Thursday, September 30, 2010

cutie in a high chair

I know I have some explaining to do... or at least some explaining I want to do, but not tonight. Tonight, I'm tired. 

I'll just leave you with this cutie patootie (who happens to be lookin' a little cross-eyed in this pic)...



He has croup again or at least a rough cold. We're watching him close, but trying not to do the steroids if we can help it (seeing as how they made him Grouchy McFussy Pants the last time). He felt warm to me tonight but wouldn't allow me to take his temperature so I just don't know. He's so mucusy and gaggy and coughing so much that he's puked his lunch and dinner. Pedialyte in the pump tonight. Poor buddy. It's hard when they feel extra crummy and you can't do anything about it. 


He's still really cute though.

Tuesday, September 28, 2010

being intentional

I'm feeling God asking me to blog less and make time with Him a priority. For Him. For myself. For my marriage. So I'll be blogging some, but it will probably be even less than it is now... for a while anyway. Please bear with me and keep checking back.


I have to be intentional and MAKE time or it won't happen. And I really need/want it to happen. I want God and Matt to stop getting my leftovers. I know you understand.

Sunday, September 26, 2010

our weekend and also, i still hate computers

We've had a good weekend. On Friday, my best good friend from college, Katie, and her two sweet girls came for a spontaneous visit. (I called Katie on Thursday, told her how much I missed her, asked her what she was doing the next day, and she rescheduled an appointment and came! Good friend. :) ) We had a great day, and in the afternoon, after the kids' naps and Jonah's lunch tube feed, we went to an adorable bakery in our cute downtown for cupcakes, then to a gift shop (mistake: that was breakables central... luckily our kids didn't break, but it was stressful), and then to the public library. It was Jonah's first trip to the library (and my first one to the library in our town - three years... shameful), and he had a great time. He played with one of those big wooden cube toys that has a different activity on each side and then sat in a big boy chair and worked on puzzles. He was so cute and had a blast! He really was a joy the whole time. And I can't tell you how much I love Katie and how great it is to spend time with her. She's one of those friends you just pick up right where you left off with, tell each other exactly how you feel or what you're thinking, and it's completely okay.


Then, on Saturday, Matt hung with Jonah for about four hours while I went shopping... for me! I had a great time, and it was so nice to get to browse and actually try things on. I met Kathryn at Marshall's and we had a good time getting to hang out for a little bit. They were remodeling though, so Kathryn and I had to share a TINY dressing room, and there was only one mirror for all of the three dressing rooms, so that part was a little inconvenient. When I went back a second time to try on pants, I just went to a back corner and tried my stuff on. I don't know about you other moms out there, but since I've pushed two kids out of my hoo-ha, I don't have the same view of modesty I used to have. My how life changes.


Saturday night, Matt and I went with our neighbor friends, Eric and Barbara, to a local church that is offering marriage talks combined with dance lessons. We had a great time and learned to T-A-N-G-O. We have three weeks left, and we'll learn more Tango and then have two weeks of Salsa. We had a great time, and I think it was really good for our marriage. Learning to let Matt lead is a good lesson for me. I'm sort of a control freak... in case you didn't know.


This morning, we made it to church and then just kind of hung around here this afternoon. It was the first day cool enough for Jonah to be outside, but it was pouring down rain, so we were still trapped inside. It's okay though because this week is supposed to be MUCH cooler and I think the rain is supposed to be gone by Tuesday! HOORAY FOR FALL!


I took some photos today. I downloaded the trial version of Lightroom but after importing the photos, even though I can see them right there in front of me, it says the photos are "offline or missing." I can see them but it won't let me edit them. Very frustrating. It has been a really crappy technology week for me. So I'm going to post unedited photos. And I don't like doing it, but I won't withhold the Jonah cuteness from you any longer... so here he is... in all his unedited glory. :)


UPDATE: I figured out Lightroom and edited them. I couldn't help it. It's a sickness really.















Friday, September 24, 2010

Deals of the Week Meets "The Outlier"


This statement may amuse you, coming on the heels of Abbott's mind-boggling $450 million up-front payment to license ex-US rights to Reata's bardoxolone in chronic kidney disease: in 2010, alliance upfronts are declining.

Reata's upfront haul is surely a giant among men (more on the deal below). But a look at all alliances signed by the industry's larger companies (big pharma, big biotech, large Japanese and European co's, and spec pharmas) over the past four years show that not only are alliance upfronts decreasing, but fewer deals are being signed overall (approximately 20% fewer).

We presented the chart below at this week's Pharmaceutical Strategic Alliances meeting in NYC, as part of a dealmaking overview. The data (which are through August 2010) suggest that at least in terms of deals where financials were disclosed, pharma is becoming more cost-conscious. This isn't really a surprise -- we're seeing more option-alliances and earn-out heavy acquisitions than ever before, and payments on the front end are bound to suffer.

But Reata's impressive terms around bardoxolone again show that there will always be assets that cause a stir, and a bidding war, and a blogger to exclaim 'holy crap that's a lot of money!' Reata retains sole possession of bardoxolone's US rights and will fund its Phase III development itself. Even so, this cash should allow it plenty of breathing room to get through NDA filing and -- if all goes well -- toward a US launch.



Abbott/Reata: Upfront payments on licensing deals have trended downward lately, but Abbott Laboratories is headed full-steam in the opposite direction. Abbott made an enormous $450 million upfront commitment to Reata Pharmaceuticals’ Phase II renal disease candidate bardoxolone methyl. It's the largest upfront ever for a Phase II product, especially given the deal is only for ex-US rights. (It also doesn't include rights in certain Asian countries that Reata has already partnered away.) Milestone payments could add $350 million to the deal, plus Reata gets royalties on sales in Abbott’s territories. Bardoxolone, an antioxidant inflammation inhibitor, has shown promise as a potential disease-modifying drug that can reverse the effects of chronic kidney disease; Reata is preparing to present Phase IIb data at the American Society of Nephrology conference in November. A Phase III trial in the coming months will further study bardoxolone's effect on glomerular filtration rate, the amount of filtered fluid passing through the kidney per unit of time. Abbott also took a minority equity stake in Reata, whose backers include Cardinal Investment's CPMG, Novo A/S, and Texas firms Ojai Goliad and StarTech Ventures. Abbott already markets Zemplar, a hyperparathyroidism treatment for renal patients, in 24 countries. As Abbott tries to move itself away from its dependence on the TNF-alpha drug Humira, it's been opening its checkbook, especially for early and mid-stage assets. Recall late in 2009, it spent $170 million to acquire PanGenetics' Phase I NGF inhibitor; in March the big pharma paid a 61% premium to purchase Facet Biotech, a PDL Biotech spin-off, developing the Phase II multiple sclerosis drug daclizumab; this past June the company spent $75 million to in-license Neurocrine Biosciences' Phase IIb gonadotropin-releasing hormone (GnRH) antagonists for women's and men's health. And don't forget the purchase of Piramal's health care solutions biz for $2.12 billion upfront and another $1.6 billion over the course of four years to establish a significant beachhead in India.--Paul Bonanos

GlaxoSmithKline/Dendreon:It may be a happy problem for a young company launching its first product to have: Demand for the new prostate cancer therapeutic vaccine Provenge is likely to exceed supply, and the company that makes the drug, Dendreon, has limited production capacity. Dendreon is a small biotech, after all, and its ability to ramp up and manage the supply of Provenge has been a serious concern for patients and investors since the vaccine launched in May. In response, the Seattle-based biotech has turned to a big pharma, GlaxoSmithKline. According to a Securities & Exchange Commission report filed on Sept. 21, the companies signed a development and supply agreement September 15, in which GSK will supply the antigen used to make Provenge to Dendreon. (Okay, so technically this is a deal of last week.)The first supplies are slated for delivery in August 2011. Sales of Provenge, which Dendreon launched last spring, were $5.2 million in July and $2.45 million in June.--Wendy Diller

Warner Chilcott/Novartis: Warner Chilcott took full control of the U.S. sales and marketing of Novartis’ overactive bladder drug Enablex (darifenacin) in a $400 million deal announced Friday September 24. The Irish specialty pharma already had a co-promotion agreement with Novartis for the drug, but scrapped that alliance and replaced it with the new one. Warner Chilcott had obtained some rights to Enablex through its $3.1 billion acquisition of Procter & Gamble’s prescription drug business in August 2009; P&G had shared promotion of Enablex with Novartis since 2005. Recall Novartis acquired the drug from Pfizer in 2003. In 2009, Enablex sales in the U.S. were $190 million, of which Warner Chilcott was entitled to a share; it also incurred advertising, promotion and selling costs for the drug. Under the new agreement, Warner Chilcott will take full responsibility for sales and marketing of Enablex in the U.S., and will assume control of its manufacturing within three years. A milestone payment could add $20 million more to the new deal as well.--PB

Novartis/Alnylam: In our “no deal” of the week, Alnylam announced Sept. 23 that Novartis has selected a “full and final list” of 31 targets for which it will seek to develop RNAi drugs based on Alnylam intellectual property. That decision brings an end to a five-year partnership in which the two companies worked together to identify and advance RNAi therapeutics for a range of undisclosed indications. Concurrently, Novartis also declined to exercise an adoption license for Alnylam’s RNAi technology platform, which would have brought the biotech an additional $100 million. According to Alnylam CEO John Maraganore during a Sept. 24 investor call, Novartis determined that the 31 programs it will undertake at the Novartis Institutes for Biomedical Research will keep it plenty busy for next several years. To date, the five-year collaboration has brought Alnylam about $125 million in proceeds, both in the form of research funding and equity investments – Novartis currently holds a 13.4% ownership stake in the biotech. The partnership also funded about 25 full-time equivalents annually, Maraganore said. With the partnership’s expiration Oct. 12, Alnylam plans to reduce its workforce by 25% to 30%, he said, enabling the company to position itself for “continued growth, success and focus on the highest value activities.”—Joseph Haas

Thursday, September 23, 2010

fall questions

Katherine tagged me to do these Fall Questions, and since I don't have anything else to blog about, and certainly not any photos to post (grrrr...), I'm happy to oblige.


1. Do you like Starbucks? And are you a fan of their seasonal coffees?
I like Starbucks for hot chocolate and sweet treats (I've decided I'm going to say "sweet treat" now instead of "dessert." Somehow it lessens the guilt factor.) I would like to be a grown up and say that I enjoy a cup of coffee (or a glass of wine) now and again. But it would be a lie. I have the beverage maturity of a four year old.

2. How do you decorate and prepare for Fall?
I bought a fall type wreath last year and put out some pumpkins and mums. I also noticed that the produce market near my house has some kind of  large corn stalks/husk thingies, and I thought they looked pretty neat. Maybe they are for sale? Maybe I will buy them. I'm so excited about Fall and The Holidays, I may be out of control. I never got excited about the holiday season as an adult, but then Jonah was born, and everything changed. I just want to make it wonderful for him. Did I mention I'm excited?

3. Will you participate in your college's homecoming activities? 
No, but we really miss Greenville and East Carolina, and I've already thought how fun it would be to go to an ECU game. We do hope to make it to Greenville sometime soon, but no football or collegey activities for us. Maybe next year. 

4. What is your favorite Fall clothing item or accessory?
In my head, I'm definitely a fashion and accessories sort of person (all of a sudden), but in my reality, I hate everything in my closet. I have a dark green blouse/shirt I really like that I wear with a long necklace. I love how people layer shirts and dresses and coats and scarves with leggings and boots etc. I, unfortunately, have no vision, no style talent, and no money to shop. It's a great combination.

5. What was your favorite Halloween costume as a kid?
This is going to sound really lame, but I have a TERRIBLE memory. I don't remember 90% of my Halloween costumes. I think I was Rainbow Brite one year. And Little Red Riding Hood another year. Mostly I just remember that I usually had homemade costumes instead of store bought, and I'm so thankful for that. My mom did such a good job of coming up with great costumes. If Jonah has a costume at all, it will most likely be store bought. I'm a Halloween failure. 


6. Do you like Halloween/Horror movies? Do you have a favorite?
No way, man. I HATE feeling scared. I have had more than enough sadness and fear in my life to last a lifetime. I have no desire to feel terrified. I actually don't really get why people like that. 

7. What is your favorite Fall activity?
Probably just getting to (FINALLY) be outside. Last Fall, we went to the fair and to a pumpkin patch, and we had a great time. I hope to do those two again this year, and I also want to get to the zoo and/or a petting zoo. Jonah is getting into his animal sounds, and although he knows what they say, he has no idea what a cow, monkey, or duck actually is. 


8. What is your favorite Fall recipe?
Probably stuff that OTHER people make. I'm not so much of a baker, although I'd like to be. I like everything about eating and especially Thanksgiving eating, so it's all good to me. When it comes to food, I'm not hard to please. 

And then she added eight more quickie questions, and here they are:

1. What movie coming out soon are you looking forward to seeing? 
Secretariat

2. What will you miss most about Summer?
Nothing. It was miserable. I'm glad it's over.


3. When do you start your holiday shopping? 
Rarely ever before December 1st. I want to be one of those people who looks for good deals throughout the year and comes up with the perfect gift for everyone on my list, but that never happens. It always turns out okay though, so I don't stress about it too much.


4. Favorite exercise/activity?
Anything but the Elliptical. I hate the Elliptical. Evil Machine. Evil, evil machine.

5. Best book you've read lately?
I finished The Help and loved it. Right now I'm reading The Wednesday Sisters and I'm loving it too. 

6. Do you make your bed every day?
Yes. For now. After Gabe died, I couldn't leave the house, sometimes the bedroom, without making the bed. I had never been a regular bed maker before then. It was really strange.  Then, when Jonah was born, I rarely made the bed. I rarely put on real clothes before 4 pm. Now, I'm a little more stable and making the bed again. Who knows how long it will last? You didn't realize this was such a deep question, did you? 

7. If you could choose a personal chef or a personal shopper, which would you choose?
Personal chef. I want to do my shopping myself. Can I have a personal chef and a shopping fund? Yes, I choose that.

8. Which TV show are you most excited for this Fall?
I'm most excited about Glee, but we've started watching Modern Family and Parenthood this season, and I really like those too. 

Okay, that's it. Feel free to tag yo' self.

Financings of the Fortnight Checks Out Big Rounds in the Big Apple


Even in good times it's not easy for a private biotech to take its lead compound to market all by itself. These dreary days, it's rarer than an empty cab in the Midtown rain. That's a New York reference, pal. It's PSA week, whaddya expect?

Despite all the distractions, like the perfect weather and giant slices of pizza everywhere, we couldn't help but notice when this fortnight brought us not one but two venture-backed firms whose investors are doubling down to get their protégés through Phase III.

Bully for them, we say, if they can get through registrational trials without a Big Pharma partner. At that point, Big Pharma partners hungry for near-market pipeline assets won't have a choice but to lavish riches upon them, right? Well....that's what we used to say about getting to a Phase II/proof of concept milestone. Now we're hearing things like this: "How do VCs fund all of these companies to Phase III, which seems to be the stage that Big Pharma is comfortable with?" That's what Quaker BioVentures founding partner Brenda Gavin told START-UP recently.

Let's not make too much fuss about two biotech fundings -- and we'll get to them in a moment -- but it's hard to ignore the larger context: Of the many biotech-focused venture funds running out of gas, not all are likely to re-up. So our first instinct was to wonder who's behind these whopping late-stage rounds that are designed to push a biotech's lead asset through Phase III. Are they the product of VCs rolling the dice one last time on portfolio companies that represent their best chance to get out with a bang?

So far, no. As you'll see below, one recipient of generous funds, Relypsa, tapped returning investors to help push its potassium-binding agent through Phase III. But the round was led by new investor OrbiMed Advisors, a firm flush with newly-raised cash. The second recipient profiled below, the German firm immatics biotechnologies (which we assume can now afford to buy some upper-case letters) turned to existing European investors for about half its new round. But one returning investor -- indeed, the one that remains its largest shareholder -- is dievini Hopp BioTech holding (again with the lower case!), which invests the cash of billionaire Dietmar Hopp, founder of software giant SAP and probably not among the biotech funds running out of gas.

An interesting side note: immatics CEO Paul Higham told our Pink Sheet colleagues that his efforts to raise cash from US investors earlier this year ran into reluctance to commit large sums, especially for a cancer immunotherapy based in Europe focused on renal cell carcinoma. (Those conversations took place before Dendreon's Provenge approval, Higham said.) Another interesting side note: Strategic Transactions tells us the three largest drug-related venture rounds so far this year are all European companies: Archimedes ($100 M), AiCuris ($75 M), and now immatics ($71 M).

Is there anything to the Eurocentric bent of these rounds? It's not as if optimism is brimming across the pond. A survey of VC attitudes released in June revealed just as much gloom in Europe as in the US, with hope for venture expansion pointed more toward emerging markets.
If you're keeping tabs, by the way, another recipient of funds earmarked for a late-stage push is Calistoga Pharmaceuticals, the Seattle firm working on isoform-selective PI3 kinase inhibitors. Its $40 million Series C round in June will fund a registrational program for its unpartnered lead CAL-101 and other clinical work, and the startup recently brought on board Pharmacia and PTC Therapeutics veteran Langdon Miller as executive VP of R&D to oversee the work, but CEO Carol Gallagher told us this week the money won't get them to NDA.

We all need a push every so often to get to our destinations. Which reminds us, the traffic outside our 44th St. hotel is a nightmare, so it's time to shut our laptops, duck into the subway, and get on board another installment of....


Relypsa: Doing its part to get a US biotech on the list of top fundraisers, Relypsa said September 13 investors had committed to a $70 million Series B round to help the firm push its potassium binder RLY-5016 into Phase III. Relypsa president Gerrit Klaerner said the firm can run the trial itself, with plans to reduce recruitment needs by incorporating Phase II data into the trial design. '5016 is a binding polymer that stays in the gastrointestinal tract and absorbs excess potassium, a potentially deadly condition. One application Klaerner would like to address is patients who would otherwise might have to avoid angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) to lower blood pressure, as these drugs can have the side of effect of releasing potassium into the blood stream. An acute buildup of potassium is called hyperkalemia and can lead to arrythmia or cardiac arrest. OrbiMed Advisors led the round, but it also included investors who backed Relypsa's predecessor, Ilypsa, which Amgen bought in 2007 for $420 million for its lead compound, a phosphate binder for chronic kidney disease patients. To create Relypsa, Amgen spun out the rest of Ilypsa's assets to the same management team. -- A.L.

immatics biotechnologies: Developers of cancer immunotherapies have attracted renewed interest from investors and big pharma since the US approval of Dendreon’s Provenge in April. But German biotech immatics biotechnologies says it had plenty of investor interest from its own countrymen before Dendreon's success, leading to a Series C funding round of $71 million (€54 million). Immatics’ technology is markedly different from Dendreon’s, however, as it's based on administering the same combination of chemically synthesized, tumor-associated peptides to each patient with a particular cancer. The skill is in identifying antigenic peptides that actually induce a strong immune response, said immatics executives. The financing will fund a Phase III clinical trial of immatics’ lead therapeutic vaccine in renal cell carcinoma. Approximately half of immatics new funds came from existing investors including dievini Hopp Biotech holdings and Wellington Partners. New investors were venture capital funds advised by MIG Verwaltungs AG and AT Impf GmbH. The latter is owned by the Strüngmann brothers, who co-founded the German generics company Hexal, before selling it some years ago to the Swiss generics-and-original-research combo, Novartis. -- John Davis

Addex Pharmaceuticals: Addex raised CHF 20 million ($20 million) in a combined registered direct offering and debt transaction with Biotechnology Value Fund. Announced Sept. 15, the deal was structured as 593,567 new registered shares in Addex for CHF 6 million and the issuance of six-month mandatory convertible notes for CHF 14 million. The transaction was priced at $10.18 a share, a 12 percent premium over Addex’s volume weighted average share price during the five trading days prior to Sept. 14. Upon closing, BVF will own 9% of Addex’s outstanding shares, while the convertible notes will become 1,371,069 new shares on March 14, 2011, representing 17% of the firm’s outstanding shares. It comes a week after Addex landed a $900,000 grant from the Michael J. Fox Foundation to help finance a Phase II study of lead compound ADX48621 in Parkinson’s dyskinesia. Addex says the BVF cash infusion will give it runway into 2012 and help it advance several programs, including '621, while leaving it less vulnerable to another stock price decline should one of its programs disappoint. BVF was able to buy into the Swiss company at a bargain price because of last December’s failure of gastroesophageal reflux disorder and migraine candidate ADX11059, which resulted in Addex’s share price tumbling by about 75%. -- Joseph Haas

Anacor Pharmaceuticals: Just as it's pulled in a $15 million milestone from GlaxoSmithKline in connection with a 2007 option deal to develop an antibiotic based on its boron chemistry platform, Anacor has decided to try again for an initial public offering. On Sept. 10, the Palo Alto, Calif. biotech filed its S-1 with $86 million as its placeholder until it determines price range and share volume. In August 2007, Anacor filed to go public with a goal of raising up to $57.7 million then withdrew in December 2008 due to unfavorable market conditions, though it's worth noting it had plenty of time to make its issue before the financial tsunami struck. As part of the 2007 collaboration with GSK, the pharma committed to invest $10 million in a future private placement, which it did in January 2009. Schering-Plough also invested in that private placement as part of a 2007 licensing deal for a topical antifungal, but S-P isn't listed in the S-1 as one of Anacor’s principal stockholders. Anacor says it has raised $88 million in equity capital since its inception in 2002. In addition to advancing its pipeline of five clinical candidates, Anacor presumably will use the proceeds to cash out its equity investors, which include Rho Ventures (25.5%), Venrock Associates (16.1%), Care Capital (12.4%) and Aberdare Ventures (11.5%), along with GSK (14%). Anacor plans to begin a Phase III program for lead program AN2690 in onychomycosis in the fourth quarter of this year. -- J.H.

Photo courtesy flickr user Adrian8_8.

Avandia Decision Today; Steve Nissen Thinks It Will Stay on the Market

Word is that US and European regulators will make separate announcements shortly about the future of Avandia. The status of GlaxoSmithKline's former blockbuster diabetes drug is once again under review, thanks to concerns about a potential increased risk of heart attacks compared to other treatment options.

What will the decision be?

Cleveland Clinic cardiologist Steve Nissen, MD, thinks he knows the answer: FDA will leave rosiglitazone on the market.

That, to put it mildly, isn’t what Nissen thinks FDA should do. But, he tells us, that is what he now believes FDA will do.

One clear sign that FDA is likely to save Avandia, Nissen says, is the agency’s recent red flag for its thiazolidinedione competitor, Eli Lilly & Co.’s pioglitazone (Actos).

FDA announced on September 17 that it had commenced a safety review of Actos after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer. The agency did note that the review is ongoing and it has not concluded that Actos increases the risk of bladder cancer.

Nissen calls FDA’s analysis “barely statistically significant” for what is essentially a small subgroup of individuals. The Actos review, Nissen says, is a “smokescreen designed and timed to keep rosiglitzone on the market.” (For coverage of the warning, click here).

Indeed, the timing of the Actos safety update is fortuitous for GSK. A key piece of the argument for pulling Avandia is the availability of a “safer” alternative, Actos. However, it would certainly be an odd decision for the agency to pull one product due to a potential increase in cardiovascular risk and recommend use of alternative that may or may not have an increased risk of bladder cancer.

Nissen, of course, has led the calls for Avandia’s withdrawal, and he is convinced that the agency’s actions with the product reflect ongoing challenges with handling post-marketing safety issues. In his view, it basically comes down to how FDA reacts to challenges from outside—and, by implication, the need for change in the drug center management.

[Editor’s Note: Nissen will expand on his views about the decision-making at FDA during The RPM Report’s FDA/CMS Summit for Biopharma Executives in Washington DC Dec. 9-10. For more information or to register, click here.]

Kate Rawson

Notes From PSA: More on Lilly's Next Project Financing Project


If at first your project financing doesn't succeed, try try again. That was the message during a panel discussion at our (20th Anniversary) Pharmaceutical Strategic Alliances conference in NYC on Wednesday. The topic of conversation was deal structures for high-risk, high-reward projects, which screamed for analysis of the 2008 three-party deal to finance two of Eli Lilly's late-stage Alzheimer drugs.

Private equity firm TPG-Axon Capital and CRO Quintiles Transnational put up much of the cash, with Quintiles running the Phase III trials. The structure is still in place for one of the compounds, solanezumab, but the other, the gamma-secretase inhibitor semagacestat, is no longer in development.

We should amend our opening statement: The deal has succeeded for Lilly in the sense that someone else helped pay for development of a drug that failed (or, at least, is currently on the shelf). Lilly senior vice president Gino Santini and Quintiles senior vice president Tom Perkins, both on the panel, said everyone knew from the start that the risk-reward calculation for Alzheimer's was high on both counts. "We went in with our eyes wide open," said Perkins.

The deal turned out to be a true product of its time, announced just two months before Lehman Brothers imploded, and cheap, leverageable private equity suddenly became a distant dream. "I don't know that we could attract capital of that size for a project of that risk profile if we went out looking today," said Perkins.

Then again, the lure of reaching the brass ring in Alzheimer's has proved over and again to be awfully tempting. Just ask Lundbeck (Flurizan, ouch), Pfizer (Dimebon -- not a happy result), and J&J (bapineuzumab -- jury's still out).

Meanwhile, Lilly keeps plugging away at project finance models. Its latest, reported in part a couple weeks ago, centers around three venture funds that Lilly is backing, putting up just shy of 20% of each fund's capital, up to $50 million in each. Lilly will be the only biopharma LP in each fund.

One will be reportedly run by CMEA Ventures in San Francisco, which Lilly officials haven't disputed; one we hear by a well-established firm in Cambridge, Mass.; and the third remains a mystery. The final two funds haven't closed yet. Lilly is also offering a portfolio of its pipeline compounds to each fund manager. They can choose from Lilly's basket or from outside opportunities. Santini said today the mix of compounds in each fund should be 50/50. Lilly gets call options on all its own molecules and on one of five sourced externally. For the calls it exercises, Lilly must pay "fair market value," though it's unclear how independently that value will be determined. The funds can also use Lilly's Chorus development team -- or teams, as the company has two in Indianapolis, one in India and could add a fourth in Europe -- to run the development.

Santini said the one general partner up and running has already chosen one Lilly molecule and one third-party molecule.

Various attempts at project financing haven't turned out very well so far, but the promise of newly freed assets, released by Big Pharma mergers and downsizing, has kept the dream alive. And we emphasize dream -- the next wave of funds mostly remain behind the scenes, as their founders scramble to convince investors to join. (We examined the dream of asset financing, and the difficulties it faces, in this feature.)

Wednesday, September 22, 2010

sometimes computers bite!

So...

My hard drive is toast. They were not able to recover anything. I've had myself a couple good cries over it today, but I'm trying to look on the bright side - I do have the best of my photos on the blog, so if nothing else, I can save the blog versions. They probably won't be great quality, but at least they're there.

Y'all, if you do not somehow back up your stuff, or at least your photos, please don't be stupid like I was. A few of my albums are on Shutterfly (my brother says I can get the high res versions back), Facebook (low res), and the blog (not really sure what quality I can recover). But I lost TONS of my photos. We don't have the disks for Microsoft Office 2007, Photoshop, and I lost all of my actions I bought in Jonah's Auction for Photoshop... not to mention all the documents and spreadsheets and videos (oh, the videos!!!) I lost. Most of Jonah's last ten months are gone, as far as having the original versions of things. It will take me hours (days, weeks!) to get back what I've lost, and even then, it will only be partial recovery. I am heartbroken. :(

Anyway, starting right now, I'm backing everything up. My brother (my go-to on all things computer) says he uses Dropbox. It's free for a basic account (2 GB), but you can earn more space by referring others or you can pay to upgrade (a monthly fee). Basically, you sign up for a free account, download it, and it puts a little blue folder icon on your taskbar. Then, I think it's as easy as drag and drop to back up your stuff. I don't want this to ever happen again. It's horrible.

Anyway, click HERE if you are interested in Dropbox. It's my referral code and I will earn some extra space if you go through me. Or you can just go to http://dropbox.com to sign up. Don't be an idiot! (You know, like some people I know... ahem.)

Tuesday, September 21, 2010

computer troubles

This will be short because I'm typing on the Dell, and we're still having the text jumping issues and sporadic functionality of the letter "x."

I didn't think about it when my computer messed up, but Matt reminded me that I had dropped it in an attempt to plug it in the day before. We don't know what's wrong with it, but it's possible I've lost everything. Some of my photos are backed up on Shutterfly and Facebook, but not close to all of them. The person we got the computer from had loaded Photoshop CS3 on it, so it's possible we've lost that (and all of my Totally Rad Actions that I won at Jonah's EB Auction) too. I'm not panicking yet. I'll just wait and see what they say. 

Okay, I can't take this anymore. The cursor has jumped about twenty times since I started typing these three paragraphs. I feel like I've been a very uninteresting and mediocre blogger lately, so maybe you can consider this break a gift from me to you. Maybe I'll get inspired during my time off. And hopefully I'll have a computer to actually blog on here in a few days. Please be patient with me.

Jonah's doing well overall. His face, though, is banged up, and he took some skin off his chin in a 2 inch fall today. His lips  are our main issue. Between a couple of random blisters he got there last week and the spill he took over the weekend, they are both scabbed, constantly reopening and bleeding, and not able to heal. I LOVE that he's learning to cruise and take some (majorly) assisted steps, but it is a very scary time. I gasp about fifty times a day. And you can baby proof till you're blue in the face, but even rubbing, in a fall, against soft things is still rubbing. But I'm just so thankful for this milestone because I had no idea if he'd ever make it. I just pray for him, protection, resilience, and perseverance. I don't want him to get discouraged.

Okay, really can't take the jumpy cursor anymore. I'll catch you guys on the flip side.

Comparative Effectiveness Research: PCORI Looks to UCLA's Washington

The Patient-Centered Outcomes Research Institute (PCORI) is beginning to take shape.


The PCORI board is expected to be announced by the Government Accountability Office on September 23.


Our understanding is that UCLA's Eugene Washington will be named the Chairman of the PCORI board. Washington is Vice Chancellor of UCLA Health Sciences and Dean of the David Geffen School of Medicine. Prior to joining UCLA this year, Washington was at the University of California San Francisco, where he was Executive Vice Chancellor and Provost. To read more about Washington, click here.


To view PhRMA's list of PCORI board nominees, click here.


Monday, September 20, 2010

and the winner is...

I was going to announce the winner of the Target Card giveaway, along with cheesy photos of my old-school (folded up pieces of paper in a bowl) way of choosing a winner, BUT...

My computer seems to be toast. I have gotten both the black and blue screens of death. I may be out of commission for a while.

In the meantime, as boring as this is to JUST say...

The winner of the gift card is Pamela at trooppetrie. Congrats! Email me so I know where to send it.

Thanks to those of you who donated, even if you didn't leave a comment about it (very sneaky). You're the best!

Saturday, September 18, 2010

today

Thanks to those of you who voted for Chris's Dare to raise money for USeb. I know several of you donated but didn't include your name in the comments. Thank you to you too. From those who did leave a comment, I'll pick a winner tomorrow.
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We haven't done much today. Jonah took a pretty good spill this afternoon and hit his gums, lips, and one cheek on the bottom corner of our TV stand. I was right there, saw it happening, and just couldn't get my hands around him in time. He cried. I cried. He bled. His cheek, upper gums and inner and outer upper lip are very swollen and blistered. He won't let me look at it. He acts okay though, so we'll just see how it's doing in the morning. This learning to stand/walk is such a scary stage. I don't think this fall would have hurt a non-EB child very much at all. He's so brave though. I took him out on the deck to get him calmed down and he was attempting to blow bubbles and mooing again within ten minutes. He's my hero.

I've been distracted this week from my book and Bible reading and worship, so I'm headed to do that now. I am constantly amazed at how I put everything else first, even when I KNOW what I should/want to do and what God desires from me. For what I want to do I do not do, but what I hate, I do... For I have the desire to do what is good, but I cannot carry it out. For what I do is not the good I want to do; no, the evil I do not want to do—this I keep on doing. Now if I do what I do not want to do, it is no longer I who do it, but it is sin living in me that does it. Satan knows when you are on the brink of coming Home. But I won't be stopped. Tonight, we regroup. :)

I have a little speaking part up on stage (in front of two to three hundred people) tomorrow. Nervous would be an understatement. But I'm confident that God will give me the words (that I've supposedly memorized) and give me the peace to get through it. I'm excited about the new series coming up, which is something along the lines of honestly talking to God. I gotta say, it may hit a little too close to home. Bring it on.

Friday, September 17, 2010

last couple days

We've had a pretty good last couple of days. Jonah has been in a great mood, today especially. I'm so thankful to have had a better week this week than last week.

Jonah playin' some tunes.

Jonah and Emma, the girl next door (or two doors down, but who's counting?).

Yesterday we went with Emma and her Mommy to the new produce market down the street and to Target. Then they were able to stay and hang out with us for dinner. Today, we went and visited some friends who are in town from Michigan. No big plans for tomorrow except for steaming and blending baby food. Good times.
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I've recently been sent several emails about two little boys who have EB and need some help.

Click HERE to read about Carson (you have to scroll down about half way). He is up for adoption, living in an orphanage in Eastern Europe (I believe). He has EB and is not getting the care he needs.

Click HERE to read about Robert. He is a one month old in Uganda. His parents brought him to a 21 year old missionary's door for help. After a quick google search, they took him to the hospital. It has been confirmed that he has EB.

I can't imagine having an EB child in a place without the proper supplies and support. It's heartbreaking.

DotW Contemplates the Beginning of the End for Genzyme


The biggest deal of the week wasn't a chart-topper just because of its size. It was also likely the tip of a much larger iceberg.

We're talking about Genzyme's sale of its genetic testing unit to Lab Corp. for $925 million. Combined with 1,000 layoffs at the big bio, the spinout of the unit -- at a price 30% to 40% higher than at least one analyst expected -- could be a big step toward getting Genzyme ready for a sale. It comes a year and a half after serious manufacturing problems at a Boston-area plant were first disclosed in early 2009, an event that opened top executives to criticism from tub-thumping shareholders.

Now, our chilly choice of metaphor a few sentences ago might lead you to think that anyone steaming toward a rendez-vous with Genzymic destiny could be making a mistake of Titanic proportions. You, dear reader, must let your powers of speculation be your guide. We're certainly not ones to scream at Chris Viehbacher to pull hard alee, or astern, or throttle the jibbers, or whatever you're supposed to say to a ship's captain who needs a course correction, fast. Sanofi has offered $69-a-share, but it could take an offer of $75-a-share to bring Genzyme to the negotiating table, analysts told our Pink Sheet colleagues this week.

Viebacher doesn't seem ready to rush headlong into anything, let alone a $18.5 billion disaster. After all, Genzyme is less an iceberg -- although you have to wonder if other manufacturing nightmares still lurk beneath the surface -- than a collection of islands, which like the Galapagos, have inhabitants that have evolved quite separately, and in some cases, more successfully than others. (We leave it to you to sort out the finches from the tortoises and figure out what the hell to do with the feral goats.)

The sale of the genetics business, combined with the planned sale of the diagnostics and pharmaceutical intermediaries units, don't automatically point Genzyme toward M&A. Nor do the layoffs. The Cambridge, Mass. biotech has plenty of reasons to shift resources around, whether it's hiring more in manufacturing to shore up quality control or amassing cash for a share buyback. The firm raised debt this summer to fund the first tranche of the buyback, and the Genetics unit sale will pay for the second tranche, Genzyme said. But CEO Henri Termeer has publicly said there's a "high probability" of a deal with Sanofi, so every move Genzyme makes from now on must be viewed in that context.

For Sanofi, the sell-off of Genetics and the other two businesses would make for a cleaner eventual acquisition of Genzyme, but otherwise shouldn't make much difference, as they're tangential to the French pharma's interests. Sanofi is willing to wait. Viehbacher said as much at a conference this week: "I don't think they are in a hurry and neither are we in hurry. I don't see anybody else coming into the deal, so that's not pushing anybody in terms of speed."

The wild cards, of course, are the shareholders. Viehbacher spent last week meeting with Genzyme's. Termeer has said his board, which includes dissident investors who agitated their way into the boardroom, is adamantly opposed to the current offer at $69 a share. And don't forget Sanofi's shareholders, which include French corporate titans L'Oreal, the cosmetics company, and the oil firm Total. They haven't revolted, but it seems they're casting a wary eye on the proceedings.

Viehbacher has already served notice early in his term that he'll only appease shareholders so much -- dividends yes, buybacks no -- so how he handles the Genzyme situation, given his previous pledges of no purchases over $20 billion, could be the defining moment of his tenure.

Same goes for Termeer, who was on the buying end of many acquisitions as he built Genzyme over twenty five years into the powerful but hodgy-podgy (or, if you prefer, "diversified") business it is today. He may well come to the end of his term as the big biotech's mastermind, even if Sanofi bows out. Should a deal not transpire (we'll keep the "NO DEAL!" JPEG warm), Genzyme's share price will likely sink back to the pre bear-hug level of the low $50s. With the activist shareholder presence on Genzyme's board, does anyone really believe Termeer can keep his post if the deal doesn't get done?

AstraZeneca/University College London and Cancer Research Technology: AstraZeneca this week revealed a pair of new arrangements to advance its stem-cell research targeting blindness related to diabetes and, separately, its oncology program. The Big Pharma said it will collaborate with researchers at University College London, led by Dr. Marcus Fruttiger, in a three-year partnership to explore uses of regenerative medicine to address diabetic retinopathy, a leading cause of blindness which afflicts about a quarter of Type I and more than half of Type II diabetes patients. The collaboration echoes Pfizer’s ophthalmological research deal with UCL, in which the two are searching for new therapies for age-related macular degeneration. AstraZeneca also said UK-based charity Cancer Research UK and its partner Cancer Research Technology would perform a Phase I/IIb clinical trial on oncology candidate AZD-3965, an inhibitor of the monocarboxylate transporter 1 (MCT1) that is crucial for cell metabolism. Once the trial is completed, AstraZeneca will retain a right to further develop the drug, or offer it to CRT to seek a different partner; the charity will receive a royalty on the drug’s revenues if it’s ever approved, regardless of which company develops it further. -- Paul Bonanos

Merck/Beijing Genomics Institute: With the president of Merck Research Laboratories Peter Kim in attendance, the Beijing Genomics Institute this week announced the signing of a statement of intent to form a working relationship with Merck. The organizations aim to utilize BGI’s high-throughput DNA sequencing and analysis capabilities in a research collaboration, primarily to analyze genomic and epigenetic data generated using Merck samples. “The key is epigenetics,” said one person familiar with the discussions. The deal comes at a time when several US-based next-generation sequencing companies are trying to establish a foothold in drug discovery, including current IPO hopefuls Complete Genomics and Pacific Biosciences, while also aiming at the more lucrative clinical diagnostics market down the road. At the same time, academic genome sequencing centers are operating more frequently as businesses, competing with commercial entities in terms of cost, throughput, and accuracy. For its part, BGI currently boasts a combined sequencing and bioinformatics staff of just under 4000, including 1500 bioinformaticians, and it expects to boost the overall number to 5000 by year-end. Given the scale and complexity of genetic information and the speed at which it is being obtained, a relationship with BGI could offer significant advantages, including on the regulatory front. “From the patient standpoint, we risk getting scooped by others outside this country, whether we are then sending the results to BGI in China to be interpreted or some other offshore thing,” cautions one CSO. -- Mark Ratner

GenMab/Seattle Genetics: The Danish firm GenMab has licensed Seattle Genetic's antibody-drug conjugate (ADC) platform to use with its own HuMax-TF antibody technology to develop drugs that target the Tissue Factor antigen. GenMab is responsible for all research, manufacturing, preclinical development and Phase I trials of ADCs that combine the two technologies. At the end of Phase I, Seattle Genetics has the right to opt into co-development and share all costs and profits fifty-fifty. If Seattle Genetics does not opt into a compound, GenMab would pay fees, milestones, and single-digit royalties on worldwide net sales. GenMab is paying Seattle Genetics an undisclosed upfront fee. The Seattle, WA-based biotech's ADC technology links cell-killing agents to antibodies to deliver precise payloads to tumor cells while leaving, in theory, healthy cells undisturbed. Its molecules have yet to reach FDA approval, but its lead, brentuximab vedotin, is in Phase III for Hodgkin lymphoma. The collaboration comes as GenMab shifts development focus on its flagship anti-CD20 product Arzerra (ofatumumab) to subcutaneous autoimmune indications. More accurately, GenMab's partner GlaxoSmithKline will make the shift, as it holds development rights to the compound. The partners amended in July their long-running collaboration to give GSK the autoimmune rights, a move that paid GenMab £90 M at the forfeit of development milestones. GenMab still helps pay for oncology development, but its contribution is capped at £145 M total. -- Alex Lash

Santarus/Pharming Group: Faced with a cash squeeze, Dutch protein therapeutics developer Pharming Group inked a deal with San Diego-based Santarus to license Pharming’s late-stage orphan drug Rhucin (conestat alfa) in North America. Santarus will obtain rights to Rhucin, a recombinant human C1 inhibitor which alleviates swelling related to hereditary angioedema, for $15 million up front, plus $5 million if and when the FDA grants approval of the drug’s biologic license application. Further milestones, including ones based on sales goals, are also built into the agreement. Pharming will still be in charge of obtaining approval of the BLA in the U.S., while Santarus will address regulatory hurdles in Canada and Mexico. In April, Pharming dealt away Rhucin’s distribution rights in 24 European countries to Swedish Orphan Biovitrum for an undisclosed amount. The upfront payment will help Pharming deal with a cash flow crunch due to a bond debt payment owed in the fall. Separately, Santarus said it had obtained Covella Pharmaceuticals and its anti-VLA-1 antibody program for $1.8 million plus royalties, future considerations and other expenses; that deal also includes an amended agreement with Biogen Idec, from which Covella licensed the program in January 2009. -- Paul Bonanos

Johnson & Johnson/Crucell: The far-flung Johnson & Johnson health care empire may be adding a vaccines unit as J&J bid €1.75 billion (about $2.3 billion) to buy Crucell NV on Sept. 17. The pharma giant said that if the deal goes through, Crucell would continue to operate as a subsidiary, retaining its facilities, ongoing programs, senior management and its “entrepreneurial culture that has fostered innovation and growth.” J&J’s bid works out to roughly €24.75 per outstanding share of the Netherlands-based vaccine maker, nearly a 58% premium over the closing price of €15.70-a-share on Sept. 17. Recall that in September 2009, J&J acquired a 17.9% stake in Crucell for €301.8 million, a 28% premium, in a transaction that also partners the two companies on an effort to develop a universal monoclonal antibody against all types of influenza A. That deal included a standstill agreement specifying that J&J would not attempt to increase its holding in Crucell for at least three years, but the acquisition bid is going forward as a mutual effort between the two companies. In a joint release, the companies indicated J&J’s board of directors and Crucell’s supervisory board have authorized the negotiations to proceed. This is not the first time a big pharma company has tried to acquire Crucell--Wyeth made a bid estimated at €1.35 billion in early 2009 but dropped the effort when it was bought out by Pfizer.--Joseph Haas

Photo courtesy of Flickr user Rob Lee.


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