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Posts Tagged ‘heart-disease’

TODAY’S HEADLINES:

optimedica-logo-150px.gifOptiMedica takes in $16M for eye-treatment lasers – OptiMedica, a Santa Clara, Calif., medical-device maker, raised $16 million in a third funding round. Investors included Kleiner Perkins Caufield & Byers, Alloy Ventures and DAG Ventures.

The startup makes and sells an eye-treatment laser system called Pascal — the acronym stands for “pattern scan laser” — which is approved for treating of retinal diseases such as diabetic retinopathy and other conditions involving the abnormal growth of blood vessels that can leak and obscure vision. The laser works by “photocoagulation,” which simply means it burns and fuses tissue at the point of focus — sealing off blood vessels, for instance, healing tears in the retina or even reattaching a retina that’s come loose.

Genome analyzer BioNanomatrix raises $5M – This item is now a standalone post here.

Heart diagnostic startup Aviir gets another $1.5M – Palo Alto, Calif.-based Aviir, a biotech focused on heart diagnostics, raised an additional $1.5 million as a follow-on to its second funding round, the company’s chief operating officer, Avi Kulkarni, said. The money is an equity investment related to a still-undisclosed partnership with a large pharmaceutical company, he told me.

Aviir is still in stealth mode, as we noted last year when we first wrote about its use of Stanford technology for detection and monitoring of cardiovascular disease. Kulkarni did offer a few additional details, telling me, for instance, that the company’s name is actually an acronym that stands for “atherosclerotic venous inflammation and insulin resistance.”

That, plus the fact that Aviir is working on what Kulkarni said is a “multiple biomarker panel assay” for heart disease, suggests to me that the company plans on measuring the levels of various proteins, probably from blood, in order to get a more precise picture of stressors such as inflammation and insulin resistance that might lead to heart problems. (”Insulin resistance” is an interesting choice, since that’s the cause — or the effect, perhaps — of type 2 diabetes, which is also linked to heart trouble.)

Aviir raised $11.5 million of a planned $25 million round last September, it disclosed in an SEC form now available online (PDF link) via the California Department of Corporations. The remainder of that round will become available when the company hits unspecified milestones.

For a look at the sort of thing Aviir is probably working on, check out this 2007 paper from Physiological Genomics, in which a research team from Stanford and Aviir detail the use of inflammatory proteins known as chemokines to identify patients with atherosclerosis. On the more whimsical side, a self-described friend of the company’s founders describes what he knows about Aviir on his blog, and also posts a odd homemade video “commercial” that suggests the company will be predicting lifetime disease risks for infants.

TODAY’S HEADLINES:

amira-logo-150px.gifAmira Pharma strikes GSK partnership on lung, heart drugs worth up to $425M – Amira Pharmaceuticals, a San Diego biotech focused on drugs for lung and heart problems, struck a partnership with GlaxoSmithKline potentially worth $425 million in upfront and milestone payments.

Amira is developing anti-inflammatory drugs based on its understanding of immune-system elements called eicosanoids. These fatty molecules are produced by white blood cells when foreign threats are perceived, triggering several different types of inflammation, which can damage healthy tissue when it’s prolonged by allergies or autoimmune disease.

Diseases such as asthma, chronic obstructive pulmonary disease, atherosclerosis, arthritis and psoriasis are often the result. Amira aims to defuse the underlying inflammation caused by eicosanoids by inhibiting “upstream” molecules that are necessary for their production.

The company’s two lead candidates have entered early stage, phase I human tests. One compound targets asthma; Amira hasn’t identified which diseases the second drug is being tested in.

Under the partnership, GSK will have rights to develop and commercialize all of Amira’s compounds in its current development program, which are technically known as FLAP inhibitors (FLAP standing for 5-lipoxygenase-activating protein). In return, Amira will receive an undisclosed upfront payment, milestones related to development and potential tiered royalty payments.

logical-images-logo-150px.gifWolters Kluwer Health takes stake in Logical Images – Logical Images, a Rochester, N.Y., developer of medical image-analysis tools, sold a minority equity stake to Wolters Kluwer Health, a healthcare-information company in Conshohocken, Pa. The companies didn’t announce terms of the deal.

Logical Images makes visual healthcare tools for physicians and patients. Its products include VisualDx, a diagnostic tool designed to help physicians identify some 900 visually identifiable diseases, and VisualDxHealth, which does roughly the same thing for interested consumers. The companies said they intend to integrate VisualDx with Wolters’ product Clin-eguide, a “decision support” tool for physicians.

Featured companies: Cerus, LabNow, Reliant Pharmaceuticals

UPDATED: Expanded items on Reliant Pharmaceuticals and Cerus.

reliant-pharma-logo.gifGSK acquires Reliant Pharma for $1.65 billion — And then there were none. Reliant Pharmaceuticals, a Liberty Corner, N.J., specialty pharma that filed for an initial offering back in August, has instead decided to sell itself to GlaxoSmithKline for the eye-popping sum of $1.65 billion. The release is here. The acquisition news comes just days after doppelganger Reliant Technologies abandoned its own IPO bid (see our coverage here).

Although that sum is pretty large, it’s a mere 18 percent premium over the $1.4 billion market capitalization Reliant Pharma would have fetched had it priced at the top of its expected per-share range at $27. As we noted earlier — see our previous coverage here and here — Reliant is kind of a mixed bag insofar as specialty pharma companies go. It yanked an earlier attempt to go public back in 2005, and remains unprofitable despite pulling down $360 million in revenue for the first nine months of this year.

Reliant sells four unrelated cardiovascular drugs, the most significant of which is Lovaza, an omega-3 fatty-acid pill for people with high levels of triglycerides. Although GSK touts it as the only omega-3 supplement “clinically proven” to reduce triglyceride levels in adults with high triglycerides, it’s kind of hard to imagine that this really sets it apart from all the other omega-3 supplements you can find on the shelves of your local drugstore or supermarket. (Here at Chez Hamilton, we take the Costco house brand fish-oil supplement, which is plenty high in omega-3s, even if it hasn’t been “clinically proven” to reduce triglycerides. For Reliant’s song-and-dance as to why Lovaza is superior to fish-oil supplements, click here.) Yet Lovaza is exactly what GSK touts as its reason for dumping a billion-plus bucks of its shareholders’ money on this company.

Don’t think that Reliant has a secret weapon in its labs, either –because, you know, Reliant doesn’t really have labs. Like most specialty pharmas, it’s a bottom-feeder, acquiring drugs that no one else wants or can find a good use for. That can be a perfectly good business, and there’s no question that Reliant’s shareholders have done well in this transaction, but no one should mistake what companies like Reliant do for actual innovation. As for why GSK thinks this company is so valuable — well, chalk it up to desperation and the madness of crowds.

cerus-logo.gifCerus spins out venture-backed immunotherapy unit — Concord, Calif.-based Cerus is spinning off its cancer-vaccine program into a new, and as-yet unnamed, venture-backed company. The release is here.

Cerus will focus its own efforts on its Intercept blood-safety system, which theoretically neutralizes viral and bacterial pathogens in donated blood using a small molecule that binds to DNA or RNA and “cross-links” the molecules, rendering them incapable of replication. Intercept has had tough sledding in the U.S., but is approved in Europe.

Cerus didn’t identify backers of the new immunotherapy company, although it said David Cook and Thomas Dubensky have joined it as CEO and chief scientific officer, respectively. Cerus will retain a 16 percent interest in the new company, and is eligible for milestone payments of more than $90 million, plus royalties, should any of the new company’s vaccines pay off.

OTHER HEADLINES OF NOTE:

(UPDATED: See below.)

relypsa-logo-1.jpgA common dilemma in biotech acquisitions is how to keep a startup’s entrepreneurial management happy and productive when they’ve just been assimilated by the Borg. The answer, often enough, is not to bother, and to let them spin out a new company with scientific “leftovers” that weren’t the point of the acquisition in the first place.

That’s more or less what Amgen has just done in launching Relypsa, a new Santa Clara, Calif., biotech just spun out of the big biotech’s Ilypsa unit. Relypsa is basically a full restart of Ilypsa — thus the name, I suppose — which Amgen acquired earlier this year for roughly $420 million (see our coverage here).

Of course, the new startup now lacks the kidney-disease drug (specifically, a treatment for hyperphosphatemia) that Amgen had shown particular interest in. But Relypsa is free to rev up its existing drug-discovery platform — one focused on making drugs out of long-lasting polymers that grab and eliminate excess molecules such as potassium or sodium — and also managed to keep a pipeline of promising candidates that might one day be useful in treating kidney and heart disease.

Such restarts of acquired biotechs aren’t unknown in the industry, although they’ve been growing in popularity. For instance, the former management of Eyetech Pharmaceuticals recently banded together to form Ophthotech with technology left over from Eyetech after it was swallowed by OSI Pharmaceuticals (our coverage here). This sort of strategy is likely to hold increasing relevance for Big Pharma as its companies fire up their biotech-acquisition machines.

The Relypsa deal, however, may set records for speed and continuity. The former CEO of Ilypsa, Jay Shepard, reprises that role at Relypsa; Ilypsa co-founder Garrett Klaerner returns as COO; and Ilypsa’s former chief medical officer Detlef Albrecht now resumes that position at Relypsa. (Honestly, props to whoever came up with the name “Relypsa,” because it’s really apropos here.) And so on down the line.

Relypsa raised $33 million in a first spinout round, with investors that included 5AM Ventures, New Leaf Venture Partners, the Sprout Group, Delphi Ventures, CMEA Ventures and Mediphase Venture Partners. Amgen, of course, retains a minority stake in Relypsa, and probably insisted on some form of right-of-first-refusal should Relypsa get interested in striking a partnership with — or selling itself to — another company. (I’ve asked Relypsa’s representatives about that, and will report back if I learn more.)

UPDATE: Relypsa’s external PR person got back to me on the right-of-first-refusal question, but kudos to you if you can make any sense of it. Here’s the response in its entirety: “Amgen retained certain rights related to transferred programs customary for spin outs at this stage. Relypsa will initiate partnering campaigns for certain indications and territories as appropriate.” Well, that was helpful. Sometimes I wonder why I bother asking.

UPDATE REDUX: In a later interview, Relypsa COO Gerrit Klaerner told me that “of course” Relypsa has an “entanglement” with Amgen, although he wouldn’t go much further than the official statement in describing Amgen’s particular rights. “There is enough skin in the game for Amgen to keep an interest in Relypsa,” he said. “If you see us doing a partnership, you will get an answer to your question.”

Klaerner added that the idea of recreating Ilypsa came up shortly after the acquisition. “We wanted to save a bunch of jobs and create a new home for the technology,” said Klaerner, who worked as an advisor to 5AM for the deal. “We had 38 people who, after the success of Ilypsa, had multiple job offers and asked them to stick with us, even though the company wasn’t really created.” What’s more, he said, Amgen’s backing of the deal didn’t waver despite the company’s recent woes (see, for instance, here). “Given what they were going through, to give this level of high-level support was really, really remarkable,” Klaerner said.

Oh, and the name Relypsa was apparently an internal placeholder that turned into the real thing when no one could think of anything better, Klaerner said.

FINAL UPDATE: I started thinking about other recent deals that resemble Ilypsa-Relypsa after an email correspondent planted the bug in my ear. The one that comes most immediately to mind would be the launch of Sequel Pharmaceuticals — another clever name — out of NovaCardia’s acquisition by Merck (our coverage here). Another example would be Cerexa Pharmaceuticals, which spun out of Peninsula Pharmaceuticals in 2005 after Peninsula was purchased by J&J. Cerexa was acquired by Forest Labs this past January, and doesn’t appear to have launched another spinout.

Have any other good examples? Sound off in comments.

Featured companies: DirectFlow, Direvo, Indigo Biosystems, MacroGenics

direct-flow-medical-logo.jpgDirect Flow raises $27M for heart-valve implants — Santa Rosa, Calif.-based Direct Flow Medical, a startup developing heart implants, raised $27 million in a second funding round. Investors included Johnson & Johnson Development, Foundation Medical Partners, VantagePoint Venture Partners, ePlanet, EDF Ventures, New Leaf Venture Partners and Spray Venture Partners.

Direct Flow makes minimally invasive aortic-valve replacements for the heart. This particular field happens to be booming — we’ve previously covered competitors JenaValve, AorTx and Sadra.

macrogenics-logo.jpgMacroGenics signs Eli Lilly pact worth initial $43M for autoimmune disease — MacroGenics, a Rockville, Md., biotech developing antibody-based therapies for autoimmune disease, signed a partnership with Eli Lilly that could be worth more than $600 million. MacroGenics is working on antibodies designed to tamp down autoimmune responses by inducing tolerance to antigens that might otherwise promote strong immune reactions to the body’s own cells. The company’s first drug candidate targets diabetes — specifically “type one” diabetes that results when the immune system targets insulin-producing cells in the pancreas.

OTHER HEADLINES OF NOTE:

Featured companies: Aveo Pharmaceuticals, Aviir, deltaDot, Origen Therapeutics

aviir-logo.jpgHeart-diagnostic maker Aviir raises $11.3M — Palo Alto, Calif.-based Aviir, a biotech developing cardiovascular diagnostics based on Stanford research, raised $11.3 million of an expected $25 million second funding round, PE Hub reports. The news is presumably from one of those paper-based SEC filings that are supposed to be digitized before long.

Investors include Bay City Capital, Aberdare Ventures and New Leaf Ventures. Aviir hasn’t said much about its technology beyond the fact that its tests are designed to provide “accurate diagnosis and prognosis” of heart disease and that it expects to reach the market next year. That’s ridiculously fast for anything that needs to move through clinical trials, so chances are good that Aviir is aiming for some sort of “home-brew” strategy in which it will conduct the tests itself instead of selling kits and reagents to clinical laboratories around the country. Home-brew tests are regulated less strictly by the FDA.

deltadot-logo.jpgDeltaDot, biological tool maker, raises £3M — The London maker of tools for identifying and separating biomolecules drew in £3 million ($6.1 million) (PDF link) from investors in a fourth funding round, bringing the total raised in that round to £6 million. Investors included FF&P Private Equity, Imperial Innovations, NPI Ventures, Sitka Health Fund VCT and London Technology Fund.

DeltaDot, which spun out of the Imperial College of Science, Medicine and Technology, uses technologies from high-energy physics to measure the ultraviolet-light absorption of molecules and then applies signal-processing algorithms to identify them.

aveo-logo.gifAveo Pharma raises $5M in broader deal with OSI Pharma — Cambridge, Mass.-based Aveo Pharmaceuticals, a biotech developing targeted cancer drugs, raised $5 million in equity and received another $10 million in cash as part of a broader development partnership with publicly traded OSI Pharmaceuticals. The deal will also include payments for future milestones and royalties, if any, although the companies didn’t estimate their potential value.

The alliance is aimed at developing drugs that target a cellular process known as “epithelial-mesenchymal transition,” a natural stage of cellular development mimicked by tumor cells as they spread, or metastasize, throughout the body. See our previous coverage of Aveo here.

origen-logo.jpgOrigen receives $2M grant for chicken-based antibodies — Burlingame, Calif.-based Origen Therapeutics, a company focused on developing biotech products from genetically engineered chickens, received a $2 million grant from the National Institute of Standards and Technology. The funding is intended to spur development of human polyclonal antibodies — which attack a variety of different protein targets instead of a single one, the way monoclonal antibodies do — that can be produced by chickens and deposited in eggs for harvesting. The first goal of the program will be to develop therapies for antibiotic-resistant hospital infections, which represent a growing threat to patients.

From the Origen press release:

Most antibody therapeutics today, such as the cancer treatments Avastin® and Herceptin® and the anti-infective Synagis®, are monoclonal antibodies that attack a single antigen target on a cell or viral surface. In contrast, when the human immune system produces antibodies against disease, it makes polyclonal antibodies capable of recognizing and attacking different antigens on the same cell, enabling that disease target to be simultaneously attacked at many different points. Thus the ability to produce fully human polyclonal antibodies on a commercial scale for use as therapeutics could take antibody-based therapies to a new level of efficacy by more closely mimicking the full potential of the natural human immune response. Until now, the production of safe and effective polyclonal antibody treatments has been hampered by the lack of an appropriate system for the development and production of such antibodies.

Featured companies: BioVascular, Carefx, ClinResearch, Healthcare Management Directions, NanoCor, OxyPlus, Revitus, Spotlight Surgical, United BioSource

UPDATED: See below.

carefx-logo.jpgHealthcare IT provider Carefx pulls in $17.9M — Carefx, a Scottsdale, Ariz., provider of hardware and software that “aggregates” patient records, has raised $17.85 million in a third funding round, Private Equity Hub reports, citing a regulatory filing. Investors included Carlyle Venture Partners and UV Partners.

Carefx’s pitch is basically the same as that from any system integrator — a term guaranteed to glaze eyes in most circumstances — in that they offer to tie together hospital-patient information that’s currently scattered across disparate computer systems. As with all system-integration pitches, it sounds like a terrific idea, if it works. Of course, many systems-integration efforts often only work after creating a significant amount of chaos and disarray within their respective organizations, which would certainly be interesting in critical-care areas such as the emergency room or intensive care. None of which to say that efforts to make electronic medical records more comprehensive and easier to use aren’t worthy, of course.

spotlight-surgical-logo.jpgMedical imager Spotlight Surgical pulls in $7.4M — San Francisco’s Spotlight Surgical, a maker of medical-visualization software, raised about $7.42 million in a second funding round, Private Equity Hub reports, citing a regulatory filing. Attractor Ventures led the round.

Secretive drug developer OxyPlus gets $8M — OxyPlus, a Boston biotech working on drugs for cancer and heart disease, raised $8 million in a first funding round, VentureWire reports (subscription required). Index Ventures provided the funding, which follows an undisclosed amount of angel seed investment.

From the VentureWire story:

Based in Boston, OxyPlus is developing compounds discovered by Claude Nicolau, a professor at the Universite Louis Pasteur in Strasbourg, France, and Jean-Marie Lehn, a professor at the College de France. [President Conrad] Bletzer said the company is keeping the scientific details under wraps, but the company’s drugs are being targeted for several high-profile indications. “They’re small molecules for the treatment of cardiovascular issues and cancer,” he said.

nanocor-logo.jpgMedtronic pumps up to $7.5M into heart treater NanoCor — Chapel Hill, N.C.-based NanoCor Therapeutics, a biotech working on gene therapy for heart failure, raised $3.75 million from Medtronic, with another $3.75 million dependent upon certain performance milestones.

For some reason, NanoCor doesn’t want to come right out and say it’s a gene therapy company — instead, it wants to create the first “intracellular genetic protein therapy” for heart failure. That amounts to the same thing, since the company plans to use some sort of nanoparticle to shuttle a “proprietary” and so-far unnamed gene to the heart, where it will be taken up by heart cells in order to begin producing some form of useful protein.

NanoCor plans to use nanoparticle technology from Asklepios BioPharmaceutical, or AskBio, from which NanoCor was spun out in 2005. Medtronic will have certain rights to license any resulting treatment.

Healthcare Management Directions gets almost $1.5M for “smart hospitals” — Brentwood, Tenn.-based Healthcare Management Directions, developer and would-be operator of “smart hospitals” with a heavy emphasis on IT systems and electronic records, raised just under $1.5 million in a first funding round following its 2004 recapitalization, VentureWire reports. Investors included Evergreen Investments and new and undisclosed individual and institutional investors. The funding will cover the firm’s investment in an Oklahoma facility it plans to manage.

Heart-drug developer BioVascular acquires Revitus for platelet drug — BioVascular, a San Diego biotech at work on anti-clotting drugs, acquired Revitus, another biotech working on similar drugs. Terms of the deal weren’t announced. Revitus was founded out of the Oregon Health & Science University in 2004.

United BioSource acquires controlling stake in ClinResearch — United BioSource, a Bethesda, Md., a provider of various services to the life-sciences industry, acquired a controlling stake in ClinResearch, a German firm with expertise in designing and conducting flexible, or “adaptive,” clinical trials. The companies didn’t announce financial terms.

UPDATE (1:00pm PT): Added items on NanoCor, Healthcare Management Directions, BioVascular/Revitus, and United BioSource/ClinResearch.

(UPDATED at 12:30pm PT — see below.)

Featured companies: Capnia, AutekBio, Novacta Biosystems, XLHealth, Leprechaun, Agility Healthcare Solutions, AM Pharma, Milestone Pharmaceuticals, ChanTest

capnia-logo.gifCapnia names former Alza head as CEO – The tiny Palo Alto, Calif., biotech Capnia hired Ernest Mario, a storied figure in the pharma/biotech world, as its CEO. Mario was most recently chairman — and previously CEO — of Reliant Pharmaceuticals, but he’s best known for running drug giant Glaxo (now GlaxoSmithKline) and, immediately thereafter, helming Alza for eight years until Johnson & Johnson acquired it for $10.5 billion in 2001.

Ever since his Alza experience, however, Mario has kind of been hopskotching his way across the industry. He headed Apothogen for four months until it was acquired by IntraBiotics (now Ardea Biosciences), then ran the combined company for a year before skipping to Reliant. Needless to say, the Alza lightning hasn’t yet struck twice.

Capnia’s interesting strategy is to develop drugs that can be delivered as a gas, presumably to be breathed in through the lungs. The company’s lead product, Capella, aims to treat migraines and nasal inflammation such as hay fever, and is currently in mid-stage testing.

Here’s the take on Capella from VentureWire (subscription required):

Capnia uses a gas dispenser to administer carbon dioxide into the nose. The company contends that this may be a safe and effective way to quickly relieve pain caused by migraine attacks and stuffy nose caused by allergies to pollen or environmental things like dust mites or pets. The company has conducted multiple Phase II studies in migraines and rhinitis and is planning additional Phase II trials, said Graham Crooke, managing partner of Asset Management Co.

autekbio-logo.jpgBiologics manufacturer AutekBio raises $1.1M — AutekBio, a Silicon Valley-Chinese hybrid with its headquarters in Santa Clara, Calif., and operations in Beijing, raised $1.1 million in a first funding round, VentureWire reports. Acorn Campus Ventures and Desert Spring Life Sciences Capital led the round.

The company is a biological contract manufacturer that cultures genetically engineered cell lines for biotech and pharmaceutical concerns. AutekBio plans to raise a larger $10 million round in early 2008, according to VentureWire.

novacta-logo.jpgNovacta Bio raises $827K for new antibiotics — U.K.-based Novacta Biosystems, an antibiotic developer in Welwyn Garden City, England, raised $827,000 (€600,000). Investors in the round included Esperante, Westgate Hall, GEIF Ventures and Oxford Technology 4 VCT. Novacta is developing drugs to treat hospital-acquired infections, which are often resistant to standard antibiotics. Its lead candidate, for C. difficile infections, hasn’t yet been tested in humans.

xlhealth-logo.jpgHealthcare specialist XLHealth raises $290M, acquires Leprechaun — XLHealth, a private-equity backed healthcare-services company in Baltimore, raised $290 million in debt and equity and used part of the proceeds to acquire Leprechaun, a provider of healthcare-technology services based in Fort Worth, Texas. Funding was provided by MatlinPatterson Global Advisors, a private-equity firm. XLHealth says it is focused on improving the care of chronically ill seniors.

agility-healthcare-logo.jpgRFID patient-tracker Agility Healthcare raises $2M in debt — Agility Healthcare Solutions, a Richmond, Va., developer of patient-tracking systems utilizing RFID chips, closed a $2 million “credit facility” that supplements an earlier $6.25 million first funding round it raised in February. Square 1 Bank provided the loan.

am-pharma-logo.jpgDutch biotech AM Pharma raises $3.4 million against infection and inflammation — AM Pharma, a biotech based in Bunnik, the Netherlands, raised $3.4 million (€2 million) in bridge financing. The company’s two main investors, Forbion Capital Partners and Inventages Venture Capital, provided the funding. AM Pharma is primed to begin raising a third round of funds; its lead drug candidates are respectively in mid- and early-stage human tests against kidney failure, ulcerative colitis and hospital-acquired infections.

milestone-logo.jpgMilestone Pharmaceuticals raises $2.6M against inflammation and heart disease — Montreal’s Milestone Pharmaceuticals, a biotech developing drugs against inflammation and heart disease, raised $2.6 million (C$2.75 million) toward its first funding round, VentureWire reports. Investors included MSBI Capital, Fonds Bio-Innovation and an undisclosed individual investor.

chantest-logo.jpgCleveland’s ChanTest draws funds from Ampersand — ChanTest, a Cleveland, Ohio, developer of cell-based tests for drug safety, raised an undisclosed amount of funding from private-equity firm Ampersand Ventures. The company said the funding would support “strategic investments.”

From the company’s press release:

ChanTest’s primary focus is on a family of proteins known as ion channels. There are 400 genes encoding ion channels in the human genome, and countless more can be assembled from this gene collection. These ion channels may either represent targets for new drug development, or unintended targets that can result in unwanted side effects from new drugs. ChanTest pioneered the development of functional, cell-based ion channel testing as a means to predict cardiac side effects produced by non-cardiac drugs. Such testing is now a standard component of regulatory submissions prior to approval of drugs in humans.

UPDATE (11:05am PT): Added items on Novacta, XLHealth/Leprechaun and Agility Healthcare.

UPDATE, TAKE TWO (12:30pm PT): Added items on AM Pharma, Milestone Pharmaceuticals and ChanTest.

buffalo-roundup-1.jpgArm wrestling over drug patents – Three months ago, the military government running Thailand informed Abbott Laboratories that it intended to break the company’s patents on several expensive drugs, including the HIV protease inhibitor Kaletra, thus allowing the manufacture or import of cheaper knockoffs. Abbott responded by dropping its plans to bring newer drugs, including a heat-resistant version of Kaletra, to Thailand, and the pharma and the junta have been locked in a standoff ever since. Over the weekend, Abbott offered to make the new version of Kaletra available at a deep discount price if Thailand left its patents alone; so far the government hasn’t responded.

The issue is a serious one for drug companies, including the handful of biotechs — among them, Gilead Sciences and Vertex Pharmaceuticals — who make or hope to launch drugs against developing-world scourges such as HIV and hepatitis. Years of high-handed behavior on the part of Big Pharma have fueled a militant backlash in poorer nations against the makers of high-priced, life-saving drugs. The Wall Street Journal has an in-depth look at the issue today. Here’s an excerpt:

Global drug makers are increasingly looking to emerging markets to compensate for slowing growth in the U.S., Europe and Japan. Abbott’s troubles in Thailand suggest that cracking the new markets can be tough because governments are driving a hard bargain on price. They are using the threat of breaking patents to get good deals. Thailand has won the support of nonprofit groups and world organizations while meeting little resistance from the U.S. government….

A number of emerging nations are working on plans to slash drug costs. Lawmakers in the Philippines are debating legislation that would permit breaking patents in certain circumstances and allow the country to use more generic drugs to fight AIDS and potential pandemics. Kenya is considering breaking patents as Dr. Mongkol has done to open the door to cheaper copies.

In an interview last week, Indonesia’s U.S.-educated trade minister, Mari Elka Pangestu, said her country might introduce price caps to bring the price of branded drugs closer to the level of generic equivalents. “The difference in price between nongenerics and generics is perceived to be too high,” Ms. Pangestu said.

Such moves could threaten the ambitions of drug companies in developing nations — especially those such as Thailand that are growing wealthier. While the U.S., Europe and Japan account for the vast majority of sales at big Western drug makers, their growth is slowing. The U.S. this year will contribute about 36% of total growth in pharmaceutical sales, down from 54% five years ago, according to a forecast by IMS Health, a research and consulting firm.

Heart problems in the elementary-school set – Another WSJ story chronicles a previously overlooked angle to the obesity debate: Kids as young as ten are turning up with early signs of heart disease. The finding emerged by accident when researchers enrolled 50 seemingly healthy kids in a clinical trial, only to find via echocardiogram that several had enlarged hearts — a condition known as left ventricular hypertrophy. LVH is typically associated with a high body mass index, but doctors apparently hadn’t even noticed that these kids were overweight, quite possibly because they see so many heavy children that their mental picture of “average” was skewed.

Fear and loathing among biomedical researchers – Earlier this decade, a sustained push to boost biomedical research doubled the NIH budget in five years. Now, however, the unintended consequences of that rapid increase are coming home to roost. This news story in Science lays out the basic problem: Big budgets attracted more scientists and led universities to build bigger and larger labs, but now that demand for research money is higher, budgets are flat, leaving less to go around. For a personal take on the situation, check out this post from “Orac,” a pseudonymous surgeon/scientist at Respectful Insolence.

Google your health records? – Biotech/pharma consultant David Williams, blogging from the World Health Care Conference in Washington, reports on a speech by Google’s Adam Bosworth and thinks a Google healthcare initiative might not be that far off. (A quick glossary for anyone clicking through to Williams’ acronym-heavy post: EHR stands for “electronic health record,” while PHR means “personal health record” — the distinction, apparently, being that an EHR is maintained by a health-care provider, while a PHR is owned and updated by the patient. If you want to know more, try this explanation. PBM, meanwhile, stands for “pharmacy benefit manager” — it’s essentially a catch-all phrase for pharmacy chains and other companies that manage the business of buying drugs and filling prescriptions. Aren’t you sorry you asked?)

EHR SNAFU – Yet another WSJ story today outlines the technical problems Kaiser Permanente has experienced as it tried to roll out an electronic-records system — while, of course, squelching a whistleblower who sought to draw attention to the issue. Merrill Goozner, who’s also at the World Health Care Forum, has more on the subject of electronic records and how they might — and might not — encourage competition among doctors here and here.

AstraZeneca chief acknowledges drug-promotion issue – According to this article in The Independent, AstraZeneca CEO David Brennan has acknowledged the possibility that his sales reps may have been improperly promoting the company’s chemotherapy drug Arimidex, and suggests that the issue is under internal investigation. (Hat tip: Peter Rost.)

[Editor's note: David Hamilton, a former Wall Street Journal reporter, has covered the biotech sector for years and we're delighted to have him as a contributor on news and trends in biotech, health and science (we've already run a few of his pieces). Biotech and health start-ups haven't been a VentureBeat focus, but they're important. We plan to create a separate forum for his work, and point to his more important stuff from VentureBeat.]

chagas.jpgThe world’s biggest clinical trial of stem cells is underway in Brazil, the WSJ reports, an effort that could shake up scientific and commercial expectations for regenerative medicine.

The Brazilian trial involves so-called “adult” stem cells that can be harvested from a mature individual’s own tissue — in this case, bone marrow. (By contrast, controversial but more potent embryonic stem cells must be extracted from a days-old embryo that is usually destroyed in the process.) According to Antonio Regalado’s story, the 1,200 person test aims to see if those bone-marrow cells can reverse a dangerous swelling of the heart that frequently results from a common parasitic infection called Chagas disease. The disease is spread by barbeiros, or “kissing bugs” (see image), which are rife in poorer regions of the country.

Work on adult stem cells has long had a shaky reputation among scientists because the field is rife with unverified claims, often peddled by shady clinics eager to sign up desperate patients. The Brazilian effort is significant both in its scale and its rigor, since the test is specifically designed to ensure that any successful results aren’t simply due to random chance, researcher bias or placebo effect. (Similar but far smaller trials are under way in Poland, Austria, Finland and Denmark.)

Researchers will inject 600 Chagas patients with an “espresso cup’s worth” of their own bone marrow in hopes that the stem cells it contains will regenerate damaged heart tissue. (Another 600 will get placebo saline injections.) The treatment, however, remains controversial, especially in light of recent research that suggests bone-marrow stem cells have little, if any, ability to transform themselves into muscle tissue. The journal Nature, in fact, recently called for a moratorium on tests of adult stem cells in heart disease until their properties are better understood.

The trial, however, also offers a cautionary note to the biotechnology industry, since the Brazilian government is explicitly interested in developing a cost-effective treatment — what one involved researcher calls “a poor man’s cell therapy.” Cells derived directly from a patient can’t be patented, which could greatly limit their commercial attractiveness.

In related news, researchers today reported using bone-marrow stem cells to halt, and possibly even reverse, the course of “type one” diabetes in 14 of 15 recently diagnosed patients. In this trial — which, coincidentally enough, also took place in Brazil — researchers effectively “reset” the immune systems of patients by using their own marrow cells, a process similar to the way physicians treat leukemia with bone-marrow transplants. In all but one patient, the treatment appeared to halt the immune system’s attack on insulin-producing cells in the pancreas. The results were published today in the Journal of the American Medical Association.

(Note: This item has been copied over to the Life Sciences page from its original location on the VentureBeat main page. To view it in its original context, with comments, click here.)

[Editor's note: David Hamilton, a former Wall Street Journal reporter, has covered the biotech sector for years and we're delighted to have him as a contributor on news and trends in biotech, health and science (we've already run a few of his pieces). Biotech and health start-ups haven't been a VentureBeat focus, but they're important. We plan to create a separate forum for his work, and point to his more important stuff from VentureBeat.]

chagas.jpgThe world’s biggest clinical trial of stem cells is underway in Brazil, the WSJ reports, an effort that could shake up scientific and commercial expectations for regenerative medicine.

The Brazilian trial involves so-called “adult” stem cells that can be harvested from a mature individual’s own tissue — in this case, bone marrow. (By contrast, controversial but more potent embryonic stem cells must be extracted from a days-old embryo that is usually destroyed in the process.) According to Antonio Regalado’s story, the 1,200 person test aims to see if those bone-marrow cells can reverse a dangerous swelling of the heart that frequently results from a common parasitic infection called Chagas disease. The disease is spread by barbeiros, or “kissing bugs” (see image), which are rife in poorer regions of the country.

Work on adult stem cells has long had a shaky reputation among scientists because the field is rife with unverified claims, often peddled by shady clinics eager to sign up desperate patients. The Brazilian effort is significant both in its scale and its rigor, since the test is specifically designed to ensure that any successful results aren’t simply due to random chance, researcher bias or placebo effect. (Similar but far smaller trials are under way in Poland, Austria, Finland and Denmark.)

Researchers will inject 600 Chagas patients with an “espresso cup’s worth” of their own bone marrow in hopes that the stem cells it contains will regenerate damaged heart tissue. (Another 600 will get placebo saline injections.) The treatment, however, remains controversial, especially in light of recent research that suggests bone-marrow stem cells have little, if any, ability to transform themselves into muscle tissue. The journal Nature, in fact, recently called for a moratorium on tests of adult stem cells in heart disease until their properties are better understood.

The trial, however, also offers a cautionary note to the biotechnology industry, since the Brazilian government is explicitly interested in developing a cost-effective treatment — what one involved researcher calls “a poor man’s cell therapy.” Cells derived directly from a patient can’t be patented, which could greatly limit their commercial attractiveness.

In related news, researchers today reported using bone-marrow stem cells to halt, and possibly even reverse, the course of “type one” diabetes in 14 of 15 recently diagnosed patients. In this trial — which, coincidentally enough, also took place in Brazil — researchers effectively “reset” the immune systems of patients by using their own marrow cells, a process similar to the way physicians treat leukemia with bone-marrow transplants. In all but one patient, the treatment appeared to halt the immune system’s attack on insulin-producing cells in the pancreas. The results were published today in the Journal of the American Medical Association.

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