a haircut and cute pj's

On Monday morning, Shannon, the AWESOME lady who cuts my hair offered to stop by on her day off to cut Jonah's hair. I had told her about him and how I was concerned about taking him somewhere and someone mishandling him. So she offered to cut it for me. Y'all probably can't tell it's been cut. She mostly just took some length off the very back. It needs to be cut a little more, but as you can see, he was not amused. He only allowed (and I use that term very loosely) it for about three minutes.

_______________________

And these are from tonight. Cuteness in his baseball pajamas.

Crazy Aquaphor Hair.

Is that lint?

Yep, that's lint alright. That's what I'm talkin' about.

So close to crawling. So close.

being part of the Body

These videos are from Sunday a week ago. We were having a special "I'm In" service, a recommitment to being actively involved at Pinedale, but more importantly committing to truly being an active part of the Body of Christ.

It was very powerful.

After a few testimonies of how God and the Body of Christ had worked in several people's lives, we gave our testimony as to how the Body of Christ has helped us through.

(These videos are long, so I would press play and then immediately press pause if they are lagging and talk amongst yourselves or surf elsewhere while they load and buffer. Then press play again.)

Oh yeah, please excuse the shakiness. At the beginning Bill (our preacher) asked Jonah's parents to stand up wherever we were (we were up in the balcony) so I put my camera down by my side (while still recording) while we stood. Sorry. (The rest of the shakiness I have no excuse for. I was just shaky.)

This one is the Cardboard Testimonies. I had seen online video of it from other churches, and loved it, but it is even more powerful when it's people you know and love personally.

The girl singing, Katelyn, also sang at Gabe's funeral. She gives me chills.

My good friend, Gina, who I have mentioned on the blog often (owns the diner with the good chicken stew, was the ring leader in decorating the basement, organized meals for us, helps with dressing change, got drinks donated to Jonah's party etc.) is the one who was healed from stage three cancer and does an "oh yeah" dance when she flips her card. I love her. :)

This is the song we sang directly after the Cardboard Testimonies. It's Chris Tomlin's version of Amazing Grace. I recorded it because this is one of the two songs I sang for Jonah ALL of the time during our long days in the NICU. I thought it was divinely fitting that it was the song that followed the testimonies. I'm sure others would say the same.

The woman singing at the beginning is Aimee. She also has an AMAZING voice. She is the one we were planning on keeping Jonah before we knew he was going to have so many special needs. She still helps me with dressing change every other Monday, and is one of the many women at Church who have been a huge support and saving grace to me.

I know I can't do justice to the service by just posting these few videos, but I hope, if nothing else, it makes you realize (if you don't already know) the power of being part of the Body of Christ and having a Church family of your own. I can honestly say that I don't know how we would have come through Gabe's death and Jonah's challenges without our Pinedale Family. They have truly been the hands and feet of Jesus to us. I know we're exactly where we are supposed to be. THANK GOD!

While You Were Time Traveling

OK we haven't seen it yet but on the combined strength of AO Scott's NYT review and the commercials we've seen, we'll go ahead and call next year's best picture winner for "Hot Tub Time Machine". And if you think that isn't a device designed to tie together a few of the weekend's industry happenings, well, you're not paying attention to In Vivo Blog.

While you were finding plutonium for your flux capacitor ...

• One person in the know called it "the worst kept secret in Washington": President Obama will nominate Donald Berwick to head up CMS. We suggested that might happen way back in February 2009. People, either this has taken a very long time, or we have bent space and time. Your call.
• Novartis would probably like to have a spin in the HTTM today, to go back and prevent its younger self from plunking down more than a few million for rights to Antisoma's ASA404 cancer compound. Sadly that drug didn't show a survival benefit in a Phase III lung cancer study, the companies said today. We covered their deal--the second around that compound after original partner Roche handed back rights--back in April 2007. Man, the In Vivo Blog is getting old.
• Predicting benefit from drugs before treatment? How futuristic. Bloomberg reports on the Nature paper that describes a test that may predict response to beta interferons in MS patients.

jonah's first fort - thanks, daddy!

I am still not feeling well, but don't worry... Jonah is in good hands.

Fort and all. (I took a nap this afternoon, and this is what I woke up to.)

"Okay, I'm done now. Pleeeaaase get me out." (More fake crying.)

Matt tweeted a cute one here too.

And Granny (Matt's mom) is on her way to help the next couple days since I'm still not 100%. Too bad I can't get a break from dressing change. Being sick AND the mama STINKS. Hoping to feel better soon, and still praying that Jonah stays healthy. I have to be so in his face all the time, I have no idea how he could NOT catch it.

a funny

It was Matt's turn today to keep Jonah out in the lobby during the sermon.

Matt said a kid, probably about nine years old, came up to him.

Kid: (Asking about Jonah) "Why does he have that all over his face?"

Matt: "He has a skin problem and he gets blisters on his skin."

Kid: "Oh. Is he like Jonah?"

Matt: "This is Jonah."

Kid: "Oh.... Hey, Jonah!"

Kid runs off.

Matt told me afterwards, and I just burst out laughing.

At Church, EVERYBODY knows Jonah, even if they don't really know Jonah.

jonah's amazing cake

UPDATE: Here is the link to Janel's Cake Fan Page (Crave Confections) on Facebook. Check it out! She's posted lots of photos of other great cakes she's done. I still like Jonah's the best though. I could be slightly partial.

So the cake...

I have been meaning to post this forever, but just hadn't gotten around to it.

Janel is a bloggy/EB friend that I "met" after she found my blog shortly after Jonah was born. I had never even met her in person until the day before Jonah's birthday. She has RDEB, but is married, in her thirties, and has a sweet little girl!

She says she bakes and decorates cakes for a hobby, but she is AMAZING. Janel and her family drove all the way up for Jonah's birthday from FLORIDA, and Janel made this beautiful, wonderful, perfect cake for free. Did I mention she's amazing???

Almost there.

Check out the detail.

The Final Masterpiece.

The bottom layer was vanilla cake with buttercream icing, the animal layer was chocolate with buttercream icing, the games layer was carrot cake with white chocolate cream cheese icing, and the top layer was white chocolate with white chocolate cream cheese icing. The whole thing was covered in fondant, and everything was edible.

Pretty incredible, huh? 

Jonah checking it out.

Jonah's Smash Cake (which he barely touched... cake is, after all, a solid.)

"Ready for my cake, Mom."

Jonah looking like he was trying to blow, but really just reacting to me blowing in his face.

Only a small portion of the Paparazzi.

It was almost too pretty to cut, but we quickly got over it.

So, thank you, Janel. What a beautiful gift. It was unforgettable. Thank you so much for blessing our family. We're so glad to now call you a "real life" friend. Hope to see you again very soon. (And by the way, Matt said it was the best carrot cake he'd ever had. And he does NOT play around when it comes to dessert.)

Deals of the Week: Health Care Reformation

Behold the health care reformation. Clearly the biggest deal of the week -- or in the words of our excitable veep Joe Biden, a big f***ing deal -- was passage of the US health care reform bill.

It was certainly an historic moment, a piece of legislation that its backers hope will become as transformational as the 95 Theses of Contention Martin Luther nailed to the door of the Schlosskirche in 1517. At 2,700 pages, quite the doorstop, the bill certainly is heavier than Martin Luther's masterwork. Like ML, however, its authors also had to fight against indulgences, what with the Republicans offering 40 amendments designed to derail the bill, including a comical proposal to restrict sex offenders' access to erectile dysfunction drugs like Viagra.

As we noted earlier in the week, drug makers played their cards wisely, securing market expansions and intellectual property protections beyond what many thought possible, while simultaneously resuscitating their public image. (For now the insurance industry is wearing the bright-red bull's eye.) Even with the challenges of a risk-adverse FDA and lagging R&D productivity, there's plenty of reason for pharma to celebrate.

But we're also guessing certain factions -- the tea partiers and Republicans, for starters -- have not yet begun to fight. Will the November elections be Obama's Diet of Worms? (A sure-fire weight-loss scheme, by the way, but is it reimbursable?) Does Glenn Beck get to be Pope Leo?

Obama already has his game face on. Telling Republicans to "go for it" at an Iowa rally, he warned of an uphill battle for repeal come November as voters begin to feel the benefits of near-universal coverage. Like Luther, who famously uttered before the Holy Roman Emperor "I can and will not retract, for it is neither safe nore wise to do anything against conscience," call it the prez's "Here I stand" moment.

We also say bring it on. Mining the twists and turns of the bill, and all the future amendments sure to spring forth, will keep journos like us occupied -- if not gainfully employed -- for years to come. In the meantime, there's always that little weekly round-up we like to call...



Pfizer/GSK/Global Alliance for Vaccines and Immunisation: On March 23, Pfizer and GlaxoSmithKline signed what other media outlets termed "a landmark 10-year deal" to supply hundreds of millions of pneumococcal vaccine doses to developing nations at reduced prices. It's the latest example of big pharma's desire to do well by doing good. It's also the first deal to debut under a new Advanced Market Commitment scheme that helps poor nations secure vaccines, while guaranteeing a market for the drug companies, by setting a maximum price for the preventive shots. Over the next decade GSK will supply up to 300 million doses of its Synflorix vaccine to GAVI, while Pfizer plans to donate an unspecified number of Prevnar 13 shots. According to the AMC, the companies will charge $7 a dose for the first 20% of supplied vaccine, and then just $3.50 a dose for the remaining 80%. That's far less than the $54 to $108 per-shot fee GSK and Pfizer charge in developed countries. Canada, Italy, Norway, Russia, the United Kingdom and the Bill & Melinda Gates Foundation have collectively offered $1.5 billion to fund this first AMC. (The US isn't participating, but the FDA's priority review voucher is designed to expedite development of medicines for neglected diseases.) If it goes as planned, it will likely be the first of many such tiered pricing arrangements. Pfizer and GSK have both expressed interest in future AMCs. Rotavirus vaccines and a still-experimental treatment for malaria are good candidates for future GAVI tie-ups.

Ipsen/GTx: In need of non-dilutive financing after its selective androgen receptor modulator deal with Merck came to an end three weeks ago, GTx this week revised an existing collaboration with Ipsen. It calls for Ipsen to pay GTx $58 million pegged to Phase III trial milestones for toremifene, which is being tested to reduce fractures in prostate cancer patients receiving androgen deprivation therapy. The money will certainly come in handy, but GTx is paying a heavy price. The Memphis firm will forgo some longer-term payments that Ipsen would have owed had toremifene suceeded, as well as right of first negotiation to the Phase II prostate cancer drug, GTx-758. In an interview with 'The Pink Sheet' DAILY, Rodman and Renshaw analyst Simos Simeonidis said GTx "doesn't have a lot of wiggle room right now." That's because toremifene in November garnered a complete response letter from FDA that requested a second Phase III trial to demonstrate efficacy. With just $49 million in the bank and no more money coming from Merck, GTx calculated near-term cash was more important than downstream financial rewards. It's yet another example of the new math being practiced by cash-strapped biotechs.

AstraZeneca/Xenome: On March 23, Australian biotech Xenome announced AstraZeneca's MedImmune exercised its option, originally inked in 2009, to license four peptides designed to hit an undisclosed target involved in a key pain pathway. Financial terms remain confidential, which probably means they're not very lucrative for the privately-held Xenome, which most recently raised money ($6 million) in 2008. To develop its library of 2000 peptides, Xenome turned to Mother Nature for a little help. Its potentially innovative molecules are derived from cone snail venom. Should any of the recently optioned molecules succeed in the clinic, it wouldn't be the first time gastropod poison has yielded fruit -- er, success. Elan already markets Prialt, a drug for managing chronic pain based on the same venom. It's worth noting the deal comes a few weeks after MedImmune's mothership AZ pared its internal R&D efforts in certain CNS areas such as depression and schizophrenia.

Biovail/Cortex Pharmaceuticals: If there's a prize for revamping one's business via dealmaking, we nominate Biovail. On Friday, March 26th, the company announced its eighth transaction since its 2008 decision to become a CNS specialty pharma. Recent examples include the January deal with Amgen around GDNF rights and the tie-up with Alexza for the NDA-filed candidate, AZ004, for agitation associated with schizophrenia or bipolar disorder. Biovail is paying Cortex $9 million upfront for CX717, in Phase II studies as a treatment for respiratory depression, a brain-mediated breathing disorder. The deal also gives Biovail IP and rights to preclinical ampakine compounds. Biovail will likely pay a $1 million near-term milestone and perhaps $15 million more in milestones tied to clinical success and product approval. With AZ004, the Cortex program could add another product to the detail bags of Biovail hospital specialty-focused sales force.

Senate Decides Health Reform Isn't The Time To Have The Viagra Talk

Senate Republicans this week made a vigorous, though as expected unsuccessful, last ditch bid to stall the health care reform package, offering a slew of amendments of the final budget reconciliation piece of the package.

But amidst all the sweeping soliloquies about how health reform will inflict significant damage to the health care system, rest assured that one man, Sen. Tom Coburn, is keeping watch as well on some of the most arcane details.

The Oklahoma Republican offered an amendment March 25 that would restrict sex offenders' access to erectile dysfunction drugs like Viagra. It was one of 40-plus amendments were crafted specifically to make it difficult for Democrats to vote "No."

IN VIVO Blog readers may recall this is not the first time that Coburn has lobbed up an amendment to ward off misspending of health care dollars. When the Senate Health Committee was debate health reform last June, he unveiled a proposal to prevent HHS from using federal funds to sponsor fashion shows intended to raise awareness of health issues.

Now his fiscal conservatism has gone a little more hard core. Coburn's "No Erectile Dysfunction Drugs To Sex Offenders" (Amendment 3556) would prohibit federal payment for Pfizer's Viagra and other ED medications like Lilly's Cialis and Bayer's Levitra for convicted child molesters, rapists, and sex offenders. It also would prohibit coverage of abortion drugs and enact Government Accountability Office recommendations to prevent fraud via insurance claims for prescriptions written by providers who are actually dead or provided to dead patients.

It's hard to argue that sex offenders or dead people need access to ED drugs, but Finance Committee Chairman Max Baucus, D-Mont., called the amendment a "crass political stunt aimed at making 30-second commercials." Health reform "is a serious bill," Baucus said. "This is a serious debate. The amendment offered by the senator from Oklahoma makes a mockery of the Senate, the debate and the American people." The amendment was defeated 57-42.

ED drugs recurringly draw the ire of legislators, who have often prodded the Centers for Medicare & Medicaid Services to limit federal payments for such products. Since 2007, for example, CMS has instructed that such drugs are not covered by Medicare Part D for the treatment of sexual or erectile dysfunction (Pfizer markets Viagra's active ingredient sildenafil under the trade name Revatio for pulmonary arterial hypertension; that type of use is covered).
Part of the problem may be that legislators don't like ED advertisements and often try to curb them. (Alas, no fond memories of Bob Dole's time in office?) Last year, for example, House Democrat Jim Moran introduced legislation that directs the Federal Communications Commission to consider any advertisement for ED treatment or male enhancement as indecent for purposes of broadcasting between 6 a.m. and 10 p.m. Pfizer's current TV ads ask "Isn't it time you had the Viagra talk?

Despite such diversions, the Senate cleared the reconciliation bill later the same day. (For a recap of key pharma provisions, see last week's issue of "The Pink Sheet".) A couple minor education-related provisions were deleted, so the measure will need one final House vote. Meanwhile, we are eager to see what sizzling issues Coburn may similarly detect in upcoming legislative initiatives like financial reform.

- By Lauren Smith

prayer request

I was planning on posting tonight, but it appears I am most definitely getting sick, so I think I'm going to bed early to try to kick it.

I do ask for prayers that Jonah remain healthy. I'm going to wear a mask tomorrow if I'm still feeling bad, but I'm still concerned he's going to catch it. A severe sore throat and congestion could be hard on him, especially on the eating/nutrition front. And although I can do Airborne and Zinc tablets for myself, I can't really do any "virus shortening" stuff for him.

Matt being sick was bad enough, but I don't really have the option of being "hands off" with Jonah.

Thanks :)

Financings of the Fortnight Gets Slightly Ahead of the Curve

The year is nearly one-fourth done. Is it just In Vivo Blog, or is life speeding up? For those with small children and caffeine addictions, the answer is always yes. For makers of innovative biologics, the answer is no -- take your sweet, sweet time. No rush. No pressure. The Congress's gift of 12 years of market exclusivity is the legislative equivalent of a late-night shoulder rub. Or a first date with Scott Brown in pink leather shorts.

Well, no, not with the new senator's aversion to all things HCR. (But we had to sneak that reference in somehow.)

For those raising cash in the biopharma world, life is almost certainly bound to speed up, though our most recent spin through the Elsevier Strategic Transactions Database reminded us not to get too frothy. We don't have official first-quarter data, but here's a sneak preview: as of a few days ago, year-to-date venture funding, follow-on offerings, and PIPEs for biotechs were all tracking behind last year's numbers, despite general signs of economic recovery. Nearly at the one-quarter mark, venture was at 20% of 2009's total, follow-ons were 18%, and PIPEs were 18.5%. Only IPOs were projecting north of last year's numbers, with $350 million already raised, compared to $831 million all of 2009.

What do these data mean? A lively final week of March--March Madness--could put us on pace to match 2009. But in the aggregate, there's no great case yet to make that 2010 is going to be much better than 2009, and for those who barely survived last year, that's cold comfort indeed.

Funny, then, how 2009 on the surface wasn't that bad. Twelve billion dollars of IPO, PIPE, FOPO and venture is higher than the totals raised in 2001, 2002, 2003, 2005 and 2008. Some of that $12 billion is deceptive -- as we've noted, a third of the follow-on cash last year was sucked up by three big issues, Human Genome Sciences, Vertex and Dendreon. And some of 2010's numbers aren't quite what they seem. For example, despite a few IPOs including Aveo Pharmaceuticals, which we'll describe below, no biopharma has filed to go public this year except for BG Medicine, which freshened up an old registration in January. (We hoped for a moment that recent S-1 registrant Eyeblaster was some sort of radical ophthalmology therapy, but alas, it's a digital advertising firm.) In other words, the $350 million raised so far looks nice compared to last year, but there's almost nothing in the pipeline. The S-1 storm at the end of 2009 quickly fizzled.

Perhaps passage of health-care reform will remove enough uncertainty to encourage more filings, but we haven't seen the signs yet. That means IPO financing, which has started the year ahead of the curve, could quickly fall behind the curve.

Which reminds us: Time for more coffee. We're falling behind the caffeine curve. Pull up a chair and we'll pour you a fresh cup of...



Lexicon Pharmaceuticals: Amid a flock of recent follow-on offerings, Lexicon's stood out for both its size--nearly 162 million new shares at $1.15 a share for $181 million raised--and its arrangement. Once again Lexicon, of The Woodlands, Tex., turned to its largest shareholder, Invus Group. Invus, an evergreen fund that avoids club deals, bought a private placement of 65 million shares. Lexicon simultaneously floated a public offering of 96.5 million shares (including the over-allotment) run by Morgan Stanley and JP Morgan Securities. It's an old formula for Lexicon. Last October, it raised $55 million, selling nearly 23 million units to underwriters and 15.4 million to Invus at a price of $1.50. In 2007, Invus pumped $205 million into Lexicon in a warrant-heavy arrangement and took the right to buy up to $345 million more in Lexicon stock. Lexicon, which has four homegrown small-molecule candidates in Phase II, also has a joint-venture-like structure with another private-equity investor, Symphony Capital. For the Mar. 19 issue, $1.15 per-share provided a discount to the $1.54-to-$1.80 range in the weeks prior to the offering. After the offering, the stock fell to $1.20, but shares recovered a bit to close at $1.44 on March 24. -- Joseph Haas

Merck KGaA: As if to underscore German Chancellor Angela Merkel's constant harangue of Greece during the European debt crisis, Germany's Merck KGaA -- the world's oldest drug company -- went out and raised the largest European bond offering this year. Merck issued €3.2 billion ($4.9 billion) in bonds on March 17 to help fund its $7.2 billion acquisition of R&D equipment maker Millipore, announced in February. Bank of America Merrill Lynch, BNP Paribas and Commerzbank led the issue, which was heavily oversubscribed and included 2-, 5- and 10-year notes. The Millipore acquisition was initially funded by cash and a term loan from the three banks, and Merck said at the time it would sell bonds to repay the loan. The bond float reportedly benefited from receding worries about Greece reneging on its sovereign debt and the return of investors’ appetite for riskier corporate debt. But even in the darkest hours of the financial crisis, drug companies have been able to issue debt for strategic financing. Pfizer and the American Merck both sold bonds to fund multibillion dollar takeovers of Wyeth and Schering-Plough. Early in 2009, Amgen and Novartis also raised several billion dollars under reasonable terms. -- John Davis

Rhythm Pharmaceuticals: There were larger venture rounds to choose from, but we're intrigued by Rhythm for a couple reasons. First, it was essentially carved out of the flank of Ipsen, taking its lead candidates, formulation technology, and an equity investment from the French firm. Second, it was incubated in the Boston offices of MPM Capital, which is one of the many VCs in active fund-raising mode. MPM co-led the anticipated $21 million Series A round with New Enterprise Associates. The first tranche of $10 million will go to develop preclinical candidates in-licensed from Ipsen in a deal announced days prior to the Series A. Rhythm has pledged up to $80 million in milestones plus royalties for exclusive global rights to melanocortin and ghrelin analog agonists for metabolic diseases, an area Ipsen says is no longer part of its focus. Rhythm can also use Ipsen’s formulation technology to deliver the peptide therapeutics. Included are BIM28131, with potential in postoperative ileus, diabetic gastroparesis, and cachexia, and BIM22493 for obesity and diabetes. Ipsen also took a 17% stake in Rhythm. The financing is MPM’s third recent investment in metabolic-focused biotechs, showing that not all VCs are eschewing riskier primary care companies despite changing FDA guidelines. In January, the VC led the $35 million B round for Alnara Pharmaceuticals; last year MPM, through its MPM/Novartis venture fund, led Elixir Pharmaceuticals'$12 million Series E round. That particular financing occurred with Novartis' decision to secure an exclusive option to buy the Elixir outright. -- Amanda Micklus

Aveo Pharmaceuticals: The Cambridge, Mass.-based Aveo debuted March 11 after selling 9 million shares at $9 each, as it tried to ride the momentum of lead candidate tivozanib, a small-molecule triple VEGF inhibitor that Aveo licensed in 2007 from Japanese firm Kyowa-Kirin. Tivozanib recently started Phase III trials for renal cell carcinoma. The going-out price was lower than the $13 to $15 range the company first targeted, and it had to sell 2 million more shares. The issue was delayed one day while its bankers scrambled to assemble the book, not surprising in the current environment. The 36% discount was the second-largest among 2010 IPOs, according to Renaissance Capital. The largest was also a biotech, Anthera Pharmaceuticals. Right on Aveo's heels, tissue-repair firm Tengion on Mar. 17 set a target of 4.4 million at $8 to $10 per-share. If Tengion prices, it will be the eighth biopharma to go public since the window re-opened last fall. Given investors' appetite for risk is still tepid, the pricing of Tengion's IPO is a must-watch event. -- Alex Lash

Photo courtesy of flickr user The Wolf.

Termeer Under Pressure, But Consent Decree Could Lift Cloud From Genzyme

It’s been nearly nine months since viral contamination in a bioreactor caused a temporary shutdown of Genzyme’s Allston Landing, Mass., manufacturing plant. And repeatedly, Genzyme’s executives, especially CEO Henri Termeer, have asserted that the company’s problems were fast receding into the rearview window. (Those little bits of rubber from the fill process were just a speed bump.)

But on Tuesday, March 23, the FDA said “not so fast,” informing Genzyme it would take an enforcement action—likely a consent decree—to ensure products made at Allston Landing comply with good manufacturing practices.

Looks like a full stop—at least temporarily--for Genzyme and Henri Termeer, in what has already been a long and winding journey to regain the good graces of investors. Activist shareholder Carl Icahn has been beating the drum of managerial change and in recent months has boosted his ownership of Genzyme stock and advocated that he, Alex Denner, and two other people be nominated to the biotech’s board of directors.

In the wake of this most recent announcement, investors may begin to come round to Icahn’s view point. On March 24th, the day the news broke, investors sold off shares at record pace. Genzyme’s share price slid roughly 6% with more than 14 million shares trading hands. Icahn has until May 20—the date for the biotech’s annual shareholder meeting--to make his pitch and he certainly has a shot at placing his recruits on the board. Unlike Biogen, which has also occupied Icahn lately, all 9 of Genzyme’s board members are up for election annually.

Will Termeer stay or go? Much likely depends on the exact nature of the enforcement action, including the time span of the consent decree and the size of the accompanying financial penalty. In recent months Termeer has taken important steps forward to right Genzyme’s woes, including outsourcing manufacturing to a third party, Hospira, and hiring an experienced quality of control manager, Ron Branning, from Gilead Sciences.

But these steps were clearly not enough to satisfy FDA. In an effort to put the news in the best possible light to investors, Termeer stressed in a conference call that the parameters of the consent decree will be negotiated between the biotech and FDA in the coming weeks and that the agency’s action would pertain only to Allston Landing and the products—Cerezyme, Fabrazyme, and Myozyme--manufactured and/or filled and finished there.

“This is something that always was one of the possibilities -- not something that we were hoping for. And we worked very hard indeed to get beyond this, to be something to expect. It did come, but we are very well prepared,” said Termeer.

But as our sister publication “The Pink Sheet” DAILY points out, pharma companies subject to consent decrees—a group that has included Abbott, Baxter, Lilly, GlaxoSmithKline, and Teva--rarely extricate themselves from oversight quickly. Indeed, according Raghuram Selvaraju, an analyst with Hapoalim Securities, in the past decade, only one company—Vintage—has met all the requirements of a decree to where it has been formally lifted. “Many of the others are still forced to abide by their agreements in totality,” Selvaraju wrote in a same-day note to investors.

And beyond the additional hassle required by third party oversight, there could be significant financial costs associated with the consent decree. Recall in 2002 FDA fined Schering-Plough, now part of Merck, $500 million as part of the consent decree for failing to comply with good manufacturing practices related to the production of its albuterol inhaler products. Beyond that, the agreement specified that FDA could assess royalties up to 24.6% on US net sales on products for which re-validation did not occur within the timelines specified under the decree.

Imagine if a similar agreement were imposed on Cerezyme precisely at a time when the medicine is under pressure from competing products from Shire and Pfizer.

Not everyone agrees the FDA will be so punitive. In a note to investors, Leerink analyst Joshua Schimmer wrote that while Genzyme's "failure to maintain its facility for a prolonged period of time may result in a punitive fine to set a precedent for other biologic manufacturers, we doubt the penalty would be nearly as sizeable" as Schering Plough's. But in what may a telling point for both Termeer and Genzyme, Schimmer went on to write, “That said, this is an area where visibility is poor.” Talk about damning with faint praise.

Paradoxically, the consent decree may actually be a good thing for Genzyme. The company has historically misread cues from regulators, repeatedly reassuring investors that its fixes were more than sufficient to take care of the problems at hand. But with consistent oversight from an unbiased third party, investors can finally have faith in the products manufactured at Allston. As analysts like to say, that ought to reduce the overhang from the stock price.

Will the consent decree lift those same clouds for Termeer? Well, that’s another question entirely.

--Ellen Licking

image from flickr user Grant Palmer Photography used under a creative commons license

New Pfizer BD Chief Peck Talks Consumer Health

Checking in from the Burrill Consumer Digital Health conference near San Francisco this week: Pfizer's new head of worldwide business development Kristin Peck (pictured) was on a panel Monday, which piqued our curiosity: Is this a signal from Pfizer (also a sponsor of the show) that it doesn't want to be left off the Pharma 3.0 map?

You might remember that at our PSO conference in February, Ernst & Young's Carolyn Buck-Luce talked up her firm's vision of Pharma 3.0, complete with a Sims-ish schema of a happy, busy neighborhood of interlinked businesses and organizations. Or, as we're all called these days, "stakeholders."

Microsoft was there. Patient organizations, hospitals, doctors, and insurance companies were there. Drug companies were not there.

Which, perhaps, is why Peck was there, on stage in a hotel under the SFO flight path, before the forever-pink-shirted Steve Burrill, talking about the so-called Pharma 3.0 world and Pfizer's place in it. Through a spokeswoman, Peck declined an interview, so we had to gather our first impressions of her from the fifth row of the ballroom.

Here's one: If Pfizer does deals as fast as Peck talks, there will be little rest for those who write about them. Peck also had a bushelful to say on every topic of the panel, which thankfully was structured as a conversation, not a series of PowerPoint talks. A few of her points:

* The health care reform bill wasn't comprehensive. It was just a step to improve Americans' access to health care, but it doesn't address how to reorganize care or reduce costs.

* Reform was only one step, but adding 30-million-plus Americans to the ranks of the insured might be enough of a shock to the system to prod innovation. The big question: Will the millions of new customers force doctors to embrace innovative changes? Doctors are "a large part of the problem" if they're not driving the change, she said. When a top pharma exec accuses another group of being slow to change, you can't help but raise an eyebrow and jot in the notebook "pot-kettle-black." That said, Peck isn't a pharma lifer. She joined Pfizer in 2004 after a consulting career -- and not just on pharma issues. She has real estate and financial services on her resume, too. In other words, a big change from her predecessor, Bill Ringo, who was at Pfizer only a couple years after nearly three decades at Eli Lilly.

* When fellow panelist and Wellpoint chief technology officer Carl Dumont mentioned an online tool available to Wellpoint customers to help them make health-care decisions, Peck said that if patients can't get access to the tool at the point-of-care -- when doctors are advising (or telling) them what kind of procedures they need -- what good will it do?

* Concentric rings of "community" will drive a lot of consumer adoption of health-related technology. When a person receives a disease diagnosis, for example, which community will he or she share it with? Family? Friends? Bosses and workmates? Other health care providers? How about yoga teachers, acupuncturists, and therapists?

We're watching Pfizer keenly post-Wyeth absorption to see how much of its business development shifts from traditional M&A and licensing to the network of providers, tech firms, patient advocates, and others making patient (or, if you prefer, "consumer") connections. One such deal Pfizer recently struck was with Keas, a provider of online care-plan templates.

No doubt we'll continue to have our hands full with Pfizer's takeovers, buyouts, and Phase II license deals ornamented with upfronts and milestones, but Peck's presence at today's conference could mean we'll soon see a lot more diversity among its BD targets.

don't be hatin'

My heart is kind of beating fast in my chest as I begin to write this post. I don't know why. Well, yes I do. I'm taking my all about Jonah, all about our little life, cute pictures, sweet videos blog somewhere I've never taken it before... into the realm of politics (but not really). I know why I'm nervous. I don't want people to assume things about me or judge me for writing this. I don't want it to change your opinion of me or to make you think badly of me. I don't want those of you who come here just for the cuteness that is Jonah to have to read something you'd rather not. (So stop reading now if you are rolling your eyes.)


And I feel like an idiot for feeling that way, because I know what I am saying is fundamentally right and I feel like God is calling me to write it, so really, nothing else matters. Maybe I'm overreacting anyway. I don't know.


Here it goes.


I support healthcare reform.


(Holds arms up to block fire lit arrows that are careening down upon me.)


This is not a post in support of the new healthcare bill. It is not a post against. It's not about that.


It's not about the bill. It's about some of the extreme attitudes, broad statements, and hate surrounding the bill. I can't stand it. Really, it makes me feel all tight in my chest. I hate the hate. I can't stand it.


I hate the absolute statements that are being thrown around like "government takeover" and "my tax money paying for lazy people who don't want to work" and "conspiracy."


I know that people have concerns about many things - more government control, the manner the votes were obtained, tax increases on the wealthy, the effect on insurance premium rates, the possibility of waiting lists etc. I don't want to argue those points. That is not the point of this post.


The point is I hate the hatemongering. I hate the lies (or twisting and stretching of truths) to make people hate. Did I mention I hate it?


The truth (in our situation) is this:


Not all people who need government assistance are lazy people who don't want to work. I had to give up my job (and my health insurance) to stay home with Jonah. Not because I'm lazy and don't want to work but because I have to take care of him. My circumstances require me to stay at home. Jonah is on Matt's insurance. We decided not to put me on his plan because it was going to be way too expensive. So I now I pay for a sub-standard plan out of pocket and have a $5,000 deductible before it kicks in. Jonah FINALLY qualified for Medicaid after eight months of us jumping through hoops and struggling to pay our bills. And that is WITH insurance. If it hadn't been for donations from people who, for whatever reason, love us and care for us and for the help of generous family members, we could have very easily gotten in trouble (or had to sell our house) while we waited.


What if Jonah hadn't qualified? What if Matt were to lose his job? What if we couldn't pay the COBRA payments (which are RIDICULOUSLY high) and Jonah had a lapse in coverage? What if the next insurance company wouldn't accept him because he has a preexisting condition? What would we do?


I am very thankful for government involvement.


If it weren't for government assistance, Jonah wouldn't have a nutritionist, an occupational therapist, or a physical therapist. (Well, he probably would but we would be in very bad shape financially.) Jonah qualifies for those programs. We receive them for free. I am thankful for them. Jonah has Medicaid that covers our copays and prescriptions. I am thankful.


I am thankful that he won't be denied because of his preexisting condition.


Many of the families who need help are like us - forced out of work because of circumstances beyond their control - just trying to take care of their kids, their families, just trying to survive the hand they've been dealt. Many of them are not as fortunate as Matt and I are to have the resources and knowledge to apply for help in the first place. Many of them do not have family or friends making donations to help them get by. We are so blessed. We are the fortunate ones.


So please, before you make blanket statements about the people who are receiving the benefits of your tax dollars, think about situations like ours. It is so hard. And you just don't know until you've been there. (I definitely know that people DO take advantage and there are things about the system that are VERY messed up, so you don't need to argue that point. Believe me, I know.)


For me, it boils down to this. I want to be compassionate. I want the hatemongering to STOP. I want the fear tactics to cease. I want people to stop being so prideful long enough to listen to each other. I think Jesus calls us to take care of the sick, the hurting, and the poor. I think he calls for us to pray for our government and our leaders, whether we fully agree with them or not.


Whatever comes from all of this, whatever it entails, God knew it before it happened. He will carry us through it. It is not, unless he has planned it to be so, the end the world. And if it is, then I'm one step closer to seeing Jesus and my baby Gabe.


We need to discuss, listen, share, have open minds, but most of all LOVE. Nothing else really matters.


Try to see some good in things, even if you don't agree with all of it. And please, for the love of God (really), stop with the hate already.


It's making me sick.
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On a much lighter note, Matt's mom kept Jonah this morning so I could get my hair cut today, I went to my first therapy session, and my mom kept Jonah tonight so Matt and I could go out to eat.

I got spoiled!

Here's my new do.

(Sorry for the dramatic sassy face look. It wasn't my intention... I just felt like a doofus smiling at my own cell phone.)

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I'm cutting the comments off now before things get uglier. I was so encouraged by the positive sharing of views and LOVING tone of everything at the beginning, but OF COURSE it had to get nasty toward the end. That is so frustrating, guys. Really. I'm disappointed. If you can't say things in a loving way, just keep your mouth shut. This was a post on NOT hating. I guess I should have known though. Oh well. Thank you to the 98% of you who were loving and kind. I know you are in the majority.