VentureBeat

(UPDATED: See below.)

A few weeks ago, we broke the news that 5AM Ventures is nurturing a stealthy startup called — for now — ImmunoNewco. The trail led back to the Danish biotech Borean Pharma, which is developing protein-based drugs against autoimmune conditions, and which may be in the process of transferring some or all of its programs to ImmunoNewco.

5AM partners stopped responding to calls and email when I asked them about Borean — information that emerged thanks to the incautious LinkedIn profile, since edited, of a former Borean employee — and that naturally just sparked my curiosity. Now, with the assistance of a very useful database at the California Department of Corporations, I’ve managed to dig up some additional details.

According to this ImmunoNewco filing (PDF link) with the department, it appears that the startup is headed by Phyllis Whiteley, formerly VP of business development and licensing at Perlegen Sciences and now an entrepreneur-in-residence at 5AM. Perlegen, which spun out of gene-chip maker Affymetrix, has long been focused on personalizing medical treatments to an individual’s genetic profile. In particular, Perlegen wants to salvage failed or otherwise unsuccessful drugs by using genetic scans to determine which patients are most likely to benefit or avoid side effects — a concept known formally as “pharmacogenomics.”

Whiteley, who’s named as president of ImmunoNewco in the company’s California filings, appears to have worked at Perlegen for about three years — she was hired in late 2004 and apparently left sometime last year (her signature is on an ImmunoNewco filing from last October, although her replacements at Perlegen weren’t named until two weeks ago). She has a long history of negotiating drug-licensing deals and gave an interesting interview on Perlegen’s strategy to Pharmacogenomics Reporter in 2005.

It’s entirely possible that Whiteley is involved strictly because of her business skill at acquiring drug cast-offs from other companies. But if all these pieces really fit together — and I have to stress that this is only speculation at this point — it’s beginning to look as though one or more of Borean’s drugs didn’t work out, but that the folks behind ImmunoNewco think they can be salvaged via pharmacogenomics. I tried to reach Whiteley, but she’s not listed in 5AM’s voicemail directory and their operator seems to have taken the afternoon off.

What does all this amount to? At this point, frankly, not a whole lot beyond a stealthy company that’s fun to noodle with. I happen to agree with Seth Levine’s partners that stealth is overrated as a business strategy, although of course VC firms like 5AM are well within their rights to keep whatever secrets they want to keep. But we’re also within our rights as journalists to pull on threads and see where they lead. Puzzles are fun, dammit.

UPDATE: Puzzles are also extremely satisfying when they start to come together. Borean’s Web site has been replaced with a blank page referring inquiries to “Katherine Bowdish, PhD.” in San Diego. I called Bowdish, who declined to speak on the record but hinted that there may be new developments shortly, so stay tuned.

Bowdish co-founded Prolifaron, a San Diego biotech focused on — guess what? — antibody engineering technology. That company was acquired by Alexion in 2000, where Bowdish eventually became a senior VP in charge of antibody technology. You can read her capsule biography here.

(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).