We've set up a single page where you can vote on M&A, Financing, and Alliance of the Year. Polls open til January 7. Good luck to the nominees! VOTE HERE.
Showing posts with label polls. Show all posts
Showing posts with label polls. Show all posts
Tuesday, December 24, 2013
Three Polls, One Page: Vote for IVBs Deals of the Year
Monday, December 23, 2013
And the Nominees for IVB's 2013 M&A of the Year Are ...
We've nominated five 2013 Deals for M&A of the Year. It's time for you, esteemed readers of The In Vivo Blog, to decide the winner. It's an eclectic bunch this year -- we can't wait to see what you'll choose. Our polls will stay open through the New Year, until Noon ET on Tuesday, January 7. Good luck to the nominees! VOTE BELOW! IF YOU ARE VIEWING VIA EMAIL AND CAN'T SEE THE POLL, CLICK HERE.
Valeant/B&L: The May 2013 deal was a big win for private equity owners Warburg Pincus. It put some extra shine on the reputation of then-B&L CEO Brent Saunders, who has moved on to Forest to work his Hassanian brand of turnaround-magic in the world of primary care. And it again highlighted ophthalmology -- and B&L's diversified pharma/device/consumer approach to the field -- as an industry hotspot. But the main reason we've nominated Valeant/B&L for the M&A Roger this year is that it underscores the increased activity on the big deal front of specialty pharma over its supposedly deeper pocketed Big Pharma rivals. Read the full nomination here.
McKesson/Celesio: McKesson’s purchase of German drug wholesaler Celesio for $8.3 billion is one of the largest deals of 2013, but that is not what puts it on the In Vivo Blog Deal of the Year map. More to the point, and the reason it should be on the radar of everyone in the biopharma industry, is its likely impact on pharma and the drivers that led it to consolidate in the first place. Although the deal focuses on distribution and supply chain management, some of the duller aspects of an industry prone to flaunt its contribution to saving lives, it is every bit just as important to pharma’s health as the next big deal in cancer immunotherapy. Read the full nomination here.
Amgen/Onyx: Onyx serves as a leg up for Amgen as it looks to establish itself as a major oncology innovator and bring forward a pipeline of oncology drugs it has cobbled together partly through acquisitions. Despite the possibility of drama, the deal wound up as a straightforward acquisition that hedges risk for the buyer and still rewards the seller, one where the purchase price, at $125 per share, meets a middle ground. Read the full nomination here.
The Ibrutinib Royalty: Royalty deals have long been the provenance of more conservative private-equity vehicles. And so it was odd not just to see two venture firms join the royalty deal but also to hear how much each was putting up. Aisling Capital and Clarus Ventures said in August they had paid $48.5 million to acquire a tiny slice of sales royalties from ibrutinib, a cancer drug that hadn't been approved yet. Read the full nomination here.
And The Nominees for IVB's 2013 Financing of the Year Are ...
We've nominated six 2013 deals for Financing of the Year. It's time for you, esteemed readers of The In Vivo Blog, to decide the winner. From Series A to IPO, from twinkle-in-the-eye science to Phase III drug candidate, we've got it all. Our polls will stay open through the New Year, until Noon ET on Tuesday, January 7. Good luck to the nominees! VOTE BELOW! IF YOU ARE VIEWING VIA EMAIL AND CAN'T SEE THE POLL, CLICK HERE.
Ophthotech's IPO: In a year filled with impressive public market debuts when public market debuts of biotechs were one of *the* top stories, Ophthotech's IPO hauled in $192 million and rightfully sits atop a heap of newly public biotech offerings. And Ophthotech might need every bit of that cash, and maybe more, for an ambitious Phase III program. Read the full nomination here.
Editas' Series A: Polaris, Third Rock, and Flagship more often than not will work in stealth on new potential breakthrough technologies on their own. Not the case with Editas, where the trio have teamed up to turn one of the hottest research tools around into a new wave of therapeutics. One might call it gene therapy, version 2.0: the technology known as CRISPR/Cas9 allows researchers working with cells or model organisms to delete genes or replace them with new ones, but in ways considered more precise than other gene-editing systems currently in use. Read the full nomination here.
Google backs Calico: Just Google, Art Levinson, and a small handful of drug discovery and development luminaries getting together to combat diseases of aging. Anyone else out there planning to 'solve death'? Read the full nomination here.
CHOP backs Spark Therapeutics: Spark sprung nearly fully formed (with a Phase III asset) from CHOP this year, with $50 million in funding. That's enough to carry its lead program to market, a gene therapy for an inherited form of blindness. In doing so it is riding a wave of recent high-profile investment in gene therapy. Read the full nomination here.
Juno Therapeutics' Series A: Juno unites researchers from three different institutions: Fred Hutchinson Cancer Center and the Seattle Children’s Research Institute in Seattle, and Memorial Sloan-Kettering Cancer Center in New York to pursue multiple avenues of cancer immunotherapy, and its $120 million Series A instantly sets the Seattle-based company up to become a major player in the rapidly evolving sector. Read the full nomination here.
GSK/Avalon Ventures: Pharma needs innovative pipeline candidates. VCs need faster, cheaper and easier exits. The partnership between Avalon Ventures and GlaxoSmithKline aims to accomplish both. The model sees up to $30 million from Avalon and up to $465 million from GSK come together to fund up to 10 new companies, each built around a single drug candidate. Read the full nomination here.
And the Nominees for IVB's 2013 Alliance of the Year Are ...
We've nominated five 2013 deals for Alliance of the Year. It's time for you, esteemed readers of The In Vivo Blog, to decide the winner. From medication adherence to geographic diversity to hot new technologies, there's something for everyone. Our polls will stay open through the New Year, until Noon ET on Tuesday, January 7. Good luck to the nominees! VOTE BELOW! IF YOU ARE VIEWING VIA EMAIL AND CAN'T SEE THE POLL, CLICK HERE.
GSK/Community Care of North Carolina: The deal may seem like a small marketing alliance between a big pharma company and a local provider of health care services in the medication adherence arena. But in reality it is much, much more. The alliance tackles critical challenges that are clearly on top of executives’ minds, in pharma and elsewhere in the health care system. Given the difficulties of closing deals between a pharma company and non-traditional commercial partners, notably like providers or payers, GSK certainly has pulled off a coup.Read the full nomination here.
Celgene/Oncomed: The deal once again put Celgene at the forefront of early-stage oncology dealmaking and added to the already impressive smorgasbord of drug candidates and technologies to which it holds rights or options. This is not to say the complicated deal with OncoMed was business as usual, for it was one of the most complicated agreements of the year in biopharmaceuticals, necessitating a term sheet that might have resembled a Rube Goldberg machine, and quite lucrative for OncoMed -- potentially very lucrative. Read the full nomination here.
Roche/Polyphor: Roche has given notice that it’s back in the antimicrobials space. For the first time in 30 years. Roche and Polyphor believe the timing of their alliance is good. Others have cut back, including onetime leader Pfizer, which closed its antibiotic R&D center in Connecticut in 2011, as well as Bristol-Myers Squibb Co. and Eli Lilly & Co., leaving only a few players, such as AstraZeneca, GlaxoSmithKline and Merck & Co. Read the full nomination here.
AstraZeneca/Moderna: Shortly after unveiling a revised R&D strategy and organizational restructuring, AstraZeneca made a massive bet on an early-stage platform that suggested the big pharma has taken to heart new CEO Pascal Soriot’s directive to be more willing to embrace risk. The deal boasts $240 million upfront from AstraZeneca to privately held Moderna Therapeutics and is unusually broad-based, carrying options for up to 40 programs in different therapeutic areas using the biotech's messenger RNA (mRNA) technology. Read the full nomination here.
Thursday, December 27, 2012
Thursday, December 20, 2012
Monday, January 02, 2012
A Reminder: Vote for Our Deals of the Year!
Click HERE to vote in our DOTY polls (make sure to vote in all three!), which will stay open until 3pm ET on January 4th.
Thursday, December 22, 2011
IVB's 2011 Deals of the Year: Vote Here!
Please vote, tell your friends, families, colleagues and pets to vote. (But resist the urge to vote seventeen times, we rely on your discretion.)
Thanks for participating, and we look forward to crowning our new DOTY winners in two weeks.
We've relocated the polls to make them easier to view: CLICK HERE TO GO TO THE VOTING BOOTH
Wednesday, September 09, 2009
Is There a Drug Lag? Polls NOW Open
Apologies to all who tried to vote in our poll on the so-called "drug lag" between the US and FDA. The link in our email yesterday was incorrect. Fraud? Ballot box stuffing? No. Typo? Yes.
Here is the correct link to the poll: http://answers.polldaddy.com/poll/1955904/
And here is the original post (with the poll embedded).
Friday, March 06, 2009
Roche Raises Genentech Bid to $93/share
Up, down, now up again! ... what's next IN VIVO Blog faithful? Take a minute to vote before commencing your weekends:
(email subscribers, click here to vote!)
Monday, January 26, 2009
IN VIVO Blog Poll: Immediate Reaction to Pfizer/Wyeth
Pfizer is buying Wyeth for $68 billion. Are there any winners in this monster deal, the largest in the industry since the 2000 formation of GSK?
There will be time for reflection and analysis in the coming days, weeks and months. But what's your immediate reaction? Is Pfizer smart to bulk up and diversify on top of its recent re-alignment? Does the deal position the combination for success as it approaches the Lipitor patent expiration? Are Wyeth and its shareholders getting a good deal?
We'll leave this poll open for 48 hours. We realize the answers below aren't very nuanced, but pick one that you most agree with. (Email subscribers--click here to take the poll.)
Tuesday, January 06, 2009
And the DOTY Goes To ... Alnylam/Takeda
The illustrious academy of IN VIVO Blog readers has spoken. And the Deal Of The Year bragging rights goes to ... Alnylam Pharmaceuticals' RNA interference alliance with Takeda Pharmaceuticals!
More than 2500 votes were cast in our inaugural competition and Alnylam/Takeda led the polling from start to finish. To be sure, there was rationale to vote for any of the nominees--that is, after all, why we chose the wide variety of deals we did: each was impressive, groundbreaking, interesting in its own way, and almost always illustrating an important trend in business development, regulation, or corporate strategy.
Before we say a few words about the winning Alnylam/Takeda deal, let us say a few words about some deals that weren't recognized with a nomination in this year's DOTY (the Dotties?).
First: Roche/Genentech. We struggled with this deal, which surely would have been competitive had it been nominated. Why wasn't it? Well, it's not quite a deal yet, is it? Good luck in 2009, R/G. You've inspired so many other deals through the years--including Infinity/Purdue/Mundipharma, which we were sure would have done better in the polling--and you may yet get your chance to shine in a future Dotties competition.
Others have quibbled with the omission of Lilly's acquisition of Imclone, to which we say that all the drama doesn't catapult it over what we felt was a better example of the big-oncology-acquisition-trend: Takeda/Millennium. Lilly/Imclone had the added twist of a successful shareholder activist calling the shots, and the third party billion-dollar winner in BMS, but we went with Tak/Millennium and believe that the results of the poll support that decision. (click the image below for full results)
On to the award. We've discussed the case for this alliance already: In these cash-constrained times, the deal allows Alnylam to end the year with approximately $500 million in cash and sets the RNAi pioneer up for pipeline building down the road. It makes Takeda the sole big RNAi player in Japan and cements the Japanese pharma's place among the most active and creative dealmakers of 2008. The full pitch is here.
Unlike this deal, the 2008 DOTY award isn't non-exclusive. We can't award it again next week or next month. Congratulations to Takeda (surely the Deal-Maker of the year by our poll results) for having a hand in more than 50% of the votes. And congratulations to Alnylam, who we're hoping will now share some of its beer. We've invited Alnylam to represent this deal and provide an acceptance speech of sorts, which will appear on the blog later this week.
And now, back to your regularly scheduled programming!
Monday, January 05, 2009
While You Were Waiting for the Polls to Close
Welcome back to your workaday life, readers, and Happy New Year. As we look ahead to 2009 lets not forget to wrap up those loose ends from 2008--a year that saw, global financial meltdown, the Phillies win the World Series, an exciting US presidential election, and, of course, IN VIVO Blog's first Deals of the Year competition. You have one more day to vote! We'll announce the winner tomorrow.
With nearly 1200 votes cast so far, Alnylam's RNAi deal with Takeda remains comfortably ahead with 38%. Other deals in double-digits are Vertex's sale of the royalty stream from its HIV protease inhibitors (13%), Genzyme's mipomersen deal with Isis (13%), and Takeda's acquisition of Millennium (21%). But where's the love for Infinity/Purdue? Where's the respect for FDA's forced label changes to Aranesp? Where are our partisan readers from Pfizer, GSK, Novartis, Lilly, or Congress for that matter?
If we hadn't already dragged this thing out milked this thing for two weeks set down the rules in stone, we'd be tempted to do a run-off between the top two or three deals. But there will be no run off, folks. The clock is ticking.
Welcome back to work everyone. First order of business? Get thee to the ballot box.
Monday, December 29, 2008
Have You Voted?
Voting for IN VIVO Blog's Deal of the Year continues, and with about 800 votes cast so far, Alnylam/Takeda is maintaining a pretty comfortable lead with 39% of the vote (not Eagles-over-Cowboys 44-6 comfortable, but still). But there's plenty of time left!
Click here to review the nominees and vote for IN VIVO Blog's Deal of the Year.
The poll remains open until January 6th.
Monday, December 22, 2008
And the Nominees for IN VIVO Blog's DEAL OF THE YEAR Are ...
It's time to have your say, IN VIVO Blog readers! Our poll for the Deal of the Year is now live. (Email subscribers: if you don't see the poll below, visit the blog's home page to vote.) Please vote. Get your friends and colleagues and families to vote. Tell strangers to vote too, if you like.
Below are the list of nominees, a Baker's Dozen in no particular order, followed by the poll. The poll will be open until January 6th, when we'll announce the winner. Write-ins are acceptable, just post them in the comments and we'll tally them up as well. We'll occasionally re-post this list as a reminder over the next two weeks when otherwise IN VIVO Blog posting will be in a light, holiday-hibernation mode.
Good luck to all the nominees and see you in the New Year!
Lilly/TPG-Axon/NovaQuest: In July, Lilly announced an agreement with TPG-Axon Capital and Quintiles Transnational Corp.'s NovaQuest partnering group under which Lilly's partners will pay up to $325 million in development funding for its two lead Alzheimer's disease compounds, a gamma secretase inhibitor and an A-beta antibody, each ready to begin Phase III testing.
Genzyme/Isis: Genzyme, allegedly up against ten other bidders, agreed to pay $325 million up front (including $150 million for shares, at roughly double the price they are today) and over $800 million in development and regulatory milestones for mipomersen, a Phase III, once weekly injectable that targets low-density lipoprotein (LDL).
Takeda/Millennium: Takeda's purchase of Millennium shows the determination of Japanese pharmaceutical companies to morph into global players on the biopharmaceutical industry stage.
Infinity/Purdue & Mundipharma: In return for what could be nearly 38% of its stock and the vast majority – ex-US – of its pipeline, Infinity bought probably five years of freedom from worrying about Wall Street -- enough money for both its discovery and clinical programs -- while retaining, like Genentech, the entire US market in which to create a commercial presence.
Overprotecting Therapeutic Classes In Medicare: When Congress “codified” the CMS policy on protected drug classes over the summer, it sounded like no big deal. But instead of adopting CMS’ language stipulating the classes, Congress instead gave CMS the authority to define any classes as protected. And it also made it much more onerous for CMS to create exceptions to those protections within classes.
Alnylam/Takeda: In these cash-constrained times, the deal allows Alnylam to end the year with approximately $500 million in cash and sets the RNAi pioneer up for pipeline building down the road. It makes Takeda the sole big RNAi player in Japan and cements the Japanese pharma's place among the most active and creative dealmakers of 2008.
Pfizer/Ranbaxy: In an era when product expirations – either through the lifting of exclusivity or the weight of safety problems--seem more common than product launches, this deal is an example of how big pharma can try to take its primary care jumbo jets in for soft landings.
Novartis/Alcon: Novartis is trying to minimize the problems of a pharmaceutical company managing a device business in part through the structure of its acquisition of a majority stake in Alcon. Novartis is merely investing in the company (starting out with a 25% stake -- for $11 billion -- with a plan to increase it, sometime between 2010 and 2011, to 76%, for no more than an additional $28 billion).
Vertex/Undisclosed Investors: This is the best example we can think of from 2008 of a phenomenon that will surely gather steam as biotech firms search around for non-dilutive sources of capital: Vertex's June 2008 sale of the royalty stream on its HIV protease inhibitors (which are marketed by GSK) to a group of undisclosed investors.
FDA/Amgen: The Aranesp relabeling was the the first (and, so far, only) time FDA has used its new power to order sponsors to make specific labeling to changes. FDA gained that with the enactment of the FDA Amendments Act in 2007. So far, the agency has invoked the mandatory labeling authority seven times, but in each of the other cases the sponsor (or sponsors) has agreed to the change. But not with Aranesp.
GSK/Actelion: Actelion’s worldwide licensing deal with GlaxoSmithKline for Phase III sleep drug almorexant is one of those rare (and post-crisis, even rarer) partnerships where the biotech calls the shots. And where Big Pharma is very happy for biotech to call the shots because a) it keeps risk under control and b)—here’s the good bit--it’s picking up a tip or two on the way about how to run R&D.
Daiichi/Ranbaxy: What is surprising about the Daiichi/Ranbaxy deal is that Daiichi chose to invest in a company focused primarily on generics and geographically situated in an emerging market. While India is undoubtedly an important arena, companies such as Takeda, Astellas, and Eisai have focused their efforts on building a US presence, especially in oncology.
GSK/Sirtris: Sirtris' acquisition demonstrates the sometimes astounding value ascribed to target-specific platforms and underscores Big Pharma's interest in accessing en masse technologies and human resources that may allow them to leap forward rapidly.
pre-doctored image from flickr user David Ortmann used under a creative commons license.
(Final) Deals of the Year Nominee: Lilly/TPG-Axon/NovaQuest
Ah, awards season. Why should film critics have all the fun? And voting! It's not just for presidential elections. This year your IN VIVO Blog team is nominating a handful of alliances, acquisitions, financings, regulatory negotiations and legislative compromises in our First Annual DOTY competition. And then you, dear readers, will vote (early and often, we hope) for the winner. Imaginary federal and international biopharmaceutical statutes prohibit us from awarding a monetary prize. But our winners, when they die, on their deathbeds, they will receive total consciousness. So they've got that going for them, which is nice.Aaand, last but not least: It's not just cash-poor biotech firms that need the occasional helping hand to finance their drug development efforts. Even for the likes of Eli Lilly (and, say, Bristol-Myers, which has blazed this particular trail among larger companies), hedging pre-market risk is part of the game plan when cash is becoming more expensive and clinical development and regulatory affairs more uncertain.
In July, Lilly announced an agreement with TPG-Axon Capital and Quintiles Transnational Corp.'s NovaQuest partnering group under which Lilly's partners will pay up to $325 million in development funding for its two lead Alzheimer's disease compounds, a gamma secretase inhibitor and an A-beta antibody, each ready to begin Phase III testing.
In exchange, TPG (which provides the bulk of the capital) and NovaQuest (10% of the funding and strategic development advice) will receive success-based milestone payments and mid-to-high-single-digit royalties on future sales of the two compounds. Quintiles CRO arm will act under a traditional fee-for-service contract. Finally, to sweeten the deal and hedge the risk shouldered by TPG and NovaQuest, those partners will also receive an additional undisclosed royalty on a third, unidentified product that Lilly has out-licensed to a third party. (See our coverage of the deal here.)
Not to show you how the sausage is made, but there was some internal dispute here at IVB over what this deal signifies within pharma, if not its overall importance.
See, on one hand, the deal is forward-thinking and increasingly necessary in a difficult R&D climate; with the cost of capital increasing even for the likes of Lilly and its Big Pharma brethren it allows Lilly the flexibility to take multiple shots on goal in Alzheimer's or other diseases. It's also the first publicly announced deal (we've heard rumors of deals signed but still private) in which a private equity player takes a big financing role in a Big Pharma's development program -- something they've done in small and mid-sized companies (e.g., Symphony Capital) but which Big Pharma has always shunned.
There will now likely be further variations on this theme: former AstraZeneca CFO, now Goldman-Sachs partner Jon Symonds says he's working on putting together a pool of PE capital for developing Phase I and II Big Pharma (and maybe other) compounds, which could be pulled together as soon as January. That structure, incidentally, addresses one of the big problems for PE players (and probably one of the big sticking points of the Lilly/TPG negotiations, which apparently took about a year and a half): how do you put together a marketbasket of enough develop-able compounds to offset the awful odds facing any single on of them. The drug company wants to put as few as possible in the basket; the PE investor wants as many as it can get.
On the other hand, there is something odd about offering deal-of-the-year honors to a Big Pharma company for creative financing to mitigate risk during the year when a lot of people who are supposed to be the experts in this kind of thing are bankrupt, unemployed--or begging the taxpayers for assistance.
And it is especially odd, given that (as we wrote here) Lilly is a model of a Big Pharma company that is focusing on innovative products--rather than diversifying into OTCs or related business like some of its peers. The logic of focusing--that investors want to diversify for themselves, rather than turn their money over to Novartis management to diversify for them--seems to apply here too. Shouldn't Lilly's investors just hedge for themselves, rather than have Lilly management do it for them?
Still, everyone agrees that the deal allows Lilly to shed risk (in return for a smaller reward) in this notoriously difficult therapeutic space in a creative transaction that could prove to be a model for private equity/pharma deals going forward. It's just that we don't agree about whether that's a GOOD THING.
So there you have it--your last IN VIVO Blog Deals of the Year! Nominee. Got it in just under the wire. Why Lilly/TPG/NovaQuest? For the new-model dealmaking, for the sexy private equity angle. For the Controversy!
We'll see you later, at the ballot box.
image by flickr user jacob.theo used under a creative commons license.
Thursday, December 18, 2008
Deals of the Year Nominee: Infinity & Purdue/Mundipharma
Ah, awards season. Why should film critics have all the fun? And voting! It's not just for presidential elections. This year your IN VIVO Blog team is nominating a handful of alliances, acquisitions, financings, regulatory negotiations and legislative compromises in our First Annual DOTY competition. And then you, dear readers, will vote (early and often, we hope) for the winner. Imaginary federal and international biopharmaceutical statutes prohibit us from awarding a monetary prize. But our winners, when they die, on their deathbeds, they will receive total consciousness. So they've got that going for them, which is nice.
Absent irrationally exuberant markets or dilution-friendly capital structures like the R&D Limited Partnerships and SWORDS of the 1980s, it’s virtually impossible to build a self-sustaining biotech without a Big Brother, contends Infinity CEO Steve Holtzman.
There’s thus a certain satisfying continuity in the fact that just a few months after Roche decided to end the most successful Big Brother relationship in pharmaceutical history by bidding to buy out Genentech, Infinity signed the latest incarnation of that legendary idea: a tie-up with the two Sackler-family owned private companies, US-focused Purdue Pharma and European-focused Mundipharma (see the transaction record here and our “Pink Sheet Daily” write-up here).
In return for what could be nearly 38% of its stock and the vast majority – ex-US – of its pipeline, Infinity bought probably five years of freedom from worrying about Wall Street -- enough money for both its discovery and clinical programs -- while retaining, like Genentech, the entire US market in which to create a commercial presence.
The most advanced compound in this enterprise: Infinity’s Phase I hedgehog cell-signaling pathway inhibitor, originally developed in a deal with MedImmune, then returned following MedImmune’s acquisition by AstraZeneca, which was developing a competing hedgehog program. (A few weeks after it signed the Purdue/Mundipharma deal, Infinity improved its position even more by bringing back from AZ its latest stage program, the Phase III injectable HSP-90 inhibitor IPI-504, as well as that drug’s younger brother, a Phase I oral compound, IPI-493 – drugs to which Infinity now owns all rights.)
But we don’t expect this deal to be much copied. The spec-pharmas Purdue and Mundipharma have no discovery programs to protect and Mundipharma has only a single cancer product in its portfolio: there should be no significant jealousies from internal R&D; no desire to interfere. Indeed, the deal is specifically not a collaboration, Infinity CSO Julian Adams points out: as Genentech has been with Roche, Infinity will remain a completely separate operation from its new affiliate.
That’s a rare situation for most companies that can afford a deal of this size (up to $75 million in equity by early 2009; another $200-400 million in R&D support; and a potential $72.5 - $100 million in warranty conversions). Indeed, one reason Roche is buying out Genentech is because it feels it can now do pretty much what Genentech can do – so why pay the royalties and other costs of maintaining an independent R&D and commercial infrastructure? Moreover, the Sacklers have no need to show investors regular profit growth – at Purdue and Mundipharma, they’re the only investors that matter, and they’d prefer the tax breaks from the R&D expense to a nicely upward sloping EPS line.
That’s because the Sacklers know Purdue is living on borrowed time. It was granted an almost magical but limited-term respite from generic attack after first losing exclusivity on its most important product, Oxycontin, and then regaining it in an utterly unexpected judicial reversal of the original ruling (See an in-depth “Pink Sheet” review here). But the drug will go generic again – no later, and possibly earlier, than 2013, just in time for the first of its Infinity products to hit the market.
So who else -- absent a Big Pharma's sudden and shocking conversion -- could do deals like this? Other private companies (or companies who act like them) – in particular mid-sized European firms and maybe even a Japanese company or two. They’d certainly accept the regional aspects of this deal and – unlike the Big Pharmas – wouldn’t necessarily feel the urge to tell Little Sib how to do its job.
Big Brother, Little Sister by Flickr user Onion and used under a creative commons license.
Deal of the Year Nominee: Over-Protecting Therapeutic Classes in Medicare
Ah, awards season. Why should film critics have all the fun? And voting! It's not just for presidential elections. This year your IN VIVO Blog team is nominating a handful of alliances, acquisitions, financings, regulatory negotiations and legislative compromises in our First Annual DOTY competition. And then you, dear readers, will vote (early and often, we hope) for the winner. Imaginary federal and international biopharmaceutical statutes prohibit us from awarding a monetary prize. But our winners, when they die, on their deathbeds, they will receive total consciousness. So they've got that going for them, which is nice.When the Medicare outpatient prescription drug benefit began just three years ago (seems longer, doesn’t it?), the story was all about the glitches encountered by beneficiaries, pharmacists, governments (state and federal), and insurers as they all tried to learn together, in real time, how to make stand-alone prescription drug insurance work.
For Forest Labs, though, there was a much bigger glitch. It happened when the Centers for Medicare & Medicaid Services told plans in 2005 that they must cover essentially all drugs in a handful of big therapeutic categories: the now famous six protected classes—antidepressants, antipsychotics, anti-epileptics, anti-neoplastics, immunosuppressants and HIV therapies. The Medicare agency concluded (after hearing loud and clear from patient organizations relying on those medicines) that the need to protect access among vulnerable benficiaries trumped the plans’ need to be able to exclude medicines in an effort to extract deeper discounts for manufacturers.
That was good news, of course, for companies with products in those classes. Except for Forest. Because the Medicare agency made one prominent exception: there was no need for plans to cover Forest’s antidepressant brand Lexapro (escitalopram), the agency said, so long as they covered Forest’s closely related (and off patent) Celexa (citalopram).
In essence, the federal government told plans that Lexapro is equivalent to Celexa, and so plans could meet the agency’s goal—ensuring patients have access to all options in the six critical classes—without having to cover Forest’s biggest product.
That decision took Forest by surprise, to put it mildly. Forest was ultimately able to get the language addressing Lexapro removed from CMS’ policy, and it also managed to get Lexapro on most plan formularies—but at the cost of deeper discounts than it anticipated.
That history explains why a seemingly insignificant clause slipped into a hard-fought compromise on Medicare funding in 2008 may turn out to be the biggest deal of the year.
When Congress “codified” the CMS policy over the summer, it sounded like no big deal. It sounded like a simple matter of elevating the six protected classes from an ad-hoc principle established by administrative fiat to a formal, statutory requirement. No change from the status quo, right?
Well, then people actually read the provision of the law “codifying” the policy. It did no such thing.
Instead of adopting CMS’ language stipulating the classes, Congress instead gave CMS the authority to define any classes as protected. And it also made it much more onerous for CMS to create exceptions to those protections within classes. Call it the Forest clause.
That is a very big deal indeed.
There is nothing to stop the next CMS Administrator from expanding the list to include, say, Alzheimer’s therapies as protected classes. Plenty of people wonder why—if the goal is to protect vulnerable patient populations—AD therapies weren’t on the list in the first place. And then, why not antidiabetics? Surely we shouldn’t disrupt treatment in that class, when the consequences of uncontrolled illness can be so severe and costly. Or rheumatoid arthritis, where decisions by Part D plans have a direct affect on Part D spending. You see where this is headed, right?
Sure, there is no reason to think that the people who created the six protected classes in the first place would expand the list just because Congress says they can. After all, they invented the list and easily could have decided to add more at any time.
But those people won’t be calling the shots anymore, not after January 20. The next CMS Administrator could, with the stroke of a pen, add to the list of protected classes--and be cheered for it by the Democratic leadership of Congress.
No wonder managed care plans are concerned. They weren’t happy about CMS’ policy in the first place, since it basically takes away their leverage to negotiate better prices on some pretty big line items. But they really aren’t happy about the potential for that list to expand, potentially ad infinitum.
And, while manufacturers may feel differently, they better not gloat.
That's because Medicare Part D is itself the product of one of the more unlikely deals of all time. It came about in large part because pharmaceutical manufacturers and their long-time political adversaries, the managed care sector, were able to join forces in support of a never-before-tried concept: stand-alone prescription drug insurance.
That deal helped generate enough support in Congress—just barely—to push the Part D program through in 2003.
And, as the managed care industry is busily reminding Big Pharma, that program will only work if plans are able to do what politicians historically cannot: deny access to medicines if they need to in order to contain costs. The alternative? A program that allows broader access to medicines—but with more direct government intervention in prices.
So when the new Congress turns to price intervention proposals in 2009, remember the deal struck in 2008—a seemingly noncontroversial item slipped into a hard fought compromise bill. If that small deal helps break up the coalition that made Part D possible, that would be a very big deal indeed.
Wednesday, December 17, 2008
Deals of the Year Nominee: Alnylam/Takeda
Ah, awards season. Why should film critics have all the fun? And voting! It's not just for presidential elections. This year your IN VIVO Blog team is nominating a handful of alliances, acquisitions, financings, regulatory negotiations and legislative compromises in our First Annual DOTY competition. And then you, dear readers, will vote (early and often, we hope) for the winner. Imaginary federal and international biopharmaceutical statutes prohibit us from awarding a monetary prize. But our winners, when they die, on their deathbeds, they will receive total consciousness. So they've got that going for them, which is nice.
This year's biggest RNAi deal isn't quite as big as last year's biggest RNAi deal, but we like Alnylam's Japanese alliance with Takeda nonetheless. First off it reinforces Takeda's position as one of 2008's pre-eminent dealmakers--the February Amgen alliance and the April acquisition of Millennium were its first two big noises this year--and it also marks Alnylam's move from simple-yet-unprecedented platform monetization into the kind of technology-for-product-rights deal that could see it gaining access to others' development candidates.
At the time of the deal we intentionally mangled Alnylam CEO John Maraganore's kegger analogy by which he describes RNAi's potential to help relieve the productivity problem in drug development and provide free beer for all mankind. (Did we do so again? Oh dear.) It's fair to say that this remains a ways off, but meanwhile Takeda's cash ought to keep the fridge full in Cambridge.
Alnylam received $100 million in up-front cash and $50 million in near-term technology transfer payments for a non-exclusive license to its RNAi platform in oncology and metabolic disease, and first right of negotiation on its RNAi programs in Asia (excluding ALN-RSV01) should Alnylam look for a partner there. Alnylam also gets first right of negotiation on any project Takeda decides to shop in the US and more importantly, gets opt-in rights for 50/50 co-development/co-commercialization deals in the US on up to four Takeda programs of its choosing (exercisable all the way through the start of Phase III), plus the usual gajillion biobucks in development and commercial milestone payments.
As we noted when the May deal was signed: it bears repeating that Alnylam has once again struck a non-exclusive deal--and can go out and re-license those same therapeutic areas again at any point. That said, on the call to announce the deal Maraganore essentially laid down some ground rules. "We wouldn't do a platform license for a double-digit upfront payment," he said. "Given the opportunity cost of enabling a partner we have to and will be very discriminate in how we value these kinds of partnership alliances."
In other words, pony up $100 million or it's not worth our time and effort. How many triple-digit deals it can do before its proposition is diluted below the $100 million low-water mark remains to be seen (it hasn't done any since, though there is plenty of time to fulfil its stated goal of two or more new partnerships through the end of 2009).
In these cash-constrained times, the deal allows Alnylam to end the year with approximately $500 million in cash. It makes Takeda the sole big RNAi player in Japan (though Japanese rights to Alnylam's Phase IIALN-RSV01 product were not included in the deal and later licensed to Kyowa Hakko [our take here]) and cement's the Japanese pharma's place among the most active and creative dealmakers of 2008. And it sets the RNAi pioneer up for pipeline building down the road.
Readers, it's up to you. The voting begins next week and will be open into the new year. No stuffing the ballot box!
image via flickr user furiousgeorge81 used under a creative commons license.
Sunday, December 14, 2008
While You Were Brainstorming
We're posting your weekend roundup a little early this weekend and we're bound to have missed a few things that happen Sunday and in the wee hours of Monday. Go ahead and fill in the gaps for us in the comments.
While you were getting roped into writing the IVB weekend roundup yourself ...
- Has it been a year already? It's the New York Times Magazine's "Year in Ideas" issue, one we look forward to immensely. Otherwise how would we know about Airbags for the Elderly (pretty much what they sound like) that help protect during a fall, or McSleepy, the first fully automated anesthesia system created at McGill University? (Guys, we're not even out of the As in this A-to-Z list.) Last year we devoted an entire post to the gems found in this list--no time for that in 2008, no sirree, we've got places to go and people to see and Deals of the Year Nominees to write-up. But we encourage you to read the whole list anyway. A formula for deciding whether to wait for the bus or to hoof it? Yes, please.
- Sure is quiet this weekend.
- OK, back to the year in ideas. You'll have to wind your own way through the alphabetized list over at the New York Times. But we wanted to remind you that our very own Deals of the Year! series is very much like our own version of the Times' list (except no where near as flashy, very focused on health care business strategies, and a bit haphazard--we don't need no stinkin' alphabetizin'). Sure we're not going to tell you why it might be bad to redshirt your kid in kindergarten or to eat more kangaroo meat (mmm, bouncy), but we're all over the stuff that matters: alternative financing, FDA's newfound negotiating power, technology trends, exit strategies and risk sharing. So be sure to review the nominees so far and stay tuned for half a dozen or so more this week. There will be no debates (unless you fire some up in the comments section, but we're going to call that unlikely based on past experience) but your chance to vote is coming. We'll open up the voting in about a week and leave it open into the new year, and announce your winners in early January.
image by flickr user cayusa used under a creative commons license.
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