医药生命科学动态跟踪
Vertex In The "Vortex" Over Hepatitis C Test ResultsThere's a flurry of selling going on this morning in shares of the biopharma Vertex Pharmaceuticals Vertex Pharmaceuticals Inc Overnight the embargo lifted on the long awaited results of the company's mid-stage test on a new type of Hepatitis C drug. Two studies show that six months out 60% and 65% of patients had no detectable virus in their blood.
That beats the treatments currently available which make a lot of patients feel like they have the flu and don't work in about half of them.
Hepatitis C doesn't get a lot of mainstream news media coverage. But it is a huge, burgeoning drug market. Geoffrey Porges at Bernstein forecasts that the Hep C drug market will grow from about $2.5 billion this year to $11 billion in 2012. That's a tremendous amount of potential growth in a short amount of time.
So, as you might guess, a whole bunch of biotech and big pharmas are racing to develop drugs for it. An estimated four million people are infected in the U.S., but that pales in comparison to the 170 million patients worldwide.
While the efficacy seen in the Vertex studies is unprecedented, there were side effects. As many as 18% of people dropped out of one of the clinical trials. The most common problem was a rash. You can hear what Vertex CEO Joshua Boger had to say about that and the move in his stock in this interview I did with him this morning on "Squawk on the Street". Just before, during and after his appearance the stock trimmed about half of its losses in early trading.
While I'm at it, take a look at the Vertex website . They recently revamped it and I have to say it ranks as one of the coolest biotech sites I've ever surfed. For example, check out the link to the Boger's bio where you can dress him up or dress him down. And I like the personal touch with his own mission statement versus the usual, dry curriculum vitae you find on most corporate web sites.
Boger also writes his own blog on the company's intranet. He's not unique in doing that, but I think all this goes to the more media savvy vibe I find at biotechs--especially smaller ones--compared to the big, stodgy, buttoned-down pharma corporate culture.
So, back to the drug. The stock could also be under pressure because a privately-held company, Romark Laboratories, came out of nowhere at the scientific conference called, "The Liver Meeting", (yes, that's really its name) with positive data on its diarrhea drug, Alinia, for Hep C. Patients in a small Egyptian study had a 79% cure rate on a different, easier-to-treat form of Hep C than the one Vertex is targeting. Schering-Plough Schering Plough Corp also recently announced good mid-stage results on a Hep C drug similar to the Vertex drug.
Most analysts, though, think there's enough of a market here for everyone to share and that the Vertex drug could eventually become at least a billion-dollar blockbuster. But, in the meantime, investors are a bit spooked.
Wachovia analyst George Farmer writes in a research note to clients this morning, "…we are alarmed by the seemingly high overall discontinuation rate (18% in one study, 14% in the other) versus 3% and 6% (on currently marketed drugs)….We await more details to be presented at the Liver Meeting Monday and Tuesday to gain more visibility into the side effect profile of this agent, which we believe remains an overhang on the stock." Wachovia makes a market in VRTX shares.
AstraZeneca: "Casualty" Of Generic Zocor In Statin Wars
This morning, we got more evidence about the havoc generic Zocor is wreaking on all of the companies that make brand-name statins--the pills to fight cholesterol. AstraZeneca AstraZeneca PLC is the latest casualty. On a down day in the markets AZN is one of the biggest losers in the sector.
The company reported that in the third quarter, worldwide sales of the most potent statin on the market, Crestor, went up only $13 million dollars from the second quarter. But in the U.S., Crestor sales actually dropped sequentially from $353 million in the second quarter to $342 million in the third quarter. That ain't good. And to make matters worse, a privately-held company is seeking permission to make generic Crestor in the U.S.
Merck & Co Inc and Schering-Plough recently reported that sales of their cholesterol-combo pill, Vytorin, were flat sequentially. And sales of Pfizer's Pfizer Inc Lipitor went down again. Pfizer Chairman and CEO Jeff Kindler calls it an "unprecedented commercial assault" on his company's biggest franchise. The lack of robust revenue growth in this huge drug segment is obviously bad news for the big pharmas and their investors.
Cheaper, generic Zocor, though, is good for the insurance companies, pharmacy benefit managers, big firms that are looking to cut their prescription drug costs and patients on a budget. But don't assume it's a boon for the generic drug companies. Analysts say so many of them rush in to make copies of big-selling drugs like Zocor that prices fall precipitously.
Eli Lilly: Will They Get Lucky With 'One A Day' Cialis?
Today's the day Eli Lilly Eli Lilly and Cowas expected to get a Food and Drug Administration decision on the first-ever one-a-day impotence drug. Right now, the company sells Cialis for use as needed. But men could pop this one every day--like an aspirin or multi-vitamin--so the drug would always be "on board."
Yeah, I know this will lead to a whole new genre of late-night TV jokes about the nearly 10-year-old erectile dysfunction (ED) drug class. But in all seriousness, urologists (the doctors who specialize in treating ED) say there's a market for a one-a-day.
Dr. Kevin McVary at the Northwestern University School of Medicine, who does consulting and/or works on clinical trials for the ED drugmakers, says there's a "sizeable minority" of patients who would take Cialis every day. He told me that he works with couples who don't like their foreplay interrupted by what can be a mood-killing pause to take an ED drug and then sit around waiting for it to take effect. With a one-a-day version, he says, that worry is gone.
Cialis is the one that lasts 36 hours. And it takes effect faster than Pfizer's Pfizer IncViagra and Levitra from Bayer, GlaxoSmithKline GlaxoSmithKline PLC and Schering-Plough Schering Plough CorpViagra and Levitra also only last a few hours or so. Sales growth of the ED drugs has slowed, but it's still around a $3-billion-a-year business. Cialis sales, for example, were up 27% in the third quarter.
But here's the rub. A Lilly spokesperson says the FDA has asked for more information on one-a-day Cialis, so a decision on approving it will likely be delayed beyond today. Deutsche Bank's Barbara Ryan is out with a research note to clients this afternoon saying the agency wants "additional analyses of existing data". So, that presumably means Lilly doesn't have to go back to square one and do more tests, it just has to crunch more numbers or something.
But you gotta love Ryan's take on all this: "Once daily dosing could appeal to men with ED who are eternal optimists or have relatively active sexual lives, and we expect it could provide some modest incremental growth to the Cialis franchise." Deutsche owns at least one percent of LLY, makes a market in the stock and has done and wants to do more investment banking for the company.
The Lilly spokesperson told me the drug is intended for men "who anticipate having sex at least twice a week." It's already approved in Europe where Lilly is launching it now. American men will just have to wait.
Amylin's Once A Week Byetta: Good Is Not Enough
This morning Amylin Pharmaceuticals, Eli Lilly and Alkermes announced the highly anticipated test results on their once-a-week, Type 2 diabetes drug. One analyst recently called this the most important biotech data of the second half of this year. Many expect the drug to become a multi-billion dollar blockbuster.
AMLN and LLY are partners on the twice-a-day injectable diabetes drug Byetta. Over the past few weeks they started doing direct-to-consumer advertising for the first time. And in the last week I've noticed that the campaign has escalated from a very basic brand-awareness tone to a more pointed approach where they're even mentioning how much weight patients lost in clinical trials.
I'm assuming the FDA is cool with that, but it does make me wonder. Analysts have long talked about how they believe a lot of people who are not diabetic are going on Byetta just to help them shed pounds. That would be what's called "off-label use" and Amylin and Lilly are prohibited from promoting it as a diet drug. Anyway, I digress.
So, the companies say that the once-a-week Byetta resulted in a greater reduction in blood-sugar levels than was achieved in a mid-stage test and with twice-a-day Byetta. Three out of four patients got their blood-sugar level below the recommended benchmark. There was a 30% lower incidence of mild, transient nausea which is a common side-effect with twice-a-day Byetta.
However, on average patients lost about eight pounds. And because that's comparable to the weight loss seen with twice-a-day, investors seem to be disappointed and are selling shares of AMLN and ALKS as I write this, while LLY has been up and down. Alkermes makes the technology that allows the drug to last a week in the body and would receive a royalty on sales. LLY and AMLN would split the rest evenly.
The twice-a-day Byetta is injected into the belly using a stick pen with a relatively small needle. There's been some concern that the size of the once-a-week needle would be so huge that some patients might be afraid to use it. One analyst on the conference call half-jokingly said some people think "it's a sword".
Amylin execs were quick to point out that 90% of the 300 or so patients in the clinical trial finished the study. The once-a-week Byetta comes with a 23 gauge needle and Amylin officials say, "It was very well accepted."
The companies say they plan to file for FDA approval of the drug by the end of the first half of 2009, but Amylin CEO Dan Bradbury said they will try to speed things up, if possible. "This is the best glucose control ever demonstrated for any diabetes drug ever and the best weight-loss data ever demonstrated in a pivotal study of a diabetes drug ever," Bradbury said emphatically on the call. He provided no other details.
The companies are saving them for publication in a peer-reviewed medical journal which in the scientific and investor communities give drug data additional credibility. Today, though, investors don't seem to be assigning any.
ASCO: 'Open Door Policy' Levels Playing Field
TheStreet.com's senior biotech writer Adam Feuerstein broke this story earlier today, but now we've confirmed it independently. The American Society of Clinical Oncology (ASCO) is changing its ways. The organization behind the World Series of scientific conferences is adopting a new policy for the release of clinical trial data that not only change the way oncologists practice, but also move biotech, pharmaceutical and biopharma company stocks.
Earlier this year I blogged and reported on-air about the controversial ASCO embargo. Thousands of doctors--along with dozens, if not hundreds of reporters--received the "ASCO Bible" containing drug study results at least a couple of weeks before the big conference. There was an honor system to keep mum. But it apparently didn't work.
Some doctors whose patients are investors, whose golf buddies are hedge fund managers, whose next-door neighbors are traders, etc. allegedly leaked data that ended up moving a small number of stocks ahead of the ASCO meeting. ImClone Systems ImClone Systems Inc , in particular, was a big mover this year.
ImClone Systems Inc
Look at the cliff around mid-May in this one year chart and you'll see what I'm talking about. So, next year when ASCO sends out the big books it will simultaneously post the same information on its web site for everyone to see. The so-called late-breaking data--typically high profile, potentially game-changing studies--will still be kept under wraps until the conference starts, but everything else will be out there.
Investors should remember, though, that the data for the ASCO book are due in early January, so it's still possible that the results that are published in the book and online could still change between the deadline and the presentation in late May and early June.
ASCO CEO Allen Lichter tells CNBC in an email, "ASCO reviews its Annual Meeting policies every year to ensure they are relevant and meet the evolving information needs of our members, patients, and others. Our abstract distribution goal was to better meet the needs of all interested parties, while preserving the responsible release of important scientific developments. We think these policies accomplish that."
ASCO has sent out three different letters to members and various interested parties informing them of the policy change. There was a lot of grumbling this year that the old way of doing things could lead to a trading scandal. Now, I'm waiting to see if ASCO will also change its policy to finally allow TV reporters to broadcast live from within the hallowed halls of the convention center during the meeting. I'm not holding my breath.
Pfizer's Lipitor Vs. Generic: Heart Of The Matter For Me
Pfizer has been using Dr. Robert Jarvik, the inventor of the Jarvik Artificial Heart, for quite some time now as its Lipitor "celebrity" pitchman. But recently I've noticed something remarkable creeping into his copy--the script he reads for TV and radio spots and the text that appears in the print ads.
In the face of a 13% decline in third-quarter U.S. Lipitor sales Pfizer Pfizer Inc
is now taking dead aim at the intense competition from cheaper, generic Zocor.
On the earnings conference call, Pfizer Chairman and CEO Jeff Kindler called the threat an "unprecedented, commercial assault in the history of our industry." Merck Merck & Co Inc and Schering-Plough Schering Plough Corp also saw sequentially flat sales of their cholesterol-fighting drugs Zetia and Vytorin in the third quarter. We'll hear from AstraZeneca AstraZeneca PLC about the sales of the most potent statin on the market, Crestor, this week when it reports earnings.
The other day I heard another radio commercial featuring Dr. Jarvik. Normally, I don't pay much attention to them since he's been on the air for awhile, but this one made my ears perk up when at the end of the spot he said, "I trust my heart to Lipitor. Not a generic." That quote may not be verbatim, but it's pretty darn close. I was driving at the time and couldn't pull over, so I repeated the line to myself over and over hoping to commit it to memory.
It's common practice to name 'Brand X' in prescription pharmaceutical commercials these days, but this is the first time that I can recall a major drug company actually calling out a "generic" in its advertising. In a full-page Lipitor ad that appeared in the Sunday "Newark Star-Ledger" Jarvik is quoted as saying, "I take Lipitor instead of a generic."
And in the "patient education" section of the Lipitor web site the language is even more direct. In copy set off in a different color it says, "There is no generic substitute for LIPITOR." (The caps are Pfizer's.)
I've been taking the 10mg dose of Lipitor for a few years now. And Medco Health Solutions Medco Health Solutions Inc GE's pharmacy benefit manager, has sent me at least two letters urging me to switch to the cheaper, generic simvastatin--the scientific name for Zocor.
But I haven't complied. It has nothing to do with the influence of Dr. Jarvik or anyone else--i.e. Dr. Steven Nissen of The Cleveland Clinic, one of this country's preeminent cardiologists, says the overwhelming majority of Lipitor patients would probably do just fine on generic Zocor. It's just that the drug seems to be working--and no, I am not endorsing Lipitor--so, why fix something that ain't broke? Pfizer probably wishes there were millions more patients like me, then its Lipitor sales and its stock price might not be sagging.
[[i] 本帖最后由 ted_sun 于 2008-7-28 14:31 编辑 [/i]]
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