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TODAY’S HEADLINES:

• Trius Therapeutics raises $30M for new antibiotics (release)
• Genomas gets $1.2M grant for genomic side-effect tests (release)
• Provasculon receives $500K, enters Biogen Idec incubator (VentureWire)
• Animal diagnostics firm Quadraspec aims for $5M round (VentureWire)
• MPM Capital names two executive partners (release)
  

Trius Therapeutics raises $30M for new antibiotics – Trius Therapeutics, a San Diego startup developing new treatments for antibiotic-resistant infections, raised $30 million in a second funding round. Investors included Kleiner, Perkins, Caufield & Byers, FinTech Global Capital, Sofinnova Ventures, Versant Ventures, Interwest Partners and Prism VentureWorks.

Trius said the funding will allow it to push its new treatment, an oxazolidinone antibiotic it calls TR-701, into late-stage human tests. The drug, which is intended for drug-resistant staphylococcus and similar infections, is currently in early-stage, phase I trials. Unlike many other new antibiotics, which must usually be taken intravenously, the Trius drug can be taken as a pill.

Genomas gets $1.2M grant for genomic side-effect tests – Genomas, a Hartford, Conn., personalized-medicine startup, received a $1.2 million small business-innovation grant from the NIH. The grant will fund genetic work aimed at identifying people who are most likely to suffer painful side effects from cholesterol-lowering statin drugs.

Statins — particularly Pfizer’s Lipitor, the best-selling drug on the market today — have built up a formidable reputation based on studies that showed they could prevent fatal heart attacks. More recently, however, critics of the drugs have pointed out that stopping one heart attack requires close to 100 people to take the drugs regularly, putting new attention on statin side effects, which can range from painful muscle aches and weakness to memory loss. The Genomas test is intended to reveal whether an individual patient is likely to experience those nerve and muscle effects, known technically as statin-induced neuromyopathy.

TODAY’S HEADLINES:

• Adnavance pulls in C$3.7M for molecular diagnostics, names new CEO (release)
• “Personalized medicine” co. Proprius sells to Cypress Bio for up to $75M (release)
• Vaccinex raises $25M in wake of GSK deal for antibody drugs (VentureWire)
• Cianna Medical receives $9M for breast-cancer radiation treatment (release)
• Electron-microscope image provider NanoImaging takes in $1.5M (release)
• CrystalGenomics, ProQuest Investments create JV co. Palkion (release)
• Portico Systems, software maker for insurance plans, raises $7.7M (release)
• Stealthy biotech Affomic takes in $7M (peHUB)

Adnavance pulls in C$3.7M for molecular diagnostics, names new CEO – This item is now a standalone post here.

“Personalized medicine” co. Proprius sells to Cypress Bio for up to $75M – Proprius Pharmaceuticals, a San Diego diagnostics maker, sold itself to publicly traded Cypress Bioscience for up to $75 million in cash. The company’s release is here.

Cypress will pay $37.5 million up front, and another $37.5 million to Proprius shareholders as milestone payments. Proprius licenses and develops drugs and diagnostics for various forms or arthritis. Its most immediate product candidates include tests that aim to predict whether certain individuals will develop rheumatoid arthritis and that monitor patients’ response to methotrexate, a common treatment for RA.

Vaccinex raises $25M in wake of GSK deal for antibody drugs – Rochester, N.Y.-based Vaccinex, a developer of antibody drugs, raised $25 million in an add-on to its second funding round, VentureWire reports. Investors included Teva Pharmaceutical Industries, Pan Atlantic Bank and Trust and individual investors.

Earlier this month, Vaccinex and its partner EUSA Pharma licensed a Vaccinex antibody to GlaxoSmithKline for up to $44 million plus royalties. Vaccinex and EUSA will split any profits from GSK’s potential sales of the drug.

Cianna Medical receives $9M for breast-cancer radiation treatment – Cianna Medical, an Alisa Viejo, Calif., developer of devices for delivering local radiation in breast cancer, raised $9 million in a first funding round. Fog City Fund, Windamere Venture Partners and several private individuals provided the cash.

Cianna, which was spun out of BioLucent when it was acquired by Hologic last year, is working on new devices for brachytherapy, the general term for temporarily implanting radioactive material at the site of a tumor in order to provide localized radiation treatment. The Cianna device is designed to improve upon existing brachytherapy techniques in breast cancer.

Electron-microscope image provider NanoImaging takes in $1.5M – San Diego’s NanoImaging Services, a provider of imaging services involving transmission electron microscopy, raised $1.5 million in a funding round. Merck Capital Ventures led the round. The company specializes in the characterization of large biological molecules such as proteins, which are used in a variety of products such as vaccines and drugs.

CrystalGenomics, ProQuest Investments create new JV, Palkion – Today’s award for most baffling announcement comes courtesy of CrystalGenomics, an Emeryville, Calif.-based U.S. unit of the Korean drug-discovery company CG Pharmaceuticals, and ProQuest Investments, a New Jersey VC firm, who together have formed a joint venture they’re calling Palkion. Their release is here.

What is Palkion going to do? Beats me. Here’s what the release says:

Under this agreement, CrystalGenomics will receive up to $6 million in upfront and initial research funding from Palkion, in addition to development and sales milestone payments of potentially more than $200 million. CrystalGenomics will also initially own 50% of Palkion, Inc. ProQuest will capitalize Palkion with a Series A investment and also provide the management personnel for Palkion. CG will use its unique structure-based drug design capabilities to identify drug candidates while Palkion will oversee the clinical development of novel drug candidates.

So, let’s get this straight. CrystalGenomics and ProQuest form Palkion, in which they’ll hold equal stakes despite the fact that ProQuest seems to be putting all the capital and personnel into the venture. Palkion will then start handing the money to CrystalGenomics, which will continue trying to discover drugs while Palkion “oversees” the process of testing those drugs in people. All clear?

The best I can figure is that this is a roundabout way of putting a more “American” face on a basically Korean startup that — to judge from its Web site and, in fact, this press release — seems to have a certain amount of difficulty communicating clearly with a U.S. audience. That could certainly be a problem if its drugs make it into clinical trials, given how dialogue with the FDA becomes rather crucial at that stage. But that’s just my guess at this point.

Stealthy biotech Affomic takes in $7M – Affomic, a New Haven, Conn., biotech startup so stealthy that it can announce a funding without giving anyone a clue as to what it’s doing, raised $7 million in a first financing round, peHUB reports. Investors included Connecticut Innovations, Elm Street Ventures, and Four Seasons Ventures. It goes without saying that Affomic doesn’t have a Web site — in fact, the startup doesn’t even exist so far as Google is concerned.

(UPDATED: See below.)

As I discussed a few weeks ago with respect to deCODEme — a “personal genomics” service hurriedly launched last November by Iceland’s deCODE Genetics in an apparent attempt to beat 23andMe to market (it succeeded by a day or so) — these sorts of services can awfully dense and difficult to navigate. The deCODEme service appears to be particularly bad in that respect, both in terms of its design and even the underlying science used to justify the genetic information displayed in a demonstration user account.

So it’s a pleasant surprise to report that 23andMe, which over the weekend began allowing people to set up demonstration accounts itself, appears to have made the process of understanding your genetic inheritance about as simple and intuitive as it can probably get. The demo accounts don’t display your own genetic information, of course — instead, they show a profile for the fictional Greg and Lilly Mendel and their immediate relatives. (The family name is inspired by Gregor Mendel, a nineteenth-century monk known as the “father of genetics” for his studies on the inheritance of pea plants; the profile uses actual data from an anonymous European family.)

These sorts of demo accounts are particularly useful given that 23andMe and its competitors are charging customers roughly $1,000 for a genetic analysis, which is a lot to shell out when you don’t have any real idea what you’re getting for your money. To sign up for a 23andMe demo account, click here.

Like all these services — of which there are currently at least four, counting the new DNATraits project launched recently by Family Tree DNA — 23andMe takes a genetic sample (here from having users spit repeatedly into a tube) and checks 600,000 or so individual DNA “letters,” or bases, known to vary between people. After analyzing those letters, the company posts your genetic information on a Web site where you can see what your particular genetic pattern says about inherited traits such as your susceptibility to cancer or heart disease, longevity and even eye and hair color. Not only can you spin through the data in as much or as little detail as you like, you can share it with relatives or friends and search for others with similar traits.

One of the first things a new visitor will see is the clean and uncluttered look of 23andMe’s “gene journal,” which lets you scroll through various genetic traits and then dive in to see how you — well, your Mendel stand-in — fare compared to the population at large. (See a screenshot of Greg Mendel’s gene journal using the thumbnail above and to the left.)

More after the jump: Read the rest of this entry »

TODAY’S HEADLINES:

• Compact ultrasound maker Zonare Medical raises $30M (VentureWire)
• TherOx raises $30M for hypersaturated-oxygen devices (peHUB)
• Accumetrics, antiplatelet-drug diagnostic maker, raises $29M (release)
• Population Genetics takes in £3.8M for massively parallel genome studies (GenomeWeb)
• “Brain fitness” trainer Dakim raises $11M (release)
• BioIQ, home-diagnostics maker, takes in $2.5M (release)
• Hospital med-tracker Sabal Medical raises funds (release)
• Seattle’s PharmaIN gets $400K NIH grant for nanoparticle staph drug (PDF release)
• SensiGen, molecular-diagnostics developer, receives Michigan state loan (release)
• Arcus Ventures aims for $50M fund, targets cancer (VentureWire)

Compact ultrasound maker Zonare Medical raises $30M – Zonare Medical Systems, a Mountain View, Calif., maker of ultrasound-imaging systems, raised $30 million in a recent seventh funding round, VentureWire reports. Existing investors provided the funding, a group that includes Frazier Healthcare Ventures, 3i Group, Mosaix Ventures, CB Health Ventures, Draper Fisher Jurvestson, Ascension Health Ventures, Kaiser Permanente Ventures, Earlybird, Saints Capital, Merrill Lynch Venture Capital and Texas Instruments.

The company said the funding should set it on the road to profitability and eventually to a hope-for IPO. Zonare makes compact ultrasound systems that can be used in sonography and for a variety of other medical diagnostic purposes.

TherOx raises $30M for hypersaturated-oxygen devices – TherOx, an Irvine, Calif., maker of oxygenation devices for treating heart attacks, raised $30 million in a tenth funding round, peHUB reports. Investors included Kleiner Perkins, Integral Capital Partners and New Science Ventures.

The startup makes devices that supersaturate blood with oxygen, then infuse that blood into areas of the heart at risk of damage from oxygen starvation due to a heart attack. TherOx has now raised over $120 million in venture funding.

Accumetrics, antiplatelet-drug diagnostic maker, raises $29M – San Diego’s Accumetrics, a maker of diagnostics that measure patient response to anti-platelet drugs, raised $28.8 million in a fourth round of funding. Investors included Arnerich Massena & Associates, BBT Fund, Essex Woodland Health Ventures, RiverVest, PTV Sciences, KB Partners and Kaiser Permanente Ventures.

The startup makes a system that measures how well individuals are reacting to treatment with anti-platelet drugs, which are used to prevent or help dislodge major blood clots. Since patient response can vary widely, often as a result of genetic factors (see our coverage of this sort of “personalized medicine” here), such monitoring can help doctors avoid dangerous overdoses or to switch unresponsive patients to higher doses or different drugs as necessary.

Population Genetics Technologies takes in £3.8M for massively parallel genome studies – Population Genetics Technologies, a U.K. startup devoted to technologies for studying thousands of genomes at once, raised £3.8 million ($5.9 million) in a first funding round, GenomeWeb reported. Investors included Auriga Partners, Noble Fund Managers, and Compass Genetics Investors.

The company raised £1.1 million in seed funding from the Wellcome Trust back in 2005 to aid in the development of the technology. PGT is working on a technique devised by Nobel laureate Sydney Brenner that purports to analyze genetic variation in DNA samples from thousands of individuals at once.

In this 2005 release, PGT co-founder Sam Eletr described the method as “will allow the mixing of thousands of samples in one test tube and the simultaneous interrogation [analysis] of all of them in one experiment, instead of in as many experiments as there are genomes in a population…. We expect our technology to allow handling much larger numbers of genomes than pooling does and to have the further advantage of protecting the identities of individuals involved in any population study by allocating them a code that may be kept confidential. We expect it also be applicable to any collection of DNA molecules and genomes, whether from plants, animals, micro-organisms or humans.”

PGT also named Mel Kronick, a former R&D manager at both Agilent Technologies and Applied Biosystems, as CEO.

23andMe held its official launch today, as expected, and in the process managed to address a few of the nagging questions that remained after I reviewed its service over the weekend. “Addressed” is definitely the operative word here, though, because firm answers are still in short supply.

For instance, can personal genomics really make money for a startup like 23andMe? (To recap briefly for those joining the show already in progress, the company will scan your genome from a tube of spit you send in, and then post the results on a personal Web page for you to browse for information on your ancestry and disease risks.) The official answer is that no one knows, in part because the field is still remarkably young — just three days old, actually — and partly because 23andMe founders Linda Avey and Anne Wojcicki decline to outline their thinking in much detail. For instance, when I spoke to the co-founders earlier today, Wojcicki insisted that “it’s really too early to specify how we might monetize and derive value from the information we’re aggregating. We’ve thought about a lot of different ways to monetize it, but we’re not ready to talk about them.”

Since virtually no one sinks $8.9 million (what 23andMe raised in its first round) into a startup that lacks even an inkling of a business plan, however, it seems safe to say that the company is simply being circumspect. Here’s my best shot at connecting the dots.

To put it bluntly, the real money is likely to lie in selling corporations — specifically, drug companies — access to the aggregate genetic information 23andMe amasses from its customers. During a Webcast this morning, and again in our interview, Avey and Wojcicki emphasized 23andMe’s plans to conduct large-scale genetic-association studies using the genetic-data database their customers will essentially create. (Talk about your ultimate user-generated content.)

Both 23andMe founders, of course, stress that the company won’t disclose personal information, but that’s not really the point. If the company succeeds in attracting the hundreds of thousands of customers Avey and Wojcicki talk about drawing, it will be sitting on one of the largest genetic databases on Earth. And there’s no opting out of any research studies 23andMe wants to conduct at that point, either, since the consent forms to which customers must agree specifically commit their genome-scan results to future research. From that form:

23andMe Sponsored Research: We may analyze your genetic and other voluntarily contributed personal information as part of our scientific research with the purpose of advancing the field of genetics; your account information will never be associated with this research. We may also analyze your genetic and other contributed personal information for the purpose of reviewing and improving our services and creating new features and services. We may ask you questions and you may choose to give us information about yourself through surveys or other features on our website. Contributed personal information might include age, sex, geographic ancestry and diseases or conditions you have, or have experienced. It is entirely within your discretion to provide information or answer survey questions.

Collaborative Research: 23andMe may enter into partnerships with other organizations—non-profit and/or commercial—that conduct scientific research. Prior to embarking on any such projects, 23andMe will establish a research advisory committee to guide such collaborations. 23andMe may grant researchers associated with partner organizations access to our database of genetic and other contributed personal information after such organizations agree to maintain confidentiality consistent with our privacy policy. External researchers will have access to your genetic and other contributed personal information but they will not have access to your account information (e.g. contact and payment information).

In the Webcast and in our interview, Avey and Wojcicki tended to stress the prospect of academic studies over commercial research. For instance, 23andMe is in discussions with foundations that support work on Parkinson’s disease and autism, in hopes of first attracting large numbers of patients to the service, and then using their data to pin down how genetic differences play a role in each disease.

Still, neither academics nor disease-focused foundations are likely to provide the level of funding that could turn a company like 23andMe from an intriguing curiosity into a commercial powerhouse. Who does have that kind of moolah? Big Pharma and Big Biotech, of course. Recall, for instance, that 23andMe is backed not only by Google, but also by Genentech.

What’s more, pharma/biotechs stand to gain tremendous “value” from studies that help pinpoint which patients are most likely to respond to a particular drug, and which ones are likeliest to suffer serious side effects. (For instance, consider the Big Pharma personalized-medicine coalition we wrote about here, and think how much easier its job would be if it could tap a gene database like the one 23andMe envisions building.) It’s almost as if 23andMe and the drug industry were made for one another — as, perhaps, they were. (Wojcicki is a former biotech investor for a San Francisco hedge fund.)

This, of course, helps explain why Avey and Wojcicki are cagey about their business plans, because people might be a little reluctant to sign up for a service that’s effectively going to turn over their genomes to help Big Pharma make more money. I’m not saying they’d be correct about that — this sort of database could conceivable yield some major health benefits in the form of better-targeted drugs — just that public perceptions of the drug industry are bad enough that dwelling on such partnerships could put a damper on 23andMe’s plans.

This sort of strategy still isn’t a slam dunk, of course. With two other personal-genomics services in business or near to it (Navigenics and DeCode Genetics’ DecodeMe), competition for pharma deals could be fierce. What’s more, the genetic databases alone aren’t much good for these sorts of association studies, as researchers will also need to know more about individuals’ “environmental” circumstances — which include anything from their age and lifestyle habits to their medical and family history. If no one answers the surveys intended to elicit this information, the studies, and the dollars behind them, will dry up in a hurry.

A few other items that emerged from today’s discussions:

• 23andMe’s basic $999 fee covers use of its genome-analysis tools indefinitely — the company doesn’t plan to hit customers up for an annual subscription fee, unlike rival Navigenics. (Except that 23andMe may eventually launch some sort of advanced service that requires a subscription fee.)
• Avey and Wojcicki argue that charging $999 for their service alone would make 23andMe a going concern. At the same time, though, 23andMe is offering “friends and family” a discount of just 15 percent to get a genome scanned “at cost,” which suggests that the gross margin on that service is really not that great.
• Regarding the medical utility of the 23andMe scan, Avey says the company urges anyone concerned by a disease-related finding should re-confirm it with a standard genetic test.
• Apparently 23andMe customers will also have access to a range of additional information that’s not available on the company’s public site. Pointers to genetic counseling will be located there.
• The company is looking into launching some form of genome-related social networking in the future.

Medical treatment that’s tailored to your individual genetic profile — “personalized medicine,” for short — has been a long, long time in coming, as I’ve noted here and here. Part of the reason, of course, is that personalizing medicine cuts against the economic interests of major players in the medico-industrial complex, particularly the large biotech and pharma companies whose business models have long been based on the prospect of getting as many patients as possible to take large doses of their drugs.

So what to make of yesterday’s news that seven major drugmakers are joining academic researchers to study genetic variations that might make patients more susceptible to side effects? At first glance, some of the coverage suggests that the industry is rethinking its passive-aggressive opposition to personalized medicine, thanks in part to a bit of a nudge from the FDA. Take, for instance, this AP story:

Dubbed the International Severe Adverse Events Consortium, the project will use genetic data to try to design safer drugs and to identify patients at risk of dangerous side effects because of a variation in their genetic makeup.

“This is what personalized medicine is really about, finding out for the individual, not just the general population … what their risks are,” said Dr. Janet Woodcock, deputy commissioner for operations at the Food and Drug Administration, which is under growing pressure to ensure drugs are safe. “Up until now we’ve been kind of helpless” in dealing with adverse effects, she said.

Reports of such events are on the rise, jumping 150 percent from 1998 to 2005, a recent study found.

Or this, from the NYT story linked above:

Seven of the largest pharmaceutical companies have formed a group to develop genetic tests to determine which patients would be at risk from dangerous drug side effects.

The new group, the International Serious Adverse Events Consortium, is one of a wave of cooperative research efforts sweeping the drug industry, as companies come under pressure to cut costs and increase their success rates in developing medications. The Food and Drug Administration has encouraged the formation of such groups.

First, this is clearly a worthy effort, no matter how late to the party it might seem. Whatever your feelings about the drug industry, anything that might spare patients from severe drug side effects represents a step forward — not just for those who can avoid dangerous health complications, but also for the people who might be put at risk when a drug that could help them is withdrawn for safety problems that are unlikely to affect them.

Second, though, it’s telling to me that one of the first major industry-wide personalized medicine efforts should focus specifically on rare side effects, since it is exactly these sorts of safety problems that pose the biggest threat to the blockbuster-drug model in the first place, as discussed here. (Put briefly, a blockbuster drug by definition is taken by large numbers of people, for long periods of time, or both, which inevitably increases the chance that safety problems will emerge.) Anything that reduces drug toxicities — specifically serious problems such as heart attacks, stroke or nasty immune reactions — also improves the odds that blockbuster products can stay on the market.

In other words, while it’s great to see the industry tackling its safety problems head-on, this consortium isn’t exactly evidence that Big Pharma (or its Big Biotech counterpart) is any more willing to adopt personalized medicine in a comprehensive way. Sure, maybe we’ll see future consortia start to address the questions of why so many drugs still only seem to work for a fraction of the patients who take them — a step that would, if successful, necessarily result in the narrowing of markets for many of these drugs, even though it would also boost public confidence in drug efficacy. Will biotech/pharma embrace that logic? I’m not holding my breath.

Pharmalot and the WSJ health blog have more.

Featured companies: Aldagen, LDR, Lyten Endoscopy, MachLabs, Permatox, TeleMedicine Clinic, ThromboVision

Spinal-implant maker LDR raises $25M — Austin, Texas-based LDR, a maker of spinal implants, raised $25 million in a third funding round. Investors included Telegraph Hill Partners, Austin Ventures, Rothschild Private Equity and PTV Sciences.

LDR sells spinal-fusion devices, artificial disks and other spine-related devices in more than 30 countries, and plans to use the funds for further expansion.

Aldagen adds $9M for adult stem-cell work — Aldagen, a Durham, N.C., biotech developing regenerative therapies with “adult” stem cells, raised an additional $9 million (PDF link), bringing its third funding round to a total of $23 million. Investors in the additional financing include Tullis-Dickerson, CNF Investments, Harbert Venture Partners and Intersouth Partners.

The company’s most advanced experimental treatment uses stem cells derived from umbilical-cord blood to somehow improve the speed and effectiveness of cord-blood transplants in children, although the company doesn’t explain how. Nor has it revealed the results of an early-stage human test. Other treatments now entering clinical trials use stem or related progenitor cells isolated from a patient’s own bone marrow to treat heart failure or clot-related oxygen deprivation in the limbs.

The Triangle Business Journal has more.

ThromboVision raises $4M for personalized-medicine diagnostics — The Houston, Texas, biotech ThromboVision said it raised $4 million in a first funding round. Investors included the private-equity firm National Healthcare Services and private investors.

ThromboVision is developing new tests of platelet activity that may help doctors determine which patients are most likely to respond to low doses of blood thinners such as aspirin or Plavix, which are used to prevent clots that can cause heart attacks or strokes. This is similar — in concept, at least — to the FDA’s recent push to require the use of genomic tests to determine the proper dosing of warfarin, another blood thinner. (See our coverage here.)

MachLabs launches two device companies — MachLabs, a Redwood City, Calif., investor partnership founded by entrepreneurs Michael Laufer and John Lonergan, recently launched two medical-device startups, VentureWire reports (subscription required). Lyten is developing a minimally invasive treatment for obesity, while Permatox hopes to introduce a non-invasive alternative to Botox.

TeleMedicine Clinic receives €7M for radiology services — Barcelona-based TeleMedicine Clinic, a center for the outsourced analysis of medical images such as X-rays and MRIs, raised €7 million ($9.7 million), VentureWire reports. Investors included Kennet Partners, Active Capital Partners and an undisclosed European seed investor.

(UPDATED at 11am PT on Sunday, 8/26/07: See below.)

Featured companies: Clinical Data, Epidauros Biotechnologie, Precision Therapeutics, UMD, Zars Pharma

UMD to close $8M for menstrual pain and osteoporosis — Cincinnati’s UMD, a developer of vaginal drug-delivery technologies, expects to close up to $8 million in a fifth funding round, VentureWire reports (subscription required). The company has backing from an undisclosed new investor, and expects former investors Charter Life Sciences and Asset Management to join the round.

UMD is developing a new version of an off-patent anti-inflammatory drug called ketorolac that can be administered on the end of a tampon for menstrual pain, and hopes to begin mid-stage human tests this year. It plans a similar delivery formulation for the active ingredient in Merck’s osteoporosis drug Fosamax, which loses patent protection this year. The company doesn’t have a Web site.

Precision Therapeutics aims to raise $81M in IPO for personalized cancer tests — Pittsburgh’s Precision Therapeutics, a developer of diagnostic tests that aim to predict patient response to chemotherapy, filed to raise $80.5 million in an initial offering. The company’s tests use biopsied tumor cells to assess the likelihood that a given drug or drug combination will be effective.

This is a fairly low-tech sort of diagnostic — as its filing makes clear, Precision basically just removes tumor cells and then starts hitting them with various drugs in the laboratory to see whether they live or die. The company has only been marketing its current test, which it calls ChemoFx, for the last year or so; although it has had ChemoFx on the market since 1997, it ceased sales activity in 2003 and didn’t resume it until last year. Revenues have been predictably anemic, as until recently Precision didn’t have an active sales force, and last year the company managed the feat of posting a gross loss, in which its cost of sales in terms of lab expenses exceeded incoming revenue.

There’s other bad news, too. Precision notes that two respected organizations — the technology-evaluation center of the Blue Cross and Blue Shield Association and a working group of the American Society of Clinical Oncology — concluded in 2004 that “chemosensitivity/chemoresistance assays” such as ChemoFx lacked supporting data that would justify their routine use.

The company also parses several complex reimbursement decisions in a fairly convincing illustration of the risk that relatively few insurers may actually want to pay for its test. It further notes that clinical data supporting use of its test is “limited,” and although it cites the results of three studies carried out between 2002 and 2006, none of them look particularly convincing. In one of the few bright spots in its filing, Precision says it is currently conducting five additional studies, some of which appear to be fairly rigorous “prospective” studies of the diagnostic.

Zars Pharma sets IPO price target — Zars Pharma, a Salt Lake City specialty pharmaceutical company that reformulates pain drugs for delivery via skin patches, set a price range for its IPO and now seeks to raise as much as $92 million in the offering. (See our previous coverage here; the company has apparently changed its name to “Zars Pharma” from “Zars.”) The company plans to offer up to 5.75 million shares at a price of $14 to $16 apiece.

Clinical Data acquires Epidauros Biotechnologie for $11.8M — Clinical Data, a publicly traded diagnostics and personalized-medicine company in Newton, Mass., agreed to pay $11.84 million (€8.75 million) to acquire Epidauros Biotechnologie of Germany. Founded in 1997, Epidauros studies genetic factors that may determine how individuals respond to drugs.

UPDATE (11am PT on Sunday, 8/26/07): Added Clinical Data/Epidauros item.

(UPDATED: See below.)

Personalized medicine — the idea that doctors will one day tailor your medical care based on your genetic profile — has been a long time coming, as I’ve previously written. As it turns out, that’s no fault of the Food and Drug Administration, which has emerged as one of the biggest fans of the concept. Yet the FDA is now pushing ahead with efforts to pair drugs with genetic tests in a way that has alarmed critics, who claim the agency is forging well ahead of the medical evidence, as the WSJ’s Anna Wilde Mathews reports today.

The current controversy involves warfarin, a one-time rat poison now commonly used as an anticoagulant designed to prevent dangerous blood clots from forming. The generic drug was prescribed more than 30 million times last year, but because it can sometimes cause patients to bleed excessively, it also frequently sends people to the emergency room — 43,000 times a year, by one estimate, making warfarin the second-most dangerous drug after insulin.

Roughly a decade ago, evidence began to emerge that genetic differences between patients might explain why some people were more likely to experience bleeding on the drug. In particular, researchers identified two genes that seemed to play a major role in modulating warfarin’s effects. Some variants of the gene CYP2C9, for instance, appeared responsible for breaking down the drug more slowly, meaning that it tended to linger in the blood, effectively mimicking the effects of a higher dose. Variations in another gene, VKORC1, affect how the body processes vitamin K — a crucial finding because warfarin’s activity depends in part on its ability to interfere with vitamin K.

The FDA concluded that patients with some of these genetic variations should probably receive lower initial doses of warfarin — which is exactly the sort of thing personalized medicine is supposed to do. Today, the WSJ reports, the FDA is scheduled to announce changes to the warfarin label that urges lower doses for patients based on their genetics, albeit with a variety of caveats.

Many doctors, however, think the FDA has moved too fast. The genetic tests, which cost between $300 and $500, are covered by Medicare but not many private insurers, and doctors fear that patients who don’t get them and end up with bleeding problems may sue. It also takes time to get results from genetic testing, meaning that doctors aren’t necessarily any better informed when starting patients on warfarin, often following a heart attack, a stroke, or another blood-clot-related problem.

Adding fuel to the fire is the fact that the link between the genetic variations and better patient outcomes hasn’t been fully established by the field’s gold standard of evidence, a prospective randomized, controlled clinical trial. So one of the fascinating aspects of this story is that it pits two of medicine’s emerging trends — personalized medicine and evidence-based medicine (see our coverage here) — directly against each other.

Has the FDA acted precipitously, or is it pushing forward where other parts of the medical establishment fear to tread? Feel free to give us your take in comments.

UPDATE: The FDA statement is now available here (hat tip: Pharmalot).

(UPDATED: See below.)

For at least a decade, biotech futurists have been predicting that the genomics revolution will lead to medical treatments tailored to the genetic quirks of individuals. And for at least as long, we’ve all been waiting for evidence that this “personalized medicine” revolution is coming to pass.

On Monday, the field took a baby step forward when the FDA approved Selzentry, a new AIDS drug from Pfizer. Selzentry is unique in a number of ways — for instance, it’s the first drug that tries to “lock down” T-cells to prevent HIV (that’s the culprit, above and to the left) from entering and infecting them. Fuzeon, a less-than-successful drug from Roche and Trimeris, does something similar, although it works to gum up HIV’s “landing gear,” not the T-cell’s docking port.

But the particularly interesting thing about Selzentry is that it only works against a particular sub-strain of HIV — those that dock to a T-cell surface protein called CCR5 in order to invade. (Most HIV strains use another protein called CXCR4 or a combination of the two.) That means would-be Selzentry users first have to be tested to ensure that their HIV strain will respond to the drug. And that, in turn, makes Selzentry one of the first drugs to be paired with a diagnostic test that limits the number of people who can try it, but which also greatly enhances the odds that it will work in those who do.

That test, offered by Monogram Biosciences, requires “amplifying” the HIV genome in the lab, producing scads of genetically identical viruses that are used to infect cultures of T-cells that lack either CCR5 or CXCR4. When infection occurs, a transplanted gene in the cell cultures begins to produce fluorescent proteins, making it easy to tell whether the viral strain is CCR5-specific. (There’s more info in this Monogram press release.)

Of course, Selzentry — generically known as maraviroc — most likely wouldn’t appear to work at all if tested in a general population, which helps explain why Pfizer was willing to pair it with a diagnostic. Genentech’s breast-cancer drug Herceptin — long the sole poster-child for the nascent field of personalized medicine — likely would have gone the same way had researchers not realized that it appeared to work particularly well in an identifiable subset of tumors.

So far, however, there aren’t too many other similar personalized treatments out there, or even in development. One exception is the beta blocker bucindolol being developed by Arca Discovery, which aims to test the drug in patients who have specific genetic variants; I wrote about them here.

Why aren’t there more? The simplest explanation is that most drug developers, whether pharma companies or biotechs, don’t want to risk circumscribing their patient population unless they have to, since doing so by definition limits the potential sales of a new drug. Up to now, drug makers haven’t really faced much economic pressure to embrace personalized medicine, or “pharmacogenomics,” as it’s technically known. With pipelines drying up and the patent environment getting a lot harsher for the me-too drugs drug giants have long relied on, however, they may soon have little choice.

(Brief aside: Pharmacogenomics, of course, is also the answer to the oft-touted assertion that me-too drugs — meaning a variety of drugs that all target the same biological mechanism, such as the half-dozen statins approved to lower cholesterol — aren’t the waste that drug-industry critics often assert. This argument holds that patients who, for instance, don’t respond to one statin might actually benefit from a different one. The short and simple response is, Where’s the proof? If the makers of statins, or of the depressants known as SSRIs, really want to know which patients their drugs work best in, it’s certainly within their ability to find out. The fact that no one is conducting such tests tells you quite a bit of what you need to know about decision-making in the drug industry.)

UPDATE: Apropos of nothing, I just stumbled across this Reuters story describing a Royal Society report on personalized medicine. The bottom line:

“Personalized medicines show promise but they have undoubtedly been over-hyped,” said David Weatherall, who chairs the working group that produced the report.

UPDATE REDUX: For more on the FDA’s big push behind personalized medicine, see this more recent post.