The Memo to End All Memos

The wheels of FDA public affairs can sometimes turn a bit slowly, but we finally have an explanation from Office of New Drugs director John Jenkins on why he authorized the review divisions to miss PDUFA deadlines, due to resource constraints.

We reported on that story in an earlier post, but here's Jenkins' explanation in its entirety. Enjoy.

"Over the past several years the rate of growth in workload for OND has far outpaced our ability to increase our staffing. The workload growth has occurred in many areas, including the number of meetings conducted with sponsors, the number of requests for Special Protocol Assessments (SPA), work related to emerging safety issues and early communication, work related to responses to Congressional inquiries, etc.

This workload imbalance was one of FDA's primary areas of focus when we were discussing with industry the PDUFA III and PDUFA IV program, and the PDUFA IV program includes a significant increase in resources to FDA to help address the workload concerns through increased staffing and better IT systems.

More recently we are faced with the increased workload related to the implementation of FDAAA and FDA's Safety First/Safe Use initiative. In addition to the resource increases under PDUFA IV, FDA also saw increased appropriations for FY2008 to help meet the growing workload. The new resources will have a significant impact on our workload/staffing balance in the long term, however, in the short term CDER is approximately 550 FTEs below its ceiling for FY08.

While we are working hard to recruit and train the necessary new staff (including replacement of staff who depart CDER for various reasons), it will take several years to achieve full staffing and to have all the new staff fully trained and productive. In that interim, it will be necessary for CDER and OND to make careful decisions about our work priorities, and those priorities will be reflective of our stated goals under Safety First/Safe Use to ensure proper balance between our focus on pre-approval activities and post-approval safety issues.

To that end, I have granted permission to OND division and office directors to make decisions to bring their unit's workload into better balance with their existing resources. These decisions will be made on a case-by-case basis since the balance is not the same in all divisions or even the same over time in any given division.

We will still strive to meet our PDUFA goals whenever we can, however, in some cases we may not be able to meet PDUFA goals and managers have been given the discretion to make those decisions. We have actually failed to meet many PDUFA goals (e.g., goals related to meetings with sponsors) over the past few years, although we have generally been able to meet most of our application review goals.

In the short term our ability to meet PDUFA goals is expected to decrease. In some cases we may have to cut back on work by declining requests from sponsors for guidance (e.g., meetings, multiple cycle SPA reviews) and in other cases we may decide to go past the PDUFA goal date for review of an application. In cases where we decide to go past the PDUFA goal date the sponsor will be notified by the division management of that plan.

It is important to note that decisions to miss the PDUFA goal date are separate and distinct from a decision to extend the PDUFA goal date by 3 months, which is allowed in response to the submission of a major amendment during the last three months of the review cycle.

CDER faces significant challenges in hiring the 550 additional staff (plus replacements for staff who depart for various reasons) authorized in our budget for FY08.

First, we have to find qualified candidates for the positions. We are aggressively undertaking that part of the effort through various channels including extensive advertisements and the use of recruitment incentives. Once we have identified a qualified candidate they must navigate through the complex Federal/HHS personnel system before they can receive an official job offer.

We have worked to gain permission to streamline that process as much as possible, however, in many cases it can still take months for the paperwork to make its way through the system before an official job offer is made. In some cases, candidates choose to take other positions before an official job offer from FDA can be made.

Finally, our pay structure often is not competitive to what qualified candidates can make in the private sector. We are working through existing authorities to make FDA's pay as competitive as possible in order to attract and retain the best candidates. As noted above, it is likely to take several years before CDER achieves full staffing and all the new employees are fully trained and productive. It can take 1-2 years, or more, for a new reviewer or project manager to be trained to do the complex work required at FDA.

We will be continuously assessing our workload and resources over time and make decisions on our priorities. There is no specific end date since I cannot predict when our resources will be in balance with our work. That is why there is no blanket policy but rather permission to reduce work as needed on a case-by-case basis."

image by flickr user oddsock used under a creative commons license.

Deals of the Week: March Madness

It's that time of year again. The nip in the air is almost gone; the birds have returned from their southern haunts, and madness grips the nation as men, women, and children suddenly grapple with one of spring's deepest mysteries: NCAA brackets.

But before you place your bets in the office pool, take a moment to review the madness that has gripped pharma land this week. 2007 may have been a tough year for J&J, but CEO Bill Weldon isn't taking it on the chin--his executive pay package increased 10% to $31.9 million. Merck's CEO, Dick Clark, also earned a hefty 80% raise. Meantime heparin continued to dominate the news (no pictures please), while an FDA advisory committee recommended placing new restrictions on the anemia drugs Epogen, Aranesp, and Procrit. And Pharma's vultures began circling Wyeth after the company and its partner Progenics Pharmaceuticals announced that their intravenous bowel drug, methylnaltrexone, failed in Phase III to improve GI function after surgery. Moreover, Wyeth withdrew its European application for the approval of Pristiq for menopausal hot flashes, citing the need for more data. Thank goodness the FDA approved that same medicine for depression last month; frustrated Wyeth execs might need it. (Alternatively maybe they should indulge in a glass of New Jersey's finest tap water. It could be just as potent.)

Here's a look at this week's mad, mad deals:


EUSA/Cytogen: Two-year old spec pharma EUSA Pharma continued pursuit of its rapid product- and infrastructure-build-up this week with the $22.6 million cash acquisition of US oncology and pain control group Cytogen Corp. EUSA—whose ambition is to become the next Shire—spotted a good moment to buy the ailing US group, whose shares have fallen steadily since early 2007, in part due to poorly-focused management. (See this IN VIVO Blog post for more.) Unlike most other spec pharma, EUSA’s goal has been to establish from the outset a business in Europe and in the US (as its name suggests). A tall order for a start-up, perhaps, but one that allows it to access a wider pool of product opportunities, larger growth potential, and to avoid the trap that many other European spec pharma hopefuls have fallen into: lack of focus. (See this IN VIVO feature for more background.)

AZ/Silence: Whatsamatta, our haiku wasn’t enough? Perhaps we were being unfair to Silence Therapeutics and AstraZeneca, who signed a deal in RNAi delivery yesterday. The financial details remain undisclosed and they probably don’t amount to much up-front anyway, and that’s just fine—the story here is the application of Silence’s proprietary Atuplex RNAi delivery system to the molecules AZ is developing against targets in the two firms’ earlier collaboration, which will probably net Silence some additional cash down the road. In addition, AZ and Silence are combining forces to develop novel delivery technologies in the RNAi space; the resulting delivery tech can then be used independently by either firm.

Lilly/Transition Therapeutics: Late in the week, Lilly announced it was teaming up with Transition Therapeutics to develop and commercialize the biotech's gastrin based therapies, including the lead compound TT-223, which is currently in early Phase II testing. Gastrin based therapies are an emerging class of drugs to treat Type 2 diabetes; preclinical and early human trials have shown they provide sustained improvement in glycemic control. Deal terms were very small, especially considering that TT-223 has already reach proof-of-concept: Transition receives just $7 million in an upfront payment and as much as $130 million in downstream sales and development milestones. No doubt the novelty of the class played some role in the low upfront. It's also possible that new draft guidelines issued in February by the FDA that recommend ratcheting up patient enrollment in Phase III trials of drugs tested for Type 2 diabetes may also have played a role. Many analysts believe those new guidelines were a key reason Lilly scrapped its partnership with Alkermes to develop the Phase III AIR Insulin program.

Reed-Elsevier/Windhover: On Monday, M&A got personal for the IN VIVO Blog. Reed Elsevier, publishers of Cell, Neuron, Lancet, and a host of other mags, acquired Windhover. Undoubtedly there will be synergies (sorry, we had to use the word) with another of Elsevier's offerings: FDC Reports, publishers of The Pink Sheet and The Gray Sheet. (Some mergers really do add value.) Meantime, we writers are muddling through the transition and speculating about the undisclosed deal terms. (Staffers are always the last to know.) If you've got information--or gossip--feel free to drop us a line.

Wyeth/Curis: In addition to dealing with the methylnaltrexone fall-out, Wyeth also announced Monday that it was ending its four-year collaboration with Cambridge biotech Curis Inc. to develop small-molecule treatments to treat stroke and cardiovascular conditions. The original collaboration gave Wyeth exclusive rights to Curis's hedgehog protein agonists for neurological disorders, while Curis kept the rights in other indications, including wound healing, hair growth, and bone disorders. (Hedgehog proteins play an important role in cell physiology and have been an important source of new pharmaceutical targets.) Deal terms at the time were small: Wyeth paid Curis a $3 million licensing fee and agreed to provide research funding for several years. Daniel Passeri, Curis's CEO, remained upbeat, saying "We remain hopeful about the future prospects of the Hedgehog agonist as a potential therapeutic for various diseases and we will seek a new partner to continue advancing this program." Meantime the company is focused on its cancer programs, and announced that collaborator Genentech was taking a hedgehog antagonist molecule into Phase II trials.

(Photo courtesy of Flickr user diz8882002 via a commons license.)

EUSA: Powering to Become the Next Shire?

Two-year old spec pharma EUSA Pharma continued its rapid product- and infrastructure-build-up this week with the $22.6 million cash acquisition of US oncology and pain control group Cytogen Corp.

EUSA—whose ambition is to become the next Shire—spotted a good moment to buy the ailing US group, whose shares have fallen steadily since early 2007, in part due to poorly-focused management (CEO Michael Becker was booted out last November). Thus even $0.62 per share represented a 35% premium to the company’s price on March 10.

And that’s not bad, considering that this acquisition completes EUSA’s transatlantic commercialization infrastructure, as well as slotting right into its therapeutic area focus. Cytogen is the “ideal complement to our business,” said Bryan Morton, EUSA’s founder and CEO, and previously CEO of Zeneus, the pan-European spec pharma acquired by Cephalon in December 2005 for $360 million.

Unlike most other spec pharma, EUSA’s goal has been to establish from the outset a business in Europe and in the US (as its name suggests). A tall order for a start-up, perhaps, but one that allows it to access a wider pool of product opportunities, larger growth potential, and to avoid the trap that many other European spec pharma hopefuls have fallen into: lack of focus. (See this IN VIVO feature for more background.) And while other European start-ups have found the road to spec pharma glory far longer and more tortuous than expected, EUSA has, so far, built what it said it would—and fast.

“Buying Cytogen took about three months,” Morton told the IN VIVO Blog. “That’s terribly long—we usually close such deals in about six weeks.” Since Cytogen was public, there were some more formalities to go through, he explains. The burdens of being public in part explain why EUSA didn’t reverse merge into Cytogen; instead it promptly de-listed the group (which, for its poor performance, would have been chucked off Nasdaq soon enough anyway).

With nine marketed drugs, five late-stage programs, a sales force in the US (Cytogen brings about 40 reps) and Europe (over 50 reps), and having raised a total of $275 million, EUSA almost makes building a spec pharma look easy. Morton’s experience and credibility helps; so does the fact that he explicitly sought out money from fresh VC funds (from founder-VC Essex Woodlands and from TVM, the lead in a recent $50 million round done in conjunction with the Cytogen deal), granting EUSA a 5-7 year runway to provide the payback.

But already, we have the “foundations of a world-class specialty pharma company” in place, according to EUSA’s Chairman Rolf Stahel (yes, he’s the ex-Shire CEO). Within the next five years, Morton hopes EUSA will be worth $1 billion—a mere tenth of Shire today, but moving in the right direction.

High Noon Haiku: Endo, RNAi, and EPO

Sometimes we don't have the time to cover all the stories we'd like. But occasionally we'd like to link over to them anyway, while encouraging you, the reader, to give us a short take on the rest of the day's news. Welcome to High Noon Haiku. Give it your best shot in the comments (remember, it's 5-7-5) ...

AZ and Silence
New deal in RNAi
Where are the details?

***

Amgen, J&J:
EPO benefits outweigh
The risks, FDA!

***

Peter Lankau's gone
Endo didn't waste much time
Holvek's the new boss

***

Wall St. Journal blog
Has good piece on new blind gov
Too bad they're Mets fans

(image via threadless.com)

When Life Gives You Lemons, Make Lemonade (Caution: side effects may include forgetting you made lemonade)

Developing drugs that block the pain receptor TRPV1 just got a whole lot more complicated.

A study published in today's issue of the journal Neuron suggests these drug candidates may interfere with learning and memory, and that this action may be responsible for the reported psychiatric side effects of Sanofi-Aventis' rimonabant, as well.

A quick search through our Strategic Transactions Database throws up at least two recent TRPV1 deals--by Eli Lilly and Wyeth--to gain access to inhibitors of the receptor (which goes by the full and catchy name of transient receptor potential vanilloid 1). Lilly paid Glenmark $45 million up front plus milestones for access to the TRPV1 inhibitor GRC6211 just last November and Wyeth teamed up with Mochida Pharmaceuticals in January (naturally, Deals of the Week! was there to cover these for you in real-time). Activation of TRPV1 causes pain associated with inflammation and is triggered by molecules like capsaicin, which is found in chili peppers.

Wyeth and Lilly and others (such as NeurogesX, Pfizer, and Merck) aren't intending to mess with the brain, of course, they're targeting the receptor in the peripheral nervous system to ease pain associated with osteoarthritis, neuropathy, and other maladies. But the researchers, led by Brown University's Julie Kauer, working with slices of rat brain demonstrated for the first time the function of TRPV1 receptors in the CNS, where they appear to be part of the neural circuits of learning and memory in the hippocampus.

From the press release accompanying the paper:

“The broad distribution of TRPV1 receptors in the brain suggests that these receptors could play a similar role in synaptic plasticity throughout the CNS.” ... The researchers said their findings suggest that drugs targeting TRPV1 could act not only on pain receptors in the PNS, but in the brain as well. They also wrote that their findings and those of other researchers “indicate that drugs that bind to CNS TRPV1 receptors are likely to influence more than just pain-related functions.”

Kauer and colleagues also noted that TRPV1 was inhibited by rimonabant, possibly introducing new headaches for Sanofi-aventis and other -abant hopefuls like Merck & Co. (the latter has yet to officially comment on the abstract referring to some poor Phase III data due to be presented later this month at the big ACC meeting in Chicago).

But wait, you say, we understood there was to be lemonade? Fair enough. Despite the fact that Kauer's findings "have important implications for the development of drugs targeting TRPV1," and that they "cloud the prospects of TRPV1 analgesics," there may be some good news, according to the authors of a preview of the paper (also in Neuron), Benedict Alter and Robert Gereau, from the pain center at the Washington University School of Medicine.

Apparently, TRPV1 inhibitors that act both in the periphery and in the brain actually work pretty well at soothing pain. And what's more the drugs could find uses in other brain disorders, such as epilepsy, Alter and Gereau write.

Pain is a notoriously tricky clinical space that is nevertheless receiving quite a bit of pharma attention--Pfizer devoted more time to pain at its recent analyst day than to any other therapeutic area, to our surprise. Though this is just one study, in rats, and concerns just one target, it's another reminder that the science of pain and pain relief is complex, and in its early days.

Hat tip: Reuters

FDA’s Careful Reading of the EPO Market

The headlines today focus, quite logically, on the big question that the Food & Drug Administration will be asking the Oncologic Drugs Advisory Committee on March 13: should the approval of EPO (Amgen’s Aranesp and Johnson & Johnson’s Procrit) for use as supportive care in oncology be rescinded?

In briefing materials posted on FDA’s website today, the agency lays out the issues it wants the committee to discuss, including the possibility of removing the indication for use of the drugs in the cancer setting. (EPO products are also used to treat anemia in other indications, primarily kidney disease.)

The possibility of FDA withdrawing the approval of what has been a standard component of chemotherapy regimens for almost 15 years is truly astonishing to consider. But it is by no means surprising that the committee will be asked to discuss that possibility. When FDA announced the latest ODAC visit for EPO in January, the agency made very clear that it would be at least raising the possibility of withdrawing that indication altogether. (You can read our analysis of the issues at stake March 13 here.)

The more interesting reading for biopharma executives trying to make sense of the new drug safety climate comes in an appendix to the briefing materials, containing the review of potential risk management options for EPO by FDA’s Office of Surveillance and Epidemiology.

Assuming the committee supports leaving at least some oncology indications in place for EPO, the discussion will quickly turn to risk management options. And, as of the end of this month, FDA is armed with the power to make those programs mandatory.

The FDA Amendments Act, signed into law in September, spells out a series of tools that FDA can require as part of Risk Evaluation & Mitigation Strategies. What it does not do is spell out how, in practice, FDA will choose which tools to apply—and how to determine what is or is not an effective strategy.

That is where Appendix 2 in the briefing documents comes in.

To us, it reads like a case study in how the agency will define the metrics for success in REMS.

The message it sends is unmistakable: "success" for a sponsor facing a serious safety question looks an awful lot like failure in a commercial context. When FDA wants to know if a REMS is working, it will look at market data or other commercial tracking statistics for evidence that use is declining—either overall or in submarkets of concern.

The analysis is filled with market research statistics. The agency uses retail prescription data to look at how use of the drugs has been affected by risk management steps taken so far. The review acknowledges reimbursement changes by the Centers for Medicare & Medicaid Services as an important factor as well (though we would argue that CMS’ policy probably is the biggest reason for reduced use of EPO.)

But the agency drills down much deeper, looking into metrics like settings of use. Aranesp, FDA finds, is used most commonly in outpatient clinics (54% of vials sold), while Procrit’s largest in non-federal hospitals (39%). Outpatient pharmacies are relatively small markets for each brand, FDA notes. “Interestingly, the long-term care channel accounted for approximately 10% and 5% of sales distribution for Procrit and Aranesp, respectively.”

The agency also looks at indications associated with use of the drugs. “The top two diagnoses or indications associated with the use of Procrit and Aranesp as reported by office-based physician practices were ‘other and unspecified anemias’ (ICD-9285), and ‘chronic kidney disease’ (ICD-9 585), each accounting for roughly 60% and 12% of use during year 2007.”

FDA and the committee will discuss options ranging from informed consent procedures to “voluntary” limits on advertising to restricted distribution programs—including programs that would restrict use by setting of care or by indication. So data on prescription trends, settings of use and indications will be useful for determining what types of risk management tools might work—and, more importantly, for future assessments of whether the programs are in fact working.

And, let’s be blunt: until FDA has better measures it will be looking for less use of a product with safety considerations. That is one of the uncomfortable new realities of the era of REMS: investing in marketing campaigns that intended to produce overall reductions in prescriptions, reductions in off-label indications, or reductions in vials shipped to “interesting” submarkets, like long-term care.

If You Want a Job Done Right....

Well, this is a bit of a surprise.

After a lengthy search for a permanent head of FDA’s Center for Drugs Evaluation & Research, the agency is turning the reins over to an old hand—Janet Woodcock.

We admit it: like most of Washington, we didn’t see this one coming. While we wrote about the probability of a candidate emerging from inside FDA in last month’s issue of The RPM Report, we didn’t predict that Woodcock would be the final choice to head CDER.

But we take some comfort in the fact that no one else did either. For most folks in the policy world—including those on Capitol Hill—Woodcock’s return to CDER (she was director from 1994 to 2005) was a big surprise, and frankly, a bit of a head-scratcher.

After all, moving from the number-two spot at FDA to head the center for drugs could be seen as a demotion of sorts—especially since Woodcock was given a position in the commissioner’s office at a time when it was perceived that she might leave the agency altogether.

Rather than risk her leaving FDA altogether, Crawford gave Woodcock the title of deputy commissioner for operations and chief operating officer, and named Steven Galson to succeed her as CDER director. Under Andrew von Eschenbach, Woodcock became FDA's chief medical officer. But when Galson was tapped to be the acting Surgeon General, she stepped back in as acting head of CDER.

So if nothing else, relinquishing her commissioner office-level roles to become the permanent head of CDER frees up Woodcock's schedule a bit. According to FDA, the agency will be looking for someone to succeed her as deputy commissioner and chief medical officer. That may not be an easy task, given that the position of CMO was created precisely with her in mind after it was recommended by the Institute of Medicine in a review of the agency's drug safety programs.

So it comes as a bit of a shock that Woodcock is back in the director’s chair. But given that she was leading the CDER director search committee—and therefore ultimately picked herself as Galson’s successor—we assume she found enough good reasons to return.

Many point to a potential political advantage: as director of CDER, Woodcock will be well-positioned with the incoming Administration. Being outside the Office of the Commissioner will allow Woodcock to be viewed more as the career FDA official she is, rather than a political functionary of the outgoing Bush Administration.

But someone like Janet Woodcock doesn’t need to worry about playing politics to stay employable: there are plenty in industry and elsewhere who would welcome her with open arms—and a hefty pay raise. And people that know her well argue that she’s not the kind of person that would try to preserve her job at all costs.

Perhaps what Woodcock’s appointment really reflects is a commitment on her part to steer CDER through this time of transition. After all, there will be plenty of action in the drug center around the implementation of the FDA Amendments Act, a task Woodcock herself has acknowledged will be a unique and historical challenge.

Plus, she’ll be returning to CDER at a time when the future of the prescription drug user fee program is in question, so she’ll have an opportunity to fix the program that she first helped implement back in 1992. Indeed, the news that Office of New Drugs Director John Jenkins had given his medical reviewers the green light to slip a little on user fee deadlines may have helped push the CDER announcement along.

Plus—and let’s be frank here—given the resource and morale issues at CDER right now, who else would want that job? As one policy person we spoke to pointed out, there are only so many “buckets” of people that would even qualify.

FDA can’t bring in anyone that might appear to be conflicted, or risk the ire of Capitol Hill, so candidates with industry ties are out. That leaves either:

(1) academia. With CDER in such disarray, there are few academics with the management skills to steer the center through choppy waters; or

(2) current FDA officials. While CBER chief Jesse Goodman looked to be a solid pick to head the drugs center, Woodcock’s experience—and a thick skin that was on display at Rep. Rosa DeLauro’s appropriations hearing last month—ultimately helped make her the only viable choice.

For industry, this couldn’t be better news. Woodcock is well known by pharmaceutical and biotech manufacturers, and is certainly a familiar face to head CDER. While some critics question whether she is too cozy with industry, on the whole, she is seen outside the agency as a smart, honest and pragmatic leader.

The Pharmaceutical Research & Manufacturers of America issued a statement of strong support, noting her “willingness to work with diverse partners.” And one VP of global regulatory affairs, Amgen’s Paul Eisenberg, gave her a thumbs-up. When we asked him what type of person Woodcock should pick for CDER, he suggested that she should pick someone like herself. “She is really a leading driver for improvement of how FDA focuses on science and approvals," Eisenberg said.

Well, if the right prescription for FDA was to find someone just like Janet Woodcock to run CDER, then she certainly made the right choice.

Drug Approvals Rorschach: What Do You See?

Derek Lowe over at In The Pipeline posted some observations today about a recent Nature Reviews Drug Discovery article, authored by Bear Sterns analysts Elizabeth Czerepak and Stefan Ryser, regarding the origin of drugs that are approved by FDA and drugs that fall at the last clinical hurdle.

In this analysis of a total of 103 FDA approvals and 91 Phase III failures between January 2006 and December 2007 drug candidates straight outta pharma seemingly performed best: 36 approvals vs only five failures--adding an additional four approvals for pharma based on acquired programs takes the figure to 40 (whereas biotech-pharma alliances yielded 16 approvals vs 18 failures, and biotech-only figures were 47 and 68). But there is a caveat: these are not all novel chemicals and biologics--line extensions and me-too drugs are included in the tally and fairly evenly spread between pharma and biotech.

Still, when looking purely at the approvals (63 generated by biotech, compared to 40 by pharma), the upshot of the original analysis is no suprise: that biotechs ought to continue to enjoy good leverage over their would-be pharmaceutical partners when it comes to filling pharma pipelines via acquisitions and licensing deals.

Though as the analysts themselves point out (and Derek & co concur), if biotech-pharma collaborations boast solid results it is potentially because pharma has already cherry-picked the most promising biotech drug candidates. You'll find no argument from us there--that's one reason Phase II deal values are on such a dramatic up-swing. It also begs the question: for pharmas, mightn't it be a prudent strategy to do more alliances?

Maybe, maybe not: if biotechs sport the most success, they also sport the most failure, and in the process drag down the stats of their pharmaceutical partners. Czerepak and Ryser hypothesize that the abundance of clinical failure by biotechs is a result of under-funding, leading back to their "More Alliances, please" conclusion.

Could it be, as others have suggested, that the failure rate among biotechs can best be explained by their lack of regulatory and late-stage clinical development experience? That probably plays a role. We also considered the possibility that biotechs' high failure rate during the '06-'07 time frame could be an artifact of the relative abundance of financing available, even for mediocre projects, back during the biotech bubble, when many of these molecules would have been entering the clinic.

And on top of that, even though there are many more biotech projects in this sample than pharma--149 for biotech and biotech/pharma collaborations vs. 45 pharma-only ventures--many smaller firms are likely to only have one or maybe two clinical projects. Killing off a lead compound can mark the death of a small firm: that means even iffy Phase II compounds can find their way to pivotal trials. Despite their recent pipeline woes, Big Pharma have the luxury of attrition.

Finally, as Derek and his commenters point out, it should be noted there is some semantic confusion around what is and what is not a biotech product. For the purposes of the Bear Sterns analysis a 'biotech' drug is one developed by a company listed on the AMEX or Nasdaq biotech indices--not the more traditional (and accurate) definition related to biologics vs small molecules. But that argument is for another post; besides, isn't everyone just specialty pharma these days anyway?

What do the numbers tell you? Write back and tell us.

Self-Portrait in a Convex Mirror: Writing about Your Own Acquisition

Given how often acquisitions have been the meat of my articles, it feels not a little odd to be writing about the subject on such a personal level.

Last week, Windhover – the publisher of this blog -- was acquired by Reed Elsevier. We'll be merging with its FDC Reports division, which publishes The Pink Sheet, among other industry newsletters.

I’m aware of the potential for self-delusion about the strategic rightness of deals and also aware that awareness is not in itself an antidote.

But – caveat emptor -- the fact is that, even seen in the convex mirror of self-interest, this deal makes sense. It gives us a chance to provide readers with an information platform stretching from daily and weekly news reporting to serious monthly analysis, informed by lots of data, on the Windhover side, about transactions, and, on the FDC side, clinical development. Windhover has long contemplated how to get into the news business that FDC publications like The Pink Sheet and The Gray Sheet have got down pat; and FDC into the kind of analysis I think we do pretty well at Windhover.

I don’t know the vast majority of my new colleagues from FDC, though I have of course long known the publications. And I know the kind of quality I’ll be working with—having lured into Windhover, back in 2005, the former president, the former editor in chief, and two other stellar FDC journalists – all four of whom, in addition to creating and running for us The RPM Report, have been prolific contributors to this Blog and to Windhover in general.

That said, there’s also no overlap between us. Along with its analytical publications, Windhover runs conferences, publishes market-research reports in the medical-device business, and puts out, IMHO, the world’s best database of industry transactions. FDC doesn’t do any of that– but does publish news-oriented newsletters in pharmaceuticals, medical devices, and OTC and consumer products—along with a stunningly compatible database of compounds in development.


The opportunity to put all of that onto a single electronic platform, to provide readers a seamless source of intelligence capable of informing a variety of decisions from a variety of points of view – financial, regulatory, commercial and scientific – is too appetizing to turn down.

Watch this space.

While You Were Springing Forward

It certainly doesn't feel like spring at Windhover UK, but we'll take your word for it. Here are a few newsy things you may have missed over your abbreviated in-like-a-lion weekend.

• Lilly's Alaskan Zyprexa adventure rumbles along. The New York Times took a look on Saturday at Friday's testimony from Dr. John Gueriguian, a diabetes specialist and ex-FDA reviewer testifying on behalf of Alaska, whose bottom line is this: Lilly put “profit over concern of the consumer" by waiting too long to inform doctors of Zyprexa's links to severe weight gain and blood sugar changes.
  
• The WSJ interviews Amgen CEO Kevin Sharer, who talks about Amgen's recent tough times, its deal with Takeda, the difficulties of drug discovery and development, and some of the Big Biotech's new products, denosumab (D-Mab) and N-Plate, among other things. No word on why Amgen is giving all its product candidates these celeb-esque nicknames though.
  
• Hey, check it out. Free pharmaceuticals! (In your drinking water supply.) But just how will pharmacos charge for these freebies?
  
• More on this later, but for the moment allow us to get our Kent Brockman on to say we, for one, welcome our new insect corporate overlords.

The Windhover photo from flickr user greg.turner used under a creative commons license.