Thank You

I ain’t saying this is my final blog post.

But it is my last one as an employee of Elsevier Business Intelligence, this blog’s publisher. As of November 2, I’m relinquishing my operating role, taking a few steps back, and figuring out what’s next in my life. (I’ll still be around, consulting with Elsevier a few days a week, at least for the immediate future.)

Elsevier has been a great acquirer: in the 18 months since they bought Windhover, we've pretty successfully melded two very distinct editorial and marketing groups. I’ve liked running the combined pharmaceutical group; we've put together an extremely capable group of successors. This place has all the talent it needs.

And it's time to let them have their chance to run things while I figure out the next thing to do, taking some time off to let my subconscious health-care mind play about on the problem.

It's been a great ride. I’ve had the nearly unique opportunity to go to graduate school in the pharmaceutical industry by reporting on pretty much whatever I wanted to, without much worrying about how the folks reading it would react and while naively assuming that what I wrote would be of some value to at least some readers. It's paid the bills. And you can’t ask much more than to combine your avocation with your vocation.

For that extraordinary gift, I’ve got to thank many of you – customers, contacts, colleagues. I've bugged you for interviews for articles, for talks at our conferences, for business advice. And you’ve helped me far more than I should sensibly have hoped.

I’m humbled by your generosity.

Roger Longman

Finding Common Ground on Off-Label Promotion

There were plenty of highlights at the FDA/CMS Summit last week. Our colleague Roger Longman already shared his, singling out shrinking violet Steve Nissen and the decidedly less sexy, but critically important, discussions about reimbursement and drug development.

For anyone worried about the boundaries between scientific exchange and off-label promotion, though, the highlight had to be the discussion between First Assistant US Attorney Michael Loucks and former FDA Chief Counsel Dan Troy (now with Sidley Austin, LLP). And since virtually every pharmaceutical and biotech company with products on the market is under investigation somewhere, shouldn’t everyone be worried about that topic?

On paper, the face off promised plenty of fireworks. Troy has been a passionate advocate of First Amendment rights throughout his career, and maintains that the recent climate of prosecution of marketing practices is chilling scientific exchange. Loucks’ Boston office has spearheaded most of the biggest investigations in the area.

But a remarkable thing happened. Instead of a shouting match, there ensued a lively discussion of the policy issues underlying off-label promotion cases—and several points of agreement that could serve as a basis for moving the debate forward.

The first point of agreement was one of philosophy. Troy was the first political appointee at FDA in the Bush Administration, so you know where he is coming from . But here is something you may not have known about Michael Loucks: “I am, believe it or not, a conservative Republican,” he said.

“I think the government ought to be, consistent with the rules, out of people’s pocket books and lives,” Loucks said. “However, if you have a set of rules that requires taking certain actions when you market a product, that set of rules has to be applied equally across the board.” Dan Troy couldn’t have put it better himself.

The more important points of agreement, though, came in discussion of the topics raised by moderator John Bentivoglio (King & Spalding).

Troy has been pushing FDA to issue guidance clarifying permissible forms of scientific exchange, starting with a policy governing dissemination of peer-reviewed medical journal articles that discuss off-label uses. The topic is so controversial that House Oversight & Government Reform Committee Chairman Henry Waxman announced an investigation of the guidance before FDA finished drafting it.

Loucks agrees with Troy that FDA guidance would be useful in this area. He even offered a new idea: having FDA create some form of advisory opinion process, modeled on a program already in place for the HHS Inspector General. Such a system would allow sponsors to ask FDA for clearance before conducting some activity that they worry might expose them to liability for off-label promotion.

Loucks also agreed with Troy’s position that dissemination of truthful, non-misleading scientific information should not be criminalized, even if it is about an off-label use. There has to be “something else” in the case, Loucks said—like an illegal inducement to a doctor, or evidence that the information was false or misleading.

The two also agreed on one other thing: the issues surrounding off-label promotion encompass more than prosecutors and manufacturers. Payors, prescribers and patient groups all have a stake—and strong beliefs—as well.

Look for lots more coverage of the current state of off-label promotion policy in The RPM Report in December.

What Does the FDA Drug Safety Law Mean for Drug Development?

If you have been reading the IN VIVO Blog you know what we think.

But why trust us?

That's why we've lined up a bunch of top R&D executives--like Pfizer's new R&D head Martin Mackay, Bristol's head of development Brian Daniels, and Glenn Gormley from Novartis--to talk about that at this year's FDA/CMS Summit for Biopharma Executives. It is just a month away: December 6-7 in Washington DC.

Our own Roger Longman will moderate a panel discussion among that group, tackling the big question: Did FDA kill the blockbuster?

And that is just one of more than 20 different sessions featuring top industry and government officials who will discuss all aspects of the new FDA law, as well as the new realities of reimbursement, Medicare Part D and the broader political landscape. All with an eye to helping you understand what it means for your business.

Why are we telling you this? Because we want you to come. Click here for more information.

How Do Some of the Biggest Deals the Year Measure Up Against Regulatory Realities

Its fun to play Monday morning quarterback.

That is essentially what Roger Longman asked me to do at this year's Pharmaceutical Strategic Alliances conference: look at some of the biggest (and a few small but still interesting) deals in the biopharma sector over the past 18 months through the prism of changes taking place in Washington DC.

The big one, obviously, is the new FDA drug safety law. As you've figured out by now, we think this means big changes in what it takes to bring a product to market and to sell it successully.

But there's a lot else going on too: Medicare Part D is having an impact, and the Medicare agency is starting to assert itself. And then there is a growing sense that line-extensions don't fit well with regulators, payors or politicians.

So there is a lot to think about.

If you weren't at PSA, shame on you! But if you want you can still hear our take on some of these big deals. Click here. It's free.

And by all means, let us know what you think. The regulatory landscape is changing rapidly, and we certainly don't have all the answers. What are your perspectives?

Phase II is the new Phase III

It's what you might call a slow news day for us so we figured we would dip back into our colleague Roger Longman's presentation from our Euro-Biotech conference last week. Roger's on vacation, see, so he can't stop us from pilfering his slides.

One of the points he emphasized during his talk and illustrated with some data from our Strategic Transactions Database is the idea that products that have cleared clincal proof-of-concept, i.e. the Phase II hurdle, are attacting the kind of deal dollars only seen previously for Phase III-stage products. The value of relatively scarce Phase III products these days is another thing altogether.

Taking a look at this phenomenon using upfront payments as a proxy for deal value, above, and you can see what we mean. So while those biotechs that excel at drug discovery can in fact sustain themselves by selling IND-stage candidates, which we pointed out last week, others can play on the next valuation inflection point at proof-of-concept.

Are Phase II deals a remotely new feature of the biopharma dealmaking landscape? Of course not. But the volume of deals for Phase II products has shot up in the past few years, and upfront payments are simply booming. A few recent examples include Novartis and Antisoma's deal around the oncology product AS1404 ($75mm up front), Bayer and Regeneron's deal on ex-US rights to Regeneron's VEGF-trap product in ophthalmology ($75mm u/f), and going back to last summer, Johnson & Johnson's ex-North America, ex-Japan deal for Vertex's hepatitis C protease inhibitor ($165mm u/f). Follow the links to a more detailed analysis of each deal.

Various pharma execs have chalked the rise in Phase II prices up to their own companies' inability to reliably and predicably get products through proof-of-concept themselves. This is excellent news for clinical-stage biotechs. A few, like CNS-focused Synosia, have set themselves up as proof-of-concept specialists, in-licensing compounds in preclinical or IND or even Phase I, shepherding them through a human efficacy trial, and licensing them on for a significant profit.

Live from Paris: Roger's dealmaking overview

Everyone was feeling a bit fuzzy this morning

Day two of our Euro-Biotech Forum opened up this morning with Roger Longman's dealmaking overview. One of the topics that Roger touched on was the increased specialization of biotech companies along the development continuum: Phase III specialists, proof-of-concept specialists, and--perhaps getting back to biotech's roots--discovery specialists.

The idea is to latch on to a particular and finite piece of the so-called value chain where investors can take advantage of an inflection point. Thanks to some of the astounding deal values we heard about yesterday this specialism is increasingly popular and undeniable profitable (when products work out--of course it's also a cheaper means of finding out quickly when they don't).

Below is a quick snapshot of the upshot for some of the discovery shops out there. Of course not all discovery companies opt-out at IND; some hang on to considerable upside. But the very idea that biotechs can subsist, and even thrive, as pure drug discovery purveyors recalls what seems to be a different, pre-FIPCO era.

Drug Discovery Pays