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$TEVA gets approval of generic lovaza, to ship immediately $AMRN
Yeah , you know some of these guys are really nervous with patient phone calls etc.
Loved this laughable bit
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While the AMA is “committed to transparency” and supports the release of some physician data, the group urges the government to *allow individual doctors to review and correct their information prior to its public release*, Ardis Dee Hoven, the association’s president, said in a statement.
Doesn't seem that inconsistent. MNTA/NVS essentially need to do an at risk launch to stop the conversion. They just don't admit that it isn't your typical at risk launch, since this is a weaker patent.
That trial isn't going anywhere. I don't expect it to hit the endpoints.
Cowen on TEVA / MNTA
A Stay Is Possible –But Not Necessary –As Even If The Generics Are Approved, They Still Need To Seriously Contemplate Damages
Although there will now be a debate about the potential for an injunction/stay on generic approvals (if those approvals are actually about to occur, which itself remains controversial) there does remain a more overriding issue, which is the actual strength of Teva's case in front of the Supreme Court. This has seemingly been overlooked. Our legal consultants note that even without a stay, Novartis/Momenta and Mylan/Natco legal teams will need to make their own independent judgments about the likely outcome at the Supreme Court in deciding their launch actions. Our legal consultants indicate that a stay actually appears unlikely (given the previous rulings); however, the decision to grant a stay would unlikely provide any insight into the merits of the case in front of the Justices (it would be more from precedent/procedural and not based on strength or weakness of the case). Importantly, without a stay our legal consultants indicate that Teva would still have recourse of damages (single, not treble) if the Supreme Court found in favor of Teva's arguments, and then there was an eventual reversal of the appellate ruling.
Therefore, the decision to launch – in the case of no stay granted – would come down to likelihood of a favorable Supreme Court ruling, and then an eventual patent validity finding (and therefore infringement). Given that we believe that Teva has a very reasonable chance of success at the Supreme Court level, an injunction might not necessarily be critical, as Sandoz/Momenta and Mylan/Natco would still need to seriously pause in deciding to what degree would they like to put themselves in a position to be accruing what could be substantial damages. Recall, all damage findings are unique, but note there was the first ever "at risk" ruling in the Protonix case versus Teva and Sun ($2.2B in total, $1.6B for Teva alone). Time on market and franchise erosion would be critical in calculating – but given the size of Copaxone in the U.S. market ($3.2B currently) – the damages would likely not be inconsequential. It is not clear whether Sandoz/Momenta and Mylan/Natco – if they believe that there is a reasonable chance for reversal – would want to very knowingly take this risk. We believe they would not. The bottom line is that four hurdles now remain: (1) the still controversial issue of whether Sandoz/Momenta and/or Mylan/Natco have approvable generics; (2) if the products are indeed approvable, what is the timing of the FDA's decision given the 3x weekly conversion is proceeding rapidly, so any regulatory delay has become exceedingly meaningful; (3) can Teva secure an injunction/stay (which our consultants believe is unlikely, but still possible); but most importantly (4) even if no stay is granted, what is Sandoz/Momenta and Mylan/Natco's independent legal team's likely conclusion in terms of strength of Teva's case in front of the Supreme Court. We think the Street is likely too focused on issues (1), (2) and (3), and not focused enough on (4), which could ultimately be the deciding factor. We would note that the Supreme Court is unlikely to hear the case until October 2014 at the earliest (which is the beginning of the Supreme Court calendar), with a likely ruling not until early 2015 (with the outlier timing be June 2015, the end of the Supreme Court calendar).
If Sandoz/Momenta and Mylan/Natco believe the chance of Teva prevailing is significant, we believe the chance of withholding a generic launch – even if approvals are in hand – is a distinct possibility. We also wonder that given this new uncertainty/risk whether settlements are still possible. With the opportunity fading fast for the potential generic entrants given the speed of the 3x weekly conversion – and our belief that managed care cannot and will not recapture those patients that have switched – this decision tree becomes a bit more complicated. The bottom-line, however, is that nearly all of these outcomes now sway more in favor of Teva then at any moment in time (successful conversion and at risk launch now introduced).
We would be buying TEVA shares aggressively at these levels, as we believe that the most successful outcome (near total conversion to 3x weekly and long-term retention) is now possible. We would note that the 3x weekly formulation is at a 9-10% discount to the current brand price and that the orals are degrading the franchise. But netting out a near total retention could place our 2015/2016 estimated Copaxone revenue estimates low by nearly $1.0B. Replacing that level of high margin sales in our model means that a $5.75-6.00 estimate in 2015 now looks in play. If true – and the franchise erodes only slowly due to oral brand competition and not due to generics – the shares need to be purchased right now.
Background On 3x Weekly Conversion And Financial Implications
We would note that any delay could be exceedingly meaningful, as Teva has rapidly converted a substantial amount of the franchise to the 3x weekly (see our full review below). Even a delay into year-end 2014 (and not until September 2015) could be critical as the complete franchise could theoretically be fully converted by then. If this were to occur this would place the generics and managed care in the exceedingly unenviable task of trying to recapture a product that forces patients into 200+ more injections annually, which would clearly call into question compliance benefits, and therefore provide clinicians/patients with an efficacy argument. It would likely cause a significant negative patient response to force what is typically a relatively young woman that is on a chronic product to forcibly take 200+ more injections a year if already successfully converted to the 3x weekly. Our managed care checks have already indicated that they do not believe they would be successful (or would even try) to reconvert patients that have switched to the 3x weekly if the generic was made available in the near term. It is difficult to believe that this reaction would change.
Depending on the magnitude of conversion, Teva could rapidly transform into what we previously believed was a low-growth entity, back to a growth story as the Copaxone decline (which is inevitable due to the success of the oral competition) would be significantly less than feared without a near-term generic risk to the daily. Combined with what could be significant cost savings, our 2015 EPS estimate may find itself low by $1.00, or closer to $5.75-6.00 per share. With better cash generation than originally anticipated and a balance sheet that could accept further leverage, we believe that Teva might be able to leverage its core neurology branded infrastructure more rapidly than previously assumed (either with on market or development programs). The bottom line is that this story is reversing (for the positive) much faster than previously anticipated.
Recall, we are on the cusp of Teva's Copaxone patent expiry on May 24, 2014, and investors continue to await the outcome of the FDA's decision on approvability of either Momenta/Sandoz' or Mylan/NATCO's respective daily Copaxone formulations. As for the specifics, first, we believe that the conversion could eventually reach 50%+ by the time of generic market formation and managed care consulting checks indicate that they do not believe that they will require — or be successful in recapturing — the 3x weekly patients to a daily generic Copaxone if available. That means that if successful in converting 50%+ of the Copaxone franchise, roughly $1,500MM of US revenue will likely be retained. Second, our checks indicate that physicians remain skeptical on the quality and "bioequivalency" of generics — if and when they launch — and our consultants remain adamant that if payors force them to prescribe a once-daily generic, they will fight that decision with the respective patient's carrier, and if unsuccessful, would then alternatively write for the more expensive MS drugs like Tecfidera and Avonex.
They simply do not want to use an unproven generic. Interestingly, Tecfidera and Avonex cost around $60K a year, while 3x weekly Copaxone is the most inexpensive first-line agent available priced at roughly a 10% discount. Therefore, continued aggressive managed care decisions that attempt to force clinicians to prescribe generic Copaxone likely will lead to clinicians seeking other agents that would be more financially damaging to managed care. Stated another way, the 3x weekly Copaxone, at its price discount, will likely be the most favorable financial option if the clinicians continue to fight utilization of the generic. Alternatively, we do believe that Teva has an option to execute a "hard switch" to 3x weekly Copaxone, and our understanding of the regulations is that Teva would simply have to notify the FDA of their decision. However, given our conversations with numerous consultants, it does appear that Teva will unlikely take this option due to the overwhelming clinician community support for the 3x weekly and their willingness to push back against managed care. Teva likely would not want to damage the current clinician goodwill by forcing conversion via a "hard switch."
If we are correct that Teva will continue to experience significant levels of success in the 3x weekly Copaxone conversion and retention, the financial implications are significant. For perspective, using 2013 as the base year, total Copaxone revenues reached $4,330MM, with $1,135MM coming from Europe which is not impacted by the potential U.S. generic launches. That leaves the U.S. revenue base at $3,195MM. Assuming 40% conversion by May 2014 (midpoint of management's guidance; even though we believe 50% is achievable) would equate to roughly $1,300MM in annual revenues, and it does not appear that managed care will be able (or will even try) to reconvert. The remaining $1,900MM would then be in play for additional conversion in the face of the generic launches – and this assumes those launches actually occur in May/June 2014, which remains controversial. Given the conversation above, we would assume that there is a certain group of aggressive clinicians and patients that would still demand the more convenient formulation – and depending on the individual patients' plans – we would likely see another $300-400MM able to take the 3x weekly even if generics were available. The residual $1,500MM would therefore theoretically be in play for the generics on an annual basis.
With little incentive to meaningfully discount price, we would assume only a 15-20% decrease necessary, making the residual generic market roughly $1,200MM to be divided amongst Sandoz/Momenta, Mylan and Teva (which we would assume would compete with their own daily product as a generic – and still be able to provide those on the Teva generic with their Shared Solutions Program). This means that it could be a fairly lucrative, durable and high margin $400MM annual generic product for all three, which we believe would be very well received by each company. Adding up these components to Teva of: (1) not impacted Europe in the near term; (2) 3x weekly U.S. sales; and (3) the once-daily generic of the original formulation, could theoretically equate to a total durable Copaxone franchise of nearly $3,000MM+ annually for Teva versus 2013 of $4,330MM. For perspective, our current 2015 Copaxone franchise estimate is $2,250MM, declining to $2,000MM in 2016. Stated more clearly, we might be off on our out-year expectations for this franchise by roughly $1,000MM per year. This could clearly provide substantial relief to the 2015E/2016E P&L. More specifically, we believe that if correct with our above discussion that our current 2015 EPS estimate of $4.80 could ultimately be closer to $5.75-6.00.
Surprised the cult leader, Dr Tanzi, isnt on Twitter defending the data like last time. Sad so many believed in this.
CELG
Anyone following the (upcoming) Celgene Markman hearing in any detail?
Re LJPC
Odd that 30 has no activity, but 1.5 stat sig? Anyways, split the alpha here and it's not significant.
Other food for thought
“@biotechguy55: @adamfeuerstein you posted $LJPC data. I put it in a form with mean and SD. hmmmmm? http://twitter.com/biotechguy55/status/443158097435951104/photo/1
ARWR fully diluted is about $1.5B. TKMR still much cheaper.
What do you think of the HBsAg hypothesis? I'm skeptical it will boost cure rates.
AACR abstracts come out on March 5th. (don't think much for PALOMA-1 will be in there since top line read came after late breaking deadline. Current one is likely a placeholder)
Re PRAN
You can already write the PR for them
Executive function test(only one of 8-10) was positive, things like ADAS-Cog/MMSE/etc all unsignficant/no change versus placebo.
From Bloomberg reporter, "@SashaDamouni: $ACAD chatter: Pimavanserin filing may come sooner, despite mgmt. saying it will come YE; AND M&A rumors w/ cos. like $ALKS, $LLY, $PFE #BFW"
Company also looking to sell off consumer health unit.
Yeah, it was incredibly condescending on so many levels and downright embarrassing for him, especially in light of the data. Had there been some actual trends in endpoints, I wouldn't be nearly as bearish. But, there is no evidence this works.
Agree, Prana not helped by their delusional CSO(Tanzi). Its also partially his theory on the line with respect to MPACs.
Can't believe he tried lecturing me about how he understood multiple testing because he is a geneticist! Sure.... missed every major endpoint.
IMAGINE is 40 patients, market won't care. Company was originally supposed to make it 500 patient trial.
I don't consider trail making a valid test of executive function
Good breakdown of PRAN data in HD by @DrADKline ( http://about.me/adam.kline )
So this should put to rest any notion that this drug works.
No separation in *real* endpoints like UHDRS, TFC or Clinician’s Global Impression Severity Scale and HD Patient Reported Outcomes. You can bet they also pooled the data to look for something and found nothing.
I dont buy their executive function crap. They pulled the same thing with their analyses of the failed PBT2 trials as well. Their previous drug, PBT1, also failed in AD.
Repeat offender.
Cochrane provided a good review of their previous trials
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0013434/
Wow Dew, dont know how you reached this conclusion. It missed all signs of success, irrespective of data dredging, they could have even pooled the data and no difference in placebo.
You forget your coffee today?
re PRAN
Trial failed all real secondary endpoints. The company along with Dr Tanzi(thier delusional CSO) continue to spin this crap.
The 'primary' efficacy endpoints was a measure composed of 7 different values, then they made up 3 z-score test. Only one was successful.
Actavis in talks to acquire Forest
Brent Saunders going for another quick flip of a company, bravo.
Company has a poor history of being able to develop these things. Remember Linjeta?
Where was that rumor from?
Re MNTA
"• Timing uncertain; likely before 5/24/14: FDA action on MNTA’s Copaxone ANDA. The FDA’s new GDUFA guidelines take into account the patent-expiration date of the branded drug (#msg-95940872). "
Is it just as likely that we don't here anything until 5/24?
Re NRX
Trial failed if I remember correctly. Sounds like rinse repeat with the posthoc nonsense. CEO I spoke with laughed at them.
$MDCO briefing docs out http://t.co/fdV85ebEaL
FDA not happy, referred to one trial as unethical
Financial Times : US Biotech IPO fever stokes bubble fears
The fastest start to a year for US biotech initial public offerings is stoking fears of a bubble amid concerns investors are taking risks on companies at the earliest stage of medical research.
Another eight biotech companies raised a combined $502m in US listings last week, setting a weekly record for the sector and continuing a boom that has seen the Nasdaq biotech index rise more than two-thirds in the past year.
However, fears of overheating are growing as companies come to market at an early stage of drug development when failures are high – and in one case without the usual restrictions that bar existing owners from making a quick profit on IPOs.
The recent listing of Dicerna Pharmaceuticals, which raised $90m in late January and saw its shares surge 207 per cent on its first day of trading, is becoming a focal point for concerns.
The Massachusetts-based company has yet to enter clinical trials for the liver disease and cancers it seeks to treat, which typically means it has a less than 5 per cent chance of one day getting a drug to market, according to industry analysts.
In its prospectus, the company said that it would not make majority shareholders agree to long-term restrictions on their entire holdings. But in most IPOs, these so-called “lock-ups” are a common feature, designed to align the interests of existing and new investors.
“I’ve never seen an IPO in my career where the existing [majority] shareholders?.?.?.?were not subject to a lock-up,” said one senior capital markets expert, who added that other companies planning IPOs have since inquired about following Dicerna’s example.
Michael Zeidel, a partner at Skadden Arps, said: “A 180-day lock-up is one of those check-the-box provisions for investors.”
Shares in Dicerna have dropped 30 per cent from its first-day closing price though it is not clear if its main investors, including the venture capital arm of GlaxoSmithKline, have sold eligible portions of their holdings.
The prospectus warned that about 7 per cent of existing shares could be immediately sold and 93 per cent within 90 days. “The sale of a significant number of our shares may cause the market price of our common stock to drop significantly,” it said.
A person close to the transaction, which was underwritten by Jefferies, Baird and Stifel, defended the arrangement: “What makes this situation unique is that insiders ended up buying about 50 per cent of the offering, so there was a real shortage of stock to go around and we figured not having a lock-up would facilitate after-market liquidity.”
Investors have been attracted to the biotech sector by a fresh wave of scientific innovation and hopes that some of the latest market entrants can emulate the success of companies such as Biogen Idec, Gilead and Amgen, which have grown into multibillion-dollar drugmakers.
But while new IPOs have kept coming at a ferocious pace, there are signs that investor appetite may be weakening. Of the 14 companies to list this year, six are currently trading below their issue price. “I think the IPOs are a little stretched,” said Brian Skorney, an analyst at Baird.
John Carroll, editor of industry newsletter FierceBiotech, said: “The investment community still has enough appetite for risk to send a select group of these new IPOs over the range, but?.?.?.?they’re getting choosy.
“Inevitably, you’ll see more high-risk IPOs without a good story to tell come along to see if they can make it through this window, and it will get harder. When the inevitable crunch comes, it will be painful.”
The boom has so far been concentrated in the US, with several European companies, including Oxford Immunotec and GW Pharmaceuticals of the UK, crossing the Atlantic to join Nasdaq. UniQure, a Dutch gene therapy specialist, was among last week’s crop of US IPOs, raising $81.9m.
However, European markets could be about to catch the biotech bug. Circassia, a UK company developing allergy cures, last week announced London’s biggest IPO in the sector for years.
Bankers will defend any stock, as long as they're being paid.
I was just asking, I took an exact quote from your original post. Here did you mean a poster named summer or Summer Street?
Might have been my misinterpretation.
"I plan on holding onto a few thousand shares. **As summer speculated**, the PBT2 HD trial could have positive data on one or two targets and the stock could continue appreciating on apparent great news. Of course it would be even better if the drug actually works. In any event I am enjoying my time with PRAN so far. "
The Summer Street call was independent of the company.
EMIS has a lot of warrants O/S and gave up good portion of what royalty they had, if I remember correctly.
Don't have more updated info, but Deutsche made some slides back in August
http://www.zerohedge.com/news/2013-08-13/deutsche-bank-hopes-not-all-margin-calls-come-once-case-sell
PRAN - no one I respect thinks it will work, but company will spin whatever data they get. Been doing that since 2004.
Re REGN
Ha, oops - I was probably a bit careless with that comment at the time.
What pipeline asset do you like the most now?
Think the MYC drug will initiate Phase 1 this year?
Summer Street recommending a short position or stay away long. Have heard borrowing PRAN shares difficult/expensive.
When was I *very negative* on REGN? Might have been quite some time since I have updated my view on here. Certainly think Eylea a good product and they're delivering with recent Bayer expanded collaboration. Think they may be coming a little late to the immuno-onc space.
Sanofi needs them, holding on tight. Dupi data in asthma was fantastic, less thrilled on RA program - crowded and not sure if differentiated enough. Difficult to judge PCSK9 potential revenues without knowing outcomes study result. Amgen will be stiff competition and moving to market quick.
HeFH is a decent size market and will likely take some away from AEGR's Juxtapid.
While Juxtapid is approved for HoFH, no one is doing genotyping to confirm it, mostly being diagnosed phenotypically. I suspect most of these patients are severe HeFH. Juxtapid tolerability major issue vs PCSK9's.
Really? I asked if you actually listened to the Summer Street call since you claimed they speculated about success in HD. In actuality, the call discussed why PBT2 isn't likely to succeed.
Summer Street is a decent research shop and spotting all the issues with PRAN is easy money for them.
There are 9 measure a part of the NTB they used. Just by random luck finding one or more significant tests is about 40%. They also aren't highly stat sig if you read the original paper.
NTB also isnt standard in Alzheimers trial, MMSE or ADAS-Cog. Both of those measures didnt hit with either PBT1 or PBT2
Drug is a placebo.
Whats you're point? PRAN has a history of failed trials, spinning the data, and moving forward. Expecting the same.