The Vytorin Limbo: Going Just A Little Lower
6 CommentsBy Ed Silverman // August 19th, 2008 // 8:01 am
Is it possible? Have Vytorin prescriptions finally hit bottom? Maybe. Back in January, when preliminary results for the Enhance trial were released, scrips were about 1.8 million, but then sunk to 1.33 million in June. Last month, though, scrips rose about 90,000, according to a filing by Schering-Plough with the Securities and Exchange Commission. This happened despite the confusion over the recently released Seas trial, which failed a primary endpoint and, moreover, yielded a puzzling number of cancer cases.
However, there is another way to slice the data (isn’t there always?) Although scrips were up for Vytorin and Zetia, both of which Schering-Plough and Merck co-market in a rather strained joint venture, scrips for the entire cholesterol market also rose to their highest levels since January. You know the rising tide theory…
And so Vytorin’s share of the overall cholesterol market, which stood at 9 percent in January and 6.9 percent in June, fell to 6.6 percent last month. The drugmakers’ combined ‘franchise,’ which amounted to 15.2 percent of the cholesterol market in January and 12.1 percent in June, slid to 11.7 percent last month. Meanwhile, the gossipy reps who love to dish at CafePharma, that electronic bathroom wall, say Schering-Plough is playing musical sales teams to boost scrips. How low can you go?
Condor
Great stuff, Ed — I thought I’d amplify one point, from yesterday — probably lost on the casual reader of your fine site, here. I’ll likely write more on these thoughts in a moment, on mine. [Do feel free to liberate/filch my graphics, if you like, as well!]:
http://shearlingsplowed.blogspot.com/2008/08/july-2008-ims-scrips-data-vytorinzetia.html
Yesterday, you noted that a consulting firm has labeled Schering’s pipeline the “deepest” in the business — it has the most potential to be self-replenishing by 2012. For the moment, let’s assume that is true.
To bring the number — and variety — of drug candidates to approval by 2012 — that these consultants (and Schering, itself) forecast, Schering will need MASSIVE cash-flow generation mechanisms — perhaps 2 to 3 billion per year, every year — over and above the cash-flow needed for ordinary operations.
That “machine” was to be Vytorin. As US market share melts, like an ice cream sandwich, in the August heat on the beaches of Fire Island. . .
I wonder, honestly, which of those wonder-licious new drug candidates are going to have to be shelved — or scrapped — for lack of cash flow to bring them forward fast enough — by 2012.
Schering’s own SEC filings plainly warn that Schering is “substantially dependent” upon Vyotrin — to fund its future pipeline delivery strategy.
That may be the meta-narrative, here.
In any event, I think I’ll go make it so.
Cheers!
Dan A.
Redundant, I know:
Published on http://www.brainblogger.com:
A Failed Attempt to Improve Misperceived Greatness: The ENHANCE Trial
While it seems that pharmaceutical company sponsors of clinical trials usually end up with results that clearly favor their meds studied in their trial, there are rare exceptions, and Merck and Schering proved that with their disappointing ENHANCE Trial, which many have heard about through the media not long ago. The drugs studied were Vytorin, which was compared with Zocor
Vytorin is a combination med for high cholesterol and contains Merck’s Zocor, which is now generic, and Schering’s Zetia, which works differently than Zocor, which is one of many statin drugs. Both Vytorin and Zetia are co-promoted by Merck and Schering. So, several years ago, an outcomes study was initiated to prove superiority of Vytorin over Zocor. The trial was named the ENHANCE trial, and possibly this trial was initiated because Zocor is generic now, and not a priority from a profit paradigm of its creator.
After several years passed, a disappointment arrived for the sponsors of this trial, which was first brought to the attention of Schering in March of 2007, yet the results existed since the spring of 2006, I believe upon information and belief.
The disappointment is that Vytorin lacked anticipated benefit or superiority over Zocor. Since about 1 million scripts were written for both Vytorin and Zetia every week in 2007, combined with what I believe was about 5 billion in revenue for these two drugs that year, this was a problem for the drug makers, meaning a fear of shareholder reaction. Perhaps for Schering in particular, it was more of a calamity, since over half of their profits and earnings were from these two drugs with Schering, I understand.
Being the responsible corporations both companies are, of course, alterations occurred after such events were discovered that fractured numerous rules and regulations with clinical trials, possibly in illegal and unethical tactics.
The trial sponsors delayed the release of the trial results for secrecy reasons, it has been speculated. Results from the trial existed, yet were not disclosed at the time of their discovery. After several months of possessing these trial results that were only known to the manufacturers, they created or implemented some atrocious tactics to improve the trial’s unimpressive results following the original results of this ENHANCE study. At the end of 2007, the companies changed the primary endpoint of the trial, which is what the results were measured upon during the entire course of the trial. Sort of like sorting cards to make a good hand not dealt to you. Anyway, since their deliberate concealment of these trial results was clearly wrong, to respond to those who asked where the results were actually as they had been anticipated for quite some time, and while such trial manipulation was occurring and results were being kept secret, Schering stated that continued data analysis from the trial results was the etiology for the delay.
With clinical trials, case report forms are used to record data from the trials, and are created in a manner where further analysis is not normally necessary, as such forms are quite clear and often not subject to interpretation as implied by the trial sponsors, one could conclude. So at the end of 2007, both Merck and Schering got the attention of relevant government officials who contacted both companies regarding this ENHANCE trial due to such suspicions on the facts known and presented, and an investigation began into the activities of both companies regarding this trial at that point.
This became a catalyst for the ENHANCE trial results to be finally released at the beginning of 2008, which caught the attention of major media organizations, as expected. In the spring of 2008, a very large cardiology meeting was held, where the audience was told, I understand, to stick with statins due to this trial’s lack of outcomes for Vytorin, when the ENHANCE trial was discussed at this meeting. Furthermore, it has been said that a cardiologist at this meeting also suggested that a moratorium should occur with the utilization of Vytorin by prescribers, since statins are much less expensive, and are highly regarded, as they have been available for a couple of decades, starting with Mevacor in the 1980s. Of course and as expected, Merck and Schering were not pleased, nor were they surprised at the review of Vytorin at this particular meeting. The following month after this cardiology meeting, Schering’s earnings dropped by 48 percent, as I recall. Also during much of this year, Schering in particular blamed the media for amplifying the situation regarding the ENHANCE trial.
Now, these cholesterol drugs promoted by Merck and Schering, Zetia and Vytorin, were aggressively marketed in a number of ways, including investing I believe about 200million dollars in 2007 for DTC ads for these products. To add to this, and soon after both meds were launched, reps from both companies made inferences to doctors about outcomes regarding plaque accumulation and how Vytorin was superior in that area, which, of course, this ENHANCE trial proved it is in fact not the case whatsoever. It did not matter, apparently, to both Merck and Schering that such claims were is entirely void of proof, which is not unique to any pharma rep, in my opinion. No remorse or regret from the makers of these drug makers, either, which did not shock many. Yet what is known now is that these companies, as stated by other researchers, performed junk science with their deliberate manipulation of this ENHANCE trial using such tactics. Also, last year, Zetia and Vytorin had about 20 percent of the cholesterol lowering market. It does not seem that there will be an increase of this percentage because of this scandal. Possibly if they presented the truth, the future of these meds might be better than what is anticipated presently.
Worst of all regarding this ENHANCE trial scandal is the harm caused to both doctors and patients. The ENHANCE trial concerned and confused both of these participants in the health care system. Furthermore, it’s likely they were devastated by being so clearly misled by the marketing of both Merck and Schering regarding the false benefits of Vytorin they were led to believe by the companies that promoted them- the health care providers in particular.
This whole situation is another example of the progressively frequent discovery of corruption of the scientific method by placing profits over the well-being of patients, which harms the well being of patients. In addition, most were shocked by Merck behaving in such a way in particular because of what use to be their excellent reputation as an ethical pharmaceutical company. And this alone shows the progression and infiltration of such damaging ethical atrophy that desperately needs to be stopped and corrected for the sake of others- for everyone.
Don’t just say something. Have something to say- to the right people, with conviction and with others who share your views.
“Try not to become a man of success, but rather try to become a man of value.” — Albert Einstein
Dan Abshear
Author’s note: What you have read is based upon information and belief. Thank you
Mike
Condor, it’s true that if SGP is to replenish revenue lost from Vytorin, Clarinex and it’s Hep-C franchise, much hinges on the approval of golimumab, SCH-503034, and SCH-5034308. Our analysis only considered new products on their own merits, and didn’t go into the company’s ability to develop and commercialize them. (Maybe SGP could take a page from BMS and cut some creative out-licensing deals?) Keep in mind that SGP has pretty much passed through its loss-of-exclusivity crisis, and is starting at a lower base than other companies in its peer group. Its remaining big products will maintain exclusivity until 2014. That’s why it’s replacement ratio looks so good.
Mike Goodman
VP Research Products,
AVOS Life Sciences, LLP
Condor
Mike — Thanks for the quick reply!
I think you are right — Schering HAS passed through its “loss of exclusivity” crisis — I would NOW be concerned about its coming “cash flow” constrictions. Those could prove daunting.
Steadily-losing share on Vytorin — in addition to impacting perhaps 55 percent of Schering’s 2008-2009 profitability — will seriously hamper Schering’s ability to generate free cash flow.
It will truly be “cold comfort” if Schering has the “best in class” pipeline — but will (perhaps) be unable to FUND all the activities associated with acheiving approval (capacity expansions, Phase IIb and Phase III trials, and marketing juggernauts), for all those candidates.
It may end up “selling off” a chunk of its vaunted pipeline. . . .
That was my central point. Cheers — And, Well met!
Condor
Hey Mike —
One man’s “creative out-licensing deal” may be another man’s “forever lost profits”, right?
That said — I think you are RIGHT — Schering HAS passed through its “loss of exclusivity” crisis — I would now be concerned about its coming “cash flow” constrictions. Those could prove daunting.
Steadily-losing share on Vytorin — in addition to impacting perhaps as much as 55 percent of Schering’s 2008-2009 profitability — will seriously hamper Schering’s ability to generate free cash flow.
It will truly be “cold comfort” if Schering has the “best-in-class” pipeline — but will (perhaps) be unable to fund all the quite-expensive activities associated with securing approval, for all of those candidates.
That is, Schering may end up “selling off” a chunk of its much-vaunted pipeline, to raise cash, for the rest of it. . . .
That was my central point. Cheers — And, Well met!
Former SP
IMO, the top management of SP is so crooked and incompetent, they will surely screw everything up along the way. Before I left, they had cut resources to such an all-time low that morale had greatly suffered. Employees can’t wait to leave and 50% are looking. I was never so glad to leave a company in my life. Once the execs get their due, it may have a chance!