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Pharmas Market with Mike Huckman

  Wednesday, 3 Mar 2010 | 2:12 PM ET

The Statin Of The Union

Posted By: Mike Huckman
President Barack Obama
Photo by: Pete Souza
President Barack Obama

President Obama has high cholesterol.

For now, his doctors are prescribing healthy living. But some say he should be put on a statin or cholesterol-lowering drug pronto.

I'm not a doctor or a political expert, but I think the President might be missing an opportunity to lower his LDL number and raise his POLL numbers.

While I'm certain Pfizer, Merck and AstraZeneca would give anything to have it leak that Obama's been put on Lipitor, Vytorin or Crestor, respectively, he might be better off, politically, at least, going on generic Zocor.

What better way to set an example about how to save the health care system money as the debate over reform rages on?

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  Tuesday, 2 Mar 2010 | 3:17 PM ET

Nuthin' Like A Little Dendreon Dendrama

Posted By: Mike Huckman

I'm still decompressing from a very stressful morning.

Shares of Dendreon fell around 10 percent before the market opened. And now, in regular trading, they're at a new intra-day high.

Here's what happened.

Dr. Elliot Favus emailed me a research note this morning. I'd never heard of him before. He was telling investors to sell DNDN because he claimed to have been in contact with doctors who told him they'd been invited by the FDA to sit on an advisory committee to review Dendreon's prostate cancer treatment Provenge.

So, why would that be a big deal?

Well, biotech investors don't necessarily like outside FDA panels. They usually translate into a delay on an FDA decision about whether to approve a drug and they increase the uncertainty about a drug's fate. The committees only make recommendations to the agency on what it should do. The FDA usually, but not always follows the advice of its expert panels. Veteran DNDN investors learned about that the hard way. A few years ago, an advisory committee recommended approval of Provenge. The stock soared. Then, the FDA shocked the Street and said, "No." The shares tanked.

I emailed Dr. Favus to find out a little bit about him and his research. I asked him to send me some of his previous research reports on DNDN, including his coverage initiation note. He got back to me quickly saying this was his first call on DNDN, that he doesn't do "passive, ongoing research," and that his relatively new boutique firm, bearing his name, focuses on providing "money making ideas and divergent information in the healthcare sector."

He boasts that since he started the company a little more than a year ago that he's written a dozen reports, 10 of them with "Sell" recommendations. Dr. Favus used to work at Lazard Capital Markets.

Anyway, the controversial call triggered a flurry of tweets in my Twitterverse and a selloff in the stock in the pre-market and shortly after the opening bell. But then the FDA took the rare step of publicly commenting on whether a product would go before an advisory committee. Bloomberg broke it, the stock suddenly did an about face and started trading at new highs.

My producer and I began frantically trying to confirm the story on our own. But lemme tell ya how difficult it was reaching the media relations folks at the agency. We repeatedly emailed and voicemailed them; called the main news media line at the FDA, sometimes got a live person, sometimes voicemail, were told the people we needed to talk to were in a meeting, and on and on. Argh!

I told the person on the other end of the line to get the person out of the meeting. This was urgent. I'm on deadline. No luck. Eventually, I got a call back from one point-person and my producer got patched through to another. Both of them confirmed the FDA will not convene another Provenege panel. I hung up, ran downstairs and jumped on the air.

After I caught my breath, I sent Dr. Favus a follow-up email. Did he still stand by his call? Were the doctors he cited misinformed? Did he care to comment on what the FDA said? I haven't heard back.

Meantime, the FDA is expected to make a decision on Provenge on or before May 1st, which is a Saturday, by the way.

Update: After two spokespeople told me over the phone this morning that there would be no FDA panel meeting on Provenge, one of them sent this email to my producer this afternoon:

"Whatever you folks are saying on Provenge it should be this: Upcoming meeting dates for the Committee are published on the FDA website and in the Federal Register. At this time there no dates published for CTGTAC meetings for 2010. FDA will post meeting dates for the CTGTAC as soon as they are available. As you know we can not disclose any AC meeting prior to the FR notice. Currently, there is no advisory committee scheduled to discuss Provenge."

CTGAC stands for Cellular, Tissue and Gene Therapies Advisory Committee.

Questions? Comments? Pharma@cnbc.com and follow me on Twitter at mhuckman

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  Monday, 1 Mar 2010 | 11:48 AM ET

Can't Get A Break From Bristol

Posted By: Mike Huckman
DreamPictures | The Image Bank | Getty Images

When a major pharma company holds analyst/investor meetings as infrequently as Bristol-Myers Squibb , it's kind of a must-cover event.

But here's why I'll be following BMY's event in New York City this Thursday from my desk, via webcast, here at CNBC HQ.

Longtime "Pharma's Market" readers probably know I have little tolerance or patience for CEOs who don't do TV. It's a way for them to communicate in real time with a big audience of current and prospective shareholders and to answer important questions on the fly. But Bristol Chairman and CEO Jim Cornelius hasn't done and won't be doing any TV interviews.

I mean, c'mon, even Warren Buffett did three straight hours of live TV this morning on "Squawk Box" fielding questions from viewers via social media and email. But Cornelius can't sit down for four minutes with me? Some CEOs are unafraid of the camera and lights and do a good job on TV. Others, not so much. There's a whole industry, much of it populated by former TV news anchors and reporters, devoted to training execs to look and be more relaxed on camera. Expensive coaching like that works for a lot of folks. Others, not so much. I have no idea whether Cornelius has been coached or what his deal is.

The last time BMY held a big meeting with Wall Street, a company spokesperson had officially confirmed a live CNBC interview with Cornelius. So, we went through all of the logistical preparation of arranging cameras and a live satellite hook-up. It's no easy technical task, especially when the meeting is held on a high floor in a Manhattan skyscraper. It's very labor intensive and it takes hours to set up. But at the next-to-the-last minute BMY canceled the interview saying Cornelius was sick. The CEO made reference to his feeling under the weather when he addressed the crowd for several minutes at the meeting, but he soldiered on. And, then, came the last straw. During a coffee break, Cornelius walked into the hallway and started doing an impromptu little news conference with print and wire reporters. It went on for several minutes. But he apparently didn't have the time or the good health to talk to me.

Cornelius still hasn't done a CNBC interview and a spokesman told me this morning he won't be doing one at this week's meeting. There've been scattered reports and rumors he'll be retiring soon. Hopefully, his successor is more of a 20th-century (20th is not a misprint) kind of person and TV savvy and friendly. In 2010, for gosh sakes, it should be a prerequisite for any CEO candidate.

Questions? Comments? Pharma@cnbc.com and follow me on Twitter at mhuckman

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  Thursday, 25 Feb 2010 | 12:15 PM ET

FDA Says "Snow" To Lilly, Amylin & Alkermes

Posted By: Mike Huckman

The Food and Drug Administration says its decisions are always based on the science. But on rare occasions ol' mother nature apparently can get in the way.

Usually the FDA delays a decision on whether to approve or reject a drug because the agency simply needs some more time, wants more data, a company didn't cross a "t" or dot an "i" on its application, etc.

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  Wednesday, 24 Feb 2010 | 4:03 PM ET

Glaxo Gets Aggressive On Avandia

Posted By: Mike Huckman
The company logo of GlaxoSmithKline, is seen on the headquarters building in London, Wednesday May 10, 2006. GlaxoSmithKline PLC said Wednesday it has been granted a High Court injunction against animal rights activists who sent threats to the drugmaker's shareholders, barring them from sending more letters or revealing private information about the investors. (AP Photo/Alastair Grant)
Alastair Grant
The company logo of GlaxoSmithKline, is seen on the headquarters building in London, Wednesday May 10, 2006. GlaxoSmithKline PLC said Wednesday it has been granted a High Court injunction against animal rights activists who sent threats to the drugmaker's shareholders, barring them from sending more letters or revealing private information about the investors. (AP Photo/Alastair Grant)

On day five of Avandiagate, GlaxoSmithKline communiques about the brouhaha surrounding the controversial diabetes drug now number six.

One rejecting the conclusions drawn in the "New York Times ," which broke the story, another rejecting the findings of the Senate Finance Committee investigation that the Times story was about, two blogposts , including a rare one penned by the company's top U.S. corporate communications exec, and today a press release and 30-page "White Paper" formal response to the Senate probe.

Someone's been burning the midnight oil.

The Senate investigation claims GSK knew about the heart safety risks of Avandia long before The Cleveland Clinic's Dr. Steven Nissen published a study about them and tried to conceal and/or downplay the evidence. Dr. Nissen's study, which is the subject of much debate, caused Avandia sales to plummet. But GSK is trying to protect what's left of the franchise and to defend itself from litigation.

According to plaintiffs' lawyer Mark Lanier, who made a name for himself in big pharma suing Merck over Vioxx, there are approximately 15,000 Avandia lawsuits.

He's scheduled to try the first one in June in Philadelphia, where, until recently, the British Glaxo had its U.S. headquarters. But that number pales in comparison to the nealy 50,000 Vioxx cases. And, what's more, Lanier says the statute of limitations has already run out on Avandia in most states. The FDA ordered that a boxed warning be put on the Avandia label about the possible heart risks a couple of years ago, so Lanier says it'd be really tough for any new plaintiffs to claim they didn't know the drug might hurt their heart.

Lanier calls the Senate findings "old news" because he's been working with the same, previously undisclosed info for a couple of years already. I was incredulous when Lanier of all people told me that over the weekend. I expected him to be drooling, ready to pounce on Glaxo and jump on TV. But as Joe Kernen suggested on "Squawk Box " the other day, Lanier may see more dollar signs in Toyota cases right now. His is a big firm, though, so I'm certain it can handle lots of different stuff.

And the rhetoric is escalating. Here are just a few colorful snippets from the deep dive GSK takes in its "White Paper":

"...the (Senate) Staff Report mischaracterizes and distorts the efforts that GlaxoSmithKline took to continue to monitor the safety and efficacy of its diabetes medication. The Staff Report repeatedly cites documents out of context; thereby, crafting a misleading narrative...."

"These numbers (about heart risk cited by an FDA whistleblower) simply do not reflect reality."

"There is no scientific basis on which to assume that Avandia causes excess (heart attacks) or cardiovascular death."

"...methodology is seriously flawed and based on incomplete data."

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  Monday, 22 Feb 2010 | 3:41 PM ET

Is AstraZeneca's Crestor Cresting?

Posted By: Mike Huckman

In a federal courthouse today, a trial is getting underway that could determine the fate and fortune of AstraZeneca and its blockbuster cholesterol drug Crestor.

The company is suing more than half a dozen generic drug firms that want to make a cheaper copy of Crestor years before the patent on the drug is set to expire. But you won't find me sitting in the pews furiously taking notes.

No doubt this case is a big deal.

AZN sold $4.5 billion worth of Crestor last year. And 2009 Crestor revenue grew a whopping 25 percent at a time when sales of the other brand-name statin, Pfizer's Lipitor, are going down. Crestor sales could climb again this year because the company just won FDA approval of a new use for the drug.

But first of all, it's a trial in federal district court.

You can't bring in a TV camera or any recording equipment, for that matter. Video of armies of corporate and patent lawyers walking in and out of court with their assistants pushing dollies loaded up with cardboard boxes containing documents just doesn't make for compelling TV. No offense against courtroom artists, but there's only so many ways you can shoot (take video of) that stuff. And the subject matter here is dense, dull and dry. A few years ago I sat through a couple of relatively short hearings on the Plavix patent when Bristol-Myers Squibb and Sanofi-Aventis were fending off a threat from privately-held Canadian generic drug company Apotex. As they were taking boring testimony about who discovered the bloodthinner and how, I discovered the cure for insomnia. I haven't patented it yet, though.

And to make matters worse in this case an AstraZeneca spokesperson says the scientists who own the patents and the lawyers defending them speak Japanese. So, all of the questions and answers from those key witnesses will apparently have to be translated in court by interpreters. Can you imagine being the poor stenographer?

Leerink Swann pharma analyst Seamus Fernandez says there's a 30 percent chance AZN loses the case. He claims the judge has a track record of favoring patent holders. And you have to take into consideration that the trial is on AZN's home turf of Wilmington, Delaware where its U.S. headquarters are located. The company says between 4,000 and 4,500 people work there. And I'd be willing to bet the judge might know or live in the same neighborhood as some of them, maybe even golf or go to church with them. But, of course, decisions are based solely on the evidence.

Sure, there will be an appeal no matter who wins, but Fernandez estimates if the company ultimately runs out of legal options and comes out on the losing end that it could cost as much as 80 to 90 cents in earnings per share. At first he had forecast the stock could take a five to six dollar hit in a discounted cash flow value analysis, but in a research note to clients today Fernandez bumped that up to eight to nine bucks. LS may trade in BMY shares.

Finally, it's not like this is a jury trial where there will be deliberations that result in a verdict. It's a bench trial. So, when it's over the judge will ask the attorneys to submit some more stuff and then make a decision down the road. He recently announced he's retiring in July, so presumably the ruling will come by then. For now, I will be following dispatches from unfortunate wire service reporters who've been assigned courthouse duty on this one and from a Fernandez team member who has been planted in the courtroom for the duration of the trial.

The analyst told me he'll owe that guy big time.

Questions? Comments? Pharma@cnbc.com and follow me on Twitter at mhuckman

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  Friday, 19 Feb 2010 | 11:47 AM ET

Pharma's Premium Pricing Power

Posted By: Mike Huckman
Cost of healthcare
Lilli Day | Photodisc | Getty Images
Cost of healthcare

I just got back from the annual meeting of the Generic Pharmaceutical Association whose timely tagline is "Improving lives for less."

Meanwhile, big pharmaceutical companies have been raising prices on a lot of drugs recently. Some critics say the industry's trying to cash in before government price controls possibly get put into place. Analysts say the firms are propping up their toplines in the face of increased generic competition and a lack of fast-growing, popular new drugs. For example, Lilly actually acknowledged in its most recent earnings release that a 12 percent rise in sales of Cialis was "driven primarily by higher prices."

But there are two new examples of the industry's emboldened attitude about charging a premium. Granted, neither drug has been officially launched yet, so it isn't clear yet how much, if any, pushback there will be. But I think it does say something that even in the current political and economic environment at least a couple of companies are not ashamed to aim high.

Yesterday, Auxilium announced it's going to charge $3,250 per vial of its newly approved drug Xiaflex for a disease that causes fingers to curl.

The company, in partnership with Pfizer , is also developing the drug to treat a condition that causes curvature of the penis . And, yes, I'm aware that makes two references in one blog to genital-related drugs. Anyway, in a research note to clients Jefferies analyst Thomas Wei said the Xiaflex price is 117 percent higher than what had been the Street consensus on where it would come in and 160 percent above his estimate. AUXL did say that it expects fewer doses to be used in practice than had been used in clinical trials, so maybe that's why the cost is higher than expected. But Leerink Swann analyst Joseph Schwartz says more doses will be needed to treat the penis problem than the finer problem. "Biggest positive, in our view, is the impact of higher Xiaflex vial pricing on the Peyronie's (penis curvature) disease opportunity," Schwartz wrote. LS and Jefferies make a market in AUXL. Jefferies was also the sole bookrunner on an equity offering last September.

And a couple of weeks ago Acorda Therapeutics announced that it'll charge nearly $13,000 a year for its new drug, Ampyra, which helps some multiple sclerosis patients walk better and faster.

That's almost twice the amount many analysts thought the company would charge for the twice-a-day pill.

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  Friday, 12 Feb 2010 | 1:20 PM ET

Clinton's Stent

Posted By: Mike Huckman
Former U.S. President Bill Clinton seen speaking during the inaugural Rural Summit in Washington, DC
Getty Images
Former U.S. President Bill Clinton seen speaking during the inaugural Rural Summit in Washington, DC

A source tells CNBC that former President Bill Clinton received two drug-coated stents, called "Xience," made by Abbott Labs .

A spokesperson for New York-Presbyterian Hospital/Columbia University Medical Center would not confirm or deny the information, telling CNBC, "We are not providing the brand of the stent or the manufacturer." At a news conference Thursday evening Clinton's cardiologist also declined to answer a reporter's question about the type, brand or manufacturer of the two stents.

Stents are tiny wire mesh tubes that prop open clogged arteries.

There are bare-metal stents and more expensive drug-coated stents, which are believed to prevent artery reclogging better than the uncoated ones. Abbott, Boston Scientific, Johnson & Johnson and Medtronic make them. The Xience stent is one of the newest ones on the market. Boston Scientific sells the exact same stent, but under a different brand name: "Promus."

ABT sold $1 billion worth of stents in the U.S. last year, an increase of 54 percent from the year before.

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  Thursday, 11 Feb 2010 | 3:50 PM ET

C'mon Roche: Gimme Some Sugar

Posted By: Mike Huckman

Suffice to say that diabetes is a huge and fast-growing problem and represents a huge and fast-growing drug and device market.

Novo Nordisk recently won FDA approval of Victoza , a one-a-day injection of a new type of diabetes medication. Lilly, Amylin and Alkermes are hoping the FDA will approve their similar once-a-week drug on or before the scheduled decision day of March 5th. Meantime, GlaxoSmithKline, Sanofi-Aventis and Roche are in various stages of developing potential competitors.

So, this morning Roche (which now goes by Genentech in the U.S.) announced that five late-stage studies of its experimental once-a-week diabetes shot met the main goals of lowering blood sugar. By how much; patients, investors and competitors might ask?

Well, Roche ain't tellin'.

At least, not yet.

A spokesman said the company is simply holding back the detailed data for presumably a high-profile presentation at the upcoming American Diabetes Association meeting in Orlando. One big late-stage drug study is usually enough to get prestigious late-breaker status at a scientific meeting like ADA. But five of 'em all at once? I'd say Roche's results are a lock. Roche spokesman Terry Hurley said the ADA doesn't require that every single datapoint be kept under wraps, but that the company decided not to release any numbers at all on its own.

In its earnings press release last week Roche said the market potential of taspoglutide--the Street calls it taspo, for short--is "best in class." After my interview with Roche CEO Severin Schwan last Friday I asked him off camera how he could make that bold prediction. He replied that Roche wouldn't be pursuing the drug if he didn't think it's going to be number one.

Okay.

AMLN, LLY and ALKS didn't seem to have any issues disclosing the amount of blood sugar reduction in previous studies of its once-a-week version of the current twice-a-day injectable Byetta. And those results were later presented at scientific meetings, including ADA, and/or published in peer-reviewed medical journals. The same can be said for NVO when it was still developing Victoza. The amount that a diabetes drug lowers blood sugar levels is the key measure of its efficacy.

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  Wednesday, 10 Feb 2010 | 1:57 PM ET

My Heart & The American College Of Cardiology

Posted By: Mike Huckman
CNBC.com

For nearly my entire 27-year career, work has almost always come first. It’s just me. For whatever reason\(s\) I’m driven that way. It’s one reason why I think I’m addicted to Twitter . Even though I’m tweeting directly to a little more than 5,600 people, I’m still very competitive with other biopharma journo twits about being first. I’m the same way on air. Just ask anyone at CNBC who has seen me sprint down the stairs to our studio when there’s breaking news. The day I lose that edge and that adrenaline rush is the day I’ll know it might be time to move on.

And so, I’m kind of torn over the fact that I’ve decided I won’t be going to the annual American College of Cardiology meeting in Atlanta about a month from now. It’s not because there aren’t going to be some newsworthy scientific studies coming out at the typically must-cover conference. Wells Fargo med tech analyst Larry Biegelsen has been alerting clients since last Spring, for example, about an Abbott Labs versus AstraZeneca cholesterol drug study that he recently flagged as a high-profile late-breaker at the ACC.

Big drugs, big stocks. It’s right up my alley. And I’m sure there’ll be other stuff, too.

But my dad’s 80th birthday party is that weekend in my hometown of LA. It’s on Sunday night. And I’m not going to miss it. Life’s too short. And, especially at his advancing age (he’s a very young 80, though) you’ve gotta celebrate the good stuff. I still have some guilt over not jumping on a plane a day earlier to be at my mother’s deathbed a few years ago. While my flight was sitting at the gate back East, my sister called to tell me my mom had passed. I had decided to work one more day. My bad.

Some people are irreplaceable. I might like to think I am, but I know I’m not one of them. I and my producer will make sure CNBC is on top of whatever it needs to be coming out of ACC. My dad, on the other hand, is irreplaceable.

Questions? Comments? Pharma@cnbc.com and follow me on Twitter at mhuckman

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