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New patent application
HIGH MANNOSE GLYCANS
https://worldwide.espacenet.com/publicationDetails/biblio?II=0&ND=3&adjacent=true&locale=en_EP&FT=D&date=20170217&CC=ES&NR=2602108T3&KC=T3
Boing X 2
My take after dwelling on the news last night.
A question I have is Scott’s presentation that all appeared to be on track for approval. Two days later not so. I would be steamed, if I were him, about my reputaion and be asking Momenta if they had any the warnings about the problem.
Nest question I have would be was Momenta aware of prior FDA warning of issues as some indicate they give warnings before the letter.
If they were not, why not? That could be a problem for Pfizer if they had not made us aware of prior warnings. Doing a google search they have had a lot of warnings on other drugs. PFE should well be aware of the standards to avoid this kind of problem.
If they made Momenta aware, then why would that not be mentioned as a potential issue prior to approval and what we were discussing with them. All the facts here are going to come out sooner or later once we find out what the FDA letter said.
Who picked PFE? Sandoz or Sandoz and us?
Next, the time frame they expect to correct the problem or problems.
Next any other possible alternatives to speed things up towards approval.
Any agreements that might or might not protect Momenta its shareholders for this delay. I would guess we suffer delay of potential large earned payments and therefore resulting lack of interest earned due to the lack os sales of the 40mg Glatopa drug.
We know there are multiple calls to out right buy our M923. hsIvig is in the wings along with other drugs. I am hanging tight waiting on the CC along with taking a deep breath.
Now is the time for straight clear answers as they know the facts.
Boing X 2
t57,
I forgot to add this is another reason I think Momenta is smart to just discover and develop the drugs and leave the Mfg. production and sales to others. Many less headaches.
Here is hoping there is no agreements to prevent recovery for our damages.
Of note, PFE had no PR on the failure to comply, that I could find, yesterday.
Boing X 2
t57,
Great question that should be answered on the CC.
I am not a sue type of guy but, in this instance loss of180 day exclusivity is a major damage to the shareholders. Also, a further loss of profits until approval.
If there are no agreements stating otherwise, that we can't recover damages, Momenta needs to try and recover damages for the shareholders.
There would have to be no damages on the 180 day exclusivity if no other product is approved within 180 days from the time we get FDA Approval.
There would still be damages from the delay they caused until approval.
Hopefully they answer these questions on the CC. Just all IMHO.
Boing X 2
DewDiligence,
Thank you for your feedback. It is appreciated very much.
Boin x 2
DewDiligence,
Do you have an educated estimate of what kind of offer would be made by multiple parties to outright buy our drug. I go for the partnering as I have stated.
Would the offer be based on a percent of the total sales or a percent of some portion of the total. Any idea?
14 billion in sales a year for Humira.
Boing X 2
floblu14,
Thank you for this important information.
I think MNTA would be smart to do a deal and leave the production headaches and sales force headaches to the partner.
Just keep on developing more drugs, do more deals and rake in more money. Ever increasing cash flow to the coffers. Just my opinion.
Boing X 2
Quite interesting.
Also, thank you to all for the feedback on the cc as I could not get the audio to work. I guess they don’t realize millions of us have Apple Safari and not the other options.
http://www.nasdaq.com/symbol/mnta/institutional-holdings
This only covers to year end and not if 4.6M shorts covered in Feb. Ownership jumped over 1 percent from yesterday when I checked. End of year filings updated last night.
6422000 less 4600000 shorts, provided shorts covered, leaves 1822000 shares to the public per my calculator. Subtract individual investors and 179 institutions can suck the remaining shares up in several days.
IMHO something is going to have to give shortly. Tonight the shorts report and we will know on the 27th how many covered or not by the 15th. If they have been adding institutional shares at 1M a month it is not hard to see what is happening.
The general public is likely to have to pay dearly for our stock once the FDA approval is issued.
Institutional Ownership 90.56%
Total Shares Outstanding (millions) 71
Total Value of Holdings (millions) $1,230
Active Positions
HOLDERS SHARES
Increased Positions 83 7,872,611
Decreased Positions 61 4,039,147
Held Positions 35 52,667,240
Total Institutional Shares 179 64,578,998
New and Sold Out Positions
Total ActiveShares
New/SoldShares
-5M
0M
5M
10M
HOLDERS SHARES
New Positions 25 4,194,668
Sold Out Positions 18 1,785,83
Second article today by a different writer.
"http://finance.yahoo.com/news/forget-gilead-buy-5-biotech-141402577.html"
Boing X 2
Sorry about the extra posts. Hit submit and would not go through.
We might get some answers on the 15th. I am sure the question will be asked.
Upcoming Events
Date Details Remind Me
Feb 15, 2017
10:30 AM ET
Leerink Partners 6th Annual Global Healthcare Conference
Listen to webcast
Boing X 2
Nice,
Hope they are right on Momenta comments.
"http://finance.yahoo.com/news/5-stocks-buy-trump-chalks-135301352.html"
Boing X 2
Full Disclosure
Just found this.
My family owns this dot.com. It covers all combinations of the letters hsivig.com and Momenta hsivig.com.
We did not order this to be set up. It appears someone else might see the potential of hsivig.com to go to the expense and time to set this up.
Interesting to say the least ,as, I doubt someone would go to the expense to do this for every single dot.com that might never take place.
http://site-assay.com/site/hsivig.com
Just being up front and letting all know before someone else finds and posts it. Bought them when I saw they were not taken. Might take years, but I am patient.
Boing X 2
DewDillegence,
Thank you for the ariticle.
Throw in these two
"Anti-Inflammatory Therapeutics Market
Anti-Inflammatory Therapeutics Market Inflammation is triggered by the defense system of the body in response to harmful stimuli, damaged cells, irritants and microorganisms. Inflammation is the mechanism of innate immunity, which seeks to eliminate the cause of injury, clear dead and necrotic cells ... Published Date:
Sep 2015 Price:
$4740(SU)
Biosimilars Market
Biosimilars Market Biosimilars or follow-on-biologics are highly similar versions of reference biologics derived from living organisms such as plants and animals. The development of biosimilars and validation with reference biologics play a significant role in the commercialization of biosimilars. Economic pricing of ..."
and we have some pocket change to go after.
Boing X 2
jborg
I admit I was wrong about Necuparanib but, I never said it was worth billions. I believed what had been told on results at the time and the slides did show improvement. I would have no way of knowing without them saying they say a problem. I honestly did believe they were getting top line results. There were no warnings otherwise until they dropped it.
Watson Pharmaceuticals, or who owns them now, is most likely on the hook, if Amphastar looses and can't pay it all.
The ruling was they violated the Wax Hatchman statute on our patent.
Boing X 2
jbog,
And Amphastar has a good chance of paying very dearly for doing it to MNTA. Time will tell.
As things currently stand, you fail to mention that big fact on the current status of litigation. It might change, but then again they might well pay us big time. They have nice back up to foot the huge bill they might well face.
The facts are in our favor, right now, and you fail to mention that. Why would you even bring this up except to put MNTA down.
If you are going to keep putting MNTA down, give the total facts. THEY RULED THAT THAT THEY VIOLATED OUR PATENT. Until that changes we are in the drives seat.
Boing X 2
indigokid,
Thank you for that feedback.
Boing X 2
indigokid,
You are welcome. Just my guess on putting a pencil to what I feel can happen.
I note last quarter we were -.26 cents a share and with whisper numbers showing around .23 cents this quarter. That means we should break into the black this next quarter or close to it.
I think we are looking pretty strong on a down day. Keeps clawing its way back up.
You might be more right than me and I hope you are. At any rate, we should be in the black next year.
I feel still way under valued for what is in the works compared to some other stocks. Time will tell.
Now we just need that approval.
Boing X 2
indigokid,
I forgot to add,
there should be a substantial reduction in costs of syringes per patient reducing the number from 365 a year to 156 a year. That is a reduction of 209 syringes per patient a year with the 40mg. approval. That is a substantial number if talking about each 1,000 patients.
I am not sure as to how much more it costs to produce 40mg vs. 20mg. Glatopa but, there should be an economy of scale on production.
Boing X 2
indigokid
Great posts by all while I was gone. FDA has my approval to give approval today.
Sorry for the delay in response.
I based my estimate of 6K cost per quarter. While I was estimating 50M cost of production and sales costs. A margin of 66.33% While that might sound high it might not be as they already have the production in place, there should be less legal expense on this launch. The margins should go up as they are not having to convince every doctor this go around.
Like I said, others can play with the numbers.
It was great to see the pop while on the high seas. It took me a while to ready through all the posts this am.
Boing X 2
One other statistic,
In the United States, about 200 new cases of MS are diagnosed each week.
Boing X 2
The Sky is falling, The Sky is falling,
Total number of people worldwide with multiple sclerosis is 2.5 million. Number of people in the US with multiple sclerosis is 400,000. I suspect these are older figures.
We have 42% of the 20mg Copaxone market. I suspect they will convert those scripts to 3X a week 40mg Glatopa.
Approval of Glatopa 40mg is shortly going to take care of our quarterly expenses and likely then some. We are earning 20M a quarter now.
We only need to get to 50M a quarter to break even and cover overhead, salaries and research.
I estimate it will take us a total of 25,000 scripts a quarter to get us to our share of 50M after sales costs, and Novartis 50% profit, at 6,000 a script per quarter.That would be 500 or so scripts per state we need.
Right now I am seeing 2,500 a month as the lowest monthly cost for 30 shots for the 20mg. For the sake of this example I am using a 6k quarterly number.
Double it to 1k scripts per state should be more than doable. It would be nice if we knew the number of scripts the 42% of 20mg injections represents right now.
I frankly think Teva is very worried that we are going to take way more than 1k scripts per month per state average, They would probably be very happy with us taking that few.
Play with the script numbers and it is not going to take us long. I don’t see future dilution if we exceed 25,000 scripts per quarter. Again, that is only 500 per state per quarter or 166.66 per month per state. That would be 8,333 people with monthly scripts out of 400,000 people.
Like Craig said, we hold a lot more cards on a 40mg approval. I can see pharmacies directing that many scripts to us.
There are 67,000 pharmacy’s in the US and the top six have this many pharmacists. 2nd number is the number of stores. CVS 25,436 pharmacist filling one script each would do it.
CVS Corporation Woonsocket RI 24,000 9,700
2 Walgreens Deerfield IL 10,578 8,232
3 Walmart Stores Inc Bentonville AR 6,358 3,646
4 Rite Aid Corporation Camp Hill PA 5,523 4,608
5 Kroger Company Cincinnati OH 1,866 1,156
6 Target Corporation now CVS Pharmacy Minneapolis MN 1,436 1,672
Other drugs will likely be kicking in, prior to any future dilution, IMHO. With a shorter process to FDA approval I think we are going to be alright.
I will not even discuss on how undervalued I think we are right now. Look at Blue for a clue.
With all this being said, Wed. we are heading out of the country on a two week cruise to where it is warm. I am hoping to see approval come in while we are on the high seas. I will be watching the net.
Ciao,
Boing X 2
DewDiligence,
I agree.
A couple of thoughts,
I think this is critical wording to avoid the games of sales reps telling the doctors to write a script DAW {drawn as written) to keep competition away.
"57 351(k)(4) of the PHS Act, means that “the biological product may be substituted for the
58 reference product without the intervention of the health care provider who prescribed the
59 reference product.”6
"134 An interchangeable product may be substituted for the reference product without the intervention
135 of the health care provider who prescribed the reference product "
I have seen comments by sales reps doing that exact thing and joking about it on line. Keeping sales away from us by telling the doctor’s to write the script DAW so the pharmacist can’t change it.
I would get the patent to cover either way of injection. Doesn’t mean you have to do it but, it would keep others from saying well they didn’t cover auto injector. Amphastar comes to mind on an end around.
"A sponsor developing an
654 interchangeable product generally should not seek licensure for a presentation for which the
655 reference product is not licensed. For example, if the reference product is only marketed in a
656 vial and a prefilled syringe, a sponsor should not seek licensure for the proposed interchangeable
657 product for a different presentation, such as an auto-injector."
Boing X 2
indigokid,
You might well be right. It caught me off guard.
No matter which drugs ,they are thinking big.
Throw in Express Scripts while they are at it.
Boing X 2
Bickema;
Craig mentioned about the potential to contract with them selling the generic 40mg Capxone along with the 20mg.
Boing X 2
Bickema,
Right you are.
Another comment, about CVS and Walgreens about blew me out of my chair.
Boing X 2
Bickema,
I agree.
I see more and more potential with this company and how they are proceeding.
I like how Craig said we hold a lot of cards for the 40mg launch that we did not hold on the 20mg launch of Copaxone.
Boing X 2
Least anyone forgot,
" Craig Wheeler, President and CEO, will present at the 35th Annual J. P. Morgan Healthcare Conference. The presentation is scheduled for Tuesday, January 10th at 3:00 p.m. PT (6:00 p.m. ET).
Following the presentation, management will participate in a question and answer session at 3:30 p.m. PT (6:30 p.m. ET).
The webcast of the presentation and Q&A session will be available live on the “Investors” section of the company’s website located at www.momentapharma.com. A replay of the presentation will be posted on the Momenta website approximately one hour after the event."
It would be nice to hear something about 40mg Glatopa.
Boing X 2
Breakout trade
"WATCH for possible breakout above 16.68
Target: 18.1,"
Just found this from this morning,
"Momenta Pharmaceuticals's buy rating reiterated at Stifel Nicolaus. $20."
Nice little Birthday present this Sunday AM.
Boing X 2
Dew,
Thank you. I thought likely.
The thing that was throwing me off was the three momentas in the parser.
Boing X 2
Possible new pre grant patent application
BIOLOGICAL CHARACTERIZATION OF A GLATIRAMER ACETATE RELATED DRUG PRODUCT USING MAMMALIAN AND HUMAN CELLS
Before you click, prepare your mind for a wall of text. Mind boggling.
http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PG01&s1=momenta&OS=momenta&RS=momenta
[0009] Copaxone.RTM. also increases the number and suppressive capacity of CD4+CD25+FOXP3+ regulatory T cells, which are functionally impaired in MS patients (29-31). Furthermore, treatment leads to antigen-nonspecific modulation of APC function. Copaxone.RTM. treatment promotes development of anti-inflammatory type II monocytes characterized by an increase in interleukin (IL)-10 and transforming growth factor-beta (TGF-.beta.) and decreased production of IL-12 and tumor necrosis factor (TNF) (32).
I am not sure but, I think it might be Momenta based on the three momentas at the end of the parser. momenta&OS=momenta&RS=momenta On the other hand where some of the applicants are from, makes me wonder.
Any feedback would be appreciated. I should have got my cup of coffee first. Boy that hurts trying to read this.
Boing X 2
Breakout trade
"CONFIRMED breakout above 15.59
Target: 17.04"
Boing X 2
I think this is funny!
1st. They file a suit before there is a ruling to show we started selling before an FDA or court ruling. I smell desperation.
I can see nothing that says one can’t attempt to get approval before a patent expires. One could be seeking approval prior to the patent expiration That is one all the time. No approval no damages. Approval, still no damages if one has not yet sold until after a patent expires.
,
2nd How can there be a patent infringement prior to us getting an FDA approval or prior to selling the 40mg product. Just because one is thinking about it or trying to get an approval doesn’t meet the test.
3rd. This suit reeks for attorney fees and costs to be awarded for filing prior to all the above having occurred. With as many as they sued it could be a chunk of change.
4th. How can we be enjoined, when we have no approval yet nor any sales. Stopping us for doing something that might never occur. This just is guessing it might or might not occur or we might or might not get approval.
5th. With the current court case based on the 5th patent, if applicable, again it is premature until the ruling. If the ruling is adverse to Teva it supports are claim for attorney fees and costs.
Dew, I see it as a likely abuse likewise. I would be filing for attorney fees, costs and the whole nine yards. PREMATURE SUIT. I don’t think one can sue for what might or might never happen.
If that is the case, I have a lot of suits I want to file for what may/or will never happen.
Teva might just be giving MNTA and others more of a claim than just attorney fees and costs. How about a bond if they don’t prevail. I remember a company that did that to us!!! Any one can file a suit, but, they might regret it when they loose.
The big exposure to Teva would be if the FDA grants approval to MNTA prior to a resolution in their favor and then the damages go up big time if MNTA prevails.
A lady we know, would just say RIDDICALUS.
Boing X 2
Pre grant patent application,
CELL CULTURE PROCESS
http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=2&f=G&l=50&co1=AND&d=PG01&s1=momenta&OS=momenta&RS=momenta
DETAILED DESCRIPTION
[0112] The inventors have discovered that polypeptides (e.g., antibodies) having targeted levels of carboxyl terminal (C-terminal) lysine or arginine residues can be produced from cells cultured in a medium having sufficient levels of lysine, arginine, and/or agents that change intracellular pH. Surprisingly, culturing the cells under such conditions does not affect cell growth, cell viability, or titer. The present disclosure encompasses polypeptides (e.g., antibodies) having targeted levels of C-terminal lysine and/or arginine residues, methods of making such polypeptides (e.g.,
antibodies), and methods of using such polypeptides (e.g., antibodies).
[0170] The methods described herein can be used to produce any polypeptide of interest, such as an antibody, an Fc-containing polypeptide, and/or a fusion protein.
[0181] Nonlimiting, exemplary polypeptides that can be produced using the methods described herein include abatacept (Orencia.RTM., Bristol-Myers Squibb), abciximab (ReoPro.RTM., Roche), adalimumab (Humira.RTM., Bristol-Myers Squibb), alefacept (Amevive.RTM., Astellas Pharma), alemtuzumab (Campath.RTM., Genzyme/Bayer), basiliximab (Simulect.RTM., Novartis), bevacizumab (Avastin.RTM., Roche), certolizumab (CIMZIA.RTM., UCB, Brussels, Belgium), cetuximab (Erbitux.RTM., Merck-Serono), daclizumab (Zenapax.RTM., Hoffmann-La Roche), denileukin diftitox (Ontak.RTM., Eisai), eculizumab (Soliris.RTM., Alexion Pharmaceuticals), efalizumab (Raptiva.RTM., Genentech), etanercept (Enbrel.RTM., Amgen-Pfizer), gemtuzumab (Mylotarg.RTM., Pfizer), ibritumomab (Zevalin.RTM., Spectrum Pharmaceuticals), infliximab (Remicade.RTM., Centocor), muromonab (Orthoclone OKT3.RTM., Janssen-Cilag), natalizumab (Tysabri.RTM., Biogen Idec, Elan), omalizumab (Xolair.RTM., Novartis), palivizumab (Synagis.RTM., MedImmune), panitumumab (Vectibix.RTM., Amgen), ranibizumab (Lucentis.RTM., Genentech), rilonacept (Arcalyst.RTM., Regeneron Pharmaceuticals), rituximab (MabThera.RTM., Roche), tositumomab (Bexxar.RTM., GlaxoSmithKline), and trastuzumab (Herceptin.RTM., Roche).
One might want to have a cup of coffee before you start to read this one.
Boing X 2
Nice words,
WATCH for possible breakout above 15.75
Target: 17.41
96% Buy rating on Barcharts,
Point and Figure chart looking strong with a target of 21.
Thank you Dew for all you do and provide to this board. Greatly appreciated.
Boing X 2
Breakout trade
CONFIRMED breakout above 14.54
Target: 16.15
Point and Figure chart gives a price objective of 21.00 now.
Find out the latest short positions tonight after close.
Boing X 2
Breakout trade
WATCH for possible breakout above 14.51
Target: 15.95,
For IRA tax reasons I hope this doesn't explode until after Jan 2nd. I get a 2 year break that way.
Boing X 2
"Pre grant patent application,
MULTI-DIMENSIONAL CHROMATOGRAPHIC METHODS FOR SEPARATING N-GLYCANS
http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=3&f=G&l=50&co1=AND&d=PG01&s1=momenta&OS=momenta&RS=momenta
[0091] In some embodiments of the disclosure, a desired glycosylation pattern for a particular target glycoprotein is known, and the technology described herein allows the monitoring of culture samples to assess progress of the production along a route known to produce the desired glycosylation pattern. For example, where the target glycoprotein is a therapeutic glycoprotein, for example having undergone regulatory review in one or more countries, it will often be desirable to monitor cultures to assess the likelihood that they will generate a product with a glycosylation pattern as close to identical with the established glycosylation pattern of the pharmaceutical product as possible, whether or not it is being produced by exactly the same route. As used herein, "close to identical" refers to a glycosylation pattern having at least 90%, 95%, 98% or 99% correlation to the established glycosylation pattern of the pharmaceutical product. In such embodiments, samples of the production culture are typically taken at multiple time points and are compared with an established standard or with a control culture in order to assess relative glycosylation.”
Boing X 2
Breakout trade
WATCH for possible breakout above 14.51
Target: 15.93
cpaok1,
I wouldn't doubt it one bit. Shares are starting to dry up. I am not budging.
Next quarter could be big with potential news on two fronts.
Boing X 2