I just wanted to post a prayer request tonight. I don't know if you've had a chance to follow Daylon and Bella's transplant journeys, but the Edlings (Daylon's parents) got some pretty tough news yesterday. Between dialysis and the drug he's having to take for his VOD (a complication of the BMT), he's suffered some brain hemorrhaging and probable brain damage.
Here is the link to the update in his Mommy's words.
Please, please be in prayer for Sweet Daylon. I just can't imagine what his parents are going through right now. What a hard road.
Saturday, July 31, 2010
Friday, July 30, 2010
family photos
Our Family Photos from the beach. Thank you so much, Katherine. I am completely in love with these pictures. To be treasured forever and ever. Amen. Did I mention I love them?
Deals of the Week Waits for the Bear Hug
C'mere and gimme some sugar!Sanofi's much-anticipated bid for Genzyme should arrive some time this weekend, or maybe Monday. Reports of the so-called Bear Hug strategy popped up on the wires this week, and a formal bid for the Big Biotech has been rumored between $18-20 billion.
The French pharma's CEO Christopher Viehbacher declined to comment directly on the situation during yesterday's earnings call, but he said enough that pretty much everybody expects Sanofi to at least attempt the acquisition, reports "The Pink Sheet" DAILY:
"We are clearly looking at external growth opportunities," he said. "We'veThe rationale, as far as large-scale M&A rationale goes, is pretty compelling. Sanofi's work to rebuilt its pipeline has been steady (33 deals last year according to the CEO) -- but remains no match for the hit it will take when generic competition for Lovenox, Plavix, Eloxatin, and Taxotere hits over the next couple years. Genzyme's well publicized manufacturing problems make it vulnerable. Big Pharma has become enamored by high value, niche-market orphan drugs. And Genzyme has a couple near-ish market opportunities in alemtuzumab for MS and even perhaps mipomersen that could ease some of the tension at Sanofi.
always said we are going to avoid the mega mergers and concentrate on small- to
medium-sized." Those targets include companies with market capitalization
ranging from $5 billion to $20 billion, he said, a ceiling high enough to
include Genzyme. The Cambridge, Mass., biotech - plagued recently with
manufacturing contamination that has limited supply of its key drugs and
dampened revenues - has a market cap of $18.6 billion.
And so: we await the bear hug; perhaps the white-knight (an old Viehbacher rival, at that, in Andrew Witty); and then the inevitable haggling over premium. As one institutional investor told us recently, "most shareholder protections are just delay tactics -- if an acquirer really wants to acquire you, it's all middle game. They'll eventually get you."
Ah, that's right. Sometimes, the bear gets you. And sometimes you get ...
UCB/Actient: It's tempting here to go back and dig up the last time we wrote about a UCB deal in this space and just cut and paste the whole blurb. UCB ... you know what? Why not. We'll change the relevant bits: UCB has slowly but surely been paring down its primary care activities in favor of specialty products, even garnering an IN VIVO Blog Deal of the Year nomination for its emerging markets deal with GSK. Today, the company announced it would accelerate that process by offloading US rights to Astellas/Regeneron: For big mAb technology platforms, Regeneron seems to think it may be the only independent game in town, and that suits it just fine. On July 28, Regeneron announced that it and Astellas had more or less torn up and replaced their ongoing six-year, non-exclusive licensing deal through which the Japanese drug maker uses the VelocImmune technology platform to discover fully human monoclonal antibody candidates. Under the original deal signed in 2007, Astellas paid Regeneron $20 million annually for VelocImmune access. Terms of the new deal call for Astellas to pay Regeneron $165 million upfront for continued use of the platform from 2011 to 2018, a slightly higher annual rate than the original agreement specified. Further, if it wants to continue the relationship through 2023, Astellas will pay another $130 million in 2018. Regeneron said Astellas has 20 ongoing development projects from VelocImmune, for which the biotech could receive a mid-single-digit royalty on products that reach the market. The Astellas cash adds to an impressive pile of up-front payments Regeneron has stacked up from the likes of Sanofi-Aventis and AstraZeneca for non-exclusive use of its technology. "This is just a reaffirmation of the fact that some very sophisticated consumers have believed and invested at an unprecedented level in this technology," CSO George Yancopoulos told "The Pink Sheet" DAILY. "Astellas has gotten to play with this for three to four years and they're so excited about it that they don't want to risk at all not maintaining their access to this, so they're willing ... to pay the $165 million upfront."--Joseph Haas
Illumina/Helixis: The deal closed almost three months ago, just days into its second quarter, but Illumina did not announce the acquisition of real-time quantitative PCR specialist Helixis until this week, when it said it would begin shipping the latter’s benchtop Eco Real-Time PCR System for benchtop genetic analysis next month. Though clearly not anything close to a material event, the deal, for $70 million cash plus up to $35 million in potential contingent revenue milestone payments through 2011, extends Illumina’s product line, “very consistent with our strategy of having tools that address the broad range of complexity that customers want, all the way from full sequence down to single marker,” said CEO Jay Flatley on Illumina’s 2Q conference call, held the same day the product launch was announced. “This is a technology that reinforces that to a great extent on the very low end,” he said, referring to genetic analysis requiring less than 96 markers, at “approximately a quarter of the price of systems with comparable performance,” and with a smaller footprint. Initially focused on the research market, the Eco system will run most commercially available qPCR assays. But Illumina also expects to add its own consumables, creating a high-margin follow-on business and more closely aligning itself with competitors such as Life Technologies. The acquisition is expected to be breakeven to “somewhat accretive” in 2011. -- Mark Ratner
GSK/Anacor: Not actually a new deal, but we like to highlight when options get exercised -- or passed over -- given how much we like to talk about option-dealmaking as an integral part of the future of biopharma business development. This week Anacor said that GSK was optioning GSK2251052 (f.k.a. AN3365 and thankfully abbreviated '052), one of the systemic antibiotics from Anacor's boron-chemistry platform available to the Big Pharma under the terms of the companies' 2007 option-alliance. Anacor gets a $15 million option-fee and is eligible for further milestones and royalties as GSK takes over the program and pushes it toward commercialization. The compound, which is in a Phase I study, is potentially active against a raft of gram-negative bacteria and will be developed as a potential treatment for complicated urinary tract infection, complicated intra-abdominal infections, and hospital/ventilator-associated pneumonia. --CM
Charles River/Wuxi Pharmatech: Shanghai's WuXi PharmaTech has been abandoned by the Massachusetts-headquartered Charles River Laboratories on the eve of the two contract research organizations' merger. To halt a nascent rebellion by shareholders who were set to vote on the merger one week from now, Charles River called off its $1.6 billion pursuit of WuXi and will instead pay China's leading drug research outfit a $30 million breakup fee. It’s not the first time WuXi was left at the altar; the CRO was jilted in mid-2008 by Covance, which abandoned plans for a joint preclinical drug testing lab. RiskMetrics Group, a proxy advisory firm, issued a report on Monday recommending that Charles River Laboratories shareholders vote against the WuXi acquisition, tipping the scale toward the vocal opposition. The insurrection by shareholders was led by New York money management firm Jana Partners, which cited its high cost, integration risks and bad timing. Not everyone saw it that way. The combination, aimed at creating a platform allowing innovative drug developers to conduct preclinical studies across the Northern Hemisphere, would be "laying the foundation for future R&D in China," predicted WuXi CEO Ge Li. Full coverage in today's PharmAsia News.--Kevin Holden
Thursday, July 29, 2010
this and that
Hey Everybody,
Mommy got kinda mad at somebody on the phone today. She talked to a lady on the phone at 11am and at 2pm to try to get someone to come and switch out my feeding pump for a new one. Even though I'm trying to sleep through the night, that stupid pump is waking Mommy, Daddy, and me up like five times a night with its false alarms: "no food" when there's still plenty in the bag and "no flow" when there's no kink. Anyway she talked to this lady TWICE and told her we needed a new one before tonight, and it was after 7pm and she still hadn't heard anything. So she had to call the after-hours number and gave a different lady the 'what for'. Guess who has a brand new pump tonight?
Mommy was kind of a spaz today. The camera guy and interviewer were supposed to come interview Mommy and get some footage of us for a video for the new Brenner Children's Hospital site (hopefully going up in September), and she forgot ALL about it. They showed up at 4:30. Guess where we were? The grocery store. Not good. Daddy called us at 4:55 to ask where we were. He had just gotten home and they had been waiting there for 25 minutes not able to get in the house. Mommy felt SO bad. But she changed clothes (out of her Aquaphor shirt) and threw on some make-up, asked them not to focus the camera on her nasty carpet, and on we went! They were so nice, and I think they forgave Mommy so everything is okay. I was afraid they might be mad at her, so I made sure to give them my really sweet smiles and played like a good boy for my part. I wooed them. I'm cute like that.
Mommy says I have to go to bed now, but here are some photos from yesterday. They're all kind of blurry, but Mommy and Aunt Shaina were really trying not to use the flash. Gotta go... Mommy's giving me her angry eyes.
Financings of the Fortnight Sees More Conflicting Indicators for Biotech VC
By Joseph HaasReading the sometimes conflicting data from the venture capital sector can be just a bit confusing. Last time out, for example, this feature tried to divine whether VC fundraising was on a slow pace or was rallying, with a pair of sources differing on the sector’s second-quarter take by nearly $2 billion.
As Congress would say, now we’re talking about real money.
One possible factor that could dampen the hopes of life sciences companies looking for VC investment is the difficulty some venture firms are having raising new funds themselves. See our Valuation Watch piece in the July/August 2010 issue of START-UP for details on how big life sciences backers like Polaris Venture Partners, Atlas Venture and Sofinnova Partners are closing new funds well short of stated goals and an update of our 'gas tank chart' that got, um, a lot of mileage last year. Of course at least a few VC firms recently met or exceeded their fundraising goals, including OrbiMed Advisors and SV Life Sciences. Once again, the indicators in VC financing appear somewhat conflicted.
Still, an attempt to read the quarterly trends suggest that the outlook for biotech companies looking for venture investment may be a sunny one, even as a few venture outfits lower fundraising expectations.
The life sciences sector (both biotechnology and medical device firms) saw venture capital investment increase during the second quarter by 52% in dollars and 36% in deal volume, according to the July 16 Money Tree Survey by PWC and the National Venture Capital Association, based on data from Thomson Reuters. Such investments totaled $2.1 billion as 234 deals were crammed into the April through June period; we covered the survey in-depth in “The Pink Sheet” DAILY.
Of those, biotech deals accounted for $1.3 billion spread across 139 deals. Biotech accounted for the largest share of venture capital financing during the quarter, enjoying a 59% uptick in dollars compared to the first quarter, as well as a 34% increase in the number of deals.
Overall, venture capital investment occurred at levels not seen since 2008, said Tracy Lefteroff, global managing partner for venture capital practice at PWC.
“The rise in companies lining up to go public in the life sciences space in Q2 was also a likely driver of the strong rebound we saw in investing in this sector during the quarter,” he said. “If the markets remain positive, we’ll likely continue to see robust investment levels for the remainder of the year, with VC funding in 2010 poised to surpass 2009 levels.”
Another hopeful trend suggesting an improving environment for start-ups during the second quarter was an increase in seed and early-stage investments. These rose 54% from the first quarter to the second quarter to a total of $2.3 billion, with deal volume rising 32% to 429. Likewise, first-time financings were up 7% during the quarter to $1.1 billion, with biotech leading the way among sectors in terms of first-time dollars raised.
Speaking of leading the way, it's time for another installment of ...
As Congress would say, now we’re talking about real money.
One possible factor that could dampen the hopes of life sciences companies looking for VC investment is the difficulty some venture firms are having raising new funds themselves. See our Valuation Watch piece in the July/August 2010 issue of START-UP for details on how big life sciences backers like Polaris Venture Partners, Atlas Venture and Sofinnova Partners are closing new funds well short of stated goals and an update of our 'gas tank chart' that got, um, a lot of mileage last year. Of course at least a few VC firms recently met or exceeded their fundraising goals, including OrbiMed Advisors and SV Life Sciences. Once again, the indicators in VC financing appear somewhat conflicted.
Still, an attempt to read the quarterly trends suggest that the outlook for biotech companies looking for venture investment may be a sunny one, even as a few venture outfits lower fundraising expectations.
The life sciences sector (both biotechnology and medical device firms) saw venture capital investment increase during the second quarter by 52% in dollars and 36% in deal volume, according to the July 16 Money Tree Survey by PWC and the National Venture Capital Association, based on data from Thomson Reuters. Such investments totaled $2.1 billion as 234 deals were crammed into the April through June period; we covered the survey in-depth in “The Pink Sheet” DAILY.
Of those, biotech deals accounted for $1.3 billion spread across 139 deals. Biotech accounted for the largest share of venture capital financing during the quarter, enjoying a 59% uptick in dollars compared to the first quarter, as well as a 34% increase in the number of deals.
Overall, venture capital investment occurred at levels not seen since 2008, said Tracy Lefteroff, global managing partner for venture capital practice at PWC.
“The rise in companies lining up to go public in the life sciences space in Q2 was also a likely driver of the strong rebound we saw in investing in this sector during the quarter,” he said. “If the markets remain positive, we’ll likely continue to see robust investment levels for the remainder of the year, with VC funding in 2010 poised to surpass 2009 levels.”
Another hopeful trend suggesting an improving environment for start-ups during the second quarter was an increase in seed and early-stage investments. These rose 54% from the first quarter to the second quarter to a total of $2.3 billion, with deal volume rising 32% to 429. Likewise, first-time financings were up 7% during the quarter to $1.1 billion, with biotech leading the way among sectors in terms of first-time dollars raised.
Speaking of leading the way, it's time for another installment of ...
NuPathe: Central nervous system drug developer NuPathe revealed terms for its initial public offering, scheduled for next week. The Conshohocken, Pa.-based company is expected to sell 5 million shares for $14 to $16 apiece, raising about $75 million and giving it a market capitalization of about $212 million after the offering, based on the midpoint of the price range. Lazard Capital Markets and Leerink Swann are co-lead underwriters of the offering. NuPathe has completed Phase III trials on a patch that delivers the migraine drug sumatriptan through the skin via a small electric charge. NuPathe expects to file an NDA for its patch, called Zelrix, during the fourth quarter of 2010. NuPathe has raised $53 million in private funding to date; Quaker BioVentures, which led NuPathe’s $30 million Series B round in May 2008, is the company’s largest outside shareholder, while Safeguard Scientifics, Birchmere Ventures, Battelle Ventures and SR One hold smaller stakes.—Paul BonanosEuthymics Biosciences: A new company formed to advance and commercialize a novel anti-depressant, Euthymics raised $24 million in a tranched Series A round from a venture syndicate led by Novartis Venture Funds and Venture Investors LLC, along with Hambrecht & Quist Capital Management, GBS Venture Partners and the State of Wisconsin Investment Board. The Cambridge, Mass.-based start-up paid $2 million to acquire shuttered DOV Pharmaceutical Inc., which ceased operations last year when it ran out of capital. Publicly-traded DOV was in the midst of Phase II trials on a triple reuptake inhibitor that features unbalanced potency against the neurotransmitters serotonin, dopamine and norepinephrine, in an effort to reduce side effects such as weight gain, sexual dysfunction and cognitive impairment. Euthymics expects to use the funding for a Phase II/III trial on the drug, which if approved would be marketed to patients who do not respond to selective serotonin reuptake inhibitors. Among Euthymics’ founders are former Orexigen executive Anthony McKinney and longtime Lilly executive Frank Bymaster, who was on the original development team for Prozac in the 1970s.—PB
Xoma: Through a committed equity financing facility, antibody specialist Xoma has the option to sell up $30 million of its registered common shares at a discount to Azimuth Opportunity Ltd. over a 12-month period. Just for signing on July 23, Azimuth got 1.7 million Xoma shares. Despite diluting shareholder equity and having a potential short-term negative impact on the price, CEFFs help companies avoid the more time-intense and often more expensive FOPO path. Like with most CEFF arrangements – limited only in how much capital is drawn down within a specific time period – Xoma controls the timing, dollar amount and share price of each draw, is not obligated to dip into the fund, and is free to pursue other financing. Azimuth is no stranger to Xoma; the private equity firm provided $26 million last September through two separate CEFF draws and now holds about 42 million of Xoma’s shares (approximately 261 million were outstanding as of May 31). With $28 million cash in its coffers, Xoma’s priorities – according to CEO Steven Engle – include expanding IL-1 beta antibodies IP, pursuing new partnerships, and advancing other autoimmune, cardio-metabolic, inflammatory and oncology candidates. Lead antibody XOMA52 is in Phase II for diabetes and cardiovascular disease. Xoma's isn't the only CEFF signed this fortnight -- just this morning Omeros announced a $40 million/24 month CEFF deal with Azimuth.—Maureen Riordan
Immune Design Corp.: Nearly doubling its June 2008 $18 million venture financing, Seattle start-up Immune Design took in an impressive $32 million in a July 26 Series B round led by new backer ProQuest Investments, which was joined by returning Series A participants Alta Partners, Column Group and Versant Ventures. According to Elsevier’s Strategic Transactions, the only immunotherapy firm raising more in a recent Series B – in 13 such transactions done since January 2007 – was CureVac GMBH (in a $47.7 million round July 2007); in fact, the average take of vaccine players in a Series B raise during that time period was about $20.5 million. So how did IDC manage to secure such a hefty sum? Perhaps its strong management team led by Corixa alum Steve Reed, also founder of the Infectious Disease Research Institute, promoted investor confidence. Recent success of its IDRI-pioneered GLA adjuvant technology in a second Phase I study in flu, couldn’t have hurt either. The financing gives IDC at least two-and-a-half years-worth of cash to advance GLA as well as its second platform, known as DC-NILV, designed to target and stimulate dendritic cells (from David Baltimore’s Caltech research team). IDC’s near-future plans include a Big Pharma partner to further finance development costs.—MR
Wednesday, July 28, 2010
more than you want to know
Katherine always seems to help me out when I feel I’m in a bloggy slump. I know that my posts, as of late, have not been very riveting (or “ribbiting” as I said to my sister this week after she said she rescued a frog out of the pool at camp… what? That’s totally funny. Matt didn’t think so either.). Anyhoo, she had these questions and answers posted on her blog and told those reading to consider themselves “tagged.” As I am not one to (often) ignore a (not-so-official) tagging, it was my bloggy duty to follow her lead. (Warning: this is long and possibly not that interesting… I don’t know seeing as how I haven’t answered them yet… so feel free to skip this one.)
What experience has shaped you most and why?
I guess this one is an easy and obvious one for me…
Receiving my GPS. Without a doubt, this little apparatus has greatly changed my life for the better. Without it, I seriously don’t know where I’d be. Get it? As in “I’d be lost”? But in the physical rather than metaphorical sense. Get it? Oh yeah, and motherhood has changed me a lot too… mostly for the better though I do find there are days now when I cuss like a sailor.
If you had a whole day with no commitments, what would you do?
Unbeknownst to Matt, I’m currently planning a day for myself like this. Because that’s just how utterly selfless I am. I’ll have to do dressing change because that just can’t be helped but THEN, I’m going to go get a greasy breakfast and read a book while I eat and nobody is allowed to talk to me. THEN, I’m going to go to a used bookstore and take forever perusing the aisles, lovingly touching all the book spines, and picking out several books of my very own. THEN, I’m going to go to a few scrapbooking stores and spend way too much money. THEN, I’m going to meet some girlfriends for lunch, and we are going to spend the afternoon shopping and hanging out. And we will also spend way too much money. And then I will come home, help get Jonah fed and ready for bed, and then I will go to bed early and get approximately 9.4 hours of sleep. Ribbiting, I know.
What food or drink could you never give up?
Mexican Food. I know that’s a whole category rather than one single food, but seriously, I couldn’t give up tortilla chips or pico or enchiladas or burritos or refried beans or tacos or any of it. It’s all so magically delicious, it really wouldn’t be fair to isolate just one Mexicanny goodness. And those who know me also know that asking me to give up food, any food, is like asking me to please just stop breathing. Thusly, this is a difficult question.
If you could travel anywhere, where would it be and why?
This one is hard too. I’d love to go to Hawaii (my hopes for our ten year anniversary) the most. But I’d also like to go back to Mexico and Argentina and to the rest of the Spanish-speaking countries. I’ve only been to Mexico, Nicaragua, and Argentina. Spain would be awesome, and I’d also like to go to Ireland. But if I had to choose JUST one, okay, Hawaii. Fine.
Who do you have a crush on?
Jonah. Also known as Jonut, Baby J, the J-Man, Sweet Babe, Jumping Jonah, Ja-nonah, and J-dizzle (okay, I made that last one up.)
(And also, Marky Mark.)
If you were leader of your country, what would you do?
I have no idea because I would never ever want that job in a million years. I feel so sorry for the President and all of the past ones actually. People criticize them too much and pray for them too little. I’d definitely have to start by making regular hair-coloring appointments for when my hair started to go gray.
Give me one savory recipe that doesn’t include cheese.
I can’t. The Squash Muffin one is pretty good, but I don’t think you can even describe a recipe as “savory” UNLESS it has cheese. On second thought, I bet those muffins would be pretty good with some cream cheese. It definitely wouldn’t hurt!
What did you think you were going to be when you grew up?
It was actually always a teacher, I think. I was an idiot.
If you could spend just one day in someone else’s body, who would it be?
I would say somebody who had a really sexy body, but then I would probably choose the day of her hardest workout routine, and honestly, that just doesn’t sound like fun to me. So, I think I’d pick somebody who’s funny and most everyone loves. Tina Fey would be good. But I guess she kind of has a sexy body too. (Shut it, Matt) So I’d just choose to be Tina Fey on a relaxing, binging, off day, because she’s going to have to deal with the leftover calories from her day off, not me. (And also, she knows Marky Mark… “I bet you do all kinds of right.”)
Which woman writer, living or dead, do you admire most?
Julia Alvarez. Look her up. She’s Dominican and her stuff is so good.
What character trait inspires you the most?
The word “inspires” makes me want to throw up a little bit, but I like when people are really honest and funny and real. And randomly break into a Bon Qui Qui voice and cuss at random. (MS, I am talking to YOU.)
What is your favorite kind of music?
I mostly listen to Christian, but music-wise, it’s not my favorite. I like stuff from the late 60’s and early 70’s and also dig some older country (90’s) now and again… but mostly just for karaoke purposes.
What is one fact about you that most people who know you wouldn’t guess?
I am a very difficult person to live with and extremely moody. Or maybe people would guess that. Maybe I only THINK I’m good at hiding it. Another is that I have major teeth issues. MY teeth are in great shape, but I have serious MENTAL issues with people talking about, wiggling, or showing me loose teeth. I have recurring dreams that my teeth are falling out. My sister does too, so at least I know I'm in equally crazy company.
If money were no object, what's one thing you don't own now or can't afford to do that you'd like to have or do?
Is it way pathetic that my first thought was a mini-van? Yep, I’m just that exciting. But seriously, if we ever do get one, I will probably wet my pants from excitement.
I think I’m supposed to make up my own question for the end, but I just don’t have the brain power to do that. Feel free to consider yourself tagged though. If you are as desperate for blogging material as I am, this will make your day. It did mine.
____
Jonah's good, but we just put him to bed and he immediately threw up all over himself. Clean up was a pain. Thus the lack of brain power. So tired.
What experience has shaped you most and why?
I guess this one is an easy and obvious one for me…
Receiving my GPS. Without a doubt, this little apparatus has greatly changed my life for the better. Without it, I seriously don’t know where I’d be. Get it? As in “I’d be lost”? But in the physical rather than metaphorical sense. Get it? Oh yeah, and motherhood has changed me a lot too… mostly for the better though I do find there are days now when I cuss like a sailor.
If you had a whole day with no commitments, what would you do?
Unbeknownst to Matt, I’m currently planning a day for myself like this. Because that’s just how utterly selfless I am. I’ll have to do dressing change because that just can’t be helped but THEN, I’m going to go get a greasy breakfast and read a book while I eat and nobody is allowed to talk to me. THEN, I’m going to go to a used bookstore and take forever perusing the aisles, lovingly touching all the book spines, and picking out several books of my very own. THEN, I’m going to go to a few scrapbooking stores and spend way too much money. THEN, I’m going to meet some girlfriends for lunch, and we are going to spend the afternoon shopping and hanging out. And we will also spend way too much money. And then I will come home, help get Jonah fed and ready for bed, and then I will go to bed early and get approximately 9.4 hours of sleep. Ribbiting, I know.
What food or drink could you never give up?
Mexican Food. I know that’s a whole category rather than one single food, but seriously, I couldn’t give up tortilla chips or pico or enchiladas or burritos or refried beans or tacos or any of it. It’s all so magically delicious, it really wouldn’t be fair to isolate just one Mexicanny goodness. And those who know me also know that asking me to give up food, any food, is like asking me to please just stop breathing. Thusly, this is a difficult question.
If you could travel anywhere, where would it be and why?
This one is hard too. I’d love to go to Hawaii (my hopes for our ten year anniversary) the most. But I’d also like to go back to Mexico and Argentina and to the rest of the Spanish-speaking countries. I’ve only been to Mexico, Nicaragua, and Argentina. Spain would be awesome, and I’d also like to go to Ireland. But if I had to choose JUST one, okay, Hawaii. Fine.
Who do you have a crush on?
Jonah. Also known as Jonut, Baby J, the J-Man, Sweet Babe, Jumping Jonah, Ja-nonah, and J-dizzle (okay, I made that last one up.)
(And also, Marky Mark.)
If you were leader of your country, what would you do?
I have no idea because I would never ever want that job in a million years. I feel so sorry for the President and all of the past ones actually. People criticize them too much and pray for them too little. I’d definitely have to start by making regular hair-coloring appointments for when my hair started to go gray.
Give me one savory recipe that doesn’t include cheese.
I can’t. The Squash Muffin one is pretty good, but I don’t think you can even describe a recipe as “savory” UNLESS it has cheese. On second thought, I bet those muffins would be pretty good with some cream cheese. It definitely wouldn’t hurt!
What did you think you were going to be when you grew up?
It was actually always a teacher, I think. I was an idiot.
If you could spend just one day in someone else’s body, who would it be?
I would say somebody who had a really sexy body, but then I would probably choose the day of her hardest workout routine, and honestly, that just doesn’t sound like fun to me. So, I think I’d pick somebody who’s funny and most everyone loves. Tina Fey would be good. But I guess she kind of has a sexy body too. (Shut it, Matt) So I’d just choose to be Tina Fey on a relaxing, binging, off day, because she’s going to have to deal with the leftover calories from her day off, not me. (And also, she knows Marky Mark… “I bet you do all kinds of right.”)
Which woman writer, living or dead, do you admire most?
Julia Alvarez. Look her up. She’s Dominican and her stuff is so good.
What character trait inspires you the most?
The word “inspires” makes me want to throw up a little bit, but I like when people are really honest and funny and real. And randomly break into a Bon Qui Qui voice and cuss at random. (MS, I am talking to YOU.)
What is your favorite kind of music?
I mostly listen to Christian, but music-wise, it’s not my favorite. I like stuff from the late 60’s and early 70’s and also dig some older country (90’s) now and again… but mostly just for karaoke purposes.
What is one fact about you that most people who know you wouldn’t guess?
I am a very difficult person to live with and extremely moody. Or maybe people would guess that. Maybe I only THINK I’m good at hiding it. Another is that I have major teeth issues. MY teeth are in great shape, but I have serious MENTAL issues with people talking about, wiggling, or showing me loose teeth. I have recurring dreams that my teeth are falling out. My sister does too, so at least I know I'm in equally crazy company.
If money were no object, what's one thing you don't own now or can't afford to do that you'd like to have or do?
Is it way pathetic that my first thought was a mini-van? Yep, I’m just that exciting. But seriously, if we ever do get one, I will probably wet my pants from excitement.
I think I’m supposed to make up my own question for the end, but I just don’t have the brain power to do that. Feel free to consider yourself tagged though. If you are as desperate for blogging material as I am, this will make your day. It did mine.
____
Jonah's good, but we just put him to bed and he immediately threw up all over himself. Clean up was a pain. Thus the lack of brain power. So tired.
FDA and REMS: A Symbolic Start
FDA just wrapped up a two day public meeting to review the implementation of its Risk Evaluation & Mitigation Strategy authorities.The hearing involved almost 70 different presentations from a diverse base of stakeholders offering input into how to make sure that REMS best allow drugs to be marketed safely without disrupting the entire health care system.
It also featured an unusually active and engaged panel of FDA officials; these agency meetings are often fairly magisterial in nature, with FDA listening but saying nothing. Not here: questions and comments aplenty.
So there is tons to digest, and we will have plenty of coverage of the meeting in The Pink Sheet, The Pink Sheet DAILY, and The RPM Report.
But we wanted to take note of how the meeting began, since we think that says volumes about where FDA is going with REMS.
The very first presenter was the American Society of Clinical Oncology’s Karen Hagerty. As we have written, ASCO has some concerns with how FDA has been developing REMS, and especially with how the agency and Amgen put together a new program for use of erythropoiesis stimulating agents in oncology. ASCO wants to make sure that they have more input in the development of REMS in the future.
That, to us, is the key theme of the two day hearing—and it surely says something about FDA’s openness to that theme that it kicked off the two days with a panel of providers, including ASCO, the American Medical Association, specialty pharmacy execs, and Kaiser. Industry (the Pharmaceutical Research & Manufacturers of America, the Biotechnology Industry Organization, Eli Lilly) came second.
The input of outside stakeholders is what prompted FDA to reconsider its REMS implementation—and we’re betting those stakeholders will end up gaining more input into the actually crafting of REMS for products going forward.
It won’t be easy: after all, as FDA officials pointed out, they regulate sponsors and many of the discussions about the potential need for and design of a REMS has to remain confidential. But providers and other stakeholders want in, and they are not likely to give up until they get in.
Take Kaiser. The non-profit health plan submitted a petition at the end of last year that really kicked off the REMS reappraisal at FDA. And Kaiser is clearly committed to seeing the process through: the non-profit had three different representatives speak during the meeting, making a total of six presentations on each of the six topics identified by FDA for the agenda.
For sponsors, the concerns raised by providers may sound like a blessing. After all, anything that stops FDA from slapping restrictive distribution programs and other post-marketing controls on new products willy nilly has to be a good thing, right?
Sure. But one other thing is clear from the two day meeting: REMS are here to stay. Providers don’t want them eliminated altogether, they just want a seat at the table in helping to shape programs before they are launched. We’re not sure how or when they will get their way, but we bet they will eventually. And then sponsors may pine for the days when the REMS was theirs to control.
Tuesday, July 27, 2010
growing jonah
Jonah is still refusing to eat, but the nutritionist came today and said he's growing great. He's gained a pound and a few ounces since last month and has grown 2.5 cm, I think she said.
He's in the 45th percentile for height, 50th percentile for weight (WHAT???!!!), and his weight to height ratio is in the 75th percentile.
So as frustrating and maddening as long g-tube feeds are, they are obviously working. I would rather deal with the frustration I'm feeling now than deal with the constant fear I felt before we had the g-tube... when I literally had to force milk down his throat (just for him to puke it right back up).
I know y'all have a lot of questions about what I have and haven't tried, and why I can't do this or that. I don't really have a good way to answer them since they're scattered throughout the comments. I'm up for suggestions, though, if you've been here before. Thanks for letting me know what's worked for you. Anything is worth a shot!
He's in the 45th percentile for height, 50th percentile for weight (WHAT???!!!), and his weight to height ratio is in the 75th percentile.
So as frustrating and maddening as long g-tube feeds are, they are obviously working. I would rather deal with the frustration I'm feeling now than deal with the constant fear I felt before we had the g-tube... when I literally had to force milk down his throat (just for him to puke it right back up).
I know y'all have a lot of questions about what I have and haven't tried, and why I can't do this or that. I don't really have a good way to answer them since they're scattered throughout the comments. I'm up for suggestions, though, if you've been here before. Thanks for letting me know what's worked for you. Anything is worth a shot!
Monday, July 26, 2010
so frustrating
UPDATE: Just to answer the "why not 'on the go'" question: Jonah will throw up if we don't get the blended mixture (about 5-6 oz of food with 3 oz of formula) to a thick pudding consistency. It can't be pumped, but has to be pushed at a rate of 10 cc's every 2 minutes. Given the fact that it has to be blended, pushed at such a slow and continuous rate, and just the fact that it's a MEGA mess (think green and purple goo flying up and hitting the ceiling as you try to shake/push out air bubbles), it's just not conducive to "on the go" feedings. The only place I'll feed him is a kitchen where I have access to a microwave (for thawing blended cubes), electricity (for mixing in the Magic Bullet), and a sink (for clean-up). Thanks for the thought though. If only it were as easy as Pediasure in a back-pack pump. Unfortunately for us, that means PUKE CITY.
_______________
Jonah continues to NOT eat. We had our evaluation today by a speech pathologist, and basically, it boils down to this:
- Speech can't work with him on the tongue thrusting thing if HE WON'T EVEN OPEN HIS MOUTH.
- Speech can't do much if he's refusing all together and has a psychological issue, not a physical issue.
- He definitely has a psychological issue (in my opinion).
- Kids Eat will only see him in their environment, not his, so his eating is not representative of how it is daily for us.
- It will be three more months before Kids Eat will see us again. In the one and a half months (ish) since we've seen them, he's regressed A TON.
- The OT who we need to work with will not have openings until the Fall.
- Even then, I'm not sure what we'll be able to do for him.
- We will soon be getting an evaluation from a psychologist to determine what I already know.
- The psychologists only do evaluations, not therapies for feeding.
What does this mean for Mommy, Daddy, and Jonah?
- Continued one step forward, five steps back.
- Mommy's getting more frustrated, Jonah's getting more frustrated, Mommy's getting more frustrated and so on and so forth.
- We don't even have a chance to get out of the house until 2:30 (you know, the hottest part of the day) because we do feeding, bath, dressing change, nap, and another feeding before we have "unscheduled" time.
- We can't make any morning trips anywhere.
- We can't go anywhere for more than a two hour period.
- We can't meet anyone for lunch.
- We can't feed in public or be anywhere other than home (or a home where we feel comfortable hauling a huge bag of food and supplies) for feedings.
- If we go out when Matt gets home, we have to be home by 6:30 to feed him. That gives us about an hour to get out and do anything as a family.
- Feedings take an hour because we can only do water/food through the tube at a slow rate.
- Jonah's aversion to sitting in his high chair is growing.
- Mommy's aversion to trying to keep him content and entertained in his high chair for at least three hours a day is growing.
I can't begin to explain how incredibly frustrating these kinds of feeding issues are. You only get it if you've been there. Just take my word for it. I tell people all the time that I can handle the blister popping and bandage changes, but the feeding stuff is going to SEND ME OVER THE EDGE.
Knowing that your child cannot (or won't) do such a basic and supposedly inherent thing and knowing that you, as his mother and primary caregiver, can't help him down that road... knowing that this takes him one step farther from "normal"... knowing that he is missing out on all kinds of normal childhood experiences and activities because he can't eat/be fed outside of our house... AAAGGGHHH!
Please pray. I'm so out of ideas, I don't even know what to do. And it doesn't seem like anyone knows what to do to help us. It's so very isolating. While my friends blog about going with their kids to the zoo and story time at the library and the swimming pool or even for a milkshake, I sit home and push green crap (really want to use stronger word here) through a tube, tethered to a high chair.
PISSES ME RIGHT OFF.
_______________
Jonah continues to NOT eat. We had our evaluation today by a speech pathologist, and basically, it boils down to this:
- Speech can't work with him on the tongue thrusting thing if HE WON'T EVEN OPEN HIS MOUTH.
- Speech can't do much if he's refusing all together and has a psychological issue, not a physical issue.
- He definitely has a psychological issue (in my opinion).
- Kids Eat will only see him in their environment, not his, so his eating is not representative of how it is daily for us.
- It will be three more months before Kids Eat will see us again. In the one and a half months (ish) since we've seen them, he's regressed A TON.
- The OT who we need to work with will not have openings until the Fall.
- Even then, I'm not sure what we'll be able to do for him.
- We will soon be getting an evaluation from a psychologist to determine what I already know.
- The psychologists only do evaluations, not therapies for feeding.
What does this mean for Mommy, Daddy, and Jonah?
- Continued one step forward, five steps back.
- Mommy's getting more frustrated, Jonah's getting more frustrated, Mommy's getting more frustrated and so on and so forth.
- We don't even have a chance to get out of the house until 2:30 (you know, the hottest part of the day) because we do feeding, bath, dressing change, nap, and another feeding before we have "unscheduled" time.
- We can't make any morning trips anywhere.
- We can't go anywhere for more than a two hour period.
- We can't meet anyone for lunch.
- We can't feed in public or be anywhere other than home (or a home where we feel comfortable hauling a huge bag of food and supplies) for feedings.
- If we go out when Matt gets home, we have to be home by 6:30 to feed him. That gives us about an hour to get out and do anything as a family.
- Feedings take an hour because we can only do water/food through the tube at a slow rate.
- Jonah's aversion to sitting in his high chair is growing.
- Mommy's aversion to trying to keep him content and entertained in his high chair for at least three hours a day is growing.
I can't begin to explain how incredibly frustrating these kinds of feeding issues are. You only get it if you've been there. Just take my word for it. I tell people all the time that I can handle the blister popping and bandage changes, but the feeding stuff is going to SEND ME OVER THE EDGE.
Knowing that your child cannot (or won't) do such a basic and supposedly inherent thing and knowing that you, as his mother and primary caregiver, can't help him down that road... knowing that this takes him one step farther from "normal"... knowing that he is missing out on all kinds of normal childhood experiences and activities because he can't eat/be fed outside of our house... AAAGGGHHH!
Please pray. I'm so out of ideas, I don't even know what to do. And it doesn't seem like anyone knows what to do to help us. It's so very isolating. While my friends blog about going with their kids to the zoo and story time at the library and the swimming pool or even for a milkshake, I sit home and push green crap (really want to use stronger word here) through a tube, tethered to a high chair.
PISSES ME RIGHT OFF.
Sunday, July 25, 2010
While You Were Watching Mad Men
On Friday, it seemed like everything happened at once. Generic Lovenox. Teva saying generic Lovenox doesn't mean generic Copaxone (we described that contortion in Pink and on IVB back in January: nobody is in quite the same predicament as Teva). Sanofi-Genzyme? GSK-Genzyme??Thankfully that momentum failed to generate a wave of weekend announcements and let everyone keep their mind on Sterling Cooper Draper Pryce. Oh, but there was news anyway, of course, news aplenty. And since this is going out late on Sunday, maybe even more news than this -- we'll try to update.
While you were following "team orders" ...
- Britain's new Lib-Con governing coalition is shaking up the NHS, as we and many others wrote about a couple weeks back. The New York Times takes everyone's temperature on the proposal. The reaction is predictably mixed.
- The WSJ profiles NIH's TRND program -- Therapeutics for Rare and Neglected Diseases. Last week "The Pink Sheet" took another look at the program, launched in 2009, to create a drug development pipeline within NIH that can get compounds through preclinical testing and ready for licensing to biotech or pharmaceutical companies in a competitive process.
- Onyx data on carfilzomib expected around 7am -- conference call at 8am ET.
- Bloomberg does the math: Teva fell as much as 8% on news that generic Lovenox was approved; analysts suggest shares will be volatile no matter how well Copaxone continues to grow.
- Yet another murine version of human disease falls to the almighty sirtuin family, reports the NYT. This time, mouse-Alzheimer's.
- Cerenis pulled in more than Eur 50 million to advance its HDL-mimetic program, and JP Garnier is joining its board. PR on the Eur 40mm Series C here, we'll have more -- including info on the Eur 10.7mm grant the company landed, in today's "Pink Sheet" DAILY.
- A Boston Globe editorial suggests: "Publish data on drug trials -- even when it's not flattering."
- A New York Times editorial asks: "Will the agency have the courage to reverse course when a medical treatment that it approved based on preliminary evidence flops badly in follow-up studies?" Gee, i wonder what they're talking about?
- Roche's Genentech has licensed a late-preclinical stage fully human IL-17 mAb from NovImmune. Upfront, milestones, royalties -- but specific terms not disclosed.
- This is from last week, but it's not every day someone gets a prosthetic arm belonging to the mannequin of Lefty O'Doul in the mail.
- Contador doesn't lose his chain or take a tumble, wins 3rd Tour.
- I'm not sure what I think about Brewdog's End of History beer. Not that I'll ever get to try one. Meanwhile, about a week until the GBBF. Recommendations? In the comments, pls.
Saturday, July 24, 2010
title goes here
This will be quick because I don't have a whole lot to talk about, and my sister has my camera this weekend so I don't have any new photos to fill up blog space. BUT...
We've had an okay day. Jonah's been fussy and a little frustrating, but I guess that's in typical not-quite-toddler fashion. We got up and did dressing change, fed Jonah, and then headed up to Stone Mountain to visit with my Maw-Maw and Paw-Paw. My brother and his kids and my dad were all going to be up there today, and I have been wanting to take Jonah for a while, so it was a great time. We had a nice lunch and got to hang out a little, but we had to stay inside while the kids went on golf cart rides and to the playground, so we missed out on some good family time. Meanwhile, back at Maw-Maw's cabin, Jonah was fussy, clingy, and an all around a pain-in-the-patooty. So we cut it short and headed back home. He was overly tired because he had only slept 45 minutes on the car ride up there, and he's always pretty ornery in a new place.
Peyton and his kids (ages five and three) came into town on Thursday night, though, so I had gotten to spend some quality time with them before today. Peyton came yesterday morning, while my mom took the kids to the park and library, and helped with dressing change. Then I went over to my mom's for a late lunch on Friday and hung out with them and the kids. Last night, Matt and Peyton kept Jonah and played a couple games of chess (Matt is a very good chess player, and he says that Peyton is a smart player and good considering he hasn't played that much) while Mom and I took the kids to see a local performance of Peter Pan the Musical. It was fun, and although the kids were a little restless at the beginning, they really liked it (it was three hours long - they did GREAT!).
That's about it for our weekend so far. We hope to make it to church tomorrow, but don't have any big plans. It is still SO HOT here, and I'm praying for relief soon. I'm fairly certain it got to 100 degrees here today, and you'd think it would have been cooler up in the mountains. You would be incorrect. And the humidity is just so bad. You just feel damp and sticky as soon as you walk out the door. Gross. And impossible for Jonah.
Please say some extra prayers for Daylon and Bella tonight. Daylon's had some bleeding on the brain and a seizure from a trial medicine he's having to take to prevent a potentially fatal condition (VOD) from getting worse that has resulted from Transplant. So far, they've been able to avoid surgery (which would hold GREAT infection risk for him) and have stopped the medicine and increased his platelets in hopes to thicken his blood. Bella is on the same medicine for the same condition. Both of them are on continuous dialysis because their kidneys aren't functioning, which thins the blood further. VOD is potentially fatal. Kidney failure is potentially fatal. Stroking from this medicine is potentially fatal. Nothing about this transplant is easy. Please be in prayer for both of them. As always, many thanks for the prayers, love, and support for all the EB Sweeties.
We've had an okay day. Jonah's been fussy and a little frustrating, but I guess that's in typical not-quite-toddler fashion. We got up and did dressing change, fed Jonah, and then headed up to Stone Mountain to visit with my Maw-Maw and Paw-Paw. My brother and his kids and my dad were all going to be up there today, and I have been wanting to take Jonah for a while, so it was a great time. We had a nice lunch and got to hang out a little, but we had to stay inside while the kids went on golf cart rides and to the playground, so we missed out on some good family time. Meanwhile, back at Maw-Maw's cabin, Jonah was fussy, clingy, and an all around a pain-in-the-patooty. So we cut it short and headed back home. He was overly tired because he had only slept 45 minutes on the car ride up there, and he's always pretty ornery in a new place.
Peyton and his kids (ages five and three) came into town on Thursday night, though, so I had gotten to spend some quality time with them before today. Peyton came yesterday morning, while my mom took the kids to the park and library, and helped with dressing change. Then I went over to my mom's for a late lunch on Friday and hung out with them and the kids. Last night, Matt and Peyton kept Jonah and played a couple games of chess (Matt is a very good chess player, and he says that Peyton is a smart player and good considering he hasn't played that much) while Mom and I took the kids to see a local performance of Peter Pan the Musical. It was fun, and although the kids were a little restless at the beginning, they really liked it (it was three hours long - they did GREAT!).
That's about it for our weekend so far. We hope to make it to church tomorrow, but don't have any big plans. It is still SO HOT here, and I'm praying for relief soon. I'm fairly certain it got to 100 degrees here today, and you'd think it would have been cooler up in the mountains. You would be incorrect. And the humidity is just so bad. You just feel damp and sticky as soon as you walk out the door. Gross. And impossible for Jonah.
Please say some extra prayers for Daylon and Bella tonight. Daylon's had some bleeding on the brain and a seizure from a trial medicine he's having to take to prevent a potentially fatal condition (VOD) from getting worse that has resulted from Transplant. So far, they've been able to avoid surgery (which would hold GREAT infection risk for him) and have stopped the medicine and increased his platelets in hopes to thicken his blood. Bella is on the same medicine for the same condition. Both of them are on continuous dialysis because their kidneys aren't functioning, which thins the blood further. VOD is potentially fatal. Kidney failure is potentially fatal. Stroking from this medicine is potentially fatal. Nothing about this transplant is easy. Please be in prayer for both of them. As always, many thanks for the prayers, love, and support for all the EB Sweeties.
Friday, July 23, 2010
Deals of the Week Watches Medigene Squeeze Out of a Jam of Its Own Making
On Tuesday, Medigene said it had landed €25 million from its Eligard partner Astellas as part of a renegotiation of the companies' distribution deal for the prostate cancer drug in Europe. In addition, Medigene will get about a 2% royalty from Astellas -- roughly a third of its current net margin on the drug now. We're not covering it below the DOTW banner because it's not a new deal, or a no-deal. It's not even a terribly unusual deal (agreements get renegotiated all the time, right?) -- but the circumstances around why Medigene needed this deal are very peculiar indeed.Medigene secured European rights to Eligard (leuprolide), an LHRH agonist used to treat hormone-receptive prostate cancer, from Atrix Labs (now Tolmar) back in 2001. The tab, for a drug at NDA stage in the US, wasn't that huge: $6mm up front--$2mm in cash and $4mm in equity at a premium--plus clinical, regulatory, and sales milestones. In addition, the deal also included royalties, with Atrix manufacturing the products for MediGene.
Medigene got Eligard to the European market in 2004, and that same year signed up Yamanouchi (now Astellas) to sell the drug. It nearly made its money back doing so: the deal netted Medigene an up-front payment of €4mm, success milestones of up to €19.5mm, and royalties.
So: Medigene pays Tolmar royalties and cost-of-goods. Astellas pays Medigene royalties. And therein lies the squeeze, and the reason why Medigene has extricated itself from the middle of this deal-chain.
Rock, meet hard place.
"Medigene has been in the sandwiched position between our supplier Tolmar and our distribution partner Astellas," pointed out Medigene CEO Arnd Christ on a call to announce the new arrangement. This "led to a complex and in some respects unfavorable situation for us."
Howso? The cost of sales was high and a little unpredictable, and someone at Medigene perhaps forgot to account for the fact that Eligard sales may actually take off a little, meaning Medigene would owe Tolmar a bit more cash, relatively speaking. In 2009 Astellas racked up more than €100 million in Eligard sales.
As a result, "the structure of the two contracts led to a situation in which Medigene was not able to gain from further growth of Eligard due to a decrease in the net margin," said Christ.
Come again? "Once in-market sales reached a certain level we had to pay for the incremental amount more royalties to Tolmar than we received from Astellas. We have reached this level already in 2009."
At least Medigene wasn't taking excess risk on top of that? Well there was the risk that Tolmar would raise Medigene's cost-of-goods bill too. Surely not! "According to the previous agreements Tolmar was entitled to increase the prices for Eligard, whereas Medigene was not able to pass on such an increase to Astellas," said Christ.
Is that it? "Medigene was responsible for the supply chain, and was exposed to various regulatory risks, like risk and quality assurance, regulatory product liability and so on and so forth."
It's easy to see why--oh, there's more? "Last but not least, we've been exposed to foreign exchange risk, since the contract with Tolmar was based on US dollars whereas the royalty stream with Astellas was based on euro. A significant change of the euro-dollar exchange rate had a significant impact on our P&L," said Christ.
All in all the new arrangement with Astellas seems to get Medigene out of a bind, and shores up its balance sheet with non-dilutive funding. But it was the kind of self-inflicted bind we mostly see on sit-coms, Brad Lidge save attempts, or maybe an old episode of Scooby Doo, not so much in ...
Actelion/Trophos: This deal -- in which Trophos granted Actelion an option to buy based on the results of a pivotal study for its lead ALS project -- puts the number of options-to-buy so far this year at at least six, compared to 2009's five. Actelion paid €10 million up-front to the French biotech and will pay €125 million to complete the deal upon conclusion of a Phase III pivotal trial of Trophos' lead amyotrophic lateral sclerosis candidate, olesoxime. Enrollment in that 512-patient study is complete and results are expected by the end of 2011; thus, Actelion will need to make up its mind within a couple months of seeing the data or by the end of 2012, whichever comes first. Should Actelion exercise its option, Trophos' backers could see up to €70 million in further milestone payments based on the clinical progress of the company's pipeline and the regulatory success of olesoxime. Meanwhile, Actelion has gained access to Trophos' proprietary CNS assay technology and cholesterol-oxime chemistry compound library; Trophos will also test proprietary Actelion compounds with its technology. The research collaboration is early stage and specific terms have not been disclosed, but should Actelion not exercise its option to buy Trophos, the biotech has at least lined up a fully-funded partnership to complement its internal, rare-disease focused R&D.Our full write up is in "The Pink Sheet" DAILY.--CM
Merck/Hawaii Biotech: In something of a stealth transaction – neither company issued a press release – Merck has purchased bankrupt Hawaii Biotech’s dengue fever vaccine program for undisclosed terms. The deal was approved July 19 by a
Cypress/Ramius: Investors in specialty drug developer Cypress Bioscience had already expressed their displeasure with the company's latest licensing deal. But one shareholder is going one step farther: hedge fund operator Ramius, which already holds 9.9% of Cypress' shares, has made an unsolicited all-cash offer to acquire the biotech firm outright. At $4 per share, representing a 60% premium over Cypress' closing price of $2.50 on Friday, July 16, the deal would be worth $154 million. Cypress gets most of its revenue from the fibromyalgia drug Savella, but has turned around and spent money on M&A and in-licensing development candidates. It's latest deal, with BiolineRx for CYP-1020, a novel anti-schizophrenic, has not been well received by its investors. As part of its hostile bid, Ramius proposed that shareholders and management split CYP-1020 rights but with management funding future development on its own or with third-party help. Although details were left vague, the unusual proposal seems to give shareholders upside from CYP-1020 without taking on more development risk, while rewarding them with some immediate liquidity as well. Our write up -- with full coverage of Ramius' displeasure -- is (you guessed it) in the PSD. --Paul Bonanos
image from flickr user bernatcg used under a creative commons license
Thursday, July 22, 2010
nothing
I keep waiting for something exciting to post, but it never seems to happen, so here goes.. well... literally nothing.
It has been so hot here this week, Jonah has maybe made it out in the open air one or two times. I don't even think I've taken him in the car anywhere. Monday night I ran a few errands, Tuesday night I helped host a baby shower for a friend (not at my house), and today I went to the gym for about 45 minutes. So I haven't been getting out much either thus the lack of interesting blog fodder.
Jonah is doing well, although he refuses to eat at all by mouth. No yogurt. No nothing. Even our go-to's don't cut it anymore. In equally frustrating news, he's now learned to shake his head back and forth "no" when food is approaching his mouth. Good times. We have a speech pathologist coming Monday. I sure hope she can help because I am COMPLETELY out of ideas.
I mentioned I went to the gym today. And then I proceeded to eat pound cake and banana pudding. The end.
I really, really want to write a novel these last few days. Too bad I have no ideas and feel that all the creativity has been zapped from my body. I have no jokes, no funny ideas, no sarcasm. Nothing. I'm going soft. I'm friends with Bella's mom on Facebook, and she took some quiz on "how old you act." She got age 72. Yep, I know the feeling. Can you hear the monotone droning in my voice? Maybe those are just the voices in my head.
Jonah has discovered, this week, that crawling allows him the pleasure of getting into/doing things he shouldn't. This week he's almost gone head-first down the stairs, almost stuck his fingers in an electrical outlet, thrown his shoes in the trash can and pulled every blanket and burp cloth we have off of their shelf. I'm just thankful he hasn't discovered the toilets yet. Yes, friends, it's time to baby proof. His favorite pastime, apparently, is chewing on the metal trashcan downstairs. Did I mention that he has weak tooth enamel? Not good. He got popped for that one today. Don't let him fool you. He knows what "no" means. He has a stubborn streak for sure. He must get that from his dad.
I just did a two page scrapbook spread. I haven't done any scrapbooking since way before Jonah was born. Two back-to-back pregnancies will do that to a girl. So anyway, yesterday I had the chance to finish a scrapbook I'd been wanting to complete for a while. The one with our wedding and honeymoon that occurred six years ago. What?
We are watching the new Star Trek movie. I'm not really paying attention. All I know is that Sylar (bad guy from Heroes) playing Spock (good guy in the movie) is not right. Demetri from Flash Forward is in it too. I feel that all my worlds are colliding.
We are currently dog sitting my brother's dog. He and Deac are best buds. They are currently humping one another. The excitement around here never ends.
That is all.
It has been so hot here this week, Jonah has maybe made it out in the open air one or two times. I don't even think I've taken him in the car anywhere. Monday night I ran a few errands, Tuesday night I helped host a baby shower for a friend (not at my house), and today I went to the gym for about 45 minutes. So I haven't been getting out much either thus the lack of interesting blog fodder.
Jonah is doing well, although he refuses to eat at all by mouth. No yogurt. No nothing. Even our go-to's don't cut it anymore. In equally frustrating news, he's now learned to shake his head back and forth "no" when food is approaching his mouth. Good times. We have a speech pathologist coming Monday. I sure hope she can help because I am COMPLETELY out of ideas.
I mentioned I went to the gym today. And then I proceeded to eat pound cake and banana pudding. The end.
I really, really want to write a novel these last few days. Too bad I have no ideas and feel that all the creativity has been zapped from my body. I have no jokes, no funny ideas, no sarcasm. Nothing. I'm going soft. I'm friends with Bella's mom on Facebook, and she took some quiz on "how old you act." She got age 72. Yep, I know the feeling. Can you hear the monotone droning in my voice? Maybe those are just the voices in my head.
Jonah has discovered, this week, that crawling allows him the pleasure of getting into/doing things he shouldn't. This week he's almost gone head-first down the stairs, almost stuck his fingers in an electrical outlet, thrown his shoes in the trash can and pulled every blanket and burp cloth we have off of their shelf. I'm just thankful he hasn't discovered the toilets yet. Yes, friends, it's time to baby proof. His favorite pastime, apparently, is chewing on the metal trashcan downstairs. Did I mention that he has weak tooth enamel? Not good. He got popped for that one today. Don't let him fool you. He knows what "no" means. He has a stubborn streak for sure. He must get that from his dad.
I just did a two page scrapbook spread. I haven't done any scrapbooking since way before Jonah was born. Two back-to-back pregnancies will do that to a girl. So anyway, yesterday I had the chance to finish a scrapbook I'd been wanting to complete for a while. The one with our wedding and honeymoon that occurred six years ago. What?
We are watching the new Star Trek movie. I'm not really paying attention. All I know is that Sylar (bad guy from Heroes) playing Spock (good guy in the movie) is not right. Demetri from Flash Forward is in it too. I feel that all my worlds are colliding.
We are currently dog sitting my brother's dog. He and Deac are best buds. They are currently humping one another. The excitement around here never ends.
That is all.
Times Are A-Changing and Tough, Says Roche
Roche's CEO Severin Schwan isn't the only pharma CEO facing a highly unappealing economic reality (and not just talking of it) – executives of practically every pharma reporting for the second quarter to date has laid made this point. But Schwan's remarks to analysts on today's half-year earnings call were particularly harsh, especially coming from one of the industry's best long-term performers. "The financial crisis has arrived for the pharmaceutical industry," he stated.Not only did Roche suffer two important clinical development setbacks in the past month, but it, like the rest of the industry, is facing accelerating pricing pressure—a point which he and his top lieutenants honed in on repeatedly. These hits will fall through to the bottom, he noted, adding, 'We won't suddenly have more products [to offset the shortfall] because prices are coming down."
To some extent, he was playing to analysts, who are wary of Roche's promises to cut cuts in the face of a slowing top line. After all, the company, which has demonstrated its scientific prowess by launching a series of unexpected blockbusters, isn't, as one analyst put it, known for being "mean and thin."
But on another level, the setbacks to Avastin and the experimental Type 2 diabetes drug taspoglutide, really hurt --especially if FDA ultimately decides to take up ODAC on its recommendation earlier this week against full approval of Avastin in first-line metastatic Her-2 negative breast cancer. In that case, Roche will have to stop promoting the drug and re-educate physicians about its use for first-line breast cancer (it now is available for that indication under the accelerated approval process) – which could cost the company hundreds of millions of dollars in sales.
To some extent, he was playing to analysts, who are wary of Roche's promises to cut cuts in the face of a slowing top line. After all, the company, which has demonstrated its scientific prowess by launching a series of unexpected blockbusters, isn't, as one analyst put it, known for being "mean and thin."
But on another level, the setbacks to Avastin and the experimental Type 2 diabetes drug taspoglutide, really hurt --especially if FDA ultimately decides to take up ODAC on its recommendation earlier this week against full approval of Avastin in first-line metastatic Her-2 negative breast cancer. In that case, Roche will have to stop promoting the drug and re-educate physicians about its use for first-line breast cancer (it now is available for that indication under the accelerated approval process) – which could cost the company hundreds of millions of dollars in sales.
And the hypersensitivity issues that arose during a Phase III trial of taspoglutide, Roche's first drug for Type 2 diabetes, mean a delay of 12 to 18 months in the regulatory filing, which Schwan called "a big disappointment." That is likely to translate into some restructuring in the U.S., including of the U.S. primary care sales force – a group of about 750 reps – executives said, although they weren't specific about details of what they would do.
Meanwhile, Stefan Frings, Avastin Franchise director, was less circumspect in his response to the ODAC committee vote. Accusing the agency of having "stacked the deck against Avastin by choosing voting members who were previously negative" on the drug, he also noted that the briefing booklet "honed in on median PFS [progression-free-survival], ignoring hazard ratios."
And Roche, he added, wasn't alone: immediately after the vote, he told analysts, thought leaders contacted the company to say they "were appalled" by the committee's decision. "This is not a Mylotarg situation," he went on, referring to Pfizer's recent decision to withdraw that acute myeloid leukemia drug from the U.S. market because of excessive mortality. "Avastin mortality isn't excessive and risk factors work in its favor," he insisted, adding "Avastin is a meaningful option for certain patients with breast cancer."
Pascal Soriot, chief operating officer of Roche Pharma, took a less acerbic, more diplomatique tone, stating that the company "needs to work with FDA" to understand the relationships of PFS and hazard ratios and to have clear "expectations for rules of the game for all projects going forward."
Whatever the outcome of the Avastin decision - due in mid-Sept - this is a year when Roche steps in line with its pharma counterparts and focuses on the new frontier of "operating excellence."
Meanwhile, Stefan Frings, Avastin Franchise director, was less circumspect in his response to the ODAC committee vote. Accusing the agency of having "stacked the deck against Avastin by choosing voting members who were previously negative" on the drug, he also noted that the briefing booklet "honed in on median PFS [progression-free-survival], ignoring hazard ratios."
And Roche, he added, wasn't alone: immediately after the vote, he told analysts, thought leaders contacted the company to say they "were appalled" by the committee's decision. "This is not a Mylotarg situation," he went on, referring to Pfizer's recent decision to withdraw that acute myeloid leukemia drug from the U.S. market because of excessive mortality. "Avastin mortality isn't excessive and risk factors work in its favor," he insisted, adding "Avastin is a meaningful option for certain patients with breast cancer."
Pascal Soriot, chief operating officer of Roche Pharma, took a less acerbic, more diplomatique tone, stating that the company "needs to work with FDA" to understand the relationships of PFS and hazard ratios and to have clear "expectations for rules of the game for all projects going forward."
Whatever the outcome of the Avastin decision - due in mid-Sept - this is a year when Roche steps in line with its pharma counterparts and focuses on the new frontier of "operating excellence."
Monday, July 19, 2010
the results are in
We got the results from Jonah's genetic testing today. They didn't really tell us much we didn't already know. He has two mutated genes, which makes sense since JEB is a recessive disorder. Both of his mutations mess up his production of Collagen XVII. He produces some, but not enough. We have definitely ruled out Dystrophic, which is good news. The expert at the lab said he's most likely non-Herlitz (which we already thought), and will have hair, nail, and teeth issues in addition to skin (which he already does). He only has three nails out of twenty, his teeth are too small and are weak, and his hair is thin and thinning more. One of his mutations has been seen in one other person. The other has never been seen before. JEB is POINT five in a million. Jonah's mutations make him, well, just one. That's why the results don't tell us much. He is a more severe non-Herlitz, meaning that he probably won't grow out of it and it will definitely affect more than just his hands and feet (obviously). So what does it all mean? I really don't know. I know that I'm happy it's not dystrophic and I'm happy to get more confirmation that he's non-Herlitz (although it's a spectrum disorder and they don't really classify it that way anymore - Herlitz (lethal), non-Herlitz (non-lethal)). The truth is, regardless of what he's classified, he could get a deadly infection at any time. In that regard, classification means nothing. On the other hand, his trachea, so far, has been unaffected, and he's gaining weight well. These are both very good signs. There is a deep down part of me that was hoping they would say, "We've found his mutations. They're the same as this person and this person and guess what? They're grown, living healthy lives and only have to spot wrap." I know it was unrealistic but I really wanted that. And maybe he will toughen as he grows. Maybe he won't have to be wrapped forever. We really just don't know. So today's been a day of the "what if's" for me. But I'm just trying to refocus and concentrate on today. Because today is all I know I have for sure. And he's here TODAY.
HELLO?
Daddy, Is that you??? Hold on, I'll get her.
MOMMY!
Daddy's on the phone.
And still (and forevermore?) in love with his ball popper.
Jonah's gtube button change went okay today. He cried and screamed (heaving sobs) the entire time. But he didn't throw up, and as far as I know, there was no skin damage. Matt held his arms, the surgeon held his legs, and I changed out the button. I think it will go a lot better here at home. We have to change it out again in about four months, and we'll do it at home from now on. Next time, we'll snag a third person for dressing change and take care of it while he's already unwrapped. I think with video diversion and being on his own table, he won't react as much. Thank you so much for your prayers. He got really upset but recovered quickly. That's it for me. It's been a long day, and I'm spent. Goodnight.
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