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"I was conned into buying this issue."
Me too.
io_io Thanks for the informative message. So glad we have you as the moderator. Keep up the good work
Amr101: Poll on exclusivity.
There are 2 polls to the right. Pls vote...We'll tally on 20th.
stks.co/e1gu
ahande - my guess
1) something happened in lovenox court case ?
2) an equally plausible scenario is institutions/funds believe in the strong case MNTA has in copaxone trial and are betting on MNTA winning. Looking at the back and forth arguments in Copaxone case, I think their case for indefiniteness(lack of enablement) is very STRONG. IMO
3) Also,keep in mind, the cash is growing and we are approaching 2014! so use of cash to buyback stock is also becoming a real possibility
btw no pacer documents today as of 10:30 in both cases. on copaxone case, company has told me, judge is not accepting any more briefs....so now it is judgement time in that case..may still take a few weeks
"Preferably two or maybe even three because one could possibly be over-turned within the 2.5 year period. That may be a stretch as the patent court cases take about that long anyway."
pre-trial motions, other trial Motions , judge schedule, appeals....of course 1 patent could have several claims...of course they could list multiple patents
Eg:Momenta and Sandoz submit paragraph IV ANDA filing for Copaxone. August 2008: Teva files patent infringement suit against Sandoz/MNTA
trial ended 3 years 3 months later...Judge will rule in next 3-6 months ...so in total 3.5+ years - the actual trial itself was just a week or two.
Have you also factored ANDA backlog ? Fondaparinux under the so called expedited GIVE review took 2+ years. Generic Copaxone(while complex) has taken how many years and is still pending with FDA...
I think it is safe to assume FDA will take 3-4(?) years ...so if ANDA is filed on the 4th year likely we will be in the 8th year
Also, I am pretty sure they will get some defendable patent claims which will hold in the court. My take is 8 years , if NCE is granted...I think very likely they will get NCE...
"FDA confers five years of Hatch-Waxman exclusivity to AMR101 as a new chemical entity, a generic could be on the market much sooner than 2021"
IO/Stock_inv - The above info is incorrect.
If AMR101 gets the NCE status (I think it will ...Lovaza has considered as 1 moiety by FDA not 2 active moieties EPA and DHA - see CP), then it will have a 8 year exclusivity period.
5 year NCE + 30 month stay (on any para IV for listed orange book patent) + 6 month PED exclusivity
So exclusivity of 8 years
Take an average yearly sales of $1.5 billion (conservative IMO considering Lovaza sells for $1 billion for the smallest indication)
Assume 33% profit (after partnership royalty) = 0.5 billion
$4 billion in 8 years
For patent expirations of various products one of the following companies: Glaxo/Pfizer/Abbot may buy this company IMO
Ahande - Good find. I'll leave it to the legal experts here
stock_inv
i have seen the Aoki patent. Yes there are similarities...there are some novel stuff in Amarin patents ..We'll have to see.
Here are some novelties
1) EPA plus hydroxy-atorvastatin exhibited significantly lower lipid hydroperoxide formation compared to EPA+ atorvastatin, EPA+ simvastatin or EPA+ rosuvastatin.
2) Aoki Claims is deciding factor in infringement. Aoki claims pitvastatin only (see ALL claims 1-7)
3) Aoki also does not quantify the purity of EPA (possible enablement issues?)
http://appft.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=%22momenta+pharmaceuticals%22.AS.&OS=AN/%22momenta+pharmaceuticals%22&RS=AN/%22momenta+pharmaceuticals%22
BACKGROUND OF THE INVENTION
[0002] The terminal galactose-.alpha.1,3-galactose glycan (herein referred to as Gal-.alpha.-Gal) can be a functionally consequential modification to N-glycosylated proteins given its immunogenic potential in humans when presented on heterologously derived biologic therapeutics. The presence of this carbohydrate epitope on endogenous proteins appears to be highly species specific, e.g., detected in pig, mouse, and rat, but absent in primates. Thus, the epitope can be present on recombinant biologics produced in cellular expression systems derived from certain organisms (e.g., Mouse NS0 or SP/2 cells, transgenic pigs). The monoclonal antibody cetuximab (Erbitux.RTM.) is one such example of a commercial protein drug product produced in a mouse derived cell line and also reported to contain the Gal-.alpha.-Gal carbohydrate epitope (Chung et al. (2008) N Engl J Med 358:1109-1117). The enzymatic biosynthesis of the Gal-.alpha.1,3-Gal glycan has been ascribed to 1,3 glycosyl transferase-1 (herein referred to as Ggta1) (Taylor et al. (2003) Glycobiology 13:327-337; Smith et al. (1990) J Biol Chem 265:6225-6234).
SUMMARY OF THE INVENTION
[0003] The invention is based, at least in part, on the discovery of .alpha.-1,3 glycosyl transferase-1 (Ggat1) gene sequences in both the Chinese Hamster (Cricetulus griseus) from which CHO cells are derived and in a CHO cell line used for recombinant protein production. Accordingly, the invention relates to nucleic acid and polypeptide compositions related to the discovered genes, and related vectors and cells (e.g., CHO cells genetically engineered to reduce, eliminate or increase Ggta1 activity and vectors useful for producing such cells). In addition, the invention relates to the use of the identified sequences in various methods, e.g., methods to detect Ggta1 activity in CHO cells (including Ggta1 transcriptional activity and/or enzymatic activity), e.g., for screening CHO cells for the ability to produce Gal-.alpha.-Gal structures, or to identify and quantify Ggta1 expression or activity in a CHO cell, e.g., a cell used for production of a therapeutic glycoprotein.
Mouton
if 35m was posted by MNTA, that leaves what 365m in cash/cash equivalents....probably more like 380m (1.5 months after q3)
ps: Wonder what doomsday scenario shea is budgeting for ?? lovenox continues to bring in cash for at least another 12 months (no trial decision by then...unlikely PI decision will be overturned) . Also some analysts are forecasting Copaxone trial victory for MNTA. Highly likely Copaxone ANDA will be approved in 6-9 months timeframe. FOB partnership will high likely bring in cash. Yet 365m is in bank earning 0.1%
"think this is meant to streamline the NDA process."
I think it is probably talking about approval pathway for biobetter. Keep in mind MNTA in its last cc talked about biobetter. And we also know MNTA is not interested in going through the entire clinical trial(their core business is in proving that their drug is same as brand albeit better using all characterization data). They are also actively talking to FDA on this pathway as cw mentioned. Maybe they are arguing with their FOB characterization research data that, look we can rationally design(selection of cell line,clonal population) a biologic and get it to be almost the same as branded biologic and in some sense make it better(remove some undesirable characteristics that we know manifest because of selection of clonal population/cellline). However as in the example below there may not be surrogate end point/biomarker. MNTA has found if a particular gene is not there in starting cell line, then it will likely result in bio-better(safer product).
The big question will the market uptake for such a bio-better which has not gone through extensive clinical trials. What kind of "therapeutic equivalence" rating would FDA allow on such? I am guessing it may not have AB rating like generic lovenox??
Eg:
http://www.nature.com/nbt/journal/v28/n11/abs/nbt1110-1153.html
For biotherapeutics production, control of glycosylation is critical because it has a profound effect on protein function, including half-life and efficacy. Additionally, specific glycan structures may adversely affect their safety profile
we report here the identification of the CHO ortholog of N-acetyllactosaminide 3-a-galactosyltransferase-1, which is responsible for the synthesis of the a-Gal epitope. We find that the enzyme product of this CHO gene is active and that glycosylated protein products produced in CHO contain the signature a-Gal antigen because of the action of this enzyme.
Furthermore, characterizing the commercial therapeutic protein abatacept (Orencia) manufactured in CHO cell lines, we also identified the presence of a-Gal. Finally, we find that the presence of the a-Gal epitope likely arises during clonal selection because different subclonal populations from the same parental cell line differ in their expression of this gene.
who deposited the 100m cash bond ?
was it 50/50 split or did our CFO volunteer to deposit in full (use our company's approx 400m cash that is otherwise wasting away in bank earning 0.1% so we are covered for the scenario of heavy floods in Cambridge, Ma)
Senate to consider new FDA approval paths
CW was talking about this...So i guess this bill has to be passed for MNTA's FOB...as they are expected to file for "progressive approval"....I maybe reading this wrong. Feel free to correct me
http://www.biocentury.com/dailynews/topstory/2011-11-11/senate-to-consider-new-fda-approval-paths
Published on Friday, November 11, 2011
A draft of legislation produced by Sen. Kay Hagan (D-N.C.) seeks to create two new FDA approval pathways. Drugs would be eligible for "progressive" or "exceptional" approval if they are intended to provide meaningful advances in the treatment of an unmet serious or life threatening condition, according to a copy of the bill obtained by BioCentury. FDA could also approve drugs based on approval in the EU as well as in Australia, Canada and some other countries.
The draft bill would permit progressive approval based on data "reasonably likely" to predict clinical benefit, the standard currently used for accelerated approval. Unlike accelerated approval, drugs could receive progressive approval without data from a surrogate endpoint. Exceptional approval could be granted when the data necessary to satisfy the standard for approval "cannot ethically, feasibly or practicably be generated." The Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act would also relax conflict of interest restrictions for advisory committee members, create a fixed term for the FDA commissioner, and revise FDA's mission statement to emphasize the promotion of biomedical innovation.
Can this be posted ?
http://www.drreddys.com/investors/pdf/q2-fy12-earnings-call-transcript.pdf
Surajit Pal I have just one question. Going by the company’s pretty fantastic performance on protein based products, though there is no news from company’s side. Is there any kind of activities on Lovenox filing? Because it is a big product and very few competition is there.
Kedar Upadhye Surajit, which molecule you are referring to?
Surajit Pal Enoxaparin
Umang Vohra We are not disclosing that, Surajit. Sorry, we cannot not disclose at this pointin time.
Surajit Pal But will it be right to think that there’s some activities are on around from the
company’s side going by your efficiency in fondaparinux?
G. V. Prasad They are not related. Fondaparinux is a synthetic molecule and Lovenox is semi synthetic. That’s not a conclusion you could draw.
as far as I know Mochida does not have patent for combo. If you are saying that their jelis trial included patients taking statin, then you are right. but they dont have a patent for combo product as far as I know. Would be glad to know more info , if you have
ariad
what is being forgotten is Amarin has patent pending application on Combo of statin(lipitor) and AMR101. We have all seen how good the data in Anchor was. all the patent concerns / exclusivity issues do not consider this simple fact. keep in mind from the very beginning that the seed investors always talked about making a combo with a lipitor/statin. I have done extensive search in world patents db to see if there was any patent claim of combo treatment of epa and statin...didn't find any.
at least 15 years of exclusive sales of combo - billions of dollars
I will hopefully bring awareness of this fact .
check this link->
http://twitter.com/#!/IG2002
io__io
biotech ventures board is a joke. If you follow that every penny that u have should have been or should be invested in nothing but MNTA. In short it is an attempt to convince people to throw their winnings from AMRN to MNTA (whatever maybe the motive).
I do like MNTA the company. I HATE THE MANAGEMENT. ESP CRAIG WHEELER. HE DISPLAYS NO SENSE OF URGENCY. HE TALKS LIKE A REPORTER/JOURNALIST REPORTING A STORY IN THE CONF CALL. I HATE THE WAY HE STOLE 2% OF THE COMPANY WHILE AT THE SAME TIME (5 YEARS) HE CAUSED SHAREHOLDER LOSS OF 40%.
I PERSONALLY THINK MANAGEMENT CHANGE CAN WORK WONDERS HERE. I HATE THE FACT THEY ARE THROWING MONEY AT CLINICAL TRIALS FOR M402. I HATE THE FACT THAT 400M IN CASH EQUIVALENTS IS WASTING AWAY IN BANK. IS THERE ANY SENSE OF DOING THE RIGHT THING FOR SHAREHOLDERS IN WHEELER AFTER GRABBING 2% AND CAUSING 40% LOSS TO SHAREHOLDERS IN HIS 5 YEARS AT THE HELM. WHY CANT THEY AT LEAST DO A TOKEN BUYBACK OF SAY 75M .
I believe they have good scientist base including Ganesh the CSO. But these comics (CEO & CFO) need to be replaced. Look how they go to conf calls (almost 25) and they have repeated the same shit. There is no accountability to maximize shareholder value. they will likely soon get copaxone approval. what is the need to hold cash for funding expenses for full 4 years (esp now lovenox is still earning big money)
BTW what happened ? Why did u leave the mod pos in MNTA board ?
io_io
have u seen how some consorts are working tirelessly on spreading fear on AMRN!? its just funny
Rockrat
I just listened to cc cursorily. I also felt cw was talking about legislation. I was also under impression that the act is all done and what is left is FDA's implementation of the pathway to facilitate that act.
io_io
it is good to see MNTA board moderation is in your hands. you were one of the few thoughtful posters that can add value to those discussions.
jbog
MNTA is run by the BEST MANAGEMENT EVER.
MNTA's use of cash(380m earning 0.1%) thus far is THE MOST OPTIMAL EVER
MNTA's selection of research program and spending (M118,M402,Complex generics) is THE MOST OPTIMAL ALLOCATION EVER
buyback?
we will know in the call today if Sandoz will also share part of the 100m bond to be posted for PI.
If Sandoz would share half(50m), that still leaves MNTA with nearly 325M in cash/cash equivalents
and we know they will be cash +ve for another year (assuming PI if teva gets approval).
With prospect of cash coming in via FOB partnership , I predict a buyback with at least 75m of the cash. Let's see
Copaxone legal case
1. No TEVA's process patents would be infringed by MNTA including the test reaction - Non-infringement of process
2. MNTA probably has provided evidence under seal that 9-24KDA mol weight copaxone(MNTA's formulation) is NO more toxic than 5-9kda copaxone doing rodent studies. Maybe MNTA has also shown that 9-24KDA has same effect on biomarkers (cytokines) as 5-9kda- Patent on lower m.w copaxone is deemed Invalid.
Maybe the judge will also take in to consideration the 2 prior human clinical studies on higher m.w copaxone where TEVA itself concluded it was safe.
The judge will probably ask for FULL data on rodent studies done by TEVA where they concluded higher m.w copaxone was more toxic. was there any cherry picking of data by teva?
Hard to say what will happen on this point.
Hoping Judge jones will deliver verdict before xmas. It appears all filings have been made by both parties as of 11/01.
Is it possible that there could be settlement discussions between the 2 parties now ? For example, if TEVA believes the case is 50:50 it may want to settle with MNTA for a launch in 2013?
TEVA for one does not believe that generic copaxone will not be approved by FDA...
Also, note that if Mylan/Nacto does not follow teva's process of making copaxone and just measures the molecular weight in the end and amino acid ratio for conformance it is no good as shown by MNTA in the example(see bold below)
So as far as I am concerned, Mylan/Nacto will likely end up in a similar situation as Ampha. So FDA would approve MNTA's copaxone based on detailed characterization. At the time of approval, FDA will publish the criteria , which will include Pyro-gluco as a physio-chemical criteria. Then if Mylan were to change their application to test for Pyro-gluco, while they may get their ANDA approved by FDA like Ampha...they will be blocked by court via a PI.
The only way Mylan would be able to circumvent it is discover another proxy signature like pyro-gluco and use that prove equivalence in their ANDA as well as in their commercial manufacturing.
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=6&f=G&l=50&co1=AND&d=PTXT&s1=%22momenta+pharmaceuticals%22&OS=%22momenta+pharmaceuticals%22&RS=%22momenta+pharmaceuticals%22
"both deviating samples A and B were outside of the range for pyro-Glu content determined for Copaxone.RTM.. Sample A was within the range for Copaxone.RTM. molar mass and amino acid composition"
USPTO site has description
My biggest take from this is, NACTO/MYLAN better find another proxy signature or else even if they satisfy by checking Pyro-gluco(presumably finding about this criteria either via FDA interactions or through MNTA's patent estate) they will get a PI. see the below bold. Note if MYLAN follows teva's process of making copaxone to get the right molecular weight copaxone they will infringe on teva's process patent.
Doubt if there could be another proxy signature? iwfal?
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=%22momenta+pharmaceuticals%22&OS=%22momenta+pharmaceuticals%22&RS=%22momenta+pharmaceuticals%22
16. The method of claim 1, wherein the concentration of pyroglutamate in the purified glatiramer acetate is selected from the group consisting of 2000-7000 ppm, 2500-5500 ppm, 3000-5000 ppm, 3500-4500 ppm.
17. The method of claim 1, wherein the Mp of the purified glatiramer acetate is 5000-9000 Da or 6500-7500 Da.
[0003] The invention is based, at least in part, on the identification of methods for controlling the level of L-pyroGlutamic Acid (pyro-Glu) in glatiramer acetate (GA). Pyro-Glu is present in GA, and the ability to control the level of pyro-Glu in GA is useful in controlling both product
and process quality in the manufacture of GA.
[0015] Other than a statement about molecular weight and amino acid composition, which are recited in the FDA-approved label for the product, the label and other available literature for COPAXONE.RTM. does not provide detailed information about the physiochemical characteristics of the product. It has been previously found that Pyro-Glu (FIG. 1) is a component of Copaxone.RTM. (glatiramer acetate or GA) that is present within a predetermined range (U.S. Ser. No. 12/408,058). For example, in many cases the pyro-Glu content of a GA preparation can be between 2000 ppm and 7000 ppm or 2400-6500 ppm.
[0016] The production of GA entails polymerization of amino acids to produce a mixture of peptides, referred to as Intermediate-1, followed by partial depolymerization and deprotection of Intermediate-1 to yield Intermediate-2. It has now been found that the level of pyro-Glu in GA can be effectively controlled by controlling the water present during the depolymerization step of the GA manufacturing process, for example, by adjusting the water content at the beginning of and/or during the depolymerization step, e.g., by adding water to a predetermined level at the beginning or during the depolymerization step. Moreover, it has now been found that by properly controlling (e.g., adjusting) the amount of water present during the depolymerization step and the duration of the depolymerization step it is possible to produce GA with a specified pyro-Glu content and a specified peak molecular weight (Mp). In many cases it is specified to have the pyro-Glu content of copolymer or GA be 2000 to 7000 ppm, e.g., 2500-5500 ppm, e.g., 3000-5000 ppm, e.g., 3500-4500 ppm, 2400-6500 ppm, and the water present during the depolymerization reaction or added at the end of the depolymerization reaction is preferably controlled or adjusted to achieve this specified pyro-Glu content. In many cases it is desirable to have the peak molecular weight (Mp) of GA be 5,000 to 9,000 Da, e.g., 6,000 to 8,000 Da, as measured as described in U.S. Pat. No. 7,074,580.
[0025] The amount of water present during the depolymerization step can impact the pyro-Glu content and molecular weight of the resulting GA, as shown by the experiments described below. However, the amount of water present during the depolymerization step can vary over a reasonable range and still be compatible with the production of GA having a desirable pyro-Glu content and molecular weight.
MNTA's New Patent on Copaxone
Floblu maybe sleeping in the parking lot or fixing his Lamborghini.
1. WATER-MEDIATED CONTROL OF DEPOLYMERIZATION STEP OF GLATIRAMER ACETATE SYNTHESIS
I guess this is the way they ensure certain molecular weight of end product copaxone as opposed to TEVA's test reaction method
http://worldwide.espacenet.com/searchResults?DB=EPODOC&locale=en_EP&query=momenta+pharmaceuticals&ST=singleline&compact=false
description not posted yet
Ron yes. they have 5 years exclusivity for NCE. Plus, they have a COM patent on pure EPA that will expire in 2021. Everything else is up in the air. The drubbing in the non-rejection letter was unexpected for me esp the LDL neutrality I thought was a surprise finding and was not obvious. I still think there would be buy out from big pharma albeit at lower price than i originally predicted
To Ron,
yes MNTA has been disappointing thus far. it should recover soon. AMRN no complaints...my average cost was <3.
jbog- care to explain ? Are they releasing AG ? Inevitably there will price erosion after 180 day exclusivity with entry of multiple players?
http://online.wsj.com/article/SB10001424052970204528204577011492595048250.html
Longer-term, Pfizer will seek to sell an over-the-counter version of Lipitor, which, if successful, would counter the generic market and potentially revive the brand.
"The body language suggests to me that WPI is a reluctant partner who would like nothing better than to have Amphastar reacquire WPI’s rights to the product."
If Ampha wins the appeal and PI is overturned(unlikely) WPI will launch. If Ampha loses appeal, WPI will not launch. Let's just keep it at that. Thank you
Copaxone suite -MNTA filings under seal today
320
Filed & Entered: 11/01/2011
Notice (Other)
Docket Text: NOTICE of Materials Filed Under Seal. Document filed by Momenta Pharmaceuticals, Inc., Sandoz Inc.. (Aannestad, Anders)
321
Filed & Entered: 11/01/2011
Notice (Other)
Docket Text: NOTICE of Materials Filed Under Seal. Document filed by Mylan Inc., Mylan Pharmaceuticals Inc., Natco Pharma Ltd.. Filed In Associated Cases: 1:08-cv-07611-BSJ -AJP, 1:09-cv-08824-BSJ(Ebie, Kenneth)
317
Filed & Entered: 10/31/2011
Notice (Other)
Docket Text: NOTICE of Materials Filed Under Seal. Document filed by Teva Neuroscience, Inc., Teva Pharmaceutical Industries, Ltd., Teva Pharmaceuticals USA, Inc., Yeda Research and Development Co. Ltd., Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA, Inc.. Filed In Associated Cases: 1:08-cv-07611-BSJ -AJP, 1:09-cv-08824-BSJ(Blessing, Carolyn)
Mouton - your thoughts ?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=68492582
""Contractual profits" -- what is it? "
In simple terms, Contractual profit is the Partnership's profit (before profit is distributed to the 2 partners). It is not Sandoz's profit nor Momenta's profit until the distribution is complete. Sandoz will retain only portion of that Partnership/Contractual profit after distribution to Momenta.
Contractual law Implied terms & interpretation
-mouton,tinker,iwfal,rockrat your thoughts on this would be appreciated
Read page 82(starting "incomplete contracts & Contractual intent) and page 83
Here if AG withdraws say within week of launch or without any meaningful sale, then the contractual interpretation of "trigger of 2nd generic launch" can be called into question by MNTA. So in a sense the contract is incomplete. So contractual intent probably becomes important.
The obvious intent of the "trigger" was to reduce Momenta's %share of partnership profit with launch of second generic with the assumption that an entry of 2nd generic would reduce absolute partnership $ profit(market share of partnership's generic goes down as well as pricing). But if the AG is withdrawn within week then market share loss/pricing erosion have not happened.
http://encyclo.findlaw.com/4400book.pdf
BEGIN QUOTE
It is important to remember that all of these strategies involve presumptions.
It is all too easy for courts or proponents of a particular strategy to criticize the
alternatives as failing to hew closely enough to the parties’ intentions, when in
fact the parties’ intentions in incomplete contracts are at least uncertain, and
the question is which strategy is more likely to be successful at approximating
these intentions. For example, suppose a buyer rejects goods delivered late after
the market price drops below the contract price. A court might be called upon
to decide whether to imply a good faith limitation on the buyer’s ability to
reject. A textualist might argue no on the ground that such an implication
would be contrary to the parties’ intentions as expressed in the time of delivery
term. But the parties’ intentions - whether actual or hypothetical - may well be
that a good faith obligation should be implied rather than that the time of
delivery term should be interpreted as absolute. A proposition that textualism,
contextualism, penalty defaults, or joint maximization best represents the
parties’ intentions needs to be defended.
"Economic analysis can help to identify
the conditions under which the various interpretive strategies are more likely to approximate the parties’ intentions, and whether courts are better off pursuing a pure interpretive strategy or a mixed one"
END QUOTE
ahande - do you know of any OTC brokerage where u can buy significant volume(like 50k shares) at once ? Or maybe I should just try a broker assisted trade? Just tell broker I am interested in buying 500 options at a certain price
Flatlander
So in case of retraction of AG(which we cannot say for sure-but it is likely?), IMO it is very likely MNTA will invoke the good faith clause and try to get back to "contractual profit share". Keep in mind Sandoz relationship is now many years on. So I think it is likely Sandoz may oblige
http://en.wikipedia.org/wiki/Implied_covenant_of_good_faith_and_fair_dealing
n contract law, the implied covenant of good faith and fair dealing is a general presumption that the parties to a contract will deal with each other honestly, fairly, and in good faith, so as to not destroy the right of the other party or parties to receive the benefits of the contract. It is implied in every contract in order to reinforce the express covenants or promises of the contract. A lawsuit (or a cause of action) based upon the breach of the covenant may arise when one party to the contract attempts to claim the benefit of a technical excuse for breaching the contract, or when he or she uses specific contractual terms in isolation in order to refuse to perform their contractual obligations, despite the general circumstances and understandings between the parties.
So here the general circumstances and understanding b/w parties was a meaningful entry of AG. So a AG entry for 1 week and then a retraction may not qualify as launch in the original intent of the contract
AHANDE- Where do you do options ?
For the kind of stocks I buy (AMRN, MNTA, RDY, TSRX ) I have hardly found any meaningful volume
For eg, can u buy say 500 Call Options(control 50K shares) for MNTA in whatever brokerage that you use ?
"Would Sandoz retract if the AG fron Sanofi is retracted? "
It is possible I think. In scenario you describe the trigger(to royalty switch/hybrid mode) has really not happened because AG never really had any sale or sale and immediate subsequent retraction was insignificant so as to trigger a royalty/hybrid mode switch as originally intended in the contract. So it is possible in the scenario of retraction, MNTA may negotiate in good faith with Sandoz on this contractual issue.
Remember not everything written in contract can literally be interpreted. So the 2 parties can interpret a contract and suggest the intent of some language in the contract(in this case the trigger) really meant when a AG permanently comes to market or is meaningfully launched in the market.
I am not a lawyer but I know there is something like "Good Faith Clause"(see below) in contract agreements.
Let us see what happens here.
Here was IR reply when I had asked the question early last week
Question: If Momenta gets PI against Ampha and if Sanofi withdraws AG within the next week, is it possible that you go back to "Contractual profitshare" mode then ?
Answer: The contract doesn’t have a provision for the scenario you suggest so we are going to remain in hybrid mode unless an additional generic enters the market.
Good Faith:
A good faith agreement clause in a contract states that both parties will uphold the terms of the contract and that if for some reason they cannot, they will work together in good faith to come to mutually beneficial terms of agreement.
( PS: I am also not sure if retraction of AG is given esp if Sanofi believes that another generic may enter the market in a year's time via settlement or trial decision?? I don;'t think they would need such a long lead time for AG uptake.)
AHANDE- why care about ANAL-ysts?
where there is value , there will be price
Just like how last month's Ampha's approval raised concerns on MNTA's valuation, yesterday's single event of PI, has IMHO inevitably raised the valuation of MNTA not just for lovenox , but for Copaxone and FOB
of course overhang would be taken out further if we know what happens in appeal....
Dr Reddy's cc
interesting
http://www.drreddys.com/investors/pdf/Q1FY12-Transcript.pdf
Another point is that, as you were saying is that you are also putting money on proprietary technology through R&D expenditure and going by the kind of niche product as fonda has. Are you planning or do you have in your pipeline any similar carbohydrates synthesis based products which are pretty complex in nature and your team has done a fantastic job by scaling up. So do you have any product in pipeline or any expectation in say next two years time?
Umang Vohra We have products in our pipeline which are very complicated and require characterization like fonda required and we have got a nice emerging pipeline of that.
It will be from the US side, it will more dictated by the patent expiries and as
of now we don’t have any therapy bias in the portfolio. But from a
complexity perspective you know we would like to increase the proportion of
characterization led new products because that is where our strength lies.
biosimilars
Nitin Agarwal One is on the biosimilars front, you know even in the annual report we
stressed quite a bit upon our capabilities in biosimilars and that being our
medium term growth driver. So beyond the launches that you have done in
India, how do you see the biosimilar road map really playing out for us over
the next 2-3 years?
G. V. Prasad We have started registering the products in markets, which will allow us to
register products on basis of the clinical trials we have done in India and
some marginal additional trials. So that revenue, I think will become
significant by 2014 or so. But the real value unlocking will happen when the
products are launched in the US and European markets. So for these, we have
to do much bigger trials and our plan is to partner with somebody who has
the expertise to do large scale clinical trials as well as detail and market the
product in these geographies. So, in the meanwhile we are progressing the
product and we had EMEA meetings. We have requested a meeting with the
US FDA and the process of registering and doing the clinical trial will
continue, we will not wait for a partner. But we believe that the full potential
of the first few biosimilars from Dr. Reddy’s portfolio will be unlocked only
with a strong partner. So but you know these patents have to expire, we have
to do the trials, we have to file. So they are a little bit away 2015-16 onwards.