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It definately has been a sore point. Especially since I'm increasingly hearing reports of adverse events for Januvia. I think NVS decided not to resubmit Galvus in the US do to an apparent bias on the part of FDA.
FL
I'm a former shareholder of GNVC and a current shareholder of NVS. Seems like I recall the 1st press releases about GNVC's hearing loss treatment more than 2 years ago. In that time they have not moved the treatment into clinical trials. Obviously GNVC's cash was being directed to TNF Pancreatic cancer treatment and at the time it was also being evaluated for cancer of the esophagus.
What surprises me is that one of the few potential treatments for an indication with huge unmet need would go unpartnered for so long. My impression is that NVS is buying a lottery ticket (a longer shot than most partner agreements).
Any thoughts.
FL
Possible 2010 NVS news flow
I think NVS is in the sweet spot for the next two years (i.e., until the Diovan expiration). The positive news flow will be lead by pharma. NVS has had more launcnes in the past 3 years than any other pharma company. The costs of these launches were realized in 2008 and 2009 and now the the sales ramp should help grow the top and bottom line. Look for this to become evident in the 4th qtr 2009 conf call on January 26.
In addition, I'm optimistic for the new drugs in COPD and MS (FTY 720 filed in December). While the FDA contiues to be difficult for NVS and just about anyone in pharma, the rest of world sales are ramping nicely. The EU approval of Onbrez, NVS' COPD is significant since the smoking rates are much higer in some areas of the EU than in N. America. This could also represent a tremendous play on emerging markets. COPD drugs should help emerging market sales since the smoking rates are quite high in the developing and emerging markets.
FTY720 could be a home run by hitting the market in 2010. I believe NVS filed for FDA approval in December 2009. Since Merk Serono got shot down, NVS could have the firs oral MS drug on the market a year or more ahead of the competition.
The over the counter business should benefit greatly by the sales of Prevacid which launched in Mid Nov. I read an independent piece that suggested that it could be poised to be the best selling OTC drug on the market.
Finally, I think NVS and MNTA are poised to get approval for M-enoxaparin (generic lovenox). I believe Sanofi had about $3B in sales of this drug last year. So if NVS MNTA gets the only generic approval, this could be a huge generic launch worth at least an estimated $1B to the NVS/MNTA team.
In terms of the NVS valuation, I have little fear and added more on the recent pullback. NVS is still trading at historically low PE and they are growing the E with a very diversified pipeline (geographically diversified, product offerings are diversified etc.). Even the Alcon accuisition serves to diversify the sources of sales and earnings. The combination of Ciba and Alcon will control about 1/3 of the vision care market and will be the largest player in this area at a time when the baby boom demographic bulge will create peak demand for vision care products (think cataracs, mac. degeneration, etc). While I think NVS paid full value for Alcon, time will prove this to be a tremendous purchase.
The analyst following NVS are pretty limited, so NVS could stand to benefit from additional coverage. This should happen as the sales growth of the new products makes it apparent that NVS will grow its way out of the upcoming Diovan expiration.
Obviously, I'm long NVS. Best wishes for 2010.
FL
Personally, I think the offer is fair since NVS is undervalued relative to long term valuation metrics. I think the fourth qtr earnings will provide guidance which will narrow the gap between the 2.8 share NVS per 1 ACL offer and the $180 offered to Nestle. By the time the deal with the minority shareholders closes (i.e., mid year), the deal will not look as one sided.
FL
I have no position in EMIS.
The statement in the last Qtrly rept that they only had sufficient cash to remain solvent into February 2010 was enough to dissuade me. I agree that the Alpha piece was worthless. Still NVS' involvement adds some credibility. I'm also certain Icahn would rather not flush his money down a bottomless pit without decent potential upside.
Either way, I'll play it through NVS rather than EMIS.
Thanks
FL
Any information on EMIS?
The attached SA piece makes it sound like they are on the cusp of a breakthrough in OA. However, review of their regulatory filings suggests that they may not have enough cash to survive through February 2010. Sounds like any milestone payments they received from NVS must have been pocket change. Not exactly the kind of compensation you would expect for a breakthrough in OA.
FL
http://seekingalpha.com/article/179100-a-window-of-opportunity-to-buy-emisphere
Did NVS File FTY720 before the end of 2009?
It was a self imposed deadline by NVS. I did not see any information on this filing. However, they usually only announce approvals not filings.
FL
In their last qtly report, EMIS expressed that it could not pay the Novartis note and continue as a going concern past Feb 2010 without a source of financing.
Has this improved? if not, is Novartis poised to gain their intellectual property?
FL
NVS Launches OTC Prevacid.
http://www.novartis.com/newsroom/media-releases/en/2009/1354451.shtml
Would this have any impact on a potential NVS takeover of Alcon?
I know that both NVS' acquisition of a majority stake in Alcon and the potential market for POT-4 are a ways off. But assuming that both were to be successful would NVS be allowed to control another Macular degeneration product given that they have rest of world (outside N. Amer) marketing rights for Lucentis? Is the method of action difference a consideration or just the indication?
Would European regulators require divestment?
FL
Thanks
That's where I thought things stood. However, I was surprised that no costs were broken out for this litigation effort.
FL
NVS v Teva Lotrel litigation.
Dew thanks for pointing out that may question was answered in the call.
I also appreciate you posting the link to the pending NVS legal activities. I did not see any mention of the patent infringement litigation against Teva for Lotrel. Did I miss something. Was there a settlement or a dismissal?
Thanks
FL
Paremavir Emergency use
I'm not trying to turn this into a swine flu discussion board, but I saw a video of a physician pleading for a broader authorization of paremavir to treat extremely critical patients. The Dr claimed that the present compassionate use guidelines require several hours of paperwork (time that could make the difference for these extremely critical patients). The attached link suggests that the intravenously administered drug is better under these circumstances than the approved/available antivirals.
Any thoughts, on whether a broader emergency use exemption is likely for these types of critical patients?
FL
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=42534704
Things look pretty lonely here. For a company with such great fundamentals you would think that a good discussion board would exist somewhere. Perhaps this constitutes the ultimate contrarian indicator.
FL
As an NVS shareholder I certainly agree on the first point (screw up). Whether they have shown wisdom by regaining the rights remains to be seen. I think a re-evaluation of the go, no go decision process is required.
FL
Might NVS use it's priority review voucher for FT720?
Dew
As you recall NVS was awarded a priority review voucher from FDA for its Malaria drug Coartem (see link).
http://www.keionline.org/blogs/2009/04/10/novartis-games-the-fda-priority-review-voucher
Do you think NVS will use it for FT720? If it is used would the voucher allow NVS to leap frog a potential competitor (i.e., MERK KGaA's Cladribine)?
Seems like it could be a delicate position for the FDA.
Regards
FL
I was unaware of J&J's Nevo. It will be interesting to see how this platform (use of reservoirs) performs long term.
Thanks
FL
ABT Terms for stent coating
Dew do you have any idea what the terms are for ABT and Boston Scientific to compensate NVS for the mtor inhibitor used to coat the stent Xience?
Is there anything that obligates NVS not to provide this drug to competing stents? NVS reports do not seem to break out the compensation.
Thanks
FL
Being in a position where I work with regulators on a routine basis, I do not find it unusual that people like John Jenkins and Janet Woodcock have repeatedly stated on the record that there has been no change in FDA policy on drug approvals. It is totally conceivable that they did not want to call attention to the executive branch issuing policy guidance that is a departure from decades of past FDA practice. There are numerous examples of good soldiers in the Bush administration. This is an administration that praised loyalty above all else throughout the ranks. It is very easy to point to a subjective reason (i.e., the quality of the applications as being the reason for a denial or an approvable letter).
I consider myself an Independent so I hope not to sound to much like a Bush conspiracy freak).
Alternatively, Jenkins and Woodcock may not have totally agreed with the policy memo and decided ro adopt the much more conservative approach until clarification was provided thru either the executive, legislative or judicial branches.
Why did the FDA have to be sued by NVS for approval of omnitrope? I think just about everyone will agree that it occurred because there was a vacuum since no approval process was provided by legislature. I think the same kind of mindset applies here. I believe the FDA bureaucrats may have followed the policy memo to the letter, either out of allegiance or possibly to point out the shortfalls (i.e., increased burden of proof placed on the FDA).
I still think FDA will bear watching to see if this the Supreme Court clarification on this matter provides them a little more lattitude and reduces the hyper conservative nature of the past few years. I find the change in the level of review scrutiny in the past three years after several decades of relative consistency a little to coincidental.
Thanks
FL
Might Levine influence FDA?
Hi Dew
I find the Levine case an extremely interesting study in the law of unintended consequence. During the trial the defense pointed to an executive branch policy memo that FDA approval restricted potential plantiffs from sueing in State Court. This was apparently sought to provide protection from what the Bush administration viewed as runaway frivolous lawsuits. The unintended consequence appears to have been an FDA that viewed the lack of plaintiff recourse in the State court system as reason to put the clamps down on the whole approval process by demanding numerous additional studies etc. There has been much discussion on this board on how conservative the FDA has become. This change in FDA attitude appears to correspond precisely with the executive branch policy memo issuance.
Now, might the Supreme Court decision have the unintended or maybe intended consequence of lifting some of the burden of infalibility off of FDA's shoulders? In short, if product liability can be determined in the State Courts- I believe FDA may see this as a positive since they may weigh that damaged parties will be left with a recourse, if an unknown side effect results in damages.
While I realize that high profile fumbles on the FDA's part (i.e., Vioxx) undoubtedly play into the level of conservatism they have exhibited over the past few years. However, I can't help but feel this has to be looked upon by FDA as taking some of the heat off.
Do you think this could result in some level of reduction in the ultra conservative mindset at FDA?
Regards FL
Luckily I fought the urge to sell some IDIX for Tax loss purposes at the end of the year. I suspected it could turn around quickly on good news.
Good Luck
FL
Hi Dew
These stupid class action suits have gotten ridiculous. I'm an independent but this is one issue that needs to be addressed by congress. It is an attempt at legalized extortion. You better settle with us or you're going to blow several million in defense. There aren't that many holders of NVS in the US, it will be interesting to see if what bafoon signs up as lead plaintiff.
Good Luck
Teva shareholders ought to be more than a little scared right now. They have proceded with quite a number of at risk launches in the past year. If the courts start upholding patents it looks like they will take a hit. I know that each case has its own merits but it seems like this is one of those things that swings like a pendulum and the balance of the power had been on the side of the generic producers.
FL
There is probably considerable overlap in the at risk populations since HBV is also transmitted by intervaneous drug use and unprotected sex.
FL
I agree about combination thrapy potentially being put back a couple of years.
My opinion on this matter is less of an economic one since I hold both NVS and IDIX. The number of polymerase HCV failures is becomming worrisome. I recall in one of the conference calls that Doug M. indicated that the gasterological effects were temporary (primarily 1st 10 days or so) and not all that severe for a large portion of the participants (participants asked to stay in the trial). Furthermore the effects were said to be reversible. Seems strange to pull the plug on it before all the data was in, especially now that many polymerase candidates are encountering difficulties.
That said, I don't doubt Dew's explanation of NVS pulling some strings. However, It would seem that the next generation drugs would be that much harder for NVS to license if that were the case.
Thanks
FL
I agree with what you are saying but these are economic determinations that FDA should not play a role in. It is really between IDIX and NVS whether the drug held enough promise to warrant further testing. If serious health issues existed I'd expect FDA to step in otherwise cost benifit decisions seem like they would require all of the data.
I suspect that you may be correct that NVS saw that something beyond just the VRTX Protease inhibitors would make NMP283 obsolete quickly. Possibly the next generation drug from IDIX? Question is how would NVS lobby FDA to kill the program so they don't have to be the bad guys.
Have a good weekend.
FL
The scenario I alluded to a week ago seems to be playing out. More late stage HCV failures appear to make the FDA decision to pull the plug on NMP 283 seem premature. It looks like slow incremental gains could be tolerable. Especially since nobody knows what will happen when combination testing occurs.
FL
Thanks, I know we are all trying to sort things out. The 10% I was refering to was the discontinuation rate due to skin rash (I believe 10% is the figure I heard).
As much as anything, I was interested in thoughts as to the precident for FDA killing a drug in Phase II when it showed benefits (albeit marginal ones) when the rest of the treatment landscape was so up in the air. I can see a scenario where late stage trials indicate problems of one kind or another with some of drugs currently in phase II or preparing for phase III. It seems like the this determination should have been made after all the data was in or potentially by the market. I tend to agree, that NVS may be relieved that it played out as it has.
I also agree that the imediate future will be dependent on the Tyzeka subscription ramp and the clinical updates. If it follows the Baraclude model the share price should be in much better shape next year.
Thanks
FL
We are seeing HCV candidates collapse in later stages of testing. To some extent it appears that FDA is annointing the VRTX drug (I beleive it is furthest along in development), but didn't VRTX experience 10% discontinue due to SAE's. Any thoughts where the possible combination of protease and polymerease is headed. It's apparent that ?IDIX was dealt a serious blow in this department.
Hopefully, IDIX learns from this experience and the 2nd generation drugs are more effective. One of the many things that seems to be discounted at IDIX (besides Tyzeka being given no value) is the drug development capacity. The Sebio\Tyzeka appears to have been brought to the market in a relatively expedient manner. This R&D capacity is valued at 0. Hopefully updaits as the early pipeline moves into clinical testing will demonstrate this.
I have not heard any anouncements of staffing cuts at IDIX. Have the personnel working on NMP283 been shifted to the 2nd generation drugs? Should there be staffing cuts as a result?
Right now, the situation is not dire by any means. IDIX can wait a couple quarters to make such decisions to see how sales of Tyzeka ramp. Any thoughts?
FL
Stewing on NMP283
I've been pretty well pounded into submission on IDIX. Bought some recently below 3 thinking it had to bottom slightly above cash value since it has a product on the market. Amazingly it still shows little sign of bottoming. I know that the market downdraft is contributing heavily to the recent sell off.
In any case, I almost hate hate to bring up this topic but I've been stewing over it for the past month. How common is it for FDA to kill a drug for a deadly indication such as HCV when it demonstrates improved response relative to the SOC (Albeit minimal improvement)? I'm aware that the side effects appeared to be related to dosage and there were few discontinuations in the 200 mg trials. Was the fear of the side effects at 400 mg that great?
It seems like several potential HCV candidates have been halted or discontinued and outside of VRTX it appears that any improvements in the treatment of this diseas are likely to occur in relatively small increments. As such, unless the drug puts the trial participants in worse danger it would seem that the trials should continue and decisions whether to kill the drug should be rendered when all the data is in and its response can be compared to available treatment alternatives.
If the drug provides marginal improvement over SOC, market prospects would presumably not be all that bright, but perhaps the drug might work in a combination better than a stand alone drug (The sprinter vs. marathoner analogy). Killing the trials makes research into such combinations unlikely to ever occur. All this said, as a NVS shareholder as well, it is probably better for NVS that the program was killed now rather than proceeding with a drug with a questionable stand alone market potential. I just wish it's potential as a combination drug had been evaluated.
Out of curiosity, I'm interested in what the guidelines are for FDA to step in and hault a drug. Risk-benefit appears best judged when all the data is in.
Thanks
FL
.
Thanks for the post.
I'm interested in Bruker's potential markets in follow on biologics. The biogeneric business is on the cusp of rapid growth and BRKR appears to be well situated as a toolmaker for biogeneric pharma. Here is an article I found interesting. Any comments?
FL
http://www.labtechnologist.com/news/ng.asp?n=77189-sandoz-momenta-pharmaceuticals-biogeneric-biosimi...
FAT MARGINS
You're right the margins will draw the ire of congress to light a fire under the FOB legislation. It may also act to attract other players into the FOB space.
I found your previous post on the COWN review of the FOB landscape interesting. It appears that the review was written before NVS got the recent EU nod a week or two ago for EPO.
Thanks for continuing to call attention to FOB. A few years from now I think we will look back on this period and say it marked a golden oportunity.
FL
Not so very NICE for Lucentis
If this blog is correct Britain's National Institute of Health Care Excellence (NICE) should be forced to change its acronym to MEAN.
http://astuteblogger.blogspot.com/search/label/UK
Wednesday, June 13, 2007
NHS TO BRITS: GO BLIND IN ONE EYE BEFORE WE GIVE YOU ANTI-BLINDNESS DRUG
AND THE BRITS ARE RIGHTLY OUTRAGED AT THE "National Institute for Health and Clinical Excellence" ["NICE"]:
BBC:
Steve Winyard, of the Royal National Institute of Blind People (RNIB), said he was "outraged" by the guidance.
"It ignores the overwhelming body of evidence that these new treatments are cost-effective and have the potential to halve the number of people going blind each year," he said.
"It is simply unacceptable that only a small minority of patients within England and Wales will have access to these ground-breaking drugs.
"NICE must re-consider and show that it makes its decisions based on cost-effectiveness rather than simply cost containment."
Tom Bremridge, chief executive of the Macular Disease Society, said: "Limiting the treatment options to 20% of patients who would benefit is unjustifiable, and allowing one eye to go blind before treating the second eye is cruel and totally unacceptable."
TIMES UK:
Thousands of people face severe loss of sight after a decision by the health watchdog to deny two leading treatments to NHS patients.
The drugs Lucentis and Macugen have been shown to be the most effective means of halting the onset of wet age-related macular degeneration (AMD), the only treatable form of the most common cause of blindness in Britain.
The condition affects about 250,000 people and claims 26,000 new sufferers each year. It damages the central part of the retina called the macula and leaves one in ten sufferers blind.
The National Institute for Health and Clinical Excellence has been under intense pressure to approve the drugs. Its draft guidance recommends that Macugen should not be used at all on the NHS in England and Wales, while Lucentis is recommended only for a small group of patients who have already gone blind in one eye and whose disease is progressing in their second.
UK GUARDIAN:
The Royal College of Ophthalmologists said that the draft ruling, from the National Institute for Health and Clinical Excellence (Nice), was "completely unacceptable". It meant that only patients already in effect blind in one eye because of the condition wet age-related macular degeneration would be able to get the newest and most effective drug, Lucentis.
Only 20% of those people whom the drug could help, those with the fastest progressing form of the disease, would get it at all via the NHS. Yet, doctors warned, half of the remainder of patients would reach the same stage of the condition within a year. Critics were also unhappy that a second drug, Macugen, was ruled out for use in the NHS.
The Royal National Institute for the Blind accused Nice of allowing 20,000 people in the UK, the number diagnosed with the condition each year, to go blind.
THIS PROVES - ONCE AGAIN - THAT SO-CALLED "UNIVERSAL HEALTHCARE" FUNDED BY TAXPAYERS AND ADMINISTERED BY THE GOVERNMENT IS A DISASTER EVERYWHERE.
THIS IS WHAT HAPPENS WHEN THE GOVERNMENT GETS TO DECIDE WHAT'S COST EFFECTIVE FOR EVERYONE.
IT IS INSANE TO DO ANYTHING LIKE THAT HERE IN THE USA.
YET THAT'S WHAT THE DEMS WANT TO DO. EVERY SINGLE ONE OF THEM RUNNING FOR THE PRESIDENCY.
DON'T FALL FOR IT.
Labels: 2008 election, Democrats, HILLARYCARE, NHS, SOCIALISM, UK
Any news on recent Sebio/Tazeka sales? I sold some July 7.50 calls and I'm curious what the numbers will give IDIX any boost.
I try to follow this board whenever I get a chance. I may have missed some posts but does anyone have a firm grip on the Phase II data so as to be able to provide a comparison of IDIX vs. its competitors. Outside of VRTX I'm not real certain who has run triple therapy studies and how the performance has neted out. I realize in some instances it is difficult to provide direct comparisons due to other variables (the test population, the duration etc.).
Thanks
FL
Biogeneric toolmakers
Thanks Dew (MSG 48607) Poorgradstudent (48601) and DaveD (48572) for your thoughts and links on this subject.
FL
That is certainly the senario I was alluding to previously. The interaction data release was like sending up a flag that IDIX/NVS is available to team in a combination. - No interaction issues with SOC, combination therapy will be most likely be necessary, but just in case nothing materializes we are prepared to go ahead with another PIIb. Phase IIB because it is cheaper than a Phase III. I question whether they really intend to pursue the PIIb hard because they know that a combination is the best means to show a sizeable incremental increase in SVR over SOC and the best way to put a product on the market that will grab market share.
I keep thinking about the sprinter v marathon runner analogy and wondering if that will really play out to provide the best Quad combination.
Good Luck
FL
Thanks Dew
TMO and BRKR have specialty Mass Spec geared toward protein analysis. TMO is much larger and established. Bruker has made recent acquisitions and has strengths in x-ray crystallography. Bruker ran up a couple hundred percent but pulled back as a result of lower estimates. WAT is also atrong in MS and HPLC but I don't think their protein platform is as strong as TMO or BRKR. BRKR has had significant insider purchases and has recently introduced equipment for portable screening of biohazard which is aimed at the homeland security business. Not trying to pump BRKR but I just tend to follow it closer.
I'm interested in a couple angles:
1) How legislation governing biogeneric equivalency demonstration/approvals might drive equipment sales.
2)I'm also curious about the Momenta approach to sequencing sugars (i.e., what equipment is used).
Obviously, I have not done comprehensive DD yet. But the market for equipment/specialty software would seem to be emerging.
Good Luck
FL
Biogeneric investigational tool makers.
Dew posted the following message on the GTCB board that emphasized the importance of new tools to investigate and develop biogeneric drugs. I own some BRKR but was interested in the opinions of this board as to what companies sell the hardware most likely to be employed in developing biogeneric drugs.
FL
http://www.investorshub.com/boards/read_msg.asp?message_id=20282923
The market for IDIX was really on a roller coster today which I think will continue for a while. The preliminary data is out that NMP283 is viable in a triple therapy. I think IDIX and NVS wanted this message out there to prompt a protease inhibitor partner to look more seriously at NMP 283.
It seems like another couple years chasing a triple combination therapy which would likely have have serious competitition when it hits the market would be questionable. However, the data would seemingly help open establish the desire to team with IDIX/NVS to develop a quad combination.
FL
Thanks Dew
This article elaborates on a question that I wanted to pose to the Biotech values board. What do you think the best plays are in companies that will supply the tools to investigate biogenerics?
About 2 years ago I established a position in BRKR with this in mind. It went up about 200% I unloaded half my position (not enough in retrospect since it has pulled back substantially in the past 2 months).
BRKR is active in protein MS and X-ray equipment for bioscience use. Are there equipment suppliers you like?
Regards
FL