-finds.html
By Drew Armstrong Mar 4, 2014 12:01 AM ET
The number of Americans with hepatitis C fell 16 percent to 2.7 million over almost a decade, a government survey found, just as new, more effective treatments for the chronic liver disease reach the market.
The survey by the Centers for Disease Control and Prevention covers data gathered from 2003 to 2010. It updates information collected in 1999 to 2002 that counted 3.2 million people as being infected. Hepatitis C can be symptomless for years before it begins to scar the liver, leading to cancer, organ failure and, eventually, a transplant.
New drugs such as Gilead Science Inc. (GILD)’s Sovaldi, which costs $84,000 for 12 weeks of treatment, are coming to market as more-convenient therapies with with fewer side effects. The profile of U.S. patients with the disease may stymie sales of the drugs, according to the study published in the Annals of Internal Medicine.
“Our study and others have found that persons with chronic hepatitis C virus infection are frequently poor and less educated, factors that could pose barriers to the receipt of these costly novel hepatitis C virus treatments,” the study’s authors said.
The researchers looked at 20,042 patients’ blood samples to test hepatitis C rates, and found that 1 percent of those tested were infected. Neither new data nor the previous study include people in prison, where hepatitis C rates are higher, or the homeless.
Trend Decreasing
The study released yesterday put the range of those infected with the virus in the U.S. at 2.2 million to 3.2 million, compared with 2.7 million to 3.9 million in the earlier survey. “The trend is that there’s a decrease in the number of people living with hepatitis C,” John Ward, the CDC’s director of the division of viral hepatitis, said in a telephone interview.
The CDC, based in Atlanta, recommends screening for everyone in the U.S. born from 1945 to 1965. The virus is transmitted by blood and wasn’t tested for until 1992. Patients can be infected from blood transfusions as well as through intravenous drug use. About 150 million people worldwide are estimated to be infected with the virus.
While the total number of U.S. patients may be declining as people die from the disease, the rate of new cases is increasing as younger people -- mostly intravenous drug uses -- become infected, he said.
Infection rates were highest among males, blacks and those 40- to 59-years-old. Those with the virus were more likely not to have completed education past high school, and to have incomes less than $23,000. They were also more likely to be intravenous drug users or have had more than 10 sexual partners, the study found.
Gilead, AbbVie
Drugs for the disease are being developed by Gilead, AbbVie Inc., Bristol-Myers Squibb Co. (BMY), Johnson & Johnson (JNJ) and Merck & Co. Gilead’s Sovaldi was approved last year. The new therapies are taken as pills and replace injections.
Because the disease is symptomless early on, patients may not seek treatments because they don’t know they have the virus, researchers said.
“All available current information indicates that no more than one half of persons with chronic HCV infection have been tested for anti-HCV; many who are anti-HCV–positive do not receive medical care,” the researchers said in the study.
as DD mentioned FDA leaks are pretty rare and that coupled with CW's presentation yesterday I highly doubt that is the reason.
I think JBog is probably correct in that a major holder is unloading and at a feverish pace. Why though is anyone's guess.
Yeah that didn't seem out of the ordinary. He still emphasized that the FDA is focusing on the patent expiration dates for approval priority. I think the issue is the new way the FDA communicates.
On another note, if MNTA gets another small CRL for their application, would that have to be PR'd since it is essentially so close to the patent expiration?
Option activity is through the roof again as well.
Yes nothing from CW there and if any response from the FDA had been terribly concerning they would have been required to PR that.