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jborg,
I would have to see the contract. In viewing another company contract they show 2M per occurrence and 3M excess coverage for their breech of contract and gross negligence.
It would depend on the contract Sandoz worked out.
The question is does each day of lost profits constitute another occurrence.Does the loss of FDA approval cover another occurrence. The FDA is going to say they didn't approve our drug due to the problems.
Boing X 2
jborg,
Have you heard of breech of contract? That is covered by by most liability contracts if I remember correctly. I also suspect they might also carry an excess policy.
At any rate they have paid some big judgements.
Boing X 2
jbog,
Totally wrong,
https://www.pfizer.co.uk/content/insurance-details
A short search shows they have had coverage for years.
Boing X 2
Speaks for itself,
ISI noted that Momenta's patent filings indicate that the remaining 5 products may include biosimilars for Rituxan, Prolia/Xgeva, Vectibix, Xolair and Campath.
"Rituximab, sold under the brand name Rituxan among others, is a medication used to treat certain autoimmune diseases and types of cancer.[2] It is used for non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, idiopathic thrombocytopenic purpura, pemphigus vulgaris and myasthenia gravis.[2][3] It is given by slow injection into a vein.”
"Denosumab (trade names Prolia and Xgeva) is a human monoclonal antibody[1] for the treatment of osteoporosis,[1] treatment-induced bone loss, metastases to bone,[1] and giant cell tumor of bone.[2].”
"Panitumumab (INN), formerly ABX-EGF, is a fully human monoclonal antibody specific to the epidermal growth factor receptor (also known as EGF receptor, EGFR, ErbB-1 and HER1 in humans).
Panitumumab is manufactured by Amgen and marketed as Vectibix. It was originally developed by Abgenix Inc.”
"Xolair is an injectable medicine for patients 12 years of age and older with moderate to severe persistent allergic asthma whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids.”
"Alemtuzumab is a drug used in the treatment of chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell lymphoma under the trade names Campath, MabCampath and Campath-1H, and in the treatment of multiple sclerosis as Lemtrada. It is also used in some conditioning regimens for bone marrow transplantation, kidney transplantation and islet cell transplantation.
and,
"We are delighted to announce this collaboration with Momenta, who are leaders in the Fc biology space,” said Paul Perreault, CEO and Managing Director, CSL. “M230 is a very exciting prospect and offers CSL the potential to further grow and expand our long-term global leadership in helping those patients with autoimmune diseases that are treated with immunoglobulins.”
Under the terms of the agreement, Momenta will grant CSL an exclusive, worldwide license to Momenta’s intellectual property relating to M230. Momenta will receive a $50 million upfront license fee payment from CSL and will also be eligible for up to $550 million in contingent clinical, regulatory and commercialization milestone payments. Momenta has the option to elect a cost and profit sharing arrangement, for which Momenta would fund a proportion of global development and commercialization costs in exchange for a share of U.S. profits, and milestones and royalties outside the United States. Momenta has the option to enter into an agreement to co-promote M230 and any other collaboration product in the U.S.”
MNTA has opted in for the 50% sharing.
Found this=
"Preclinical
Autoimmune disorders; Epidermolysis bullosa; Rheumatoid arthritis
Most Recent Events
05 Jan 2017CSL enters into agreement to in-license M 230
17 Nov 2016Preclinical trials in Epidermolysis bullosa in USA (Parenteral)
17 Nov 2016Preclinical trials in Rheumatoid arthritis in USA (Parenteral) "
This,
"At the end of November 2016, the firm.MNTA, reported positive topline data from a confirmatory Phase III study evaluating M923, a biosimilar of Humira® (adalimumab) We own this one 100%."
Boing X 2
Regulardoc,
Keep the Kleenex handy.
Sorry but, I want you bawling.
Here is hoping we hear soon.
Boing X 2
Regulardoc,
Are you starting to feel bad yet?
"Breakout trade
WATCH for possible breakout above 18.89
Target: 20.16"
Boing X 2
jbog,
My thinking is they see the potential us long term holders see on the drug pipeline.
Right or wrong that is my thinking. They didn't sell off when we took the hit and kept on adding shares.
A high number can be positive for the price if and when short decide to cover and can't.
We have a break out at 18.47. New target is now 19.50.
There can or can't be less volatility if they hang onto their shares making the newbies pay a higher price to acquire shares. FDA approval of the 40MG might just be the catalyst when there might be few shares available to buy.
The fact they have chosen to put us at high ownership. i.e.. only 115 other companies with this high ownership says something about their opinion going forward. Just my opinion.
Time will tell.
Boing X 2
inthegrass,
I am with you! It has been a long haul with many bumps in the road.
As I mentioned prior, in my opinion shares are being dried up by the big boys. High institutional ownership. I had been noticing the decreasing volume.
We are going to see how much of an increase from the 93.36 percent institutional ownership as of the end of June very soon.
The third quarter numbers will be out around the middle of Oct. I am guessing it will be much higher.
Basically two days and a few hours until the end of the quarter.
Luck to all longs here.
Boing X 2
floblu14,
Hope you are right. We are long overdue for a great Holiday season here.
In the mean time,
Breakout trade
WATCH for possible breakout above 18.36
Target: 19.50
Boing X 2
indigokid,
I agree. Thank you for your input.
Boing X 2
Institutional Ownership
An observation while we are waiting on the FDA to get in their car and inspect the plant.
Most interesting. As an example Apple has 62% institutional ownership. MNTA is at 93.36% institutional ownership with only 15 days left, after today, before the institutional figures for 9 months are started to be reported.
I am guessing that number is likely to go up based of what appears to be a declining volume of shares being traded recently. If the number of institutional shares owned at the end of 9 months is 79M or higher, which I think is very possible, it is likely to get interesting fast.
There are 82.6M diluted shares outstanding per Dew.
In my opinion this stock has the potential to be explosive when the small investors wake up and decide to buy shares. That well could be with a 40mg Glatopa approval. At the rate the institutions are buying shares there are not going to be many shares left to buy if the institutional owners are not willing to sell their shares.
One also has to add the total shares owned by management and individual investors. I don’t have a handle on the total number of individual investors. I would suggest that individuals and management numbers alone might make up the 79M number not including any last three months institutional buys. Management has around 1,500,000 shares alone.
When added to the 76M it would give 77.5M without the individual investor number.
We still have 4.9M shares short sitting out there, as of 8/31 that will likely have to be covered at some point. We will know the 9/15 short position on 9/26 close. Something is likely going to have to give before much longer.
Here is the final volume today. Someone covering? I had this written way before the close and was waiting for the close. Of note there are only 115 or so companies with higher than 93% institutional ownership on a scan I just did. That scan didn’t even name MNTA so I added them in the 115.
Volume 2,259,092
Avg. Volume 564,004
Just my opinion,
Boing X 2
As of 6/30
Institutional Ownership 93.36%
Total Shares Outstanding (millions) 76
Total Value of Holdings (millions) $1,235
Pre Grant MODIFIED GLYCOPROTEINS
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
0210] In another aspect, the invention features a sulfated version of abciximab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of adalimumab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of alemtuzumab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of basiliximab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of bevacizumab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of cetuximab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of certolizumab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of daclizumab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of eculizumab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of efalizumab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of gemtuzumab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of ibritumomab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of infliximab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of muromonab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of natalizumab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of omalizumab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of palivizumab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of panitumumab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of ranibizumab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of rituximab comprising a sulfated Fc region or sulfated Fc fragment, a sulfated version of tositumomab comprising a sulfated Fc region or sulfated Fc fragment, or a sulfated version of trastuzumab comprising a sulfated Fc region or sulfated Fc fragment.
[0211] In another aspect, the invention features a sulfated version of abciximab comprising a sulfated glycan, a sulfated version of adalimumab comprising a sulfated glycan, a sulfated version of alemtuzumab comprising a sulfated glycan, a sulfated version of basiliximab comprising a sulfated glycan, a sulfated version of bevacizumab comprising a sulfated glycan, a sulfated version of cetuximab comprising a sulfated glycan, a sulfated version of certolizumab comprising a sulfated glycan, a sulfated version of daclizumab comprising a sulfated glycan, a sulfated version of eculizumab comprising a sulfated glycan, a sulfated version of efalizumab comprising a sulfated glycan, a sulfated version of gemtuzumab comprising a sulfated glycan, a sulfated version of ibritumomab comprising a sulfated glycan, a sulfated version of infliximab comprising a sulfated glycan, a sulfated version of muromonab comprising a sulfated glycan, a sulfated version of natalizumab comprising a sulfated glycan, a sulfated version of omalizumab comprising a sulfated glycan, a sulfated version of palivizumab comprising a sulfated glycan, a sulfated version of panitumumab comprising a sulfated glycan, a sulfated version of ranibizumab comprising a sulfated glycan, a sulfated version of rituximab comprising a sulfated glycan, a sulfated version of tositumomab comprising a sulfated glycan, or a sulfated version of trastuzumab comprising a sulfated glycan.
Boing X 2
pre grant Method of Cell Culture update
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
28 Potential drugs in one patent,
[0045] In some embodiments, the reference therapeutic product is selected from the group consisting of: abatacept, abciximab, adalimumab, aflibercept, alefacept, alemtuzumab, basiliximab, bevacizumab, belatacept, certolizumab, cetuximab, daclizumab, eculizumab, efalizumab, entanercept, gemtuzumab, ibritumomab, infliximab, muromonab-CD3, natalizumab, omalizumab, palivizumab; panitumumab, ranibizumab, rilonacept, rituximab, tositumomab, and trastuzumab.
Go get em Holly et al.
Boing X 2
Two more pre grant,
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
http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=4&f=G&l=50&co1=AND&d=PG01&s1=momenta&OS=momenta&RS=momenta
Boing X 2
floblu14,
My My electronics patent.
Also check this out. Just mind blowing when you read it.
https://worldwide.espacenet.com/publicationDetails/description?CC=CA&NR=2972822A1&KC=A1&FT=D&ND=3&date=20160804&DB=&locale=en_EP
Boing X 2
Regulardoc,
Any substantial verdict leaves them with a major problem.
Assuming the following is correct AMPH and Watson better have what they are going to do all worked out. They are likely not going to have much time to argue who owes what in court.
"How much does a supersedeas bond cost?
The cost of an appeal bond is set on the basis of individual circumstances when a plaintiff brings a specific case to an appellate court.
Unlike the cost of other surety bonds, the supersedeas bond cost does not depend on the personal credit score of the bond applicant. Because it’s difficult to predict the decisions in court cases, appeal bonds are seen as high-risk. That’s why appellants have to pay at least 100% collateral in order to get bonded.
Besides the collateral, the plaintiff needs to pay a bond premium, a percentage of the surety bond amount. This amount depends on the specific court case and is usually equal the financial costs set in the initial court judgment.
Can I get a supersedeas bond with bad credit?
Because of the particularity of supersedeas bonds, there are no special bonding markets for them. Getting an appeal bond is possible only with good finances, so there are no bad credit bonding options.
In general, obtaining supersedeas bonds is more difficult and requires a higher financial responsibility on the side of the bond principal. As supersedeas bonds are high-risk surety bonds, the minimum requirement for 100% collateral is in force. Appeal bond applicants should thus prepare to cover these costs to get bonded."
No appeal bond and Momenta can start executing 10 days after a judgement is entered if there is no appeal bond posted for an appeal. I have seen that happen in other litigation before.
Then comes the unknown on what Watson will do. Based on the above it appears unlikely that AMPH will ever get an appeal bond on its own. Estimated interest and costs would have to be included in the appeal bond if I remember right.
Boing X 2
A couple of more filings,
https://worldwide.espacenet.com/publicationDetails/description?CC=HK&NR=1221655A1&KC=A1&FT=D&ND=3&date=20170609&DB=&locale=en_EP
I thought CW said they were giving up on this one,
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
Confusing as it was just filed. I must be missing something as it does talk about pancreatic cancer.
Boing X 2
Breakout at 17.49
Next target 18.74.
Boing X 2
mouton29,
It will be interesting to watch the open for sure.
Boing X 2
WHOA someone wanted in bad. What do they know?
Pre-Market Volume: Pre-Market High: Pre-Market Low:
250 $ 18
(07:48:37 AM) $ 18
Plus 80 Cents. 17.20 to 18.00
Could also be a worried short that just wants out bad.
Boing X 2
Thank you,
Well
That might have to change. No reason to hold up one for the other unrelated issue. I hope Momenta argues that as something that should change while they are discussing all the biosimilar issues.
Boing X 2
I forgot to add,
Drug approval and production are two separate issues.
We are only talking about adding more medicine to the same syringe.
I can see a jury not pleased about the hold up of the drug over the production line that can be
changed, corrected or moved to another company.
Either the drug is approved or tell Momenta what the problems are. Don't hold up the approval just the line approval if necessary.
Boing X 2
Here is what I think,
The FDA, IMHO, could have a major big problem if it can be shown they are withholding Glatopa 40Mg approval due to Pfizer not complying at their manufacturing plant.
Here is what should happen.if they have no issues on the drug for approval but only the production line, the FDA should inform Momenta that the drug is approved but not for the current
Pfizer line. That upon a new approved production line or correction of the current line they will give final approval.
One can’t hold Momenta hostage for someone else's mistakes. They can make us have an approved line and they should give approval subject to an approved line but not hold up approval of the drug subject to an acceptable line. Time is of the essence for Momenta having first approval.
This is a hugh potential monetary damage suit for Momenta if they hold us hostage over a production line, that we have no control over, when the drug has no further approval issues. Should they then give anyone else approval prior to us it would be game on.
I don’t think they could defend themselves if there were no issues on the drug and only on the approval of the production line. I even feel a jury would feel that they could have given approval subject to an acceptable line.
Boing X 2
2 cents to go!
BREAKOUT WATCH for possible breakout above 16.59, no resistance in area just above.
Type: True breakout from triple resistance.
Target: 18.07, 9.6% Stop: 15.97 Loss: 3.1% P/L ratio: 3.1 : 1 - Excellent
Boing X 2
Regulardoc,
I am sure you have a better handle on this then me.
Just saying what CW said that they are ready to get their hands on the 40mg and won't be tied down by the contracts they had last year. i.e. faster up tick on sales when approved.
Time will tell.
Boing X 2
biotech researcher,
I agree.
It also sounds like the Humira filing will be around Oct 1-15th.
Boing x 2
inthegrass,
Indeed great news for Momenta.
I was thinking this am. that almost every bit of bad news is baked into this stock price. I then checked to see what happened on institutional holdings after the Feb. debacle.
Much to my amazement, there were very few sellers at the end of March. For the most part the big boys held on.
CW said they were working full speed ahead on another line and that the problems at the current line had been being worked on for a year when the warning letter was received.
Top quality companies talking to us about Humira. Hopefully partnership by end of year.
It sounds like Express Scripts is chomping at the bit for us to get FDA approval on the 40mg Copaxone. CW doesn’t think it is going to take as much time to get ahead when the 40mg gets approved.
It sounds like we might go with the 50 % with CSL. It sounds like CSL has another potential drug as a result of the initial plans.Will have to make the decision in the next two months.
CW said there was another 200 Million not priced into the market on the CSL deal as I heard it.
IMHO no one is pricing anything in the market for Amphastar potential or HSIVIG potential.
What could blow the lid off this stock is if we get a sooner then expected FDA approval on Copaxone.
Boing X 2
CW is going to have to talk to us soon
He can't avoid the first quarter conference call that should be around May 1st or so.
He is going to have to spill the beans where we are. I doubt the analyst will just sit there and not really push for answers.
The board might want to put some questions down in the hopes they are reading this site and ask the questions.
They are going to have to come down from Mt. Olympus and give us a couple of crumbs so to speak.
I sure will be interested to hear when they start begging for more options. They sure will be talking then. The question is if anyone will be listening with their poor performance on checking Pfizer out and the lack of communication on a very serious issue that has crushed the shareholders.
Why have they not pressed Pfizer to get us rolling on their new site?
Boing X 2
floblu14,
So they are adding some risk management of our contractors.
" as well as oversight of contractors, CROs, CMOs for process development, characterization, optimization including associated scale-up, technology transfer, manufacturing and validation activities."
Nice find. " Oversight of contractors, associated scale-up and manufacturing and validation activities."
Those should have been in place from the get go! Hopefully this mess will not happen again in the future.
Boing X 2
floblu14,
You are most welcome.
Boing X 2
alternatepatel,
No thank you.
I think I am paying them good dollars to keep me and the rest of us informed. I want to see how long it takes them to give the shareholders a response. Every shareholder should not have to call to get a status report.
We have not had the luxury of one status report.
I have an early test at the hospital in the am. and that is enough to deal with for one day.
Boing X 2
jbog,
With your yes answer, If Pfizer would not voluntary let us out of the contract I would be moving for breech of contract against Pfizer to let us out of the contract at least as to the 40mg Glatopa and take our production to someone without the problems Novartis has. Otherwise Pfizer should have already arranged for a back up plant to take on the 40mg production.
I doubt any court would make us wait a year or several months for what may or may not get fixed by Pfizer and approved by the FDA.
I think the FDA warning letter makes a case for relief.
One month is gone now and no word from Momenta what they are thinking.
They need to tell us how they are going to fish or cut bait.
If they don't have an idea by now what to do, what makes one think they will in another month.
I know Sandoz has a lot of say, but, our interests also must be taken into consideration with the 40mg
approval being held up.
Boing X 2
I like the drugs that the company is trying to produce. I think the company has great potential.
I think management has been absolutely pathetic on no update after a major loss to shareholders. One month later and not one word, no guidance, no nothing.
Is this going to take a year or another month?
Is it not us that pays their salary and is entitled to some kind of word on what is going on? Stop the bleeding by some guidance. I have never seen a major company that never said a word after this kind of lossto its shareholders.
Boing X 2
New pre grant patent application,
METHODS RELATED TO BIOLOGICS
http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=5&f=G&l=50&co1=AND&d=PG01&s1=momenta&OS=momenta&RS=momenta
"
[0030] Detailed, high resolution, physiochemical and/or structural information about Actemra.RTM. (e.g., related to the presence of signature glycan species or quantitative analyses ascribing site-specificity for backbone modifications) can be used in the manufacture of products that qualify as tocilizumab, e.g., that are interchangeable versions of Actemra.RTM.. Such information is also useful in monitoring product changes and controlling structural drift that may occur as a result of manufacturing changes. 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 et al "An Introduction To Safety Issues In Biosimilars/Follow-On Biopharmaceuticals", J. Med. CBR Def, 7:1-18, (2009)). This disclosure provides, in part, methods and compositions sufficient to make and test products that qualify as tocilizumab, e.g., that are interchangeable versions of Actemra.RTM.. “
Boing X 2
First that I heard of this one.
http://www.biopharminternational.com/momenta-receives-warning-letter-generic-copaxone
"Meanwhile, on Feb. 16, 2017, a day before Momenta formally recognized the warning letter, Pfizer CentreOne announced it has expanded its fill/finish capabilities to its Kalamazoo, MI site. The site will now handle sterile injectables.
Source: Momenta"
This brings up a lot of interesting question. Does Pfizer owe us an obligation to get the 40mg Glatopa approved and manufactured at the MI plant if they can’t get approval, at the Kansas plant, for months yet. Apparently the MI plant has the ok for production of sterile injectables..
How hard would it be for Pfizer to tell the FDA that the 40mg Glatopa would be manufactured there while they work out the Kansas problems.
Note the PR.
https://www.pfizercentreone.com/news/contract-manufacturer-pfizer-centreone-expands-fill-finish-services-its-kalamazoo-michigan
Why did I have to scour the net to find out about this blurb? Why is Momenta not pushing hard on Sandoz and Pfizer to do this.
Pfizer is costing us all big bucks and this should be a no brainer to cut our losses since they have a new plant with the capacity and should give us priority so we can get the FDA approval.
Not sure if the FDA could hold us hostage on approval because of Pfizers problems if they tell them they will manufacture at the new plant.
How about this as an option? Manufacture at the new plant. Momenta is aware of this MI plant based on the PR. I know Sandoz and Pfizer control but, they should not control to the detriment of our FDA approval by not mfg. at a new plant.
It would seem that after 18 days that is what we should be hearing is going to be being done or if not why not. Days count big time on all our losses. It would take one day to let the FDA know they are switching to the approved plant. That would take us out of the twilight zone here.
There might be reasons why they can’t, but. no one is telling us why not.
Boing X 2
New pre grant patent application,
COMPOSITIONS AND METHODS RELATED TO ENGINEERED Fc CONSTRUCTS
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
"XIII. Indications
[0141] The pharmaceutical compositions and methods of the invention are useful to reduce inflammation in a subject, to promote clearance of autoantibodies in a subject, to suppress antigen presentation in a subject, to reduce the immune response, e.g., to block immune complex-based activation of the immune response in a subject, and to treat immunological and inflammatory conditions or diseases in a subject. Exemplary conditions and diseases include rheumatoid arthritis (RA); systemic lupus erythematosus (SLE); ANCA-associated vasculitis; antiphospholipid antibody syndrome; autoimmune hemolytic anemia; chronic inflammatory demyelinating neuropathy; clearance of anti-allo in transplant, anti-self in GVHD, anti-replacement, IgG therapeutics, IgG paraproteins; dermatomyositis; Goodpasture's Syndrome; organ system-targeted type II hypersensitivity syndromes mediated through antibody-dependent cell-mediated cytotoxicity, e.g., Guillain Barre syndrome, CIDP, dermatomyositis, Felty's syndrome, antibody-mediated rejection, autoimmune thyroid disease, ulcerative colitis, autoimmune liver disease; idiopathic thrombocytopenia purpura; Myasthenia Gravis, neuromyelitis optica; pemphigus and other autoimmune blistering disorders; Sjogren's Syndrome; autoimmune cytopenias and other disorders mediated through antibody-dependent phagocytosis; other FcR-dependent inflammatory syndromes e.g., synovitis, dermatomyositis, systemic vasculitis, glomerulitis and vasculitis. “
Boing X 2
jborg,
"Everything you say is fine, but the main point is that the manufacture, sales and distribution of Glatopia is Sandoz's responsibility. Momenta has zero to none involvement at this level.”
I agree, except, they have a responsibility to make sure of what is going on, what they are doing and how it might impact them.
"I'd have to assume that there is a joint management team consisting of Sandoz and Momenta personnel to make any decisions. The problem would be that Sandoz would carry a stronger vote.”
True, but that does not stop Momenta from recognizing any potential problems and recognize any risk and make an informed decision how to handle them, as far as Momenta shareholders, should anything go wrong.
"Let's understand one thing, Momenta contracts to its customer which is Sandoz. Momenta has no relationships with the Pharmacies or Customers. Momenta has no relationship to Pfizer”
I will accept that. Then Sandoz should be speaking up. It still does not relieve Momenta of having everything covered with Sandoz or, determining if there is an insurable problem should Sandoz be unable to perform, as far as
Momenta shareholders are concerned.
That is the point I am trying to make. It takes risk management to Identify potential problem areas, Determine potential exposure and alternatives, Identify potential solutions and implement solutions and then control and monitor the results.
So far no word from Momenta on the problems so we know nothing.
Boing X 2
jbog,
No I am not getting Sandoz and Pfizers responsibilites confused. If you see I said both Pfizer and Sandoz has that responsibility at the end of my post. As far as I am concerned they owe us shareholders some explantation either through them or Momenta.
I am saying we should have a risk manager on board or hire one for input of a risk assessment to determine Momenta's risk potentials. i.e. business interruption would likely cover a problem with Glatopa 20mg but I doubt not the 40mg without an FDA approval and the start of manufacturing.
Risk Management would identify all Momenta's potentials for exposures and make a conscious decision to insure or self insure or get indemnity agreements if someone else messes up.
Like I say, what if they have a Kansas tornado and we are out of business for a year. Momenta needsback up plans ready to implement on a moments notice if Sandoz or Pfizer can't perform. We don't have the luxury of waiting a year here and there.
Boing X 2
randychub,
Glad you asked. I have revised this so many times but here goes.
I for one am disappointed at the long silence.
Momenta has not seen fit to give any kind of an update to the shareholders. I don’t consider them their attending a Cowan conference the same an an update to shareholders after our shock loss. PFE and Sandoz have been quiet likewise.
If they can’t give us an update yet, say so and give us an idea when they can.
I still want to know when they first became aware of the problems. June of last year or when? It is going to come out sooner or later.
The full FDA letter is out there and I am not as optimistic things can be corrected so fast with a fast FDA approval. We don’t have Momenta’s input on their feeling yet. Surely they have had numerous discussions with PFE and Sandoz by now.
Per the FDA letter,
"These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate.” and ''You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements.” Have they done this since June? Don’t know yet. Don’t know how far along they are yet. Bringing people into one site for a quick fix doesn’t sound like a correction of a global problem that will get the FDA approval. I guess they
could give piecemeal approval but, it doesn’t sound like they are after that kind of approval.
Did we not have some kind of cooperation deal with WuXi for potential drug manufacture not too long ago. I just could not find the PR. If I remember right they even opened an office in Cambridge to be close to Momenta. I am aware they were taken private.
I see they opened a plant in PA not long ago. They were building a new plant in Shanghai. The PA plant appears to be in compliance right now as well as the one in Shanghai.
It would seem that Momenta needs to assure with the manufacture or manufactures, in the future, that there has to be a back up system in place should this problem arise again. It is called Risk Management. What if the Pfizer plant has a fire or a tornado or another warning letter. Will we have to wait months for repairs, with major losses, before they can produce our drug again?
Not acceptable. Momenta should consider adding a risk manger if they don’t have one or hire a risk management firm to identify the companies potential risks. The Risk Manager should make sure their are back up plants in place with FDA approved plants that can take over on short notice. Just my thoughts. I don’t want to be going through this ever again. Momenta just develops the drugs so they have to make sure they are protected from this kind of exposure in the future.
Sandoz and Pfizer as big as they are, should have had these contingency plans in place. A risk manager could have made sure those plans were in place or have indemnity agreements should they not be in place.
Not a I’m sorry to the Momenta shareholders by either Sandoz or Pfizer to this point.
Boing X 2
New patent application,
METHODS AND COMPOSITIONS FOR THE DIAGNOSIS AND TREATMENT OF KAWASAKI DISEASE
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
IVIG
Boing X 2