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Survey idea. I would be interested to see the results of the following survey please. Not sure if this request belongs here or the Biotech Values message.
#1. When will there be a MNTA buyout
a) In 2011
b) In 2012
c) In 2013
d) Unlikely if ever
#2. Projected buyout offer (assumptions: approval of m-Copaxone by FDA and MNTA wins patent suit; maintains solo generic status of m-Lovenox)
a) $35-$45/share
b) $46-$55/share
c) $56-$65/share
d) $66-$75/share
e) >$76
Thank you for considering the idea.
Did he say "Vegas" was a better gamble? Wow! Totally speechless!
One of the issues we were faced with as I audited manufactures in China of ingredients for the nutraceutical industry is the requirement of traceability. Given the dynamics in regional communities, small slaughter houses and local village butchers, animal carcasses (swine) would be collected by families, transported to local manufactures (non-GMP) where “crude” preparations where extracted, then resold to GMP “workshops” were the materials were reconstituted and further processed. In my personal experience, very little if any paperwork was available demonstrating the “traceability” of said finish ingredients. I am speaking specifically of chondroitin sulfate and glucosamine HCl. All FWIW.
Reason being as you cited, cost, cost, cost
Thank you.....I appreciate your assessment. Continues to be a fascinating story.
"Absent any new information, I rate the cumulative probability of FDA approval of NVS/MNTA’s Copaxone ANDA by the end of 2011, 2012, 2013, and 2014, respectively, at 42%, 68%, 78%, and 84%. JMHO, FWIW"
Any additional thoughts on updating your probabilities? TIA
Understood your point. My counter point is that TEVA would want the trial sooner than later, or am I missing something?
Thank you Dew. Not surprising, but very nice to get confirmation I would say. Minimum of 8 more quarters of unfettered m-Lov maximum profit.
LOL!!!!!! I don’t subscribe to the conspiracy theory…..but did get a chuckle reading your post. Happy Tuesday!
"Can it be attributed to the non approval by the FDA for M Copax?"
I firmly beleive it has nothing to do with M-Copax. Most investors I think don't expect M-Copax to be approved any time soon by the FDA.
Bladerunner.....simply stated, I shared my opinion apropos the lawsuit saying that I didn't think it had anything to do with the recent MNTA stock offering. Outside of this opinion.....I don't have much else to say. This is an incredible story and I'm excited and anxious to see how it all plays out. Our own version of a Soap Opera. :)
"If TEVA gets their approval and it turns out that they didn't use any of MNTA's patents, will that in some way lessen the value posters ascribe to MNTA's technology?"
Yes, to some degree. Perhaps then 2 companies have IP that can measure very complex molecules by different methods/approaches.. As a biochemist, there are always more than one method of characterizing a given molecule.
"What is the likelihood that MNTA filed their patent lawsuit only because they were doing a stock offering and the lawsuit was more like PR to give more value to their offering? The timing was certainly a bit suspect. And I am sure no company wants to go through discovery, least of all a drug company that has many trade secrets."
Very unlikely as anything to do with the stock offering. As others here have pointed out, it was more likely a strategic offensive move directed at TEVA.
"How would TEVA have learned enough about MNTA's technology to be able to duplicate it? Is it easy to learn the details, I didn't think enough details were in patent filings to be able to duplicate them."
Patents are written is such a vague way that they offer very little in terms of details that a competitor or anyone else can use.
JMHO
I fully agree! Also interesting that so far this morning that Novartis shares appear to be unaffected by the news, moving up 0.34%.
"Many investors remain unconvinced that NVS/MNTA will receive FDA approval for generic Copaxone before Teva’s patents expire in 2014; for those investors, the patent case is mostly academic."
On the MNTA board....I expressed my views. Specifically thinking MNTA would recieve approval from the FDA by the end of 2011. In your view....do you think I'm too optimistic?
TIA
my 2 cents.....i disagree with most of what is stated in the Credit Suisse comments as outlined here.
#1. I continue to believe that MNTA will get FDA approval without new clinical trial(s) for m-Copaxone.
#2. Given the experience MNTA had with m-Lovenox approval, I believe FDA approval will take place before the end of 2011.
#3. Finally, I see MNTA getting a positive outcome on the Copaxone litigation and moving m-Copaxone into the market before the end of 2011.
Thank you for sharing!
I was hopeful some additional insight might be shared.
Regardless.....good luck to all.
Thank you for your comments....I understand the "missed" opportunity from $0.90-$2.30 PPS. I wasn't in the position finacially to move until recent. Clearly if CBRX has all you cited that they have all WPI wants/needs to execute thier (WPI) business strategy in this unique niche market, then this issue potentially still has significant upside. My question remains the timing of a buyout (if that is the true strategy of both parties) and the "fair" price for such an assest.
TIA
Inquiry
I'm interested in investing in CBRX, but have concerns about their need to raise working capital. It appears they have approximately $20 Million or so on hand.....and with the NDA submission scheduled for Q2-2011, is WPI's milestone payment to CBRX for this NDA submission enough to keep CBRX afloat until the FDA approves of PROCHIEVE 8% which looks to be Q4-2011 or Q1-2012.
Also I would like your (anyone that is currently invested) thoughts on WPI eventually buying out CBRX after the FDA approval. What is the guess % probability would you subscribe to this event and the time frame? Since WPI already has 11.2 Million shares of the 84.13 Million....wouldn't it seem prudent for WPI to buyout CBRX soon after the pending approval?
PS....I thought the following "fluff" piece was more detrimental to CBRX given I don't personally like these types articles given they attract "day traders".....
http://www.thestreet.com/_yahoo/story/10949369/1/5-pharma-stocks-trading-for-under-2.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
CBRX has been on my watch list since July 2010....I'm just a tad anxious about the cash situation.
TIA
Rich
Speaking of Bill Marth.....5 more days and he/TEVA will be extremely disappointed.....LOL.
What is the new date that TEVA says they will have FDA approval for t-Lovenox? End of Q1-2011?
A question if I may......would MNTA be legally required to notify the underwriters (UBS) if as you mentioned "something material is going on"? TIA
Dew,
Assuming MNTA gets final approval of the Copaxone ANDA in Q1 2011, what probability would you assign (%) that MNTA/NVS will launch at risk? TIA for your insight/opinion.
Happy Holidays!
I too was both surprised by that and perplexed.
News for 'MNTA' - (*DJ Momenta Pharmaceuticals Started At Neutral By Goldman Sachs >MNTA)
(END) Dow Jones Newswires
December 20, 2010 08:31 ET (13:31 GMT)
Copyright (c) 2010 Dow Jones & Company, Inc.- - 08 31 AM EST 12-20-10
Source: DJ Broad Tape
Neutral????? Seriously, I don't get it? How can MNTA only be a "Neutral" rating????
Very unlikely this would happen IMHO. I think this would be a mistake on the part of MNTA executives if they sold mL for anything south of $2 Billion. Look how many years it took MNTA to get approved and the total investment they have made getting m-Lovenox to market. Again, JMHO.
Regards
Agreed. Most likely after the FDA releases the clinical hold on 184/320 when the pps jumps up a bit in response to the positive news that 184 is back on track. Do you have any opinion on the timing of either the issue of additional shares and the release of the clinical hold? I see DD has moved the FDA news into the first part of 2011. Thoughts everyone? TIA
Quote...."I am surprised IDIX P/S held up this week given a cloudy vision out of the 30 Oct analyst meeting"...
Me too! Perhaps an institution is accumulating while retail investors are slowly giving up for now. The pps normally is pretty volatile. But over the last 3 weeks it seems if this has stabilized around $4.25 (plus/minus a few cents).
After giving this some more consideration, I believe Renaud is only a transition man, a figure head until whatever strategy has been executed. Whether it's a complete sale of the company, which "may" be the best course of action to keep programs like 184 going forward without losing too much momentum, or some other type of partnership that JPS was against, who knows. At the moment, my gut tells me that IDIX given the observations we have witnessed this last week is working a complete buyout. I ask for the right to change my opinion as more facts present themselves.
The only word that continues to come to my mind is "odd". With JPS "deciding" to move on and the rehash of previously presented material as you pointed out, it appears this company is lost and investors may start to walk away......
Perhaps if and when the FDA clinical hold on 184 and 320 are released, more clarity will be provided by the IDIX executive team.
Thank you for your continued updates and comments, I sincerely appreciate them.
I don't think the company is as good as "sold" IMHO....I think additional setbacks have taken place (yet to be disclosed) and JP had to step back as he is too close and perhaps too emotional to be running the business anymore. I would love to be wrong.......I see this announcement as a big negative......
"I mean, if they are that different then why hasn't the FDA rejected it outright?"
I am wondering the same thing. Why then if TEVA and the manufacturing partner have not met the criteria for "sameness"......hasn't the FDA rejected the application?????? Perhaps I am missing something?
Idenix Pharmaceuticals to Hold an Investor/Analyst Day Event on October 30, 2010
CAMBRIDGE, Mass., Oct 27, 2010 /PRNewswire via COMTEX/ --
Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX) announced today that the Company will hold an Analyst Day event during the upcoming 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) on Saturday, October 30, 2010 from 9:00 a.m. to 12:00 p.m. ET at the Mandarin Oriental, Boston.
The live and archived webcast of the presentation can be accessed under "Calendar of Events" in the Idenix Investor Center at www.idenix.com. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived replays will be available on the Idenix website for two weeks following the event.
Wow....3 hours to communicate with our friends on Wall Street
Quote DVT in general and Factor V Leiden in particular - As I have noted before DVTs get amazingly little attention given that they are the proximate cause of death for a surprisingly large fraction of the population. Studies of random autopsies indicate that percentage of deaths from pulmonary embolism (a little different than DVTs) is about 2% of all deaths
I couldn't agree more with your observation. I myself have help two men in their late 60's this summer alone (both healthy & active) by insisting that they immediately get an ultrasound of their leg.....both turned out to have DVT behind their knees. With 30 Million in the US alone having Factor V Leiden....you would think the pharma companies would be better addressing this indication. Just my 2 cents.
It would be interesting if one of MNTA heparin fractions could be enteric coated for release in the intestines providing a preventative therapeutic dose for indications like Factor V Leiden. Just pondering…..
7 years later from my original post regarding DVT's and Factor V Leiden. To date I have only had one DVT behind my left knee thank heavens and that was how personally found out I had this inherited trait. To date as far as I know, there is nothing on the market for those of us that have this trait can take to prevent future DVT's. Perhaps this is an indication that could someday be addressed.
MNTA
Nice to see M118 get some attention……
AMBRIDGE, Mass., Oct 26, 2010 (GlobeNewswire via COMTEX) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex mixture drugs, today announced that its next-generation novel drug candidate, M118, was selected by an expert panel from Windhover Information and the publishers of In Vivo and Startup as one of its "Top 10 CV/Metabolic Projects to Watch".
Criteria for the "Top 10" designation included:
-- Large market, large unmet need, with increasing opportunity
-- History of the molecule and drug
-- Strong science
-- Strong company
-- Diversity of indications
-- Potential for new opportunities beyond the initial indications
-- Multi-level partnering opportunities
"We believe this recognition supports the considerable promise of our novel anticoagulant drug candidate M118 in patients with acute coronary syndromes for both medical management and in the peri-procedural setting," stated Jim Roach, M.D, SVP and Chief Medical Officer of Momenta. "M118, a low-molecular-weight heparin, was rationally designed to capture the positive attributes of both unfractionated heparin and enoxaparin in one compound. We have reported positive results from our 500 patient Phase 2a clinical trial in patients with ACS undergoing elective percutaneous coronary intervention, and look forward to finding a suitable collaborative partner to continue development of M118 in ACS."
About M118
M118 is a novel anticoagulant that has been rationally engineered using Momenta's proprietary technology and analytical methods to provide anticoagulant therapy to patients with acute coronary syndrome (ACS). M118 is designed to interact at multiple points in the coagulation cascade by selectively binding to both anti-thrombin III and thrombin, two critical factors involved in the formation of clots. Preclinical and Phase 1 studies have shown that M118 is a potent inhibitor of multiple factors in the blood that lead to clot formation, that its anticoagulant effects can be neutralized and that its activity can be monitored with standard point-of-care assays. An anticoagulant possessing these properties has the potential to satisfy a currently unmet medical need within the ACS patient population by capturing, in a single anticoagulant therapy, the positive attributes of both UFH (reversibility, monitorability and broad inhibition of the coagulation cascade) and low molecular weight heparins (adequate bioavailability and predictable pharmacokinetics to allow for convenient subcutaneous administration).
About Momenta
Momenta Pharmaceuticals is a biotechnology company, headquartered in Cambridge, MA, specializing in the detailed structural analysis of complex mixture drugs.
Momenta is applying its technology to the development of generic versions of complex drug products, as well as to the discovery and development of novel drugs. To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release.
Our logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.
About Windhover
Windhover Information Inc., an Elsevier company, has provided analysis of the healthcare industry to decision-makers at all levels since the founding of its flagship publication, IN VIVO: The Business & Medicine Report, in 1983.
Windhover provides its information and analysis in many formats, including print, electronic databases, international conferences and webinars. For more on the company's products and services, please see www.windhover.com.
Forward Looking Statements
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including our beliefs regarding the potential development and commercialization opportunity for our M118 product candidate, including the quarter ended June 30, 2010, and current and future development and commercialization efforts, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "hope," "target," "project," "goals," "potential," "predict,"
"might," "estimate," "expect," "intend," "is planned," "may," "should," "will,"
"will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors referred to in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by Momenta from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein.
Momenta is providing the information in this press release as of this date and assumes no obligation to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Momenta Pharmaceuticals
By Staff
CONTACT: CONTACT: Momenta Pharmaceuticals
Beverly Holley, Director of Investor Relations
(617) 395-5189
bholley@momentapharma.com
Sorry, was just stating I had a hard time thinking the increase in IDIX was due to AASLD meeting. I'll keep my 2 cents to myself. :)
Given we are still two weeks away from the start of the AASLD conference, I'm more inclined to think that some investors felt the "intrinsic value" of the company as a whole depreciate too much since the FDA hold and have been accumulating for a while. Just my 2 cents.
Conspiracy Theory Yahoo is owned by Teva and won't allow pro NVS/MNTA news. Sorry....I had to.
MNTA - Last night when I went to pick up a prescription from the Walgreens in our little town here in Wisconsin, I asked the pharmacist about the "new generic Lovenox" and if she had heard about it. She mentioned that the new generic was all that they now carry and had been for a few weeks now. Just thought that was interesting. Jumped in this week for the first time and hope 12 months from now to be celebrating.
Finally jumped in yesterday for 3k shares. Very excited about the prospect of this issue.