blue

I'm feeling a little blue tonight. I just got trapped in Harris Teeter for a while (have no idea how long) because of a bad storm and still had to eventually give in and go out. Soaked to the bone, loading groceries, afraid of lightening, no fun. That's not why I'm blue but the weather has kind of reflected my mood.


And I've missed my run the last two nights because of storms. It's not that I crave the running (don't be crazy) but I crave the time with my friend, Barbara, and I crave being outside. AND, I haven't run since Friday, and I just don't want to take any steps back.


But the real reason I'm blue and what's motivating the funktification of everything else...


We have lost three EB babies in the last five days.


The first was Lucas, one month old, with Junctional-Herlitz. His dad and I corresponded by email early last week. He passed away on Friday.


The second was Baby AJ, 14 weeks old. I'm not sure what type he had, but he died on Sunday.


And the third, Friends, was sweet Baby Malachi, two months old, the baby boy I had the privilege of getting to know and help with for a few weeks in April and early May. He was here at our local NICU, and his mom and I have regularly emailed back and forth and shared several phone calls since they've been home. They had just found out he was Junctional-Herlitz. He died on Monday morning.


When I think about the three families who have just had their tiny babies ripped from them, I think about the loss of our own tiny baby, and I think about all the things that EB takes away from Jonah, from our family and from countless other families all over the world, it makes me so angry. Why is it allowed to rob us of so much?


Run free, sweet babies. Our hearts are breaking, but your hearts are full, and your skin is whole.

this and that

Sorry for a few days without updates. Sometimes sleep just wins. :) 


We are doing well. Jonah is finally healthy after the week of stomach virus followed by a week of respiratory issues. He's been doing well for about a week now, and I hope we can keep it that way. I have a cold or sinus infection though, so we still didn't make it to church on Sunday. I miss my church family very much. I just needed the sleep and felt terrible. I didn't feel like it was a good idea to get up at 6:45 to do the whole rushed get everyone ready (which includes Jonah's bath and bandage changes) to make it. I felt like poop for a couple of days, but besides some congestion and coughing, I'm feeling better today.


Matt's mom stayed with her dad for five weeks, caring for him without much change in his condition. Last week, they came to a mutual decision to move him into a rehab facility. I think that is so good. He needs professionals who can force him to work and get his muscles moving again. Anyway, on Sunday, Debbie was working in his closet trying to get things sorted and packed, she fell and broke her hand in four places. Matt's dad had some friends offer to drive him up here last night, so he came up and drove her home in her van today after they got Grandaddy settled. Needless to say it's been kind of a crappy several weeks for her and ending it by breaking your dominant hand just one week before your beach vacation pretty much stinks. I know she would love your prayers. She's been so good to us, and I feel pretty useless not being able or not knowing how to help her back. 


On Sunday afternoon, Matt and I took our first aid/CPR class for adoption. One 1/2 day down. I think that makes us 1/10 of the way there, class wise. And we have to finish our classes before we can do anything else, so I'm eager to get them underway. We will take our MAPP classes all day on four consecutive Saturdays starting July 16th. Then we'll have to take a medication administration class in September. I think we can get started with paper work and stuff before we take that last class though, so hopefully we'll be well underway by mid to late August.


Okay, I'm off to bed. Couch to 5K was stormed out tonight, so Matt and I worked a couple of hours in the garage and then came upstairs and had some celebratory (absolutely delicious) chocolate cookies my neighbor sent home with me. Oh, what neighbor you may ask? Why, my running partner neighbor, that's who. She inspires and encourages me for both good and evil. 


Hope you're all having a good week.

Deals of the Week's Summer Song

Why do so many summer songs include a twinge of regret? Take “Summer Wind,” made famous by Ol’ Blue Eyes, whose lazy August tempo belies its remembrance of a lost warm-weather love at least two seasons later. Or Chad & Jeremy’s lovely “A Summer Song,” which predicts autumn's sadness even as the lightning bugs still blink. Buffalo Tom’s poetic “Summer” is vague, but it's a past-tense tale of a wasted season of lost heroes and things left behind. And while Percy Faith’s “A Summer Place” is an instrumental that’s about as easy as listening gets, it’s also the theme from an entire movie about The One That Got Away.

(Perhaps it’s only natural that a songwriter would wrap up a story a few months onward. After all, if you start in summer and stay there, you get Seals & Crofts’ “Summer Breeze,” which has confounded us for decades. Did I have jasmine in my mind all along, and I just didn’t know it?)

At any rate, perhaps there’s something we can learn from these seasonal snapshots, particularly those that depict someone special slipping away like a handful of sand through your fingers. As VCs, execs and bankers steal away to places like Aspen and the south of France (after BIO of course), it’s easy to imagine them sleeping on a deal that could’ve been.

But with one healthy licensing arrangement, a reverse-merger that took another company public, a funding in the hotly contested epigenetics arena, and more action around the industry this week, it’s clear some are keeping their oars in the water, even as many of us dream of sticking our toes in the sand.

They say that all good things must end someday, but until then, stay cool and beat the heat with…
Abbott/Biotest: Already the owner of a strong rheumatoid arthritis franchise, Abbott Laboratories now hopes it’s found a new drug that will pick up where Humira (adalimumab) leaves off when it loses patent protection in 2016. Abbott paid $85 million up-front to license German biotech Biotest’s BT-061, a Phase II anti-CD4 antibody designed to act on a T-cell regulation pathway and combat inflammatory diseases such as RA and psoriasis. Milestone payments could add another $395 million to the deal, which also includes royalties if the drug is approved and marketed. For its cash, Abbott gets worldwide rights to the drug outside of five major European markets: U.K., Germany, France, Italy and Spain. In those countries, Abbott and Biotest will co-develop and co-promote BT-061. It’s the latest of Abbott’s moves to shore up its post-Humira pipeline. Last fall, the company paid $450 million upfront to license ex-US rights to Reata Pharmaceuticals’ bardoxolone, which announced positive data today; Abbott also bought Facet Biotech for $722 million in March 2010, giving it the multiple myeloma treatment elotuzumab, scheduled to enter Phase III later this year. Both products could be marketed before Humira’s expiry if all goes well. - P.B.

Allozyne/Poniard: The latest company to execute a reverse-merger transaction and emerge as a public company is Allozyne, a conjugated protein therapeutics specialist with a focus on autoimmune disorders. Allozyne revealed plans to merge with publicly traded Poniard Pharmaceuticals, whose stock has been trading at less than 25 cents since the beginning of June and hasn’t cracked the $1 mark for more than a year. Allozyne shareholders will receive 65% ownership of the surviving company, which will keep the Allozyne name, Seattle headquarters, and CEO, while Poniard’s stakeholders will get 35%. The combined company will seek a partner for Poniard’s primary asset, the Phase III oncology drug picoplatin, while focusing its attention on Allozyne’s portfolio. That includes AZ01, a multiple sclerosis drug set to enter Phase II, and AZ17, a preclinical antibody Allozyne says has broad potential in autoimmune and inflammatory diseases. The deal sets up a path to liquidity for Allozyne’s venture investors, who have poured at least $39 million into the company since 2005; they include MPM Capital, OVP Venture Partners, Arch Venture Partners and Amgen Ventures. Poniard shareholder Bay City Capital will loan the company $2.4 million as part of the transaction. Last month, Radius Health raised funding and concurrently reverse-merged with an as-yet-unlisted shell company, intending to go public by early next year. - P.B.

AstraZeneca/Dentsply: AstraZeneca’s pending sale of its dental supplies and medical devices business, AstraTech, to Dentsply International, the world’s largest maker of dental supplies, comes with a handsome valuation and a strategic challenge: now that it is entirely a pure-play pharma, AZ will have to deliver on growth through innovative medicines. The sale of AstraTech, announced June 22, removes AZ from a business it has been in since the 1950s. Still, with sales of roughly $535 million, that hasn't been enough buck for the required operational bang. But Dentslply's offer -- at a multiple of roughly three times sales and nearly 20 times EBITDA--gives AZ plenty of dry powder, adding substantial cash to a net cash position of just $1.5 billion based on the multi-national's first quarter filing. AZ will need that money to support strategies that bolster its top line as it enters into what analysts peg as one of the steepest patent cliffs in the industry, beginning in 2012 and lasting through 2016, with the expiration of the U.S. patent of Crestor. AZ ‘s emphasis on focus has met skepticism on Wall Street, but the recent success of pure-play Bristol Myers Squibb andequally lackluster results at diversified companies like Pfizer may change some analysts' minds. - Wendy Diller

Epizyme/LLS: Well-funded epigenetics startup Epizyme already has $54 million in VC money to play with, but that hasn’t stopped it from pursuing alternate sources of capital. The Cambridge, Mass.-based startup announced that it will receive $7.5 million in new money from the Leukemia & Lymphoma Society, intended to support preclinical and early-stage clinical development of a drug targeting Mixed Lineage Leukemia. The capital, which will be delivered in installments as certain milestones are reached, will support development through Phase I of a histone methyltransferase inhibitor targeting the gene DOT1L. In January, Epizyme struck a partnership with GSK covering a defined set of HMT inhibitors that brought in $20 million upfront, with milestone payments potentially yielding $630 million. Two months later, the biotech forged a pact with Eisai around the EZH2 enzyme worth $6 million up-front and $200 million in milestones. Enthusiasm for epigenetics has run high lately, as rival Constellation Pharmaceuticals added $15 million to a previously announced $22 million round earlier this month. - P.B.

Sanofi/Medco/UBC: Sanofi-Aventis became the second Big Pharma this year to form an alliance with a clinical outcomes research organization, tapping MedCo and its United BioSource Corp. unit to deliver payer perspective on drugs still under development. Sanofi will pay Medco and UBC an undisclosed amount for their expertise, particularly in identifying patient populations for drugs before they come to market. MedCo has pharmacy claims data for 65 million Americans, which Sanofi may find useful as it develops plans for late-stage compounds such as its Phase III dyslipidemia drug mipomerson and multiple sclerosis candidate Lemtrada (alemtuzumab). The deal follows AstraZeneca’s February agreement with health benefits provider WellPoint and its clinical outcomes unit HealthPoint, intended to provide it with “real-world” data concerning cost, clinical and comparative effectiveness as it negotiates with payers. - P.B.

Financings of the Fortnight Can't Escape Velocity

Last we checked in with San Francisco venture firm CMEA Capital, it was April and the firm's health care team was looking to raise a new fund dedicated to buying individual drug assets, developing them with a virtual network of contractors, and selling them to Big Pharma buyers hungry for late-stage products.

The plan, dubbed Velocity, was to partner with a preferred pharma, which would contribute a sizable chunk of change; CMEA's fundraising pitch said Eli Lilly would be the partner. Lilly has been building its "Mirror" fund strategy to find VCs as drug-development proxies for pieces of its pipeline, and reserving preferential rights to the drugs if the VC teams develop them quickly and successfully.

Your faithful FOTF correspondent wrote about that plan in START-UP's April Capital Matters column, juxtaposing CMEA's approach with that of Altas Venture, which has carved out a piece of its current fund for its own "development corporation."

Well, now. CMEA's plan has changed, and it looks a lot more like Atlas's.

Velocity Development Corp. is now structured as an LLC holding company, not a fund. It will still buy assets and develop them, but not aligned with a specific pharma partner, CMEA managing director (and newly minted Velocity CEO) David Collier told us today.

Instead, Velocity will use $20 million from CMEA's current fund to launch, with a $40 million Series A upcoming and a $50 million Series B in 18 months. Those figures came from CMEA managing general partner Jim Watson in a VentureWire story earlier this month. Collier said today he wasn't allowed to discuss fund-raising, but he acknowledged and did not dispute the report.

Velocity will use the cash for operations -- $15 million maximum to develop each drug through proof of concept, for no more than three years -- not to acquire drugs if it can help it, Collier said. Instead, he and his colleagues, including three biotech veteran executives, will pay sellers with equity in the one-off companies they create around each drug. "Cash is dear, and people should be happy to take equity," he said. The blueprint is to offer a 20% stake, but Collier cautioned that was a "ballpark number to begin the negotiating process."

Is it a model that other venture firms might be forced to follow? Only if they're willing to give up venture compensation. The Velocity employees will basically be biotech employees, with an annual salary and stock options in the newco's they create around the drugs they acquire. No management fees, although it remains unanswered how the $20 million carved out of CMEA VII will be treated.

Nothing's signed, sealed or delivered yet, but the Velocity team has four or five deals in due diligence, Collier said.

A Lilly spokesman confirmed that CMEA was not part of Mirror but declined to discuss whether the Indiana pharma is looking for a replacement. Lilly said last September that one Mirror fund already had two molecules in its portfolio, one from Lilly.

VCs becoming drug developers? Veteran investor Kurt Von Emster calling his new firm VenBio an "unventure firm"? (My colleagues and I will have more on that soon.) Does anyone actually want to fund new companies anymore? Sure they do; witness the big sack of cash orphan disease firm Ultragenyx just received (description below). But the news from the innovation front -- the Series A rounds that we love to track as a rough guide to the mood of the venture industry -- remains grim. (We'll have more on that soon, too.)

Speaking of Series A recipients, one of our A-List alumni said this week it wants to go public in a big way. Others are finding it easier to crawl hermit crab-like into the shell of another hollowed-out company as a way of reaching the public markets. We told you last month how well those usually turn out.

By the way, it's a smaller world without The Big Man in it. To you, Clarence Clemons, we dedicate this edition of...

BliNK Therapeutics: The UK's top cancer research nonprofit has done it again. Cancer Research Technology, the tech transfer arm of Cancer Research UK, announced the spin out of its latest oncology-focused biotech BliNK Therapeutics on June 13, with £1 million ($1.8 million) in initial seed financing from Paris-based investor Kurma Life Science Partners. BliNK will concentrate on monoclonal antibodies for therapeutic and diagnostic uses. Kurma, which operates through the €51 million Kurma Biofund I, could put another £6 million into the start-up in the future. BliNK marks the 22nd spin-out from CRT, which has also created Antisoma and Chroma Therapeutics, both of which have secured Big Pharma partnerships, and Piramed, a PI3-K specialist that Roche acquired for $175 million in 2008. BliNK is developing new technology that prompts the immune system’s B-cells to produce cancer-fighting monoclonal antibodies against clinically relevant antigens. The company says the antibodies can be generated even when parent B-cells, which later produce millions of daughter B-cells capable of producing antibodies, are rare, or when the B-cell doesn’t easily recognize its antigen. The platform was developed by Dr. Facundo Batista, whose lymphocyte interaction laboratory is housed at Cancer Research UK’s London Research Institute, and Dr. Vincenzo Cerundolo of the University of Oxford. -- Amanda Micklus

Ultragenyx Pharmaceutical: Year-old startup Ultragenyx closed a $45 million Series A round, among the largest early-stage deals yet for an orphan disease specialist. TPG Biotech and Fidelity Bioscience led the round, investing alongside HealthCap and Pappas Ventures. The two lead investors recently enjoyed an exit in the rare disease arena, having held stakes in protein misfolding disorder startup FoldRx prior to its acquisition by Pfizer in September 2010. Led by former BioMarin executive Emil Kakkas, who relocated just a few doors down from his previous employer, Ultragenyx has already in-licensed its first candidate, UX-101, intended to treat the muscle-wasting disorder hereditary inclusion body myopathy, which afflicts about 2,000 people worldwide. Discovered in Japan, the drug previously belonged to Nobelpharma, which will retain its rights in several Asian territories. UX-101 triggers the production of sialic acid, a sugar essential for several bodily processes. Delivered in an extended-release oral formulation so as to overcome overnight clearance from the patient’s system, UX-101 is scheduled to enter Phase I trials in the US next month. Ultragenyx has subsisted for the past year on $3.4 million in seed funding from onetime BioMarin colleague John Klock and FoldRx chief commercial officer Bill Kaliski, as well as Kakkas. Ultragenyx has licensed four other preclinical drug candidates in the lysosomal storage disease area, and the firm intends to bring one into the clinic within the three- to four-year lifespan of the Series A round. -- Paul Bonanos

Tesaro: Is this the new MGI Pharma, the cancer and acute care company bought by Eisai in 2008? Tesaro has the same top executives, including CEO Lonnie Moulder, and now it has a massive infusion of cash to push its lead candidate rolapitant into Phase III for chemotherapy-induced nausea and vomiting. Tesaro said June 21 it has raised $101 million in Series B cash from a syndicate led by existing investor New Enterprise Associates. NEA kicked in $40 million, an astounding amount for one firm to contribute in a round. The syndicate included new investors Kleiner Perkins Caufield & Byers, InterWest Partners, T. Rowe Price, and Pappas Ventures, which also had a hand in Ultragenyx's A round. In December 2010, Tesaro in-licensed rolapitant, a selective neurokinin-1 receptor antagonist, from drug, diagnostic and device company Opko Health for $6 million upfront, potential milestones up to $115 million, plus double-digit royalties. Opko also took a 10% equity stake. Moulder told "The Pink Sheet" DAILY that the funds would also be earmarked for "one or two more oncology assets" to fit mid-stage between rolapitant and a preclinical anaplastic lymphoma kinase (ALK) inhibitor that Tesaro hopes to move into the clinic next year. -- Lisa LaMotta

Aveo Pharmaceuticals: For a lesson why it's worth going public if the markets allow, Aveo has netted $104.3 million from a follow-on public offering that closed June 21. The offering consisted of more than 6.3 million shares of common stock, including the overallotment, sold at $17.50 per share. The stock then gained 3% to close at $18.34 the day after the transaction. The oncology developer is on a roll. It debuted with a $83 million IPO in early 2010, then earlier this year it signed a pair of big deals with Astellas Pharma and Johnson & Johnson’s Centocor Ortho Biotech. AVEO received $125 million upfront from Astellas in February for rights to co-develop and commercialize tivozanib, which has a lead indication of renal cell carcinoma. Then, in May, Centocor paid $15 million upfront, half of it an equity investment to acquire 1.25% of AVEO, to license global rights to AVEO’s antibodies that target the RON (Recepteur d’Origine Nantais) receptor. Presumably, the funds will help the continued development of a pair of candidates in the clinic in a variety of oncology indications – tivozanib, a small molecule triple VEGF receptor inhibitor in Phase III, and ficlatuzumab, an antibody that inhibits the HGF and cMET pathways, in Phase II for non-small cell lung cancer in combination with Iressa. -- Joseph Haas

Photo courtesy of flickr user virtuallykc via a Creative Commons license.

last weekend

First of all, sorry to scare you guys with the below video. I promise I would use words if there were any drastic change in any of the EB kids' conditions, especially Tripp's. I didn't know he was going to be the freeze frame when I posted it. Sorry I gave many of you a heart attack. I know Tripp would probably be "mean" to me (smile), but I would LOVE to go to Louisiana to meet him. I love that kid.


The Cannells are in Eastern Europe now (left on Monday) to spend 8 weeks doing all kinds of legal stuff, court dates, traveling, waiting etc to get their boys! Because of several different blogs posting, a couple of fundraisers, and a MIRACLE from God, they raised all the money they needed (over $40,000) in just a few weeks. WOW! If you aren't following their story, Karrie is updating on their blog HERE.


Okay, now to our weekend. Even though Jonah wasn't breathing great, we tried to get him out a little this weekend. It has been very hot here so we tried to get him out while we could. Kernersville was having their Summerfest with live beach music, food vendors and a few rides. Mom kept Jonah one night so Matt and I could go, and then we took Jonah a couple nights later.


Last week's Project 52 theme was "Make it Tasty," so I took lots of photos of food, before settling on the topping dispenser photo. Matt and I went to a frozen yogurt place after this. It was all in the name of Project 52, I swear.

DINNER! Yum.

This photo is blurry because I had to crop it way in, but I thought this was hilarious.

Matt wanted me to take a picture of him in Las Vegas.

'

I wanted him to take a photo of me in Montana. Sometimes I am certain we could not be more different. (Also, this photo is my motivation to complete Couch to 5K (Day 3 is tomorrow). I've gained 10 lbs in the last 8 months. That's crazy! I feel so crappy about myself. I just want to be healthy!!!)

Matt walked the entire United States and knew every state. Again, with the "we couldn't be more different." I pretty much only knew NC and its surrounding states. And of course the big ones, especially Texas, you know, the state where all my friends are moving. That one. (Thanks to Matt for showing me which one Montana was! To my credit, I did know its general whereabouts.)

Trying to tell Jonah that he loves trains, remember?

"I know you want to take a photo of me with the train, Mom, but this isn't exactly natural."

I die.

Nana bought Jonah a bubble gun! Coolest toy ever. Matt has enjoyed it as well.

About as close to the train as he would get. He really did love it (screaming in excitement: Choo-Choo, TRAIN!, All Aboard!, Chugga-Chugga, Here it comes!) but he just wanted to love it from a distance.

I die. Again.

This picture is funny and a little sad. He wanted to love the fire truck from WAY far away.

No words...

I love Tripp and all these other EB Sweeties (and their parents) so very much.



http://thebutterflyfund.org

our God of miracles

Very quickly because it's been an exhausting day.


Jonah cried all morning because of the steroids. By the time I got him on the bandage change table, he had been crying for about two hours straight. Because I had his torso bandages off, I could see that he was retracting at his rib cage and his breathing had become much more rapid.


I called my mom to come over and Matt to come home from work.


By the time they arrived, Jonah's breathing had become more stable (still sounded bad, but didn't seemed distressed anymore). Matt and I decided to take him to the hospital. We called the pediatrician and they set it up for us to go to the ER, with the understanding that we would be taken straight back, evaluated by the attending ER doc, and then his ENT would be paged. They had spoken with both the ER attending and Jonah's ENT so everyone was on board. Since he had stabilized, we were told it was okay to wait a couple of hours so we let Jonah take a nap. While he slept we packed EVERYTHING in case we were admitted - everything we could think up he might would eat by mouth, all his medicines, his g-tube stuff (for his water and meds), bandaging materials, toys, the laptop and DVD's etc. All we had left to do was change his diaper when he woke up, and then we would be on our way. For six days he had been having terrible growling type stridor and a hoarse voice. For six days I've been worried non-stop about my Sweet Boy's breathing.


He woke up.


He was breathing easy, no stridor, and had more of a voice than he's had since last Thursday. (I guess he had a blister and it finally popped in his sleep?) That Legion of Angels seems to still be protecting him, even now.


We're never alone. Praise God!


Oh, I guess you got that we never had to go to the hospital? Life is good.


Thank you so much for your prayers. 

breathing update

I took Jonah to the doctor at noon, and here's the skinny.


He's still moving air well and although he sounds HORRIBLE, he doesn't seem to be in any distress and is getting the oxygen he needs. If things stay as they are, he will be okay for now. If he's not better after 72 hours on the steroids (Wed night), we will have to see the ENT at the hospital (bronchoscopy? admission?) on Thursday.


If things worsen (he stops playing, begins breathing rapidly and is struggling, struggles talking, won't sleep, retraction etc.), we will be headed to the hospital. I asked the doctor to call the ENT at the hospital to give the department an idea of what's going. I'm trying to work it out to where if we do have to go to the hospital, we can get a direct admission through ENT rather than having to go to the emergency room.


In other news, having to suffer Jonah on steroids until Thursday morning is going to make me batty. Like seriously, y'all will be checking me in cause I'll have checked out. Prednisone, I loathe you (but also love you... funny).

to my daddy

Dear Daddy,

Mommy and I just wanted to say (even though it's almost not Father's Day anymore) how much we love you and appreciate you. Daddy, you are seriously THE BEST dad in the whole world. Mommy or I just can't imagine our life without you, and we don't want to. I know when I came along, I kind of blew your concept of "normal" out of the water, but you have been so great at going with the flow and learning how to perfectly care for me. But even though you take such good care of me, you also still let me live. You don't hold back on the wrestling, the ball playing, and all the good things boys should get to do. You make sure I FULLY live and realize that that is part of taking care of me too. Mommy can't believe that before I came along, you had never even changed a diaper. You are amazing, Daddy. I love our play times, our quiet times, and most especially our night night times. The way you read me book after book and never rush our rocking and singing time is so great. Thank you for never seeing time with me as a hassle or something you have to do, but always valuing it as a privilege. You are my hero.

Thank you for the bubbles...

the snuggles...

for always keeping us laughing...

and lightening the mood...

for the swinging...

for the wrestling...

the quality time...

the kisses...

the "Jonah slams"...

the laughs...

the smiles...

the love...

and all the hugs.

Mommy and I can never thank you enough for the man and Daddy you are. We are so thankful, so grateful, so blessed. We love you, Daddy. Happy Father's Day.


Love,
Jonah and Mommy

jonah's breathing - update 2

Matt's mom wasn't super scared about Jonah's breathing. (She's a nurse.) She thinks we're fine to wait until tomorrow as long as he doesn't get worse. He's still running and playing and talking, and she said he'd be taking more breaks and having to stop and breathe if he was in too much distress. She says his fingernail beds (he has only two actual fingernails left) are still nice and pink, and they would be one of the first things to go blue if he wasn't getting enough oxygen. 


But we will be turning back on the breathing part of his Angel Care monitor tonight, just to make sure. 


Thank you for all your prayers. I would like to do a Father's Day post later on tonight but am not sure how much energy I'll have (stupid yard sale prep). I'll definitely give a Jonah update tomorrow after we go to the doctor. Not sure what time they'll be able to see us.

jonah's breathing - update

Jonah's breathing is a little worse today. Matt's mom is coming over (still in town, caring for her dad) to listen to him and help us decide if we can wait until tomorrow to take him in. The Emergency Department would pretty much be the most dangerous place for him germ wise, and maybe even skin wise since it would be doctors and nurses who don't know him or what EB is. I've also put in a call to the after hours doctor, and we're getting some oral prednisone called in (evil baby, here we come). So hopefully that will help keep us until we can get him to the doctor tomorrow. Ugh. 


Please keep praying.

quick prayer request

This will be quick because Matt and I are going to work on organizing the garage/start yard sale pricing stuff tonight. But I did want to mention that Jonah has been really hoarse and wheezing for the last three days. Matt and I suspect he has some blistering in his trachea and so his airway is at least partially constricted. I talked to Dr. Heather (his NICU doctor) today and described what was going on. She said she doesn't think he's in immediate danger yet (not retracting, color is good), but that if he gets any worse (stridor gets louder, retracting, color changes, rapid breathing), we need to take him into the Emergency Department. If he stays the same, I'll take him to the pediatrician on Monday. But hopefully he'll be fully restored by then.


Trying not to get discouraged with "It's always something" and be thankful. It doesn't help my attitude much that I spent the entire day sorting and pricing TONS of baby boy clothes, hardly any of which either of my sweet boys ever got to wear. So much of it is new and has only been washed twice - once before Gabe and once before Jonah. And there are also many many things that are new with tags. Having to sell them feels so... final. I don't know. I shed some tears. It's been hard. Anyway, we're having a yard sale on July 9th, so if you live close by and you have a baby boy, you should come. I would love some of these clothes to go to families who know our story. Either way, it's time to close the door on old dreams and start focusing on our new ones.


No church for us tomorrow given Jonah's fragile state right now, but I hope all of you have a blessed weekend.


I'll keep you posted on Jonah if there is any change, one way or the other. As always, thank you for your prayers.

DOTW: Save The Date

Miss the crowds? BIO’s just around the corner. This year there’s an added je ne sais quoi to the trade event as deal makers and execs converge on the regulatory swampland that is our nation’s capital. Amidst discussions of the state of the industry -- the strengthening IPO market (?), the venture financing climate, and the impact of both on deal making -- all eyes will be on FDA as it holds forth on Provenge and Avastin.

But while there’s no question BIO is a must-attend event, here at IN VIVO Blog, we’re admittedly biased in believing there’s another networking opportunity that is de rigueur for the industry’s top deal makers. That’s right: IN VIVO’s annual Pharmaceutical Strategic Alliances meeting, taking place September 22 and 23 in New York City at the Millennium Broadway Hotel.

Yes, we’re tooting our own horn, but once you’ve checked out our stellar line-up you’ll understand why. Key notes by Biogen Idec’s George Scangos and Bristol’s Lamberto Andreotti kick off the meeting. Then there’s an all-star discussion of biz dev on day 2 with help from Pfizer’s Kristen Peck, BMS’s Jeremy Levin, J&J’s Tom Heyman, Roche’s Joe McCracken, and Glaxo’s Ian Tomlinson.

You want deal making? We have it in spades. And not just at PSA. As we head into a summer time Friday, we bring you your weekly wrap up of the deal making headlines…

Boehringer Ingelheim/Zealand: Surprise! The Danish biotech Zealand pharma inked a deal this week for its Phase I-ready dual-acting GLP-1 and glucagon agonist for type 2 diabetes and obesity, ZP2929. But the partner, Boehringer Ingelheim, probably wasn’t the one folks expected given Zealand’s previous tie-up with Sanofi (the pharma formerly known as Sanofi-Aventis). This week’s deal, which includes a research collaboration, is worth €20 million in committed funding to the Danish biotech during 2011, and up to €41 million in the first two years. Zealand will conduct the first Phase I study with ZP2929, but Boehringer will pay for the research, development and commercialization of the compound, as well as any other additional GLP-1/glucagon agonists that eventually. Total biobucks for ZP2929, hailed by its inventors as a “next-generation GLP-1 agonist that improves on Byetta and Victoza, could reach €376 million. According to “The Pink Sheet” DAILY, Zealand, which raised nearly $60 million via the public markets in October 2010, had plenty of suitors for the compound. But with Zealand's most advanced compound, the GLP-1 agonist Lyxumia (lixisenatide) an increasingly important asset within partner Sanofi's diabetes pipeline, "we felt... it was better to diversify its partnership base," CEO David Solomon explained. Boehringer is a relative newcomer to diabetes, only unveiling its interest in the therapeutic area in 2008. Still it has moved rather quickly, and boasts a newly expanded late-stage pipeline thanks to the broad-ranging, risk-sharing deal it signing with Lilly in January of this year. As part of that tie-up, the two drug makers agreed to co-develop and co-commercialize up to five diabetes drugs, including Boehringer's DPP-4 compound Tradjenta (linagliptin), which FDA approved in May 2011, and a Phase III sodium-dependent glucose transporter-2 inhibitor. – EL

Vertex/Alios: Less than a month after FDA approval of its protease inhibitor for hepatitis C Incivek, Vertex Pharmaceuticals is looking to bolster its ability to offer potential combo therapies. Thus, it’s tie-up this week with Bay Area-based Alios Biopharma. The worldwide license to a pair of preclinical polymerase inhibitors, ALS-2200 and ALS-2158, is worth $60 million upfront to the privately-held Alios. In addition to the licensing agreement, the deal includes a research collaboration between the two companies: Vertex will provide undisclosed funding to Alios for discovery of additional polymerase inhibitors and retains an option on compounds unearthed via the collaboration. The bio-bucks owed Alios aren’t insignificant either: the biotech could earn up to $715 million in research and development milestones related to these two nucleotide analogs. Vertex has plans to move both molecules into Phase I trials during the fourth quarter of 2011. Longer-term, the big biotech intends to test the two molecules in varying combinations with telaprevir and VX-222, its Phase II non-nucleoside polymerase inhibitor, in an effort to find and develop an all-oral combo of drugs to treat HCV. Vertex said it expects to pay out $35 million in milestones this year, when both programs are scheduled to enter the clinic, but would not specify whether that also might cover other milestones to be met this year.—Joseph Haas

Sanofi/Audion: Sanofi has signed a two-year research agreement with Amsterdam-based Audion Therapeutics to discover and develop small molecule treatments for age-related hearing loss. Financial terms of the agreement weren’t disclosed, but Sanofi will have the option to license any compounds resulting from research done under the collaboration. Audion, a regenerative medicine play, aims to stave off deafness via developing compounds that protect and resurrect the inner ear hair cells, which are responsible for the amplification and transduction of sound waves to the auditory nervefor relay to the brain. As might be expected, Audion will work with Sanofi’s Aging unit, one of five new therapeutic strategic units established in the past year under the pharma’s revamped R&D model. Sanofi’s Early-to-Candidate Unit will also be involved. Paul August, U.S. head of the Early-to-Candidate unit, said his team aims to provide the Aging unit with a clinic-ready candidate by the end of the two-year collaboration. As this Start-Up feature noted, big pharma generally has stayed out of hearing loss, which has been dominated by med-tech firms providing hearing aids and, more recently, cochlear implants. Many venture capital firms and other investors see hearing loss as a potentially lucrative space, similar to ophthalmology, because of unmet medical need and demographic trends. The Sanofi/Audion tie-up is the first drug development partnership for hearing loss since Novartis licensed rights to a group of preclinical hearing loss and balance disorder programs from GenVec in exchange for a $5 million upfront payment and a $2 million equity investment last year.—JH

Pfizer/pSivida: Is Pfizer in or out of ophthalmology these days? This week’s amended deal between the big pharma behemoth and drug delivery play pSivida makes it clear Pfizer is willing to do what it must to protect its once daily glaucoma eye-drop Xalatan, which generated $1.75 billion in revenue in 2010 but lost key patent protection in March. Still, as Pfizer continues to redefine its innovative core (without, one hopes, experiencing a breach), it’s not so interested in ophtho that it wants to consider a broader deal with pSivida any longer. The Watertown, MA-biotech pSivida originally aligned with Pfizer in 2007 under a far-reaching deal that gave the big drug maker exclusive world-wide rights to its implant technology, as well as a 10% ownership stake. Under the revised agreement announced June 14, Pfizer will pay the biotech $2.3 million upfront for an option, which can be exercised at the end of Phase II, on an implant device that bathes the front of the eye with a sustained-release version of Xalatan. If Pfizer options the product, it will pay pSivida an additional $20 million and up to $146.5 million more in clinical and regulatory milestones. Despite Xalatan’s ability to effectively lower intra-ocular pressures without terribly onerous side-effects, compliance is a problem. (One main reason: Administering drops on a daily basis is a pain in the…er, eye.) As a result, there’s a lot of effort in the start-up community to develop implantable devices that improve adherence by obviating the need for daily administration. The 2007 deal revision provides significant potential upside for pSivida since it can now solicit partnerships with other drug makers. Among the most active deal makers in ophtho: Merck (which took out Inspire earlier this year), Novartis (via its Alcon group), Roche/Genentech, and of course specialty players like Allergan and Baush & Lomb. This wasn’t the only ophtho deal to be revised this week. On June 16 came news that Alcon was pulling out of its he collaboration with NovaBay, returning all rights to the first-in-class anti-infective Aganocide and back-up compounds. -- EL

Merck/Hanwha: Merck vaulted to the pole position in the race to bring a low-cost version of Pfizer and Amgen's rheumatoid arthritis blockbuster Enbrel to market this week, gaining rights to a late-stage biosimilar version of the biologic developed by South Korea's Hanwha Chemical. According to the June 13 partnership, Merck will develop and commercialize a biosimilar form of Enbrel, HD203, in all markets except Korea and Turkey, where Hanwha has retained marketing rights. In exchange, Hanwha receives an undisclosed upfront payment, and is eligible for milestones as well as tiered royalties on sales. Although financial terms of the deal were not disclosed in the official release, Hanwha Chemical spokesman Kwon HyukBum confirmed to PharmAsia News that the total potential cost of the collaboration to Merck is $720 million. Although Merck declined to confirm that figure, Merck BioVentures President Michael Kamarck said in an interview with “The Pink Sheet” DAILY that the deal is heavily back-end loaded. Nonetheless, the financial arrangement is "symbolic” of the huge opportunity for Enbrel biosimilars, he said. Merck has assembled a pipeline of biosimilar drugs since announcing the formation of Merck BioVentures in December 2008. Still, the company has revealed plans only for a couple of products, including a granulocyte colony-stimulating factor referencing Amgen's Neupogen and a pegylated version of Neulasta. Earlier plans to develop a biosimilar version of Amgen's Aranesp were scrapped in 2010, given emerging safety issues with the class. Merck continues to stand by its goal of having five biosimilars in Phase III by the end of 2012 and says it is mainly interested in harder-to-replicate monoclonal antibodies. – Peter Chang & Jessica Merrill

project 52

This week's Project 52 photo.

Theme: Make It Tasty

Feeney's Frozen Yogurt Bar
Kernersville, NC

better!

Sweet Jonah has done much better the last two days. He still had diarrhea yesterday, but did not throw up. This morning's poopy was not nearly as runny (sorry, y'all), and no pukes again! Tomorrow we'll be moving up to seven ounces a meal, hopefully! Thank you so much for the prayers. It was just lasting so long and was so sporadic, I was starting to get freaked out. Your comments were so comforting. The normal stuff is just so scary because I don't know if it's normal or EB related. (I mean, he eats his freakin' bandages... seriously???)


I've been feeling a little sorry for myself (and Jonah, of course) over the last couple of weeks. We've just not gotten out much and we can't go to the pool and he can't play outside. He's feeling the effects of being cooped up and has been really whiney the last couple of days. My patience has been low, and I feel like I've been snapping at him more the last couple of days. I think we're both just a little stir crazy so I'm going to try to get us out somewhere tomorrow and Friday, just because we are driving each other crazy. :) He's so good, though. And I really really shouldn't complain. I've really been convicted today about how much we, as Americans especially, complain SO MUCH about EVERYTHING (it's too hot, it's too cold, stop raining, oh we need rain so bad, I hate my job, I want to be a stay-at-home-mom, my kids are driving me nuts, I have to get out of this house, There's nothing to eat (really?), My air condition is broken... and on and on and on). It just made me sad to think about. You know that verse about always being ready to give a reason for the hope that you have (I Peter 3:15)? Well, ain't nobody gonna ask me about my hope if I don't have any. O-U-C-H. My life and my attitude should look different. I should be and feel like an alien in my air conditioned house, my mini-van, and with my full pantry. If we're just going through the motions, living like everyone else, and complaining with the rest of them, we're not being much of a light. And we're surely not living in the joy and hope that comes with a true life in Christ. Well, kick my butt and call me Sally. That. Just. Hurt.


Anyway, I'm thinking A LOT these days. That's not always a good thing.


Hey, wanna see some cute shots of Jonah? Alrighty then.

Whiney or not. Summer or not. Crazy Momma or not. I love this kid. I love my life, no matter what it looks like. I have lots and lots and lots of hope. Now, come on, ask me. Cause I've got a whole bunch of reasons. :)