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Even if MYL no longer felt it had a viable Copax, they may have decided that it was in their interest to continue to pursue these patents just for the PR value to offset the negative press on EPI.
It would make for an uncomfortable relationship if MNTA had to sue MYL if the latter actually get their Copaxone approved.
The below comment doesn't match the link which is for Copaxone.
#msg-118423273 Lovenox patent trial scheduled for 9/26/15 (if not mooted by IPC)
Among other things, the price of 40-mg Copaxone rose 7.9%, while the price of 20-mg Copaxone was not raised.
TEVA can't be too aggressive on pricing the daily or they'll risk more patients moving from the thrice weekly. The potential for switching means the normal competitive dynamics on the daily may not apply.
Do you really think TEVA wants to start a price war on their top seller?
BMO on AMP (July 21 research report):
Some progress on Biosimiliars (not MNTA but at least there is progress in the field):
U.S. paves way for Novartis to copy Amgen biotech drug
U.S. paves way for Novartis to copy Amgen biotech drug
MNTA said they would aggressively build inventory after May 24 so Mylan might be doing the same thing. In that case it would make sense for Natco to be going up if they're the supplier.
Any chance that FDA is holding back MNTA to approve both generics at the same time?
Canadian submission. Was this expected? Is this what's driving the price today? Has GILD done a Canadian submission?
http://finance.yahoo.com/news/abbvie-files-drug-submission-health-114500457.html
The important news is that MNTA won't be at risk of bankruptcy if TEVA eventually wins. All that's at risk is the Copaxone revenue stream. That wasn't clear to me before the CC.
Feuerstein on ONCY:
http://www.thestreet.com/story/12030933/1/oncolytics-pumps-stock-with-worsening-lung-cancer-drug-data.html
Oncolytics Pumps Stock With Worsening Lung Cancer Drug Data
CALGARY (TheStreet) -- Oncolytics Biotech continues to mislead investors about the clinical profile of its experimental cancer drug Reolysin. The company's latest stock-promoting stunt: Issuing a press release Monday (ONCY_) claiming "positive final" results from a mid-stage study of Reolysin in lung cancer. Reality check: The new Reolysin data are actually worse than what Oncolytics reported last March.
Oncolytics says the final analysis of the phase II study involves 25 patients with squamous cell carcinoma of the lung. All the patients were treated with Reolysin in combination with the chemotherapy drugs carboplatin and paclitaxel. The study has no control arm, making results clinically meaningless.
Per today's press release, of the 25 patients evaluated, 10 patients showed partial tumor shrinkage, equal to an overall response rate of 40%.
Last March, Oncolytics reported results from 21 patients in the same study. At that time, nine patients reported partial tumor shrinkage for an overall response rate of 43%.
So, in about five months, Oncolytics managed to enroll another four lung cancer patients into this trial, with just one additional tumor response.
Oncolytics actually first reported results from this lung cancer study in February. At that time, the company had enrolled 20 patients with 9 showing tumor shrinkage, or an overall response rate of 45%.
According to ClinicalTrials.gov, the Reolysin lung cancer study was designed to enroll 55 patients. The study is no longer recruiting patients, so if today's results are "final" -- as Oncolytic claims -- where are the missing 30 patients?
-- Reported by Adam Feuerstein in Boston.
You may want to change your post footer as well.
There is no reason to suppose that MNTA management has any special insight into what the Supreme Court will do.
Given that the Chief Justice wrote such a scathing minority opinion and given that the legal community feels its such an important case (based on my reading of legal blogs, some of which have been posted on Ihub) and given that the Momenta and Classen decisions are seen to conflict, I still expect the Supreme Court to take up the case.
Do ASCO members see them earlier?
Cool. Thanks. EOM
Is there any reason for this ridiculous sounding name "Talimogene Laherparepvec"? Are either of these actual words (not in the on-line dictionary I checked) or does Amgen gives its drugs surnames?
You don't think Dew has 37 relatives?
I think short covering may be driving the move today. There were greater than 6 MM shorts last time I checked. The neo adjuvant theory is welcome as long as its not a bait and switch - the primary driver of value has to be the OS results in the primary H&N trial. Agree with you that this patient population is likely close to that in the H&N trial so I do view this as positive, but the market reaction seemed to overdo it.
I'm long but surprised by the market reaction to this (up 27% right now). It's not that much different from the earlier PR at 15 patients that showed disease control rate of 87%.
The lower netback is almost entirely due to the lower Brent price which was expected. Not a bad report but they're spending more than their making and they may be close to using up their debt facility.
Reasoning from a layman fwiw: Mets tend to have very high RAS activation even if the primary tumor is not RAS active. I would think they may also have less non-tumor connecting tissue just because they would be of recent origin versus the primary tumor which may have been growing for years. This may then make it easier for the virus to penetrate / spread through the tumor.
The ONCY presentations have contained scans from many different studies showing metastatic lesions with large responses without necessarily seeing much of a response in the primary.
I think the mets are much more important to overall survival than the primary tumor so I think overall survival may be good in both groups even if PFS is much better in the mets only group.
I'm disappointed by the delay. I've never seen this type of trial change before but since the data is still blinded, I don't see any reason to believe it's a failure. In fact, given the long time to PFS, I'm inclined to think the drug is working very well (and yes I've seen many trials where the control group did much better than the supposed historical numbers so I'm well aware of that possibility as well).
I added 5% to my position today at 2.23 $C, hopefully for a short term trade and I plan to keep my core position until we get results on this trial.
If by RAS status, you mean KRAS, its because they believe the drug works in a broader population than just KRAS mutant. If you mean "RAS ACTIVATED", is there a readily available test for this?
Also, which tumor do you test? If the primary tumor is not RAS activated, the mets probably are so the drug would still be expected to provide a benefit.
I agree with the article on one point - the company has not properly communicated with investors.
Its interesting that a guy with that background would come in at a VP role.
Insect regulators wouldn't have to worry about covering their butts (because they can see 360 degrees) so they'll approve based on the science and not on political considerations.
Virtually identical wording to the NR for the Teva suit except for the defendant name and the last part of the CW quote:
Today's PR:
Momenta Pharmaceuticals Sues Amphastar for Patent Infringement
CAMBRIDGE, Mass., Sept. 21, 2011 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that it has sued Amphastar Pharmaceuticals, Inc., Watson Pharmaceuticals, Inc. and International Medical Systems, Ltd. in the United States District Court for the District of Massachusetts for infringement of two Momenta patents. The patents cover the company's innovative methods of producing enoxaparin sodium, which assure that the commercial product meets standards for identity and quality. One patent, U.S. Patent No. 7,790,466, is related to methods of processing enoxaparin to determine the presence of certain tetrasaccharide structures. The second patent, U.S. Patent No. 7,575,886, is related to methods of analyzing enoxaparin for the presence of a certain structural signature.
"Momenta has made a substantial investment in the development of novel methods that make it possible to assure the quality of complex products such as enoxaparin sodium," stated Craig Wheeler, President and Chief Executive Officer of Momenta. "This is the second lawsuit we have filed with the intent to vigorously enforce these patent rights and protect our investment in innovative science."
Teva PR
Momenta Pharmaceuticals Sues Teva for Patent Infringement
CAMBRIDGE, Mass., Dec. 2, 2010 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that it has sued Teva Pharmaceutical Industries Ltd. in the United States District Court for the District of Massachusetts for infringement of two Momenta patents. The patents cover the company's innovative methods of producing enoxaparin sodium, which assure that the commercial product meets standards for identity and quality. One patent, U.S. Patent No. 7,790,466, is related to methods of processing enoxaparin to determine the presence of certain tetrasaccharide structures. The second patent, U.S. Patent No. 7,575,886, is related to methods of analyzing enoxaparin for the presence of a certain structural signature.
"Momenta has made a substantial investment in the development of novel methods that make it possible to assure the quality of complex products," stated Craig Wheeler, President and Chief Executive Officer of Momenta. "We intend to vigorously enforce our patent rights to protect our investment in innovative science."
I don't have the full reports. BMO may provide them if you call. Only, the summaries are publicly available.
Looks like BMO must have a new biotech analyst. The link below has a short summary of his opinion on the below companies.
http://www.bmonesbittburns.com/IA/IAHomepage/NewsToBrowser.asp?IA_ID=NCHOWBAY&LANGUAGE=EN&NEWS_ID=426&VERSION=305
Initiating Coverage
Chefs’ Warehouse: A Long Runway for Growth K. Short 8
Amgen: Initiating Coverage With Outperform Rating J. Birchenough 12
Ariad Pharmaceuticals: Initiating Coverage With Outperform Rating J. Birchenough 14
Cardiome Pharmaceuticals: Initiating Coverage at Outperform J. Birchenough 16
Celgene: Initiating Coverage With Outperform and $90 Price Target J. Birchenough 18
Halozyme Therapeutics: Initiating Coverage With Outperform Rating J. Birchenough 20
Human Genome Sciences: Initiating Coverage With Outperform Rating J. Birchenough 22
Isis Pharmaceuticals: Initiating With Outperform Rating and $15 Target J. Birchenough 24
Regeneron Pharmaceuticals: Initiating Coverage With Outperform Rating J. Birchenough 26
Rigel Pharmaceuticals: Initiating With Outperform Rating and $17 Target J. Birchenough 28
United Therapeutics: Initiating Coverage With Outperform and $54 Price Target J. Birchenough 30
Amylin Pharmaceuticals: Initiating Coverage With Market Perform J. Birchenough 32
Arena Pharmaceuticals: Initiating Coverage With Market Perform J. Birchenough 34
Array BioPharma: Initiating With Market Perform Rating J. Birchenough 36
Gilead Sciences: Initiating Coverage With Market Perform Rating J. Birchenough 38
NPS Pharmaceuticals: Initiating Coverage With Market Perform Rating J. Birchenough 40
Onyx Pharmaceuticals: Initiating Coverage With Market Perform Rating and $34 Target J. Birchenough 42
Synta Pharmaceuticals: Initiating Coverage With Market Perform Rating J. Birchenough 44
ZIOPHARM Oncology: Initiating Coverage With Market Perform J. Birchenough 46
Biogen Idec: Initiating Coverage at Underperform With $74 Price Target J. Birchenough 48
Genomic Health: Initiating Coverage at Underperform J. Birchenough 50
The article was implying that Sanofi's actions delayed the approval. If so, it cost MNTA a lot of money.
There must be some suggestion that their actions were illegal or they wouldn't feel the need to come out and say it was legal.