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The fact that TEVA has decided to hire a former senior level FDA Scientist as their US regulatory affairs VP suggests that they are unhappy with the progress on their reviews at the FDA. I believe that this may be a signal that they feel the need for more regulatory liaison capabilities in the US. This may be a direct outgrowth of their Lovenox ANDA being stuck in the mud for so long.
FL
http://online.wsj.com/article/SB10001424052748704049904575554410462752310.html?mod=googlenews_wsj
Novartis International AG / Swiss law expert counters Alcon Independent Director
Committee's legal position in proposed merger with Novartis processed and transmitted by
Hugin AS. The issuer is solely responsible for the content of this announcement.
* Merger decision must be approved by the entire board of the company and cannot be
delegated to, nor vetoed by the Independent Directors Committee (IDC)
* Expert confirms that Novartis-nominated directors are not legally conflicted solely
because of being nominated by a majority shareholder
* Alcon board, including Novartis-nominated directors, can validly approve a merger with
a majority shareholder. Novartis may validly participate in the Alcon shareholders' vote
on the merger
* Contrary to the IDC's view, the Alcon full board may validly amend the Organizational
Regulations
* Creation and funding of the Alcon IDC litigation trust with funds of Alcon is contrary
to Swiss law, also creating a conflict of interest between the IDC members' fiduciary
duties as Alcon board members and their duties to the litigation trust
Full article Here:
http://www.reuters.com/article/idUS44068+30-Sep-2010+HUG20100930
GNVC Milestone on Hearing Loss
http://finance.yahoo.com/news/GenVec-Achieves-First-prnews-3905633229.html?x=0&.v=1
This is a very vague press release. Does anyone have a clue what the pre-clinical progress was or what the milestone payment made by NVS amounted to?
I'd also be interested if anyone on the board has an informed opinion on the viability of GNVC's hearing loss treatment. Obviously the market is huge, but I get the impression that NVS treats it as much more of a long shot gamble than a normal license agreement (hence the press-releases that downplay specifics).
FL
Given what we have seen this year in terms of program trading, I would not be surprised that larger institutional investors might use leverage afforded by these options to try to gain control of shares at a more attractive entry point. After watching the trading the week of July 23, it became clear that significant resistance countered any upward price momentum. However, these strategies are easier to implement in a environment where uncertainty exists (what are the sales, will Teva get approval in the near future, etc). Some of these uncertainties will get worked out with time and investors will get more comfortable with the uncertainty. In the mean time dips provide opportunities. While it does not seem like it based on the share price, there is much less risk in MNTA then there was two months ago.
FL
Seems a little premature to be making this statement. The pricing announced by Sandos left considerable room to negotiate additional discounts.
___________________________________________________________
In hindsight, Sandoz's initial pricing kept Sanofi in the ballgame.
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If Lovenox becomes viewed as a commodity (isn't that what fully substitutable means) with only two suppliers then the pricing will gravitate to a price point where both suppliers remain " in the game". Hopefully each of those suppliers are smart enough not to gut the margins right out of the gate.
The night of Sullivan's ruling I said a short term MNTA pop would be met by another sell off. I still feel that this sell off will be followed by a long term run which will likely be Stoked by Sandoz quarterly sales information (Oct 21 and thereafter).
The average investor is exhibiting short term focus on the hidden reason for MNTA not skyrocketing. They fail to recognize that the market can undergo irrational periods. Large Cap stocks with excellent earnings, visibility, and dividends are trading at huge discounts to historical valuations. Given the current tone of the market, why isn't it understandable that the market may need to see the earnings materialize for MNTA before the valuation catches up.
MNTA is has demonstrated at least two instances where it's reverse engineering technology has received the FDA seal of approval (contaminated heparin and M-Enox). I'd be surprised if additional collaboration opportunities don't materialize for MNTA in the near future. Perhaps that is why they are hiring.
Good Luck
FL
FDA NME approvals
Thanks Dew
The question remains, is the post Vioxx hangover on the part of FDA beginning to fade and how might that translate to Pharma growth. I'm not suggesting that the FDA floodgates are braking open. However, I do see some evidence that the ultra conservative nature that Vesella used to talk about is beginning to lift.
I'm not certain if it is an internal change on the part of the FDA or whether the applicants are just better at crafting applications that anticipate potential sticking points.
FL
No. of NME FDA approvals seem to be increasing
A couple of years ago we hypothesized that the FDA night have become more conservative as a result of an unintended affect of a Bush administrative doctrine (can't remember what the doctrine was called) but it appears that the FDA might be shaking off some of this conservatism which would be a positive development for Pharma (not trying to start a politically motivated discussion just interested in whether it bodes well for the industry as a whole).
By my count the NME approvals over the past couple years are:
2007 17
2008 23
2009 26
2010 could not find a count of many so far (anyone know).
Any thoughts on whether the increase from 2007 to 2009 is significant or just a function of natural ebb and flow of R&D pipelines. Is the review process getting easier relative to a few years ago (2007) or are the applications getting better?
FL
Lighten up!
My point is that the market is extremely skittish right now and the ultimate pop that some of the anxious types want to see may be months or years away since they are other variables that need to play out.
I've been long both NVS and MNTA for years, so the experience has taught me to not swing to euphoria with every positive development. I may lose a few shares if my call options get exercised but I still have a long term core in MNTA.
I think that MNTA would be well served if in the near future they draw attention to their platform, their pipeline and how the FDA decision and bolster future prospects. They are now squarely in the spotlight with a great chance to emphasize future growth prospects.
In the mean time, you might want to limit your caffine intake.
FL
while I hope you are correct, however my pragmatic side says this market needs to see definitive proof that Sandoz is successful with sales at a decent margin. 2nd there is a lot of chatter that TEVA approval is right around the corner. I beleive that these two factors are likely to put a near term lid on MNTA.
I anticipate a short pop maybe followed by a slight pullback and then a long grind higher. Maybe the 3rd quarter NVS earnings call in October will ignite some excitement when we get a better feeling for market penetration. Every day without a TEVA approval represents another ring of the register for MNTA. I think the market will slowly do the math and realize that MNTA is making good money and paying off their share of development costs before share price appreciation takes off. I think MNTA news on copaxone and/or news on other high profile targets will help demonstrate the robustness of MNTA's platform.
That said I wouldn't mind being wrong and see a quick return to the mid 20's.
FL
This link suggests that orencia is patent protected until the end of 2019. Seems like there are better near term targets. Is their an obvious hole in the patent anyone is aware of.
This does raise an interesting point of discussion on what targets (other than those listed on MNTA's web site) that might be on the horizon. I kind of recall NVS mentioning on a conference call a couple years ago that the MNTA collaboration might extend to as many as 5 or 6 compounds. Assuming Copaxone and M-118 were under consideration at the time, what other targets might have been envisioned.
FL
http://wherepharmameets.bdmetrics.com/CPR-6043143-46262/GenericsWeb-Europe-Ltd/GenericsWeb-exposes-differences-between-Abatacept-generic-launch-contraints-in-EU-and-US.aspx
Does this sentence suggest that future potential targets might be FOBs that target products coming off patent such as enbrel or Humira etc.
FL
_____________________________________________________________
"This individual will be responsible for establishing and performing in vivo testing to guide the selection and development of therapeutic agents for the treatment of inflammatory and immune mediated diseases. "
_________________________________________________________________
Thanks
This is a topic that is generating a lot of ire. It is apparent that the risk to reward is out of whack such that no Pharma can justify the level of trials required by the FDA. I read an article that suggested that the testing could possibly be rationalized if additional years of patent protection were provided to justify the expenditures.
There will be a lot of ugly finger pointing and unfortunate patients will be hurt or killed if this situation is not addressed.
FL
Status of PZ601 - MRSA antibiotic?
The Chicago trib ran an article about how pharma companies were not advancing new antibiotics due to a disagreement with the FDA on the clinical testing protocols. This jarred my memory that NVS bought Protez in 2008 to get access to PZ-601, supposedly at the time a very promising antibiotic. The 2008 press releases indicated that the clinical testing program would result in a regulatory filing in 2012. Since that time I have heard nothing about it. I do not see it listed in NVS' R&D summary.
Does anyone know whether this antibiotic was dropped, whether it is still in development or whether the clinical testing program has been put on the back burner while the clinical trial issues are ironed out with FDA?
FL
While I agree with your rationale for Teva being down, shouldn't NVS get at least a small pop by the same rationale. Not only do they share 50% of generic Lovenox their stake in generic copaxone looks a lot more viable today. Assuming FTY 720 gets approval, their MS franchise would be second to none.
I'm not complaining to much, MNTA became my largest holding today, but it seems like NVS is perpetually destined to be the Rodney Dangerfield of Pharma. I've noticed that Swiss Firms (Take Nestle for example) seem to be subject to a discount. This is interesting since it seems that firms like RIG, TYCO, Noble etc. are moving to Switzerland for preferential tax treatment.
I know you can make a case that NVS is at a premium to US pharma but they are outperforming by a wider margin than the valuation would indicate.
More interesting than the diatribe about NVS is the validation of the MNTA reverse engineering technology. This seems to me to make MNTA the most sought after acquisition and/or teaming partner in biogenerics.
I plan to hold long term.
Good Luck
FL
MNTA's Largest Shareholder
At one time NVS held about 13% of MNTA. what is NVS' current holdings?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=19222901
Why does the bulk of the worlds heperin come out of China and how hard would it be to change suppliers of this raw product? I understand that FDA has already inspected MNTA's heperin supplier facilities but the lack of a Chinese oversight in this matter is troubling. On the other hand, who better than MNTA to perform quality control to detect adulterated or deficient heperin in the supply line.
FL
Rasilez or Tekturna approved in China
http://www.novartis.com/newsroom/media-releases/en/2010/1432666.shtml
FL
I tend to agree. The current BOD knows NVS is reaching to acquire Alcon as evidenced by the bond offering earlier this year. I think they are content to reduce the cash on the balance sheet before NVS gains control.
FL
I have trouble believing that this objection could not have been made much earlier. It is blatantly obvious that these physicians are requesting testing at a time they believe MNTA is close to approval.
Why didn't they file similar requests when the application was filed with FDA?
Hopefully FDA sees thru this smoke screen.
FL
Status of QAB149 - Onbrez for COPD.
I know NVS got a complete response letter from FDA last October. Apparently FDA wanted additional information on dosing. Anyone know the status of NVS' response or how long might be anticipated to respond.
I know the drug was approved in the EU but I can't tell whether additional trials were necessary in the US or just re-analysis of existing data.
Thanks FL
The problem might not be in legislation but implementation. Obviously, FDA has felt uncomfortable reviewing FOB applications in any way that can be considered timely. Either review schedules need to be stipulated by the regulations or FDA needs more specific guidelines.
What was FDA's rationale for the delay for omnitrope which required NVS to sue for approval. I don't claim to be an expert here, just an observer who believes the system is disfunctional.
FL
I agree. The increased emphasis on generics and especially biogenerics and the embracing a discovery model that emphasizes rare diseases are both part of the business model Vasella has promoted.
However, PFE seems to suffer from from being late to the game as witnessed by them recently losing out on Ratiopharm to TEVA. I also think NVS was correct to try to avoid commodity type pricing by focusing on harder to manufacture generics. However, I have been dismayed by the slow pace of adoption of biogeneric legislation. This market has not materialized nearly as quickly as I had hoped. Amazing that we as a country lament the cost of health care but then move at glacial speed to correct obvious points where cost savings can be gained.
Hopefully we see movement on implementing biogenerics in the near future. I'd hate to think NVS (and MNTA) will have to sue FDA (as was done with omnitrope) to force them to move.
Regards
FL
Does PFE opening a rare disease research center indicate that they are adopting a strategy similar to NVS. NVS has long maintained that rare diseases study would allow development of drugs that might have broader application to other diseases which have similar genetic origins.
FL
FTY 720
Assuming FDA follows the recommendation within the expedited review period (next 2 months or so), which existing pharma stand to lose the most in the MS market:
A) Biogen
B) Teva
C) Elan
D) others
Even if the approval comes in the next couple of months, NVS owners should not gloat since there are already other oral MS drugs in late stage testing.
FL
Afinitor meets Pancreatic cancer endpoint
With the use as a stent coating, kidney cancer, transplantation and half a dozen ongoing trials, this is begining to look like a pipeline in a single drug.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=50871739
FL
Everimolus meets endpoint for Pancreatic cancer
This is an extremely difficult cancer to treat. Unfortunately the press release makes it difficult to quantify the results.
http://www.novartis.com/newsroom/media-releases/en/2010/1421290.shtml
The best reason to buy is the tie to emerging markets. They are on a pace to eclipse N Amer. in 5 yrs.
Teva indicates it is more concerned about new oral treatments entering the MS market. Either way I think NVS is positioned to challenge Copaxone.
How do you handicap the odds that FTY720 gets approved in 2010.
FL
Teva At Risk Launches
I also question whether some of the at risk launches by Teva might eventually be litigated in the oppositions favor. They have been very aggressive and for the most part successful. It seems like the majority of these cases are settled at terms favorable to Teva. Does anyone have a handle on the what potential risks this poses. I'm aware of Lotrel and thought the Protonix launch was also challenged.
Regards
FL
Teva launched generic lotrel at risk in 2007. The NVS patent runs thru 2017. Yet here we stand almost 3 years later with no litigation scheduled or other resolution. Correct me if I'm wrong and there was some type of settlement. If NVS was to prevail in litigation, how would damages be calculated? I believe the law allows for treble damages (are these calculated based on sales or profits? Seems like it would have to be based off a sales figure since Teva could claim higher costs (marketing etc.) reduce profits. After 3 years this could be a huge monetary sum that is being litigated.
The NVS & MNTA approach to challenge the patent of Coxapane prior to launching highlights a contrast on how aggressive the NVS management is much more conservative than Teva. Some might indicate that means the the Coxapane challenge might be weaker. I think, NVS management does not want to subject the company to this type of risk.
From what I can see, the NVS Annual Report does not elaborate on the litigation schedule.
FL
That helps me think that NVS was in a fairly knowledgable position when they made the decision not to license IDX 184. The link indicated that it could be used in combination with the SOC.
Is Debio likely to be amenable to use as a combination oral drug?
Thanks
FL
Debio 025 HCV
Cyclophilin Inhib a new class of HCV treatment
Anyone familiar with this class of drugs potential for treatment of HCV? Last week NVS licensed Debio 025 which is in Phase IIB. I don't recall much of a discussion on this board of this class of drugs.
NVS has had several missteps in its entry into Hepatitis market. I can't help but wonder whether this licensing agreement played any role in the decision not to license IDX-184. NVS certainly is in a position to evaluate the potential of both. How likely is it that NVS opted not to license IDX 184 because they saw less potential competition getting a new class of drug into a cocktail or as a stand alone treatment than the nucleotide polymerase inhibitor IDX 184?
Any Thoughts on the link.
http://www.novartis.com/newsroom/media-releases/en/2010/1381968.shtml
If both avastin and leucentis are administered by intravitreal injection why would leucentis have a lower drop out rate? Is the needle larger?
I guess we'll have to see if the drop outs are similar for this study.
FL
Leucentis v. Avastin
CNBC interviewed Roche's CEO this morning. When asked whether the Kaiser report would open the door for substituting avastin for leucentis, he defended leucentis strongly.
Noting that the Kaiser study was not set up in a manner which would allow statistical interpretation. He also noted that Leucentis was designed specifically for application in the eye. 23% of the subjects receiving avastin treatment dropped out of the program vs only 3% for leucentis.
FL
NVS' Cortem treatment for malaria is derived from wormwood. Supposedly a ancient Chinese remedy for may ailments.
Good Luck FL
No mention of GSK Sanofi or NVS.
FL
Bloomberg had an interesting observation that the last 2 times that we have posted a GDP increase of 4.5% or more after a recession (1991 and 2001) the SP followed this by dropping 10%. I think the market had anticipated the good GDP showing and took that as a cue to take some off the table assuming that a similar decline was going to occur.
If this is the case we may have a little bit more to fall before pulling out.
FL
The Vol on the up days is running significantly higher than on down days. Based on today's results, it looks like NVS should run to 60. Of course overall market and the sector conditions could act as an anchor. If the run to 60 happens it should help silence some of the Alcon minority stakeholder gripping.
The good performance from all units and the recent trend by major pharma to copy NVS' moves (i.e., ABT getting into eye care, pfe & MRK starting generic units etc.) strongly demonstrates the quality of the management at NVS.
NVS would be completely blowing the doors off the competition if the FDA did not render a couple questionable decisions (i.e, Galvus, Prexige, etc.). NVS has taken these shots by FDA in stride and has proceeded to gain approval for these products in the developed and emerging markets in the rest of world. This has resulted in geographic diversification. N. America use to account for 40% of sales about 2 years ago, it is now down to 32%.
Given the demographic trends, and the earnings visibility I see no reason why NVS should not trade at its historic average PE of about 19. I suspect this will occur as vaccines gains traction and the new vision care group is formed later this year (assuming successful completion of the Alcon deal).
FL
It also answers why NVS did not use its priority review voucher.
Thanks
FL