Breaking News- FDA advisory panel votes in favor of Vivus’ Qnexa

By a surprisingly overwhelming vote, 20-2 in favor.
Reporting by
But my good friends and neighbors, will the FDA accept the panel’s recommendation?
Is Qnexa really the drug that the Agency wants to have as the first obesity agent in many years? The one with the ever so slight risk of cleft-palate? I’m just saying….


What an amazing? time we live in – “watching” the Qnexa advisory panel right now

I”m following a live blog from the on the Qnexa advisory panel. There are no secrets. cool stuff.

Bydureon: if you build it, will they come? We will know soon

Amylin and Alkermes announced last week that Bydureon was now available in U.S pharmacies.  

(On a side note, I love any launch press release with “first and only” in the headline.  I’m sure that was mentioned in every market research session as “important,” it happens every new launch, I love looking for it, but I digress.)

What I do like about the press release announcing Bydureon’s availability is the comprehensive approach Amylin is taking.  They are leaving nothing to chance:

A) Live patient support, and apparently an “in-person” education session if needed

B) A co-pay coupon card for up to 24 months at $50/month value

It does appear that Amylin has learned from past issues, and is providing what is needed to support the product, considerably different than Byetta’s launch.

This is the first picture I have seen of the Bydureon presentation, it does not look particularly easy, but with the patient support offered, the kit itself should not be too tall a barrier.

The billion dollar question will be, does once weekly injection change physician prescribing habits, even if patients can learn to manage the Bydureon kit?

Time will soon tell.

email me you predictions for Bydureon.  closest to the pin for U.S. market share at the end of the year wins a Metabolic Markets t-shirt.

The oft-debated role of the Employer in the obesity/diabetes discussion continues…….

It sounds so simple.  Employers, particularly large ones should care (code for “invest”) in their employees wellness and reduce multiple healthcare risks, and potentially reduce employee absenteeism.  So simple.  so straightforward.

Metabolic Markets has an ongoing employer project and it has been fascinating to see only a segment of employers truly embrace this concept and instate policies and “invest” in these efforts.  It is somewhat the same refrain, “We know it is a good idea, but we are worried about short-term financial performance, and when we can, we will invest in wellness to reduce total healthcare costs to us.”

A recent Employer Healthcare conference in DC had many of the usual suspects, all with case studies and data detailing the economic benefit to employers if they invest in total employee health, wellness and prevention. Nevertheless, employers still dance around the subject.  What will it take?

By Lisa Gillespie
February 9, 2012

Stand up.” The audience stands. “Sit down.” The audience sits. “Now stand up again.” An audience member mutters under his breath, “No way,” while Fikry Isaac, chief medical officer for Wellness and Prevention, Inc., a Johnson & Johnson company, makes his commands to make a point. Wherever your employees are — a meeting, a desk or at a conference, simple movement can go a long way to create a corporate culture where health is truly valued and lived.

On the second day of the 7th Annual Employer Health and Human Capital Congress in Washington, D.C., Isaac and three colleagues addressed a room of benefits managers and company executives on how to bend the employer health care cost curve through plan design.

They presented seven steps to achieve this goal, with Chief Medical Officer Roger C. Merrill of Perdue Farms, Inc. taking special interest in the last three:  Set health goals; create value-based plan design; and integrate patient-centered medical home and chronic care management.

“We have in-your-face health coaches that go into our chicken plants, they take blood pressure, we gather data based on our big risk factors,” he said. “We’re not chasing pancreatic cancer, that’s a tiny piece of what causes our aggregate health misery.” Instead, he referred to the “seven deadly interventions,” which include heart disease and diabetes that can be easily intervened upon if timed right. Eight-five percent of their employees participate in their wellness programming, which includes onsite patient clinics (where 90% of primary care is delivered) in every factory and higher copays for deemed unnecessary medical treatments. They’ve seen health score improvements seven years in a row.

Johnson & Johnson also had lessons to teach, with their “spectrum of care,” ranging from employees with little to no health risk, to those at high-risk. With each section of their population, Isaac said they use different strategies and incentives.

“You cannot put a dollar and cent value to prevention, which is what we’ve been working under currently,” Isaac said of current wellness trends. “If you want to sustain an effort, it’s not just putting it in and you leave , it has to be woven into the process, you have to focus on prevention.”

About three-quarters of all U.S. health care spending is focused on patients with one or more chronic conditions, which the panel agreed is a mistake. Ron Z. Goetzel of Emory University said that after looking at Johnson and Johnson data over the years showed that when obese employees went to non-obese, their health care costs went down 2.3%. When a non-obese person remained healthy over time, his health care costs reduced exponentially to -9.9%.

The panel was made of large employers, so when asked how these programs could be applied for small to medium employers Goetzel said “small employers are looking for ways to figure this out for their population, they don’t have the HR staff to do the things we’ve done,” but he recommended using tools created by the Centers for Disease Control and Prevention to deal with obesity in the workplace, or to pool together.

The question of a business case for getting employees into healthy shape was also questioned by an audience member, especially for full-insured companies who don’t get premium decreases with better outcomes.

Isaac said, “At the end of the day, we do not measure effort, we measure outcomes.”

Raymond Fabius, chief medical officer for Thomson Reuters agreed with this, citing a study that showed companies who focus on health have better stock prices.

“When you look at the clients who have implemented full service on-site, they out performed Dow Jones over period of five years; this competitive advantage translates into better stock performance, which may help in getting the attention of your CEO or CFO.”

Bydureon vs. Victoza? Super Bowl? M2 makes our prediction

Metabolic Markets has developed a GLP-1 market briefing for our clients education and discussion. Entitled: “The U.S. GLP-1 Market Brief: Yesterday, Today, and Tomorrow”  The brief slide deck reviews the history of Byetta, shares our clinical and commercial experience, Victoza introduction, and short term considerations to watch as the market unfolds with the pending Bydureon launch.

Available to you, dear reader,  for only the cost of an email:  

The Franchise – Januvia / the 800 lb gorilla

Merck release 2011 results yesterday, and to no surprise, the Januvia machine, 800 lbs gorilla, or as I like to call it “The Franchise,” continues to perform.

The Franchise posted $3.324 billion in 2011 global sales, up from $2.38 billion in 2010.  Let’s contrast this to the later entrants in the DPP-IV class

Galvus: $677 million (all ex-US, not bad), Onglyza; $156 million, and Tradjenta (only launched mid-2011, BI/Lilly have not reported product level sales for Trajenta)

Januvia, approved in 2006, has been a tremendous success. I remember the pre-launch “expert” chatter about the DPP-IV class: “modest efficacy, no one will use it”, the “ubiquity of the DPP-IV enzyme, so who knows what else is suppressed-safety issues are sure to be uncovered.”  In short, the  market  has not cared one bit about these early concerns.  The modest efficacy matched with tolerability and a clean safety profile (so-far), was just what primary care needed at the time.  One must remember the emerging concerns around the TZD class at the time.  Januvia was also the beneficiary of Galvus’ FDA problems in 2007, and Novartis never re-submitted in the U.S.

So Januvia was born under a lucky star, but it also is a clean, reasonably effective agent.  It now serves as Merck’s platform for diabetes care and co-morbid conditions.  Could Januvia be a $5 billion dollar franchise within two years while the other DPP-IVs scuffle along?


Lilly/BI get their DPP-IV combo

The Trajenta crowd has brought their combination product to the race with “Jentadueto”, the Trajenta/metformin offering.

This adds another option to the DPP-IV combination competition against Janumet and Kombiglyza.  We have been commenting in this space that the DPP-IV platform will likely see a myriad of combination approaches in the months to come. Merck’s Juvisync the most novel, combining Januvia with a statin. If alogliptin ever sees an audience with the FDA (see various posts on the ongoing agency delays for Takeda), we may see the first DPP-IV / TZD approach. is filled with multiple studies and multiple sponsors using various combinations with DPP-IVs.  Will any competitive efforts have any impact on the 800lb gorilla Januvia franchise?




Persistance.  it has paid off for Amylin.  And so far, so good.

Late Friday, Amylin announced the approval of Bydureon. Although roughly a year late, it seems that the preparation time has paid off.

The market has reacted positively to the news and to the investor conference call late Friday.  this is in stark contrast to the original Byetta approval in 2005 when AMLN went down on approval.

We wish our friends at Amylin very well.  We are excited for you and the prospects of Bydureon.  It is a good drug, good data, and without the Lilly involvement, so far we have seen good execution.


Tick tock goes the Bydureon PDUFA clock

With the sglt-2 shot down last week, that has cleared the fda’s calendar for Bydureon. The official pdufa is january 28, but fda watchers have told me the fda doesn’t like to let things linger. So will tomorrow be the day?  Or as Garth sings “if tomorrow never comes….”  we wish our friends at AMLN all the best in their efforts to deliver Bydureon to the world.

Dapagliflozin – FDA says “Not so fast, my friend”

In the least surprising FDA news in some time, dapagliflozin has been sent packing,   Metabolic Markets has been watching and commenting on various efforts to pump up dapa’s chances which you have read about in this space, including the Cleveland Clinic’s listing of dapa on its “Top 10 innovations for 2012.”  As we commented when that story first broke, the curious bullishness of Dr Nissen who said about dapa, ““My guess is that within the next year, this will get over the goal line. This is as good as anything we’ve seen.”

As “good as anything we’ve seen.”  Except for a 9-6 panel vote against and unexplained safety signals.  A cursory PubMed search for dapa data outlines a good, but distinctly not great oral agent, in Metabolic Markets opinion.  Modest A1c and good weight loss, but not earth-shaking. Edward Chao has a very good (and free) summary of the SGLT-2 class and data if you really want to know more than you will ever need.

So is this a death knell for the class?  There are several others in mid-stage development, with J&J’s canagliflozin the next one up.  As we have learned over the years, intra-class variation is not uncommon, but will this mean the FDA will require additional data for any of those in the class?

Until then, BMS/AZ seem to be saying they will have the data soon to address the FDA.  Watching what happens in Europe will be quite telling.  Do they “withdraw” their application, which is the polite European way of saying “you don’t have a chance.”