Novartis HF drug will sink Ivabradine...Run from CV

Not only will Novartis destroy Amgen INBU in Psoriasis with their IL-17 coming out first and with better data, they will destroy CV ivabradine with their new HF drug. Doctors won't try both drugs as add-ons at the same time. Since IVA has safety concerns and looks less efficacious, they will likely use the Novartis drug first. This means a slow IVA launch and more layoffs as AMG 145 is delayed.

Screw trying to get in Amgen CV, work for a company with first in class drugs.

http://www.ibtimes.com/novartis-new-heart-failure-drug-cuts-cardiovascular-death-risk-20-1674484

Novartis AG’s (NYSE:NVS) combination heart-failure drug LCZ696 made pulses race Saturday as the company released the final results of its comparative Paradigm-HF clinical trial. The data showed the medication in relation to the ACE-inhibitor enalapril cut the risk of death from cardiovascular causes by 20 percent and from all causes by 16 percent. The pill also reduced hospitalizations due to heart failure by 21 percent.

The major drug manufacturer disclosed its big news at the European Society of Cardiology congress in Barcelona, Spain, in the New England Journal of Medicine and on its own site. Based in Basel, Switzerland, it is among the top five pharmaceutical firms in the world ranked by annual revenue.

“By demonstrating a very significant reduction in cardiovascular deaths while improving quality of life, Novartis’ new heart-failure medicine, LCZ696, represents one of the most important cardiology advances of the last decade,” David Epstein, the head of the company’s Novartis Pharmaceuticals unit, said in a statement. Elaborating in an interview in Spain, Epstein told Reuters, “This result is better than we ever could have anticipated.”

Novartis announced in March the early closing of its Paradigm-HF clinical trial at the recommendation of the data monitoring committee overseeing it. Such committees historically have made these kinds of recommendations because the drugs being tested are performing either very well or very not well. In this case, LCZ696 met the primary endpoint for efficacy in its interim analysis, as the company detailed at the time, and met it with room to spare, as the firm detailed Saturday.

In March, Novartis described its investigational heart-failure medication this way:

LCZ696, a twice-a-day pill for heart failure, is a first-in-class medicine that acts in multiple ways on the neurohormonal systems of the heart, blocking receptors exerting harmful effects while simultaneously promoting protective mechanisms. Known as an ARNI (angiotensin receptor neprilysin inhibitor) LCZ696 is thought to reduce the strain on the failing heart, promoting the ability of the heart muscle to recover.

Analysis of the Paradigm-HF clinical-trial safety data showed LCZ696 side effects were manageable, Novartis said, so the company plans to file applications for marketing authorization with the U.S. Food and Drug Administration this year and with the European Union next year.

The analyst consensus forecast for LCZ696 sales in 2019, four years after its anticipated launch, is $1.9 billion, according to Thomson Reuters Cortellis. However, Deutsche Bank analysts have predicted the firm’s sales of the drug could eventually reach as high as $10 billion a year under certain conditions, Reuters reported.

 

Amgen is a neophyte in CV, much like osteo launch. In fact, beyond blood doping products Amgen not launched much and purchased Immunex.

 

Loss in neupogen, enbrel, neulasta, aranesp combined with lackluster Kryprolis 2nd line launch, Evo delays and mistakes, Iva getting killed by Novartis means more layoffs from banker bob.

I honestly see more layoffs in 2016-2018 because of these factors or banker bob selling while it's high before people see how dire Amgen is looking.

 

Applicants should run away from Amgen and go apply to Novartis.

 

If people do not find a place to go by 2016, it is their own damn fault. I understand some people are waiting around for the package.

 

BB going to sellout. He wants $100 million by age 55. Contracting every part of Amgen makes it ripe for a buyout to buy the intellectual property assets for biologics/biosimilar capabilities. That's really Amgen's core asset - it's manufacturing processes - manufacturing for the future.

 

Dr. Fu-Quen Lin at Amgen invented EPO. Real name, look it up.

 

As a former cardio rep, this data is ground breaking and their timing will surely sink the IVA launch in many ways.

1. Cards will not try 2 new drugs on top of each other
2. Two branded drugs will be too costly for a senior population even if IVA could be used on top of the Novartis drug
3. The same team will be frustrate with IVA and that will set a poor tone launching Evo knowing that Sanofi beat them to the market.


Better start looking for another job. Amgen is dead.

 

Amgen is already dead to many employees.

 

Novartis has a history of claiming great things with their pipeline and they almost always fail. Outside of Diovan they have launched NOTHING of relevance in recent years. There is just a trail of one failure after another. Be careful with this Swiss Miss cluster...

 

Culturally, yes. Amazing how one CEO can destroy a company so quickly by a thousand cuts.

 

If goal is to be bought, why is Amgen bothering with a new business unit (CV)?

 

Maximize value.

If Amgen not being built to sell why launch with 40% contract reps? CSO reps not for the long-term. It's a job so they can keep looking to get on somewhere full time like Sanofi.

 

IVA is going to get blown away -

http://www.foxbusiness.com/industries/2014/09/02/most-exciting-ever-novartis-drug-points-to-huge-sales/

""It will be possibly the most exciting launch the company has ever had," Epstein told investors."

"Analyst forecasts for LCZ696 have been climbing in recent months and the consensus for sales in 2019 - four years after its expected launch - stood at $1.9 billion at the end of last week, according to Thomson Reuters Cortellis.

That number now looks out of date, with several analysts in research notes on Monday anticipating peak sales of $5 billion or more.

There could be more upside too. Jefferies analysts, in common with many others, are not currently including in their $5.2 billion sales estimate a second group of heart failure patients beyond those in the current clinical trial."

"Industry analysts believe it could be priced at around $7-8 a day in the all-important U.S. market and less in Europe. With a compelling clinical profile and very little in the pipelines of other companies in terms of competing products, Novartis looks to be in a strong position." --- WAIT THE ANALYST ABOUT IVA!!!!!!!!

http://www.bloomberg.com/news/2014-09-01/novartis-rises-most-in-five-months-on-heart-drug-trial.html

"

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Sept. 2 (Bloomberg) -- Bloomberg’s Olivia Sterns reports on promising new medication from Novartis for heart disease. She speaks with Betty Liu on Bloomberg Television's “In The Loop.” (Source: Bloomberg)

Novartis AG gained the most in almost three years after a study showed that an experimental heart failure drug kept more patients from dying or being hospitalized than the standard therapy, a result that may transform treatment of the disease that afflicts 26 million people worldwide.

Novartis rose 4.3 percent to close at a record 85.90 Swiss francs in Zurich, extending the stock’s increase this year to 21 percent. The gain was the biggest since Sept. 6, 2011.

In a trial involving 8,442 patients, Novartis’s LCZ696 reduced the risk of death and hospitalization because of heart failure by 20 percent, compared with enalapril, the standard therapy. The research was published Aug. 30 in the New England Journal of Medicine and presented at a conference in Barcelona.

“My reaction was, ‘Wow, are you sure?’” said David Epstein, head of Novartis’s pharmaceuticals division, in a telephone interview. “Whenever you see numbers like this you want to make sure you didn’t hear wrong. This is going to become one of our key brands. It’s clearly a multi-billion dollar opportunity,” he said, without giving a more precise sales forecast. "

"“This means Novartis should have a long and uncluttered runway ahead of it,” Anderson, the Sanford C. Bernstein analyst, wrote in a report yesterday. Analysts at Credit Suisse Group AG raised their peak sales forecast for the drug today to $4 billion from $3 billion. " -- ONCE AGAIN NO ONE MENTIONS IVA....WHY CUZ IVA BLOWS HARD LIKE YOUR NEIGHBORHOOD WH0RE!


“Any patient that has reduced ejection heart failure that’s currently on an ACE inhibitor or an ARB should be switched over to this drug once it’s approved,” he said. “ACE inhibitors will be used in other places –- they lower blood pressure, for example -- but in heart failure from what I can see here there’s no place for them any longer.”



AMGEN IS SCREWED!!!!

 

I seriously question if IVA will even be approved or approved with a very heavy rems.

There is a reason why IVA was not brought to the US years ago and why it's mediocre in Europe. It's just not a great drug. It has some effect but should really only be given to severe patients who are already screwed. Moderate patients should get it because the first rule of medicine is do no harm.

 

We can sell this stuff on ebay and make a profit. No question!

 

The only reason IVA got a fast track is because HF has huge unmet needs. The thing is once the FDA reviews the data package and including data in the public domain, IVA is going to have a much tougher time gaining approval.

Novartis has the momentum, better data and a cleaner drug. IVA will help amgen gain access to cards but the drug won't sell well. I hope the bad press from IVA doesn't skew the Evo image when the same reps carry that drug.

 

I will sell it with my used condom collection

 

The number needed to treat for a benefit is 72 patients. It's less than half of that for lCZ696. Amgen is done.

Pro's of novartis:

1. They have a PCP team
2. They have a cardio team

This means they will have access immediately when the product is launched. Amgen reps will be learning new doctors and earning the right to detail while novartis starts day 1.

3. better efficacy on all metrics
4. cleaner side effect profile
5. will likely get better access across all patient types


Unless there is a LCZ696 + IVA combo study, no doctor will use IVA when they can try the novartis drug, especially with the limited efficacy and safety concerns.

 

IVA better have clear patient subtypes or will need training in how to answer questions on why your product is a dog. Why should I use your drug versus the Novartis drug.

Good luck CV team. Selling IVA is like selling horses in the age of cars.