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Why would there be?
Also, from what I've heard Sanofi has been ultra aggressive with pricing as it is.
It's been sent back to the lower court:
"Under the correct interpretation of 35 U.S.C § 271(e)(1), Momenta’s admission that Amphastar’s testing is carried out to “satisfy the FDA’s requirements,” Appellee’s Brief at 40-41, makes it unlikely that Momenta will succeed on the merits of its infringement claim."
"The district court’s findings with respect to the irreparable harm, balance of the hardships, and public interest factors were all, to some extent, predicated on its erroneous conclusion that Momenta’s patent was likely infringed by Amphastar’s product.
"Because Momenta has not established a likelihood of success on its claim of infringement, the preliminary injunction must be vacated. On remand, the district court may want to consider whether Momenta’s admission that Amphastar’s use of the patented invention is to “satisfy the FDA’s requirements” makes this case amenable to summary judgment of non-infringement in favor of Amphastar."
] MNTA Appeals Court vacates and remands district court ruling in Momenta vs Amphastar case ($14.05 -$0.07)
The 2015 patent is not an orange book patent silly. But the point stands that as of right now they can't sell until Sept 2015 which sucks but isn't the end of the world because getting copax approved is ultimately more important then when they can sell. However, and I'm sure youll disagree with me, but IMO MNTA overturns the 2015 in appeals.
In other news,, if MNTA gets copax approved and all the patents are upheld, MNTA will still have between $280m-$300m cash on hand by Sept 2015. Not bad.
all in all a good sign then about the program's progress, yes? Especially considering how quickly they exercised it.
Solid revenue from enox, but expenses were certainly on the high end at 32.4m (2.9m from litigation). Wasn't RS's top end range 28m?
Also, this is pretty interesting... Does the one below fall into the profit split category?
Momenta announced today that Baxter selected a third biosimilar product to be developed under the collaboration. Momenta has initiated development of this product, a monoclonal antibody for oncology, which has been designated as M511.
I'm bored at an airport so will give this a shot, although it is extremely silly and one could just look in the last 8k which I'm sure lists all these:
FDA requires full fledged trials for M-Copax
Mylan gets their copax approved before MNTA or at same time
MNTA loses all appeals including sept 15 patent
Judge rules Amphastar is nor infringing on MNTAs patents
TEVA gets their enox approved
MNTAs FOB program requires massive, expensive trials and Baxter drops them
MNTAs enox gets hundreds if people sick leading to multiple deaths
Amphastar poisons MNTAs bagels used during bagels with CW session
If, and its a big if, MNTA were to win, I'd be more than happy with 35% of the damages which I imagine would be north of 100m for MNTA by the time the trial is decided and also the further confirmation about the strength of MNTAs IP. But I think we need to get past the trial first and foremost :P
WPIs 10% of the market approach is certainly curious. I've also heard that Sanofi has been unexpectedly ultra aggressive with pricing, which may be contributing to WPI not wanting to go to far in the retail (not sure I buy that reasoning). But I certainly think the wait and see theory holds water.
I also know that WPI is doing as little as possible with regards to lovenox. They've been very hands-off thus far.
Also, WPI seems pretty confident they would not be liable for any damages per their contract with Ampha. Is that confidence unfounded as clearly if MNTA did win the patent trial, Ampha would not be able to pay. I guess I'm not exactly sure as to how the courts would go after WPI.....
Also, what the heck happened to that $200m in product that was "about to expire"??!?
Thanks for posting floblu...
I know some folks take issue with these being posted, but I find them helpful.
IMO The sheer number of new jobs reflect a company that is confident in its future growth and sustainability.
UBS downgrade: reason for drop here?
http://www.ims-limited.com/
In 1968, IMS began business with the launch of unit dose emergency drugs. Over the years, the company continued its growth through the licensing of their products to major manufacturers of drugs and health care products.
In 1998, Amphastar acquired IMS from Medeva, PLC, a London based pharmaceutical company. Under Amphastar's management, IMS experienced tremendous growth in research and development.
IMS is a federally registered manufacturer of sterile injectable pharmaceuticals. These sterile injectables are used with a wide variety of IMS delivery systems, including prefilled syringes and vials.
IMS maintains an excellent regulatory/cGMP compliance record and has a wealth of experience in dealing with Federal, and local regulatory agencies. Our facilities are registered and inspected regularly by the United States Food and Drug Administration (FDA), the United States Drug Enforcement Agency (DEA), and the California State Food and Drug Board.
I would say this is definitely not standard and IMO shows the quality of company Amphastar is.
Actually, not sure where I got Sept for the major amendement. lol. It looks like MNTAs amendment date is blacked out
Interesting point on "major amendment" in September 2011. From this it seems to be a work-around to TEVA's patents, but I would of figured any "major amendment" would need to be announced by MNTA?
I know and I don't know why I respond to IO's posts. :P
Interesting point about those planned sales OB. But as jbog likes to bring up, they could stop them at anytime...
Pictures!
I've never actually seen what they look like. lol
The 50m was a serious is misquote by seeking alpha. Rick Shea recently said q burn rate going forward will be 22-28m. Enox should bring in 12-15m a q so the ultimate burn rate would be 7 - 16m a q, which would would certainly rip into MNTAs 400m, but not completely deplete by the 2015 worst case scenario (it's still not clear if 2015 process patents will hold).
So even if MNTA had won, it would of been a tentative approval with all the appeals right?
Could one of Amphastar's reason for doing this is that they are trying to develop an alternative to MNTA's test while they are in fact using theirs right now?
Question on appeals process: Is it often that the one appealing will win in a patent case like this?
TEVA has won the patent case against MNTA until 2015....
TEVA has won the patent case until 2015....
TEVA is up A/H.. I'm gonna assume mnta lost the patent case
MNTA pretty impressive today all considering...
Related to OPEX I imagine
Can Amphastar conceivably keep dodging MNTA's request for discovery for the next 6 months like they have the first 6 months?
Then I would agree that 30% seems quite high if they never intend to do so and especially with a generic coming any day that would lower the cost of the daily :)
Does TEVA have a trial currently going on against daily Copaxone?
TEVA thinks they could nab 30% (from an analyst report I get):
"Our conversations with Teva management as well as physicians indicate that around 30% of the Copaxone franchise could be converted to the less frequent dosing regimen should it ultimately receive FDA approval."
It goes on to say that they expect TEVA to file for approval this year, FWIW.
Thanks mouton. I would think the court would have to grant MNTA the extra time considering how difficult Amphastar has been. Is Amphastar's behavior pretty normal for a discovery case?
DD,
can you or someone else elaborate on why CW stated that losing some in the trial might actually make them stronger in the appeals process?
a very thorough prediction :)
Any idea on the quite long delay on the CAFC's final ruling? Does it normally take this long? Any insight into why?