what a difference a year makes

One year ago today, I wrote this:

After Matt and I finished our visit, I took Amy back to see him. We looked at him for about 10 seconds when he started turning purple. She and I were both freaking out, trying to get someone's attention. Luckily the dermatologist was still in there and was more assertive in getting someone to attend to him. He was purple for what seemed like a really long time before the alarm went off, and everyone went into action. He had stopped breathing, and it took them several minutes to get him breathing again. Amy ran out and got Matt. And for a few minutes, Matt stood and watched them work on Jonah while I cried in an opposite corner of the room. It was extremely scary, and I still have not settled down from it. I'm somewhere between afraid to leave his side for a second and not wanting to be back in there at all.

This night last year I experienced this:

I took a sleeping pill last night (a generic form of Ambien) and had MAJOR hallucinations. I can’t begin to explain how horrible it was, but by the time it was over, Matt was lying on one side of me, his mom on the other, with Matt holding my eyes closed trying to get me to go to sleep. I knew they were both there, but I could either not see them or they looked very scary. All kinds of creatures and figures floated around me (their skin peeling off), all pulling me back trying to take me away. I knew there were two realities – the reality of Matt in the room trying to calm me, and the reality of the hallucinations. One was no more real than the other. I kept saying to Matt, “Where are you? They are trying to take me.” It was the scariest non-reality reality I’ve ever experienced, and unfortunately I remember every detail. I felt Satan’s presence very real there. Although the hallucination was drug-induced, Satan definitely took advantage of my weakness. Between the stress and worry over Jonah, lack of sleep, having to face going home without a baby in my arms again, and the sleep drug, it was a bad night.

Last year, this time, I had seen my baby stop breathing and had thought he was going to die right in front of my eyes (at 37 weeks and one day, just like Gabe). And I had gone home, now for the second time, having given birth but with no baby to take home with me. I had dreamed of demons and zombies coming after me with their skin falling off. This day and night last year was pretty hopeless for me.

What a difference a year makes.

Tonight I go to bed with hope for a cure and hope for Jonah's future. I smile and laugh more than I cry, and I just got to celebrate with my Jonah at the coolest kick-butt party EVAH (about a gazillion birthday party posts to come...).

I'm exhausted, but I'm hoping for sweet dreams.
*********************************

On a side note, between the $7,553.01 from the auction and the donations we got at Jonah's birthday party, DebRA will be receiving $9,222.01. And that's not counting Meg's Avon Event sales or anything that was donated directly to DebRA.

What a difference a year makes.

twelve months today

Hi Friends,

It's me, Jonah.

Today I turned twelve months old. Mom says that means I'm ONE YEAR OLD. She said that in a big voice and put one finger up on her hand, so I guess it's a pretty big deal.

What's that?

I'm a big boy???!!!

Right on.

Don't tell anybody but on Saturday, I heard Mommy say that the next person who called me a big boy was getting punched in the face. I think she wants me to stay her baby forever.)

I'm getting so big. I weigh 21 lbs 9 oz now. I'm 30 inches tall, and my head circumference is 45 cm. I'm in the 25-50th % for weight and in the 60th % for height and head circumference. Dr. B says my growth is GREAT! I'm staying right on that curve. I'm cool like that.

I have six teeth now. Two on the top and four on the bottom. See?

I have all sorts of noises these days, and I'm babbling like a champ. Mom and Dad can't decide if I'm saying any words yet, although I keep telling them that I'm saying all sorts of things. It's not my fault they haven't learned my language. G seems to be my favorite sound, and my favorite things are growling, blowing raspberries, and fake coughing. Mom is pretty sure I'm trying to say Deac, but it's not quite identifiable yet. I also regularly say Ma Ma and Da Da, but am not really saying them TO Mom and Dad. When I see a photo of our family, I can point out my Mom and Dad when asked. Mommy says I'm so smart.

Usually when you put a book (or in this case a birthday card) in my hands and open it up, I start reading. Most of the time it sounds like this, "ahhhh tickle tickle tickle a guh duh guh duh guh duh." Mom says it's just about the cutest thing she's ever seen.

My favorite songs right now are "Malti," "Do-Re-Mi (Sound of Music)," and "Jump Up." I dance now when I hear music. I LOVE music. It calms me down during dressing change or when I'm upset (like today at the doctor when I had to get four shots and a big vile of blood drawn from my arm).

Between Christmas and my birthday I have lots of new toys. I just opened my birthday presents so I haven't really played with them yet, but my (old) favorites are my ball popper...

my exersaucer...

... my pull back cars that zoom across the floor, and still my basketball goal.

For a kid who can't even crawl yet, I sure am hard to keep up with. Mommy can't leave me alone for five seconds or I've fallen over (on purpose), leaned forward and am about to fall on my face attempting to crawl, or I've rolled half way across the room.

I'm eating a little better these days. I usually drink around 30 ounces a day (27 cal formula) and am starting to show a little more interest in solids. I have a really bad gag reflex though, so right now we're mostly stickin' to purees. Otherwise I puke up not only my baby food, but also my previous bottle. I'm still having gushers every two to three days. Too much information? Oh, my bad.

I'm becoming less and less interested in TV these days (too busy trying to move around), but for a few minutes at a time, Mom can sit me in my new toddler chair and I'll watch some Jack's Big Music Show or Yo Gabba Gabba.

I want to crawl so badly I can barely stand it. I can get my hands out or sometimes my knees up, but I haven't figured out how to do both at the same time. I can put weight on my feet and stand with support, but when Mom tries to lean me over to help me get into a crawl position, instead of going to my knees, I stay on my feet and put my hands on the floor, so my butt's straight up in the air. Mom says I may want to look into Yoga.

Mom and Dad can't believe how far I've come in this last year. On February 27th of last year I was born in TERRIBLE shape. There was not a whole lot of hope for my future. On February 28th, I stopped breathing, and Mom and Dad thought I was going to die. I spent 32 days in the NICU. I had to go back to the hospital over Easter for breathing issues, and have been on the verge of a g-tube more times than I can count (you know, because I don't really count yet). But so far, I've stayed infection free and haven't been back to the hospital (except for doctors' appointments) since last April.

Mom and Dad say they love me sooooo much (they tell me about a MILLION times a day), and they don't take one day for granted.

They think I'm the most beautiful, perfect little boy baby in the whole world.

They are amazed at what I've overcome and what God is doing in my life. They know I have a big story to tell and look forward to many, many, many more years for me to tell it. And thanks so much to all you guys who have come along on the journey. Mom and Dad say to tell you how much they appreciate the love and support. You guys are the BEST!

(Thanks to Aunt Katherine for the photos of me with my ball popper, in my exersaucer, and in my chair.)

happy birthday, jonah

Dear Jonah,

Today you turn one year old. I’m fighting back tears as I write this to you. Some of them are happy tears, some sad. There are so many emotions I feel when I think about this day last year and pretty much all the days since.

Daddy and I waited so long for you. We prayed for you every night on our knees. We could not wait for you to come, but after losing your big brother, we were so scared. The night before you were born, in tears, I cried out to God that he would let you live. I checked your heartbeat every few hours, just to make sure things were still okay. I waited on pins and needles. I hoped.

We went to the hospital very early in the morning, and guess what? I started having contractions on the way. We think it was your way of saying, “I know you guys planned this, but it’s cool. I’m ready to come anyhow. Just lettin’ you guys know that I call the shots.” We waited all day for you.

We were so excited.

Everything was ready.

Then, at 3:50 in the afternoon, God gave us you.


And we were breathless.

Sweet Jonah, you were not what we expected. Something wasn’t right. This was not the way it was supposed to be. Why were your hands, feet, knees, and elbows completely raw? Why were there blisters on your face and head? What was wrong?


But, still, you were perfect.

You were beautiful from the moment you were born. Blonde hair, blue eyes. I could see Gabe in you, but you had your own look. Beautiful. Really, I know everybody says, “All babies are cute,” but most babies look kind of funny and squishy when they’re first born. But not you. You were adorable from the first moment.

We were elated and relieved that you were here, alive and breathing. And we were heartbroken and devastated, terrified that you would not be with us for long.

But here you are today, Jonah, a whole year old.

You’re our miracle.

And you are still completely perfect, beautiful, and you still leave us breathless.

I just want to tell you today how much we love you, how much you’ve changed our lives for the BETTER. You are far more wonderful and amazing than anything I ever could have hoped or dreamed, and I ache for you to know how much we love you. I don’t think we could love you any more if we tried. You’re the light of our lives.

So, Happy First Birthday, my sweet Baby Jonah.

We pray and wait in expectation for many, many, many more.

Deals of the Week is Not Optional

Early in 2009, Cephalon purchased for $100 million an option to buy a smaller biotech, Ception Therapeutics, for $250 million. This week, Ception investors had their big pay day.

Cephalon's decision was dependent upon successful results from Ception's lead project for eosinophilic asthma, the anti-IL-5 antibody Cinquil (reslizumab). An earlier opportunity to exercise its right to buy was thwarted when the same drug didn't pass the muster in a related condition, eosinophilic esophagitis.

The news should cheer private biotech investors, who are largely resigned to accepting downpayments of one type or another to get their exits-by-acquisition deals sealed. In 2009 nearly every acquisition of a private biotech comprised a downpayment plus contingent value rights based on development, regulatory, reimbursement or commercial milestones.

These option-to-acquire deals are designed to similarly share risk and potential upside. And we argued at this week's Pharmaceutical Strategic Outlook meeting that these structures are only becoming further entrenched as biotech investors continue to struggle and the IPO climate remains chilly at best. Outcomes like Ception's help demonstrate that option-structures aren't necessarily low-value deals, which may momentarily stop the handwringing of some venture capitalists.

The week's nearly over. We advise you opt in to another edition of...

Pfizer/Merck/Lilly: Recognizing the merits of pre-competitive collaboration, the three pharmacos announced Feb. 23 the launch of the not-for-profit Asian Cancer Research Group, which will gather pharmacogenomic data on Asia's most prevalent cancers. Initially, ACRG will focus on identifying biomarkers for lung and gastric cancers in Asia. Unlike another pre-competitive venture Pfizer, Merck and Lilly have stakes in--Enlight Bioscience--the ACRG is not-for-profit. The companies hope to gather 2,000 tissue samples from lung and gastric cancer patients in the next two years, at which point the data will be made publicly available to researchers through non-exclusive licenses. Within five years, the database will be updated with clinical data, including quality of life and survival data. "The beauty is that we'll be collecting all the clinical outcome data associated with patients that will really give us an extensive understanding of whether a genetic signature will be linked to either a good or poor prognosis," Pfizer oncology CSO Neil Gibson told PharmAsia News. Lilly will be responsible for managing the open-source data from its Singapore Center for Drug Development site, which it established in 2002 in partnership with Genzyme for research in diabetes and biomarker discovery in cancer.--Daniel Poppy

GSK/Regulus: Call this the collaboration so nice, they did it twice. GlaxoSmithKline and Regulus Therapeutics, a pioneer in the microRNA field, announced a new collaboration Feb. 25, through which they will co-develop and commercialize therapeutics targeting microRNA-122 in hepatitis C and other indications. The deal occurs less than two years after the Carlsbad, Calif., biotech and GSK signed a strategic alliance to discover, develop and bring to market novel microRNA therapies for inflammatory and immunological indications (See our coverage of that deal from “The Pink Sheet” DAILY). Regulus, a joint venture between two pioneers in oligonucleotide technology, Alnylam and Isis, has access to plenty of IP and scientific skills in this fast-moving field. GSK was drawn to additional collaboration with Regulus because it has gotten an inside view on the potential microRNA therapeutics and how they work and because Regulus has done significant preclinical work with “the dominant IP” in the space, Regulus president/CEO Kleanthis Xanthopoulos told us. Regulus could earn more than $150 million in upfront and milestone payments over the course of the partnership, the companies said, although they did not disclose most of the deal terms. Like the previous transaction, this deal breaks the upfront payment into two components – cash and a convertible note that can be transformed into Regulus equity at a time of the company’s choosing. In the first deal, Regulus got $15 million in cash plus a $5 million convertible note. The upfront “essentially covers all of our R&D costs so far to bring the compound to the preclinical stage,” Xanthopoulos said. He said the remainder of the $150 million will be spread out “evenly and at frequent intervals.”--Joseph Haas

Astellas/Basilea: Just a few days after losing one partner, Swiss biotech Basilea on Feb. 24 pulled in another. When Johnson & Johnson exited a five-year partnership on antibiotic ceftobiprole on Feb. 19, most analysts saw this as good news for the biotech, given that the partners were in arbitration over J&J’s allegedly shoddy trial data management and subsequent regulatory delays. Basilea’s fortunes then continued to shine when Astellas stepped in with CHF 75 million ($69.4 million) up front and up to CHF 478 million in milestones for rights to the biotech’s other Phase III candidate, anti-fungal isavuconazole—widely perceived as now more valuable than ceftobiprole anyway. Astellas will lead (and thus fund most of) development and commercialization of the drug, but, significantly, Basilea will participate—paying a minority of development costs and retaining a option to co-promote isavuconazole, which is in development for invasive fungal infections, in the US, Canada, major European countries and China. In fact such participation was a pre-condition of the deal, according to Basilea’s management; not surprising, perhaps, given the extent to which the biotech was apparently left out in the cold in the J&J deal. Astellas’ funding provides a welcome cushion for Basilea given the uncertainties created by a contractual year-long transition period with J&J, and the biotech’s commitment to the European rollout of its severe hand excema drug Toctino. As importantly perhaps, it provides validation of both Basilea’s pipeline, and its attractiveness as a partner despite the unusually acrimonious J&J relationship. --Melanie Senior

image from flickr user nettsu used under a creative commons license.

Financings of the Fortnight Needs a Haircut

The first time we used this awful image to the right was about three years ago, when seemingly well-positioned biotechs destined for snazzy IPOs were running into a wall of scissors and electric razors wielded by public investors.

It turns out that in most cases their arguments that biotech offerings were overpriced were pretty accurate, if you consider how those biotechs that went public during the 2005-2008 timeframe have performed in the market.

We presented the data below (click image to enlarge) at our Pharmaceutical Strategic Outlook meeting this week in New York. An investment in the collective IPOs from 2005-2008 would have returned only 6% as of this Tuesday. Keeping in mind the market value performance illustrated in this chart comes after the steep discounts demanded by public investors, it's an ugly picture indeed. The success stories (among which we'd include Pharmasset, the subject of that 2007 post) are few and far between. In addition to the companies represented by the bars below, eleven were acquired, but the vast majority of those deals were done at valuations well below where companies were when they IPO'd.

Which brings us around to this week's non-debut of Anthera, a closely watched pricing event that wasn't. Anthera was due to raise up to $64 million by selling shares to the public at $13-15 per. That offering was postponed on Wednesday, while investors chewed over a new $8-9 per share price tag that could raise $54 million for the company.

It didn't take long for Anthera to trim that price yet again. Today an amended filing says the biotech will raise up to $42 million by selling shares at $7 apiece. For those of you keeping score at home that's a 50% haircut from the midpoint of its initial range.

Anthera is being watched closely as a barometer for investor interest in biotech IPOs. It's not hard to see that interest isn't exactly rabid.

Eleven Biotherapeutics: This me-better biologics play raised $35 million in a Series A round led by Flagship Ventures and Third Rock Ventures on Feb. 17. Asked to describe whether this was the entirety of the Series A of if more was to come, CEO David St. Hubbins* replied* "Well, I don't really think that the end can be assessed as of itself as being the end because what does the end feel like? It's like saying when you try to extrapolate the end of the universe, you say, if the universe is indeed infinite, then how - what does that mean? How far is all the way, and then if it stops, what's stopping it, and what's behind what's stopping it? So, what's the end, you know, is my question to you." (*For a more accurate version of what Eleven's management actually said, check out this piece in "The Pink Sheet" DAILY.)--CM

Labopharm: Just two months after agreeing to a $25 million standby equity distribution agreement with Yorkville Advisors, this Laval, Quebec, firm took a more conventional route to fundraising, closing a follow-on public offering Feb. 18 that including the overallotment netted $21.6 million. Labopharm, which specializes controlled-release technologies will use the funds largely to prepare for launch of its second US product, Oleptro, a once-daily formulation of trazodone approved by FDA for major depressive disorder on Feb. 3. The company has said it is opening to licensing out the drug or doing some form of co-promotion, and that its FOPO cash would support those efforts as well as launch. Like many FOPOs of recent months, Labopharm’s deal is somewhat warrant-heavy. It sold 13.5 million shares at $1.70 per unit, with each unit comprising a full share and a warrant for half a share. During a 30-month period beginning six months from closing, warrant holders can redeem their warrants for up to 5.9 million additional shares in Labopharm, at $2.30 per share.--Joseph Haas

Tioga Pharmaceuticals: Just over four years after pulling in $24 million via its Series A financing, GI drug player Tioga Pharmaceuticals completed its Series B round on February 17, raising $18 million from new investor Genesys Capital Partners, which participated with previous backers Forward Ventures, New Leaf Ventures, and BB Biotech Ventures. Tioga is placing all bets on asimadoline, an oral selective kappa opioid agonist it obtained when it spun out of Merck KGAA in 2005. The European pharma had been developing the candidate for musculoskeletal pain, but it failed to show efficacy in early studies. Merck eventually saw more potential in treating the visceral pain and bowel motility associated with IBS and as part of a reorganization to focus on cancer and cardiometabolic diseases, sold the asset to Tioga (for more history on Tioga, see our START-UP profile). Since asimadoline had been extensively tested in the past, Tioga had an advantage that other start-ups typically don’t have, which is to almost immediately start a large-scale efficacy trial, and at a much lower cost. The Series B money will support a US Phase III trial--one of two registration trials needed to get the drug approved in the US—slated to begin in March in 600 patients with diarrhea-predominant IBS. Perhaps Tioga is following in the footsteps of Movetis, another GI-focused company that began operations with discarded large pharma GI assets; and that wouldn’t be such a bad thing–Movetis has managed to bring its chronic constipation drug Resolor to the market in Europe. It also pulled off a successful IPO this past December and is still trading above its IPO price.--Amanda Micklus

Another Snowstorm, Another Complete Response Letter?

The snow is falling and that can mean only one thing – a Complete Response Letter for Amylin Pharmaceuticals’ Byetta LAR (long-acting exenatide). At least that’s what Jon LeCroy, an analyst at Hapoalim Securities, suggests after trying to decipher how the FDA reacts to inclement weather.

For those who weren’t aware, the agency yesterday extended the PDUFA date for the once-weekly diabetes drug from March 5 to March 12. Normally, a delay of a few days isn’t expected to amount to much, if anything. Besides, the agency had signaled PDUFA user fee dates could slip by up to five business days due to the blizzards that shut down the federal government earlier this month.

But LeCroy worries something ominous is under way. Given that PDUFA delays have become the norm, the March 5 date was always uncertain. Until now, in fact, LeCroy assumed the date would just slide by. But the fact that the agency assigned a new and specific date suggests to him that, not only will a decision actually come down on March 12, but the likelihood is it won’t a be positive for Amylin and its two partners, Eli Lilly and Alkermes.

As a result, he’s ballparking approval this way – the odds of a full approval on March 12 are just 20 percent; a Complete Response Letter is a 60 percent bet and there’s a 20 percent chance the FDA will simply miss the PDUFA date. In an investor note, he points out that Xenoport, after all, recently received a PDUFA extension, ostensibly due to bad weather, and wound up with a rejection letter.

In his note, LeCroy writes that he thinks “approval will likely be delayed” until the FDA reviews several studies – including data from ongoing animal trials for twice-daily Byettta – that were requested at the time the Byetta monotherapy indication was approved last October. The last required study on Byetta LAR is expected to be done mid-year and a final report submitted to the FDA next January. “This implies,” he wrote, “that the FDA will not approve (Byetta LAR) until mid-2011."

Unless it keeps snowing, in which case the drug may never get approved.

--Emily Hayes

photo thanks to LD Flickr creative commons

Merck Puts Up Its Asset-Sale Shingle

Big Pharma has been slow to adopt out-licensing strategies for a plethora of reasons: fear it will regret giving up something that could turn out to be a hit, the perception that out-licensed compounds are tainted, and an ingrained mentality that it could afford to develop everything worthwhile on its own.

Merck is the latest company to change its tune in the face of a resource-constrained reality however; Lilly, Pfizer and others started earlier, by far, as IN VIVO has long tracked. At Elsevier's Pharmaceutical Strategic Outlook conference Thursday morning in NY, David Nicholson, the company's new SVP and head of Worldwide Licensing and Knowledge Management, gave the largely biotech and Big Pharma audience a message loud and clear: Merck's new out-licensing department is open for business-or will be shortly. "We have set up an out-licensing group, headed by Meeta Chatterjee," and are now looking at "what we want to out-license" and "how," he said in a talk with Elsevier's Roger Longman.

"In the past, Merck didn't out-license because out-licensing was traditionally used to jettison "rubbish," but that is not the case anymore," noted Nicholson, who previously headed worldwide licensing at Schering-Plough. The company has some very attractive assets, but there is "no way Merck can afford to develop everything" in its R&D program. "Our R&D model is to generate a lot of output—more than we can deal with. So we have to make some tough choices and it poses the question: What do we do with these other assets?" And who might be potential in-licensors? Take note: Merck's not only interested in talking to biotechs and small pharma—its Big Pharma competitors could take a look too.

Details have yet to be worked out – Merck's looking at the best business models and deal structures for outlicensing and "brainstorming" ideas. And the company is generating a list of out-licensing assets.

Meanwhile, its in-licensing program is also moving forward. Now that its merger with Schering is completed, it's finalizing a list of its revamped pipeline, which it will announce in the next few weeks, and shortly after that it will "be able to talk to the world," Nicholson said.

Nicholson also spoke –albeit generally-- about Merck's partnership strategy going forward, i.e. biotechs will remain an incredibly important to Merck, because "the vast majority of new science is done outside Merck's walls," he said. "There are more opportunities outside than inside," and Merck wants to partner with all kinds of technologies, companies, and at all stages of development."


That includes externalizing discovery- a hot topic within Big Pharma at the moment, especially in light of a recent Morgan Stanley report, which argued that Big Pharma isn't doing worthwhile research and should evolve its "R&D" model to an "S&D" or search and develop model. Nicholson quarreled with the report's conclusions, but noted it did raise "interesting questions" about how much discovery research pharma should be doing internally versus externally.

Nicholson's message –a willingness to work with new kinds of partners in new ways--wasn't new for Merck – but it honed in on a trend that's been ongoing in Big Pharma for several years now, and practiced with more urgency as patent cliffs loom: In a growth constrained reality, companies need to evaluate what they can and can't afford to do internally and work with partners in new ways as they become more cost efficient and upgrade pipelines.

--Wendy Diller

Washing Away Post-Deal Blues With A De-Sanofizer

There's nothing like a gathering of insiders to generate some candid chat about the latest doings, and that's what you can hear at the BioWindhover Pharmaceutical Strategic Outlook conference this week at the Grand Hyatt Hotel in New York. Despite threatening forecasts of snow and more snow (and it's falling heavily right now), some 300 or so people have gathered to swap tales and insights into the latest dealmaking trends.

On the topic of back-end loaded deals, Shelagh Wilson, a GlaxoSmithKline vice president who heads the European arm of the drugmaker’s Center of Excellence for External Drug Discovery, said Glaxo is making a point of adding milestones for achieving reimbursement, not just for achieving regulatory or sales goals. "What is driving all of this is the pressure from the payers for us to produce differentiated medicines, and the risk associated with that,” she said. “We’ve got to be innovative, not just in the drugs we bring forward, we’ve got to be innovative in the early stages of drug discovery, and that means taking more risk."

Of course, a perennial wild card for investors is gauging the FDA's next move, not only as a result of safety scandals - can you spell Vioxx or Avandia? - but with the hiring last year of FDA commish Margaret Hamburg, who continues to insist the agency will become more responsive to such problems. "The biggest issue with us for our in-licensing deals (for our portfolio companies) is misprojecting where FDA is going with regards to safety or efficacy," said Brian Atwood, managing director of Versant Ventures, explaining why his firm doesn't make investments in cardiovascular or metabolic opportunities.

Hoyoung Huh, meanwhile, garnered the day's biggest laugh. The chairman of BiPar Sciences, which Sanofi-Aventis acquired last year for $500 million and now operates as a wholly owned, independent subsidiary, confessed that retaining BiPar's culture can be challenging. So what did some employees do to underscore the point? "If you walk into the BiPar offices, the first thing you do is walk up to a hand sanitizer and it's called 'de-sanofizer,'" he said with a big grin. "It's not that we're trying to be rambunctious or nasty, though." And who was sitting two seats away? Sanofi's Philippe Goupit, vice president of corporate licenses.

first time at the park

On Sunday it was in the 60’s here (finally!), so we took Jonah to the park for the first time.

I won’t clog this post with words. He had a great time. As you can see…

What's on Steve Nissen's Tape Recorder?

click for larger.

it's time!

THUNDERCATS ARE GOOOOOOOOOOOOO!

http://jonahsebauction.blogspot.com

While You Were Upsetting

Big upset at the Olympics last night, but before we get to that there is of course the latest industry news. Until you can get biopharma wrap-ups at ESPN, we'll keep on keepin' on.

While you were pondering reconciliation ...

• A bad weekend for GSK (after a tough week): a report released by Sens Baucus and Grassley that notes FDA reviewers' 2008 recommendation that diabetes drug Avandia get pulled because it causes "500 additional heart attacks per month" was the subject of about six thousand articles. Oh look, here's one.


• A good weekend (a good Monday morning, anyway) for Novartis. Oral MS drug candidate Gilenia (f.k.a. FTY720) received notice of FDA priority review and meningococcal disease vaccine Menveo received FDA approval.


• The NYTimes begins a new three-part series, Target Cancer, with a moving, in-depth look at oncologist's attempts to push forward new targeted therapies for melanoma: earlier failures and hopefully a success story of Plexxikon/Roche's PLX4032.

• It's almost time for that health care summit at the White House. Reuters reports on the administration's updated proposals, expected out on Monday. Here's a Bloomberg piece on a proposal to limit insurance price hikes.


• HOCKEY: USA 5 - 3 Canada. Wow.
  
• You're probably reading this at about 7am. You know, if you stay up late to watch olympic hockey, it's never too early for a nap.
• UPDATE: The board battle you've all been waiting for... Icahn v Genzyme. Adam Feuerstein at TheStreet.com has the scoop.
  
  image © VANOC/COVAN

bidding tutorial

I wanted to post some photos of Jonah's first time at the park (cell phone picture here) tonight, but Jonah didn't go down until close to 10:00, and I haven't even gotten them off my camera yet... so, hopefully tomorrow.

Just stopping in to let you know that Katie has put up a Bidding Tutorial on the Auction Blog and you can even practice bid, just to make sure you know how it works. It's super easy, and you should definitely try it even if the instructions make it sound complicated (Katie's words), because it's really not hard at all.

So go practice already. All the cool kids are doing it.

another guilt-free shopping opportunity

Hi Friends.

We are back from our mini-vacation, and we had a great time. It was so good to be away and get to relax a little bit. I made it all night long. I thought it would be fun to go out to breakfast but was pretty sure I'd wake up at 6:30 and want to come directly home. But I actually made it until 7:15, AND we went out to breakfast. I missed Jonah, but I also remembered how much I love greasy breakfast food - so off we went. We got home, did dressing change, and now Jonah is being SUPER fussy because he hasn't napped enough today and is exhausted. Not sure how we're going to hold a nap off until 4 to coincide with his next feeding. Probably won't happen.

I just wanted to let you guys know that Meg (Leah's mom) is hosting an Avon event where she'll donate 100% of the proceeds of her sales to DebRA. You can get all the details and the purchase code here. Happy Shopping!

(I don't know about you guys but I am LOVING all this guilt-free shopping with all money going to help cure EB. THAT is what I'm talkin' about.)

And in case you haven't been by lately, Katie has put up all the items up for bid on Jonah's Auction Site. The comments are closed until the Auction starts (Feb 23rd, 12:01 am, EST), but you can go preview all the items, make your lists, and plan your strategy. Let the games begin (well, almost, anyway)!

Deals of the Week Has Gold Medals and Free Money on the Brain

That was some spectacle, eh? No we're not talking about Tiger's not-a-press-conference, we're talking about The TOMAHAWK. Pretty incredible.

Meanwhile as USA's Olympic squad surges in (and around) Vancouver the Canadians have been getting some stick on and off the ice and snow. We don't mean to pile on but with Canada's 'Own the Podium' strategy not quite working out yet (there's always hockey, my Canadian friends), perhaps the hosts could learn a little something from one of their homegrown biotech's ability to turn that frown upside down. Or at least, you know, to monetize its losses.

Say what now? On Thursday, Seattle-based oncology-focused biotech Oncothyreon (yes we know that's not in Canada, but the co is an Edmontonian by birth) sold its interest in its 'indirect wholly owned subsdiary' Oncothyreon Canada Inc. and a related company for approximately C$8.425 million to an outfit called Gamehost Income Fund. Essentially the subsidiary houses Oncothyreon's non-monetizable tax losses (the IP and actual assets were transferred to Oncothyreon Inc.).

Niiice, right? Rodman & Renshaw analyst Simos Simeonidis explained it thusly in a note yesterday: "The company “owned” net operating losses from its Biomira days, which were tied to its Canadian subsidiary, and is not allowed to use them for income tax purposes in the US." Useless! Unless ...

"We point to investors that this is essentially free money in the form of non-dilutive capital, since it does not involve the sale of any ONTY shares or any rights to products, and it is simply the monetization of an asset that the company would not be able to use otherwise," pointed out Simeonidis.

Well played Oncothyreon, you get this week's DOTW gold medal. As for the rest of the podium ...

Sanofi/AVIESAN: Sanofi CEO Chris Viehbacher might have already helped shed the Big Pharma’s previous reputation for being inward-looking and somewhat Franco-French in its orientation, but he’s certainly not missing out on local opportunities as he pursues this more externalized approach. This week the group announced a research partnership with the French Life Sciences and Healthcare Alliance (AVIESAN), which groups together all the major health care players in the French academic research community, and agreed to sponsor a young researchers’ support program organized by the CNRS and INSERM. Sanofi says it will invest €50 million into these partnerships over the next five years. It’s all good stuff—enhancing life sciences knowledge, contributing to (and showing off) France’s strong position in the field, and developing projects in areas including aging and infectious disease that can directly benefit patients. But as well as keeping the French government happy (the Strategic Committee for Healthcare Industries has outlined plans to bolster funding for more tie-ups between academia and industry), it also buffs up Sanofi’s CV by positioning the group as a friendly and sharing supporter of national public research. “To encourage creativity, mutual teams, laboratories, technological platforms and even research centers for Sanofi and AVIESAN could be considered,” coos the PR. All that for just €10 million a year—bargain.--Melanie Senior

AstraZeneca/Rigel: AZ is building itself a bit of a reputation for forking out good up-front cash for mid-stage in-licensed assets: this week it signed its third deal in just five months with an upfront cash payment of $100 million or more. This time Rigel was the lucky recipient, granting the Big Pharma worldwide rights to its Phase II oral RA candidate fostamatinib and in exchange banking over $1 billion in potential development and sales milestones as well. Now sure, AZ has little choice but to win such valuable booty—fostamatinib could be among the front-runner oral drugs in a multi-billion dollar market—given the heavier-than-average near-term patent expiry burden the company faces. That’s how come it paid Nektar $120 million upfront for a Phase II OIC candidate in September, and Targacept a record-breaking $200 million for a Phase II depression-busting nicotine channel blocker in December. In the Rigel deal, AZ will cover all future development costs. The milestone payment split is up to $345 million during development, regulatory and first-commercial-sale (we read that as reimbursement!) and up to a further $800 million in sales-related payments (Rigel is expecting a further $25 million in milestones this year). AZ will also pay "significant" stepped double-digit royalties on net sales worldwide. Read our full coverage in "The Pink Sheet" DAILY--MS

Genentech (A Member of the Roche Group)/UCSF: Forgive cheeky pundits if they start calling the University of California at San Francisco's new Mission Bay campus "Genentech North." The agreement announced Feb. 19 is the latest tight connection between the neighbors, a history that stretches back to UCSF professor and Genentech co-founder Herb Boyer and the insulin work of UCSF professor Bill Rutter. Genentech will fund the work of several researchers at the UCSF Small Molecule Discovery Center (SMDC), which is run by ex-Genentecher and Sunesis Pharmaceuticals founder Jim Wells, now head of UCSF's pharmaceutical chemistry department. The team will use prior research from UCSF and Genentech to develop drug candidates, which in turn could trigger $13 million in milestones for the school, and royalties if Genentech brings a resulting product to market. It's the latest example of industry leaning on academia for early-stage and translational work, a trend that FDA drug chief Janet Woodcock this week spoke about at length, with several words of caution. UCSF is a pioneer in cross-over collaborations and deals.The school has in place several "master agreements" with private firms, including Genentech, that allow research groups to strike industry partnerships quickly. This is the first major deal since former Genentech executive Sue Desmond-Hellman took over as UCSF chancellor last summer. -- Alex Lash


J&J/Basilea: J&J handed back to Basilea full rights to ceftobriprole, the Swiss biotech's drug for complicated skin and soft tissue infections (cSSTI), after the CHMP recommended against EU approval of the drug. Unfortunately, no drug exists for complicated big pharma-small biotech alliances (cBPSBA). J&J's decision therein ends a tortuous relationship, which resulted in the drug's rejection by two regulatory agencies and an ongoing arbitration proceeding between the partners. In a conference call, Basilea execs said that they were happy to regain control of development and commercialization of the drug and are determining their strategy for it, including whether to seek a new partner or proceed independently. Execs said the arbitration, which Basilea initiated, is proceeding, with a decision expected by year end. In keeping with the rocky relationship, however, it's not a clean break: Under terms of the contract, J&J still is responsible during a year-long transition period for meeting all contract obligations—including clinical development, manufacturing, and commercialization—of the anti-infective. Basilea execs said they plan to meet with J&J to figure out a plan, which they expect will involve no cost to the Swiss biotcch. --Wendy Diller

image by flickr user LeeLe fever used under a creative commons license

this and that

Just a quick update before I have to give Jonah his next bottle.

Jonah's doing well and seems to be gushing less these days. He's now going several days in between instead of the nightly requisite puking he was doing a couple weeks ago. I'm thankful and fully realize it probably won't last (it never does), but am thankful for it for now. He had a huge wrap-around blister around his elbow yesterday when we unwrapped him, but other than that he's looking pretty good. His face is in pretty rough shape right now, and his little boy parts are still a little blistered, although better. He's sad several pretty bad nosebleeds this week. I don't really know why. I have a humidifier that runs in his room and a fan on so he doesn't get overheated, but he still gets them. It's kind of a bummer because it makes his inner nose all scabby which tends to pull the skin and make it pretty raw in there. I'm hoping it stops soon.

I had my Girls' Night last night. Only three of the five could make it, but it was still great. We just laugh and talk non-stop, and it's just what the doctor ordered. I'm slowly coming out of this funk of mine, but have lost some serious party planning time. This weekend and next week will be very busy. Nothing like a looming deadline to make you get your butt in gear. I'm kind of just having faith that it will all work out and come together, but I definitely have a lot of facilitating I need to do to make that happen. Matt's mom is coming on Sunday night and Matt can help a lot this weekend, so I should be able to get a lot done.

Matt and I are getting a hotel room here locally tonight, and Kathryn and my sister, Sarah, are coming to keep Jonah OVERNIGHT! It will be really good for us to get away, and we plan to be back by 10:30 in the morning to do dressing change. Matt keeps saying, "I'm gonna sleep 12 hours." Amen, brother. I'm with you. I'm excited about the sleep and relaxation. I'm one of those people who has a REALLY hard time relaxing in my own house if I know there are things that need to be done. I need to get OUT to vacation. But I'm also feeling anxious about leaving and slept horribly last night because of it. I'm not anxious about Jonah's care. I'm anxious about being without him. I'm way more dependent on him than he is on me, I think. Really hoping I'll be able to relax and enjoy it and use the missing him to make the coming back better, not let it ruin our time away. Any prayers for me to chill the heck out are much appreciated. :)

Alright, that's it for me. Bottle time.

Happy (beautiful weather finally!) weekend.

Swiss Addex Now on BVF's Watch List

Biotechnology Value Fund is making moves. Public records show the high-profile public investor recently grabbed a 6.6% share of the staggering Swiss firm Addex Pharmaceuticals. BVF sometimes makes public its reasons for piling into a stock, but the Feb. 5 document held no clue, and so far BVF hasn't gotten back to us. (We'll keep you posted.)

Allow us to cogitate upon the news. BVF could be making a straight value play. Addex closed today at 11 CHF per share. That's down nearly 75% from a high of 41.95 CHF just before safety data for its lead candidate tanked the stock in mid-December.

Addex pulled the plug on its lead candidate ADX10059, a metabotropic glutamate receptor 5 (mGluR5) modulator, when its Phase IIb data for migraines revealed elevated liver enzymes. Addex immediately halted another Phase IIb, for reflux. The company was expected to pull in a big licensing deal, but hope for that vanished with the safety revelations.

Obviously BVF thinks the company is undervalued. Addex, after all, has generated a pipeline of molecules via its allosteric modulation platform. But how much will it push for managerial and/or strategic change? CEO Vincent Mutel said in December he didn't think the safety failure of '059 was a class effect that would cripple another important compound in Addex's pipeline. It remains to be seen if BVF will attempt to steer Addex's R&D efforts in a different direction.

Given BVF has done its share of cage-rattling recently, it certainly might. Recall the fund used its 30% stake in Avigen to steer the firm into a merger with MediciNova last August. And last week BVF went public with a suggestion that diagnostics firm Celera, of which it owns nearly 10%, spin out the royalty stream associated with the Phase III osteoporosis drug odanacatib.

Merck is developing odanacatib as a potential replacement for its now-generic Fosamax (alendronate), once a $3 billion annual cash cow. Celera, which has reinvented itself several times since its founding by Craig Venter, doesn't do drug development anymore--its main business is developing diagnostic tests, including ones for cystic fibrosis and HIV genotyping. Still it's owed a "mid- to mid-high single digit" percentage royalty on sales if odanacatib comes to market.

BVF wrote in the Feb. 9 filing that, "if successful, the royalty asset could generate tremendous free cash flow for the Issuer’s shareholders and, accordingly, this single asset could be worth a significant multiple of the Issuer's current market value."

Since October BVF has bought about a million shares of Celera, all in the range of $6.09 to $6.30 per share. Shares closed Thursday at $7.01, giving it a market cap of $574 million.

With at least one portfolio company, however, BVF has bided its time. It holds a 16% stake in Facet Biotech but agreed not to tender its shares when Facet development partner Biogen Idec went hostile with a $14.50-per-share bid last fall. In exchange for permission to up its Facet stake above 15% without triggering a poison pill plan, BVF held fast when Biogen upped its offer to $17.50. Biogen dropped its bid in mid-December. -- Alex Lash

Photo courtesy of flicker user kevin.

XenoPort Experiences Restless Investor Syndrome

File this one under Regulatory Setback Syndrome. The FDA decision to issue a complete response letter to XenoPort and GlaxoSmithKline for their Horizant drug to treat Restless Leg Syndrome appears to have stunned the drugmakers. In a conference call this morning with analysts, XenoPort chief executive Ron Barrett confessed he didn't see it coming until the FDA missive arrived yesterday.

"It certainly did surprise us," he told the listeners, insisting the issue was never raised in any discussions with the agency during the entire pre-approval processs. "Many of the activities that you would expect to happen going into a PDUFA date had and were happening, including the REMS, and this one came out of left field."

What went wrong? The FDA bounced the drug because a trial showed a cancer risk in rats, specifically a prevalence of pancreatic acinar cell tumors in male rats. Interestingly, a similar finding showed up in Pfizer's Neurontin (gabapentin), which is approved to treat refractory epilepsy, and Barrett said the strength of the signal was no worse than what was seen with the Pfizer drug.

The FDA acknowledged that findings in lab animals don't necessarily translate into risk in humans, Barrett continued, adding that the agency "noted that gabapentin products have been available for over 15 years, and they do not appear to be associated with a clinical signal for pancreatic cancer based on analysis of spontaneous reports in the adverse event reporting system."

The issue for the FDA, though, is that treating epilepsy is a more serious matter than Restless Leg Syndrome, a line of thinking that may bolster those who have criticized the marketing surrounding the condition, even though it is deemed to be kosher by the National Institute of Neurological Disorders and Stroke (take a look).

For now, the implications for XenoPort are more immediate and severe than any marketing debate. Glaxo already announced plans to exit research into pain, and Barrett concedes their deal for the drug may be up in the air, possibly threatening further development of Horizant to treat neurothropic pain, where a Phase II trial failed last year, and migraines. Barrett, however, refused to offer any definitive insights on this particular topic. "The question of risk-benefit is something that is going to have to be probed for each indication."

In response to a question about Glaxo's ability to end the deal based on development setbacks, Bennett offered this sobering reply: "I think it's fair to say that any license agreement of this type is going to have termination provisions. And without speaking to language that might be redacted, I think it is reasonable to expect that this agreement is no different than that GSK would have the ability to terminate for reasons that include what you have articulated, among others. So I think people should understand that a termination by GSK is possible in the wake of this news, as well as in the wake of other developments."

Consequently, XenoPort is now suffering from Restless Investor Syndrome - its shares are down a whopping 67% in midday trading to about $6.54 on nearly 10 times normal trading volume. Given these events, Bennett has to be sorry Horizant isn't already available to treat migraines.

arrow thx to austinsdkeys on Flickr Creative Commons

mostly a whole lotta nothin'

I got eight and a half hours of sleep last night AND Jonah has slept all night the last three nights. WOOHOO! I was getting worried because the previous two nights had been bad and he had woken up for one to two hours and just screamed. We rocked him back to sleep, but then he'd wake up and cry every time we put him down... So, I was afraid he was deciding he was all done with the all night sleeping. Shwoo. That was a close one.

This not blogging every day is really helping me. I know that might bum some of you out, and I'm really sorry, but I just can't do it everyday if the first time I sit down to do it is 9pm. My energy is zapped by then, and if I'm editing and uploading pictures or video and writing a post it can sometimes take up to two hours. And I'd just rather be sleeping. Another thing is that it is extremely hard to find something to blog about when we've been in the house all day. Really, if I blogged about our day everyday, it would go something like this:

Hi friends. Today we changed diapers, watched Blues Clues, tried some solids, ate a bottle, did bath, did dressing change, ate another bottle, took a nap while being held, played in the floor, played in the exersaucer, watched Gabba and/or Sesame Street, played with our cars, read some books, played in the high chair, tried more solids, ate another bottle, maybe took another nap, played with our ball popper, played with our basketball goal, took meds, popped blisters, aquaphored our face, and went to bed.

Exciting huh?

It's getting tough to come up with blogging material and having to write about how boring it can get around here and how cold and unforgiving the weather has been doesn't make for fun posts, that's for sure. So...

I'll try to continue blogging three or four times a week, but I can't do daily anymore (as I assume you've already figured out). Feel free to pray for two hour naps in the crib, and I'll be glad to go back to daily blogging. :)

Mom and Shaina babysat Jonah last night so Matt and I went to Sagebrush. A while back I signed up with Coupon Mom and got a code for $25 restaurant gift certificates for only $5 (or something like that), and Sagebrush was one of the ones we had a coupon for. You had to spend at least $35 to get $25 off, so needless to say, we ate way too much. It was awesome.

I wanted to show you Jonah's birthday invitation. Heather over at PictureItCards did it for me. She also did his birth announcement and our Christmas card which I've posted on other occasions. I sent some invitations and invited some people through word of mouth, email, or Facebook. I just couldn't afford to send that many people a real invitation. I would love to be able to invite all of you, but it just wasn't possible. Plus, I want to be able to really BE at and in the party. I don't want to feel too stretched. I DO want to meet everybody sometime though (at least you more local folks). We'll have to work that out. :)

So with no further ado, here it is:

Completely adorable, right?

I do have some cute videos of Jonah I want to try to post soon, but I'm STILL trying to figure out my new camera. It takes great video but is a lot more complicated. There's dubbing and editing and the process of just getting them from memory card to computer is a lot more involved. I'm working on it though. I hope they'll be worth the wait.

Anyway, I feel like his post was a whole lotta nothin' (except for the cute invitation, of course). Sorry about that. Today and tomorrow are supposed to be cold still, but Matt says it's supposed to be in the 50's Friday, Saturday, and Sunday. I think Jonah's ready for swinging at the park (we've never been), so I hope to get to go this weekend.

Hope everybody has a Happy Wednesday.