camping trip, part three

The long awaited final night photos of our sibling camping trip. (You were holding your breath, weren't you?)


We didn't want to overdo it with the too-outdoorsy stuff since we only had two days together, so on Saturday night, we went out to eat in Boone. It took us a while to figure out where to go but we finely landed at a southern cuisine restaurant called Proper.

Peyton went to snap a photo of the girls, but little did we know the camera was still set on the 10 shot setting from when we were taking our photos on the rock earlier in the day. So I took advantage of it and acted like a fool. (You're only seeing four of the ten. You're welcome.)

Pretty sisters.

Peyton, attempting to be artsy.

Shaina's the cutest.

I made them do this.

I am definitely getting 30-year-old eyes.

My turn at attempting to be artsy.

Our food. Everyone's was really good except Shaina's. Not sure how they made Baked Ziti (it didn't have sauce), fried potatoes (THEY DIDN'T HAVE KETCHUP!), and hushpuppies (um, not where I'm from, those aren't) so weird.

Shaina is considering Appalachian for college, so we made sure to go by the campus after dinner to let her check it out. It really is a beautiful campus.

This is the part of the story where I walked down the hill to get these photos, fell smack on my bottom and DIDN'T pee my pants. HOORAY! (Thank you, Couch to 5K.)

And then it was back to the camp site for S'mores!

The next morning, we packed up camp and headed to Mellow Mushroom for lunch before we came back home. We had such a good time, and I really hope we can (and our spouses will agree to) make it an annual thing. Either way, memories I'll treasure forever.


On a completely different note:
- It's 10:31 and Jonah is still awake, talking in his bed.
- I napped when he napped today and will probably be up all night. WHY DO I DO THIS?
- I completed Week 8, Day 1 of Couch to 5K tonight. This is my current FB status: 
Tried running a new route today. I ran to and around the Sedge Garden Rec Center. Problem is I ran downhill to get there so the second half of my run was mostly uphill. My running mantra on the way back was, "You're so stupid. You're so stupid. You're so stupid." But it was more of a "Yoooou're sooooo stuuuppiiid" sort of pace. 
- I've eaten 3/4 cup of Chocolate Cheerios with milk and two pieces of bacon since I've been home from my run, but I'm still starving. Just go to bed, you say? Um, hello, did you not read item two? I'm starving and I want a steak. It's going to be a long night.
UPDATE: At approximately 11:47 pm, I made myself a grilled cheese sandwich. I'm still hungry.

checking in

Feeling pretty unmotivated to post tonight, but just thought I'd check in. Matt had a minor surgical procedure on Friday morning, so he's been on strict "don't walk except to get up and pee" rest since. I'm pooped with taking care of Jonah and all Jonah chores (drawing meds, g-tube meals, washing tubes and syringes, setting up for next day's dressing change, dressing change, picking up toys, night time blister draining etc) without a break. Jonah has been an angel but he's thrown up three times in the last two days (after barely throwing up at all in the last two months), so it's been a long couple days. Matt's recovering well though and he has been a good patient. :)

Funny story:

Background - One of the worst things Jonah deals with is itching skin when his wounds are healing. He takes Zyrtec in the mornings and Atarax in the evenings, and I use some creams and stuff to help, but no matter what, he has some days and moments where the itching drives him crazy. I will often times scratch his boo boos (most of the time on his fingers, heels or wrists) in a safe way to give him some relief. He really can't scratch because he only has two fingernails and does more of a dangerous rubbing against something. Anyway, when I scratch for him, you should see the look on his face. He smiles and laughs and says, "Scratch!" like I've given him the best gift in the world. It's really break-your-heart-cause-it's-so-sad-and-adorable-at-the-same-time sweet.

Anyway, I've tried explaining that Daddy can't walk and play right now, telling Jonah that Daddy has boo boo legs, just cause I don't know how to explain why he can't walk around. Anyway, when I first told him, Jonah walked over to Matt, said "Boo boo legs," and started scratching them for him. It was one of the sweetest things I've ever seen. It was the only way he knew to make Daddy feel better. I won't lie. I  teared up a little.

He is such a compassionate, affectionate little kiddo. Any time anyone coughs or sneezes, he'll say "Okay, Daddy?" or "Okay, Nana?" or whoever. When you get your mean voice and scold him, he'll rub your arm and say, "Iss okay, Mommy. Iss alright. I sorry, Mommy. Iss okay." He loves my friend Lindsey's little boy, Mason, who's four, and just hugs all over him every time he sees him. When his occupational therapist comes, after feeding therapy, they play on the floor and he is ALL OVER HER, wanting to sit on her while he plays. I love how sweet and affectionate he is. I really think he is going to have a beautiful tender heart. (But I'm also preparing myself for him to be the weird kid in school who pets his neighbors.)

Anyway, he's been very helpful with Daddy down, helping clean up his toys, helping feed Deac, and helping carry the trash from the bedroom to the kitchen. I'll tell him to go tell Daddy what he did and how he was a helper, and he'll squeal and run to the living room, so proud of himself he can barely stand it. I hope he always wants to help his Mommy.

Switching gears, I made Mongolian Beef last night for dinner, and it was A-MAZ-ING.

I found the recipe on Pinterest (have I mentioned that I love that site?), and it did not disappoint. Click HERE for the recipe. It calls for flank steak, but I used beef tips because that's what I had and it was super delicious. Let me know if you try it!

PS - We are in the western middle part of NC, so we are safe and sound but many of our Greenville friends have lots of damage and power outages, so please keep them in your prayers. Lots of flooding and I know the Northeast is about to get hit badly too. Praying that everyone stays safe. Don't take stupid chances!

Deals Of The Week Battens Down The Hatches

Mother Nature, you've been busy this week. The entire East Coast population remains glued to Wunderground or The Weather Channel as it tracks the path of the lumbering hurricane Irene. The good news? After the strongest earthquake in nearly seven decades struck outside Washington DC, everyone should have already stocked up on batteries and bread. Just in case, you know, there's an after shock.



Yes, residents of the bankrupt but beautiful California mocked the twitter outcry that ensued after the 5.8 temblor. Consider it pay back for the repeated digs about our obsessions with tree-hugging, organic grass-fed lamb, Steve Jobs, and the Facebook IPO. Maybe the daily lack of humidity just makes us mean. Based on this blogger's perspective, the only truism that matters is that residents of neither coast know how to drive in the snow -- or rain.



If it's been quiet in biopharma land on the deal front, companies like Seattle Genetics are finding ways to make noise. Lots of noise. Hundreds of thousands of dollars per patient worth of noise. Yes, hard on the heels of the Friday August 19 approval of Adcetris came the Monday August 22 unveiling of SeaGen's pricing strategy for the new conjugated antibody. And it's ambitious: depending on the course of treatment, the biologic, which is approved for late-stage Hodgkin lymphoma and systemic anaplastic large cell lymphoma, could cost as $121,500 based on the clinical trial experience.



We applaud the company's chutzpah; the company's CEO, Clay Siegall has come out swinging as to why this hefty price will pass the ever higher bar payers set on "value". Indeed, this is the first drug for Hodgkin lymphoma in 30 years and boasts a strong objective response rate. And we understand that the two approved indications in the drug's label are not the most prevalent cancers, meaning insurers likely won't balk at paying the price tag, given the total dollars won't quickly run into the billions.



All of which is not so subtle messaging from Seattle Genetics execs that they think Adcetris won't suffer from what is now widely being termed the "Provenge Problem" (and before that "the Folotyn Foible") -- essentially the lackluster launch of a new oncologic in part because of the drug's high price tag. Still, given the lack of traction for Dendreon's Provenge in the marketplace, it's not surprising that investors reacted to SeaGen's pricing news with all the enthusiasm of Cleveland welcoming home its prodigal son, LeBron James.



Siegall and his commercial team are confident they won't repeat Provenge's mistakes. As we write in this week's "The Pink Sheet", the biotech has a plan -- an extended payment plan to be exact -- to overcome the reluctance of physicians, who may hesitate to front the cost of the drug before there is clarity on its reimbursement. That has apparently been a major issue for urologists when choosing between Provenge and other alternatives, like the significantly cheaper Zytiga from Johnson & Johnson.



But the twinning of Adcetris and Provenge may not ultimately prove the best comparison. What Seattle Genetics really wants to avoid is the Avastin issue. You see, while payers may not balk at shelling out $120K (or whatever the drug ultimately costs, since labeling permits administration of up to 16 cycles of the drug, which potentially raises the price tag north of $200,000) for a few thousand patients, eyebrows could rise as the biotech and its partner, Takeda Pharmaceuticals, look to expand the drug's label into more prevalent cancers like non-Hodgkin lymphoma. Especially if there aren't overall survival data and/or quality of life measures to support Adcetris's use in a particular indication.



You can bet the topic will be front and center at this year's 21st annual Pharmaceutical Strategic Alliances meeting (tune in September 22 for a discussion officially titled "The Changing Oncology Landscape and watch for #PSA11 tweets).



We know. You haven't had time to check out the agenda because you've mistakenly been crooning "Come On, Irene" all week. By now, you've bought the candles and the water. You've unearthed the hand-crank radio. Take a break from battening down the hatches and tune into another Category 5 edition of...



Baxter/Baxa: Publicly traded Baxter International made a move to expand its medication delivery business by acquiring Baxa, a closely held maker of pharmacy products used to prepare and administer fluid drugs. Baxter will pay $380 million in cash to acquire Englewood, Colo.-based Baxa, which posted $157 million in 2010 sales. Founded in 1975, Baxa still sells its first product, an oral syringe, but also manufactures automated compounding devices used in pharmacies, as well as dose preparation systems for intravenous and oral drug delivery. Baxa is thought to have about a 65% share of the automated compounding device market, placing it ahead of the larger but more diversified Baxter, which also has a bioscience division and significant sales from renal health products. Baxter’s medication delivery division, which includes a variety of pre-mixed drugs, syringes, drug reconstitution systems, infusion pumps, and nutrition products, brought in $4.8 billion in 2010 sales, about three-eighths of its $12.8 billion in overall sales. Baxter has since merged its medication delivery and renal businesses into a single unit; the company also bought irregular heartbeat drug developer Prism Pharmaceuticals for $170 million up-front, plus contingent payments worth up to $168 million, earlier this year. Analysts regarded the Baxa deal as sensibly-priced and low-risk. – Paul Bonanos and Zach Miners



Par Pharmaceuticals/Anchen: The earthquake and impending storm didn't stop Par from making s.its second acquisition this year: the $410 million purchase of privately-held generic drug maker Anchen Pharmaceutical. The latest acquisition, announced August 24, is significantly larger -- and thus, more important -- than the company's May purchase of Edict Pharmaceuticals for $37.6 million. Chairman and CEO Patrick LePore said during a same-day conference call that the Anchen buy would be immediately accretive to earnings, expand the Woodcliff Lake, N.J., company's R&D capacity and nearly double its pipeline of ANDAs awaiting FDA approval. The company, which has both a generics and a proprietary drug business unit, called Strativa, has been focused on topping up its generics portfolio, which generates 80% of its total sales. Through the deal, Par acquires 218 Anchen employees, including about 70 R&D staff, greater expertise in extended release technology, and manufacturing capabilities in southern California. Anchen also brings with it five marketed products that are expected to generate about $125 million in gross revenues this year, including generic versions of GlaxoSmithKline's antidepressant Wellbutrin XL and Bayer's Cipro. Par had $307 million in cash as of June 30, 2011, and plans to finance the acquisition with cash and a $350 million loan.--Joseph Haas



Sanofi/Universal Medicare: After rumors started to circulate early in the week that Sanofi was eyeing acquisitions in India, came Wednesday's news that the French pharma's subsidiary, Aventis Pharma Ltd., will purchase the over-the-counter drug biz of Mumbai-based Universal Medicare. The final purchase price was undisclosed but The Indian Express reports the take-out could cost around $110 million based on discussions with undisclosed sources. The deal gives Sanofi, which has been a nominal player in the Indian OTC space, around 30 brands with estimated annual sales of around one billion rupees. It's no secret big pharmas have been moving aggressively into high growth emerging markets, especially India and China, as sales of key drugs in emerged arenas like Europe and the U.S. stall due to patent expiries. Even as companies eventually look to sell their expensive, on patent medicines in these markets, much of the initial effort has been on creating a presence via a stable of more affordable products aimed directly at consumers. Sanofi has been among the most aggressive of the big drug makers in its pursuit of local EM players (it's recent hunt for Genzyme not withstanding). This latest bid doesn't eclipse its 2009 take-out of the Indian vaccine player Shanta Biotechnics, which cost the French pharma an estimated $784 million. But hopefully the revenue pay back will be better. Shanta hasn't turned out to be such a great deal for Sanofi, given the vaccine company's manufacturing woes.--EL



Image courtesy of www.nasa.gov.

me complaining with some cute videos at the end

To say that Delilah did a poor job sharing Jonah's story and telling how great Brenner is would be an understatement. We listened to her show for two and a half hours all for her to say the following in about ten seconds:

(the transcript from last night, which is posted on her website today)

We all imagine babies being born with the softest skin,  and swaddling them in soft baby blankets as soon as they come into this world. In my travels and time with the doctors and nurses working with  Children's Hospitals and Together For Kid's, their national organization,  I've come to know it doesn't always work that way.  Take little Jonah for instance;  He was born with portions of his little body  without fully developed skin, let alone soft skin. Doctors at Brenner children's Hospitals went to work immediately  on finding the right proteins to feed Jonah. Now he's two years old and  living at home, with his parents so convicted to care for him and so  grateful that God chose them to be his parents. The support that families receive from Together for Kid's hospitals across  the nation is one of the wonderful things I observe when I visit.  You can support that with a gift of $10 by texting to a certain  number from your cell phone. Write this number down: 8-5-9-4-4 When you text "T and the number four and the word 'Kids', to 8 5 9 4 4,  and reply with the word, 'yes', you make it possible for Jonah and many  other children to receive this kind of miracle treatment. Thank you for doing so! Um, WHAT? The doctors immediately started working on proteins to feed him?  No mention of EB, blisters, bandages, or the great job Brenner did  (and what they really did) to help him. Anyway, it's just frustrating because  I read and approved the great story Brenner put together and submitted. And it  seems like they just didn't even take the time to read it at all. I just feel like  she had an amazing opportunity and a big responsibility to make a difference  and could have really made this story and the other one she told (in which she  called the child, Nathaniel, "Nathan" on the air) very powerful and raised lots of  awareness and money for the children's hospitals. Oh well.  On to other things. Even though I get frustrated with being at home all the time, even though  most of our weeks we only go to church on Sundays, to get my allergy shots  on Thursdays, and an occasional trip to Target or the grocery store if we're  feeling crazy, I'm still thankful to be at home. So I can treasure moments like  these. (jonah watching this video from his birthday last year) (jonah watching an episode of tom and jerry. this one's from today.)

jonah on delilah!

The nationally syndicated radio show host(ess), Delilah, is the spokesperson for Together For Kids, a national network of children's hospitals. 


From an email I received: Brenner is a founding member of a national network of children’s hospitals called Together for Kids (T4K). Radio personality Delilah, who is heard in our area each weeknight on 99.5 WMAG-FM, is the national spokesperson for T4K. She has agreed to share stories about patients who have been treated at T4K hospitals and encourage listeners to donate funds to T4K and its members.


Anyway, Brenner asked if they could submit Jonah's story. Of course we said yes, and we just found out that his story will air on Delilah tomorrow night, Tuesday, sometime between 6pm and 10pm EST, or at least those are the times for our local station (99.5). Click HERE for the station and times in your area.


Hope you can listen in!


(singing) Deee-liiiiie-laaaah

jonah's new shirt

Today was laundry day. Jonah decided to try out Mommy's favorite, first-out-of-the-clean-laundry shirt.

It's WAY cuter on him. Just in case you were wondering.

adoption update

Our social worker came for a visit on Tuesday. We have finished our MAPP training and are scheduled to take our Medication Administration class on September 13th. If all goes well, we'll be licensed by the end of the year.

Yet to go:
- Med Admin class
- Fire inspection
- Physicals
- Finger Printing (6-12 weeks)
- Filling out forms (medical history, discipline, background check permission etc and so on)
- Home study interviews
- Environmental inspection check list
- Home study document
- Family profile (a photo and word description of our family written to our future kids)

Anyway, hopefully we'll be licensed by the end of the year. HOWEVER, in talking to our social worker, we found out that, given Jonah's age and how selective we (and they) will have to be in finding a referral for us, we could wait a year or more (an indefinite amount of time, really) for our kids. There are families like ours, with small children and open to legal risk (like we most likely will be), who have been waiting well over a year. It's disheartening, to say the least. BUT, we're trying to keep the perspective that any time we have to wait is just time God is giving us to prepare. To prepare our marriage, our family, our home, our finances, our hearts, our minds, our everything to successfully give this kid (or these kids) the life and home they deserve. We know it will not be easy, and we know that we can't fully prepare ourselves for it, but we can read books, pray, hope, trust, budget, spend time in the Word, rely on God, and do as much as we can to ready ourselves.

I'm excited, apprehensive, anxious, hopeful, but surprisingly at peace and fully trusting. God led use here, and as we continue on this road, I know more and more that this is where we're supposed to be. And I haven't said this in a while, so I'll say it again. God is not in the business of bailing.

We just trust and take it one day at a time. I found this Martin Luther King Jr. quote today: "Faith is taking the first step, even when you don't see the whole staircase." This is going to be a long staircase. But it's worth it. We just keep on climbing.

Deals Of The Week's Tale of Two Drugs

It was the best of times (Vacation!). It was the worst of times (Market turmoil, London's riots, and unemployment; the Middle East.) It was the age of wisdom (Drug reprofiling! Warren Buffett. A new Muppets album); it was the age of foolishness (2012 Presidential election! Phone hacking scandals!).



We had everything before us -- with the waning of summer, the impending season of investor meetings ought to mean renewed opportunities for deal making, after all. Or maybe not. Big Pharma's aversion to take risk could well mean that for biotechs of a certain ilk, we had nothing before us.



Meantime, if regulators weren't exactly channeling a tale of two drugs this week, news of the extension of Eylea's PDUFA and the months-earlier than expected approval of Zelboraf, announced within 18 hours of each other, sure set up an interesting comparison. (The Friday announcement of an early nod for Seattle Genetics and Takeda's Adcetris means we could have written a tale of three drugs. Alas, it messes with my metaphor.)



On the one hand you have Eylea, a VEGF-inhibitor developed by Regeneron to treat the wet form of age-related macular degeneration, whose primary commercial advantage isn't improved efficacy but a more patient-friendly dosing regimen. Its new PDUFA data has been delayed three months from August 20 until mid-November. On the other hand, you have the small molecule BRAF inhibitor Zelboraf, a targeted therapy that is being co-launched with a companion diagnostic and becomes just the second new drug in decades to treat deadly metastatic melanoma. It's original regulatory action date was October 28.

Two different medicines both treating areas of high unmet medical need. But one is first-in-class and one is a essentially a convenience play, albeit an important one given the importance of sight and the potential to avoid onerous monthly eye injections. Still, it's tempting to wonder if stealth comparative effectiveness is at work by U.S. regulators.

That seems unlikely. No new safety or efficacy concerns are behind Eylea's regulatory extension; in a call with investors Wednesday August 17, the biotech's execs emphasized questions tied to the chemistry, manufacturing and controls portion of the drug's biologics license application were responsible for the postponement of the drug's approval. And if the recent advisory committee meeting vote is any guide -- the committee voted 10-0 in favor of the drug's approval -- there's no reason to think the drug won't make it to market later this year.

Still for Regeneron, which is leaning heavily on Eylea to catapult itself into the realm of commercially-focused biotechs, the news undoubtedly came as a psychic blow. The biotech is now in hurry-up-and-wait mode, having lined up a commercial team approximately 70-people strong to launch the product, according to this story in "The Pink Sheet" DAILY. On the August 17 conference call, the biotech revealed it will take a third quarter SG&A charge in part because of the estimated $70 million to $80 million associated with Eylea's launch. Unsurprisingly, investors reacted negatively, sending the company's stock price down about 8% as of the market's close August 18. (Though it could have been worse given the general market turmoil and the massive sell-off late in the week.)



Plexxikon, the biotech which originated Zelboraf, is in a completely different position entirely. Having exercised an option to co-promote the drug in the US, the VC-backed start-up was snatched up by Daiichi, which like so many other pharmas, is looking to double down in oncology. Roche's Genentech is leading the commercial efforts, and as our colleagues at "The Pink Sheet" DAILY report, has identified a crafty plan that puts the targeted therapy's value front-and center. At an estimated $60k for a course of therapy, the drug, which can only be prescribed for patients with a specific mutation, is significantly cheaper than Bristol-Myers Squibb's competitor Yervoy.



The dichotomy between the forces now steering Regeneron and the insulation Plexxikon now enjoys as a division of Daiichi show that for biotechs, the more things change, the more they stay the same. Or in the words of Charles Dickens,

in short, the period was so far like the present period, that some of its noisiest authorities insisted on its being received, for good or for evil, in the superlative degree of comparison only.

On one of the last Fridays of summer, perhaps it is a far, far better thing that I bring you another edition of...



General Dynamics/Vangent: Government contractor General Dynamics shored up its health care information technology division this week with the $960 million cash purchase of Vangent. The deal brings an exit to private equity fund operator Veritas Capital, which owned 90% of publicly traded Vangent prior to the sale. Veritas acquired Vangent’s predecessor, Pearson Government Solutions, for $600 million in 2007; Vangent has since expanded by acquiring two other companies, FDA and Medicare contractor Buccaneer Computer Systems and Service ($65 million) and the health care IT unit of Aptiv Technology Partners ($4 million). Vangent derives about 90% of its business from U.S. government agencies, including the Departments of Health & Human Services, Defense, State, Education and Labor. It provides IT services including electronic health records to military personnel and Federal employees, as well as informing Medicare recipients of health care options. Vangent will be integrated with Falls Church, Va.-based General Dynamics’ information technology division, which also recently grew by acquiring cloud computing company Network Connectivity Solutions. Arlington, Va.-based Vangent posted net income of $40 million on revenues of $762 million during 2010, and had $27 million in cash and equivalents at the end of the year. The deal comes as many government agencies seek to cut costs in anticipation of reduced budgets and buy-out firms as well as traditional venture groups see opportunity in the relatively nascent healthcare IT space. – Paul Bonanos



Paladin/Labopharm: Canadian drug formulator Labopharm had sought a suitor pour longtemps, and finally found one in acquisitive specialty pharma Paladin Labs. This week Montreal-based Paladin agreed to buy struggling Labopharm for CN 28.57 cents per share in cash, valuing the company at about CN$20 million ($20.4 million). Paladin, which markets a variety of drugs including pain relievers, contraceptives and injectable emergency treatments for hypoglycemia and allergic reactions, is already attempting to acquire cold remedy developer Afexa Life Sciences of Edmonton in a hostile bid. The offer for Labopharm is friendlier, however, and has already been accepted by its board. Labopharm, which brought in new management in March as part of a restructuring, develops drugs using its controlled-release and nano-delivery systems; in its earnings report earlier this month, Labopharm said its expenses and obligations would likely exceed its revenue and cash reserves in the coming months, and its ability to survive as a going concern was in question. While the deal seems likely to close without incident by the fall, Paladin has cause for concern elsewhere: Hours after the acquisition was announced on Aug. 17, Paladin CEO Jonathan Goodman was in a bicycle accident, and is currently hospitalized with what the company calls “serious injuries.”--PB

Human Genome Sciences/4-Antibody: Even as HGS's investors wonder what additional late-stage clinical assets the biotech will bring in to continue the revenue upsurge the biotech has enjoyed from the recent launch of its lupus biologic Benlysta, the Maryland-based biotech continues to ink early stage deals to ensure its continued access to innovative products. This week comes news that the firm is teaming up with the Switzerland-based 4-Antibody. Financial details of the tie-up weren't disclosed, but the licensing deal seems like a pretty standard early-stage R&D deal, giving HGS rights to use 4-Antibody's proprietary high through-put antibody discovery platform to produce two novel molecules. The technology is rooted in rapid flow cytometry and is designed to produce fully human antibodies that are "better behaved" (according to official 4-Antibody statements) than molecules produced via alternate methods. It's 4-Antibody's second deal; the start-up inked an alliance in 2010 with Boehringer Ingelheim worth more than $240 million in biobucks. (As with this week's HGS deal, the upfront in that collaboration was not disclosed.) HGS, meanwhile, continues to show its interest in large molecule therapeutics. Just one week after winning approval for Benlysta, it announced it would pay $50 million upfront for rights in the US, EU, and Canada to FivePrime Therapeutics' lead asset, a Phase II oncology medicine, FP1039. --EL

Pfizer/Qiagen: Is the biopharma industry finally getting real when it comes to companion diagnostics? It's hard to say given the economics of deals between biopharma and testing companies are rarely announced. But at least such tie-ups are happening with greater regularity, and this week we have another reminder (if Zelboraf's early approval wasn't already reminder enough) of the strategic importance of companion tests. On August 16, Qiagen and Pfizer revealed the two groups were teaming up to develop a molecular test to accompany the Big Pharma's Phase III dacomitinib, which works by blocking three related tyrosine kinases in the human epidermal growth factor receptor (HER) family. Details of the collaboration were undisclosed but it's a no brainer that Pfizer would align with Qiagen. The two have partnered before in the companion diagnostic realm and Qiagen has considerable expertise in developing FDA-approved tests to diagnose patients' KRAS genetic status. (Recall that mutations in the KRAS gene are commonly observed in human cancers and EGFR-inhibitors like dacomitinib are most effective in individuals who do not have these aberrations.) Indeed, Qiagen recently submitted a premarket approval application for KRAS companion tests associated with two separate drugs targeting metastatic colorectal cancer. While the Pfizer companion test is being adapted for specific use in lung cancer tissue, it uses the same core assay components as Qiagen's other KRAS diagnostics. Qiagen is a relative newcomer to the space of companion diagnostics, building its capabilities primarily through its 2009 acquisition of DxS; this additional Pfizer deal illustrates just how valuable that purchase has proved for a company whose historic strength has been as a purveyor of kits and reagents. That Pfizer is preemptively taking the step to pair dacomitinib with a companion test is a smart move; there are plenty of competing EGFR-inhibitors in development. Providing payers and physicians with a diagnostic that can help triage lung cancer patients helps provide an added level of differentiation.--EL



Bayer Healthcare/Pathway Medical: In the midst of the increased chatter about reviving the question of whether drug companies should also be in the medical device business, fueled by Endo Pharma’s recent $2.6 billion acquisition of American Medical Systems, at least one pharma company that is already in the device space appears to be quietly expanding its presence there. As reported by Xconomy, Bayer Healthcare’s Medrad device unit has reportedly reached an agreement to acquire atherectomy company Pathway Medical Technologies for $125 million, although the deal is not yet final.

Earlier this year, Medrad received CE Mark approval of its Cotavance drug-eluting balloon to treat peripheral artery disease and is selling that product in Europe, while also pursuing an IDE on the path to seeking US commercialization. Drug-eluting balloons hold great promise as the next major platform to treat vascular disease, particularly in areas where even drug-eluting stents have proven ineffective, with the peripheral vascular market representing the largest of those opportunities. Pathway’s atherectomy devices are also focused on clearing peripheral vessels. Medrad has long been a secondary player in this market, largely through its Angiojet thrombus removal system, which the company added in 2008 with its acquisition of Possis Medical. By adding atherectomy and drug-eluting balloons to their current product line, Medrad, which is located in the Pittsburgh suburb of Warrendale, PA, appears to be taking its cue from the hometown Pirates baseball team in looking to move up in the standings by assembling an armamentarium of endovascular devices for clinicians in the under-served and growing peripheral vascular market.

For Pathway, the deal appears to be a welcome exit, albeit one of uncertain return for its investors, for a company that has struggled for much of its 13 year history. The company was nearly out of business in 2004 but was able to revive its fortunes by switching its focus from the coronaries to the peripheral market. The reported $125 million acquisition price doesn’t quite match the $130 million that the company raised – and the Xconomy report suggested that only investors in the most recent Series D will see any benefit from the deal -- but $125 million is a strong acquisition price in the device space and in a glass-half-full kind of way represents something of victory for Pathway executives. --Steve Levin



Due to an editing error, the Anjojet device was inapprorpiately refered to as a drug eluting balloon. The post has been updated as of August 22, 9am ET.

Financings of the Fortnight Cuts Its Budget

You can't talk about financings of the past fortnight without talking about the wild gyrations of the stock market, which again is doing its crazy thing as we write this. And you can't talk about the stock market without wondering what lies ahead after Labor Day, when summer vacationers (those who haven't cancelled vacations, that is) return to their trading desks, VCs return to their term sheets, and the Congress (ugh) returns to Washington, D.C.



Maybe it's that tightening belt cutting into our waistline, but we're already feeling nauseated thinking about the Stupor, er, Super Committee of 12 that's charged with sorting out the long-term U.S. budget deficit by Nov. 23. Much of the posturing, table-pounding, ultimatum-making and hand-wringing will take place in our little patch of forest. Just yesterday a Democratic member of the committee took a shot across the ever-rustier bow of Big Pharma. Some of our colleagues will be crawling all over the story from the reimbursement and regulatory angles, while some of us will be eager to see how inevitable budget cuts affect the other end of the pipeline. For example, what will happen to the fledgling programs at the National Institutes of Health to do more translational work for which the private sector -- whether Big Pharma or venture-backed biotech startups -- is losing its appetite? And what if, despite successful lobbying efforts in the past, venture investors can't fend off a change in their tax rates (as some VCs advocate)? Will biotech innovation get Buffeted?



It should be an interesting three months as we all lurch toward the next mini-Armageddon. Meanwhile, we're living day to day, endpoint to endpoint. We don't have any spiritual advice, but if you don't want to be left behind -- the curve of the latest biotech financing news, that is -- we recommend checking out the latest rapturous edition of...





Enobia Pharma: Having raised more than $100 million from venture backers since 2005, Enobia turned to a different breed of investors for its latest funds and let its existing investors conserve their cash. On Aug. 8, the Montreal biotech announced it had raised $40 million in a private placement to a syndicate comprised of undisclosed pharmaceutical companies and crossover public equity buyers. The cash will help move its lead candidate, an enzyme replacement therapy for hypophosphatasia (HPP), through the late-stage clinic and regulatory process. The new funds also replace the remaining tranches of a $47 million Series D round, $25 million of which Enobia has already drawn down. The final $20 million or so will not be necessary, said Enobia chairman Jonathan Silverstein, also a general partner at OrbiMed Advisors. The cash from new pharma and financial investors comes "at a significant premium price to the D," Silverstein said. He also noted that the pharma companies that invested did so directly rather than through their venture arms. The biotech’s lead candidate, ENB-0040, currently in Phase II in HPP, is not partnered and Silverstein indicated that the new investors included firms that might be interested in a collaboration. “I think their hope is to someday be more actively involved in the company,” he said, stressing that their investment does not give them rights to Enobia's products. Besides Orbimed, other existing investors in Enobia include CTI Life Sciences Fund, Fonds de Solidarite FTQ, Desjardins Venture Capital and Lothian Partners. Together, those five backers contributed $50 million toward Enobia's 2009 Series C round. -- Joseph Haas



T2 Biosystems: With the close this month of a $23 million Series D round, investors in T2 are sending the message: We can do candida. The company is concluding initial studies of its mobile diagnostic device, which can identify five species of the hard-to-detect fungus, a leading cause of hospital-acquired infections that affects more than 10% of sepsis patients. T2 expects to begin a trial in hospitals in the first half of 2012 geared towards an FDA submission later in the year. Currently, candida can only be detected through blood culture, which takes several days. T2 says its device can identify its presence directly in whole blood in a matter of hours using a magnetic biosensor. Other molecular methods for pathogen identification rely on optical detection, meaning the infectious agent must first be extracted from the blood sample to then be “seen.” That’s especially difficult with organisms like candida that only exist in very low copy numbers -- less than 10 per ml of sample. T2 has data on 400 patients showing over 99% concordance with culture methods, which was enough to convince Aisling Capital to lead the new round. Nine existing investors, including Flagship Ventures, Polaris Venture Partners, and Flybridge Capital Partners, also participated. With the new funding in hand, the company now aims to broaden its test panel, and earlier this year brought in Kirt Poss, formerly of VisEn Medical, to lead business development. According to CEO John McDonough, field trials of its device continue with the US intelligence community, a program started in 2008 in conjunction with an investment by In-Q-Tel as part of T2’s Series B financing. -- Mark Ratner



Pulmatrix: Insider investors have supplied $14 million in new funding to respiratory therapy developer Pulmatrix, intended primarily to support ongoing development of a dry-powder inhaler product for COPD and cystic fibrosis. Nominally a Series B-1 round, the new cash could be either converted to Series B shares at the same terms as its last funding in fall 2009, or rolled into a Series C round if a new investor takes a stake in the startup. Polaris Venture Partners, 5AM Ventures, Novartis Venture Fund and ARCH Venture Partners all participated, bringing Pulmatrix’s total funding to $60 million. Founded in 2003 to investigate therapies useful in countering bioterrorism, Lexington, Mass.-based Pulmatrix had previously aimed to commercialize a broad-spectrum antibiotic delivered via a nebulizer, but that project has been set aside in favor of PUR118, a Phase I dry-powder product with the same active ingredient. Both use Pulmatrix’s iCALM platform, which lines the airway to provoke the body’s natural defenses against pathogens. CEO Bob Connelly said the new money will support Phase Ib and Phase IIa trials in both COPD and cystic fibrosis over the next 18 to 24 months. The company will also seek a partnership in COPD, but is mulling commercialization in cystic fibrosis on its own. -- Paul Bonanos



Second Genome: First-time backers Advanced Technology Ventures and Morgenthaler Ventures have led a $5 million Series A round for Second Genome of San Francisco, a developer of diagnostic tools for gastrointestinal disorders based on the microbiome, the set of bacteria in a patient’s gut. The two-year-old startup, formerly known as PhyloTech, had previously collected $1.2 million in seed-stage funding from Wavepoint Ventures, Seraph Group, and individuals including neuroscience professor and serial entrepreneur Corey Goodman and Asuragen CEO Matt Winkler, both of whom are board members. Spun out of Lawrence Berkeley Laboratories and based on research in microbial ecology of water and soil, Second Genome is designing tools that identify microbiome “signatures,” the relative balance of various types of bacteria in the gut that can be aligned with new and existing therapies for patient subtypes. The company performs profiling services based on its PhyloChip technology, developed at LBL, which analyzes the 16S ribosomal gene sequence to deliver a “fingerprint” of a patient’s microbiome. CEO Peter DiLaura said that will eventually lead to its own discovery programs in GI disorders such as inflammatory bowel disease, irritable bowel syndrome, Crohn’s Disease and antibiotic-associated diarrhea. The new round is expected to last into 2013, when a Series B is expected. – P.B.



Photo courtesy of flickr user Matt Dinnery.

Tweeting Around Europe's DTC Ban: Bayer Named and Shamed

A press release about a new drug launch is ok; a tweet isn't.



That appears to be the conclusion of a months-long saga over drug firms' -- in particular Bayer UK's -- use of social media to allegedly 'promote' its drugs in Europe, where DTC advertising remains a no-no.



Never mind that tweets don't respect geography. Bayer will be named and shamed in various medical journals (The Nursing Standard, 17 Aug; BMJ and The Pharmaceutical Journal, 20 Aug.) for tweeting about new UK drug launches earlier this year, according to the PMCPA, which administers the UK drug industry's (the ABPI's) Code of Practice.



The German conglomerate in March tweeted on the launch of "first and only melt-in-the-mouth erectile dysfunction treatment" (Levitra), following a similarly promotional tweet the year before about multiple sclerosis drug Sativex, according to the Digital Pharma blog.



The company claimed at the time that it was issuing only 'factual and non-promotional' information, linked to approved press releases. It also said at the time that guidance from the PMCPA on the use of social media was 'far from clear'.



The guidance has been updated to include what amounts to a ban on tweeting about prescription medicines, however. But Bayer would not comment specifically on whether it now found the guidelines clearer, saying only that "as a member of the ABPI, Bayer recognises the industry Code of Practice and, as a company, is absolutely committed to compliance with all laws, regulations and good business practices."



Of course it is. And that -- could we call it contrition? -- is the effect that the watchdogs wanted this naming game to achieve. Any companies perceived as attempting to circumvent Europe's DTC ban via social media networks like Twitter had better think again, or risk being brandished as, per the ABPI code, 'bringing discredit upon' the pharmaceutical industry.



This case will almost certainly fuel the ongoing debate around a stalled piece of EU legislation attempting to harmonize and update the region's policy on information to patients (what's allowed, what isn't).



Meantime, notwithstanding the name-and-shame ads, we bet that the @bayerukireland twitter account may have picked up a few more followers-- if only to keep tabs on them. Whatever its intention, Bayer did effectively circumvent the DTC ban in the case of Levitra: plenty of non-medical professionals know what's available as melt-in-the-mouth.



image by flickrer fanie used under creative commons

giggles

Matt's getting a Guys' Night Out tonight and Jonah's in bed, so I'm headed to snuggle under my covers, in the complete quiet, and read.

But continuing this week's camping theme, my brother sent us this after we got back. I just love Jim Gaffigan.


Also, if Matt were being completely honest, I'm pretty sure this is how he feels about camping too.