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

Amgen acquired T-Vec, a re-engineered virus designed to destroy cancer cells while spurring an immune response, in a $1 billion buyout of BioVex, a 2009 Fierce 15 company. The biotech has been aiming at a big year for new drug approvals, determined to shake off critics of its R&D strategy. But the recent approval of the heart drug ivabradine was dogged by comparisons with Novartis' big LCZ696, which is widely expected to get an approval later this year. Amgen is also in a close race with Sanofi ($SNY)/Regeneron ($REGN) on a new PCSK9 drug.

 

no one talks about IVA!!!!!


Summary

Two choices for large markets for Class III heart failure: stem cells or simple devices.
The needle: stem cell therapies (Mesoblast, NeoStem) offer promise, but struggle with late stage clinical trials.
Is the stem cell field too immature yet for successful heart repair?
The knife: Sunshine Heart's C-Pulse is a simple heart assist device that gives the heart a rest.
Sunshine Heart's C-pulse is simple and progressing along a well worn path to a fully implantable device (think pacemaker).
Of all the organs in the body, the heart has mystical and romantic significance, but it is one of the most prosaic of organs… it's just a pump! The problem is that it is a pump that can never fail. Failure means death.

While the technology of heart transplants is mature, there are not enough hearts available and it would be better to be able to address the problem of a failing heart earlier and less traumatically. LVADs (Left Ventricular Assist Devices) are a holding pattern, but it's doubtful that they will ever be more than a temporary solution as a bridge to transplantation. Although some LVADs are being adopted as a long-term solution, risks associated with them being inserted into the bloodstream make it challenging to imagine that they will ever make a big impact as a permanent solution to treating earlier stages of heart failure (such as NYHA Class III).

So what is out there?

Conventional drugs: For some time now, improvements in a conventional drug approach to heart failure have not been very successful, although the recent PARADIGM trial for Novartis' (NYSE:NVS) drug LCZ696, a first in class angiotensin receptor/neprilysin inhibitor combination, produced superiority over the drug enalapril for treating heart failure with reduced ejection fraction (HFREF), where the heart muscle fails to contract effectively and so less oxygen-rich blood is pumped. While there have been stepwise improvement through introduction of various drugs (ACE inhibitors, beta blockers, angiotensin receptor blockers and mineralocorticoid receptor antagonists), LCZ696 is seen as providing a major improvement in treating HFREF heart failure. However, LCZ696 is not without downside, the most notable being symptomatic hypotension, which is likely to mean that those treated will be carefully screened for suitability. However, the drug is targeting approximately half of the six million people in the US living with heart failure, 50% of whom die within 5 years of diagnosis. Note that LCZ696 still needs to get approval and reimbursement, although it has recently been granted FDA priority review and has been given access to the UK Early Access to Medicines Scheme.

Notwithstanding progress with a conventional drug approach, there is a need for better solutions as it does not seem that the conventional drugs prevent long-term decline for those suffering heart failure.

Fully implanted pacemakers: Because the heart pump is controlled electrically, implantable electrical pacemakers have been developed over the last 50 years to address lethal signaling problems. More than 3 million people around the world have had a fully implanted pacemaker inserted to manage irregular heartbeat or risk of atrial fibrillation. Having a pacemaker inserted is not a big deal today.

Heart assist devices: Sunshine Heart (NASDAQ:SSH) has a device (C-Pulse) that does the job of an LVAD, but importantly the device is not a pump that is inserted into a blood vessel. Instead, it supports blood flow by squeezing the aorta to provide extra flow for an ailing heart. It is like a "bandaid" with a small parachute that is inflated by an external device. The inflation is coordinated with the pulsing of the heart.

The device is simple and has features similar to a pacemaker, but provides a mechanical squeeze instead of an electrical signal. At this stage, the controller is worn by the patient, but a fully implantable device (like a pacemaker) is in advanced development in animals.

The key attributes of C-Pulse are that it effectively rests the heart by taking some of the load using a device that can be turned off without risk, and which has no risk of stroke that a blood contact LVAD device has. The early trials have indicated that C-Pulse may in some cases be a route to cure, as some patients have been able to turn off their device and reduce medication. Robert Honeywill has produced a series of excellent articles on the financial, technical and clinical prospects for Sunshine Heart and I refer readers to these.

Stem cell therapy: With emerging understanding of regenerative medicine, and the role of gene therapy and stem cells, it isn't surprising that the heart would be seen as an organ that might be repaired using such technologies. Indeed, my recollection is that about a decade ago Genentech CEO Arthur Levinson said that his company would become a stem cell company and fix hearts using this technology within 10 years. While today Genentech is still excited about stem cells, the early vision of Levinson has been tempered. Levinson has moved on to head up Google's (NASDAQ:GOOG) (NASDAQ:GOOGL) anti-aging startup Calico, and Genentech is talking up stem cell science as an adjunct to improving drug discovery, not as the definitive treatment for ailing hearts.

However, there are companies with advanced clinical trials for both gene therapy and stem cell treatments for treating Class III heart failure or heart repair after heart attack.

In one of Robert Honeywell's reports, he considered stem cell approaches to repair the heart after heart attack with treatments under development by Novartis and NeoStem (NASDAQ:NBS). The results of NeoStem's Phase II PreSERVE AMI study were discussed recently by Steven Giardino, and an update indicates results haven't excited the market, with NBS' share price in steady decline.

Mesoblast (OTCPK:MEOBF) (OTCPK:MBLTY) [ASX:MSB] is a stem cell company with advanced stem cell heart failure products. Teva (NYSE:TEVA) acquired a 17.6% interest in Mesoblast when it acquired Cephalon, and Teva became a partner for Mesoblast's Phase III heart failure candidate MPC-150-IM, which has application both at Class II/III failure as well as in Class IV to assist patients with an LVAD. Mesoblast also has MPC-25-IC for supporting patients who have had a heart attack to maintain/assist heart repair. These products are interesting, but it is still early days and the mechanism of action isn't clear.

The simplistic initial view of stem cell therapy was that you put the cells into the patient and then cross your fingers and hope they target the area you want to fix. It isn't so simple. The heart is a muscle and the status of understanding the use of stem cells for muscle repair is still at an early stage. It's not clear that it will be as simple as injecting some stem cells and waiting for success. Indeed, the early excitement has given way to doubts in the light of many studies.

The problem of getting stem cells to work in heart repair is resolving in two directions:

i) Getting them targeted to the right place, e.g. getting stem cells to lock into the region of the heart that is injured.

The recent failure of NeoStem's autologous stem cell therapy to restore blood flow after heart attack could be due to the cells not staying where they needed to be.

ii) Very recent reports suggest that therapy for skeletal muscle repair may come from a drug approach based on providing signals to stimulate stem cell production from within.

The above studies are great science, but they are a long way from a proven and effective therapy. It shows that the way forward in the stem cell area is still not straightforward, notwithstanding enthusiasm for putting stem cells back into people who face grim future prospects.

While I've focused on stem cells here, use of gene therapy approaches where a gene is transferred into diseased cardiac tissue is similarly challenged, with recent failure of Celladon's (NASDAQ:CLDN) gene therapy Mydicar not meeting endpoints in its Phase IIb CUPID2 trial. There seem to be many challenges to developing a successful gene therapy product, including getting the relevant gene to the right place and persisting, having the gene turned on, and the relevant protein being an effective treatment. This is a big call. Robert Honeywill has just published a detailed commentary on Celladon's Mydicar problems.

There is a need now, and will be for a long time, for a device to give the heart a rest (or ease the load). That's what the C-Pulse is, and all of the evidence points to this device becoming about as important as pacemakers have been for treating electrical problems of pacing the heart.

Of course, implanting a C-Pulse device is more complicated than inserting a pacemaker, as this just needs the device to be put in a pocket near the shoulder and get wires in place to monitor the heart beat and provide ability to reprogram the heart beats through electric stimulation.

For the C-Pulse, a "bandaid" needs to be applied to the outside of the aorta, and the means to assess when the heart is pumping needs to be positioned on the heart. But, unlike inserting an LVAD, no blood vessels are cut and the operation can be performed as a mini-thoracotomy, which does not involve cutting the breast bones. As yet the device is not fully implantable, but animal trials are well advanced with a fully implantable C-Pulse system. Only the timing of when a fully implantable device becomes available for humans is in doubt.

I'm cautious about near-term stem cell solutions because it is still very early days in the science of cell-based therapy.

I find it intriguing that there is a significant scientific effort to develop next generation stem cell pacemakers, with good evidence of potential, but still a long way from imagining that implantable pacemakers will become redundant. Here is a recent review on gene therapy and stem cell solutions as biological pacemakers for those with access to a science library and here is the full text of an older review

I've been mulling over why SSH has been ignored by the market for a long time, and I acknowledge the excellent analyses that Robert Honeywill has written on this company (check out Robert's profile for many excellent articles both on financial as well as technical analysis).

I argue here that the stem cell approach (the "needle" injecting cells) is still immature both intellectually and practically. While C-Pulse involves surgery (the knife), it has a different risk profile to LVADs and it is capable of becoming a widely available therapeutic approach to treating Class III heart failure.

Because of the optimism about prospects for stem cell therapy, I suggest that Sunshine Heart's C-Pulse has been overlooked as a transforming device for early stage heart failure. Put simply, I suggest that the reason that SSH languishes is because the market thinks it is old fashioned and will be overtaken by stem cell technologies. This is a classic case of market expectations missing the reality of a technology.

Conclusion

I've written this article because I think SSH fits the requirements for Seeking Alpha's Best Contrarian Idea.

If you review the history of stem cell science, it has been repeatedly positioned as the next big thing after monoclonal antibodies. This is a very powerful image, as monoclonal antibodies have transformed biotech products over the past decade and made fortunes for many investors.

I can't help thinking that subliminally this is why SSH is overlooked as being old fashioned and clunky. I like simplicity, and the success of the heart pacemaker is a good example of such simplicity. There is substance to the view that the heart pacemaker is pretty primitive, but it has changed millions of lives. I see C-Pulse in the same light.

Ambitious claims about near-term stem cell heart therapy still have resonance. I've indicated here that stem cells have great promise, but it is still very early days and I think SSH will have its fully implantable C-Pulse in a lot of patients before stem cell therapy will be a serious challenge. Indeed, it could end up that stem cell therapy is used as an adjunct to C-Pulse treatment. I'm cautious about how long the value of C-Pulse will take to be appreciated by the market, as the pace of device development can be agonizingly slow. However, I shall be very surprised if within the next 12 months SSH's fortunes have not dramatically changed for the better.

Editor's Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.

 

bye bye amgen

 

Entresto. That’s the brand name Novartis has chosen for LCZ696, its new heart failure drug that is expected to be a blockbuster. The name won’t be final until official confirmation, which comes with FDA approval. But Novartis will introduce the name for the first time this weekend in presentations at the European Society of Cardiology Heart Failure meeting in Seville, Spain.

FDA approval of Entresto is expected to occur by August at the latest. There are no apparent roadblocks to approval since Novartis has stated that it doesn’t expect an FDA advisory panel. Approval might well come earlier this summer.




ONLY A FEW MORE MONTHS TO SELL CORLANOR CV!!! THEN ITS GOING TO BE ENTRESTO TIME BITCHES!!!

WE AT ONYX PHARMACEUTICALS KNOW YOU WILL ALL FAIL!

 

Wow, do you patients ask for IVA or are you begging for scripts with Starbuck runs?

Look at LCZ696, patients ask for it!

More than 70% of HFrEF patients achieved the target dose
The TITRATION study has confirmed that LCZ696 is safe and tolerated by patients with heart failure and reduced ejection fraction (HFrEF) in clinical practice, announced principal investigator Dr Michele Senni in a late breaking trials session today at Heart Failure 2015
Seville, Spain – The TITRATION study has confirmed that LCZ696 is safe and tolerated by patients with heart failure and reduced ejection fraction (HFrEF) in clinical practice, announced principal investigator Dr Michele Senni in a late breaking trials session today at Heart Failure 2015. More than 70% of patients achieved the target dose 200 mg BID over a 3- or 6-week up-titration regimen.

“At the end of the study patients asked us to continue LCZ696 because they felt better.”

 

Amgen sucks...dumping my RSUs asap!

 

We are going to destroy Amgen CV.

Novartis

 

How is the launch going. What do the sales for IVA look like.
How many millions have we banked since launch?

 

Ivabradine is useless.


Among its most anticipated blockbusters is a heart failure drug, LCZ-696, which is due to be approved in US this summer.

The drug is expected to rake in $3.7 billion in annual sales by 2019 and has been referred to as the most exciting launch of the company ever by pharma chief, David Epstein. The drug may have a slow start, sales, as Novartis may need to convince doctors of its edge over cheaper existing treatments, but sales are expected to later pick up fast.

 

BYE BYE IVABRADINE!!!!!!

Novartis' new heart failure medicine LCZ696 approved by FDA to reduce risk of cardiovascular death and heart failure hospitalization; now called Entresto™ (sacubitril/valsartan)

Published: July 7, 2015 4:50 p.m. ET

- First in the world approval brings hope of longer life and fewer HF hospitalizations by reducing the devastating impact of heart failure with reduced ejection fraction for millions of patients in the US1-3- Entresto is the first and only treatment to show a significant mortality benefit in a head-to-head trial against ACE-inhibitor enalapril4- Heart failure is a life-threatening condition affecting nearly 6 million Americans; about half have the reduced ejection fraction form2,3,5- Approval comes six weeks ahead of FDA's priority review action date; Novartis is working to make Entresto available to patients as quickly as possible

EAST HANOVER, N.J., July 7, 2015 /PRNewswire/ -- Novartis announced today that the US Food and Drug Administration (FDA) has approved Entresto™ (sacubitril/valsartan) tablets, previously known as LCZ696, to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction (HFrEF). It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker (ARB).1 Reduced ejection fraction means the heart doesn't contract with enough force, so less blood is pumped out.6

To view the multimedia assets associated with this release, please click: http://www.multivu.com/players/English/7488651-novartis-fda-approval-entresto/

"The approval of Entresto marks a new era in the treatment of heart failure made possible by the collective efforts of our Novartis associates, the hundreds of cardiologists and nurses, and thousands of patients who participated in the research," said Christi Shaw, US Country Head, President of Novartis Corporation and Novartis Pharmaceuticals Corporation. "We have so many people in the heart failure community to thank for helping bring this exciting new treatment to patients and are working hard to make it available at pharmacies as quickly as possible."

 

I bet the CV reps are crying now. Wahh wahhh wahhhh

 

Novartis drug Entresto is off the chart great! Game changer. The data is insane. I'd question my doc if he didn't prescribe the novartis drug if I or a loved one had HF.

 

Of course you would! Because you are soooo much smarter more educated than he is, especially when it comes to medicine! Idiot fuckingreps killed this industry like 10 yrs ago. All they do is bitch and moan. No wonder their wives or kids don'trespect them....because they act sooooo tough over an Internet site.

Novartis drug is a good drug with better overall data then ivabradine. Yes. But that doesn't mean that there isn't a place for both drugs. It's good for the patients that there is now possibly more than one new medication out there for them. It's always seems to be about these faggotreps always crying over something

 

Corlanor belongs in the trash, just like to momma!

 

Corlanor is like the fat chick who thinks her love rolls are hot!

 

Overall better data?!?!?! Are you fucking kidding me?!?! Have you seen Entresto's data? God you are an idiot.

 

There data is only okay....who cares about outcome. We slow heart rate and that's why Corlanor will be used WAY MORE.

 

Like any old beta blocker does anyway! You are delusional!!

 

And it's "their" not "there"......typical amgen genius...which would also explain your insane comment.

 

I bet you are an onyx rep. You will be fired shortly maggot!