While You Were Settling

Well, it was an interesting weekend: the writers' strike may have been settled, Obama swept (and won a Grammy), and there was an unusual amount of blood spilled around the NHL (Lets Go Flyers!). But what happened in your world?

• First up: AstraZeneca is considering sale of some GI research projects, according to a Swedish newspaper (via Reuters). Perhaps Dagens Industri reads IN VIVO: we reported this news back in November!


• The NYT reviews the options for those of you who want to do a little personal genome spelunking. In other consumer genomics news, deCODE announced on Sunday the launch of a genomic test to identify individuals with a higher risk of prostate cancer.
  
• Newron announced early Monday that it was buying the private CNS-focused biotech Hunter-Fleming, for €8 million in stock plus a potential €17 million in earnouts (also in shares).


• “Generally I am very brave…only today I happen to have a headache.”
  
• Sorry, but we have to be firm on this one: Atonement should not have won best film at the BAFTAs last night (we loved the book, but...). And riddle us this: how does it lose in the 'best British film' category yet win 'best film'?

photo by Flickr user Here in Van Nuys used under a Creative Commons license

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While You Were Eating Chili and Drinking Beer

Sometimes coming up with a headline for our weekend roundup can be difficult. This was not one of those times.

While we went with what we figured was the most universal of Super Sunday experiences, we had choices. Also considered: While You Were Watching It For the Ads, While You Were Giants, While You Were Eli-d, While You Weren't Going Undefeated, While You Were Choking, While You Were Jumping Off the Pats' Bandwagon, While You Were Participating in the Unauthorized Use of Game Footage Without the Express Written Consent of the NFL, and While You Were Praying There Would Be No Tom Petty Wardrobe Malfunction.

Some of us here at the IN VIVO Blog are Eagles fans (no, really, we probably haven't mentioned it before) and so the only suitable Superbowl outcome would have been for both teams to get disqualified somehow. But alas, at least it was a tight game.

Believe it or not there was more than Super Sunday and Super Tuesday prognosticating going on this weekend. Or so we heard.

• Amgen and Takeda inked a broad alliance to develop and commercialize 13 Amgen products in Japan. In a second and related deal, Takeda becomes Amgen's worldwide partner for the Phase II oncology candidate AMG-706 (motesanib). Amgen gets up-front payments of $200 million and $100 million respectively, and a further hundreds of millions in milestones and R&D expense sharing, plus royalties on Japan sales (and worldwide 50/50 profit sharing on motesanib). Takeda is also acquiring Amgen's Japanese subsidiary Amgen KK.
  
• From the Financial Times: a preview of GSK's forthcoming results this week with one key question--can the Big Pharma get FDA approval for Cervarix? We weighed in on this question on Friday.
  
• [Self Promotion Alert] The line-up for our Pharmaceutical Strategic Outlook conference in New York (March 18-20) keeps on getting better.

Photo from Flickr user jwinfred used under a Creative Commons license

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While You Were Almost Upsetting

We've been told by certain football (soccer) fans that there are not enough allusions to the beautiful game in our weekend roundups. So as equal opportunity sports enthusiasts we thought Saturday's FA Cup fourth round near-upset of Premier League giants Liverpool by the part-timers from the curiously named Havant and Waterlooville away at Anfield warranted a mention. (And hey it's the NFL's ridiculous weekend off anyway.)

Even though they lost 5-2, this team of teachers, builders and trash collectors (not sure if there are any pharma bloggers on the team, but who knows maybe the mysterious Insider from Pharmagossip plays for them) led twice and gave one of the top teams in Europe quite a scare, at least in the first half.

What else was going on this weekend?

• Vytorin snafu: New York State AG Andrew Cuomo piles on. More at Pharmalot.
  
• Ben Goldacre highlights a few recent studies about publication bias (including one concerning SSRIs from last week's New England Journal of Medicine). Your indispensible Bad Science is here.
  
• Our Vytorin poll is closing today. Vote here.

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While You Were Staying Put

It's always sunny in ... London?

Lets kick off the weekend wrap-up by highlighting a trio of stories from The Times about incoming GlaxoSmithKline CEO Andrew Witty. The paper calls Witty a "survivor" and notes that he'll need all of those Bear Grylls skills in the tough year ahead. It also points out that Witty might be immune to the many charms of Philadelphia and will be running the show from west London. We guess he opts for fish 'n' chips over Philly cheesesteak, Lord's over Citizen's Bank Park, Twickenham over The Linc. (That said, GSK's dual-HQ model remains.) Interesting sure, but we don't know why it took them three articles to establish all this.

In other news ...

• Has Idenix's refocusing on its early stage virology pipeline begun to pay off? At least one analyst thinks so.


• The Financial Times rounds up some analyst comment suggesting that despite an incredible week for drug stocks like GSK and AstraZeneca, pharmaceuticals, long a haven for investors in tough economic times, may no longer be able to satisfy investors looking for a defensive stance.


• Researchers at the University of Minnesota have grown a functioning rat heart in the laboratory. Reuters, via WSJ.


• The Boston Globe writes that Boston Scientific Corp. execs insist the company is on the verge of rebounding from two years of post-Guidant woe.


• Drug development is hard. Drug discovery, dealmaking, getting a drug approved, growing rat hearts in some tricked-out ehrlenmeyer flask: all tough, worthy jobs. But they all pale in comparison to catching a swordfish with your bare hands. Have a good week, and try to keep it in perspective, people.

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While You Were Going to California

Before the eyes of the healthcare world turn to the overcrowded hallways of the Westin St. Francis, here's a quick roundup of the weekend that was--and it was Quiet. We'll try to post a few missives from the conference while we're here & hopefully we'll meet some loyal readers.

• The San Francisco Chronicle's primer on the JP Morgan health care conference.


• Bad Science has some thoughts on the as-yet-released ENHANCE trial of Zetia, which we wrote about here.


• Reuters reports that Sanofi-aventis is looking for growth in the vaccines market.

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While We Weren't Blogging

Our apologies for the service outage this week. Everyone needs a break now and then, and we at the IN VIVO Blog are no different. Those of you who were in the office last week, we hope you got your fix elsewhere--our blog roll on your right provided some excellent recommendations, we're sure.

Before 2007 becomes 2008 we'll be back with our own version of that end-of-year tradition, the "top-ten" list. And next week a few of us will head west to attend the annual JP Morgan Health Care conference--where we'll plan on blogging about the year to come. And going to parties.

Finally we want to thank you for dropping by our little corner of the Internet. We've been at this for eight months now, and we hope you reading the IN VIVO Blog as much as we enjoy writing it. Happy New Year.

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While You Were Hanging Your Stockings By the Chimney with Care

"It's a major award!"

Not many creatures stirring this pre-holiday weekend, but we couldn't resist keeping up our weekly roundups of what you might have missed anyway. Basically, not much. We guess it isn't a surprise that you won't find us keeping up the not-quite-rigorous blogging pace this week and the beginning of next, though surely we'll pop up from time to time to amuse those of you hard at work. For the rest of you, bundled up on the couch watching "A Christmas Story," be careful not to shoot your eyes out this week.

• Winner: IMS Health: Maine's state law that restricts access by medical-data companies to doctors' prescription information is unconstitutional, says a Federal Judge, according to an AP report in today's WSJ. You could have seen this one coming if you a) thought a previous ruling in New Hampshire pointed toward a similar result in Maine or b) you read about this on Friday (hey we told you it was a slow weekend).
• The Boston Globe ran a Q&A with CMS boss Kerry Weems on Sunday. Weems is on the road encouraging consumers to shop around for the best medicare plans.
• The Times profiles Renovo CEO Mark Ferguson, whose career has taken him from "dentist to alligator biologist to pharmaceutical chief executive eyeing an estimated £6 billion virgin blockbuster market."
• Ben Goldacre's Bad Science reminds us that particularly around the holidays, some health studies are too good to be true.

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While You Were Snowed Under

Better to be snowed under by actual snow than pretty much anything else, we suppose. Here are a few other flakes that accumulated over the weekend ...

• Not everyone is happy with Shire's managment manouevrings. The Financial Times points out that the Association of British Insurers suggests its members, which the hold roughly one fifth of the equity, might press for a more detailed explanation of Matt Emmens' move from CEO to chairman.


• Highlights from the San Antonio Breast Cancer Symposium: GSK presented Phase II results suggesting Tykerb may be beneficial as part of combination therapy in breast cancer that has spread to the brain. Amgen's osteoporosis drug denosumab increases bone strength in patients receiving hormone therapy for breast cancer, the company reported. Genomic Health said it has confirmed the efficacy of its Oncotype Dx test in predicting breast cancer recurrence. Regenerative medicine company Cytori reported positive preclinical and clinical results from studies of its adipose-derived stem cell platform, in fat graft retention and breaset reconstruction, respectively.


• Intrigue at UCSF medical school. Bloomberg News is reporting that former FDA commish David Kessler says he was fired from the school's top post on Friday for pointing out financial irregularities. One hundred million dollar financial irregularities Hat Tip: Pharmalot.


• Hello, Santa!

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While You Were at ASH

We'll start our weekend-roundup jamboree with some news out of the American Society of Hematology meeting in Atlanta. So in a way this should be called, 'while you weren't' at ASH, but we're sticking with convention. Here are a few bits of late-stage clinical news out of the blood meeting:

• ASH: JNJ and Bayer said on Saturday that their Phase III Factor Xa inhibitor anticoagulant rivaroxaban was superior to enoxaparin (Lovenox) in preventing venous thromboembolism in patients following hip replacement surgery. Rivaroxaban is a once-daily oral, while Lovenox is injected. Boehringer Ingelheim's rival treatment dabigatran, a thrombin inhibitor, has begun a mid-stage trial in acute coronary syndrime says Reuters.


• ASH: Bayer, with Biogen Idec, also posted postive results in oncology, as the companies' Zevalin lymphoma therapy significantly increased progression-free survival in follicular lymphoma.
  
• ASH: Celgene's Revlimid added to dexamethasone in a Phase III study significantly boosted progression free survival in newly diagnosed multiple myeloma patients compared with dexamethasone alone.
  
• ASH: Adding Millennium's Velcade to standard of care in front-line multiple myeloma treatment "achieved a fourfold increase in complete remission rate," according to results of a Phase III study presented at ASH.


• MGI Pharma, the oncology and acute care specialist, was bought early today by Japanese pharmaco Eisai for $3.9 billion. You can read our first take here, and we'll no doubt have more to say on this later when we're, you know, awake.

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While You Were Dealing

The weekend was not without some dealmaking action. More to come on Monday, for sure. But lets kick off the weekend roundup with a big biologics deal between Novartis and Morphosys ...

• Morphosys has signed a "transforming" deal with Novartis. The two companies are building on their existing 2004 alliance with a potential 10-year deal to develop monoclonal antibodies. Morphosys will receive $600 million in committed payments--in addition to potential milestones and royalties and co-promotional options. The deal reduces Morphosys reliance on fee-for-service antibody collaborations, and make no mistake, in terms of guaranteed payments, it's a monster. But it also seems to entwine Morphosys' fate with Novartis Biologics', as Novartis will have near exclusive access to the biotech's platform (Morphosys is ending existing collaborations with J&J's Centocor and Bayer-Schering). We may have more to say after Morphosys' conference call on Monday.
  
• Forest Labs received an approvable letter for its nebivolol beta blocker, a decision related to FDA issues with a manufacturing plant in Belgium. As we wrote last week, approval of nebivolol could buck the trend, and Forest (and partner Mylan's) insistence that FDA found no safety or efficacy reasons to deny the drug will be heartening to the companies. Forest is continuing to plan for a January launch.
  
• Hey, did you know that Biogen Idec was up for sale? No, really, we swear. Apparently they look expensive, given the current credit crunch and aversion to Big Pharma paper.


• The FT points out that the UK's Human Genetics Commission is warning the public off the various consumer genomics information providers. For background, David Hamilton at Venture Beat Life Sciences has been all over the recent consumer genomics news.


• GSK to Viehbacher and Stout: Thanks for playing. Second prize, two weeks in Philadelphia £2 million!


• Addex has announced that it has something to announce--most likely a deal on lead project ADX10059, which is in Phase II trials for GERD, migraine, and anxiety. The details on Monday morning. [UPDATE: Nope, Addex announced an alliance with Merck & Co. this morning to discover and develop positive allosteric modulators targeting the metabotropic glutamate receptor 4 (mGluR4) in Parkinson's disease. Addex gets $3 million up-front and up to $106.5 million in first-product milestones, plus royalties, and retains co-promote options in certain European territories.]

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While You Were Giving Thanks

Time to shake the rust off after the long holiday weekend. We hope you had a great Thanksgiving, though ours ended on a bit of a sour note with last night's Philadelphia Eagles defeat. We are not giving thanks for covering the spread.

In the news while you were in food-coma ...

• Paul Kedrosky points out a paper from NBER that suggests that public biotech co's may find themselves with a cost-of-capital problem.
  
• A pretty fascinating peek inside the pharmaco-physician 'thought-leader' relationship, courtesy of Daniel Carlat of the Carlat Psychiatry Report, in Sunday's NYT Magazine.
  
• Finally, it may be the holiday sale season, but not everything is on sale. Biogen Idec is apparently a little too pricey for Gerard Le Fur.

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While You Were Acquiring

Back when we ran our "who's gonna get bought next" poll on the IN VIVO Blog most of you followed the herd--and chose Biogen Idec. All of you who chose "someone else," take a bow (we know you had Pharmion in mind). Tonight Celgene announced it was buying the cancer-focused biotech firm for $72 per share, for a grand total of $2.9 billion. We'll have more on this on Monday. (Had this deal not happened we may have gone with "While you weren't covering the spread against MIAMI.")

• In other news--does anyone else feel like the world is hurtling toward the 99-cent genome? Forget the $1000 genome, Bionanomatrix is touting its efforts toward a $100 genome (last Monday's Philly Inquirer). And on Friday consumer genomics hit the front pages, as Iceland's deCODE Gentics announced its deCODEme business and Google/Genentech-backed 23andme responded with a 'we're launching our business too' press release late Friday afternoon. Saturday's New York Times has a review of those efforts and more. The Financial Times chimes in as well.


• Barron's isn't confident that prasugrel's data is enough to buoy Lilly, reports Reuters.


• Just when you thought there was nothing more to write about insomnia. The New York Times magazine presents the 'sleep-industrial complex.'

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While You Were ...

So what were you up to this weekend. Perhaps you were flying to Hamburg for the BIO shindig? Or throwing back a few half-pints at the (outstanding) Woking Beer Festival? Re-reading "The Naked and the Dead," maybe. Whatever your poison (ours was Tryst Brewery's Carronade IPA) we hope you had a good weekend.

• Novo Nordisk tells the Times: Exubera may have gone up in smoke, but inhaled insulin isn't dead yet. We'll be taking an in-depth look at the future of inhaled insulin in the next IN VIVO.


• Medical meeting season rumbles onward; at the American College of Rheumatology, on Saturday, NicOx presented further Phase III data from its '301' study of naproxcinod. Specifically, the company reported positive GI- and blood pressure-related safety and adverse event data for the drug candidate, a nitric oxide-donating form of naproxen that some analysts hail as a blockbuster alternative to the blighted Cox-2s. We've written extensively about naproxcinod here.


• Drug-coated stents are the new eggs. First they're good for you. Then they're bad for you. Now, apparently, good for you again. But manufacturers aren't holding their breath for a massive rebound in sales. The New York Times reports.


• Has Merck been punished adequately in the whole Vioxx debacle? Not everyone thinks so. Pharmagossip rounds up the usual suspects.

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While You Were at AHA

Well, the big prasugrel v clopidogrel showdown went down pretty much how observers expected it would: Lilly's prasugrel has the edge in efficacy--cutting heart attacks by 24% over Bristol/Sanofi's Plavix--but comes with an increased risk of bleeding. The press release is here. The WSJ covers the news here. We'll probably have more on this later.

• In other AHA news, Integrilin: a little jab'll do ya. Probably not great news for Schering-Plough, which, unsurprisingly, did not fund the study that suggested angioplasty patients do just as well with a significantly smaller dose of the drug.


• The New York Times chronicles Pfizer's fight to protect its Lipitor franchise from incursion by generic simvastatin. As the Financial Times pointed out last week, AstraZeneca has its own simvastatin-induced challenges with its blockbuster statin Crestor.


• GSK's gepirone antidepressant received a non-approvable letter from FDA. This is the third time FDA rejected gepirone, previously under development at Akzo Nobel (Organon), so not exactly a shocker.


• A study in Nature published on Sunday describes a new lung cancer target. Mutations in NKX2-1, which controls the activity of alveoli, may be responsible for up to 12% of lung cancers, according to researchers led by Matthew Meyerson of the Dana-Farber Cancer Institute and the Broad Institute. Reuters has the story.


• The Boston Globe looks at MIT professor Lenny Guarente's dormant relationship with Elixir Pharmaceuticals, the about-to-go-public company he founded in 1999, and his potential relationship with Elixir competitor Sirtris Pharmaceuticals.

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While You Were Sweeping

Congratulations to the Red Sox and their fans, victorious in a 4-0 rout of the Rockies in the WS. Some of us were hoping for a little suspense, but oh well ... other news from the weekend that was, below.

• JP Garnier, one foot out the door at GSK, taking one for the (management) team, sort of. Check out the Times (London).
  
• The New York Times takes a look at which presidential candidates are drawing donations from the health care industry. Bucking recent trends, Democrats are outpacing Republicans.


• Pharmagossip knows what AZ's David Brennan is wearing this Hallowe'en ...
  
• Bayer-Schering's Betaseron ... double the dose shows no improvement over single dose and Teva's Copaxone.
  
• The Wall Street Journal ($$) asks whether Biogen Idec's pipeline is going to deliver the growth that a Big Pharma acquirer would need. Want to change your vote now?
  

(Photo by Jeff Gross/Getty Images)

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While You Were Coming Back

It would be wrong for us not to mention the Red Sox in this space, the Boston nine having completed their three-game comback victory over the Tribe last night (sorry, Steve). There are a few contributors to this page that despite seeming to be upstanding citizens in most other respects actually cheer for the Sox. Probably some of you dear readers too. So there you have it. Congratulations.

So what did you miss while your favorite baseball/football/rugby/formula one team was golfing/losing ugly/coming up short against South Africa/driving really slowly?

• Cancer rates may be declining in the US, says the American Cancer Society, but as the New York Times reports, rates of certain cancers are increasing. Why?


• The Times laments the loss of Cambridge Antibody Technology, the name anyway, in the wake of AstraZeneca's MedImmune integration.
  
• Kirin Brewery has settled on the terms of its offer for a stake in Japanese drug company Kyowa Hakko Kogyo. Kirin aims to take a nearly 28% stake in KHK in a deal valued at roughly $2.6 billion.
  
• Two days left to guess which big biotech will be the next pharma takeout target. Check out our poll in the upper-left hand corner of the blog.

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While You Were Considering the Alternatives

"When you come to the fork in the road, take it."

We hope the weekend gave you a chance to look in on the news of the day, Strategic Alternatives: Biogen Idec edition. We saw it coming (and said so here last Thursday). Late on Friday Biogen Idec confirmed that it is up for sale, having received offers from both strategic and financial buyers (the latter being Carl Icahn). We've noted the folly of buying Biogen for its current products, since any acquirer would have to share Rituxan with Genentech and since Elan has a change-in-control right to buy Tysabri (and the Irish drugmaker has brought in Lehman Bros. to help decide what to do with Tysabri in the event of a sale). But beyond a beef-up in biologics, such a move--likely to cost at least $30 billion--would help a primary-care acquirer to radically shift from primary care drugs into specialist marketing, an expensive kind of reality-show makeover for Big Pharma.

But what else happened this weekend?

• A team of scientists at Stanford University and elsewhere have published preliminary bu promising results of a new Alzheimer's diagnostic. The New York Times reports on the Nature Medicine article. Satoris is the company that aims to commercialize the test.


• News out of ECTRIMS in Prague: Bayer and Genzyme's good-news-bad-news Phase II results for Campath in multiple sclerosis. A Phase III is in progress.


• Reformulation specialist Orexo is buying Swedish R&D co Biolipox for SEK 856 million ($133 million). "The acquisition will create an innovative specialty pharma company [there's that term again!] with a broad product pipeline, global partnerships with major financial potential, and established sales channels" says a statement.


• Second prize, two weeks in Philadelphia! Glaxo considers CEO-also-rans for its board, says the Financial Times.


• The FT also interviews Sanofi-Aventis CEO Gerard Le Fur. What do we learn? Well lets just say there's a lot of color. For starters, Le Fur doesn't smoke marijuana. He prefers the Continental two-kiss to the Anglo one-smooch. And he's a rugby guy, so he probably had a very bad weekend!

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While You Were Watching the Upsets

This weekend we were in Cardiff for the Rugby World Cup quarterfinal between France and New Zealand, which saw France upsetting the favorites. Earlier in the day defending champs England upset heavily-favored Australia, setting up a very surprising all-Europe semifinal next weekend. Suckers for a lost cause, we managed to keep tabs on the Phils into the wee hours, and showed our support on the streets of Cardiff amongst the hordes of Kiwi and French fans (see below--it's a jungle out there).

So what'd we miss?

• The repercussions of the failure of Merck's HIV vaccine are being felt across the entire field, points out the Philadelphia Inquirer.
  
• Roche isn't raising its offer for Ventana, the company said this weekend, but it remains convinced Ventana shareholders will see the light.
  
• And the winner is ... Andrew Witty. GSK's head of Europe appointed CEO-designate, will replace JP Garnier in May 2008.

gotta support the team

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While You Were Winning the NL East!

M-V-P

How 'bout them Phillies! Could we be heading for an intrablog standoff between IN VIVO's Philly and Boston contingents? Only time will tell...

Sorry for the late and skinny weekend roundup; our flight was delayed several hours returning to the UK after the PSA conference and we were too excited about the Phillies victory (and frankly, without an easy internet connection) to post yesterday.

So we'll keep it short:

• Vernalis' and Endo's Frova hits the wall. The migraine drug's second time around at FDA--its supplemental NDA for expansion of its label into menstrually associated migraine--turned ugly over the weekend when the agency sent the companies a surprise "Not Approvable" letter. As one analyst told IN VIVO Blog today, "there's a lot of egg on a lot of faces" at Vernalis and Endo. The companies had been extremely optimistic about the drug's label expansion prospects.

(AP Photo/Tom Mihalek)

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While You Were Packing for New York

A few notes from the weekend that was. We hope you had a good one. Several of your resident bloggers will be converging on New York this week for our Pharmaceutical Strategic Alliances conference (remember, UBS isn't the only game in town this week!). Hope to see some of you there. Stay tuned to IN VIVO Blog for a few updates from the conference on Wednesday and Thursday.

• Profit up but care down at many PE-backed nursing homes, says the New York Times in a Sunday feature.


• Pfizer gets maraviroc approval in the EU--here's the early morning release--and Novartis gets an EU OK for its transdermal Exelon mild-to-moderately-severe Alzheimer's disease patch. Both approvals were expected.


• The WSJ is the latest paper to take a gander at GSK's slightly unusual CEO succession contest, while the FT wonders who will replace Jon Symonds as CFO at AZ (hat tip, Pharmagossip).

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