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floblu14,
I agree. I am trying to get a handle on how much the initial stocking of 27 major drug retailers might generate. I might be wrong, again, but it would seem that all the big ones will need an initial stock to supply prescriptions. The question then becomes do the initial orders happen in June?
Also, I believe we manufacturer the drug so we should realize the cost of the drug as income along with our 50/50 share after selling expenses if I am thinking right.
I did note this today for those that have no insurance.
"http://medicationcoupons.com/glatopa_coupon" So the word appears to be spreading.
I have tried to find examples of initial stocking sales of new drugs without luck. I am sure it is out there but, I just am not doing the right search.
Boing X 2
DewDillengce,
Sorry my bad. Looked three times and still didn't get it right.
Another board talking about some ABCJ article on an agreement and I got it wrong. And it trying to find out what they were talking about I got it wrong.
Boing X 2
DewDiligence,
Thank you for that information.
That is a $11,158.05 savings a year for a shot every day. A whole lot better than the cost earlier today. I suspect the price will come done further in the future.
Thank you to all who have made this board great and help to get through the long wait.
Boing X 2
anotherbiotechguy,
I also believe Sandoz will act in our best interest. The question is will they act fast enough?
In the litigation game, our competitor might just not feel all warm and fuzzy on our launching. Therefore, one must act before, the one that has shown they will take us to court forever, to prevent us from making a sale.
My thoughts are that the gloves are off with this court ruling, and it is on like gang busters.
Boing X 2
floblu14,
I hope you are right. If they did launch just a simple PR would help to let us peons to know.
Open and up front is nice.
I do believe the court said give us 24 hours notice if you are going to launch. Not sure how that would now apply but, best to just send the letter to the court and CYA.
Boing X 2
DewDilligence,
I hope they are acting before our competition.
I don't assume, until I hear otherwise. Last one to the court house in not in the best position sometimes.
First filing puts the second on defensive. I await to hear that we were first.
Any other pharmaceutical company would have likely got a 5/10 dollar bump on todays news. Go figure.
Boing X 2
DewDilligence,
The silence from Sandoz has been deafening. Why don't they advise the court they are going to launch within 24 hours. I do believe the court said to give them 24 hours notice.
If Teva then files a delaying action, we should require a mega bond should they not prevail as damages will be accruring daily.
Sort of a reverse of what they have done to us on our other litigation. Jborg's post indicates they are going to try and delay us. Make them pay for being wrong. We are in the drivers seat right now. We need to take advantage before they file anything. The court has ruled our favor so lets get it on.
Boing X 2
biopearl,
Thank you, Thank you, You will never know how much your post meant to me.
Old, Heart problems, leg problems, dealing with stress on Cox problems and on and on.
Some times I think I am loosing it, but the few brain cells say no you are not. Just perk up and fight.
It does get harder as one gets older.
Bro Love,
Boing X 2
Guess what I found,
http://www.law360.com/articles/493712/amphastar-sanctioned-for-veiling-docs-over-blood-thinner-ip
My experience is one must come into court with clean hands and have clean hands in court.
Just saying,
Boing X 2
DewDillegence,
Did AMPH not get sanctions for misleading the court in our litigation? I don't think I am wrong on that.
Not trying to argue, just trying to keep an open mind as to what I thought I heard the Judge and the Attorney for AMPH say during the court hearing. Time will tell.
I just find it hard to believe the Judge would say the comment about bootstrapping on our patent if they were using a total different patent. Also, he specifically asked AMPH if they could use another method for reporting records to the FDA after the FDA approval and they said yes to the best of my recollection.
Without going back and doing a re listen I swear I heard them say they continue to use our patent for continued production and reporting to the FDA. Otherwise I would have expected the attorney to argue we are not using their patent for continued reporting to the FDA so why are we in this suit?
Boing X 2
Excuse me If I misled anyone,
Listening to the last oral argument I must have misunderstood when the Judge question them and they said they still use the same method for keeping records for FDA approval. Confusing to say the least, that they use our patent to get FDA approval and now say they don't use it for continued production. I admit my hearing is getting bad, but, I thought I heard them say they continue to use our system when the judge questioned why they did not use some other system after the FDA approval.
In fact the Judge said it was like they were trying to bootstrap on our patent if I heard correct.
Boing X 2
mouton,
Thank you.
I am slightly positive for the following, if they thought AMPH and the court were right, why take all the time and effort to respond with a brief. Just ignore the request to file a brief and say nope. Time will tell.
I know they were alright to use our patent to get FDA approval but, after FDA approval who gives them the right to use our patent forever without paying us for its use. They agree they use it, so pay us.
30 years involved in litigation and I understand your comments.
On another front,
Pre Grant Patent Application filed June 11, 2015
ttp://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
[0003] Adalimumab (Humira.RTM.) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). Adalimumab is an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kD.
Luck to us all,
Boing X 2
floblu14,
They are working down your list.
Pre Grant Patent application filed yesterday June 4, 2015,
"
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
0003] Panitumumab (Vectibix.RTM.) is a recombinant, human IgG2 kappa monoclonal antibody that binds specifically to the human epidermal growth factor receptor (EGFR).
[0004] Panitumumab is an epidermal growth factor receptor antagonist presently indicated as a single agent for the treatment of metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens. Retrospective subset analyses of metastatic colorectal cancer trials have not shown a treatment benefit for Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13 (from Vectibix.RTM. Product Label dated Jul. 17, 2009, Amgen, Inc.).
One exemplary report states that "[t]he size and complexity of . . . therapeutic proteins make the production of an exact replica almost impossible; therefore, there are no true generic forms of these proteins . . . . Verification of the similarity of biosimilars to innovator medicines remains a key challenge" (Hincal, supra). This disclosure provides, in part, methods and compositions sufficient to make and test products that qualify as panitumumab, e.g., that are interchangeable versions of Vectibix.RTM.. "
Boing x 2
correction,
May 28th filing date.
Boing x 2
floblu14,
Not trying to steal your thunder. Just letting all know that it was just filed. Unless I am missing something ee the May 31st filing date.
I agree you were first on the comments. A lot of water has gone over the dam since your Feb, post.
New people might not pick up on the older posts and the specific comment of interchangeability.
I luv it likewise. Sorry if I upset you.
Boing x 2
A couple of things,
New Pre Grant Patent Application filing,
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
All might want to pay particular attention to this paragraph,
"[0032] Detailed, high resolution, structural information about Avastin.RTM. (e.g., related to the presence of signature glycan species or quantitative analyses ascribing site-specificity for backbone modifications) is useful to be able to make and test products that qualify as bevacizumab, e.g., that are interchangeable versions of Avastin.RTM.. Such information is also useful in monitoring product changes and controlling structural drift that may occur as a result of manufacturing changes. The art supports, however, that information necessary to be able to make and test products that qualify as bevacizumab, e.g., that are interchangeable versions of Avastin.RTM., or any other branded biologic, is unavailable (see, e.g., Nowicki, "Basic Facts about Biosimilars," Kidney Blood Press. Res., 30:267-272 (2007); Hincal "An Introduction To Safety Issues In Biosimilars/Follow-On Biopharmaceuticals", J. Med. CBR Def., 7:1-18, (2009); Roger, "Biosimilars: current status and future directions," Expert Opin. Biol. Ther., 10(7):1011-1018 (2010)). One exemplary report states that "[t]he size and complexity of . . . therapeutic proteins make the production of an exact replica almost impossible; therefore, there are no true generic forms of these proteins . . . . Verification of the similarity of biosimilars to innovator medicines remains a key challenge" (Hincal, supra). This disclosure provides, in part, methods and compositions sufficient to make and test products that qualify as bevacizumab, e.g., that are interchangeable versions of Avastin.RTM.. “
And more so this wording,
“One exemplary report states that "[t]he size and complexity of . . . therapeutic proteins make the production of an exact replica almost impossible; therefore, there are no true generic forms of these proteins . . . . Verification of the similarity of biosimilars to innovator medicines remains a key challenge" (Hincal, supra). This disclosure provides, in part, methods and compositions sufficient to make and test products that qualify as bevacizumab, e.g., that are interchangeable versions of Avastin.RTM.. “
In other words, it appears this is the second drug that couldn’t be done and, it appears like the little Choo Choo has made it an interchangeable version of Avastin.RM.
On another front,
From the Y message board on AMPH,
“Just attended AMPH annual Meeting and it went smoothly. Some important items revealed was the company is strongly working on a vertical integration of their most important drug the generic Lovenox and that they are expanding on various Orphan drugs. This is to maintain control and quality on the work. Primatene will probably be approved next year and the company's operations are doing well. I look for a profitable year and the next year as well due to the various activities going on. Litigation is on going and they expect to collect from MNTA the 100 million dollars Bond in due course.”
So they are going for vertical integration of Lovenox? At what point do they violate our patent? Never? Karma in the wings?
BoingX2
A bunch of things.
Searched and didn’t find this posted.
New FDA Guidelines. Might want to put in Read Me First. No discussion so I am assuming no one has yet picked up, read, or digested as to what this will mean to MNTA.
"http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM444661.pdf …
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf …
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf …"
New pre grant patent application filed 5/7
"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"
Check this out.
"
[0033] Detailed, high resolution, structural information about Campath.RTM. (e.g., related to the presence of signature glycan species or quantitative analyses ascribing site-specificity for backbone modifications) is useful to be able to make and test products that qualify as alemtuzumab, e.g., that are interchangeable versions of Campath.RTM.. Such information is also useful in monitoring product changes and controlling structural drift that may occur as a result of manufacturing changes. The art supports, however, that information necessary to be able to make and test products that qualify as alemtuzumab, e.g., that are interchangeable versions of Campath.RTM., or any other branded biologic, is unavailable (see, e.g., Nowicki, "Basic Facts about Biosimilars," Kidney Blood Press. Res., 30:267-272 (2007); Hincal "An Introduction To Safety Issues In Biosimilars/Follow-On Biopharmaceuticals", J. Med. CBR Def., 7:1-18, (2009); Roger, "Biosimilars: current status and future directions," Expert Opin. Biol. Ther., 10(7):1011-1018 (2010); Schellekens et al., Nat. Biotechnol. 28:28-31 (2010); Sekhon et al., Biosimilars, 1:1-11 (2011)). One exemplary report states that "[t]he size and complexity of . . . therapeutic proteins make the production of an exact replica almost impossible; therefore, there are no true generic forms of these proteins . . . . Verification of the similarity of biosimilars to innovator medicines remains a key challenge" (Hincal, supra). This disclosure provides, in part, methods and compositions sufficient to make and test products that qualify as alemtuzumab, e.g., that are interchangeable versions of Campath.RTM.. "
Note, " there are no true generic forms of these proteins”
This means to me, that they were able to accomplish the impossible and do the interchangeable version. My thinking.
This is a 3 Billion underserved market.
Patent expires Dec this year.
No one had commented on the big, big IVIg comment near the end of the CC where Wheeler said "we intend to come up with a test to basically get 65 potential treatments approved at one time by the FDA." Gutsy and I like it. They better get the right partner on this.
"Takeda Pharmaceutical Company Ltd (?????????? Takeda Yakuhin Kogyo Kabushiki-gaisha?) is the largest pharmaceutical company in Japan and Asia and a top 15 pharmaceutical company. The company has over 30,000 employees worldwide and achieved 16.2 billion USD in revenue during the 2012 fiscal year.[2] The company is focused on metabolic disorders, gastroenterology, neurology, inflammation, as well as oncology through its independent subsidiary, Millennium: The Takeda Oncology Company.[3] Its headquarters is located in Chuo-ku, Osaka, and it has an office in Nihonbashi, Chuo, Tokyo.[4][5] In January 2012, Fortune Magazine ranked the Takeda Oncology Company as one of the 100 best companies to work for in the United States.”
There might be some potential confict with them. Not sure as they well might be able to be worked out.
I did not like the comment on the CC that all the employees gather around the legal office at 11am each morning to see if the court has ruled. This could be a major problem if the court rules in our favor or not, and, the eployees have advanced notice to make trades. There should be a trading stop pending news and the employees should be the last to know before the CEO, The SEC, and our partner to make any decision on launch or no launch. I see this as a major problem for a potential lawsuit.
I am having a big problem with more shares being requested for options when the price is jumping very fast. sounds like too many shares are being requested in light of what is happening. I am not against them retaining great people, just keep shareholder value in mind likewise. Why do they need 2.5M shares in one year. Less shares and look at it again next year. Do they plan to issue all 2.5M shares next year and then again ask for another 2.5M the following year? Without looking back i think they are talking a value of 15 some a share. The price is now is around 2O. That would be an increase in value of 17Million even before approval at the annual meeting. I would like part of that jackpot. How about 3 options per share for every year I have held on and made nada. Just saying.
Boingx2
Two new Pre Grant Patents showing up.
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
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
Boingx2
TEVA dollars are not welcomed here.
TEVA has cost me big money on their continuous filing of petitions and litigation and delay. I know some litigation was likely warranted but, many petitions were not.
I say Momenta should take the path they are going. I have no use for TEVA,
I guess the rest who want the TEVA dollars forget the cost they have had Momenta incur fighting them non stop, which cost us the investors lost opportunity.
It would take mega buckets of cash for me or other friends I know, who are invested, to vote for them to buy Momenta.
I have waited this long and I will stay the course without TEVA.
Momenta has the pipeline why give TEVA the time of day. They can clearly make it on their own with the right agreements and continued development of drugs.
BoingX2
Flobu 14,
I forgot to put a smilie after my post.
Boingx2
Flobu 14,
Gee, I wonder if it just might have to do with any of these pre grant patents?
"7 20140363853 NUCLEOTIDE CLONING METHODS
22 20140274912 METHODS OF CELL CULTURE
23 20140274911 METHODS OF CELL CULTURE
24 20140273057 METHODS OF CELL CULTURE
25 20140271622 METHODS OF CELL CULTURE
“
Boingx2
pollyvonwog,
I found the SC schedule. Note the green conference days for Oct. It appears they conference the weeks hearings, on Fridays in Green, and assign a judge to write the opinion.
I am guessing we hear late Oct. to early Nov. If they conference our case on the 31st it will likely be Nov.
Checking on prior hearings, over the years, the rulings have been issued within days in many cases. Many opinions have been issued in 4 days.
Here is the SC calendar, http://www.supremecourt.gov/oral_arguments/2014TermCourtCalendar.pdf
Boingx2
ghmm,
Meant to say I am guessing. Can't the computer read my mind when I am typing?
Boingx2
ghmm,
Thank you.
From the slides the following is stated.
"Orphan Drug designation granted; Fast Track designation expected to be requested Q4 2014."
We are now in the 4th quarter. Let's roll and get that request in ASAP. I guessing they might have to wait for the pier review.
Boingx2
GrthzGd,
I approve your post.
Restoring our hair lost due to holding the stock is the least they could do.
floblu14,
I likewise missed your update post.
I think it could be a large market if it can grow thick hair fast. I don't have 10 years to wait around.
I think you are right that they are close to approval after 4 plus years. I am just hoping there is no need for a FDA approval that could take years. As it would be topical I am hoping no FDA involvement.
floblu14,
I didn't pick up on your prior post. Right you are and they should be close to approval after 4 years.
I am just trying to figure out if they would then have to go through a FDA approval process or not as it involves the use of heparin.
It sure looks like they are going after that market to me.
If it works much better than Rogaine they have a potential customer here.
A major big market from Chemo patients likely, if, it grows hair fast. Apparently a need on the Vet clinic side likewise.
Dew,
They mention heparin, Enoxaparin and 402 in their patent application. They might just be covering all the bases. LWMH is the key I think.
They sure are going to a lot of trouble if they are not planning on selling a product. They comment on the problems regarding hair loss for chemo patients.
Here are the patent applications. Please take a look. You might then be able to understand if they would then require FDA approval once the patents are approved.
http://worldwide.espacenet.com/publicationDetails/inpadocPatentFamily?CC=EP&NR=2582355A2&KC=A2&FT=D&ND=3&date=20130424&DB=EPODOC&locale=en_EP
A question for the board on a patent
Espacenet- METHODS AND COMPOSITIONS FOR PROMOTING HAIR GROWTH
6-17-2010 original filing. This should be very close to approval at 4 plus years. There are 7 listings for different countries. Hong Kong being the latest addition.
Enoxaparin or Low Molecular Weight Heparin for stimulation for hair growth ie. cancer patients after chemo is one example.
They are covering the bases for cosmetics, eyelid, facial, head etc hair growth as well as vet clinic use. M402
The question I have is, with patent approval would they then have to get further approval from the FDA as Enoxaparin is already an approved drug? Any thoughts?
If it works better than the current market product, I could use some in the near future.
Double_Bagel,
Check my response to you on the MNTA board. Patent approval today on Analysis-of-Glatiramer-Acetate
Found it when checking your highlighted area about half way down.
Thank you for that find.
Boingx2
Double_Bagel,
Thank you for that post!
In your highlighted information of note there is a comment that the Momenta patent application for Analysis of Glatiramer Acetate was granted a patent today. It also shows up on an internet search.
Check your highlighted several posts down. I don't want to violate any copyright by doing a copy of the article. It said it was granted today.
I wonder if the FDA was holding off pending that patent approval. We shall see I guess.
Boingx2
Pollyvong,
I would hope not. If the FDA were to change one thing, on the drug approval, they would be holding the bag on a production of a useless drug.
Approval and then ramp up in my opinion.
I would not want to have been short this stock today.
Another thing, I have seen some say that heparin is limited. Not from something I have been watching closely. I will not comment further right now as I intend to add some shares on any pull back. I will just say, that it has my attention on being a major potential market if it comes to fruition.
I have not posted for a long time here. Just watched and waited. Kept my large position and waiting to add my last shares.
As an aside, I think I am sure I know Rock Rat. Not saying more than that right now.
Good day for those who held in here.
Best to all.
Boing
This could pan out to be a great and cheap move on MNTA's part.
When I read this,
"http://www.virdante.com/documents/VirdantePharmaceuticalsInc.Improvingantibodiesanti-inflammatoryproperties.pdf"
I see they most likely locked out the competition in this area.
The patent was just granted Jan 6, 2011. If they can apply this to a multitude of drugs coming off patent, for them to become more effective, they likely locked out any copycats.
This appears to be a very specific process to try and do a work around.
I see why CW was excited on the prior conference call. I am guessing there is more based on the CC today. They mentioned most of the 12 products coming off patent as having potential this AM.
They want a FOB partner sooner, rather then later, per the cc this AM.
Some might want to listen to the replay to hear the discussion.
Japan?
Article today.
"Massachusetts life sciences companies are increasingly attracting the attention of Japanese firms."
Might not want to rule out any one at this point. They have a ton of cash.
'Report Predicts Multiple Sclerosis Drug Market Will Reach $15.8bn in 2015' Says visiongain Report"
Also of note, the report states the UK has a high rate of MS.
The stakes for MNTA to prevail on Copaxone are big. We have the generic patents and now we just need to prevail on the FDA approval and other litigation.
Thank you go seek. I likewise hope all had a very Happy and safe Thanksgiving.
"has been assigned a patent (8058235)"
They need to learn how to report right. Not a patent number, not a patent application, but, assigned a patent.
floblu14,
Sorry, they should have said assigned a patent application number and not assigned a patent application. Big difference.
Thank you for the catch. At any rate, first to the possible GAD solution?
"GAD"
I hope you are right. :)