this and that

Just a quick post tonight. My allergies are knocking me for a loop these last couple days so my energy is low. I've been carrying a kleenex box around with me for the last two days. Bummer.
First, I just found out that Patricia Heaton (you know, Deborah from Everybody Loves Raymond) has pledged to donate $10,000 when Reece's Rainbow Twitter Page reaches 10,000 followers. Pretty awesome huh? What an awesome gift for them! Their twitter page is HERE. Please consider becoming a follower. A small way to make a big difference.

Jonah is running a low grade fever (between 99-103) for the last couple of days. I guess I'll take him to the doctor tomorrow. I don't get it. Today was day 10 of antibiotics. His skin looks great, so I don't think it's an infection, but it still worries me. I would probably give it another day if we weren't going into the weekend. I'm really wanting to make it to church on Sunday. Jonah is starting his new class with the kids HIS AGE (we've held him back with the younger ones since he couldn't walk). But now he's walking and cognitively right with his age group, so now's the time. We're leaving him all by himself, cold turkey, and have given his new teachers a list of "do's and don'ts". Nerve-wracking but exciting! Anyway, if this fever doesn't go away in the next couple of days, I guess, once again, it's no church for us. Hoping it's just a minor virus. No big deal.

In other news, Jonah busted out with "ALL ABOARD" when he was watching his train video on youtube today. The video doesn't say that. I have no idea how he learned it. He then counted backwards from 10 without skipping a beat and yelled, "Blast off!" at the end. I don't know where he learned that either. Obviously, all that TV is rotting his brain.

And just in case you want to see the video that Jonah watches over and over and over again, here it is:

You would really have to love trains to get it, I think. He just watches and giddily screams "Train! Train!" and "Choo-Choo!" It's pretty much the sweetest thing I've ever seen and actually brought me to tears yesterday. I love that kid.

That's it for me. We've mostly been hanging around the house and haven't had a whole lot going on. Hope you have a great Friday!

Financings of the Fortnight Buys Me Some Peanuts and Cracker Jack

Sometimes you go looking for a recovering economy's green shoots and instead you find a pristine swath of outfield grass and a stadium full of fans ready to shake off winter. It's Opening Day, a national holiday in waiting if we could ever rid the Congress of all those football fans.

If you're not in the US, we're talking about baseball. Though it's possible at this moment someone somewhere is getting ready for bog snorkelling season.

And it's also possible they're celebrating in Europe the large Series A round just raised by Swiss biotech Anergis, which we detail below. Big fundings across the pond are few and far between these days, so we can't blame optimists for seeing fundraises like those from Anergis and Acacia (also below) as signs of better things ahead. In venture these days, however, much more optimism is emanating from emerging markets, as this survey suggests.

Ah, regional differences. Without them we wouldn't have such wonderful things as truffle pigs, Diwali, funny Canadian accents, and fish tacos. (And bog snorkelling, of course.) But regional differences also contribute to suspicion, tribalism, and persecution. Sometimes such divisiveness is justified. You simply shouldn't trust certain people.

Regional venture differences are actually a topic for another day, or for op-ed pieces like this one, which piles on anecdotes of bad capitalization and even worse manners to explain the difference between US and European venture fortunes. Today, we cheer the men who take the field as world champions, celebrate our quasi-holiday, and sing. You know the words. Take me out to the ballgame, take me out with....

Anergis: Birch pollen. It sounds so woodsy. Makes you want to pack a lunch and take a hike. But it's no picnic for allergy sufferers, who often have bad reactions to many foods, too, including apples, carrots, peaches and potatoes. Swiss biotech Anergis said this week it has raised a Series A round of CHF 18 million (nearly $20 million) to fund a Phase II trial of its lead allergy vaccine, AllerT, for patients with birch pollen allergies. Before the Series A round, the company had raised CHF 3 million from private investors and a grant from the Swiss Innovation Fund (CTI). Anergis CEO Vincent Charlon told our "Pink Sheet" colleagues he expects to look for additional financing and/or development partners in about two years to advance AllerT into Phase III clinical trials. Anergis' vaccine technology, Contiguous Overlapping Peptides (COP), consists of a mixture of synthetic peptides each identical to a small part of the allergen. Between them they represent the allergen's complete amino acid sequence. The vaccine is administered in five injections over two months to induce immune tolerance. Because the allergen is in sections, the three-dimensional structure of the complete allergen is not present and so cannot bind to immunoglobulin E (IgE) to induce hypersensitivity reactions. This potentially means higher doses of COP-based products can be administered than with other allergy products like intravenous injections or sublingual tablets, and tolerance should occur sooner, in months rather than years. The round was led by Vinci Capital-Renaissance PME and BioMedInvest (managed by BioMedPartners AG), both based in Switzerland, as well as Copenhagen-based Sunstone Capital. -- John Davis

Acacia Pharma: We couldn't make this up if we tried. Not only is Acacia also European, based in Cambridge, UK, but it's named after a tree often blamed for bad allergies. Much maligned, apparently. The tree, that is, not the company, which certainly isn't allergic to tidy sums of venture cash. Acacia said March 31 it has raised a $10 million Series A round from Lundbeckfond Ventures and Gilde Healthcare. Nothing to sneeze at, indeed. The cash will help complete Phase II trials for its two lead compounds: one treats nausea and vomiting in post-operative patients; the other treats severe dry mouth in patients with advanced cancer. Acacia says it aims to build its own hospital-focused sales force for cancer support care in Europe and outlicense its products elsewhere. If you're wondering about Lundbeckfond, why yes, it is related to the drug firm H. Lundbeck. Known as LFI Life Science Investments until late last year, it was founded in 2009 through the holding company that owns the family shares in the pharma company. The evergreen venture firm operates independently, however, in an arrangement similar to the relationship its Danish counterpart Novo Ventures has with the diabetes specialists Novo Nordisk. Our START-UP colleagues delved into Novo Ventures' hot streak in this November 2010 piece. -- Alex Lash

Arena Pharmaceuticals: Buy low, sell high, isn't that how it goes? Not for Arena. Rebuffed by the Food and Drug Administration late last year, Arena said March 29 it raised $35.5 million by selling stock at $1.46 a share, near its all-time nadir. Half the cash will pay down existing debt from the same investor, Deerfield Management, that bought low this week. The only time Arena's stock dropped lower came last November, soon after FDA rejected its obesity treatment Lorquess (lorcaserin) with a complete response letter. The regulatory decision was hardly a surprise; an advisory committee voted in September against approval because of troubling indications of tumors in rats and marginal efficacy. The tumor problem particularly galled analysts and investors, as it had surfaced months before with Arena management downplaying its significance. Arena has said it will re-file lorcaserin this year in the US with its partner Eisai and stump for European approval, as well, though analysts wonder if the company is better off doing a 12-month study to better define the cancer risk. Meanwhile, with $150 million in cash at the end of 2010, Arena is buying financial time. Deerfield bought 12.15 million shares of common stock at $1.46 a share and 12,150 shares of preferred stock at $1,460 a share. The preferreds are convertible to common at any time unless the conversion bumps Deerfield above 9.98% ownership, according to SEC filings. In addition to the stock sale, Arena also repriced more than 14 million warrants held by Deerfield from an exercise price of $3.45 to $1.68 a share. Since Arena's setback, the outlook for obesity treatments has worsened. Development partners Amylin Pharmaceuticals and Takeda Pharmaceutical Co. recently halted Phase II trials of a combination therapy. And FDA has slapped two other drugs with complete response letters: Qnexa (phentermine/topiramate) from Vivus and Contrave (bupropion/naltrexone) from Orexigen Therapeutics. -- A.L.

AssureRx Health: Until now backed primarily by angel groups and individual investors, the personalized medicine startup AssureRx said March 25 it has completed a new Series B round worth $11 million that includes Sequoia Capital, Claremont Creek Ventures and Allos Ventures, alongside several existing investors. Led by Sequoia and Claremont Creek with a smaller contribution from Carmel, Ind.-based Allos, the round exceeds AssureRx’s stated goal of raising $9 million, and builds on $7 million in Series A money that it raised in several installments since 2006. The startup’s product, GeneSightRx, allows physicians to examine a patient’s pharmacogenetic profile via a cheek swab, shedding light on risk factors for specific antidepressant and anti-psychotic drugs and their dosage levels in an effort to avoid trial-and-error prescriptions. Based near Cincinnati, AssureRx also plans to use the funds for a second-generation product. Returning investors for AssureRx’s new round included the Cincinnati Children’s Hospital Medical Center, the Mayo Clinic, and CincyTech; Claremont Creek took two seats on the startup’s board, expanding its membership to seven. Sequoia and Claremont Creek also invested side-by-side in a $17 million Series C round for molecular diagnostics company Gene Security Network in November 2010. -- Paul Bonanos

Photo courtesy of flickr user ShutterBugChef under a Creative Commons license.

UP FOR BID - Pampered Chef Pizza Stone (Forsyth County, NC only)

UP FOR BID - Pampered Chef Large Pizza Stone. Winston-Salem, Forsyth County only unless someone lives around here that can pick it up for you. Shipping cost would be a beast. All proceeds to Anton's Adoption Fund!

Click HERE to check it out and bid.

for daddy

Daddy, while you were at work today, I learned to sing a new song.



And also, now I've taken over your computer and am watching youtube videos of Tweetsie Railroad trains. I want to go to there.

Love,
Jonah

nothing much

I am completely unmotivated these last couple days, so I don't have much to talk about. Jonah and I went and ate lunch with Daddy today (meaning we went through a drive-thru and ate in the car). After we got home, I fed Jonah a small lunch by mouth (maybe about four ounces), and then we both took over a two hour nap. See? No motivation. I have done nothing today.


And then my cat puked on our bed spread and blanket, so we're up late washing all of our bedding. Sure glad I had that nap. She's a good little kitty but if she doesn't stay off of my bed, we're going to have issues.


It snowed here yesterday morning. RI-diculous. It is not fair to be suffering from allergies while watching snow falling out your window. Not natural, I say.


Here are some photos of Jonah bundled up because it was so cold yesterday. It was sunny with a high of 60 today. I'm so confused. And so is my closet.

I'm not sure what was happening here. I may have mentioned the word "night-night".

UP FOR BID - $20 Macy's Gift Card

$20 Macy's Gift Card up for bid on Hope for Anton. All proceeds to his adoption fund. Click HERE to check it out.

UP FOR BID - hand sewn apron

Super cute hand sewn adjustable apron up for bid on Hope for Anton. All proceeds go to his adoption fund.


Click HERE to check it out!

he-man and (part of) happy birthday

If you're not sure about the "I have the power!" reference...



Daddy had to be home every day at 4:30 as a kid to see his He-Man or he was NOT happy. We'll be busting out the He-Man DVD's for Jonah shortly.


(As I type this, Jonah is lying in his bed singing his ABC's. So adorable. I'll try to get that on video next.)

dun-da-da-dah!

SUPER JONAH!

Blurry because I was, once again, refusing to use my flash, but cute anyway. :) I washed Jonah's coat today and was hanging it on a door knob to dry, so of course he wanted to put it on. The outside was pretty dry but the inside was soaked, so we just flipped that sucker inside out and voila! A cape!

Matt's folks kept Jonah this afternoon, so Matt and I got to go to Cracker Barrel (lima beans are the veggie on Saturdays!) for lunch, the grocery store, and Rack Room Shoes all by our lonesomes. We needed the time after a week of me being sick and grouchy. 


And look what we found at our little produce market down the street?

Diet DP in glass bottles! I know, right?

I'm feeling much better now. Jonah is too. He's still coughing, but is way past contagious stage, so we will be going to church tomorrow. I'M DETERMINED!

DotW:Talk Is Cheap; Debt Is Cheaper

Sanofi-Aventis set the debt world aflutter (or is it atwitter these days?) with its massive $7 billion bond offer this week. We'll spare you the gory details; suffice to say there are six tranches and a mixture of fixed and floating rates (tied to the low low 3-month Libor of 0.31). The most important thing to keep in mind? The highest interest rate Sanofi could be paying? 4%.

With debt that cheap who needs to invest in R&D?

It's a relevant question. The only story generating more ink these days than Sanofi/Genzyme (which still manages to capture a weekly headline or two thanks to ongoing production snafus), is Big Pharma's R&D crisis.

Just this week GlaxoSmithKline's Witty took to The Economist with an op-ed about the perils of industrializing the drug model and the need to think (and act) smaller via a new kind of research environment. (Our take on that model is here.) The March IN VIVO has an article of a similar vein from Bernard Munos, the former Lilly exec, who's been one of the leaders in the debate on how to move big pharma out of its R&D slump.

Still, if you believe analyses by McKinsey and other consultancies that calculates the internal rate of return for in-house small R&D at 7.5% at a time when the cost of capital is around 10%, and balance that against the low cost of debt, you start to wonder. It sure seems like big pharmas might be better off in the short term shelving R&D in preference for a more -- how shall we put it? -- transactionally driven approach.

As much as big pharma likes to talk about the intrinsic value of R&D, the real problem for many biopharma players -- and Sanofi definitely falls in this camp -- is bridging the patent chasm looming as blockbusters like Plavix go generic. To solve that problem you don't need R&D, you need products with near-term revenue. A platform for growth is nice, but as the Genzyme purchase shows, $4 billion in annual short-fall is a lot nicer -- and more attractive to investors who are often weighing not whether to invest in Pfizer or Roche of Sanofi but whether to invest in pharma versus IBM and General Electric.

Certainly if debt stays this low, Deals of The Week! ought to continue to be a happening place. And you can't quibble with our value proposition. IN VIVO Blog is one of the few things cheaper than the current borrowing rate, something to consider as you peruse this weeks offering...

Teva/Procter & Gamble: Sanofi-Aventis, which has been snapping up consumer health outfits small and large --think Chattem--for the past two years, may have some competition. This week comes news that the Israeli giant Teva is joining forces with P&G (known to midwesterners as Procter & God --they make diapers so you can understand the appellation) to create an ex-US-focused over-the-counter J/V. Teva doesn't have a sizable presence in the OTC space currently, but P&G does, with its so-called "personal health care" business generating around $2.3 billion in 2010, mostly in the US market. According to execs at the two companies, combined ex-US sales of their OTC products were more than $1 billion in 2010, with projections soaring north of $4 billion in a "a few years." As part of the deal, Teva gains access to P&G's leading OTC brands, including Metamucil and Pepto-Bismol. In exchange, P&G said it will benefit from Teva's broad geographic reach, its manufacturing capability and portfolio of 1,500 active ingredients. Teva has a stronger distribution network to pharmacies, whereas P&G has a stronger network to food and mass retail outlets. P&G is a recognized world leader in consumer brand marketing, an expertise Teva plans to tap. But while the consumer space is hot -- Sanofi isn't the only big pharma avidly interested in selling medicines direct to consumer -- the real rationale for the deal may be in creating a powerhouse well positioned to move Rx products to OTC. It could be tough to beat a Teva/P&G juggernaut in the switch, given Teva's R&D capabilities and P&G's brand equity. Sanofi's Chattem, beware.--Jessica Merrill & EFL

Cephalon/Gemin X: When Cephalon announced March 21 it was buying privately-held Gemin X in a deal worth $225 million upfront, the twitterverse erupted, with at least one biotech watcher tweeting -- and we are paraphrasing -- "one of these days CEPH will buy a company I've heard of." You may not know Gemin X from Adam, but it's true the specialty pharma has a penchant for seeing value in companies Wall St. finds arcane. Mesoblast? Ception? BioAssets? The Gemin X deal gives Cephalon two mid-stage oncology assets, including the pan-Bcl-2 inhibitor obatoclax, which will help bolster an aging franchise dominated by CLL therapy Treanda and cancer pain treatments Fentora and Actiq. Given obatoclax's Phase IIb status, the deal's price tag seems to be at a discount to acquisitions of other oncology players with assets at similar stages of development. In particular the upfront is about 60% what Gilead paid for Calistoga to obtain that privately-held biotech's selective PI3 kinase inhibitor. Nor is this take-out providing Gemin X's dozen or so backers, which include Sanderling Ventures, HBM Partners, and ProQuest-- much of a return. The upfront price is about $100 million more than the company says it raised in private venture money since its 1998 founding.--Lisa Lamotta & EFL

Sanofi-Aventis/The Vision Institute: So pharma’s sharing-caring, all-embracing, academia-targeted R&D approach continues: Sanofi Aventis this week added two further public-private partnerships to its research network, one on each side of the pond. The first was a three-year R&D alliance with the Vision Institute in Paris, France (the second is a three-year diabetes tie-up with scientists at Columbia University Medical Center in the U.S.). The ophthalmology deal stems directly from Sanofi’s 2009 purchase of eye-disease focused biotech Fovea, which is based on the Paris premises of the Vision Institute. Created in 2008, the Institute houses research teams from several of France’s top-ranking research centers, and is located within the Quinze-Vingts National Ophthalmology Hospital. Its director, Prof. Jose-Alain Sahel, helped found Fovea in 2005. Not content, it seems, with owning Fovea – now the Big Pharma’s ophthalmology division – this deal grants Sanofi “priority access” to the Vision Institute’s technological platforms, and commits the Big Pharma to supporting research projects in the areas of optical nerve regeneration, vascular biology, inflammation and gene therapy in various eye tissues. Sanofi will get exclusive global rights to anything resulting from the collaboration, and pay royalties. Fovea’s pipeline includes two Phase II compounds for retinal vein occlusion- induced acute macular edema and allergic conjunctivitis, respectively; Sanofi also has some pre-clinical gene-therapy candidates in eye-diseases from a 2009 deal with U.K. biotech Oxford BioMedica. It’s not clear how many Sanofi scientists are involved in the Vision Institute tie-up, nor what their hoped-for goals are for the three-year partnership. But the emphasis on translational R&D, the highly fashionable magic mix of private and public research, and on co-location – a driving force behind the creation of the Vision Institute as well as this deal – remind us of Pfizer’s flavor of public-private partnership, the city-based Centers for Therapeutic Innovation.--Melanie Senior


Merck/Portola: Is Merck still king in cardiovascular? In mid-January the big pharma pulled the plug on Phase III trials of its anti-clotting agent vorapaxar (remember, that was one of the major assets of the Merck-Schering reverse merger?). Now comes news that Merck is giving back to partner Portola Pharmaceuticals full rights to the Phase-III ready oral Factor Xa inhibitor betrixaban. The reason? Apparently a pipeline review. (Makes you wonder, huh?) Oh, we know the oral anti-coag space, one of the few arenas where you can point to drugs with blockbuster potential, could be a tough one to conquer if you're as far behind development-wise as betrixaban is. Boehringer Ingelheim's direct thrombin inhibitor Pradaxa is already on the market in the US and Europe; two Factor Xa inhibotors -- J&J/Bayer's Xarelto is pending with US regulators and apixaban (from Pfizer and BMS) is a not too distant third -- are next in line. In today's cost-constrained environment is there room for a fourth warfarin replacement? Maybe, but the drug won't just have to be superior to warfarin; coming so late to market, it's likely it would also have to be a damn sight better than the newer agents OR priced at a significant discount. And given the size of Phase III trials required to demonstrate the safety of cardiovascular drugs, pricing at a discount could be a money losing proposition.) Portola put a brave face on the news, talking up the advantages of having a wholly-owned Phase III asset and its desire to work with academic partners like Duke Clinical Research Institute. But the privately-held company, which has raised over $200 million in venture capital and debt since 2003, only has a $100 million in its coffers. Can it afford to run the Phase III trials on its own? Will its venture backers support such a decision? No and probably not. (In prior statements, Portola's CEO Bill Lis has estimated pivotal trials in just one indication could run as high as $400 million.) In the meantime, Portola and its venture backers have to be hoping partner Novartis, which paid $75 million for rights to the anti-thrombotic elinogrel doesn't have a change of heart.--EFL

Merial/Intervet: A little over a year after Sanofi-Aventis and Merck revealed they would combine their respective Merial and Intervet divisions to create the top dog in animal health, the pair decided to call the whole thing off. The logistics in settling anti-trust concerns are just too complicated to make the planned J/V worthwhile. It's not as if these anti-trust issues are new; since the 2010 announcement, market analysts have predicted a consummation would only occur if the companies divested assets worth about $500 million, much in the poultry vaccines arena. (In this case getting rid of the chicken would have had to come first.) In a joint statement, Merck and Sanofi announced each company will retain its current, separate animal health assets and businesses.There is no break-up fee and Sanofi and Merck will cover their individual expenses for the past year’s diligence. (Isn't it nice when a planned deal unwinds so easily?) --Joseph Haas

Image courtesy of flickrer Steve Rhodes via a creative commons license.

feeling human again

Just wanted to blog really quickly, while I eat my lunch (that's right, I'm eating again), and let you know that we're okay. I started feeling some better yesterday and although my throat is still a little sore, it's NOTHING compared to how it was. I'm feeling human again! :) I gargled warm salt water... and also peroxide. Not at the same time because THAT would be crazy.


Jonah is doing well but continues to cough a lot. He only threw up a little mucus this morning (hope you're not eating too) instead of his entire breakfast, so we'll take it. He's napping peacefully now.

Matt's parents are coming for a visit tonight, so Jonah will be super pumped about having his Granny and GrannyDaddy here to play with tomorrow.


A few cute photos of Jonah that I snapped this morning so you know he still exists.

I had a crazy dream the other night. And it was before I got sick, so I know I can't blame on all the drugs I've been taking. I dreamed that aliens were taking over and had just told us they were about to blow up the world from their huge spaceship. (Matt watches "V" and unfortunately I'm usually in the room when he does.) I was in the house where I grew up, but I was an adult. We all went outside. I handed Jonah to my dad. I looked at my parents, Matt, and who(m?)ever else was out there, and I said, in a very bold voice, "I call dibs on Gabe. Let's do this." No fear at all. Pure courage and excitement. It was pretty badass if I do say so myself. 


I guess that's what Jesus will do for you. 


My idea for "Jesus makes you Badass" t-shirts might not go over too well. Unfortunate.


Oh yeah, there's a couple new posts up over on Hope for Anton. One is a Gold Canyon (candles, bath and body etc) Fundraiser with 25% going to Anton, and the other is CJ, the maker of these cards, offering to donate 50% of all proceeds from her Etsy shop for the foreseeable future! Bidding on the Bow Holder and Clips ends at exactly 9:00 EST tonight. Make sure you are a follower (or whatever) over there so you can keep up. We have some GREAT stuff happening and more to come!


Hope you all have a happy and blessed weekend. Love those around you well, even the ones you don't feel like loving. They need it the most.

AZ's Payer Push No Help to Brilique in France

These days, you've got to schmooze with the payers as well as the regulators. AstraZeneca knows that; it has indeed been playing up its payer-focused strategy, with recent declarations of its bid to become "the number one company in terms of payer interactions," according to top AZ dealmaker Shaun Grady.

So it should have known that just because clot-buster Brilique was approved by the European authorities in December 2010, that wasn't the end of the story. And indeed, the French health technology assessment agency, known as the Transparency Commission, following a Jan. 19 review meeting, rejected the drug for reimbursement/pricing discussions. Hence AZ withdrew its submission.

The agency is concerned about the drug's side-effect profile, and was also influenced by FDA's lukewarm response to AZ's application for approval in the U.S.: FDA in December sent the company a complete response letter questioning the drug's efficacy in U.S. patients.

Fair enough; after all, the drug didn't seem to work among the U.S. cohort of AZ's 19,000-patient, multi-national Phase III trial. There are all sorts of discussions ongoing as to whether it's because the U.S. patients were on higher aspirin than those in other countries. According to AZ, the French want to see additional information, including clinical data contained within the company's response to the CRL, which was submitted on Jan. 21. (In other words, too late for the French meeting).

Anyway, the moral is that payers are likely to jump on concerns raised by any approval agency, even those outside their own territories. (We don't suspect France's concerns are anything to do with the fact that the genericizing competitor drug Plavix is ... well, French.)

It's tough luck for AZ, though, despite its best intentions (..."we're meeting payers' needs for value-based product differentiation by improving our ability to assess clinical and economic outcomes in real-world populations (as an example, earlier this year we announced a new outcomes study we were kicking off for Brilinta) declared an AZ spokesperson earlier this year).

France accounts for nearly a third of the market share for anti-platelet drugs in Europe, according to Sanford Bernstein analyst Tim Anderson. And AZ needs Brilique it faces expiries for Nexium and Seroquel. It also needs the drug to start generating revenues fast, because Plavix is either going or gone off patent.

AZ says it plans to supplement the Brilique reimbursement dossier and plans to resubmit to France's Transparency Commission within the coming months. Hopefully for it, the French set-back won't give FDA, set to rule by July 20, any further concerns. Anderson suggests in a March 23 note that "the odds of a negative ruling would seem to increase at least slightly."

Zut alors.

Update: AZ has corrected us on a couple of technicalities: The Transparency Commission didn't actually reject Brilique, they asked for additional information, and AZ withdrew its submission. Similarly, FDA wasn't questioning the drug's efficacy in U.S. patients, it was requesting additional analyses with respect to those patients. Sorry.

new day same sickness

Still feeling like a Crap Wad over here. I chose last night to tell Matt our plan in case anything ever happens to one of us during the night. I told him to call our neighbor Barbara to come sit with Jonah until my mom could get here. Why did I choose last night to tell him? 


Because I had taken -
- at least 15 ibuprofen in less than 24 hours
- hydrocodone
- two doses of my antibiotic
- Singulair 


and I think some other stuff. I was just waiting to stop breathing or go into some kind of spontaneous liver failure or something. Not really, but I was nervous.


Today I added Mucinex and Tylenol to the mix. Just trying to survive over here. My throat hurts so badly that I've barely eaten today. And if you know me at all, you know that for me to give up any amount of food means that things are bad. If you have the overwhelming urge to specifically pray for the right side of my throat, feel free to indulge. I know it's not strep. I got a strep test done at CVS yesterday. The quick test was negative and they called me tonight to let me know the longer one came back in negative too. So I'm thankful for that but ready for the current antibiotics to do their (freakin') job already. :)


Enough about me.


Jonah had a decent day. Still coughing. Threw up twice. But took an awesome nap (which means I did too!) and has been happy and mostly easy on me all day. My dad is here for a couple of days, so Jonah's really enjoyed having him around. I couldn't have asked for him to be any better today, considering how crappy I've felt. He's a gem. 


Matt is amazing. He's pretty much taken over most Jonah duties after work the last two days, and given me as much of a break as possible. And tonight, after he put Jonah down for the night, he went all the way across town and got me a Sonic chocolate milkshake. He's a super gem. And my sweet mother in law drove home last night in the dark (she's my Monday/Tuesday help every other week) so she could help Matt and I could rest. She usually leaves at 3 or 4 in the afternoon but stayed until 7, and then drove three hours home.


Moral of the story: I'm a pansy when I'm sick.


Glad Jonah doesn't take after me in the toughness (or lack thereof) department. 

Down On The Pharm: Implications of the Merial/Intervet "No Deal"

Merck and Sanofi-Aventis’ joint decision March 22 to shelve the planned merger of their animal health units may have left the other big pharmas playing in the space acting a bit like … well, chickens with their heads cut off.

Some industry observers may view animal health as -- dare we say it -- small potatoes. But a quick look at 2010 sales growth rates for big pharma animal health units indicates such business is not a poultry (er, paltry) matter.

A little over a year after the two companies revealed they would combine Sanofi’s Merial division with Merck’s Intervet to create a business with over $5 billion in annual sales, the pair decided there are just too many antitrust complications to make the joint venture worthwhile. Originally hoping to complete the merger within 12 months, Sanofi and Merck earlier this year announced it would not be finalized earlier than third-quarter 2011.

Market analysts expected a set of divestitures totaling about $500 million would have been necessary to pull off the deal, with Dow Jones reporting that the combined company’s holdings in poultry vaccines likely would have attracted antitrust scrutiny.

In a joint statement, Merck and Sanofi said each company would retain its current, separate animal health assets and businesses – there is no break-up fee and each company will cover its own expenses for the past year’s due diligence. (Isn't it nice when a planned deal unwinds so easily?)

The two companies were partners in animal health previously, jointly owning Merial, but Sanofi bought out Merck’s share of that business in 2009 as part of the antitrust review that eventually okayed Merck’s merger with Schering-Plough. Intervet was among the assets Merck acquired in that transaction, meaning the New Jersey pharma essentially stepped out of and back into the animal health business simultaneously.

Seven of the 12 publicly traded big pharma companies participate in the animal health business, along with privately held Boehringer Ingelheim. On March 15, Eli Lilly made an undisclosed offer to buy out Johnson & Johnson’s relatively small, Europe-based animal health business. But will Merck and Sanofi’s abandoned deal and the relative parity within big pharma animal health lead to additional M&A or some of the players exiting the space?

Pfizer, which acquired Fort Dodge Animal Health in 2009 as part of its merger with Wyeth, has talked recently of selling off units and focusing more on core businesses under new CEO Ian Read. Might it want to sell off its animal health unit, which generated $3.58 billion in sales, overall a bit more than 5% of the entire Pfizer enterprise, last year?

If so, would Lilly, at roughly two-fifths the size of the world’s biggest pharma company, be both willing and able to absorb Fort Dodge? Likewise, could smaller animal health players Bayer HealthCare and Novartis be looking to grow their divisions?

It’s worth noting that all of the five big pharma companies that reported their animal health revenues for 2010 recorded sales growth during the year, ranging from 2.6% for Sanofi to a very healthy 29% for Pfizer. (Pfizer’s number needs to be rationalized, though, with the reality that its growth was generated partly by the acquisition of Fort Dodge, not just sales increases.) Bayer and Lilly both enjoyed animal health sales growth in the 15% range, indicating why the firms’ may be interested in expanding that portion of their businesses.

By Joseph Haas

Image courtesy of flickrer terrydu used with permission through a creative commons license.

UP FOR BID - Monkey Bow Clip and two hair clips of choice

Up for bid on Hope for Anton. This adorable Monkey Bow/Clip Holder and two bows of your  choice!

Check them out HERE and the cute baby girl hat is still up until tomorrow night!

bummage in the williams household

Things are a little rough here today. My sinus headaches from this weekend have turned into a full blown sinus infection. I only feel okay if I'm loaded up on at least 600 mg of ibuprofen. Otherwise, I'm aching, my ears and head hurt, and my throat hurts so bad I can barely talk or swallow. Stinks. Anyway, I started on an antibiotic today and I'm going to take another dose before bed, so hopefully I'll be feeling better fast.


Jonah's still sick, but I took him to the pediatrician today. She's started him on an antibiotic (apparently he's got the beginnings of a sinus infection too), and we came home with a nebulizer and Pulmicort! We have some Albuterol too, but I'm not planning on using that unless it moves down into his chest. So far, it's all upper airway. We may not have success with the Pulmicort, but at least it's something to try. Jonah was not a fan (to say the least) of us blowing that stuff in his face, but  hopefully he'll get used to it.


I'm missing my Radical book/Bible study tonight, and these girls (well, except Vanessa, cause you know, she lives in Texas)...

... which is a real bummer. 


Please don't miss the cut pink/tangerine baby girls' hat over on Hope for Anton. It's size 3-6 months, ADORABLE, and currently has no bids!


Hope you all are having a God-is-slapping-me-in-the-face sort of week.

What Biotech Wants From Big Pharma Partners: Survey Says!?

With Big Pharma's internal R&D productivity in the proverbial toilet, business development plays a critical role in securing drugmakers' future wellspring of innovation. Thus, what biotechs think of pharma as partners matters, perhaps more than it ever has before.

Two companies that can pat themselves on the back? Roche and Merck & Co., who took home top honors as best partners in a recent survey of biotech execs published by the Boston Consulting Group.

GSK, Novartis, Eli Lilly and Pfizer also scored well, with one biotech – Celgene – sneaking onto the leader board with the third-highest proportion of respondents having a favorable impression of the company’s partnering capabilities. (Celgene's appearance shouldn't surprise our blog readers; in our 2010 Deals of the Year competition, the biotech, whose deal making prowess will be analyzed more completely in an upcoming IN VIVO feature, chalked up wins in two different categories.)

The BCG survey is the fourth in a series, following similar efforts in 2003, 2006 and 2008. The goal, says BCG partner Simon Goodall, is to determine the key characteristics companies are looking for in a partner, and which buy-siders are best fulfilling those wishes.

The survey was sent to about 500 heads of business development and chief executives during the summer of 2010, and the results are based on approximately 100 responses. Interestingly, BCG found that changes in Big Pharma corporate leadership could impact the perceptions of potential biotech partners quite quickly; despite Chris Viehbacher’s short tenure at Sanofi-Aventis, for instance, biotechs believe the French pharma is a more attractive partner because of its more outward-looking focus.

Moreover, views of Roche and Merck were not hurt by their respective mega-acquisitions of Genentech and Schering-Plough. And Japanese companies – which scored poorly in earlier surveys and were largely indistinguishable in potential partners’ view of their characteristics – have made great strides both as a group and individually. Several now score above the average overall.

“In 2003 the results told us that everyone was awful,” recalls Goodall. Less than one in three companies received a positive overall response from BCG’s list of biotech partners. Those results improved in 2006, and again in 2008, with nearly half garnering positive responses. At the same time the list of biotech ‘wants’ shifted from solid commercial capabilities to a willingness to allow biotechs to retain control over their assets. At last reckoning, in 2008, the full impact of the financial crisis was yet to be felt by the biotech community, says Goodall. “They felt they wouldn’t be as badly affected as pharma,” he says.

The financial meltdown and its impact on the biotech financing climate have helped to shape biotechs’ current wish list of important partner characteristics. In 2010, practical considerations like clinical and sales/marketing capabilities, alongside a partner’s ability to add value to a biotech’s compound, rose to the top of the list. Fuzzier characteristics, including ‘responsiveness during the deal negotiation process’, ‘fit with corporate culture,’ and ‘alliance management capability’ faded in importance. Even so, “organizations are thinking more carefully about how they project a partnership image,” says Goodall. “There’s a careful orchestration and coordination and companies are recognizing they need to make decisions more quickly, and be more efficient.”

BCG has not divulged the “losers” in its survey (feel free to ruminate in the comments below), and so we’ll have to make do with analyzing which pharma companies performed the best against key characteristics in the eyes of the respondents.

Ranked as a percentage of responders that agreed a company exhibited particular criteria, Roche struck gold in four categories, as the company is most associated with deal structure flexibility, executive leadership, alliance management, and manufacturing expertise. Merck led in five categories: responsiveness, BD/licensing group access, therapeutic areas of interest (tied with Novartis), control over development, and ‘develop and prosper,’ a metric related to post-deal success.

Pfizer and Novartis took honors in three categories apiece. Novartis took the prize for TAs of interest, regulatory capability, and research expertise. Pfizer excelled in global reach and access/reimbursement, as well as in an area it would perhaps rather forget: ‘pay highest price.’

Price tags aside, on the whole it appears that industry is moving in the right direction -- and when business development is companies' best hope at securing the next generation of important, valuable drug candidates, that's good news for everyone.

UPDATE: you can request a copy of the survey here.

UP FOR BID - infant girls hat 3-6 mths

SUPER cute baby girls' hat UP FOR BID on Hope for Anton. ALL proceeds go to his adoption fund!!! Check it out - http://bit.ly/eFRtQF

sheesh

Tonight's two pages.

The letter is here so you can stop squinting now.

And I would tell you how long they took me, but honestly, it's starting to get embarrassing.

And I would also tell you that I couldn't upload these TWO photos without buying more photo storage space from Google...

and that when I went upstairs to get my wallet, I knocked my Nifty Fifty onto the floor...

and that I feel like my blood pressure is sky rocketing right now...

and that I feel like being a sarcastic Sassy Pants because I just read Boo Mama, and she always makes me feel sassy...

But I won't.

Instead, I'll give you some Jonah and Daaapid cuteness to make your Monday night (err, almost Tuesday morning) a little cheerier.

You're welcome.

And on a super happy note, we are now out from under the holds of DirecTV. Take That, satellite company. Sometimes it feels really good to fight The Man. Why, Hello, Time Warner Digital Cable, so good to see you and your far superior DVR... ohhhhh High Def. How delightful. For $40 less per month? Don't mind if I do!

Lia Sophia Jewelry Fundraiser

Lia Sophia Jewelry Fundraiser going on at Hope for Anton. One week only! 30% of sales go to Anton's Fund and there are some AWESOME specials this month! Hope you can stop by. 


http://hopeforanton.blogspot.com/2011/03/lia-sophia-jewelry-fundraiser.html

Pfizer Channels Economist E.F. Schumacher

Okay so how 'bout that for an esoteric title?

Permit IN VIVO to flash back to the 1970s for a few minutes. In 1973, British economist EF Schumacher published his landmark series of essays Small Is Beautiful during the midst of an energy crisis and a raging debate about the risks of nuclear power. Among the many notable passages in the treatise is this gem:

“Even today, we are generally told that gigantic organizations are inescapably necessary; but when we look closely we can notice that as soon as great size has been created there is often a strenuous attempt to attain smallness within bigness.”

Schumacher, who worked with John Maynard Keynes and John Kenneth Galbraith, didn’t aim his book specifically at biopharma, but it’s striking how relevant the concepts proposed – especially the notion that “the fundamental task is to achieve smallness within the large organization” – are to our industry. As it faces its great R&D stagnation, Big Pharma is on the undeniable quest to manage size, creating smallness within the bigness in hopes of improving upon its innovation track record.

In their R&D strategies, GlaxoSmithKline, AstraZeneca, and Sanofi Aventis are all at different places in terms of promoting the small is the new big concept, with GSK leading the charge. Years into a radical R&D reorg, Glaxo continues to evolve its model, with the goal of integrating its biotech-like drug units with the respective downstream medicines development centers to create end-to-end business groups.

Beyond R&D, there’s also the raging “focus versus diversification” debate, which gained new significance after Bernstein Research’s Tim Anderson published a March 14 note suggesting the world’s biggest pharma was mulling the heretofore unthinkable: shrinking from its outsize $67 billion revenue base to a much more modest—and manageable—base of $35 to $40 billion. ( For those keeping score –and since March Madness has begun who isn’t?—it’s a question IN VIVO explicitly raised two years ago in “Why Doesn’t Pharma Get Smaller?”)

Say what? Didn’t Pfizer buy Wyeth after jettisoning its own consumer health program in part to lessen its exposure to high risk-- and expensive to develop--innovative therapeutics. Given Pfizer’s lack of immediate success, do we now throw the idea of the industrial pharma out the window?

Maybe not. Just days after the Bernstein note came news that Eli Lilly wanted to bulk up its own animal health division via the acquisition of J&J’s Janssen Animal Health group. And there’s no doubt GSK, Sanofi, and Novartis remain enamored with the diversified approach: each has formidable consumer health care operations and emerging markets strategies relying on selling branded generics. Novartis has of course pushed into commodity generics as well, through Sandoz, and still manages to notch innovative R&D successes: If the launch of the first-in-class oral multiple sclerosis drug Gilenya wasn’t proof enough, look at last week’s announcement that the pharma’s Phase III Janus kinase inhibitor INC424, partnered with Incyte, has wrapped a second pivotal trial and is on track for EU and US regulatory filings by Q2 2011.

Make no mistake. Pfizer’s ruminations on the spin-offs of its four non-traditional pharma businesses – as well as its Established Products Unit – seem unlikely to spark an “hey everybody, let’s get small” moment. That’s because there’s still plenty of risk in the high flying R&D model espoused by companies like BMS (and Amgen). One only has to look at new mechanisms like UnitedHealthcare’s Cancer Care pathway program, which bundles payments to doctors using evidenced-based medicine guidelines, to see how changing reimbursement practices could make new product launches tougher.

So maybe the lesson isn’t that everybody should get small, but some companies definitely ought to get smaller. If the words of one of Pfizer’s top executives, head of R&D Mikael Dolsten are any guide, the big pharma’s management is coming ‘round to this way of thinking. Speaking at Barclay’s Capital investor conference March 17, Dolsten emphasized: “We need...to understand what is the maximum value for those businesses, which of them actually have a higher value by being inside Pfizer…and which would...create more value for shareholders outside the company."

Let’s suppose Schumacher is right and “the large-scale organization is here to stay.” As he points out in Small Is Beautiful that also means “the stronger the current, the greater the need for skillful navigation.” For biopharma this entails managing size appropriately to restore R&D productivity but in such a way that it is possible to mitigate the risks associated with health care reform and payor decisions.

At the end of the day, a behemoth the size of Pfizer may just be too damn big to be flexible enough to pivot in a rapidly changing health care environment.

a crib sheet revolution!

UM, how have you guys not told me about these??? (And if you have told me, don't burst my bubble. Allow me to bask in my self-righteous forgetfulness.) You've been holding back. Vanessa just told me about these QuickZip crib sheets, and they are changing my world. EB Moms, you're going to want to get in on this one. 

When you go up to get your EB Baby out of bed (or at least, this is the case with MY EB baby), the sheets are typically covered with anything from blood to vomit to Aquaphor/Polysporin or are soaked from a leaking night tube. Every day, instead of having to change the crib sheet (my most hated chore), I would cover the sheet with two pads, two standard size pillow cases tucked in the vertical ends of the mattress, and two king sized pillow cases tucked across the mattress horizontally. It sounds ridiculous, I know. It was, but between having to protect the sheet and make sure Jonah was sleeping on something soft, it was necessary.


But then, Vanessa told me about these! (And she consequently returned any favor that I might have done her. I may have given her an EB education, but she revolutionized MY MOST. HATED. CHORE.)

Anyway, you can get these sheets HERE. You put the mattress inside the bottom sheet and just zip the sheet tops on and off, just like a jacket, as needed. No more bloody knuckles! I will have to zip a new one on every day but who cares? Compared to the hoopla I was dealing with, this is a piece of cake!

And they come in a "minky" material which is a really soft velvety type material. Perfect for a sensitive face!

I know I sound like an infomercial but seriously, it's GENIUS. I wish I had thought of it. Dang it.

This is Jonah's bed. QuickZip base sheet, mattress, soft and padded waterproof pad, zipper sheet, bottom bumper pad to protect his face from the bars, and the upper bumper pad to try to keep him from putting his ankles through the bars. 

And in case any new EB moms are reading this, I also really like:
Cherokee brand t-shirts from Target. (Super soft with stretchy necks.)


New Balance Extra Wide velcro shoes. (The only ones I've ever easily gotten on Jonah.) 


And SmartKnit Seamless Sensitivity Socks (The only ones I've found that really don't have a seam.)


Okay, thank you for indulging the most boring post ever. I'll try to do better tomorrow. :)
(And even though I feel really stupid saying it, I haven't been paid to say any of this stuff. The End.)