Sharp Scrutiny of Amgen Heart Drug

http://www.forbes.com/sites/larryhusten/2014/06/12/sharp-scrutiny-from-european-medicines-agency-of-amgen-and-servier-heart-drug/

 

Will the launch go on?

 

Does anyone pay attention to the details? 10 mg vs 7.5 mg/5 mg. 10 mg is not an approved dosage.

People who are worried if this drug will launch should not be applying. This drug is not a money maker. Also pay attention to what Amgen is doing before you leave your current company. Two layoffs in 1 year when the company is doing well! This is a telling sign of the new culture here.

Come if you have nowhere else to go or if you are going to get a big salary jump.

 

It is televised on the fiasco channel next week.

 

The FDA filing for ivabradine is for patients with chronic heart failure. The*SIGNIFY trial included patients with chronic stable coronary artery disease without heart failure. Different indication and disease state. Keep Calm and Party On.

 

Your are discounting spillover effects. Safety is paramount concern, not indication.

 

The Novatis post was pulled. Why?

http://finance.yahoo.com/news/novartis-investigational-heart-failure-medicine-151200800.html?.tsrc=applewf

Have fun Amgen!

 

Amgen is scared that you might leave if you know the truth and won't drink the kook aid

 

IVA won't be the main event. EVO is the star, with very favorable data to support it. By the time Novartis comes out with its PCSK9 it will be a crowded market (Sanofi, Pfizer, and Roche will beat Novartis).

 

Iva maybe on heart failure as we know it. Data to be published tomorrow from servier trial, and not good. Watch news out of EU.

 

Are you referring to the BEAUTIFUL trial? It did not meet the primary end point.

People need to read before they interview.

 

http://www.medpagetoday.com/MeetingCoverage/ESC/47429

Amgen should not launch this drug.

 

The drug looks and barks like a dog.

 

EVO will be a falling star, not a rising star.

Novartis has a PCSK9 targeted drug? Please reference the study/article.

 

Novartis drug already failed to get US approval. Novartis has a history of being 3rd -4th to market or not even getting approval. I know, spent several years at that incompetent organization. Always sold inferior products, except for Diovan. Even that drug took years before it took off.

 

Can you people read. We are talking about the NVS HF drug LCz 696 that will destroy IVA.

 

Can you read? Amgen didn't create the new CV division for IVA. It's not concerned with Novartis. It's focus is on EVO.

 

Sanofi is estimated to getn 2/3 of the Evo scripts. Amgen is screwed in second place. When big daddy pfizer comes with its psck9, then Amgen will be getting double teamed in both holes like jenna jameson.

 

Sanofi could very well end up being 2nd to market. They won't file until end of this year. Amgen has already filed, and is expected to get FDA Priority Review. Pfizer, while being the "big daddy", is not expected to launch until 2017. That gives Amgen 2+ years advantage.

Source which names Amgen “leader in the race”:

http://blogs.barrons.com/stockstowatchtoday/2014/08/28/amgen-first-to-market-first-to-set-price/


Article which cites launch date for Pfizer’s RN-316 to be 2017:

http://www.epvantage.com/Universal/View.aspx?type=Story&id=440483&isEPVantage=yes

 

Article which states numerous companies are developing PCSK9 drugs, including Novartis:

http://www.fool.com/investing/general/2014/02/18/cholesterol-lowering-drug-market-heats-up.aspx