A surprise bid, a bad surprise for Vytorin, and other bits

July 24, 2008 – 11:21 am

Folks were talking this week about Roche’s surprise bid for Genentech, the results of the most recent clinical trials for Vytorin, and GlaxoSmithKline’s announcement to shift its focus away from prescription drugs. And on a side note, former BrandWeek NRx blogger Jim Edwards has come out of retirement and is blogging again. Welcome back Jim! (See the item below in “Around and about …”).

Roche gets more acquisitive

The week kicked off with the news that Roche wants to acquire the 44% of Genentech shares not owned by the company. Over at Pharmalo, Ed Silverman asks (picking up on a Wall Street Journal story), “Who will run the Genentech Roche show?” if Roche succeeds in acquiring the company.

At the InVivo Blog, Roger Longman notes that Roche’s success has been because of Genentech but now the independence that had kept Genentech productive has become too expensive. He doesn’t buy the Roche line that the company intends to keep Genentech’s culture independent. “…the manner of Roche’s bid does much to destroy any future positive collaborations between the two companies,” Mr. Longman says. “Apparently, Genentech CEO Art Levinson only learned of the deal on Sunday, July 20th, the day before it was announced.”

“Without having spoken with him for this story, we suspect Severin Schwan’s vision of the pharma future looks a lot more like the cost-constrained world he knew at Roche Diagnostics — where innovation was rare and rarely paid for; where extraordinary business acumen counted for more than outsized research capabilities,” Mr. Longman says. “Roche’s first gamble on Genentech was all about R&D. Its new gamble: business synergies will drive the next wave of pharmaceutical success.”

Kate Rawson, also over the at InVivo Blog, perceives the proposed acquisition as a defensive play on follow-on biologics. She noted that for Roche to stay ahead on the follow-on biologics curve, the company needs to find a way to make biologics faster and cheaper. “And the best way to do that is through post-merger synergies,” she says. “So contrary to the message Roche is sending to investors, the timing of the deal probably has less to do with ‘innovation’ and more to do with squeezing out savings. At the very least, it’s another sign that that Big Pharma companies are thinking about follow-on biologics in dealmaking — either by acquiring companies with the technology to make me-betters, or by positioning themselves in a way to compete with any competing large molecules that may come down the pike.”

E. Michael Scott at the Health + Vision blog offers his own analysis of the Roche takeover attempt. “While Roche may have felt they had little option about their business strategy based on global revenue needs and projections, the successful pull-through of this strategy will require enormous skill in convincing Genentech that it is in the best interests of many of their key employees,” he says.

There has been some positive news for Roche this week, as the company’s technology helped ferret out a drugging biker in the Tour de France, says Barbara Martin at Pathophilia.

SEASick over Vytorin

At the Wall Street Journal Health Blog, Jacob Goldstein reports how Merck and Schering-Plough postponed their earnings announcements until the SEAS results were released. A week ago, Mr. Silverman noted that Vytorin prescriptions have continued to fall. They are certainly not going to be helped by the results of the SEAS study, which missed its goal and demonstrated cancer risk for the drug, Mr. Silverman says, picking up the official release here. In the postponed earnings call with analysts, Schering-Plough CEO Fred Hassan deftly sidestepped the mention of Vytorin’s cancer risk, Mr. Silverman reports.

Merrill Goozner at GoozNews was not impressed with the explanation of the study results from Dr. Richard Peto, the Oxford University expert brought in by both companies to evaluate the data. Dr. Peto had compared the results of SEAS with the results of two yet unpublished studies. “What kind of science is that?” Mr. Goozner says. “I guess I shouldn’t be surprised. Though Peto has been a leading voice in the crusade against second-hand smoke, the last time we heard from him was when he explained away the late Richard Doll’s undisclosed conflicts of interest with Monsanto. The two men issued a famous report in the early 1980s that downplayed the environmental causes of cancer. He’s always claimed to be a great stickler for the sanctity of the data. This appears to be a case where he should have let the data speak. If those larger trials come back without a cancer signal, then the famed epidemiologist (or others) can do a meta-analysis (a pooling of all the data) and say the risk is not statistically significant. But as of now, it would appear that this combination pill, still taken by millions of people, raises the risk of cancer.”

Dr. Derek Lowe of In the Pipeline, however, noted that although the results of SEAS were seemingly nasty, “For one thing, as far as I know there have been no reports of increased cancer among the patients taking Vytorin out in the marketplace - of course, one could argue that this might have been missed, but if the effect were as large as seen in the SEAS study, I don’t think it would have been. Analyses of the earlier Vytorin trials and the ongoing IMPROVE-IT trial versus Zocor have also shown no cancer risk, and the latter trial is continuing. So for now, it would appear that either this was a nasty result by chance, or (a longer shot) that there’s something different about the aortic stenosis patients that leads to major trouble with Vytorin.”

But none of the scientific and statistical arguments will help Schering-Plough and Merck, Dr. Lowe says. “Among people who’ve heard of Vytorin at all, the first thing that will come to mind is ‘doesn’t work,’ and after today’s headlines, the second thing that will come to mind is ‘cancer.’ Just what you want, to put out press releases that your compound, even though it failed to work again, isn’t actually a cancer risk. You really couldn’t do worse; a gang of saboteurs couldn’t have done worse. Of course, there’s no such gang: the companies themselves authorized these trials, thinking that there were home runs to be hit. But all these sidelines - familial hypercholesteremia, aortic stenosis - have only sown fear, confusion, and doubt. The only thing that I can see rescuing Vytorin as a useful drug is for the IMPROVE-IT results to show really robust efficacy in its real-world patients. And I wonder if even that could be enough.”

Meanwhile, Condor at Shearlings Got Plowed wonders if Schering-Plough complied with the terms of the NYSE Listed Company Manual when releasing the SEAS results. “It seemed rather strange to me, back then (and more so, now, that I have gone back to refresh my memory of the NYSE Listed Company Manual’s terms), that the SEAS study presenters — in Europe — waited until something like 7 PM (local time in Europe) to conduct the web-cast,” he says.

New direction for GlaxoSmithKline

As Mr. Silverman says, CEO Andrew Witty is trying to be clever. You can read the new strategic priorities here. Jacob Goldstein at the Wall Street Journal Health Blog has his own summary of the actions. He noted earlier this month that the company has shed early-stage drug that do not fit in with the disease areas Mr. Witty wants to focus on. Although Jeannine Whalen at the Wall Street Journal Health Blog had reported that Mr. Witty had indicated that he is not interested in the big generics marketplace, one of the new strategic priorities will focus on marketing generic drugs in the developing world.

Meanwhile, Jack Friday at PharmaGossip digs up a video that has Mr. Witty describing himself as “not the smartest person in the room.” Note that the comment function has been disabled … in this case, that’s actually a smart move. Trolls love YouTube.

Around and about …

At the Wall Street Journal Health Blog, Sarah Rubinstein notes that Merck and Wyeth have swapped spots in the eyes of investors. Analysts tore into Merck after the second-quarter results were released, but the writer implies the tables could turn for Wyeth. “Stay tuned next week, when Wyeth elaborates on bapineuzumab’s mid-stage study results,” Ms. Rubinstein says. “So far they’ve looked good, but not great.”

There’s a new Website getting some buzz: Thoreau-FDA.com. From the “About Us” section: “Thoreau-FDA.com is composed of and/or descriptive of current and ex-US Food and Drug Administration (US FDA) staff who have succeeded, in resisting their upper management’s wrongful directives and requests that put public health at avoidable risk. When unchecked, these wrongful directives/requests cause drug review outcomes to be misrepresented as carefully considered objective “science based” assessments, when they are, in fact, pre-determined.”

Peter Pitts at Drug Wonks says the site is registered to Jim Dickinson of FDAWeb.com, “no fan of the FDA and no former FDA employee. Oh well, so much for transparency.”

In his own report on the site, Ed Silverman of Pharmalot finds out exactly what Mr. Dickinson’s involvement is: “Jim Dickinson just returned our call to say that he agreed to let his name be used to register the site. ‘I have no involvement, though. A few of them asked me if I would let them use my name, because apparently they were having some trouble registering without disclosing a name. And they’re terrified of recriminations. But I have nothing do with running it or the content.’”

Rich Meyers at World of DTC marketing says the problems the pharmaceutical industry is facing are not just a bump in the road. Apparently the executive recruiters he has talked with say they have been flooded with requests by people to get their resumes out there because they are afraid they will be losing their jobs. “What is so sad is that pharma’s addiction to blockbusters is partially responsible for this mess,” he says. “With the huge revenues of these products pharma could spend money like a drunk monkey in a banana store. However the dark side is that blockbusters lead to an addiction for more blockbusters and they don’t appear out of thin air. Fasten your seat belt, it’s going to get a lot more bumpy.”

John Mack at the Pharma Marketing Blog notes that Lyrica’s DTC campaign has lightened up. “Either the Pfizer ad agency has read my blog posts about negative portrayals of women in DTC ads and about the Lyrica woman who needs more love in her life or this sequence of imagery is a crafty ’shock and awe’ campaign culminating in a ’surge’ to win our hearts as well as our minds!” he says. “I like to think it’s the former rather than the latter. Ad agencies can’t be THAT crafty!”

I got a note from Jim Edwards earlier this week; if you don’t remember him, he was the former blogger for BrandWeekNRx before he went off to Columbia for a fellowship. Well, he’s done with that now and back to blogging on a freelance basis. Among the things he posted this week, he has an interesting analysis of GlaxoSmithKline’s hiring of Daniel Troy as general counsel; and a look at sexual dysfunction among patients on antidepressants (apparently a very common side effect).

And speaking of the antidepressant-related sexual dysfunction story Mr. Edwards pointed out, Mr. Mack looks at a study that seems to be designed to extend Viagra to just this very indication (although a Pfizer spokeswoman says the company does not plan to get Viagra approved for this indication).

Fard Johnmar over at Healthcare Vox picks up a study that says pharma should stop salivating over social media.

An interesting item from Ed Silverman at Pharmalot: Apparently, blogging doctors are revealing patient information in their writings and endorsing products, according to a study done by the Robert Wood Johnson Foundation.

Dr. Daniel Carlat at the Carlat Psychiatry Blog prices out some industry-sponsored CME.

Although Pfizer posted good earnings for the second quarter, sales of the smoking cessation drug Chantix are going poof, Mr. Silverman says.

Dr. Howard Brody at Hooked: Medicine, Ethics, and Pharma, sees more loopholes in PhRMA’s new marketing code.

At the Philly Pharm Bio Blog, J.F. Duffy notes the approval of a $2 billion budget for FDA. “Now they’re gonna regulate the #@&?#!!! out of us …” he complains.

Rob Halper at J&JBTW gives us his thoughts about the BlogHer gathering.

Dr. Nancy Smerkanich at Octagon Research’s Regulatory Matters blog has finally posted again, with a roundup of what she did at the DIA meeting.

Bob Ehrlich at DTC-In-Perspective is a little cynical about PhRMA’s statements about the industry’s reputation decline. “Tauzin may be different from past PhRMA leaders in his desire to change drug company behavior to be more public-centric,” he says. “I certainly hope so. The reality is all of the issues creating negative feelings have been around for a decade and drug companies were aware of their declining image.” Mr. Ehrlich lays out four things that must happen if the industry’s image is to be restored.