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Pharmas Market with Mike Huckman

  Tuesday, 9 Feb 2010 | 2:33 PM ET

Rewriting AstraZeneca's Script

Posted By: Mike Huckman
Getty Images

If you're left-handed, bowl with your right, eat red licorice, but only on Sunday afternoons, are female under 24-and-a-half years old or male over 33-and-three-quarters and loved "Dances With Wolves," then our drug is now approved for you to take.

That was kind of my flippant takeaway from the head-spinning lead paragraph (below) in AstraZeneca's press release last night about the FDA okay of its cholesterol drug Crestor for a broader patient population.

"AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved CRESTOR (rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction (heart attack) and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD) based on age (men ?50 and women ?60), high-sensitivity C-reactive protein (hsCRP) ? 2 mg/L, and the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease."

Huh? What's that? Come again? I can just hear a patient saying after reading that, "Does that mean me? I hope my doctor can help me make sense of this."

Reporters quickly regurgitated all that medical gobbledygook in language laypeople could easily understand:

Associated Press: "Federal regulators have granted AstraZeneca approval to market its cholesterol pill Crestor as a preventive measure against heart attack and stroke in patients with healthy cholesterol levels."

Dow Jones: "...the FDA Monday said it (Crestor) can now be prescribed to prevent heart disease in people with apparently normal levels of bad cholesterol but other risk factors for heart disease, including elevated blood levels of a protein linked to heart disease."

Reuters: "AstraZeneca won U.S. approval on Monday to promote cholesterol fighter Crestor for preventing heart disease in a vast new market of people with healthy cholesterol but other heart risks."

I get that drug companies have to mind their p's and q's with the FDA and don't want to talk down to an audience of prescribing physicians, but they can still speak English. And in an era, for better or worse, when so many more patients are getting their medical information on Web sites and through social media, drug approval press releases—especially ones for a drug as widely-used as Crestor—need to be clear and concise.

You can still do all of the FDA-mandated prescribing details, please just don't put it at the top.

Analyst opinions on the expanded Crestor approval are mixed. Some say the bigger issue for AZN is the looming Crestor patent challenge.

As I write this, the stock is the biggest dollar and percentage gainer in big pharma, but it's already off the highs of the morning.

UPDATE: The Food and Drug Administration issued a press release on the additional Crestor approval a day late, but the agency's announcement is much better written than the company's.

If the FDA can put it in plain English, why can't AstraZeneca?

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

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  Friday, 5 Feb 2010 | 2:41 PM ET

Big Pharma's Shot In The Arm

Posted By: Mike Huckman

I still haven't gotten my H1N1 flu shot.

During a recent stint at the Nasdaq I kept stopping by the Kmart pharmacy in New York's Penn Station on my way home from work to get the vaccine. There were banners hanging from the ceiling heralding that H1N1 shots were now available, but every time I approached the counter I got the same answer. "Oh, we're not doing them today. Come back, next Tuesday (or some other day) between nine and four." Not convenient at all. I mean, a Kmart in the middle of commuter central and they're offering shots outside of rush hour?

Then I stumbled on a vaccine station at the San Francisco airport before my return flight from the JPMorgan Healthcare Conference. But there was only one shot-giver, two guys were waiting and my flight was boarding. I guess I just have to make the time because I still want and intend to get it.

I don't buy into the silly conspiracy theories that global health authorities worked in cahoots with the big, bad drug companies to gin up a pandemic scare just to goose vaccine and flu drug sales.

Try telling that to the family of someone who died from H1N1.

To be sure, some companies did benefit financially from the outbreak. Roche sold more than $3 billion worth of Tamiflu last year and gave some of that money in revenue royalties to Gilead Sciences, which invented the drug. And GlaxoSmithKline sold $1.1 billion worth of Relenza in 2009. A year earlier it had just $105 million in revenue from the inhalable flu antiviral. Meantime, the vaccine makers are now faced with some governments returning their unused product.

This isn't an apropos-of-nothing blog vent.

Two things happened today that prompted me to revisit this not-too-long-ago hot topic. First, Harvard came out with a survey showing 44 percent of Americans think H1N1 is done. And 61 percent of adults have not been vaccinated and don't plan to be.

And then the CDC resurrected its H1N1 telebriefing for reporters this afternoon.

Agency officials said there were nine more pediatric H1N1 deaths reported in the last week. Some of those were new cases, some were older cases only now getting counted. While the CDC says the virus has "leveled off," for three straight weeks pneumonia and flu deaths have been above epidemic threshold levels. "People are being hospitalized and they're dying," Dr. Anne Schuchat, Director of the National Center for Immunization and Respiratory Diseases, said.

When H1N1 fears were running high everyone was complaining that there wasn't enough vaccine to go around. Of course, now that the situation has abated somewhat, there's plenty of vaccine available from GSK, Novartis, Sanofi-Aventis and AstraZeneca. According to the CDC, 124 million doses have been shipped and there's much more to come. Officials repeatedly cautioned on the media call that people shouldn't be lulled into a sense of complacency. "This pandemic isn't over yet," Dr. Schuchat said.

Wall Street certainly seems to think that the danger, or at least the hype, has passed. Once again, just like they did during the H5N1 scare several years ago, flu-related stocks like BioCryst, Novavax and Crucell, just to name a few, went up and have come back down. Unless or until the fever rises again.

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  Thursday, 4 Feb 2010 | 12:59 PM ET

Bristol's Entrepreneurial Thief?

Posted By: Mike Huckman
Laurence Dutton | The Image Bank | Getty Images

The big drug companies are all looking to increase their footprints in emerging markets like India. But a young Ph.D., top-talent employee at Bristol-Myers Squibb apparently wanted to plant the flag on his own in his native country.

Yesterday the feds charged 29-year-old Shalin Jhaveri with stealing trade secrets from BMY while working as a management trainee at the drugmaker's East Syracuse, NY facility. He allegedly did it to start a rival pharma firm in India that he planned to call, "Cherish Bio Sciences." He even went so far as to buy an internet domain name for it. You can read a detailed account of the intriguing case on the Syracuse paper's Web site .

Bristol makes biologics (generally speaking, liquid drugs) at the plant for commercial and clinical trial use. According to the criminal complaint, Jhaveri has confessed to taking part of the recipe for a cancer drug in early-stage tests. It's so premature that it's not even listed yet on the company Web site's drug development pipeline page and is identified in the complaint only as "BMS-663513." Biopharma companies often refer to products in nascent development with letters and numbers.

But as I blogged last year you don't necessarily have to be on the inside to glean "trade secrets." Back then, I wrote that my lips were sealed, but since I think enough time has passed and there's a relevant and timely news peg now, I will disclose that it was an experimental drug from Bristol that I saw a PowerPoint presentation for on that long flight. In fact, coincidentally, it was for a drug that's made in East Syracuse.

I saw just enough to make out the name and purpose of the drug and to see some plans for getting the word out about it to pertinent physicians. I made only mental notes. And I certainly didn't do anything with the info except write a cautionary blog about it.

Jhaveri, on the other hand, allegedly downloaded millions of pages of documents and 1,327 of Bristol's "Standard Operating Procedures." He's looking at 10 years. His first court date is on Monday.

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

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  Wednesday, 3 Feb 2010 | 2:25 PM ET

Acorda's Lucky Number 13

Posted By: Mike Huckman
Source: Acorda

Thirteen-grand a year.

That's about how much Acorda Therapeutics says it'll charge for its newly approved drug Ampyra for multiple sclerosis.

The price is way higher than most analysts had been openly expecting ACOR to set. The Street was forecasting the cost to be somewhere between $5,000 and $10,000. Against the backdrop of the health care reform debate and all of the noise in Washington about the pharma lobby and drug costs, some might find it surprising that a company would come out of the gate with this kind of price tag.

Ampyra's the first pill designed specifically to help some MS patients walk better and faster. The cost works out to about $16.50 per dose. I think it's worth noting that in the press release headline, in the same breath as it were, the company touted that it's going to have a patient assistance program. Oftentimes, that kind of stuff comes further down in a release or a company launches one under pressure or as a post-market preemptive PR measure.

Acorda shares are hitting a new high on the pricing news and a lot of analyst research notes raising sales and earnings estimates along with their price targets. Biogen Idec will sell the drug outside the U.S. and Elan gets paid to make Ampyra. There's so much investor interest in the story that Deutsche Bank biotech analyst Dr. Mark Schoenebaum is doing a conference call for clients about it tomorrow. In an email inviting people to listen in Schoenebaum listed a bunch of serious, important questions he'll try to answer, but as is his way, threw in this one in the middle of the paragraph to see, perhaps, if people actually read through it: "How can Ron's hair be so incredibly perfect all the time?" Ron is Dr. Ron Cohen, the CEO of Acorda.

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  Tuesday, 2 Feb 2010 | 3:21 PM ET

The Shaky State Of California Biopharma

Posted By: Mike Huckman

Nearly every city and state want biopharma.

They fiercely compete for the relatively clean industry and the well-paid, highly educated jobs it brings. But only a handful of cities, regions and states have successfully established clusters: Cambridge, MA, Seattle, WA and San Francisco, Los Angeles, San Diego and the O.C. in California. But a new report says my homestate could be in danger of losing a level of its preeminence.

The San Francisco Chronicle recently reported that the Cali life sciences industry actually added more than 2,000 jobs last year. And The Wall Street Journal reports today the economy along the California coast, where tech is king, is bouncing back while the inland areas are still struggling. California still has 12.5 percent unemployment and President Obama is talking about job creation as I write this.

Against that backdrop comes a 100-plus page report out this afternoon from PricewaterhouseCoopers and the California Healthcare Institute detailing the current state and future of the state's biomedical business. Cali is home to big biotech companies like Genentech and Gilead Sciences in the north, Amgen and Amylin in the south and a whole bunch of others in between.

The authors of the report are worried about the potential impact of health care reform and California's budget crisis on the industry's big footprint in the Golden State. "More than ever, the sustainability of California's biomedical industry is influenced by decisions made in Sacramento and Washington," they write. Their concern comes, in part, from the results of a survey they did showing two-thirds of respondents expect to move more manufacturing out of state within the next two years. And in that same time frame 58 percent said they anticipate doing more research and development outside California. PWC and CHI surveyed 200 C-suite execs at California's largest (by workforce) life sciences companies.

"Our biomedical industry's formidable assets and future value are offset by daunting liabilities and serious risks. Of these, the most immediate stem directly from the Great Recession," the CHI President and CEO and PWC's Life Sciences Partner write in the preamble to the report.

I hope to get the perspective of two California biopharma CEOs in live interviews at the BIO CEO conference in New York City next Monday. Representing the north, Dr. David Hung from San Francisco's Medivation. And representing the south, Michael Narachi from San Diego's Orexigen. The state of the industry in California isn't why I'll be interviewing them, though. With MDVN, it's all about the late-stage experimental Alzheimer's drug that's partnered with Pfizer. And with OREX it's all about its two experimental diet drugs that are, as yet, unpartnered.

Both companies are working to make progress in the war against two of the biggest medical problems facing the country. As Governor Schwarzenegger writes in the report's cover letter, "This community of thinkers and doers is an engine that powers our economy, generating revenues that will certainly help us emerge from the economic challenges of our times."

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  Monday, 1 Feb 2010 | 2:28 PM ET

Eyeing An Opportunity For Genentech

Posted By: Mike Huckman

For Roche/Genentech the timing could not be worse.

At a time when cutting healthcare costs could still end up being put back on the frontburner in Washington comes a study showing how to possibly save a heckuva lot of money.

The huge Southern California healthcare plan that I grew with, Kaiser Permanente, is out with a "real-world" study in "Ophthalmology." the journal of the American Academy of Ophthalmology.

Kaiser researchers compared Roche/Genentech's cancer drug Avastin to the company's similar eye drug Lucentis in patients with what's called the wet form of age-related macular degeneration (AMD), which is the leading cause of adult-onset blindness. And they concluded they both do an equally good job of improving peoples' eyesight.

The drugs are injected straight into the eye with a needle. The computer I'm writing this blog on has caused the need for me to where glasses with a minor correction. I wouldn't wish AMD on anyone. The anxiety of getting a needle in the eye...yikes!

The AAO says with the aging population that AMD "is becoming an urgent concern for the healthcare system." I hear a Genentech-sponsored message about AMD at least once a day on the radio. Genentech/Roche sells Lucentis in the U.S. Roche's crosstown Basel, Switzerland rival Novartis sells it everywhere else. It's about a $2 billion-a-year product.

The study is relatively small and the authors acknowledge it has its flaws. But the findings are important because pharmacists and doctors can break Avastin up into little doses for the eye for a tiny fraction of what it costs for a dose of Lucentis. Using the blockbuster cancer drug Avastin for the eye is a so-called "off-label" or unapproved use. It's a common practice in medicine.

The federal government is doing a bigger, gold-standard clinical trial comparing the two drugs. All of the patients have been enrolled and the first results are expected early next year.

In the meantime, Genentech says that while doctors can choose which drugs they want to use, it continues to insist that only Lucentis has been extensively tested, proven safe and effective and approved by the FDA specifically for AMD.

But think of the goodwill and the good PR the company could generate if it tried to get out in front of the government study findings. Couldn't Roche/Genentech do a mea culpa, acknowledge the building body of real-world evidence, at least, that Avastin is just as good and Lucentis and start packaging Avastin in smaller, cheaper AMD-sized doses? I'm just asking. The company will say it has to strictly follow the science. But it's also a business.

When I tweeted the study findings on Twitter, one of my followers, biopharma consultant Aidan Finley replied , "Slow moving debacle." Another industry consultant, Sally Church, tweeted , "Ouch, that was a problem in the making."

Beyond the statement a spokesperson emailed to CNBC, Genentech had nothing to say about the study on Twitter. The company's last tweet was 10 days ago about being named to Fortune's list of best companies to work for.

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

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  Friday, 29 Jan 2010 | 9:47 AM ET

Generic Drugs and The 'Maris' Poll

Posted By: Mike Huckman

My health insurance company and pharmacy benefit manager have tried to get me onto generic Zocor. But I continue to shell out the higher co-pay for my prescription for 10mg of Pfizer's Lipitor . I figure if it ain't broke, don't fix it. I haven't had a screening done in a long time (I know I'm overdue, but I don't like having blood drawn and often get faint,) but at last check the Lipitor was lowering my bad cholesterol. It's not about the money or reservations about taking a generic drug. I'm just sticking with what works.

But I'm in the minority.

Three out of four prescriptions in the U.S. are filled with generics. But a new, albeit small, survey by a prominent generic drug industry analyst shows even the people filling those pill bottles have issues with generics. Calyon Securities' David Maris polled 25 pharmacists for part of a big research report he sent out to clients this week.

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  Thursday, 28 Jan 2010 | 10:43 AM ET

Putting the Zen in AstraZeneca

Posted By: Mike Huckman
Getty Images

They're all guilty of it.

Big pharma is in the middle of getting leaner and meaner. Most, if not all, of the majors are getting rid of employees. They need to cut costs to preserve profits in the face of tens of billions of dollars worth of brand-name drugs going generic and their pipelines not delivering enough to fill that void. It's a sad reality of the business.

The drug companies--heck, arguably all big businesses—try to couch layoffs in patronizing corporate-speak. For example, today AZN announced that it's going to eliminate another 8,000 full-timers between now and 2014 to save nearly two-billion bucks a year.

But here's my problem with it.

The British Astra says the workforce reduction (hate that term, too) is part of "productivity programmes." Some of the names companies use for downsizing plans are downright laughable. A layoff is a layoff. Let's call a spade a spade.

An investor audience usually likes this kind of stuff.

Cutting costs often means bigger profits. But, especially in this economy, how do you think it reads to one of the 8,000 people at AZN who will soon get a pink slip? "I'm part of a productivity programme? How nice!" Sure, a lot of those folks, no doubt, will get good severance packages. AZN says it'll spend $2 billion to send all of the people on their way. But would it be so difficult to write it more with more sensitivity and human feeling? For example: "Given current business conditions, we regrettably have had to make the extremely difficult and painful decision to layoff more of our employees than we had originally planned." Or something more along those lines.

I know they're just words, but it might make it less of a bitter pill to swallow.

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

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  Wednesday, 27 Jan 2010 | 11:54 AM ET

Glaxo Says, “Time For Levinson”

Posted By: Mike Huckman
Barry Levinson
Ben Hider | Getty Images
Barry Levinson

"Time for Wapner," is one of my favorite movie lines. It comes from Barry Levinson's "Rain Man," in which Dustin Hoffman's savant character, Raymond, would count down the minutes before "People's Court" came on TV.

Levinson has not had a big hit like "Rain Man" in quite awhile, but he will reportedly be taking on the topic of bigness in the new GlaxoSmithKline-funded documentary about obesity . GSK makes the over-the-counter diet drug Alli. I especially like American Public Media's "Marketplace" recent report on the controversial production in which the reporter tells listeners to search YouTube under "Poopy in the pants" to get more info on the drug's nasty side effects. Not sure I could say that on TV with a straight face. Easier to do on radio and in print.

Julia Boorstin , who covers the media and Hollywood for CNBC, says Levinson is directly affiliated with the "Creative Coalition," which is working with GSK on the doc. He most recently directed the group's film "Poliwood," which as the name suggests is about Hollywood and politics. It went straight to "Showtime," never to theaters. I suspect the obesity doc will travel a similar path.

I have six degrees of separation from Levinson.

My bio-mom went to Baltimore's Forest Park High School around the same time Levinson was there. (I'm not gonna get into it here right now, but I was adopted at six-weeks old.) My bio-mom and Levinson didn't know each other, but she tells me her father and his father were part of a weekly neighborhood poker group called, "The 100 Club." According to IMDB , another Forest Park High School attendee was Mama Cass, whose death was obesity-related. (Love "The Mamas & The Papas," btw.) Levinson and Cass Elliot (Ellen Cohen) were actually schoolmates. Interesting connection in the context of the GSK movie deal.

Time to get back to work.

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

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  Tuesday, 26 Jan 2010 | 11:51 AM ET

It's ASCO On Ice!

Posted By: Mike Huckman

While obsessively checking Twitter on my BlackBerry over the weekend I caught a tweet from one of the people I follow, Todd Ringler , a top health care PR guy at Edelman. He said he was scratching his head after spotting ASCO's logo rinkside at the U.S. Figure Skating Association Championships on NBC. ASCO, by the way, is the American Society of Clinical Oncology , the premiere cancer research organization.

We're used to major corporations sponsoring big sporting events, but a non-profit like ASCO?

Huh?

I hadn't been watching the competition, but my DVR was recording it. I quickly turned on the TV and scanned to the first skater on the ice.

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