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I assume we'll learn more Tuesday. If MNTA is still on track then it's a huge positive for them obviously and in turn MYL skirting the subject would seem very TEVA-esque circa 2010 on enox.
MYL just said there was a delay in their Copaxone FWIW. Should be a positive for MNTA would would think, but MNTA seems to be down a bit on it.
Maxim Group downgraded Teva Pharma (NYSE: TEVA) from Buy to Hold with a price target of $49.00 (from $55.00) in assumed coverage.
Analyst Pamela Bassett, D.M.D. coommented, "We are downgrading TEVA to Hold, from Buy, and lowering our price target to $49, from $55, as we anticipate a generic Copaxone approval and launch by June 2014. We expect Sandoz (NVS - $86.45 - NR)/Momenta (MNTA - $11.30 - NR) to launch M356 (generic Copaxone) in the U.S. by June 2014, likely negatively impacting Teva’s conversion of daily Copaxone patients to the three-times-weekly version. We expect M356 to receive interchangeable status from the FDA, which we believe could result in market share loss up to 50% in the first year—a $1.1 billion revenue cut for Teva. Additionally, we believe Teva could position and price three-times-weekly Copaxone like an authorized generic, potentially further eroding revenue and margins."
ENTA short interest at 1.7m shares as of 4/15. Probably not the smartest stock to be short on imo.
Teva Rejected by U.S. Supreme Court on Generic Copaxone Delay
2014-04-18 20:10:12.668 GMT
By Greg Stohr
April 18 (Bloomberg) -- A U.S. Supreme Court justice
rejected Teva Pharmaceutical Industries Ltd.’s bid to block
generic versions of its Copaxone multiple-sclerosis drug while
the court hears the company’s appeal in a patent clash.
The rebuff by Chief Justice John Roberts means Teva may
face generic competition as soon as next month. Mylan Inc.,
Momenta Pharmaceuticals Inc. and Novartis AG’s Sandoz are
positioned to start selling generic Copaxone in late May,
although they would risk having to pay damages if Teva
ultimately wins the patent case. Momenta and Sandoz are working
together.
Teva now has the option of asking another justice to
intervene. A delay would give Teva more time to switch patients
from the 20-milligram dose that is the subject of the legal
fight to a 40-milligram version that the company says is covered
by other patents.
Sovaldi: This week's numbers from twitter:
$GILD Sovaldi IMS scripts for the wk ending April 11"
TRx 7,870, -2% w/w (2nd sequential down wk)
NRx 3,645, -6% w/w (3rd sequential down wk)
I don't think there is anything to infer from it. As the last sentence says SCOTUS has yet to respond so TEVA offered this information voluntarily. And as I mentioned in my previous post, TEVA would love to put up a $500m bond regardless of the outcome because a 6 month delay is worth 2 to 3 times that amount at least.
Of course they would. A suspension until October is worth much more than $500m to TEVA. If they were really serious they would have said north of $1b which is what a 6 month delay is worth at least.
Any news? Up nearly 10%
Here's a little more color on NVS/MNTA/MYLs argument
Generic-Drug Makers Oppose Teva Bid to Delay Copaxone Rivals
2014-04-14 22:19:20.668 GMT
By Greg Stohr
April 14 (Bloomberg) -- Generic-drug makers including
Momenta Pharmaceuticals Inc. urged the U.S. Supreme Court to let
them introduce generic versions of Teva Pharmaceutical
Industries Ltd.’s Copaxone multiple-sclerosis drug next month.
In a court filing today, Momenta, Novartis AG’s Sandoz and
Mylan Inc. said they would suffer “immense harm” if barred
from selling generic Copaxone in the U.S. after some of the
drug’s patents expire May 24.
Teva is asking Chief Justice John Roberts to block generic
Copaxone while the high court considers a case involving a
different patent claim that may shield Copaxone from competition
until September 2015.
Momenta, Sandoz and Mylan haven’t explicitly said whether
they will press ahead with plans to sell generic Copaxone while
the Supreme Court fight plays out. They suggested in today’s
filing that they would do so, though they didn’t say so
directly.
The companies said a Supreme Court order blocking generic
versions would in effect “decide this litigation for Teva” by
giving it time to switch patients from a 20-milligram dose to a
40-milligram version covered by other patents before any generic
competition begins.
Copaxone brings in $3.2 billion in annual U.S. sales and
accounts for more than half of Teva’s profit. Should the
generic-drug companies start selling their versions in May, they
would be at risk of having to pay Teva for its lost profit in
the event that company ultimately wins the case.
Generic Version
Momenta has developed a generic version of Copaxone with
Sandoz, and Mylan is planning its own version.
A federal appeals court last year threw out the disputed
Teva patent, saying it didn’t clearly outline what the company
claimed was invented.
In November, Roberts refused to put the appeals court
ruling on hold while the justices decided whether to take up
Teva’s appeal. The Supreme Court later agreed to hear the case,
putting it on a timeline to be resolved early next year.
Roberts handles emergency matters from the appeals court
that handled the Copaxone case. Roberts can either act on the
Teva request himself or refer it to the full nine-member court.
The case is Teva v. Sandoz, 13-854.
Not sure what you want MNTA's management to say. NVS runs the show here.
Who knows but I picked up some more ENTA today because of it :)
I would take this as further evidence that $MYL plans to launch at-risk if approved FWIW
Anyone care to chime in on if this will have any weight with an at risk launch or SCOTUS?
United States PTO Rejects Teva's '808 Patent Reissue Application on Copaxone(R) for the Second Time
No the part that says in an interview last week. I assume they just talked to him today so the last week part is curious.
All signs points to at-risk launch if there is approval so there is a silver lining.
Curious in that NY Times article, what is with the last week comment?
Some more color:
Teva Gets U.S. High Court Hearing on Generic Copaxone Delay (4)
2014-03-31 21:02:23.986 GMT
(Updates with closing share prices in fifth paragraph,
Mylan comment in 12th paragraph.)
By Greg Stohr and Susan Decker
March 31 (Bloomberg) -- The U.S. Supreme Court agreed to
hear an appeal by Teva Pharmaceutical Industries Ltd. in a move
that may delay generic competition to the company’s top-selling
Copaxone multiple-sclerosis drug and alter how patent appeals
are handled. Teva rose on the news.
The justices today said they will hear Teva’s bid to revive
a patent that would protect Copaxone from generic rivals until
September 2015. Without that patent, Teva would lose legal
protection this May on Copaxone, which brings in $3.2 billion in
annual U.S. sales and accounts for more than half its profit.
High court review is a setback to drugmakers that were
planning to offer generic versions in May: Momenta
Pharmaceuticals Inc., which has developed a version with
Novartis AG’s Sandoz, and Mylan Inc. Should those companies
press ahead with their plans, they will be at risk of having to
compensate Teva for lost sales if the company wins its Supreme
Court appeal.
“The generic filer will have to think if it wants to
launch before the case is settled and run the risk of paying
large fines,” said Ori Hershkovitz, a managing partner at
Sphera Funds Management Ltd. in Tel Aviv, which holds Teva
shares.
Shares Rise
Teva American depositary receipts, each representing one
ordinary share, rose $3.39, or 6.9 percent, to $52.84 in New
York trading. That represented the biggest one-day percentage
rise for the ADRs since Aug. 9, 2011. Momenta fell 16.9 percent
to $11.65 and Mylan was unchanged at $48.83.
The court will hear arguments and rule during its 2014-15
term, which starts in October and runs through the following
June. Any delay in generic-drug competition would be a windfall
for Teva, which collects $8.8 million a day from its blockbuster
drug. Copaxone already is facing competition from Biogen Idec
Inc.’s Tecfidera treatment.
While Hershkovitz said he thought the generic-drug
companies would be willing to risk going to the market, Jonathan
Kreizman, an analyst at Bank of Jerusalem, disagreed, saying,
“Teva has a good case with the particular patent.”
Teva, based in Petach Tikva, Israel, said in a statement
that it’s “pleased that the court has agreed to hear its
appeal” and it “remains committed to pursuing all options to
protect its intellectual property for Copaxone.”
Novartis, Momenta
Novartis AG, based in Basel, Switzerland, said it believes
the patents are invalid.
“Together with our collaboration partner Momenta, we look
forward to marketing an affordable, high-quality generic version
of Copaxone at the earliest possible opportunity,” said Julie
Masow, a spokeswoman for Novartis.
Momenta, based in Cambridge, Massachusetts, had no
immediate comment.
Mylan said in a statement that its 2014 earnings estimates
hadn’t changed. The company, which is based in Canonsburg,
Pennsylvania, didn’t say whether it would start selling a
generic version before the Supreme Court ruled.
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.
The appeals court, reversing a trial judge, said the
invalidated patent didn’t clearly outline what Teva claimed was
invented. The patent contains ambiguities that make it unclear
what molecular weights were used to develop the product, the
court ruled.
Overturning Judges
In its Supreme Court appeal, Teva argued that the Federal
Circuit, which specializes in patent cases, should have deferred
to a trial judge’s reading of the patent.
The Federal Circuit’s longstanding approach is to review
patents without giving any weight to the trial judge’s
interpretation. In February, a divided 6-4 court affirmed that
policy in another case, which may have led to the high court
taking this case, said David Long, a patent lawyer with Kelley
Drye in Washington.
The definition of a term or phrase in a patent is key to
all that follows in a case, be it legal arguments over its
validity or presentation to a jury of what the patent covers.
The appeals court overturns patent interpretations by trial
judges 32 percent of the time, according to a study published in
September by American University Professor J. Jonas Anderson and
University of California at Berkeley Professor Peter Mennell.
‘Foundational Question’
“It goes to the heart of patents: What does the patent
cover and, more specifically, who decides that issue,” Long
said. “Whatever the Supreme Court decides will impact all
industries -- mobile phones to pharmaceuticals -- because the
value of any patent depends on what it covers.”
Teva argued that the interpretation of patents is “a truly
foundational question” of such litigation, and the Federal
Circuit’s policy injects uncertainty in every case. Had the
appeals court considered only whether the judge had “clearly
erred,” the patents would have been upheld, Teva said.
Momenta, Sandoz and Mylan all urged the Supreme Court to
reject the appeal without a hearing.
Meanwhile, Teva is trying to switch patients over to a 40-
milligram dose of Copaxone before the 20-milligram generics hit
the market. The smaller dose must be injected daily, compared
with three times weekly for the 40-milligram dose.
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 marks a trend in which the Supreme Court has taken
a greater interest in patent law as Congress considers
legislation to deal with certain litigation practices. Earlier
today, the high court heard arguments on whether software is
eligible for patent protection. It also is considering when the
loser in a patent case should pay the winner’s legal fees.
The case is Teva v. Sandoz, 13-854.
Looks like MYL is pretty much saying they'll launch at risk if approved:
Mylan Repeats 2014 View After Supreme Court Patent Claim Review
3:21 pm Mylan Labs reaffirms FY14 adjusted EPS guidance; sees Q1 adjusted EPS approx flat yoy at $0.62 vs $0.68 Capital IQ Consensus Estimate (MYL) : Related to 15:15 comment.
Co confirms its adjusted diluted earnings per share guidance range for the full year 2014 ($3.25-3.60 vs $3.45 Capital IQ Consensus Estimate), and its expectation that first quarter adjusted diluted earnings per share will be approximately equal to first quarter 2013 adjusted diluted earnings per share (~$0.62 vs $0.68 Capital IQ Consensus Estimate), all as previously stated on the quarterly earnings conference call held on February 27, 2014.
TEVA will probably ask for a stay on approval I'd imagine.
I expect NVS/MNTA to launch at risk if they were to attain approval considering the case about the process rather than the actual patents it seems.
*TEVA GETS U.S. SUPREME COURT HEARING ON GENERIC COPAXONE DELAY
A lot of diners could also be waiting for a new restaurant to open as well (ABBV/ENTA) :)
Notes from Ritu Baral (Canaccord) on Synthon
Synthon Copaxone-Like Drug May See 2015 EU Approval: Canaccord
2014-03-28 13:21:37.407 GMT
March 28 (Bloomberg) -- Synthon’s Phase 3 Gate study
showing equivalent efficiacy and safety of its glatiramer
acetate to Copaxone, has clear potential and timelines that may
lead to late 2015 EU approval, Canaccord analyst Ritu Baral said
in note yday.
* Canaccord believes Synthon has had L-T dialogue w/ EMA
around design, conduct of Gate trial which should
“translate” to high chance of timely approval
* Path forward in U.S. less clear as FDA review continues,
although Synthon confident of near-term approval
* Synthon’s strategy for U.S. most likely to impact for
Momenta and Sandoz partnered M356 generic Copaxone
* Synthon hasn’t had any real discussions w/ FDA around
application, development strategy, which is now even more
challenging given structured communications mandated by
Gdufa
* Canaccord expects full data expected to be presented at
ECTRIMS 2014 (Sept., Boston)
Tks Rocky. Looks like NRx might have stabilized.
do you have thrice weekly RX per chance? TIA!
We actually don't know if that's true because MNTA only litigated on those process patents.
I think you missed my point. Not saying they will or won't, just saying I don't think those Synthon trial results mean squat to the FDA regarding an interchangeable AB rated generic Copaxone. Like I said, I bet Natco's copax knock off in India would do a-okay in trials (they're not using the same one for their ANDA), but no way in hell that version would get approved by the FDA.
As a side regarding Amphastar, of course there's that whole thing were Amphastar used MNTA's technology to get approved and all :P
Would be nice if they actually released some data to go with this PR.
On that same note, has Natco's copax rip off in India done such trials? I bet they would come up with similar results. Doesn't mean they can past muster with the FDA.
Stock dropped a similar % prior to enox approval. I don't think there's anything to discern either way about the drop.
Beat me to the punch and considering the cost-savings of a Gx lovenox thus far one would think it a priority to get a Gx Copax approved.
Thanks for response jbog. I know you've been vocal about Synthon in the past.
I just can't see the correlation. Their Copax can't be anything alike so I'm not sure how Synthon results effect MNTA one way or the other.
The FDA has been pretty vocal regarding biosimilars and if the technology is there the there is the possibility of interchangeability. I see an m-copax approval as a practice what you preach kind of thing for the FDA.
I know you have been vocal about them jbog but as far as I can tell nothing is changed in the Synthon situation. Would you suggest otherwise?
Market hates unknowns and MNTA is full of them right now. For those who don't follow the Synthon comments, while they are same as they've always been, that might have been a surprise which facilitated the sell-off followed by the IBB drop.
That's not true as that FDA prioritizes its decisions on the orange book patents not these which are outside the orange book.
I'm actually on a webinar thing with patent lawyers discussing it and they said they'd expect SCOTUS to rule by July if they took it.
the March 28th decision is whether SCOTUS will take the case btw rather than their decision on the issue. That would take a few months or so.
I disagree as the chance of SCOTUS taking the case isn't especially high. It's this Synthon tidbit that is pushing it down.
From Andy Biotech on twitter
"Synthon claims that it thinks FDA will require comparative trials and it is the only co running such a trial ;)"