one semester of spanish love song

I just wanted to share this video of how to use minimal Spanish to woo your love. One of my fellow teachers showed this to me my last year of teaching, and I thought it was hilarious... and so true. My kids loved it too.

Thanks, Amy T., for reminding me. I needed a laugh. Good memories. :)

(And I'm kind of posting back to back here, so make sure you don't miss Jonah's 15 month post.)

jonah's fifteen month post

I back-posted Jonah's fifteen month post. I wanted it to be in the right order (it's been a looooong week), so you can see it here.

this and that

This will be short, but I just wanted to check in.

Jonah and I have had a very rough week. Sunday through Thursday was spent with him not being able to tolerate his formula and throwing up and me cleaning up vomit and trying to figure out what in the crap was going on. The last few days I've spent blending food, cleaning up my kitchen over and over and over again, calculating calories, working on a ridiculously detailed spreadsheet, and struggling to keep Jonah fed and hydrated. He's not throwing up now because I've cut out bottles completely. He's getting three tube meals a day (and whatever solids he'll eat by mouth) and getting an overnight drip of water and/or Pedialyte. Right now we're doing 20 ml per hour. I can't get him to drink any fluids by mouth during the day.

And on top of all that, he has been EXTREMELY fussy and often times inconsolable. I don't think it's physical pain because when I put him in the car or put on one very specific video or let him play with his ball popper, he's fine. But ANYTHING else ticks him off - including going places, even Target. He's never been unhappy in Target. My mom moved into a new house today, and I took him over there for about an hour and a half this afternoon, and he fussed and cried the entire time. We're having a hard time finding time to leave the house between nap times, food prep, 45 min to one hour feeding sessions, clean up and dressing change. This past week, he got to go to church on Sunday and Target on Friday. And then we got out once today. But even when we do get out, the only time he's happy is in the car... not when we arrive at our destination.

I haven't blogged much about all of this because honestly, I've been so tired, frustrated, and ticked off, I knew I would just sound whiny and be a downer. So anyway, I'm going to try not to complain too much, but it has been a long week.

I really ask for prayers for whatever is going on with Jonah that's making him so difficult. Maybe it's teething, but it sure is selective teething. I'm really wondering if it's behavioral and if it's that Jonah is cooped up in this house so much, he's really starting to have trouble adjusting to situations outside of the normal (our toys, our house, me). That makes me so sad.

So anyway, I'm looking forward to next week, and I'm so glad Matt's off work on Monday.

DotW: Navel Gazing

It was a week of painful navel-gazing from many in the venture community, as some of the industry’s best and brightest gathered in Napa for the annual C21 Bioventures conference at the Meritage Resort.

A panel of VCs kicked off the event with a gloom-and-doom overview of the private financing world. As Ilan Zipkin, a partner with Prospect Ventures succinctly put it, "It’s a good thing we’re not holding this meeting in San Francisco. Here in Napa there are no bridges to jump off."

Ouch. Are things really that bad in private biotech land?

As we’ve been pointing out for some time, for VCs, the answer is yes. Funds raising money now are having a tough time and the expectation is future fund sizes will be smaller too, with returns down across the board. As InterWest Partners’ Chris Ehrlich put it: "People feel worse about themselves. LPs, the life blood of capital for venture, are saying the role of VC an asset class is limited. That casts a pall." Ehrlich likened the current climate for VCs who came of age in the most recent decade as "born in the crossfire of a hurricane." (Our heart goes out to Ehrlich and we’d likely be far more sympathetic--if we weren’t in the publishing industry.)

For biotechs looking for financing, things are a bit more hopeful, thanks to the rise of corporate venture groups, including newly formed units from Boehringer Ingelheim and Abbott. But certainly expectations must be adjusted. In terms of exits, Alison Kiley of Alta Partners is telling her firms to "keep their heads down, operating as if there will be NO IPOs." And, as IVB has said in the past, the shift is away from big M&A to back-end licensing deals, with pharmas using their leverage to make smaller biotechs share the risk and cost of early stage drug development. Still, a negative discussion about the rise of option-based deals in the final panel of the first day suggests many in our own industry are refusing to face up to the new economic realities.

In the words of the immortal Charles Darwin, it’s worth remembering that "It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is most adaptable to change."

Of course, VCs and early stage biotechs aren’t the only ones who need to adapt. J&J and BP come to mind as well. On that cheery note...we break for a holiday weekend and no more tsk-tsking from your mother for wearing white shoes. It's time to fire up the barbecue, crack open a cold one, and turn on the tunes (The Ramones "I want to be sedated" and Greed Day's "Basket Case" come to mind.) All the while reading another edition of …

Sanofi-Aventis/ Nichi-Iko: Sanofi’s deal team has been on a role, especially when it comes to inking very early stage collaborations (see below) or tie-ups with players in the consumer and generics spaces. (So much for the coming M&A storm, eh?) The French drug maker continues its eastward march, moving from Poland to Japan this week with a joint venture with one of the top Japanese generics’ firms, Nichi-Iko. Sanofi-Aventis owns 51% of the new J/V which is less than creatively named Sanofi-Aventis Nichi-Ikko K.K. (we’re guessing the abbreviation of choice will be SANI not SANK.) One of the J/V’s top initial priorities will be to rake over marketing and distribution rights in Japan for Sanofi’s anti-insomnia medicine Amoban, which generated 2009 sales of roughly €43 million. As our sister publication PharmAsia News has noted many a time, western pharmas are increasingly interested in tapping into the Japanese generics market because of a series of national policies that are encouraging generic drug use. (Japanese cos are interested too; hence Daiichi’s desire in 2008 to take partial ownership of Ranbaxy.) Pfizer, Merck, and Novartis have all made forays into the Japanese generics market, as has Teva. In allying with Nichi-Iko, Sanofi gains a considerable footprint in the island nation. Nichi-Iko owns five distribution centers and supplies drugs to 120,000 medical facilities in Japan. Last month the company reported generic sales grew 13.7%, with net profits up 103.9% for the quarter ending in February.—Ellen Foster Licking

Sanofi-Aventis/Massachusetts Institute of Technology: Another week, another corporate/academic research collaboration surfaces. This week it’s Sanofi-Aventis’ turn to make headlines, announcing a three-year, $4.2 million research collaboration with MIT’s Center for Biomedical Innovation. The collaboration's initial focus will be in the areas of nanotechnology and biologics. Although no funding has been awarded yet, the pharma is most interested in emerging technologies that provide new solutions for patients, such as next-generation nanoparticles for drug delivery, novel sensor technologies for diagnostic purposes, needle-free and wireless drug-delivery tools, and devices that monitor clinically relevant metabolites and biomarkers. As such, it fits Sanofi’s evolving belief that the drug companies of the future will be those that provide not just pharmaceuticals but end-to-end health care solutions in the vein of its recent acquisition of glucose monitoring play AgaMatrix. The MIT partnership will build on Sanofi's existing presence in Cambridge, Mass., which includes a 60-person research center and the company's vaccine subsidiary, Sanofi Pasteur Biologics. With Big Pharma companies looking at ways to reduce R&D spending, low-risk partnerships with academia and startup drug companies, in which drug makers get access to external R&D for a nominal price, are becoming more common. Pfizer recently announced a five-year tie up with Washington University in which university researchers are granted access to Pfizer compounds and data in a reprofiling effort. In the case of Sanofi's alliance with MIT, a joint steering committee will allocate annual grants ranging from $100,000 to $150,000 to academic researchers, with the French pharma holding an option on any completed research to fund further work.—Joseph Haas

Clovis/Avila: Clovis Oncology, which raised an impressive $145 million Series A in 2009, has partnered with three-year old Avila Therapeutics to develop and commercialize Avila's preclinical epidermal growth factor receptor (EGFR) mutant-selective inhibitor (EMSI) and a companion diagnostic. Under the terms of the deal, Avila and Clovis will collaborate on the preclinical development of the drug, which is being tested as a potential non-small cell lung cancer therapy. Clovis bears responsibility—and cost—for the drug’s clinical development and commercialization, as well as for the creation of the diagnostic. Total biobucks associated with the deal are $209 million, with Avila receiving an undisclosed upfront fee. For Clovis, the deal, announced May 25, marks the second asset the company has acquired since its initial financing. The company-- led by Pat Mahaffy and a band of cohorts formerly from the oncology play Pharmion--was formed with the aim of in-licensing oncology drug candidates in clinical development and pushing them through to commercialization. In November 2009, Mahaffy’s company bought Clavis Pharma’s Phase II lipid-conjugated formula of Eli Lilly's chemotherapy Gemzar (gemcitabine) in development for pancreatic cancer for $15 million upfront. In both the Avila and Clavis deals, the importance of a companion diagnostic targeting the appropriate patients has been a central part of the deal logic. Whether or not Clovis does the actual dx development is a different question. Earlier this year, Clovis signed a deal with Roche's Ventana Medical Systems, Inc. to develop and commercialize the diagnostic for the gemcitabine compound.—Jessica Merrill

Gentiva/Odyssey Healthcare: IVB doesn’t typically devote much space to healthcare services but the size of the Gentiva/Odyssey tie-up makes it impossible to ignore. Gentiva is a major provider of home health care services, while Odyssey is one of the leaders in hospice care in the U.S. Both companies have strong balance sheets and scale, so as Daily Finance writer Tom Tauli put it "assuming the integration is seamless, the result will be a powerful combination." Gentiva will spend about $1 billion to bring Odyssey’s 20 in-patient facilities and 92 Medicare-certified programs in-house, as well as the ability to provide a seamless transition from in-home care to end-of-life care. The $27-a-share price for Odyssey represents a 40% premium to the company’s closing stock price on Friday May 21, the day before the merger was announced. Hospice care is a relative new industry but one of increasing importance, given the aging demographics in the U.S. Analysts have been debating the merits of combining hospice and home-based care for some time, with proponents emphasizing synergies in shared referral and recruitment sources and marketing staff. Certainly the recent regulatory scrutiny over home health-care billing practices may have encouraged Gentiva to diversify, especially after it divested non-core assets in respiratory and infusion therapy back in February. Still, according to the WSJ, at least one analyst, Arthur Henderson of Jefferies & Co., was "taken aback by the magnitude" of the deal, Gentiva’s first in the hospice space. "We view this deal as an indication of management’s renewed vigor in driving accelerated growth through an aggressive acquisition strategy," Henderson said.--EFL

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

Ed. Note: Let's Go Flyers!

the bee's knees

Today Jonah crawled to and discovered our laundry room tiny laundry closet.

He thought he was just the bee's knees.

But then he realized I was THREE FEET AWAY! (The nerve...)

So he crawled back to me...

Stuck out his cute little tongue...

Smiled...

And gave me about five knee hugs.

It was awesome.

Put a Cap on It

Toyota. Massey Energy. British Petroleum. Johnson & Johnson?

That is not a list J&J wants to see. But, as the company testifies today about a series of recalls affecting its consumer product line, J&J's corporate brand is very much at stake.

Sometimes, it isn't so much what you do but when you do it that matters. For pharmaceutical manufacturers, quality control problems are an unfortunate fact of life. Even the best run companies run into problems. Manufacturing is complex, QC standards evolve, and global multinational management structures invariably mean pockets of underperformance. No one is perfect.

Unfortunately for J&J, there may not be a worse time for a company to have problems like it is having. A massive recall of well known consumer product brands like Tylenol would be a black eye any time. A recall at a time when FDA is moving back towards a tougher enforcement posture is even worse. When the newly installed FDA deputy commissioner (Josh Sharfstein) has made his public health bona fides by focusing on the risks of OTC medicines, including Tylenol, it is a double whammy.

But to face all that at a time when Congress is investigating industrial disasters in multiple sectors means moving from a major FDA issue to a potential life-and-death moment for the corporation. We're talking Enron here.

What can J&J do?

Well, like BP, they need to stop the gusher. The analogy to the oil pouring into the Gulf of Mexico is a stretch, but for J&J there is a distinct sense that the bad news keeps coming. Just this year, there was an FDA warning letter for failing to follow-up with alacrity on complaints about a "musty smell" associated with some bottles of Tylenol. That was followed by the shut down of its Fort Washington, PA facility and the recall of much of the company's OTC product line.

Heading into a Congressional hearing, J&J faced two more untimely developments: the final resolution of an investigation into off-label promotion of Topamax (including a guilty plea by the division responsible), and another FDA warning letter focused on its medical device manufacturing. (Read more here.)

Today's hearing (and a likely follow-up in the Senate) will bring more negative headlines and unflattering attention. The key for J&J is to make it stop.

There is hope: as Genzyme seems to have proven, a company can indeed put a cap on a seemingly out of control compliance issue. Cynics would say it took awhile, but once Genzyme brought in outside managers to take over its manufacturing QC, the company seems to have regained control of the situation. The company moved into a consent decree negotiation, achieved a resolution along the lines it predicted, and received approval for an important new product as a result. Genzyme has a lot of work ahead of it, but the gusher of bad news has been capped, for now at least.

We don't think J&J will have the same period of time to get its house in order that Genzyme had: progress from here better be fast and sure. But it can be done.

Then there is the uncontrollable element of luck. The hearing today coincides with what might be BP's last chance to seal the Gulf Oil leak. Whether that effort succeeds or fails, that will be the lead story tonight--and J&J's issues will get a bit less attention than they might have otherwise.

Of course, if BP succeeds in capping that gusher, it means even more pressure on J&J to stop the flow of bad news about its brand.

fifteen months today

Hey everybody. It's me, Jonah.


I know it's been a while. Mommy has been a MAJOR computer hog. Something about me Aquaphoring her screen and such. Whatever.

Today I turned 15 months old.

A lot has gone on these last three months.

Mommy and Daddy started leaving my toes unwrapped. They said my toes were starting to web a little bit, and so, well, nakey toes for me!

Aren't they the cutest? They're a little blistered, but nothing I can't handle. Mommy says I'm so tough. And my toes are getting a little tougher too with time.

I'm going through a very weird stage right now. I can't talk, but I have so many opinions and that makes me VERY frustrated. See?


Yes, it's true. I've mastered the fake cry. And the fake whine. And the fake tears. And the fake angry scream. I'm a big faker. Still cute though.

These last few months have been super busy with lots of firsts.

Daddy and I made our very first fort...


I got my very first haircut (did not love it)...



I had my very first Easter AT HOME...


I went on my very first Easter Egg Hunt...





I learned to clap (and had a love affair with it for several weeks)...



I wore my very first collared shirt...


I learned to sit up on my own...


And best of all - I learned to CRAWL!

Can you believe it? Mommy just burst into tears when I first did it. She says I'm the cutest little crawler she's ever seen. I'm slow and cautious, but I am definitely on the move. Mommy knows the real trouble hasn't started yet. Just wait until I get confident. She won't be able to stop me.

And guess what else? I've started going into the nursery some at church. Mommy still goes with me since I'm so high-maintenance, but we're getting there. I love to crawl around on the floor and play with all the different toys. Mommy says it's good for me to be with kids who are close to my age. She says that in some cases, peer pressure is a good thing. I'm going to remind her she said that when I'm fifteen.

I've gotten to take a couple trips over the last couple months.

To celebrate my big brother in April, we went up to Smith Mountain Lake in Virginia. I did not love it.


Most of the time Mommy and Daddy spent putting me in the car and driving around just so I'd be happy.

And last weekend, I got to go to my (girl)friend Quinn's birthday party. *Please excuse my Mommy. She interrupted me with her parenthetical addition.*


And the biggest thing that happened in these last few months is this -

Yep, that's right. I got a new friend. His name is Mic-key. Mommy says it's going to help me get all the calories and fluids I need to be healthy. It's caused me some problems, but Mommy thinks we're getting things under control now, and that I'm doing better. I don't get much formula anymore. Mommy now gives me all kinds of crazy blended food through my feeding tube. Tonight I had Baked Ziti. Can you believe that???

Anyway, back to the point. Here I am the afternoon after my surgery. I had a couple really sleepy days, but I recovered so quickly. Mommy is not surprised in the least. She says I'm a champ.

Before I got into my "everything makes me grumpy and don't even think about breathing in my area" stage, I really loved to be outside and swing at the park. Most of the time, when nothing else makes me happy, being outside will.


I'm still loving my ball popper, and I LOVE pinwheels.

One of my favorite things to do is play up in my room with Daddy. I have one of those basketball hoops hooked on my closet, and we play basketball. I pass it to him, and he shoots. Sometimes he holds me up there to let me shoot, but I refuse to let go of the ball and just dig hangin' out in the air. I like to give Daddy's muscles a workout. I love my Vtech Alphabet Train. Some wonderful ladies at Daddy's work got it for me for my birthday, and it is one of my most favorite toys. I also really like the bubble machine my Nana got me. It makes like 1,000 bubbles a minute. It's out of control.

I weigh between 22 and 23 pounds. I'm in the 20th percentile for weight and the 35th percentile for height. I'm not saying any words yet. Mom thought my first word was "Deac" but she hasn't heard me say it for several weeks, so maybe it was just her imagination. I "talk" all the time, though, and Mom says that once I'm saying real words, she thinks I'll never stop talking. She hasn't a clue where I might get that from. I'm sleeping through the night and napping like a champ. It only took me a year to figure it out, but these days, I love sleep.

No matter what, sleeping or not sleeping, eating or not eating, being happy or fussing nonstop, Mommy and Daddy love me so much and wouldn't trade me for the world. They can't believe how far I've come and all of these milestones I'm reaching. It's been an amazing three months, and Mommy and Daddy are so excited to see what else God has in store for me. They're pretty sure it's going to be amazing.

better today

Today was better.

Jonah only had one big throw up this afternoon, but I'm pretty sure it was my fault. I was giving him yogurt, 1/4 of a banana, and two ounces of formula. It was very liquidy, and I think I might have pushed it too fast. And he may or may not be able to tolerate bananas. That's yet to be determined. I know he can't handle banana pudding, but I thought it was the sweet flavor. Maybe not. So it was either the bananas, the formula, how liquidy it was and/or me pushing it too fast. It was a fluke. I'm sure it was a fluke. It had to be a fluke, right?

I ordered my Vitamix 5200 today. I have read The Simmons Family Blog, and she highly recommends this blender. It will pretty much blend anything to liquid. Right now I can do veggies and fruits that aren't seedy in my Magic Bullet, but I have to use baby food meats. I can't do rice because it's too thick and pasty. And I haven't tried beans, but I think I would have a similar problem with those. The Vitamix can do rice, beans, meats, and grains to liquid. AND I could just blend up whatever we're eating - casseroles, lasagna, steak - whatever, and give it to Jonah. I'm excited. It's expensive, but there's a medical discount of 25%, and I ordered a reconditioned one instead of a new one. It also comes with a seven year warranty. I'm committed to trying this for Jonah, and I just don't feel like I can give him the protein and grains he needs without a better blender. And I definitely can't risk having chunks and clogging his tube. So the Vitamix it is! I'm pumped.

Life's an adventure, I guess. It seems like we're always trying to figure something out.

Thanks for all the continued prayers and support. You've got to be exhausted.

And is it just me or is this episode of Glee even more weird than usual? That Lady Gaga is a strange bird.

ugh

I'll be honest. Today was a rough day. This will be short.

Jonah gushed one time yesterday and three times today after probably five days of not gushing at all. Needless to say, I'm completely frustrated and confused. I don't get it. He barely had enough today to stay hydrated.

His tube has been leaking more than usual today. When I finally got him to drink an ounce of Apple Juice, it leaked out of his tube and all over his shirt. Yes, the little flappy was closed. I don't know why or how it leaked.

He had his fifteen month check-up this afternoon, including three shots and getting the granulation tissue that's growing under his tube cauterized with Silver Nitrate. He was completely freaked out any time they touched him to do anything.

I had my annual check-up at my OBGYN office. It was much more difficult to be there than I anticipated. Facing the happy memories of being pregnant, the horrible memories of Gabe's death and the anxiety I felt with my pregnancy with Jonah, and facing the reality that I'll never be pregnant again kind of slapped me in the face. I hated it.

And to top things off, Jonah is regressing on his solids eating. He will only eat a little bit of soup (sometimes) as compared to 1/2 cup twice a day before. And remember the yogurt he loved that one day last week? Well, now he gags, cries, and pushes the spoon away when you try to feed it to him. Same yogurt. Same time of day. Same spoon. Frustrating.

I know these are all little things in the scheme of things, but all piled into one day... too much.

I'm hoping that maybe Jonah just has a little tummy virus or something and that we're not going to start having those bad tolerance issues again. A lot of the vomit today came from oral feeding. Some came after I had used the tube.

I really want to switch to all blended foods through the tube instead of formula, but it is so hard to get the calories he needs in small enough quantities that he can handle it, while still getting all the food groups, vitamins, and ounces for hydration he needs. But man, I'm reaching my limit with formula.

It's been a long day. I'm glad it's over. Tomorrow has got to be better.

When Innovation Isn't Enough

There is always a self-congratulatory flavor to BIO’s annual meeting. Which is as it should be: it’s the lobbying group’s best venue for justifying its membership dues.

And I think they have – with exhibit 1 being their clever R&D tax credit, a $1 billion piece of reform money to provide a few hundred biotechs with non-dilutive cash most can’t get anywhere else.

And yet I still can’t shake the feeling that, by and large, BIO’s leaders – or maybe BIO’s members – are fighting the last war, over innovation, when the new fight is all about value.

Even a political idiot like me can get why Jim Greenwood reads gushing letters from patients about drugs that have saved their lives. And given just how few important biotech medicines have gotten approved lately, I understand why Dendreon’s Provenge gets a prominent mention. And I also get why Greenwood didn’t mention its cost ($93K for a full course of therapy). He would then have had to explain just how Dendreon calculated that Provenge will be cheaper than Taxotere per-month-of-life-saved (on theoretical average, Provenge gives you an extra three). Which would have been kind of boring.

But why wasn’t the Provenge price front and center in the more purely business speeches about cancer products (or frankly any biological therapy)? Given just how often people gave passing nods to the needs of payers (e.g., in Steve Burrill’s theories-of-everything talk), you’d figure that the Provenge price might be a relevant topic. Pricing is at least passingly important to a product’s commercial prospects and so apparently exceptional pricing might indeed be worth a chat, whether you think that price bodes well or ill for the industry (e.g., the Provenge price will be a) the straw that breaks the camel’s back or b) another gold nugget that shows just how strong the camel’s back still is or c) a meaningless topic because Dendreon, supply constrained, is only going to sell a few thousand therapies so total costs for any one payer won’t rise to a meaningful level). But I heard nothing about it.

Or let me put this another way. Greenwood said that "the recent recession and policy hurdles” hadn’t “diminished our passion to innovate.” First, I don’t think most investors or, frankly, executives would agree. For most VCs I know, passion for pharmaceutical innovation has turned into a massive case of indigestion (to continue the gastro-intestinal metaphor: VC portfolios are clotted with innovative companies).

But more importantly have Greenwood’s “recession and policy hurdles” increased our willingness to prove value – which isn’t the same thing as novelty and which Greewood’s r&ph will certainly require?

I don’t get the sense that drug companies have done much to show that they see the difference. (Full disclosure here: I’m now so interested in this subject that I’m part of a group exploring a new company focused on it.)

Innovation, by and large, can be judged pretty objectively. A new mechanism is innovative. A new compound too. But value is subjective – what’s valuable to you may be burdensome to me. Yet the industry’s main arbiter of value, clinical trials, too often proves value to only one audience: regulators.

That audience is certainly crucial. But everything we’ve learned over the last year says that a regulatory audience is hardly predictive of what other equally crucial audiences want: Lilly’s Effient, Bristol/AZ’s Onglyza and J&J’s Simponi and Ultram ER all provide customers with – well, given their commercial performance, very little they’re willing to pay the price for.

This isn’t to say that these drugs’ suppliers couldn’t create the necessary value. It’s to say that they haven’t, at least in part because they’re focused on just one audience.

Instead of simply proving that a pain drug reduces pain without causing other big problems, maybe the trial should prove that the pain drug does something the payer wants from it – maybe a reduction in follow-up visits to the doctor to get another pain drug. Or delays the prescription of an opioid. Or allows a generic to be used in most cases. Or shows that a GP, after a relatively low-cost visit, can prescribe the product without sending the patient along for specialist follow-up. Or can avoid an expensive diagnostic procedure. A me-too cancer drug (and there are plenty of them in development) could justify premium pricing by measuring, along with whatever purely clinical data it needs for approval, reductions in hospital-acquired infections, or length-of-stay.

I spoke with one CEO who told us that the nurses in hospitals testing his oncology drug loved it because they spent less time cleaning up after patients nauseated by the standard of care. I asked: Are you measuring how much less time they’re spending? No, he said.

Biotech wants to be paid like it’s always been paid: for promises of novelty. I’d be curious to hear a biotech claim that it should be paid, as the UK’s NICE pays for Millennium/J&J’s Velcade, when the drug delivers the value the payer and patients want. That value could be a particular medical outcome, or better quality of life, or lower medical costs. Or something that makes the payer’s services more attractive to the employers its competing with other payers to win as clients. But it isn’t necessarily whether it’s clinically better than placebo. Or even standard of care. Effient’s head-to-head trial against Plavix proved – in crude summary – that it’s clinically better. But payers clearly don’t see enough value to justify switching away from a drug soon to be generic.

So my suggestion: if BIO really wants to promote the long-term health of the biotech industry (and the broader pharma business as well), maybe the theme for the next convention should focus on customers.

How about “What’s In It for Me?”

image from flickr user zizzy used under a creative commons license

a few pics from quinn's party

The sweet birthday girl, Quinn, with pink icing on her forehead. (Katie's photo)



Quinn and Jonah eating Quinn's Mickey Mouse Maracas. (Katie's photo)


Jonah (screaming) and Quinn (being a perfect angel). How dare I put him down???

Deciding it might be okay after all... notice the tears on his cheek.

A recovered Jonah. (It did not last.)

More Jonah and Quinn - playing with (but mostly eating) blocks.

It would appear he is sharing this block. In reality, he is stealing it.

Quinn really is sharing.

Rory - Quinn's beautiful big sister.

Sweet (but not acting so sweet) Jonah.

I was so, so glad we went to Quinn's party. But Jonah barely napped at all on the way, and he fussed A LOT. We don't get out that much, and he's used to it mostly being just me and him, so he has a hard time with change sometimes. He did okay, but I was just thankful that it was at Katie and Nathan's house and not a public place. He's really getting to an age where he seems to have more anxiety about new places and people. It was great to see Katie, Nathan and the girls, and it was TOTALLY worth it.

Happy First Birthday, Sweet Quinn. So glad we got to spend it with you.

a happy weekend

This will be short, because, honestly, I just can't get enough of Friday Night Lights, and I'm ready to relax for the day. We've had a good day. Jonah did not throw up today, and he hasn't in several days. I know he probably will (he's overdue), but I'm thankful for the days he doesn't. Things are going much better. He's still not eating as much as he was by mouth pre-surgery, but he's definitely able to tolerate his tube feeds much better now. Thank you so much for praying for that specifically. I was so frustrated and overwhelmed at the beginning.

I just have to say how proud I am of Jonah. Every day it seems like he's learning new things, figuring things out, coming up with new sounds. Every month that passes, I'm like, "No, THIS is my favorite age." It definitely helps that he's napping one to two hours a day and sleeping all night. I'm much more awake to enjoy it all. But really, he's so much fun. He's somewhat of a mama's boy, for sure... There are times that is very frustrating, but I'd be lying if I said it doesn't make me feel so special. And as we know, it IS all about me. Kidding (just in case you didn't know).

Jonah crawled all the way across the rug today. He's pretty steady when he goes, but he's still timid about starting. It's so neat that he can crawl to the toy he wants instead of me choosing for him. He DEFINITELY has opinions. I'm hoping crawling can help him express them. But he already went for the power strip today, so I'm guessing it will probably just lead to more frustration on his part.

We got to go to my friend Gina's diner tonight, and we're going to Holly Springs tomorrow for Quinn's (Katie's youngest... you know, Jonah's girlfriend) first birthday. And Trent is in town too. I'm excited about a happy weekend.

Back to FNL. I'm addicted.

DotW: Wishful Thinking

The biotech M&A storm is coming. Really. So sayeth the good attorneys at the UK patent firm Marks & Clerk, based on survey data of 381 pharmaceutical execs who predict industry consolidation as various players attempt to hurdle the looming patent cliff.

Added to IN VIVO Blog’s To-Do List: Call Marks & Clerk to determine where to purchase the rose-colored glasses apparently so in fashion.

We admire the glass-half-full sentimentality. It’s cheaper than Prozac or Paxil (though purchasing either would help sales at certain pharmas). We’re just a bit skeptical that the patent cliff will translate into a big-pharma buying spree of innovative biotechs. Here's why: For starters, the big acquisitions of 2010 have mainly been about diversification, marketed products, generics, emerging markets or some combination thereof. Innovative pipeline material? Not so much. Big pharmas want revenue.

According to Elsevier’s Strategic Transactions database, the top deals of 2010 have been Merck’s acquisition of Millipore, Teva’s purchase of ratiopharma, Astellas’ flight into oncology with OSI, and Charles River’s take-out of WuXi. Of these, only the Astellas/OSI transaction fits the patent-cliff theory, in which a drug maker pays top dollar for a biotech to replace revenues lost to looming--or current--generic competition. And companies like OSI, with money-making products far from patent expiry, remain a relative rarity, which as we’ve pointed out in our reporting, is one reason that biotech’s price tag climbed as high as it did.

We’ve said it before. On the private side, companies can’t rely on the stalking horse of IPOs to force pharmas into acquisitions; M&A--when it happens-- will likely to be in the guise of earn-out heavy deals, with eye-popping returns (think >5X when all the milestones are factored in) for the future. (Want data? See here and here.)

Other forces are lined up to stifle the oft-predicted M&A storm. On the public side, many smaller biotechs are still struggling to attract investor love. (Will ASCO help?) For European companies, the debt crisis isn't going to help. With biotechs’ stock prices trending down, there’s simply not much pressure for Big Pharm to get involved in pricy bidding wars. Moreover, big pharma buyers are burdened with infrastructure and more early stage programs than they can afford to develop, suggesting that when they do bring programs in it will be via alliances not acquisitions.

Does IN VIVO Blog think there will be some M&A? Absolutely--and if there isn't, this column will get awfully lonely. But are we talking Perfect Storm? Boom Times? That smacks of wishful thinking. Any doubt? Take a look at this week’s round-up of deals, which emphasize R&D on the cheap, EMs, and branded generics.

Astellas/OSI: Japanese drug maker Astellas' pursuit of OSI Pharmaceuticals was rewarded on May 17, 2010 with a $4 billion merger agreement supported by both companies' boards. At $57.50 per share, the deal cost $500 million more than the original hostile bid that Astellas launched in late February, and it will consume roughly half of the drugmaker's available cash. It seems no other white-knight bid emerged to counter Astellas' hostile offer, which turned semi-friendly at the end of March. Astellas, meanwhile, had made OSI the linchpin of its strategy to become a global oncology player. To walk away empty-handed would have raised serious questions about Astellas management, especially in the wake of its previous hostile bid, an unsuccessful run at CV Therapeutics. The newly sweetened price is a 55% premium to OSI's stock price on February 26, 2010, the day before the Japanese firm publicly disclosed its $52-a-share hostile offer for the biotech. The price is also 50 cents more than the informal offer in the $55-to-$57 range that Astellas originally suggested in 2009, according to SEC filings. With its ability to do further big deals limited for now, Astellas must extract full value from both Tarceva and OSI's earlier stage molecules. The key will be retaining and integrating OSI's management team into Astellas' U.S. operations.—Ellen Foster Licking

Abbott/Piramal: Rumors have been circulating for weeks that Piramal, one of India's leading biopharma players, was up for sale. There was quite a bit of truth to the rumor mill, except the buyer wasn't one of the usual suspects: GlaxoSmithKline, Sanofi-Aventis, or Pfizer. The ultimate winner was Abbott, which also made waves with last week's collaboration with Zydus Cadila and the creation of its established product unit. Abbott says the deal gives it the numero uno position (in Hindi, that's nambara ēka) with 7% market share in the Indian pharmaceutical market. It doesn't come cheap. Abbott will pay a total of $3.7 billion for Piramal, but not all is upfront cash. Piramal gets an initial payment of $2.12 billion and then $400 million annually for the next four years starting in 2011. (A hedge, perhaps, to mitigate the snafus Daiichi Sankyo has encountered with Ranbaxy?) Structured this way, Abbott says the all-cash transaction will not impact its ongoing earnings per share guidance. The strategy behind Abbott's deal is obvious and one familiar to IN VIVO Blog readers. Indeed, it can be summed up in three catch phrases: diversification, branded generics, and emerging markets. --EFL

Pfizer/Washington University: The R&D belt continues to tighten, and nervous companies ask more loudly how best to cheaply and efficiently identify innovative medicines? What about academia? What about new uses for existing medicines? Why not combine the two? This week Pfizer announced a five-year collaboration worth $22.5 million with Washington University in St. Louis in what is essentially a re-profiling experiment of 500 compounds originated at Pfizer. Don Frail, the chief scientific officer of Pfizer’s Indications Discovery Unit and the brains behind the deal, said the partnership could result in the university participating in clinical trials and holding downstream financial rights to drug candidates. Pfizer, meanwhile, can tap the thinking of a different group of researchers, and it won't spend an additional dime (beyond the $22.5 million) developing idle programs. Indeed, just one moderately successful product from the tie-up could cover Pfizer’s investment many times over. Wash U researchers will submit proposals for studies of compounds to a joint advisory committee. Pfizer researchers will work with Wash U scientists, with the university owning rights to its discoveries and the ability to negotiate terms for their development and commercialization.--Joseph Haas and EFL

Quintiles/Kaiser Permanente: It's not the kind of deal we normally cover, but we were intrigued by a collaboration between a major CRO and a leading insurer/health provider. With a dearth of details in the press release, IN VIVO Blog is still intrigued. We thought perhaps this deal augured a future wave of partnerships, in which pharmaceutical companies—or their CROs—ally with groups to develop outcomes-based data to support the commercial prospects of drugs under development. While this may be one of the longer term outcomes of the project, for now the emphasis is on enhancing the quality and productivity of clinical research. As such, Kaiser’s Southern California Permanente Medical Group becomes Quintiles’ fourth global prime clinical research site, joining the University of Pretoria in South Africa, Queen’s Mary College in the UK, and Washington D.C.'s Washington Hospital. Adam Chasse, Quintiles’ head of global prime sites, says the interests of both groups are mutually aligned since SCPMG wants to expand its clinical research efforts while the CRO hopes to tap the physician expertise within Kaiser--as well as its diverse patient base.--JH and EFL

Sanofi/Nepentes: Once again Sanofi-Aventis is expanding its consumer products business with a $130 million offer for the Polish drug, dietary supplement, and cosmetics firm, Nepentes Group. Sanofi announced May 19 it would pay approximately $8-a-share to Nepentes’ main shareholders and $8.60-a-share to minority shareholders in order to establish a presence in Europe’s fifth leading consumer health care product market. According to “The Tan Sheet," Sanofi believes it can boost Nepentes’ growth by extending distribution of its products, which include Selsun Blue, Melisana Klosterfrau supplements, and the Marimer line of nasal sprays, to additional markets. The Nepentes transaction marks the seventh consumer deal for Sanofi since CEO Chris Viehbacher outlined plans in February 2009 to double the drug maker’s OTC offerings in five years, primarily through bolt-on acquisitions. The most costly so far is Sanofi’s acquisition of Chattem for $1.9 billion. It’s all part of Sanofi’s larger strategy to diversify into arenas less risky than branded pharmaceuticals while simultaneously tapping those necessary "pharmemerging" markets.--Malcolm Spicer

Image courtesy of flickrer furiousgeorge81.

Abbott Charges Into India

Rumors have been circulating for weeks that Piramal, one of India's leading biopharma players, was up for sale. And just as staunchly, management tried to quell the gossip (as recently as yesterday--if you are keeping track.)

Turns out there was quite a bit of truth to the rumorville. Only the buyer wasn't one of the usual suspects. Both GlaxoSmithKline and Sanofi-Aventis' names have been twinned with Piramal in part because of their aggressive moves into both emerging markets and branded generics.

The ultimate winner of Piramal? Abbott, which has been making its own waves in recent weeks through last week's collaboration with Zydus Cadila and the creation of its established product unit.

Abbott claims the deal gives it the numero uno position (in Hindi, that's नंबर एक or nambara ēka) with 7% market share in the Indian pharmaceutical market, but those bragging rights are costing it a pretty penny. Abbott will pay a total of $3.7 billion dollars for Piramal. Interestingly, not all of it is upfront cash--Piramal gets an upfront payment of $2.12 billion and then $400 million annually for the next four years starting in 2011. (A hedge perhaps to mitigate the snafus Daiichi Sankyo has encountered with Ranbaxy?)

Structured this way, Abbott says the transaction, which is still subject to Piramal shareholder approval, will not impact its ongoing earnings per share guidance in 2010. The diversified health care company plans to fund the deal with cash on the balance sheet.

The strategy behind Abbott's deal is obvious and one familiar to IN VIVO Blog readers. Indeed, it can be summed up in three catch phrases: diversification, branded generics, emerging markets. Abbott's CEO and chairman Miles White decided to elaborate however, stating in the press release announcing the news:

This strategic action will advance Abbott into the leading market position in India, one of the world's most attractive and rapidly growing markets. Our strong position in branded generics and growing presence in emerging markets is part of our ongoing diversified pharmaceutical strategy, complementing our market-leading proprietary pharmaceutical offerings and pipeline in developed markets. (Highlights courtesy of IN VIVO Blog.)

We'll have more on the deal later in "The Pink Sheet" DAILY and PharmAsia News. But for now we'll go out on a limb and say that one of the immediate impacts of the deal has got to be the increased liklihood of getting an authentic curry in Abbott Park, Illinois.

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

Guest Post: At ATS, a Storm of Questions for IPF Drug Developers

Michael Gilman is the CEO of Stromedix, a Cambridge, MA biotech developing novel drugs to treat fibrotic organ failure. You can follow him on Twitter @Michael_Gilman. Interested in guest blogging for In Vivo? Drop us a line here.

At around eight on Sunday morning, just as the first sessions of the American Thoracic Society meeting got underway at the labyrinthine convention center in New Orleans, the skies opened up and unleashed ropes of rain. Thunder rumbled through the lecture halls, strobes of lightning lit the corridors. Power was lost, briefly snuffing out lights and laptops and stranding attendees on towering escalators. And it went on like that for two full hours — man, this place has some serious weather.

It was hard to miss the metaphor.

This year’s ATS was to be the moment in the sun for clinicians, scientists and drug developers working on idiopathic pulmonary fibrosis, a staggering, deadly disease for which there is no approved therapy outside of Japan. Perched prominently on the calendar just two weeks prior to opening day was the PDUFA date for InterMune’s experimental IPF drug, pirfenidone.

The relatively tiny IPF crowd is usually swamped at ATS by the hordes of folks working on asthma and COPD, but this year several significant IPF sessions were on the program. A pirfenidone approval, the first for the condition in the US, would have been a jolt of electricity to the IPF community gathered in New Orleans.

Alas, it was not to be. The FDA did not approve the drug and IPF investigators reeled. I don’t have an especially informed opinion on pirfenidone. Above all, I’m disappointed for patients, who are desperate for treatment options. But, given the bafflingly inconsistent clinical data and confused deliberations of the FDA advisory panel, approval was by no means a slam dunk.

The FDA’s action left meeting participants with a long and rather painful list of questions. What targets do we go after next? What are the right endpoints? What patients do we enroll? Do we even understand the real natural history of the disease? What does the FDA want? Will anything ever work? It also sparked remarkably strong emotions among pulmonologists, many of whom are absolutely convinced the drug will help their patients and others equally persuaded it doesn’t work.

But Monday morning in New Orleans dawned bright and sunny. And the first major IPF session of the conference packed the vast auditorium to fire-code-violation levels. The centerpiece of the session was a couple of densely-packed reports from an expert panel that had deliberated for three years on formal guidelines for diagnosing the disease and treating it.

Conclusion on the latter point: No currently available treatments were recommended, including pirfenidone. Clearly, however, the troops were undaunted. You could sense people picking themselves up, dusting themselves off and getting psyched to wade back into battle. They want to beat this disease.

Which leads me to ask the following question.

Why do we do this? We are, generally speaking, intelligent folk. We’re rational and data-driven. Yet, inexplicably, we continue to pile into an enterprise in which the odds are ridiculously stacked against us. Are we nuts? Masochistic? In denial? Or just relentlessly optimistic? Convinced that our next idea is going to be better than our last? What is it that fuels our passion to develop new medicines for patients when it so often feels like a fool’s errand?

I don’t have an answer, but whatever it is, it was on display in New Orleans this week. And it’s inspiring. --Michael Gilman

image from flickr user ray devlin used under a creative commons license

Follow-On Biologics: Is There a Pathway?

So we knew that the generic drug industry was less than thrilled with the outcome of the follow-on biologics legislative debate, but we didn't realize it was this bad.

That is our conclusion after participating in a webinar hosted by the Washington Legal Foundation on the new biosimilars pathway enacted as part of the health care reform law. (You can watch a replay of the webinar here; and, yes, that is your humble blogger moderating...)

With so much attention focused on the exclusivity issue during the legislative debate, we were excited to have the opportunity at least to start to talk about the nuts-and-bolts of making follow-on biologics happen in the real world.

But boy does it sound like an uphill climb from here. We were struck by the case made by Bob Dormer, a founding partner of the DC law firm Hyman Phelps & McNamara, who argues that--all things considered--sponsors are better off just filing a conventional BLA than bothering with the new "pathway" for biosimilars created by the health care reform law.

Dormer offered the following points:

You can file a BLA at any time (rather than waiting at least four years to file the new, abbreviated BLA--and at least 12 years total for the innovator's data exclusivity to expire before marketing is allowed).

A BLA filing is secret, preserving possible competitive advantages. An ABLA must be disclosed to the innovator.

You can get to court on patent issues quicker, without going through the cumbersome-looking administrative process set up for ABLAs.

The data requirements probably won't be very different--and, for the time being at least, the BLA requirements are more predictable.

Last but not least, you are entitled to 12 years of exclusivity on approval.

Dormer's not the only one who feels this way. As we noted in "The Pink Sheet," Novartis' Sandoz division says it will focus on the BLA route, given the drawbacks it perceives with the new pathway; Teva has also opted to file a BLA for one of its biosimilar projects, and says it may do the same in other cases while it waits and sees what FDA comes up with.

That may be the key point: how will FDA translate the legislation into a regulatory pathway? As the WLF panelists agreed, there are far more questions than answers at this point.

We will of course be covering the details of FOBs implementation. And we will be hosting our own webinar on the theme in June; click here for details.

Image courtesy of flickrer B Tal who notes this piece of ancient wisdom: if we do not change our direction, we are likely to end up where we are headed.