Well-Traveled GSK Bulks Up Again in Emerging Markets

Today’s announcement that GlaxoSmithKline would pay €505 million for UCB’s commercial operations and product distribution rights in selected Far Eastern, Middle Eastern, Latin American and African markets shows in some ways just how irrelevant many emerging markets will be to some specialty pharmaceutical companies.

UCB is in the midst of implementing its so-called SHAPE program, a restructuring that will focus the company on "its core areas in CNS and immunology and to strengthen its presence in strategic markets," which to be sure include the hot emerging markets of Brazil, Russia, India and China, as well as Mexico and South Korea, which are all excluded from the GSK deal. The deal also excludes UCB's "new core products," Vimpat, Neupro, and Cimzia.

GSK, on the other hand, has shown itself to be an aggressive acquirer of emerging market businesses in the past year, and we're not just talking the so-called BRIC countries. Besides today's UCB deal, over the past few months GSK signed what it called a "transformational agreement" with the South African generics company Aspen Pharmacare Holdings and followed up with the $210 million and $36.5 million acquisitions of BMS’s Egypt and Pakistan businesses.

It's tempting to chalk all this up to the Brits' love of travel, but truth be told, the moves are part of a broader diversification strategy that also includes bulking up on consumer medicines. The overarching goal: to be less reliant on risky traditional pharma R&D output (where GSK's ongoing CEDD-based experiment continues--read more in next month's IN VIVO) and collect some more stable and reliable--if less exciting--revenue streams.

Bulking up in emerging markets--which are growing at a much faster clip (albeit from a tiny base compared to established markets) than the US and Europe--is a long-term strategy that relies primarily on marketing mature, often generic, products. Focusing on high-margin specialist products for niche indications--an increasingly popular strategy among pharmaceutical and biotech companies alike--puts many emerging markets and their enormous growth potential in a kind of commercial blind spot.

For smaller companies this is of course pretty much irrelevant. For mid-sized firms like UCB, hanging onto a presence in the larger BRIC countries is likely enough--provided patients there can afford your drugs. But for those behemoths with large primary care portfolios and the quickly approaching patent cliff to navigate, emerging markets are both the silver lining and an increasingly important source of revenue. GSK is wise to keep collecting those customs stamps.

image from flickr user mondayne used under a creative commons license.

Pfizer's Four-Legged Message For Consumers

we will spare you the screen-capture!

Movie goers in the UK beware. An ad playing on cinema screens could make you choke on your popcorn.

The clip features a middle-aged man who takes a pill from a package on his kitchen counter. He immediately starts to tug at something in his mouth – which viewers soon realize is a tail – and pulls out a huge dead rat. Pfizer created the ad campaign to warn about the risks of buying counterfeit medicines from websites and other unregulated sources. It takes a couple viewings – you can see it here at Pfizer's web site or here on youtube – to catch that message though. The rat is pretty distracting.

We first saw the ad over at Bnet Pharma, where Jim Edwards astutely wonders whether there's some sort of double standard at play. Pharma Marketing Blog and Mike Huckman at CNBC have also picked up the story, and Drug Channels has pointed out that Pfizer's other main target--besides counterfeiters and dodgy web sites hawking little blue diamond pills--is the parallel import trade (you can find some of our analysis on that topic here and here).

Pfizer told us the piece will run across 2,651 screens in about 600 cinemas from Jan. 16 to March 5. The company notes that due to its graphic nature, the ad was classified as a 15 so children under 15 should not watch it. Good luck keeping adolescent boys from watching this.

“The advert has been developed in direct response to new research highlighting that more than 330,000 men purchase prescription only medicines from unregulated sources, such as Internet sites, every year in the UK,” Pfizer states in a release. The company collaborated on the ad campaign with the U.K.’s Medicines and Healthcare Products Regulatory Agency, The Patients Association, Mean’s Health Forum and H.E.A.R.T. UK.--Brenda Sandburg

image of Banksy rat mural in NYC by flickr user caruba

UK Biotech: Shattered Dreams?

Back in 2003 a government-funded team of experts outlined its vision for UK biotech--one in which the sector occupied a leading place on the global stage, with a strong clinical trial infrastructure, early patient acess to innovative drugs, and all built around a critical mass of companies "in the mould of Amgen".

The dream hasn't come true, to say the least. This much was clear at the launch yesterday in London of a 'renew and refresh' of that original vision--encompassed in a report called Bioscience 2015. Sights are now considerably lower. Instead of building a sector "with a core of large profitable world-class companies", we're now settling, it seems, for "a sector which supports, on a sustainable basis, high value-added employment..." Even the email announcing the event was ominously entitled "Can we save the UK biotech sector?"

It's not difficult to see where this dose of... realism, defeatism, call it what you like... has come from. The UK has lost much of its lead in terms of products in development versus other European countries. Shire moved its headquarters to Ireland for tax reasons, Pfizer and others have shut down UK-based manufacturing, and the UK's stringent application of the European clinical trials directive means the proportion of European products in trials there has fallen from 46% in 2002 to 24% in 2007. Far from Amgen lookalikes, the sector appears to increasingly comprise low market-cap, illiquid companies, many fast running out (or run out) of cash. Biotech now comprises less than 0.2% of the total market capitalization on the London Stock Exchange; investors aren't interested.

Blame the financial crisis? Sure, but the problems pre-date it. And one of the big ones, said Sir David Cooksey, chairman of the Bioscience Innovation and Growth Team which produced the report, is NICE. That 'fourth hurdle' (ever notice how that expression isn't used so much now given how fashionable and inevitable HTA has become?) delays drug usage and creates uncertainty for companies--in particular when decisions are reversed or re-reviewed. And their processes aren't transparent, he argues, calling for an independent enquiry on NICE's impact on medicines uptake in the UK.

NICE would have a lot to say about that; it claims to be among the most transparent of cost-effectiveness bodies in Europe. But, hurdle or not, NICE is here to stay, if anything with ever-growing influence on drug usage (in fact, NICE and Health Technology Assessment in general is probably one area where the UK does have leading global status). And the economic crisis doesn't look as if it will go away soon either. Analyst numbers, already, said some, too low to offer all the UK companies the visibility they need, are dwindling fast.

So what's to be done? Well, many of the ideas in the original and the refreshed report are realistic and achievable. Like rewarding academia-industry collaborations, providing incentives for clinicians to move into research and strengthen the country's R&D base, extending tax credits, and improving NHS IT systems. Others, like the UK taking a lead in bringing together global regulators to adapt their approaches to embrace earlier (eg Phase II) drug access, wider use of biomarkers and simulation technologies (think FDA Critical Path) seem, if noble and sensible, somewhat blue-sky (unfortunately).

Sure, governments can and should help biotech, most usefully via tax breaks, funding for basic research, and appropriate, rather than burdensome, regulation. But they can't replace VCs or investors (remember what the German goverment's BioRegio program didn't do for German biotech). Far more valuable is is what UK entrepreneurs (yes, they exist) can do themselves: seek and find novel funding solutions and new biotech models that can exist and thrive in the tough but now familiar UK climate, just as others are doing elsewhere in Europe. Ideas, anyone?

An Orphaned Article Gets Reprinted

Awards season feels like it’s winding down. The Oscars are still to come, but there’s already been Time’s Person of the Year, the Golden Globes – you even helped us choose a Deal of the Year. But recent events have made us look back on 2008 in a new light, and now it’s time to present the award for Least Read Article in “The Pink Sheet.” Last year’s, um – we’ll just call it an honor – goes to “Orphan Drugs Are Rare Area Of Agreement In Off-Label Debate.”

The article is sidebar to our coverage last year of FDA’s development of guidance on “good reprint practices” that would set goalposts for firms that wanted to distribute reprints of journal articles about their drugs that discuss uses not approved by the agency. The rest of our coverage about the draft is here, here, and here. FDA just finalized the guidance, and you can find coverage of that here and here. And don’t miss our related coverage of Lilly’s $1.4 billion settlement for off-label promotion violations (here and here).

So, yes, we write a lot about reprint issues, and maybe that’s the reason this particular article didn’t get the attention it deserved, or perhaps there was just a glitch in our page view accounting. Whatever the cause, we thought we’d give people another chance to read the piece. Because, as the Lilly settlement shows, issues that seem small at the time can become quite significant. Here’s hoping that our least read article of 2009 doesn’t become your billion-dollar problem in 2010.

Without further ado, here in its entirety is the Pink Sheet’s least read article of 2008. Both of you who’ve already read it can skip to the next post.

Orphan Drugs Are Rare Area Of Agreement In Off-Label Debate
While promotion of off-label drug use is a flashpoint issue, off-label drug use for rare or orphan diseases is not. Regardless of where people come down on FDA's draft guidance, they generally supported patients with limited access to approved drugs. For example, in an April 17 article in the New England Journal of Medicine which is generally critical of off-label promotion, Aaron Kesselheim and Jerry Avorn state that "In certain patient groups, such as children and patients with rare diseases, off-label use may reflect the standard of care."

Indeed, the National Organization of Rare Disorders -- which has often tangled with the pharmaceutical industry on issues related to patent extensions and consumer advertising -- in this case joins many drug firms in advocating for the draft guidance. The association did not submit comments to FDA, but, "I would ask Congress to keep in mind patients with rare diseases," Diane Dorman, NORD's VP-public policy, said at an April 16 media briefing sponsored by industry supporters of the guidance.

image from flickr user '... Tim' used under a creative commons license

More Velcade-Style Risk-Sharing in the UK?

It appears that Janssen-Cilag feels a lot better now about its pay-for-performance scheme around multiple myeloma drug bortezemib (Velcade) than it did when the program was introduced in 2007.

The Velcade Response Scheme (VRS) came about out of desperation: cost-effectiveness watchdog NICE had turned down the drug as too expensive, so Janssen-Cilag, to its credit, said to the UK’s state payer, the Department of Health, ok, well if we promise to charge only when the drug is effective (and refund you if not), then will you give this to patients?

The answer was yes. And now, not only have all of the UK’s Primary Care Trusts have signed up to the VRS, according to a Janssen spokesperson, but this scheme “may now be a good example of how a performance-based scheme could be structured.” That’s not a statement from Janssen; it’s from a position document issued last year by the British Oncology Pharmacy Association on risk-sharing schemes.

Indeed, such schemes have, perhaps inevitably, become a rather more regular feature of the UK drug landscape—making Janssen feel more pioneering than desperate (though Janssen isn’t the first to guarantee performance; Pfizer tried with Lipitor too).

Most of the other recent flavors of risk-sharing programs around expensive cancer drugs emerged, like VRS did, as a result of a negative NICE appraisal. Merck-Serono offered the Cetuximab Cost-Share Program around Erbitux in metastatic colorectal cancer, which involved refunding primary care trusts the cost of any vials of the drug used for patients that fell into a pre-agreed ‘non-responder’ category at up to 6 weeks. Roche instigated the ‘Tarceva Access Program’ for its NSCLC drug erlotinib, offering a rebate, in the form of a credit note against any future Roche purchase, for the amount that the drug cost over and above the cost of the incumbent NSCLC treatment docetaxel (Sanofi-Aventis' Taxotere) for an average patient duration (with an upper limit on the total number of packs).

Now granted, Roche’s program was initially introduced as a means to claw market share off docetaxel, which it was struggling to do ahead of NICE guidance. But when NICE found Tarceva to be un-cost effective—with questions around the lack of comparative data with docetaxel in particular--the scheme was formally proposed to NICE as part of a re-review. In November 2008, NICE issued positive guidance—but only on condition that the overall treatment cost remained in line with that of docetaxel. Roche had to drop the price by about 7.5%.

Critics say such programs are simply a way for industry to coerce NICE into a ‘yes’. Maybe. But there’s no denying that such schemes represent a logical way to improve patient access without breaking the bank. Indeed, the new UK drug pricing contract, the PPRS, formalizes a bunch of patient access schemes, including risk-sharing programs. And NICE, as we heard from CEO Andrew Dillon last week, would prefer such schemes to be proposed up front, before a drug is submitted for review, rather than as a last-resort of the drug fails the cost-test.

Small wonder, then, that in the last three or four months since the PPRS was published, the department of health has been in contact with various companies about schemes around several “high profile” drugs, according to David Thomson, Lead Pharmacist at the Yorkshire Cancer Network and author of the BOPA position statement.

The big problem is administration. As it is, it’s complex to administer rebates and track outcomes. The more different schemes are available, the harder that becomes. “Anecdotal evidence suggests that the VRS [and a similar scheme around Sutent] aren’t necessarily bringing the expected levels of financial benefit to the National Health Service,” Thomson told The IN VIVO Blog.

Add to this the problem of patchy uptake or availability of some of the existing handful of programs across the country, and the possibility of multiple risk-programs across a single drug for different indications, and it’s easy to see why BOPA's pushing for some sort of risk-sharing plan template....and why we may not, after all, see a flood of VRS-followers soon.

image by flickr user fboosman used under a creative commons license

Are More Rent-A-Reps On The Way?

That's what Deutsche Bank analyst Barbara Ryan suggests in an investor note after digesting the news that Pfizer is cutting about 2,400 sales reps, or roughly one-third of its sales force, as part of its ongoing downsizing.

In her view, tapping contract sales organizations makes sense, since revenues now follow a "cyclical pattern surrounding patent expirations" and most US drugmakers will lose more than 25 percent of their revenue base during this upcoming period. The answer? A new model, of sorts, that involves moving from a fixed cost to a variable cost base in order to maintain margins.

How would it work? A mix-and-match approach that calls for augmenting a drugmaker's best salespeople with a CSO. "Mature brands will be managed by less costly outsourced sales forces, which could cost as much as 25 percent less, which can be pulled before patent expirations," she writes.

Of course, such gambits are already under way. Ryan, in fact, points out that Merck tried this a few months ago by signing a deal with InVentiv Health to market Cozaar and Hyzaar just as the drugmaker axed 1,200 sales reps. These sorts of efforts, by the way, were foreshadowed in an IN VIVO article in 2006:

"The drug industry has accepted the need to outsource R&D--now, with sales productivity down, and the rising cost and risk of owning too much commercial infrastructure, why not outsource more of the sales effort, too? Big and small pharmas resist the idea but will eventually have to accept it."

And since then, the need for a new model has been hastened by a few familiar factors - more product recalls, fewer product approvals and ongoing complaints from some physicians about the number and effectiveness of reps walking through their doors. The bright side? This is one job that can't be outsourced overseas.

image from flickr user 'Howdy, I'm Michael Karshis' used under a creative commons license

NICE’s Growing Influence on UK Drug Pricing

NICE doesn’t set drug prices in the UK, companies do. But the agency’s influence on pricing, if indirect, will nevertheless grow considerably given the UK’s new Pharmaceutical Price Regulation Scheme, published late last year following a surprise renegotiation of the agreement.

“The PPRS has increased price flexibility quite deliberately, and NICE has a role to play in enabling that flexibility to be applied in appropriate circumstances,” said NICE CEO Andrew Dillon in an interview on Thursday.

Aside from the overall 3.9% price decrease slapped on all branded drugs from February (with a further 1.9% due next year) the PPRS formalizes options for a variety of patient access schemes, including outcomes-based programs that allow for a price increase in the light of new evidence around a drug. It also proposes conditional pricing based on the collection of additional evidence, the possibility of rebates in the event that a drug fails to deliver the promised benefits, and risk-sharing set-ups along the lines of that proposed by Janssen-Cilag in 2007 for blood cancer drug Velcade.

All this means more work for NICE, since its role is to assess any additional evidence that might justify a price increase, rebate, or price decrease. Under the new scheme companies can request a re-review from NICE based on “significant” new evidence. “We already keep guidelines up to date,” points out Dillon, but “the difference is that in the past, we decided when to re-consider [a particular drug or drug class]. From now on, companies can come and ask us.”

NICE plans to meet all those additional requests—and let’s face it, there will likely be a few—by establishing a fourth advisory committee (the current three comprise about 30 experts each) and increasing staff in its technology appraisal team. It hasn’t yet committed to responding in any particular time-frame, but “we want to make sure we deal with [all requests] as fast as we can,” Dillion told The IN VIVO Blog. Step one will be for NICE to “ensure that we agree the evidence is sufficiently materially different” to be likely to warrant either a premium price, or a change in a previously negative recommendation. Assuming it is, the product would go through the same standard technology appraisal as any new product does currently.

Companies: Apply Early

But why should NICE prioritize re-reviews that could lead to price rises, over reviewing new medicines or technologies? Well, for one thing, the PPRS allows companies to implement price rises 12 months after they propose them, unless negative NICE guidance has appeared sooner. More significantly, it’s the agency’s job is to re-review important treatments in the light of new evidence anyway. “But clearly, if a company comes earlier than expected to ask for consideration, the effect is simply to advance a review that we would otherwise have done,” notes Dillon.

So get in there early, companies, with your new evidence—so long as it’s meaty.

And get in there early with your proposals for Velcade-style risk-sharing schemes, too. These needn’t only appear as a desperate last measure following a negative appraisal. “If companies have an idea that the scheme might be part of the solution, and it’s in their heads at the time of embarking on a [first] NICE appraisal, we’d much rather hear about it at the beginning,” emphasizes Dillon. “Otherwise it just extends the process” since NICE would then have to start again to review the practicalities of a risk-sharing scheme.

Extended processes are the last thing NICE needs, given its growing workload (fee-for-advice services and masterclasses for smaller companies are also on offer) and its promise to issue guidance within six months of a product’s approval.

Let’s hope the UK government, after bailing out the banks, has enough left at the start of the new financial year in April to grant NICE the extra funds its applying for.

Sharfstein Speaks: Is He Headed To Washington?

During a Baltimore City rally for Barack Obama on Saturday, Dan Rodricks, a host for the local National Public Radio station, WYPR, got a coveted interview with a Baltimore official who has been making national headlines.

No, it wasn’t Baltimore City mayor, Sheila Dixon, who was recently indicted for perjury and theft charges (and who, may we add, did not receive a shout-out from president-elect Obama when he addressed the massive crowd).

WYPR spoke to Baltimore City health commissioner Joshua Sharfstein, one of two finalists for the FDA commissioner job. (You can read all about that story in this week’s issue of “The Pink Sheet.”) Sharfstein was at the Obama rally in an official capacity as health commissioner, directing people to warming tents and trying to prevent hypothermia and frostbite.

And while that's certainly a good story, Rodricks also asked Sharfstein whether he would leaving Baltimore to become FDA commissioner. Sharfstein was non-committal (as would be expected), but also expressed his deep admiration for Obama, and the science-based policies that he will support as president.

We’ll let you be the judge on the meaning behind his remarks. Here’s the interview, as transcribed by us from an online recording of Dan’s show, which aired yesterday afternoon:

Dan Rodricks: Are you going to go to work in Washington? Are we going to lose you here in Baltimore?

Joshua Sharfstein: I’m fully expecting to be health commissioner of Baltimore. It’s a great job, and lots to do this year.

Rodricks: OK, because there have been all these stories in the press about Joshua Sharfstein and the Food and Drug Administration.

Sharfstein: I know, my mom sends them all to me.

Rodricks: But you’re going to be around here for a while?

Sharfstein: That’s what I totally expect.

Rodricks: What do you expect from Barack Obama….Are you expecting generally more progressive ideas coming out of the White House?

Sharfstein: Absolutely. The first thing he said is that he wants to base health policy on the science. That’s a huge shift from what we’ve had. When you look at the science, you look at what things have worked, those are the kinds of things that we’re trying to do in Baltimore. I think we can expect some support for that, because we’ve got evidence for what we are doing. ...

Rodricks: Have you felt this way before about a president?

Sharfstein: I’ve never experienced anything like this. It’s been terrific. I’ve had a chance to work on the transition some, and that’s been great. From the moment—I just remember Iowa and everything, it’s just been so exciting.

Photo credit: Reuters/Jason Reed

Last Call: Novartis Gets Vaccine Bricks & Mortar Money

Novartis isn't taking any chances about missing the last call from the government's cash spigot for vaccine manufacturers.

The Swiss company collected the most recent installment of its $865 million in support from the US government before a potential change in attitude towards corporate subsidies by the Obama Administration.

Novartis collected the most recent, and biggest, chunk of that support ($486 million) on January 15, five days before the Obama Inauguration.

Significantly, the new piece includes bricks and mortar, just the kind of direct support to one company – especially a non-US one -- that is most threatened by the change of administration in Washington. Many observers expect the Obama Administration to channel more funds in health to paying for beneficiaries to receive health products and services rather than to support the companies that provide those products and services.

[Editor's note: The publishers of IN VIVO Blog, “The Pink Sheet" and The RPM Report will host a webinar Jan. 29 on the outlook for vaccine developers under the Obama Administration. Dack Dalrymple, Chris Colwell (McKenna Long & Aldridge) and Isabelle Claxton (GlaxoSmithKline) will analyze the prospects for the vaccine business in the next four years. For more information, visit: http://www.windhover.com/ezine/html/ac0109-2lp.htm.]

The January 15 Novartis grant is an eight-year commitment to help Novartis finish building and qualifying its Holly Springs, N.C. facility for the production of cell-culture flu vaccine (seasonal and pandemic/prepandemic). The new money is for “design, construction, validation and licensing.”

The company got $220 million from the Department of Health & Human Services in 2006 (before selecting Holly Springs as the manufacturing site) to begin developing a cell-based vaccine. Novartis says that the first round of funding “was not for the facility, land or building.” The $865 million also includes funding for development work on adjuvants and a chunk awarded to Chiron to help get its flu vaccine production back up to par just prior to the major Novartis purchase of Chiron to get into vaccines in a big way.

By collecting commitments for $865 million from the U.S. government over the last three-plus years, Novartis has successfully defrayed much of the cost of expanding into the vaccine business. The company paid $5.7 billion to buy the part of Chiron that it did not already own in early 2006. The grants do not obviously relate directly to the cost of the initial purchase; but as a marker of the size of support for the Swiss company’s engagement in the vaccine business, the US funding represents more than 15% of that initial investment.

Novartis indicates that commercial production from Holly Springs is more than three years away. “Construction activities will continue until late 2010,” the firm says. After than, “engineering and process validation will start,” continuing through 2011-2012. FDA clearance procedures will follow the process validation.

Holly Springs will eventually produce bulk prepandemic vaccine (vaccines designed against projected pandemic strains), the MF59 adjuvant to permit lower doses of antigen in the flu vaccines and other cell-based vaccine products. By the January 15 contract, Novartis is committed to provide two commercial-scale lots of prepandemic vaccine annually to HHS for at least three years.

The new funds will help pay for the regulatory clearance, which can be a significant cost. The Congressional Budget Office has recently estimated that the FDA approval process can add approximately 25% to the initial construction cost for a new vaccine plant.

CBO, in fact, analyzed the projected government and private spending to develop cell-based vaccine manufacturing in mid-September of last year. At that point, CBO reported that HHS was intending to spend up to $600 million to support the creation of new facilities for cell-based manufacturing – as opposed to the traditional egg-based production system. The Novartis contract does not leave much left (about $115 million ) from those estimated funds.

CBO noted that Novartis says that the total cost for Holly Springs will exceed $600 million. As we reported soon after the Chiron purchase, Novartis has said from the start that Holly Springs would cost between $600 million and $700 million. CBO says other vaccine industry sources have estimated that it should cost Novartis less (about $400 million). Novartis is indicating that the final cost could be well over $1 billion.

The other big participants in the flu vaccine expansion: primarily Sanofi-Pasteur, GlaxoSmithKline and Medimmune (AstraZeneca) have also been beneficiaries of HHS largesse. Sanofi and Medimmune have received respectively $77 million and $55 million to retrofit existing flu vaccine plants.

Novartis, however, claims that it will eventually contribute a larger share (60%) to the total cost of Holly Springs than other manufacturers have put into government-supported retrofit projects. Sanofi and Medimmune each put about 25% into the projects funded by the government. CBO said that companies should be expected to put more in for the development of new cell-based manufacturing facilities.

GSK is developing a site in Marietta, Pennsylvania purchased from Wyeth for increased flu and pandemic production in the US. GSK is nearing the stage to seek FDA approval for filling and packaging of vaccines for use in the US from antigens made overseas. GSK has been reluctant to accept much direct funding for construction for the vaccine production projects: people close to the GSK effort say that the restrictions inherent in government contracts reduce the value of the subsidy funds.

The Bush Administration has really created a new vaccine industry in short order by pumping in money, making use of the public concern for a potential pandemic. Now, the new producers are likely to lobby the new administration to make sure that the products from the new production capacity find an adequate market.

While You Were Getting Your Guthrie On

Welcome to the Inauguration Edition of your (long) weekend roundup here at the IN VIVO Blog, and remember: this blog was made for you and me. On to the news!

So, while you were bird-watching ...

• Is Lundbeck considering a takeout of up-for-sale Elan? According to The Independent it is, but the paper doesn't name any sources. (h/t Reuters) But after the Flurizan debacle it seems like a strange move to us, despite the therapeutic area tie up in CNS. Lundbeck is 70% privately owned, however, and so mightn't have difficulty moving forward with a deal if its investors are on-side.
  
• Swiss biotech Arpida received an FDA 'complete response' letter for its NDA on the intravenous version of its antibiotic iclaprim. FDA, says Arpida, is requesting new clinical studies. The drug was dinged by FDA's advisory committee back in November.
  
• Galapagos and GSK expanded their alliance in anti-infectives to cover three additional targets, triggering a payment of €2 million to the Belgian biotech.
• Put down the knife, and STEP AWAY FROM THE PEANUT BUTTER.
• What? Football? Well that didn't go very well, did it? Congratulations to the Steelers and the Cardinals and their fans.