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ABBV: Morgan Stanley downgrades $ABBV from Overweight to Equal-Weight, target price to $57.
Haven't seen the report, but obviously it's based on yesterday's GILD data.
Don't know if you saw this recent quote Jbog, but perhaps could be construed as a wink towards MNTA. Either way happy holidays and safe travels! :)
Biosimilar may not need comparative clinical trial if has "fingerprint-like" analytical comparisons - FDA's Jenkins
Maybe, but I think MNTA is definitely looking beyond the Baxter partnership:
Well, we are thinking hard about where we go as a company beyond the Baxter relationship, right. And so we have six products with them, everything else is in our space. When you think about where we’ll be once Baxter – we put six Baxter programs, so we will have development engine which basically will be able to put in the new products every six to nine months, right so that’s a pretty high throughput, so we can put through. So we would like to use that.
And so we are starting to think through what categories of products we might look at. I think orphan products are not terribly different from the other products expect that tend to be smaller and the question is what’s the competition going to be like in space. So if you are in a pace with fewer competitors also pretty nice products to go after and so we are going to have make those judgments based upon, where we are at the time when we can pick up products outside of the Baxter partnership.
FWIW I actually consider this and MNTAs recent hiring spree as somewhat bullish. CW and co have historically been very conservative when it comes to using cash. My reading is they anticipate M-copax approval before the patent date and they also expect the drug to be rather profitable as well (including significant time as the only generic entrant).
Hopefully that won't be an issue as they will be bought out by then (for a much higher share price of course:))
I thought it was much ado about nothing considering their current market cap FWIW
IDIX: Any implications on news today?
Idenix announces declaration of senior party in second USPTO patent interference
Another reason and one CW has alluded too is that eventually the courts will get it fixed in regards to safe harbor etc so imo it makes since to keep pursuing these patents.
If MNTA gets approval first, do you think it will take MNTAs tech for MYL to get it right like Amphastar?
lol. they make 3d livers and have a $1b market cap. I don't know anything about 3d livers, but I know a lot about the FDA and good luck to them getting anything close to approved in less than 10 years :P
I think the difference b/t ONVO and the names you mentioned is ONVO has a pretty large float (75m) which makes this move even more insane... I really doubt it can fly like those others, but I never thought it would hit 10(down big on my ONVO short at 9.75 :P)
Why in the world would you do something silly like that!! :)
*TEVA REJECTED BY U.S. HIGH COURT JUSTICE ON COPAXONE PATENT
Teva Rejected by U.S. High Court Justice on Copaxone Patent
2013-11-13 22:04:00.299 GMT
By Greg Stohr
Nov. 13 (Bloomberg) -- A U.S. Supreme Court justice refused
to block a ruling that would open Teva Pharmaceutical Industries
Ltd.’s Copaxone multiple sclerosis drug to generic competition
in May.
The lower court ruling invalidated one of the company’s
patents and shaved more than a year off the legal protection for
Copaxone, a treatment that generated $2.25 billion in U.S. sales
for Teva in 2011. Chief Justice John Roberts today rejected
Teva’s request to put that ruling on hold while the court
decides whether to take up Teva’s appeal.
The rebuff is a victory for the generic-drug makers
challenging the Teva patents. Those include Momenta
Pharmaceuticals Inc., which is developing a generic version with
Novartis AG’s Sandoz, and Mylan Inc., which has said it expects
to be on the market in May.
Or perhaps folks are expecting to be released pre-market tomorrow...
I think CW addressed this once if my recollection is correct and I think the answer was pretty much about being nicey nice! :)
I don't think the CTs are anything of consequence considering the dates they reference which are being amended.
Well that's one way to lose $200 real quick :P
Probably because I started buying some shares! :)
My guess is much ado about nothing from this: Teva Announces Favorable Ruling on COPAXONE Patent Litigation in the Netherlands
My understanding of the price rise the other day was due to a huge bullish risk reversal play in options trading. I seriously doubt the SA article had anything to do with it.
They have publicly weighed in. See the FDA's rejections of TEVA's CPs.
Like DD said most likely had to do with OPEX. A few other tickers on my list did a similar drop at around the same time.
And IDIX is somehow ahead of both of them
And you can pretend all you want but just remember what the purpose is of the genericized drugs' laws and regulations.
And if MNTA had a different panel at the CAFC, you guys wouldn't be posting anything right now. As it is, we keep going in the circles for a reason I don't understand.
Amphastar wouldn't have been approved without the use of MNTAs technology. The courts said that is "a-okay" to do so. You can pretend all you want since it obviously makes you feel better, but no one predicted that.
lol. Only took them how long to cut $2/3m a year from their $50-70m annual burn. Nice work IDIX.
IDIX: Any reason for the rise on volume this morning?
IDIX sitting on a $730m market cap. Wowzers.
BoA a bit generous with that $5 PT IMO
MNTA is busy next week:
Momenta Pharmaceuticals to Webcast Presentations at Three Upcoming Investor Conferences
CAMBRIDGE, Mass., Sept. 4, 2013 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that it will webcast its presentations at three upcoming investor conferences.
Baird's 2013 Health Care Conference
Wednesday, September 11 at 9:40 a.m. ET in New York, NY
Morgan Stanley Global Healthcare Conference
Wednesday, September 11 at 12:20 p. m. ET in New York, NY
Stifel Healthcare Conference 2013
Thursday, September 12 at 8:35 a.m. ET in Boston, MA
The audio webcast of the presentations will be available live on the "Investors" section of the company's website located at www.momentapharma.com. A replay of the presentations will be posted on the Momenta website approximately one hour after each event and will be available for two weeks following each presentation.
Kind of odd they announce they'll release the results the day before, no? Or is that normal.
Wasn't it like $12-ish before enox approval?
I think the point here is the market doesn't like unknowns. They much prefer PDUFAs and the known factor of when the FDA has to make a decision by.
I don't think the current price is saying anything in particular
lol I agree. It really shows a lack of understanding to even comment on promotional material and its relation to an M-Copax approval
It was a lawyer, Kirby Drake, not the author who said that regarding the promotional material.
surprised Momenta wouldn't comment
"It is unclear if Momenta is ready to launch at ANDA approval as the company has not been releasing a lot of promotional material, she noted."
If it's an AB rated generic doesn't that nullify the need for any promotional material?
Teva’s Copaxone patent appeal to go unheard, May 2014 generic launch prospects debated
By Anusha Kambhampaty in New York
--------------------------------------------------------------------------------
Teva Pharmaceutical Industries’ (NYSE:TEVA) plans to appeal a US Court’s recent overturning of key patents covering multiple sclerosis (MS) blockbuster Copaxone (glatiramer acetate) are unlikely to be successful, attorneys told BioPharm Insight. Neither the US Court of Appeals for the Federal Circuit en banc nor the Supreme Court is apt to hear the appeal, they said.
Additionally, the drug maker is unlikely to succeed in petitioning the FDA to require generic manufacturers to run full-scale clinical trials prior to Abbreviated New Drug Application (ANDA) approval, most attorneys said. An ANDA, once FDA approved, allows generic drug makers to launch a copy-cat version of an approved branded drug.
Generic launch delays are, however, possible as the feasibility of a May 2014 launch ultimately lies in the FDA’s hands as well as the capacity of generic filer Momenta Pharmaceuticals (NASDAQ:MNTA) and partner Sandoz, a Novartis (VTX:NOVN) subsidiary.
Sandoz was first to file an ANDA in 2007. On 28 August 2008, Teva filed suit against Sandoz, and in October 2009, Teva sued Mylan (NASDAQ:MYL) for infringement of patents covering Copaxone’s chemical composition.
In July 2013, the US Court of Appeals for the Federal Circuit invalidated several Copaxone patents citing “indefiniteness,” maintaining Copaxone exclusivity until 24 May 2014. “Teva is disappointed with the court’s decision with respect to four of the 2014 patents and the 2015 patent and will appeal this decision,” the Teva spokesperson said.
Avenues for appeal not very promising
Teva has two avenues for appeal, the first requesting the Court of Appeals for the Federal Circuit to rehear the case en banc or appealing to the Supreme Court, said Robert Wagner, associate, Picadio Sneath Miller & Norton, Pittsburgh, Pennsylvania. Both are unlikely to be successful, he said, calling the recent decision “standard.” The Supreme Court is unlikely to take the case as there are no burning issues for the Court to address, said Robert Gould, partner, Husch Blackwell, Chicago, Illinois. As far as the Court of Appeals for the Federal Circuit rehearing the case en banc, Gould agreed it is unlikely because there weren’t any unsettled legal issues involved in the case. En banc refers to a case that is to be heard before all judges of a court.
The only thing that might weigh in favor of an en banc rehearing is Copaxone’s market size, but “I don’t think that would be enough for the Court to reconsider its opinion,” Gould noted. He indicated Teva’s plans to appeal will not delay a generic launch. Teva-recorded Copaxone global annual revenues recorded increased 12% from 2011 to 2012, or 14% in local currency terms, to USD 4bn, according to a company press release.
There is a very low likelihood the Supreme Court will hear the case, as the applicability is not broad enough, said Douglas Robinson, associate, Harness Dickey, St Louis, Missouri. The Court will not consider the economic impact of the drug, he added.
Kirby Drake, senior associate, Klemchuk Kubasta, Texas agreed, adding the chances the Court of Appeals for the Federal Circuit will rehear the case are also low, considering less than 10% of review requests are granted. If there had been a decision to wipe out all the Copaxone patents, perhaps it might be more attractive to rehear, Drake said. The decision does not seem controversial nor does it warrant more analysis, she added.
Indefiniteness is not a “sexy” IP issue and it is not unsettled in law to warrant a rehearing en banc or with the Supreme Court, added Deborah Fishman, partner, Dickstein Shapiro, Palo Alto, California. There was nothing ambiguous in the ruling, she noted. Indefiniteness refers to a patent claim that can have different meanings depending on the method used to measure it. With Copaxone, its molecular weight could be calculated at least three different ways, resulting in three different values.
Momenta did not return requests for comment.
Pre-ANDA approval trial requirement unlikely
Teva has repeatedly petitioned the FDA to rule that marketing for generic Copaxone will not be approved without clinical trials being conducted. However, it is unlikely Teva will ultimately succeed, Gould said. He pointed to the FDA’s ANDA approval of Momenta and Sandoz’s enoxaparin sodium, the generic version of Sanofi’s (EPA:SAN) anticoagulant injection Lovenox. FDA denied Sanofi’s requests to require clinical trials prior to generic approval, he noted.
There is not a lot of precedent for the FDA to buy into a branded drug maker’s request to require generics to run full-scale clinical trials, Drake said. Requiring clinical trials would essentially counter the purpose of the Hatch-Waxman Act, which rids generic clinical testing to encourage faster generic marketing, Fishman added.
However, according to Robinson, there is a chance Teva’s petition will be successful as Copaxone is not a small molecule as it has been deemed by the FDA as a “pseudobiologic.” One cannot make predictions based on Lovenox, as Copaxone is made differently and faces different circumstances, Robinson added.
Small molecules are the traditional active substances in pharmaceutical products and are produced through chemical processes. Large molecules, or biologics, are protein- or cell-based therapies manufactured in biotechnological processes via genetically modified cells. Copaxone was approved under the New Drug Application, which covers small molecules, and not a Biologics License Application.
Given Copaxone’s complexity, Teva believes unpredictable differences between a proposed generic product and the brand could lead to an immune response in patients, the company spokesperson said.
Generic launch delay possible
The ball is now in the FDA’s court when it comes to generic launch timing, Gould said. He added he would be surprised if the agency rejects the ANDA. The feasibility of a May 2014 generic launch depends on how far along the FDA is in reviewing Momenta’s application, Fishman noted.
Considering Copaxone has been characterized as a pseudobiologic, the agency could be slow to approve it, Drake said. The generic filers will likely pressure the agency to make a timely decision, she noted.
Launch timing also falls on Momenta. Drake added. It is unclear if Momenta is ready to launch at ANDA approval as the company has not been releasing a lot of promotional material, she noted.
New dosing formulation will not affect generic launch
On 30 May, the FDA accepted for review a Copaxone supplemental NDA for 40mg/1mL, a higher concentration dose three times a week, a Teva spokesperson said. Regardless of the new dosing strategy, the original dose can be launched as a generic, attorneys noted.
There are two issued patents (US Patent Nos. 8,399,413 and 8,232,250) and at least one pending application for the new Copaxone dosing regimen, Gould noted. These patents cover administration of subcutaneous 40mg over seven days with at least a day between each dose, he said.
“I don’t think these [patents] will affect the generic launch for the 20mg injection, but if the new dosing regimen is approved and is significantly superior, Teva will be better able to preserve its Copaxone franchise,” Gould noted. The patents for the new dosing regimen will not expire until 11 February 2030, plus there would likely be six months of pediatric exclusivity after that date, he added.
Teva’s market cap is USD 32.9bn.
http://www.ft.com/cms/s/2/1657223a-0f24-11e3-ae66-00144feabdc0.html#ixzz2dDHse242
very good. I always enjoy Ganesh presentations.