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CAR-T Investment Options:
I was searching through back posts and may have missed this, but of the three smaller biotechs BLUE, KITE, and JUNO, do you see any distinct advantages of one over the other or is this more of a global CAR_T "me too" phenomenon?
I was very impressed by the 100% response rate for BLUE's drug with multiple myeloma as that is a very large addressable market annually.
In case you missed this article regarding NVS, this is almost like a club cheering each other on:
https://finance.yahoo.com/news/novartis-car-t-therapy-drug-204908784.html
The news bode well for other companies who are developing CAR-T cell therapies like Kite Pharma Inc. KITE. The company submitted its BLA to the FDA in Mar2017 for the approval of lead candidate KTE-C19. KTE-C19 is a CAR-based therapy, being evaluated for the treatment for patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma and DLBCL. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Nov 29.
Meanwhile, bluebird bio BLUE and Celgene Corp. CELG also entered into a collaboration to develop CAR-T cell therapies for cancer. The collaboration was amended and restated to focus on developing product candidates targeting B-cell maturation antigen (BCMA).
Dew:
What are your thoughts on ILMN....I know they missed but the potential seems pretty robust and without a great deal of effective competitors.
Thoughts?
DB:
Morningstar has a forward PE of 31 and the stock has been a double in the last many months. Already mentioned here would be a favorable ruling on the Lovenox issue but one can never be sure about legal outcomes IMO. I suspect that a favorable ruling is NOT baked into the stock price but why are you supposing the revenue increases aren't already?
Please allow me a very simplistic question with the following background that I may be misunderstanding:
MNTA originally touted a huge technology prowess that would enable it to produce exact generic copies of complex medicines at reduced development time and cost.
Yet in the case of lovenox, a competing generic appeared in rapid succession and now with capoxone, another generic wannabe is in the wings even before any generic is approved by FDA.
I also understood that the capoxone contractual agreement again calls for dramatic reduced income to MNTA in the case of a second generic approval (similar to the lovenox situation). Dew has corrected that and confirmed tnat MNTA gets no reduction in % with another generic (other than market share issues)
So are investors better off to sell with capoxone approval (or even before) because once(if) Myl gets approval.......yet another thrashing of MNTA income and its stock price.
There doesn't seem to be another MNTA generic drug on the starting blocks awaiting FDA approval after capoxone.
Thanks in advance for your responses.
Thoughts on correlation between cash burn and success rates for biotech.
This article lists several biotech with relative low cash burn rates compared to cash on hand:
http://seekingalpha.com/article/320820-16-healthcare-stocks-with-high-cash-relative-to-expenses?source=yahoo
AEGR, AVEO, CNS, ENZN, EXAS, IMGN, ISIS, ITMN, MAPP, MNTA, NBIX, PCYC, RIGL, RPTP, THRX, VVUS, ZIOP
It seems intuitive though not absolute that companies with cash have greater likelihood to get a product to market.
Has anyone tracking biotechs over many years concluded the same or is this essentially irrelevant to the hope/hype/bust cycle we commonly see with this sector?
Any companies above with particular promise besides our MNTA?
It seems to me that MNTA receives the equivalent of half it's market cap in Baxter support in this FoB development which essentially negates the drain on its capital during the next 3-4 year development period. That doesn't seem unwise under the circumstances.
Further, there was no necessity to do a deal at this moment in time so I rather think MNTA was satisfied with the deal as it stands. It isn't as though this company was on its last stand without capital coming into its coffers. Some here seem to imply a near desperation to do a FoB deal but that just doesn't jive with their circumstances.
They are establishing many truly legitimate shots on goal.
Dew and All:
I haven't yet listened to the conference call but did Wheeler say how the FoB drugs would be selected? Who decides the order of drugs?
For example, can MNTA use Humira as the third drug and select other less robust drugs prior to assure it an opportunity for the accessing 30% sales of a greater market share drug?
There’s no need to renegotiate the old agreement insofar as a settlement with Amphastar can be negotiated de novo.
Understood insofar as the Amphostar settlement proposal. But I am referring to another issue that dovetails into the Ampho issue only because both NVS and MNTA would need to agree to any settlement to begin with.
This might be a good time to renegotiate with NVS......not to do a deal with Ampho specifically but to undo the "harm" that the royalty arrangement has done to MNTA's stock.
There is no logical reason, irrespective of number of generics on market, that MNTA should have anything other than a profit sharing arrangement. I understand that at the time, MNTA was negotiating from weakness......but they are no longer weak.
Time to leverage their IP, knowhow, future opportunities amongst "friends".......start with NVS.
Dew, do you know what the terms for the MNTA agreement were back so many years ago. Was it "exclusive" rights and indefinite in timeframe?
It still seems to me that MNTA should be negotiating with NVS regarding mitigating the royalty arrangement back in favor of a profit sharing arrangement.
At some point in time, when MNTA gets its FoB program going, it may just hold as grudge for NVS being a pig on lovenox (? capoxone) when no such position was necessary.
Were it me, I would be first knocking on NVS's door......right here, right now.
Take that "royalty" overhang off this company and its stock can ride with the wind.
Probably already asked but it is possible or likely that MNTA has information from the FDA of patent infringement on "sameness" issue?
Officially, it seems unlikely but one would think people still speak to one another "off the record" or is this impossible?
Since MNTA is essentially using the same argument against TEVA, it would seem that they may be privy to the "proof of sameness" issue that enabled FDA approval.
This makes the FoB-partnership negotiations rather different than they would be if MNTA were primarily looking for cash
If we look at the lovenox deal, they are getting 50/50 deal.
So we are presuming that they seek even better terms with the next prospect?
What is realistic in that sense....90/10, 60/40?
It does seem that they would require substantial assistance in production, marketing, distribution, etc......expetise that they do not presently have. These items are very capital intensive and could be a substantial drain on resources if they have a couple bad drug candiates.
But then again.....capoxone approval would put them in a whole new league ;)
Dew and All:
After reading the transcript of their earnings call, I was struck by what could be a significant strategy change regarding how they bring new drug candidates forth.
Previously, they seemed (wisely IMO) to prefer allowing more experienced, larger and better capitalized companies to partner with. This seemed wise on numerous levels.
But now they intimated (vaguely in all fairness) about more solo involvement.
Now while they have developed a nice war chest reserve, we have all seen how quickly these war chests can get depleted (EXEL as an example) when trying to go it alone.
Any thoughts on this new strategy or much to do about nothing? It seems either a strategy change or perhaps insight into the challenges of their present discussions with partners for the FoB program who may be playing hardball?
Here is the link:
http://seekingalpha.com/article/285192-momenta-pharmaceuticals-ceo-discusses-q2-2011-results-earnings-call-transcript?part=qanda
However, the nature of the kind of deals, I would say, both on the follow-on biologics side is potentially the new drug side as well, have changed now that we have cash balance. In other words, we have the ability to take programs along further if we feel that we actually are going to get a higher partnership value for those by bringing them further along in the pipeline.
We also have the ability to potentially co-invest which actually leaves us the potential to actually get a higher share of the revenues of those products and ultimate success. So, we think we need to use it judiciously but we still think we need partnerships. We think that actually really significantly increases our ability to invest and therefore capture upside profits in the future. So we’re looking at it as actually enhancing the trajectory of the company though we’re not really adjusting too much in terms of our goal for partnership. It does give us much more freedom to invest.
DEW:
Any thoughts on best options for the proxy votes everyone received for MNTA?
Anything you think needs to be addressed?
Highly unlikely market will value this company at 450 million (around 8$ per share)....i think it will drop to around 250 million trading on hopes of copaxone approval.
Why would you be so convinced that it should drop to well below what it was BEFORE lovenox approval?
There was certainly all that doubt before as to whether they had the technology or not......the stock lingering around $12.........why do you still doubt them? Why wouldn't their stock had been $5 all along?
We would have to go back to 2008 to get back there wouldn't we?
You are proposing this stock at $5.........that would be most unusual IMO.
One could even imagine that ignoring lovenox for a moment, what is different about MNTA with capoxone as compared to lovenox "pre-approval"? It seems like a very similar analysis that would make $5 improbable.
Your logic here seems rather contrived.
My answers: A) 12-15 B) 40-55
I know what you meant as regards a and b.
But you do seem to make a pretty good case for a long position with downside risk to $15 and upside gain to $55 :).
I assume you are making these estimates based purely on Lovenox with no consideration of capoxone or FoB?
IMO.....the present stock price at PE of 8, already factors in t-lovenox threat.
I would hope that MNTA is actively engaged in negotiation with new partners for FoB (and other) but also renegotiation with the present lovenox/capoxone agreements. There is no logical reason that they should not just benefit from sales irrespective of multiple generics. I believe there is compelling argument to renegotiate...........if they didn't try....that would be tantamount to fiduciary breach IMO.
They have the goods.......they have proved it......and the negotiating angle is that they can prove it again and again in the future. Who wouldn't want to give a little now to get so much in form of future partnerships in future??
What does it really cost to develop a new drug?
http://www.techdirt.com/articles/20110329/02440013670/drug-companies-overestimate-cost-developing-new-drug-merely-126-billion.shtml
Gerd Leonhard points us to some new research that appears to have dug deeper into the question today, and found (once again) that the $1.3 billion claim is total bunk and the real number is more like $55 million -- based on the same data used by the study used to support the $1.3 billion number.
In fact, they point out that it appears the pharma industry and those seeking greater protectionism appear to be overestimating the actual cost of drug development by $1.265 billion.
It's like she is being spoon fed by TEVA
It is pretty easy to see with her many other public staements over the years that she is "PRO" Teva.......repeatedly.
Doesn't mean that what she says about delay may not be correct......just that she is clearly biased.
There does appear to be circumstantial evidence that the FDA capoxone decision will be delayed based on the peptimmune statement and Wheeler's comment about how the capoxone process is seemingly a bit more laborious than for lovenox. But all we have is pure speculation.
IMO, it would be nice to hear of MNTA's other shots on goal......they are clearly competent with proof of concept......but our singular focus on lovenox and capaxone does little justice to its potential. Longing for the day when we are focused on 5 or 6 opportunities ;)
Apologies.....the PSA spike apparently is fairly common especially in brachytherapy:
http://www.suna.org/cgi-bin/WebObjects/SUNAMain.woa/1/wa/viewSection?wosid=oPwi45hOjcwe2JD1jiD1gw55jnW&tName=article27507510&s_id=1073743836&ss_id=536873688
http://www.goldjournal.net/article/S0090-4295(03)00505-3/abstract
Appears that the PSA spike should eventually resolve with treatment.
Don't the pictures/scans speak enough about the efficacy of the drug at this point?
Those pictures along with the biochemical improvements......I think yes.......
But it does seem that the bone scans themselves as isolated tests, are flawed unless there is concordance with other data.
BTW, has anyone seen/know an explanation for why the PSA increased?
I was looking at the drop in PSA with treatments like radiation and it is clear that the PSA can stay elevated for quite some time. But has the spike ever been described?
It does seem that everyone is rightly asking about the significance of the bone scan data especially when following metastatic prostate cancer by bone scan alone if fraught with inaccuracy:
http://www.springerlink.com/content/l168w60q62r76324/
Findings on bone scans not in correlation with clinical findings and serum AP levels are mostly misleading. Use of bone scans in conjunction with serum AP levels and most probably with prostate-specific antigen and CPS is the most reliable and therefore treatment modality changes should not be based on bone scans only.
But in EXEL's case, we have improvement in alk phos and anemia and bone pain......hence, the findings on bone scan are in synch with the laboratory improvements (other than PSA).
I guess we will need to wait for the ASCO meeting to learn more first week in June.......unless they announce a partner in interim.
A very brief review of prior reports does reveal previous encouraging data on prostate cancer such as this one:
http://theoncologist.alphamedpress.org/cgi/content/full/8/2/...
In our trial using paclitaxel, estramustine, and carboplatin for the treatment of patients with castrate metastatic prostate cancer, 67% of patients achieved a PSA level decline of 50%, 45% of patients had a major regression of soft tissue disease, 52% had stabilization or improvement of bone scintigraphy, and 79% of the patients who reported significant pain at the start of therapy demonstrated relief of that pain and a reduction in opiate use while on chemotherapy [55].
These results are commensurate with those found in other nonrandomized studies that examine combination antimicrotubule therapy [55–59].
So perhaps there are previous trials that sugggested more promise than eventually proved not to be the case.......is EXEL just another flash in the pan??
The game changer would still be survival benefit......not sure when they may have data to report on that as wll as the remaining 68 patients entered in the trial.
But they also make the case that perhaps this drug along with others might be used together rather than as standalones.....each working by different mechanisms. There may be some logic to that.
These results are spectacular overall in my view.
I would tend to agree.....in this early report. I am not aware of any other therapy that provided this degree of response to bone mets. The important question of course is how long this lasts because in the first report of smaller caseload, it seemed clear that when one stopped the drug, pain returned almost immediately.
Are you aware of any other therapy that matched this response even in the early reports?
The PSA remains one of those oddities......will be interested in how they explain this.
Most importantly, I guess we need to wait to see if this translates into improved survival.
Prostate-specific antigen (PSA) changes were observed to be independent of reduction or stability of tumor target lesions, resolution of bone lesions on bone scan, and changes in bone pain.
What do you make of the lack of PSA coorelation? This lack of coorelation has been demonstrated in other studies early on but the PSA has been used by so many to track recurrence of this disease. Maybe too early in followup to identify trend?
Practically everything else points to response from anemia improvement to reduction in alk phos to bone scan improvments.......but not PSA.
Is this an anomoly or commonly seen?
"But even in this bad (and unlikely) case scenario, MNTA is still likely to remain with a positive bottom line."
IMO, it is a bigger issue than this. If Tl gets approved, it blows a gaping hole in the whole MNTA investment thesis. That is, we now believe that MNTA possesses technology that only it can produce exact replicas of complex drugs.
If Teva drops theirs right in......that technology prowess advantage would seem very much less.
MNTA needs to possess technology that either:
1) Produces the only replicas of drugs
2) Produces them faster than anyone else can
If 1 or 2 above are not in the cards, it just seems like yet an other "me too" generic company.
http://seekingalpha.com/article/233912-momenta-ceo-discusses...
Ritu Baral – Canaccord
Okay. And in the event of a third-party generic, sort of when does the actual royalty rate to Momenta change? Is it sort of retroactive within the month, is it the quarter, is it from the day of the introduction?
Rick Shea
It's the date of launch.
Does anyone know if there was any mitigating factor for this issue in their original agreement?
This is a bit of a problem IMO. Its seems as though the revenue that MNTA is earning is in a perpetual state of "loan" since there is always threat of another generic.
Essentially, this implies that their 50/50 split revenue can be called back to Sandoz if/when it converts to a royalty arrangement as result of new generic even if 2 years from now??
I know this was negotiated back in 2003 but I sure hope there is some more favorable information missing that mitigates a massive refund back to sandoz.....
Specifically, in the case of FDA’s approval of generic menotropins drug products, the key issue was whether a non-fully characterized brand product could be insulated from generic competition because it was not fully characterized. FDA and the courts ultimately and conclusively ruled that for products such as menotropins (and enoxaparin here), the lack of full characterization is not a barrier to ANDA approval
Has this prior approval been discussed here as regards the menotropins and why that would be precedent in the case of lovenox or other generics?
Ignoring Lovenox revenue entirely......
If one just considers the capoxone sales of $2 Billion in US and that Feb 2011 (just 5 months away), MNTA may enter that arena as well (is that true?).......
Doesn't it seem that the worry over multiple generics in Lovenox is overdone if capaxone is right on the heels of Lovenox?
It would seem that at 50% of capaxone market and 20% drug discount, there is a potential revenue of $800 million to their partnership.......less expenses would seem to be a pretty nice earnings addition. These earnings may be greater than Lovenox regardless?
Would appreciate your opinion on these two charts:
http://www.stockta.com/cgi-bin/analysis.pl?symb=CSR&num1...
OK its China and therefore higher risk but with its 70% YoY earnings growth and forward PE of 2....can it maintain that growth in this global slowdown?
http://www.stockta.com/cgi-bin/analysis.pl?symb=ZOLT&num...
A wind play that will likely meet its goal of $500 million revs annually by 2012. Deal in carbon fibers. Has forward PE of 18 with revs of $180 million.
Would appreciate TA opinions about this chart on TC:
http://stockcharts.com/h-sc/ui?s=tc
It has returned back to its breakout.......seems a reasonable entry here?
Obama would do us all a favor if he would stop talking the economy down. Just when you start to pick your head up to look around......out he comes with his "its gonna get worse before it gets better" mantra. Thus......down goes the heads again....hunkered down ever more.
Why can't he just say, we are encouraged by our prospects to return our country to times of prosperity?
Had a slow Sunday so picked up the book from Schiff called "Crash Proof......". Interesting that he was Ron Paul's economic advisor ;)
Maybe this is a case of a broken clock being right and therefore pure coincidence but he was oh so right.
His premise is that the US is hosed based on numerous factors to include that we are a nation of consumers and not producers, we are debt laden both at the governmental level and personal, we are borrowing from foreign countries like crazy (Asia) and we have essentially screwed the worlds' economies by the subprime mess and the peg to the dollar.
He predicts the dollar will lose its rule in favor of another currency such as the yen or Euro. Recall the recent meeting between Russia and China discussing just this topic.
Bottom line:
Invest out of US
Invest in countries with less dollar and US exposure that earn dividends
Invest in gold.
Invest in commodities
He doesn't mention specific companies and seems to encourage use of his firm so there are some marketing aspects to his writing. He does imply oil/energy/commodity producers in Canada, Australia and Asia (some of which supposedly have yields of 7-14% annually).
His results of late have been very poor with the dollar's 30% climb but he views this as an aberration.......feels very certain that the above strategy will win.
So he is a charlatan that just happens to have been correct by coincidence and is beating the same old mantra hoping lightening strikes twice or does he have something here??
If you feel there is real insight in his thinking, what options appear best now?
Thanks in advance for your thoughts.
IPGP - Buy with break above $20??
http://www.stockta.com/cgi-bin/analysis.pl?symb=IPGP&num1=567&cobrand=&mode=stock
ISRG
http://stockcharts.com/h-sc/ui?s=ISRG&p=D&yr=3&mn=0&dy=0&id=0
Would appreciate opinions on this stock with near term and medium term prospects. Anyone think it can fill that gap back at $175 or where do we see support again?
It appeared to have a double top reversal recently....but where the bottom?
http://bigcharts.marketwatch.com/interchart/interchart.asp?symb=%24comp&time=&freq=
OK......where does everyone think the short, medium and longer term bottom will be for the NASDAQ from TA perspective?
I was thinking we were close near term but this recent financial news is causing a big push down.
ITMN Opinions
http://stockcharts.com/h-sc/ui?s=ITMN&p=D&yr=3&mn=0&dy=0&id=0
Stock appears to resting right on its support trend line. Think its too risky to take a position here?
Went to cash Friday.......several reasons:
1) Inverted yield curve appeared clearly evident (not just flat). Playing odds here that economy slumps within next 12 months.
2) Housing boom unraveling in earnest with pain just now being experienced...foreclosures, bankruptsies, lost wealth
3) Greenspan recent comments that housing bubble could be economy's undoing
4) Democrats threatening tax roll backs, increased taxes, etc.
5) Slow season for market
6) Tech stocks not behaving well.....greater volume on down drafts than upmoves.
7) Long bull run from 2003 could use a breather
Gonna be sitting in 5-6% yield investment until smoke clears.
http://stockcharts.com/h-sc/ui?s=nasdaq&p=W&b=5&g=0&id=p53879472747
It does appear if one connects the dots going back to the August 2004 low, we could see another 200 point drop in NAS.
The NAS seems to have been trading in a well defined envelop since late 2004. It has recently bounced off its rising support line. THis is best seen on a 3 year chart.
Why do you believe we would be heading down below that support line and if we do, wouldn't that suggest a lower low than many suspect?
http://bigcharts.marketwatch.com/javachart/javachart.asp?symb=nasdaq&time=&freq=