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Leerink's analyst comments very interesting
inequitable conduct case is still not lost
and the other arguments also seem potent
interesting:
"MNTA also states that their formulation does not exhibit lower toxicity than TEVA's formulation having an average molecular weigh about 8.6kDa. "
Lovenox Characterization-Question?
http://worldwide.espacenet.com/publicationDetails/description?CC=US&NR=2009061411A1&KC=A1&FT=D&date=20090305&DB=EPODOC&locale=en_EP
Here are some key novelties of the patent:
1. Characterized P8 for the 1st time
2. Discovered P8 is directly correlated to anti-Xa or anti-IIa activity
3. Found that reference batch of Sanofi's Lovenox is not randomly heterogenous from batch to batch but has the specific mole% of p1, p2......p8 within an acceptable tolerance of variation - This is structural characterization
4. 3 is actually a function of starting material and putting that quality control check when selecting the starting material would be useful to decrease batch-batch variability, and thus decrease the number of rejected batches- This is the Quality Control check
How could another company (TEVA or Amphastar) solve the characterization problem without infringing on this above patent ?
For example point 3, in essence is saying Lovenox is made of these components within a tolerance band of variation for each of those components. How could there be 2 characterization solutions to the same product ? seems impossible ?
I guess point 4) Quality control check of P8 can be avoided by just checking on anti-coagulant activity tolerance. But how could any other company solve characterization puzzle without infringing on point 3).
Relevant Quotes from Patent
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Importantly, very little, if any, unsulfated disaccharide ([Delta]UHNAc) could be detected in UFH.
[0249] In addition to the characterization of the seven disaccharides, we also completed structural characterization of unknown p8. Isolation and sequencing of this oligosaccharide using the PEN-MALDI sequencing approach (Venkataraman, et al., Science 286:537-42 (1999)) indicated that p8 is a tetra or penta sulfated, non/mono acetylated tetrasaccharide comprising of one or more of the following: [Delta]U HNAc,6SGHNS,3S,6S; [Delta]U HNS,6SGHNS,3S,6S; [Delta]U HNAc,6SGHNS,3S; or [Delta]U HNS,6SGHNS,3S.
In some embodiments, the method includes determining if all of the foregoing are present in a preselected range, e.g., peak 1, [Delta]U2SHNS,6S (e.g., 15-85 mole %); peak 2, [Delta]U2SHNS (e.g., 0.1-20 mole %); peak 4, [Delta]U2SHNAC,6S (0.1-10 mole %); peak 6, [Delta]U2SHNAC (0.1-5 mole %); and/or peak 8, I/G HNAc,6SGHNS,3S,6S; I/G HNS,6SGHNS,3S,6S; I/G HNAc,6SGHNS,3S or I/G HNS,6SGHNS,3S or a mixture thereof (e.g., 0.1-20 mole %). In one embodiment, the dose or amount to be administered to a patient is adjusted depending on the level of peak 8 present; e.g., to maintain the levels of anti-Xa/IIa activity, e.g., to maintain a dose of 100 IU of anti-Xa activity.
[0254] Peak 8 as an Indicator of Anticoagulant Function. To test whether quantification of 8 could be used to predict anti-coagulant function, we plotted the anti-Xa or anti-IIa activity of UFH and LMWH's versus p8 content. Plot of Anti-IIa and Anti-Xa values of UFH, UFH size fractionated through Bio-gel P10 column, a LMWH generated in our laboratory, and commercial LMWHs demonstrates there is a linear correlation between the anti-Xa/IIa values, and the mole % of p8 of the preparation. Thus the anticoagulant and antithrombotic efficiency of heparin and LMWH can be estimated from their chemical composition. In the case of the anti-Xa activity, p8 content showed a very good correlation with activity (r<2> =0.8) (FIG. 2). An even better correlation (r<2> =0.9) was observed when anti-IIa activity was plotted versus p8 content. Importantly, this correlation holds regardless of the source of the UFH or LMWH and the means by which the LMWH is generated. Thus, these results demonstrate that a particular structural motif, identified by CAM, e.g., peak 8, can be used to predict both anti-Xa and anti-IIa activity.
LMWH Preparations with Low Batch-Batch Variability
[0293] One of the great drawbacks of the UFH and LMWH preparations currently known in the art is their great variability in both composition and in activity. This has limited the population of patients for whom LMWH or UFH therapy was indicated, for instance excluding patients with abnormal renal function, among others. Abnormal renal function is measured by urea, creatinine, phosphorus, GFR or BUN in blood and urine. Administration of the known LMWH preparations is often a trial and error approach of titrating the appropriate dosage based on inaccurate tests, which can lead to unwanted and severe side effects such as post-operative bleeding. It would be greatly desirable to have a method for making LMWH preparations with low batch-batch variability and a desired structural signature. The methods of this invention allow for the creation of such preparations.
Methods.
[0294] Several enoxaparin preparations were depolymerized by a cocktail of enzymes, including heparinases. Next, a capillary electrophoresis (CE) profile of the resulting digest was run in an Agilent CE instrument in the negative mode. Shown in the table below are the disaccharide building blocks seen in three batches of commercially available enoxaparin. The composition is expressed as mole % of the building blocks of enoxaparin. This table teaches the composition as a mole % of the constituent building blocks. In, other words, one mole of enoxaparin is composed of X1 mole % of disaccharide building block 1, X2 mole % of disaccharide building block 2, . . . , XN mole % of building block "N". X1+X2+ . . . +Xn=100. The variation was calculated by taking the average of the three values, and dividing the largest deviation by the average.
[0000]
TABLE 10
Enoxaparin Batch-to-batch Variation, mole %.
Enox. Enox. Enox. Variation
Saccharide Batch 1 Batch 2 Batch 3 (%)
p1 60.8 63.5 63.6 4
p2 7.0 7.2 8.3 17
p3 11.8 10.8 11.3 9
p4 2.5 2.1 2.0 23
p5 3.6 3.5 3.5 3
p6 1.8 2.0 1.8 11
p7 5.4 4.3 1.9 91
p8 6.6 5.8 6.4 13
p9 0.2 0.4 0.5 82
p10 0.3 0.4 0.7 86
[0295] The table above demonstrates that the variation between batches of commercially available enoxaparin (Lovenox(TM)) is substantial. To alleviate this problem, the methods of the current invention alleviate this problem by providing a method for quality control.
Results.
[0296] One example, not meant to be limiting, of the application of this method is as follows. First, a desired reference structural signature, mole %, or activity is selected, based upon a standard preparation that has, for instance, the desired activity at desired levels. Using the data for mole % of peak 8, for example, 6.5 mole %. Within the scope of the invention, each batch of enoxaparin that is manufactured would then be subjected to the analysis methods of the invention, to determine the mole % of 8. Batches of enoxaparin that fell within a given variation of the desired range would be accepted; those that did not would be rejected. Again taking the data from table 10 for an example, if the desired mole % is 6.5, and the acceptable variation is 5%, then only those batches with a mole % of the peak 8 tetrasaccharide of 6.5+-0.3 would be accepted. Thus, Batches 1 and 3 would be acceptable, but Batch 2 would be rejected as having insufficient levels of p8 (and thus insufficient levels of anti-Xa activity).
"4) Amarin also has an old comp patent for AMR 101 for huntington's disease or neurological conditions(I think)... "
I think you are mixing things.
Comp patent is a Comp patent. I believe your reference to "non-disease specific" patent is prolly the Comp patent.
Comp patent has nothing to do with MOU patent.
The recent patent rejection letter was on MOU patent for trigs. Mochida had a pure EPA patent(may not be exactly AMR101-as you say there may have been DHA in epadel and its purity may not be >96%) for treating trigs(albeit <400tg)
MOU patent rejection for treating trigs without increasing LDL - was also a surprise to me.
10nis
Questions for you since you think this management is the best
1. Do you think management significantly can increase or decrease value in any business ?
2. Do you know how the internal R&D was used for the year 2010 (split b/w various programs) ?
3. Do you know if the management's priorities on internal and external R&D focus has always been 100% perfect ?
I think there is a question to be asked on why they spent 35m(external R&D) and internal R&D(they don't even report this detail by programs) on the new drugs -
Couldn't they have measured the partnership interest or lack of it beforehand before investing internal and external R&D ?
They publicly have said that they would not be funding the phase 3 clinical trial (not even 20% of current hoard {which is nearing 400m} is worthwhile investing in phase 3 clinical trial-however they think they can rope in a partner to fund this and take it to Phase 3 - Isn't that ironical ? lets see which sucker will come forward to partner)
4. In answering question on share buyback, the CFO of the company equates buyback action to what may result in temporary pop in price, which is ridiculous. Is he saying all companies that buyback shares do it to cause a temporary pop in their price ?
You buyback shares of your own company because you know the risk better than anybody, you control the company's future and if you think it is undervalued you buy back to add permanent value to shareholders.
Cash hoard is nearing 400M and earning 0.1%...Cash is enough to support the business for another 7 years at it's current expense rate and even assuming Teva Lovenox.
So the CFO is implying that the company's shares are NOT worth investing considering the risk and doesn't think the shares are undervalued. Not even 100m of 400m cash could be used to buyback shares..it's just not worth it (And here you are touting the value of MNTA)
5. Do you know what the management's priorities on internal and external R&D in year 2012, 2013, 2014 post copaxone ?
So should we assume this company would be spending 90m/year post copaxone launch ? Would all the 90m/year go towards developing FOB ?
After Copaxone what and when will be the next event that would bring in revenue for this company ?
6. Why is it that the 10-k for 7 years(2004-2010) mentions they had active FOB program ? How much of the internal R&D was spent on FOB program during the 7 year period ?
What has this produced so far (I see 2 patents) and a program which CEO has recently stated is in "very initial research stage"
Trust me, this company should be trading at $30 if the market knows answer to some of these questions. Without knowing any of this, market just assumes that the cash would be used to support R&D programs (right or wrong priorities), that may or may not yield results , that may take 5 years or 10 years to get to market, whose potential could be 100 million or 5 billion and of course also to support Management employment(and bonus) for another 10 years?
Voice from another retail shareholder
"I have lost so much faith in MNTA mgt and their lack of shareholder support i sold out of 50% of my postion this week and will sell 75% of the rest upon copaxone approval"
posts in yahoo: bdover
Hattie,
jmkobers
mEnox- I believe patents could prove to be valuable. see my other post from today. But yes, you are right nobody should believe half-truths(no evidence) being told by some "experts" that TEVA's ANDA is nowhere. nobody has looked at TEVA's ANDA or minor deficiency to say that. But based on TEVA's admission timing of potential approval(if successful) would be end of 2011 or 2012.Merill lynch has modeled it as an event happening end of 2012.
mCopax - I think the approval event could happen in Q1/Q2 2012. Again more a guess. Company says ANDA is under active review. keep in mind, this has the potential of being bigger product. oral competition may take 2-3 years to see how that shapes up
FOB- agreed with what u have. its blackbox in terms of what they have done. CEO tells they are in very initial research stage on that(this was a surprise considering they had this program in their 10-k for 7 years). so i am not sure what money partner would bring and how favorable a deal would it be for MNTA's shareholders.
do not ignore they have around $7+ per share and growing
trust me management can do lot in terms of bringing transparency( unveiling info of how they plan to operate this company going forward(fob investments, timeline, costs, etc). how they intend to use cash. Lack of all this info, lack of strong shareholder friendly management currently reflects on the current price. also, i don't see strong BOD. wheeler pretty much has a free reign. the 2014 copaxone award was an example..there is no sense of urgency. for example, why are they sitting this late in the game to work on "strategy" of how they want to deploy cash..they have currently 375m in cash earning 0.1%. one can easily make a case for buyback..but then the CFO says they don't want to do thing just to "temporarily pop up" the price. ridiculous statement to make to shareholders.. IMO.
With the right management this stock would be trading at 30$ TODAY.
Hattie,Polly
thank you.
polly-i write stuff the way i see it.i am currently long. but could point out +ve or -ve things for the company. (i dont think any msg board writer can permanently influence market).so it is not always +ve. but importantly it is based on info i know and my interpretation of the info;
Ps: i could care less about who has me on ignore!
Process Signature for Lovenox Summary - Patent 2-
my 0.02 cents
MNTA reverse engineers(takes various batches of Lovenox from Sanofi) and tries to find out what should be
1. Starting Material
2. Process & Process conditions to manufacture final product
so when they manufacture it, they get equivalent product to Sanofi's(within band of variance on all important markers)
Both the above parameters can add a characteristic structural signature to the final product.
In this case they are saying that process(oxidation or oxidation followed by treatment with an acid) results in a characteristic structural signature to Lovenox(or the intermediate heparin used to make Lovenox).
They also apparently found that absence of this structural signature leads to risk of coloration and hence reduced shelf life.
Assume
1) Teva or Amphastar's generic does not have this characteristic structural signature(and process of oxidation). Then their ANDA probably will not get approved because their product is not equivalent to Sanofi's
2) Teva or Amphastar's generic suppliers have this oxidation built into their process but do not test for this characteristic structural signature] in their heparin. In this case they have not fully characterized their product and hence ANDA is not approvable.
3) Teva or Amphastar generic suppliers have this oxidation built into their process and also testing for this characteristic structural signature in the end. Then it is likely they maybe infringing on this MNTA patent.
I am starting to think the blocking value of these characterization patents has been underestimated by market.Anybody? North400000?
Process Signature for Lovenox - Patent 2
Prior message was "starting material signature". This one is "structural signature due to process".
This potentially could be blocking for the suppliers of TEVA's or Amphastar's if for example their process uses oxidation conditions and in the end they look for this peak 2.10 ppm to do Quality control check on "shelf life" of the heparin...(??). Apparently the presence of this structural signature will not make the heparin not at risk of coloration. Risk of Coloration can affect Shelf life and the Quality of Lovenox.
I am starting to think the blocking value of these characterization patents has been underestimated by market.Anybody?
if teva/amphastar don't have this Quality control check built in their product, I guess they don't have control on shelf-life of the product and hence maybe their product doesn't measure up to reference standard of Sanofi's Lovenox. If they have it and they test for it, they would be infringing ?
-----------------------------------------------------------------
0002] In one aspect, the disclosure features a method of identifying if a process was used to make a heparin preparation (e.g., an unfractionated heparin preparation or a low molecular weight heparin (LMWH) preparation). The method includes:
determining if a structural signature associated with a peak in the N-acetyl region of a 1H 1D-NMR spectra, e.g., a structural signature associated with the peak at 2.08 ppm of Figure 9 and/or the peak at 2.10 ppm of Figure 1, is absent from or present in a heparin preparation wherein the presence of the structural signature indicates that the heparin preparation was made by a method (e.g., a method that includes oxidation or oxidation followed by treatment with an acid) and the absence of the structural signature indicates that the heparin preparation was not made by the method (e.g., the method did not include oxidation or oxidation followed by treatment with an acid); and
making a decision or step regarding the heparin preparation if the heparin preparation was made by the method (
[0062] In another aspect, the disclosure features a method of determining if a heparin preparation (e.g., an unfractionated heparin preparation or a low molecular weight heparin (LMWH) preparation) is at risk for coloration, comprising:
determining if a structural signature associated with the peak at 2.10 ppm of the <1>H 1D-NMR spectra of Figure 1 is absent from or present in a heparin preparation wherein the presence of the structural signature indicates that the heparin preparation is not at risk for coloration and the absence of the structural signature indicates that that the heparin preparation is at risk for coloration; and
making a decision or step regarding the heparin preparation if the heparin preparation is not at risk for coloration, e.g., the heparin preparation is classified, selected, accepted, released, processed into a drug product, shipped, moved to a new location, formulated, labeled, packaged, released into commerce, sold, or offered for sale, or if the heparin preparation is at risk for coloration, e.g., the heparin preparation is discarded or withheld.
00115] The disclosure is based, at least in part, on the finding that peaks within the N- acetyl region of a 1H 1D-NMR spectra of a heparin preparation are associated with characteristic structural signatures which reflect the process used to make the heparin preparation. For example, the presence of a peak at 2.10 ppm in a <[Chi]>[Eta] 1D-NMR spectra of unfractionated heparin represents a characteristic structural signature that is reflective of an oxidative processing step in the manufacture of unfractionated heparin
[00116] In some embodiments, a method described herein can be used to determine if a heparin preparation (e.g., an unfractionated heparin preparation or a low molecular weight heparin (LMWH) preparation) is at risk for coloration. Some heparin preparations have limited shelf life due, at least in part, to the development of color is the preparation during storage.
00142] These experiments described above show that the peak at 2.10 ppm in the <X>H 1D-NMR spectra of heparin is not OSCS and instead is a characteristic structural signature that is reflective of an oxidative processing step in the manufacture of unfractionated heparin. Based upon the experiments described above, the scheme provided likely results in structures A and B of Figure 16
[00143] In conclusion, it was found that oxidation conditions result in the conversion of N-acetylglucosamine residues at the reducing end of heparin chains to an N- acetylglucosaminic acid which yields a characteristic signal at 2.10 ppm in the iH-NMR spectrum of the heparin. Therefore, this signal does not arise from an impurity or contaminant present within heparin, but rather represents a part of the heparin chain itself.
[url]
worldwide.espacenet.com/publicationDetails/description?CC=WO&NR=2011090948A1&KC=A1&FT=D&date=20110728&DB=EPODOC&locale=en_EP[/url][tag]PATENT[/tag]
"The PTO examiner has not met his burden of proof to show that EPADEL produces merely the expected results. "
I thought the same. Who has the burden of proof here ?
Is it the inventor that has to prove "this is an unexpected result"
or the examiner that has to prove "this is not an unexpected result"
? Bottomline is as you said there is no EPADEL data TG>500 ON LDL effect
Also, what is your thought on the other finding: Is having >96.5%EPA to treat patients TG>500 OBVIOUS if EPADEL (91% and sometime later 95%EPA) was used to treat TG <500
Do you know about the Mochida patents ?
Patent issues
1) Treatment of people with TG >500 using AMR101 which is 96.5% EPA is obvious based on prior art.
Katayama and other teach that. Amarin argues EPADEL would have used 91% but then examiner gives another reference.
Now Amarin says for Katayama and other reference patients TG < 400. Examiner says that it is obvious finding that higher TG can also be treated , if lower TG patients can be treated
2) Treatment of people with TG>500 using AMR101 does not increase LDL unlike other TG lower therapies. Examiner says this is not an unexpected result as there is no data on EPADEL and one cannot say this is an unexpected result
I have the following questions:
1. EPADEL COM Patent - 91% EPA and if it has expired or not?
2. EPADEL for treating <500 trigs - has it expired or not ?
I also read EPADEL has a recent patent for preventing CV risk. That may pose a big challenge too for AMR101 for broader CV indication after REDUCE-IT trial
Did you see Lovaza reach Final rejection before it's patent got approved
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=tm&bn=998&tid=56722&mid=56722&tof=5&frt=2
Floblu- found a link below that maybe of use to you
Here is a solution to your question
"so that MNTA's cash hoard grows larger than its market cap"
Don't understand the logic. Why it is only reasonable for a company to buyback only when the cash hoard >= marketcap. but that's just me. IMO, based on business risk you are running, one should do a reasonable estimate for what cash is needed and then use rest to buyback if shares are undervalued.
ok.vinmantoo
"It is a prudent business practice to keep a good cash hoard and keep in growing as insurance against unexpected negatives"
So you are saying the company infinitely(or 7 years) keeps hoarding cash quarter after quarter as insurance against unexpected negatives !?!
Let's stop it at that. I have heard your arguments and you have heard mine. Nuff said
Has Joseph Schwartz commented anything on patent issues?
vinmantoo
buddy, where I did compare the risk of FOB to new drugs? I compared it to what MNTA has been doing..which is characterizing complex drugs and getting it approved without doing ANY CLINICAL TRIAL.
anyway the rest of your entire argument rests on "M-copaxone is delayed then MNTA is still completely reliant on M-enox"
I am relying on what company stated for the reason they diluted in Nov 2010. They claimed they want to be absolutely certain they can handle the worst case scenario which is copaxone approval not until 2014. The company is confident on Copaxone approval. FDA has rejected 3 CP's from teva. Company is saying FDA review is going well on this ANDA. We all know the company is currently hugely undervalued if you consider certainty of Copaxone approval
"You want MNTA to do what will benefit you now at the expense of the company's long term prospects and long-term investors"
Anybody can make a cliched statement. I am asking does it make sense to put part of the huge cash (150m) in less risky(Copaxone approval) that is almost guaranteed to provide/maximize return within next 3 years
OR should they sit on this huge cash entirely earning at 0.1%(350m)
OR should they throw 200m of 350m in higher risk FOB that is may or may not return high dividends after minimum waiting time of 7 years ?
MadcityClone - who is "We"
I got 3 more friends invested in this. I made them bunch of money in General growth, Amarin and now hopefully MNTA .
vinmantoo
When I invested in MNTA, I invested knowing fully an event like TL is a possibility. But I also was/am confident that a generic Copaxone will be a reality at least by 2014. I say that because the management keeps saying they have all the things in the ANDA package: structural sameness criteria,immunogenecity data, several biomarkers, etc. They also have hindsight and advantage of having generic Lovenox approved. I have also looked at their 2 patents on Copaxone...which confirms their statement "it is a broader bio-characterization story"
Copaxone launch can rake in 400m in earnings for MNTA. And even with a third entrant can rake in significant earnings (considering this is 50% contractual profit. period). Even with oral competition it is possible that generic Copaxone can rake in >100-200m So current price is way too undervalued considering a generic copaxone launch. Hence a buyback makes a ton of sense.
FOB is risky for all the reasons I have mentioned. I am not saying they don't invest in FOB at all. I am saying they carefully calibrate those investments and not throw big money at it, and certainly spin off and get partner(s) to fund it for a stake. Also, keep in mind the earliest date when you can reap fruits of FOB is 2017 or 2018 of course if successful(a good 6-7 years from now). With all due respect, lets not lose the perspective of time: some shareholders that are here today may not even exist then
"You keep talking about TEVA getting T-lovenox approved in 2011, 2012 or 2013. If that is what you really expect, why in the world would you want to spend the precious cash hoard of MNTA before the supposedly imminent price decline?"
READ MY MESSAGE CAREFULLY. I AM NOT TALKING ABOUT PRICE. I AM TALKING ABOUT VALUE
I don't have to answer on Teva Lovenox. You have to ask FDA person reviewing their ANDA or Teva scientists feverishly working to get all the issues resolved in minor deficiency.
Share Buyback
The company is sitting with >350m in cash earning 0.1%. Based on company's own guidance, the company does not need >150m(in worst case scenario of 3rd entrant in lovenox) to tide through 2014 when generic Copaxone would be launched which is expected to be a bigger product. When the stock is extremely undervalued at $15 per share (considering copaxone launch in 2014) why is the company not considering buying back shares at least with 150m in cash ?
Shareholders are not interested in "temporary pop in price" (as described by your management in a recent conference call). We are interested in buyback because it can maximize value PERMANENTLY to Shareholders considering the current prices.
We as investors believe that the company should carefully calibrate making any big investment in this highly risky FOB business. The ideal way would be spin off this unit and fund it as much as possible via external investors with MNTA getting a stake in the FOB company. As we understand, the first follow-on-biologic, the kind that Momenta wants to make would (if all things go right ) may hit the market no sooner than 2017 (6 years from now). Additionally, Follow on biologics has various uncertainties including: no FDA formal pathway, clinical trials needed, burden of interchangeability may be high both in terms of characterization as well as clinical trials, time FDA takes to review, etc.
In evaluating the 2 ways to utilize cash, the company should consider that buying back shares at these current undervalued prices would result in guaranteed and permanent increase in shareholder value. { Buying back at these undervalued prices amounts to increasing existing shareholder's stake in Copaxone earnings}
Versus
Utilizing cash to augment highly risky FOB business that may or may not result in upside and may take at least 6 years to get a product to market.
We think buying back shares ($150m at these prices of $15 per share) is the most compelling & prudent investment that this company can immediately capitalize on in terms of maximizing shareholder value, without engendering any risk to it's business/operations and should not waste any time doing this.
OMG-Another "out of office" reply from IR
4th in a row. Is this nuts or what !?!
Re: stock_investor
please provide your yahoo id. we can discuss there. your questions are all valid. BTW i started a thread to discuss all aspects of this patent risk here. feel free to comment there.
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=tm&bn=998&tid=56423&mid=56423&tof=6&frt=2
At last a dubious myth that patent trial schedule date portends FDA approval timing has finally been dispelled. Let's all agree TEVA's Lovenox can come by end of 2011 or 2012 or 2013. Nobody knows. Let's stop it at that.
stock_investor - here are my thoughts
first of all good work finding that...that contains prosecution details
Ron is right that a large percentage of cases that get FINAL REJECTION also get their patents granted on appeal....but here again looking at claim by claim is probably important
I looked a bunch of patent granted cases (including the ones being fought in the Copaxone case-They also got FINAL REJECTION and on appeal the patent was granted)
But as an investor one needs to be aware of this patent risk. However, the company at the time of getting SPA for marine and anchor and at the time of 75 million seed investment from venture investors, made sure that FDA would consider this as NEW MOLECULE. So there is no risk in 5 years (and they also say they get that 18 month or 2 years ped exclusivity i think - not sure on this).
The company claims to have a ton of patent apps around this...It is possible that may come up with PR detailing out this to the market. I am not selling this. My 1 year holding period will end this month...So I may sell after that. But considering all the above facts, I think at this price I am still going to hold on to this.I did read the prosecution details word by word . Thank you for posting it.
http://portal.uspto.gov/external/portal/!ut/p/c5/04_SB8K8xLLM9MSSzPy8xBz9CP0os3hff1NDc1NLYwN3SzcDA08PwyD_YF8zINcYKB-JW97AiCLdBgR0h4Nci992vPIGEHkDHMDRQN_PIz83VT9SP8ocpylGZvqROanpicmV-gW5oREGmQEZgY6KigBnIW_S/dl3/d3/L0lJSklna21DU1EhIS9JRGpBQU15QUJFUkNKRXFnLzRGR2dzbzBWdnphOUlBOW9JQSEhLzdfTU81MTc1OTMwRzlGMDBJSDFST1NNNjMwMjYvMWtFbkc2MDAwMDA4NC9zYS5nZXRCaWI!/
Ron - do we know which claim(s) were rejected ? is it because EPADEL had a worldwide patent on those claims ? i think 7 years of exclusivity is still guaranteed (FDA 5 for new drug +PED exclus)
jbog- what do u think of today's presentation(deja vu,eh?!)? do u think there will be a white knight or an activist fund - with the kind value MNTA presents at the moment . It was ironical to see Shea's tone turn to sorta "helpless tone" when question was asked on buyout: "Yes we are public company"...
BTW I don't see this management doing anything(buyback) for at least another quarter. they will be dithering in the name of working on some "big strategy" for another quarter.
Also, did you see that 2011 objective now does not have FOB partnership?
Also do you know why they spent management time and 30mil(in last couple years ) on M118, when they knew the drug's clinical trial costs was not worth investing?. they are absolutely sure of at least not investing their cash. Did prospect or the market of this drug dramatically change in the last 2 years?
"AMRN has filed "hundreds" of patents"
has to be hundreds of patent claims NOT patents
floblu- your messages on job postings or charts have been a lot of use for our investment
Correction-Yes "highly risky" were my words. For one, the pathway is yet to be finalized. Two, interchangeability requires difficult clinical trials that may or may not succeed. Three, biologics like mAB are more complex that lovenox or copaxone for characterization. Four, due to the above, the period to get a FOB maybe 4-5 years
Also, keep in mind lovenox or copaxone did not require investment in clinical trials.
(Now I was a bit reassured to hear that their strategy is still to rope in partner to fund (at least half) this)
I continue to believe they should spin off this "highly risky" FOB business and get external funding as much as possible, even if the parent company can get small stake in it. I would rather have guaranteed upside on lovenox and copaxone in the mid term (3 years), as opposed to unknown, risky investment in FOB that if(BIG IF) it turns out to be successful may yield upside in 6 years . At least they should try to put in very little cash
100-250m per FOB
when asked about cash:
shea says they will throw the cash savings into highly risky FOB
floblu14-listening to recording
ever get a feel we could as well play the last conf's(or the one before that ) recording ? shea's tone is not helping. these guys don't even need to go to conf now that they are sitting with huge cash
Anything new?
Case#-Inequitable conduct?
Anybody knows case# (in pacer.gov) for the recently concluded inequitable conduct trial
pollyvonwog-this is a good joke. some of you guys talk about 50 cent price increase or decrease. or daily post "sole exclusivity" status. that's a valuable discussion. yet, trying to understand what the expense rate of this company post-copaxone launch is misinformed ? trying to understand the timeline of FOB, or more details on the program is misinformed. trying to ask the company(of which we are shareholders) to provide more info in their future public filings is misinformed. trying to see why share buyback with some of the cash is yet another misinformed discussion to be had. Ok buddy. keep in mind I am not just a poster or moderator of some board or some Ph.D degree holder. I am successful investor with many real multi-bagger (low risk) picks and have beaten best funds by a wide margin in almost 10 years.
Barbara Jones - part 2
http://www.thestreet.com/story/10745945/1/goldman-should-get-fair-shake-from-judge-jones.html
Yet lawyers and other courtroom players who have worked with Barbara S. Jones -- the judge handling the Securities and Exchange Commission's case against Goldman -- describe her as even-handed, fair, apolitical and no-nonsense.
"She's smart, she's fair, she runs a good courtroom and while she has a very extensive government background before she took the bench, she's certainly not going to rubber stamp anything the government does. She's going to handle things according to the law."
The case mostly involved activist investor Carl Icahn and American Airlines (AA_), and he says Jones handled the proceedings in a smart, fair way throughout.
Her highest scores were in even-handedness, punctuality, and involvement in civil-settlement discussions. Her lowest was in "industriousness" and her tendency to be pro-government or anti-government in criminal cases landed right in the middle: A perfect 5.
Judge Barbara Jones Bernie Ebber's trial
I think one cannot rule out the possibility of ruling on inequitable conduct anytime ? Plus, I wonder who that other person(teva employee?) was that testified completely opposite of what Dr Piccasi (Teva's Manager for Copaxone development)
Anybody here read through the transcript of ic court proceedings?
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http://www.nytimes.com/2005/03/16/business/16judge.html
"Despite her early career as a prosecutor, she has a reputation for impartiality, even among defense lawyers.
Throughout the trial, she showed the efficiency that has been considered a hallmark of her 10-year career as a federal judge. By meeting her own self-imposed eight-week deadline for the trial, she made it possible for the witnesses to testify in a civil suit brought by the New York State Common Retirement Fund against WorldCom's bankers, auditor and directors and officers."
"She's very down to earth, very smart, very funny and has a wry sense of humor," said Sara Moss, who worked with Judge Jones in the United States Attorney's Office in Manhattan and is now general counsel at Estée Lauder. "She has a clear sense of right and wrong, but also compassion."
jbog couldn't agree more.
He say's MNTA is undervalued
He say's we should thank the market for these prices and all buy MNTA. This presumes we were not invested in MNTA in the 1st place and were sitting with ton of cash now.
He say's the company(of which we are shareholders), which has boatload of cash now, should not buy MNTA even with 1/4th of it's cash reserve. Keep in mind the remaining 3/4 is more than enough to run this company for another 4 years considering TL.
He equates this company buying 100m of it's stock is equivalent to American consumer throwing money on consumption
We have a great value investor advocate here!
He is another omni-boondogg-ovist