Tuesday, November 30, 2010

a video...

... in which Jonah doesn't do a whole lot at the beginning but sings Dora at the end and also says "Mommy."




****
Also, please go HERE to vote for EBMRF to receive funding for more research. A Facebook/EB friend of mine is participating in her office's Holiday Gives program where people vote on one of five charities to receive funding. They do this instead of sending out client gifts. I think that is so cool. Jonah is the featured EB Cutie, but sweet Aubrey Joy, who recently passed away at the age of six weeks from JEB, is the baby we're honoring. :)

Merck CEO-Designate Frazier and the Importance of Washington to Pharma

The announcement that Merck's global pharmaceutical head Ken Frazier will ascend to the CEO slot in January is hardly a shocker: he was viewed as the front-runner in a one-man race to succeed Richard Clark next year.

But this stable, planned succession is still an important marker about the climate for Big Pharma. Much will be made of Frazier background as chief counsel at Merck (he will join Jeff Kindler at Pfizer as the Lawyer-in-Chief CEO model), but we wanted to highlight Frazier's hands-on role in shaping Merck's public policy efforts throughout his career.

While Clark personally represented Merck in some of the critical events involving the health care reform debate, Frazier was very much on board with the plan -- and gave a thoughtful and compelling explanation for why Merck decided to take the risk of engaging in the reform debate during a keynote address during Elsevier Business Intelligence's FDA/CMS Summit for Biopharma Executives in December 2008.

We reprinted the full address in The RPM Report, here. But we thought Frazier's analysis of the risk of inaction was particularly compelling, and may be newly relevant as he takes over the top spot at Merck heading into the uncertain waters of a newly Republican Congress in 2011. So we've excerpted that section below.

Oh, and by the way, today is the last day to qualify for the "early bird" discount for this year's FDA/CMS Summit. In all modesty, we can't promise you will see tomorrow's CEOs today if you come to the Summit, but, as Frazier's address shows, you just might. What we can promise is that what happens in Washington continues to matter to the Big Pharma business, so you won't want to miss out on the chance to deepen your understanding of the rapidly changing public policy climate. (Click here for more on the Summit.)

Here is what Frazier said two years ago about the risk of inaction, if Merck chose not to support reform:

We understand clearly that we are entering this debate at a time when the pharmaceutical industry’s standing is low and we face challenges from many directions.

For years now, politicians, the media, and industry critics have disparaged our prices, our allegedly excessive profits, and our purportedly wasteful marketing expenditures. Most unfortunately, we have also seen critics challenge the integrity of the scientific research that is at the core of our value to patients and society.

These challenges have led to legislative proposals, here and around the world that could have serious negative impacts on our industry and on our ability to continue to innovate in the interests of patient health. In my new role overseeing the marketing of Merck medicines and vaccines around the world, I’ve seen first-hand the negative impact that some of these ideas have had.

Certainly, major health care reform action in the United States could provide a vehicle for the consideration of several harmful proposals, such as drug importation, price negotiation in Medicare Part D, and changes to the patent protection that is a necessary prerequisite to pharmaceutical innovation.

We’re also seeing these proposals at a time when Merck and other companies are facing unprecedented business challenges. The rapid and appropriate uptake of generic medicines, challenges to our patents, and setbacks in our pipelines are translating into layoffs as well as difficult research investment choices.

This is arguably the worst time for punitive government actions of the type some are proposing.

While the risks of action to us are clear, so are the risks of inaction. First and foremost, people without health insurance coverage have poorer health and, of course, reduced access to our medicines and vaccines. Those without coverage live with a day-to-day fear that most of us in this room can only imagine. It is a fear that... they are only one illness or one accident away from financial ruin or permanent disability.

If that were not enough in itself, as an industry we need to understand that until the nation reforms our health care system, including providing affordable access to quality care, the issues of access to medicines and the price of medicines will remain flashpoints in political and economic discourse. Further, more time without action will only embolden those who advocate anti-competitive approaches such as universal government delivered health care.

Saturday, November 27, 2010

our thanksgiving

We had an awesome week! We had Thanksgiving here, at our house, with my mom, siblings, and some friends on Wednesday night. I really don't have any photos of that, because between hosting and eating, I didn't get my camera out. I do have a few photos of Wednesday during the day when my sister, Sarah, played bubbles with the kiddos. Despite some spillage and Jonah being unwilling to share nicely, it was a fun time.









On Thursday, we went to my Maw-Maw's house and spent Thanksgiving with her, my Paw-Paw and my dad. We always have a great time there, choosing to venture outdoors. It's so neat to get to share our happy memories and experiences there with Asher, Ainsley, and Jonah.









 My brother, Peyton, and his wife, Amy.




Peyton was awesome with Jonah this week. He and Sarah both gave me so many breaks and entertained him. Jonah is sometimes not great with guys, but he LOVES my brother. Maybe he senses that he's kind of like his Mommy. I don't know, but it was awesome. They spent a lot of time looking at cars from the porch, walking, and taking golf cart rides.



Pop (my dad) and Ainsley, sharing a dessert.



My oldest and youngest siblings. Nineteen year age difference. :)


There was lots of football throwing...


And golf cart riding...


Jonah was scared out of his mind at first (notice the look of terror on his sweet little face)....


But as long as we were moving, he was a happy (or at least, not crying, clinging on for dear life) little boy.




Pop, letting Asher take a turn at the wheel.


My beautiful Maw-Maw.


My two sisters with Maw-Maw. I love them. :)



I'm thankful for so many things. I never thought I'd get to celebrate any Thanksgivings with my Jonah, and now I've had the pleasure of TWO! I'm thankful for my amazing husband who is more than I could ever have hoped for, my miracle son who continues to beat the odds and inspire the best in others, my family and friends who are such a huge support, my wonderful church family, my cozy little house, and a million other things. Most of all, I'm thankful for my God, who never gives up on me, shows me unconditional love that I could never replicate or understand, and gives me a clean slate every day. My cup runs over.

(We went to the zoo today and it was AWESOME. I'll post photos of that later. We couldn't have asked for a better day. Also, Jonah turns 21 months today. Can you believe he'll be two years old in three months? Me neither.)

Friday, November 26, 2010

happy thanksgiving

Happy (late) Thanksgiving!




Love,
Jonah 


(More photos to come another day... Daddy and Mommy get a date night tonight, thanks to Aunt Sarah, and tomorrow is my first trip to the zoo! Pray that I'm not a Cranky Pants. So far, we've had an awesome week!)

Termeer Touts Campath-Linked CVRs

While the US digests its Thanksgiving turkeys, life, work and...yes, pre-takeover posturing continues on this side of the pond. We're talking Sanofi-Aventis' attempt -- thus far too cheap -- to buy Genzyme, naturellement.

Speaking to French national daily Le Figaro (in his first interview with the French press), Genzyme chief Henri Termeer confirmed a report in the Wall Street Journal a couple of weeks ago that he's willing to explore Campath-linked contingent value rights (CVRs) in any future negotiations with Sanofi-Aventis. (We say 'future' coz they haven't started yet; "we have nothing on which to base a discussion," as Termeer insists).

Having CVRs pop up is not much of a surprise, though, is it. They're becoming part of the deal-making landscape, after all; soon enough they'll be as unremarkable as option-based structures. And wind-turbines.

You see, Termeer isn't opposed to selling Genzyme (shareholder value 'n all that). He's just opposed to selling it at $69/share (shareholder value 'n all that). It's all about price, he confirmed to the French newspaper.

The fact that Termeer is the one suggesting Campath-linked ways out of this stalemate hints that he's keen to squeeze more money out of his predator and get things sorted (so do the recent sales of the genetic testing and diagostics units); after all, he doesn't want his shareholders (particularly the newer ones) getting fed up and just turning over. He may say (he did say) that "we have time on our side, because our production issues are resolving themselves." But perhaps not that much time. Not more than Sanofi does, anyway.

So while Termeer sketches down his list of poison pills to buy time while the company rights itself, the valuation battle-ground may shift to Campath, and just what that drug could be worth.

There's a huge difference (surprise!) between what Sanofi thinks ($700m) and what Genzmye thinks ($3.5 billion). In Termeer's view, "this will be the most effective, cheapest and most convenient treatment for MS patients."

The Phase III trials, due next June and next autumn, may show who's right. They may also be the trigger-points for Campath-linked contingent value notes/rights/widgets to ex-Genzyme shareholders....if Genzyme is to become "a Sanofi-Aventis Rare Disease Company" by next Thanksgiving...

image by flikrer Chuck Coker, with permission

Thursday, November 25, 2010

Bleak Winter for Servier

Winter is coming early to Europe this year, particularly for one company situated in the suburbs of Paris. Servier faces its first court case, filed yesterday by two patients at Nanterre, France, in connection with its diabetes drug Mediator (benfluorex).

An investigation by the French medicines regulator (Afssaps) led to claims earlier this month that Mediator, and its generic equivalents – manufactured by Myland and Qalimed – may have caused 500 deaths since 1976.

Servier is being charged with “serious deception, based on the nature, substantial quality and composition of the product”, “placing the lives of others in danger”, “administration of a noxious substance” and “involuntary homicide”.
Harsh accusations, indeed (even by pharmaceutical industry standards). However, the actual number of deaths associated with Servier's drug is derived from two separate studies assessed by Afssaps and the association is, for the most part, hypothetical. At Afssaps' request, three expert epidemiologists examined the study results and suggested that on the basis that some 7 million people were exposed to the drug between 1979 and 2009, the number of deaths was likely to be in the region of 500.

Put in that context, 500 deaths doesn't sound too unusual. But use of benfluorex also significantly increased the risk of hospitalisation as a result of thickening of the heart valve (valvulopathies), according to the pharmacovigilance studies that Afssaps pulled together.
Faced with this first case, Servier has a number of factors running in its favor. Firstly, it voluntarily withdrew Mediator from the French market in November 2009, following several reports of cardiac valvulopathy and pulmonary arterial hypertension. The European Medicines Agency followed suit in December 2009.

Next, Servier may be deemed to have a point when it retorts that the “inflated” number of deaths was the result of an “extrapolation” and therefore did not represent actual Mediator-caused deaths. Moreover, the company revealed that, even if this morbidity were proven, it would only correspond to a risk of 0.005%.

The Nanterre court will have to examine the question as to whether this represents an acceptable level of risk. It certainly may do, particularly as regulators frequently stress to the public that “no drug is risk free”.

Still, Servier would do well to use this as a test case for what may yet be to come. Success for the appellants could spell trouble, not just for Servier but also, potentially, for Myland and Qalimed too.

If this first snowflake in Nanterre turns into a snowstorm, France could be prompted to re-examine the case for class actions – which the country hasn't, until now, allowed, and which health minister Xavier Bertrand is keen to avoid. That said, given the inordinate length of the legal process in France, Servier may do well to go into hibernation until winter is over.
--Faraz Kermani
image by flikrer taivasalla used under a creative commons license

Wednesday, November 24, 2010

Deals of the Week's Thanksgiving Day Massacre (In 4-Part Harmony, Of Course)

This post is called Deals of the Week, and it's about deals, and the week, but Deals of the Week is not the name of the blog, that's just the name of the post. And that's why I called the post Deals of the Week.

Now it all started four Thanksgivings ago; it was four years ago on Thanksgiving, when Chris Morrison and I started writin' a blog about deals, but not every day, just once a week. And writin' about deals once a week, you know it's a lot of work. (Hint. Hint.)

And there's a lot of garbage you gotta sift through, but we decided it would be a friendly gesture on behalf of readers. So we trolled around the Internet with our shovels and rakes and other implements of destruction (a.k.a. EBI's Strategic Transactions database) looking for deals to analyze. But then a big bad editor (also known as Officer Roger) said why are you doin' that? We are closed on Thanksgiving.

And we had never heard of a blog closed on Thanksgiving before (we don't get out much) so with tears in our eyes we drove off into the sunset looking for another place to dump our garbage -- I mean our deals.

We didn't find one. So we wrote our post anyway, went back and had a Thanksgiving Day that couldn't be beat, went to sleep, and didn't get up until the next morning when we got a call from Officer Roger... And it's been a recurring feature here at IVB ever since.

But fortunately, not another case of American blind justice since we always arrive at the truth of the matter and it doesn't even require 27 eight-by-ten color glossy pictures with circles and arrows and a paragraph on the back of each one.

In honor of the day, we hope you consider joining the IN VIVO Blog Movement. All you've got to do is walk into the office wherever you are, just walk in and say ,"You can get anything you want at IN VIVO Blog." And walk out.

You know if one person, just one person does it, they might think he's really sick and they won't take him... And can you, can you imagine fifty people a day, I said fifty people a day (okay, we'd really like 1000) walking in, quoting a line from IN VIVO Blog and walking out?

And friends, they might think its a movement. And that's what it is, the IN VIVO Blog Movement.

Remember Deals of the Week? (This is a post about Deals of the Week.)

Without further ado, we bring you this week's installment. Feel free to sing along in four-part harmony. With feeling. Cuz'...

You can get anything you want at IN VIVO Blog.
You can get anything you want at IN VIVO Blog.
Log right in, it's a click away.
Just a finger tap. You don't have to pay.
You can get anything you want at IN VIVO Blog. (Excepting Roger.)

Convergence/Selcia: Barely more than a month after it was spun out of GlaxoSmithKline, CNS-focused Convergence Pharmaceutical bagged its first drug discovery collaboration, with Essex, UK-based CRO Selcia Ltd. No financials were disclosed, but Convergence isn’t short of cash, having raised $35.4 million on inception in one of Europe’s largest A rounds. Run by CEO Clive Dix, of PowderMed fame, Convergence already has two clinical-stage assets and six earlier-stage programs targeting ion-channels involved in chronic pain. In this deal, the partners will hunt further molecules for chronic pain, with Convergence applying the ion channel biology, medicinal chemistry and preclinical development expertise it inherited from GSK, and Selcia contributing synthetic chemistry and chemistry support services. The collaboration shows that Convergence, like its parent GSK (and indeed many other Big Pharma), is willing to embrace others’ drug discovery approaches, and to tap into drug discovery resources and technology on a flexible basis.--Melanie Senior

Medtronic/Ardian: Back in the summer of 2008, Ardian sought out corporate investors to participate in the company’s targeted $30 million Series C financing, thinking some corporate oomph and expertise would help drive clinical testing of its Symplicity Catheter System, used for treating hypertension and related conditions. The following spring Medtronic led a $47 million round, acquiring 11% of the company in what was – and still is - a rare up round. Now, Medtronic is going all in, announcing that it will acquire the rest of Ardian for $800 million up front, setting a record purchase price for a medical device company that doesn’t have an FDA-approved device. (Medtronic topped the mark it set in 2009 with the $700 million of CoreValve Inc., a percutaneous heart valve company.) Medtronic also agreed to pay commercial milestones equal to the annual revenue growth through the end of Medtronic’s fiscal year 2015. Ardian’s system allows doctors to deliver radiofrequency energy to the renal sympathetic nerves surrounding the renal arteries. Decreasing conduction of these nerves is seen as a way of triggering the body’s own regulation mechanisms to lower blood pressure. For the past six months, Ardian has been releasing positive results from its ongoing clinical trials with the most recent bit of good news at the American Heart Association meeting this month.--Tom Salemi

Boehringer Ingelheim/f-star: Boehringer's R&D collaboration with f-star this week is yet more proof that the privately-held German drug maker is ramping up its large molecule capabilities. This is the fourth antibody deal Boehringer has done this year alone according to Elsevier's Strategic Transactions, building on collaborations with 4-Antibody, Micromet, and most recently MacroGenics. Financial terms of the latest transaction weren't disclosed, but f-star, a former Series A-list all-star that has pulled in more than $25 million in venture dollars, will receive an initial technology access fee, research-based funding, and of course the potential for downstream regulatory and commercial milestones. In return, f-star will use its modular antibody technology to develop novel therapeutics against up to seven targets nominated by Boehringer that span multiple therapeutic areas. Biobucks for each of the seven targets, to which BI of course holds worldwide rights, could total up to €180mm ($247mm), excluding royalties. (Prompting unintentionally hilarious headlines about the "$1.7 billion" deal.) f-star's technology allows it to introduce additional binding sites into antibodies or antibody fragments, engineering large molecules that can target multiple proteins in a single molecule. Note this isn't the first time BI has signed an alliance focused on antibody fragments (that honor goes to Ablynx back in 2007) or bi-specific antibodies (MacroGenics' DART technology competes with f-star). Such second-generation approaches are a means of circumventing established IP claims for successful traditional antibody therapeutics and may advantages over Mother Nature's molecules, as they are potentially easier to manufacture and can have greater tissue penetration.--EFL

GlaxoSmithKline/Dr. Reddy's: GlaxoSmithKline's deal with Dr. Reddy's for the big pharma's United States oral penicillin facility and product portfolio is an interesting spin on regional deal making. Under the terms of the agreement, GSK transfers ownership of its penicillin manufacturing site in Tennessee and U.S. rights to Augmentin and Amoxil brands to Dr. Reddy's for an undisclosed sum. That GSK would opt to sell out of the US penicillin market isn't too surprising. Back in 2008 the drug maker announced plans to lay off the 200+ workers employed at the 400,00-square-foot manufacturing site by fall 2009 in preparation for sale of the plant because of declining sales of Augmentin stateside as a result of generic competition. Thus, the deal makes everyone happy, allowing GSK to downsize in a market no longer deemed valuable, while still allowing the drug maker to preserve ownership RoW, where GSK sees the potential for growth via its branded generics strategy. Dr. Reddy's, meanwhile, has been angling to scale up its generics business in North America. Thus, this deal gives the India-based giant entree into the US penicillin-containing antibacterial segment and a physical footprint to boot.--EFL

Roche/Ligand: Around the same time Roche decided to close out its R&D work in RNA interference, the Swiss pharma also notified Ligand Pharmaceuticals that it was ending a partnership to develop RG7348 (formerly MB11362) for hepatitis C. This no-deal officially ends the circuitous relationship between La Jolla, Calif.-based Ligand and the Swiss pharma. The tie-up began in August 2008, when Roche paid $10 million upfront to initiate a two-year collaboration with Metabasis Therapeutics to apply the latter firm’s HepDirect platform to Roche’s lead nucleoside candidates for HCV. In June 2009, the two companies chose ‘7348, which had since advanced to Phase I, as their lead candidate, with Roche paying a $2 million milestone to the biotech. Fast-forward to October 2009, when Ligand bought out Metabasis, inheriting the HCV deal. Since Ligand/Metabasis, Roche has paid up another $6.5 million in milestones; for the bean counters in the audience, $2.7 million of that went to Metabasis shareholders who had received contingent value rights in the original sale. Ligand, which says it learned of Roche’s decision on Nov. 19, also completed a one-for-six reverse stock split that same day, reducing current outstanding shares of common stock from 117.7 million to 19.6 million. Despite the no-deal, Ligand still boasts partnerships a plenty, boasting of ongoing alliances with Pfizer, GlaxoSmithKline, Merck, and Bristol-Myers Squibb, among other.—Joseph Haas

HAPPY THANKSGIVING FROM IVB!

Sunday, November 21, 2010

jonah walking (assisted)



The bad boo boos are from a fall he took last Saturday - (this photo is from Wednesday), but they're completely healed now.

With his physical therapist, Ms. Ashley.
She is so amazing. Incredibly blessed to have her in our lives.



 "Look Ma, no hands." (No steps handless yet.)




See? All healed. Praise God!

Saturday, November 20, 2010

captain destructo

Captain Destructo...

Creating a path of disaster wherever he goes...

Leaving no cabinet unopened...

No door knob unwiggled...


("What? I'm cute...")

No string-hanging-down-from-the-stool uneaten...

("What? I'm cute...")

Uh-oh. Captain Destructo has sleepy eyes...

Yep, he's been staring at that dishwasher for five minutes...

Captain Destructo, leaving no nap untaken...
And one mommy with no energy.
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