VentureBeat

TODAY’S HEADLINES:

• Precision Thera merger with “blank check” Oracle Healthcare collapses (release)
• Sleep Solutions takes in $21M for sleep-apnea diagnostics (release)
• Trevena takes in $24M for drugs targeting G-proteins (release)
• “Specialty biotech” PanGenetics gets €23M for antibody drugs (release)
• Cancer-drug maker Unibioscreen pulls in €5M (release)
• Danish contract manufacturer CMC Biologics raises new funding (PDF release)
• Healthcare investor EDF Ventures postpones fourth fund (VentureWire)
• Global TB-drug alliance names former Sanofi-Aventis exec Jerome Premmeurer as CEO (release)
• Liquidia Tech names Neal Fowler as CEO (release)

(NOTE: Sorry for the minimal posting yesterday — I was at the Health 2.0 conference with extremely limited Internet connectivity. Normal posting resumes today.)

Precision Thera merger with “blank check” Oracle Healthcare collapses – This item is now a standalone post here.

Sleep Solutions takes in $21M for sleep-apnea diagnostics – Sleep Solutions, a Pasadena, Md., developer of diagnostic devices for sleep apnea, raised $20.5 million in a new funding round. Investors included TPG Biotechnology, MedVenture Associates, Emergent Ventures and Lava Ventures.

Sleep Solutions has developed a home-use diagnostic device for identifying sleep apnea, which are breathing difficulties during sleep. Diagnosing apnea has traditionally required patients to spend the night in a sleep laboratory. Left untreated, apnea can increase the risk of more serious problems, including stroke and heart attack.

Trevena takes in $24M for drugs targeting G-proteins – Trevena (no Web site), a Berwyn, Penn., biotech focused on a new area of drug discovery, raised $24 million in a first funding round. Investors included Alta Partners, Healthcare Ventures, New Enterprise Associates and Polaris Venture Partners.

Like many biotechs, Trevena plans to develop drugs that attack a particular biological mechanism rather than any particular disease. In this case, the company is targeting a class of proteins known as G-protein coupled receptors, or GPCR, which according to the company are affected by close to 40 percent of all drugs on the market today. The company didn’t describe its plans in any detail.

Healthcare investor EDF Ventures postpones fourth fund – EDF Ventures, an Ann Arbor, Mich., VC firm specializing in early-stage healthcare, has delayed a planned fourth fund, VentureWire reports. The postponement is related to the departure last year of managing director Beau Lasky, who left for Steamboat Ventures.

The firm intends to begin talking to potential investors again in several months. EDF didn’t say how much it hopes to raise in the new fund; its third fund closed in 2005 with $55 million in commitments.

TODAY’S HEADLINES:

• Taligen Therapeutics raises $65M for novel anti-inflammatory drugs (release)
• Dental-implant maker Biohorizons acquires Implant Logic (release)
• MAKO Surgical sets IPO terms, seeks $94M for knee implants and robots (Edgar)
• Canada’s Medical Ventures acquires two Israeli device startups (release)
• CRO Chiltern acquires Drug Development Solutions (release)

Taligen Therapeutics raises $65M for novel anti-inflammatory drugs –Aurora, Colo.-based Taligen Therapeutics, a biotech working on targeted anti-inflammatory drugs, raised $65 million in a second round of funding. The deal is one of the largest I can recall for an early stage company that’s not in the business of licensing in drugs from other companies for immediate clinical development.

Taligen’s focus is on the “complement system,” an arm of the innate immune system that reacts to threats by triggering a biochemical cascade that attracts immune cells and causes the release of inflammatory molecules such as cytokines. This sort of inflammation tends to rage out of control in autoimmune conditions such as rheumatoid arthritis or type 1 diabetes, eventually leading to serious tissue damage.

Existing targeted drugs for autoimmune disease typically take aim at only a few of the proteins involved in inflammation, leaving other “pathways” untouched. Taligen hopes to defuse the complement system at a more basic level, in particular by targeting “inhibiting factor B,” a protein that plays a key role in amplifying inflammatory response. As a result, the company hopes to merely tamp down activation of the complement system, not to block it altogether, which would likely leave individuals more vulnerable to infection.

Taligen’s drug candidates, which the company says will aim to treat both systemic and local inflammation, are still in preclinical development. That’s part of what makes the enormous size of the funding round such a surprise, since big bucks like these generally aren’t necessary until a biotech begins the expensive process of conducting human tests. In fact, though, the $65 million will be “tranched” and drawn down by the company only as necessary, so Taligen won’t have a huge pile of cash on its balance sheet until it’s ready to spend it.

Investors in the round included Alta Partners, Clarus Ventures, Sanderling Ventures, Tango and High Country Venture.

MAKO Surgical sets IPO terms, seeks $94M for knee implants and robots – MAKO Surgical, a Ft. Lauderdale, Fla., maker of knee implants and surgical robots, set its IPO terms and now hopes to raise as much as $93.8 million in its IPO. The company hopes to offer its shares at a price between $14 and $16 apiece.

MAKO markets a minimally invasive knee-repair system consisting of implants and a robotic-arm surgical devices. The aim is to minimize trauma to the knee in arthritic patients who might otherwise be candidates for full knee replacement. The MAKO system instead allows surgeons to “resurface” worn and damaged bones and then install small implants to restore their function. The company first received FDA approval for an early version of its system in 2005, and just this month was cleared to market its second major upgrade.

The company is still hemorrhaging cash — it reported a $15.9 million net loss on revenues of $355,382 in the first nine months of 2007. Most of its revenue to date has come from sales of implants and other disposable devices. MAKO says it has received some revenue from sales of the full robotic-surgery system, but that it can’t recognize it until it delivers version 2.0 of its system. The most recent release is version 1.2.

TODAY’S HEADLINES:

• 5AM Ventures puts $3.3M into stealthy ImmunoNewco (VBLS exclusive)
• NewLink Genetics raises $17M for cancer vaccine, immune drugs (VBLS exclusive)
• Biochip, stem-cell biotech Minerva Bio ousts CEO Jim Czirr and sues (release)
• Sonexa Therapeutics takes $30M for Alzheimer’s treatment (release)
• Tissue regenerator Healionics pulls in $1.7M (release)
• EGeen, clinical research organization, receives $245K (VentureWire)
• Barnvet Labs, HeMemics Bio get $75K apiece from Maryland gov’t (release)

5AM Ventures puts $3.3M into new immune-related startup – I’ve moved this item to a standalone post here.

NewLink Genetics raises $17M for cancer vaccine, immune drugs – I’ve moved the item to a standalone post here.

Biochip, stem-cell biotech Minerva Bio ousts CEO Jim Czirr and sues – This item is now a standalone post here.

Sonexa Therapeutics takes $30M for Alzheimer’s treatment – San Diego’s Sonexa Therapeutics (no Web site), a specialty pharma, raised $30 million in a first funding round. The proceeds will go toward licensing a so-far undisclosed compound from a Japanese pharmaceutical company that Solexa says is “being tested as a therapeutic to treat Alzheimer’s disease.”

Solexa will have worldwide rights to the experimental drug, excepting Japan and certain Asian countries. Investors in the round included Domain Associates, Scale Venture Partners, Alta Partners, AgeChem Venture Fund and MC Life Science Ventures.

Tissue regenerator Healionics pulls in $1.7M – Redmond, Wash.-based Healionics, a device company focused on tissue regeneration and biomaterials, raised $1.7 million in a first funding round. Individual investors, including Carl Lombardi, the former CEO of SpaceLabs Medical, and Sam Naficy, the medical director of the Naficy Plastic Surgery & Rejuvenation Center, provided the funding.

Healionics is focused on a new class of biomaterials it calls STAR, for sphere-templated angiogenic regeneration. These STAR materials are designed for insertable or implantable medical devices that need to integrate smoothly with and promote healing of the body’s tissues. In particular, Healionics claims that the materials are specifically engineered with “tightly controlled pore geometry” that maximizes the growth of blood vessels and tissue entry while minimizing the body’s tendency to “wall off” implants with scar tissue.

The company, founded last March, says it has established “multiple partnerships” for advancing the development of its materials. Possible applications include diabetes, wound care and infusion therapy.

EGeen, clinical research organization, receives $245K –EGeen, a contract research organization in Mountain View, Calif., raised $245,433 to expand its global operations, VentureWire reports. Ambient Sound Investments provided the funding.

EGeen conducts clinical trials for pharma and biotech companies in Estonia and other Eastern European nations. It has recently established a presence in the Ukraine and Romania. The company has previously raised $4.8 million in two funding rounds.

Biotechnology owes its birth as an industry to the discovery of recombinant DNA, which allowed researchers to make particular proteins by tinkering with cellular genomes. Inserting the gene for human insulin into a bacterial cell, for instance, turns it into an insulin factory. The same goes for any number of other biotech drugs, which by and large are produced in living but genetically altered cells.

Although cellular production first made it possible to make industrial levels of some proteins, the process isn’t without flaws. Some proteins can’t be produced at all in certain cells, while others end up missing particular sugars or other molecules that hang on protein “branches” and affect their function. For another take on some of these problems, see our July story on Coda Genomics, one biotech with a new take on resolving some of these issues.

A different approach involves the audacious step of doing away with the cell altogether. Fundamental Applied Biology is one company taking this tack by trying to replicate a cell’s protein-production system in a vat, a technique that — if it works — could make it possible to produce a novel variety of therapeutic and industrial proteins safely and with much greater efficiency.

Although it sounds conceptually straightforward, this is a vastly complicated task, which is one reason no one yet produces biotech therapeutics this way. FAB’s own description of its technology isn’t terribly illuminating, and neither is this 2005 Stanford publication that purports to explain the work of Stanford professor Jim Swartz, who developed the techniques now in use at FAB. I’m scheduled to speak with the company later this afternoon, though, and I’ll update with what I learn.

At this point, my guess is that such “cell-free” protein production is a long way from practical use in the biotech industry, although it may prove itself in various non-medical industrial applications much sooner. Among the neat tricks supposedly possible with this sort of system is the production of proteins using artificial amino acids (the modular building blocks of proteins), which could have any number of unexpected properties.

FAB just raised $21 million in a second funding round. Its investors included SV Life Sciences and Alta Partners. FAB also just named Daniel Gold, formerly a vice president at Human Genome Sciences, as its new CEO.

(UPDATED: See below.)

“Antisense” drugs that aim to shut down disease-related genes have long been out of favor, and these days live in the shadow of a hotter and newer technology — RNA interference — that does much the same thing. But that hasn’t stopped Encinitas, Calif.-based Excaliard Pharmaceuticals, a newly formed biotech focused on scarring and “fibrotic” conditions, from taking a fresh stab at the field.

The startup just licensed a slew of antisense technology from Isis Pharmaceuticals, and announced that it raised $15.5 million in a first funding round, presumably to help pay for it. Investors in the round included Alta Partners, ProQuest Investments, and RiverVest Venture Partners.

Excaliard is still keeping its head down — its Web site is basically a stub — so it’s not entirely clear exactly which diseases it plans on tackling. Still, it’s notable that the company appears willing to bet fairly heavily on antisense, which Isis and other biotechs have been working on for more than two decades, still without notable success.

Antisense technology essentially involves using short snippets of nucleic acid that bind to “complementary” strands of RNA produced as a gene produces a new protein. That binding effectively shuts down the protein production process, at least in theory. In practice, antisense drugs have failed to live up to their potential, partly because they have had difficulty getting inside cells, which is necessary to get at the RNA involved in protein production. For a graphic version of how this is all supposed to work, click on the image at upper left for a larger version.

Excaliard has paid a fairly substantial amount to get into the antisense field. It handed over an unspecified amount of equity to Isis and made a cash payment of $1 million for the rights to develop antisense drugs against a particular gene — presumably one whose malfunction is related to excessive scarring of some sort. Isis is also entitled to milestone payments and royalties should any drugs make progress.

Although antisense has long gotten a bad rap (multiple high-profile failures will do that), it’s also worth noting that Isis is getting some positive buzz off its leading antisense candidate, an anti-cholesterol drug it now calls mipomersin that has produced some promising results in mid-stage trials. Of course, previous antisense drugs have also looked good in such “phase II” trials, only to collapse in larger and more rigorous tests, but maybe this time will be different.

UPDATE: Actually, there may be a resurgence of sorts underway in antisense. It slipped my mind earlier that the U.K. startup Antisense Pharma just raised the equivalent of $38 million for a late-stage trial of an antisense brain-cancer drug. Also, Isis recently spun out Altair Therapeutics to pursue antisense in respiratory disease.

Featured companies: Biospace Med, Carbylan BioSurgery, GVK BioSciences, IntraSafe Medical, InViragen, Medingo, ParadigmHealth, Precimed, SV Life Sciences

UPDATED: Expanded items on Carbylan, Medingo, and GVK Biosciences.

Carbylan raises $20M for arthritis, sinusitis drug implants — Palo Alto, Calif.-based Carbylan BioSurgery, a medical-device maker focused on polymer-based drug-delivery technologies, raised $20 million in a second funding round. Investors included Vivo Ventures, Alta Partners and InterWest Partners.

Carbylan is developing a biomaterial-based drug-delivery system in which drug-impregnated polymers of hyaluronic acid are injected into the body in liquid form. Those polymers bind to one another and to the body’s tissues, allowing controlled release of the drug in a particular location. The company’s first drug candidates are aimed at treating sinusitis and osteoarthritis.

Israel’s Medingo gets $27M to develop insulin patch — Medingo, a Tel Aviv, Israel, medical-device maker, raised $27 million. The company’s group parent, Elron Electronic Industries, invested between $13 million and $22 million in the round, including $4 million in convertible loans.

Radius Ventures invested $5 million in the round. Medingo is developing an insulin-delivery patch — although given that it’s remote controlled and holds a reservoir of insulin, it’s probably more like a computerized disk that regulates insulin flow. Medingo says it can be worn anywhere during almost any activity, including showers, swimming, and the other five of the “seven S’s” the company touts on its Web site. (We’re a family Web site, but yes, that particular “S” is there.)

Medingo says it expects to receive FDA approval next year. Not bad for a company founded just two years ago. Medingo’s timetable sounds a bit on the optimistic side to me, but maybe they’re really on the ball with this new-style insulin pump.

Indian contract researcher GVK Biosciences raises $27M from Sequoia Capital — GVK Biosciences, an Indian contract research organization, raised 1 billion rupees ($27 million) from Sequoia Capital. The company runs clinical trials and performs other biomedical services for pharmaceutical clients.

OTHER HEADLINES OF NOTE:

• Inverness acquires care and disease manager ParadigmHealth for $230M (release)
• Biospace Med raises €12M for orthopedic imaging (release)
• IV-system maker IntraSafe raises $2M (VentureWire, sub req’d)
• SV Life Sciences adds Robert Palmisano as venture partner (release)
• InViragen receives funding for dengue vaccine (release)
• Greatbatch acquires orthopedic-instrumentation supplier Precimed (release)

Agami, a Silicon Valley storage company with high-profile venture backing, is doing what any self-respecting company in the sector should do these days: Raise a large amount of money before the opportunity melts away.

The company confirmed to VentureBeat that it is negotiating to raise up another round of venture capital, with regulatory filings suggesting it could as much as $50 million. The company hasn’t completed the round yet. The company competes against an array of other storage companies, including some that have gone public recently, such as 3Par (coverage). Like 3Par, Agami offers products that are compatible with virtualization, which is hot within companies right now. Many of the public storage companies, such as 3Par, are losing money.

It’s a great time to raise money or go public because investors — VCs and institutional - are still feeling flush with cash. We’re in a time when lots of money is sloshing around; all that could change quickly if oil prices and the real estate credit crunch continue to take their toll on the economy.

The company has been secretive about its previous backing. It has already raised $64 million since 2003. This round will be its third. Previous backers of Agami, according to regulatory filings, include Kleiner Perkins, along with Advanced Equities, DAG Ventures, Apex Venture Partners, Alta Partners and New Enterprise Associates.

Featured companies: Ablynx, Avant Immunotherapeutics, BioForm Medical, Celldex Therapeutics, Genomas, High-Throughput Genomics, Orchid Cellmark, ReliaGene Technologies, SarCode, TransMolecular, VisEn Medical

UPDATED: Expanded items on SarCode, Celldex/Avant and Ablynx.
UPDATE REDUX: Added items on BioForm Medical, High-Throughput Genomics and Orchid Cellmark/ReliaGene.

San Francisco’s SarCode draws down $7M for inflammation drugs — The two-year-old startup drew down $7 million as part of a $25 million first funding round the company arranged last December, VentureWire reports (subscription required). Investors in that round included Alta Partners and Clarus Ventures. The company’s post-investment valuation was $30 million in December.

SarCode is focused on developing new treatments for inflammation using technology it licensed from Sunesis Pharmaceuticals in January. The company can still draw another $13 million from its first round, and anticipates that existing funding will carry it through the end of 2009.

Cosmetic-surgery product maker BioForm sets IPO range, aims for $127M — San Mateo, Calif.-based BioForm Medical, a developer of skin fillers and other cosmetic-procedure products, set its sights on an IPO that could raise up to $126.5 million. BioForm now aims to sell as many as 11.5 million shares at a price of $9 to $11 apiece. Should it come in at the high end of that range, the offering would value the company at almost $500 million.

See our previous coverage of BioForm, which sometimes touts itself as more of a medical-device company than one focused on “medical aesthetics,” in the first item here. The company’s main customers are plastic surgeons and dermatologists.

Celldex goes public with $67M Avant acquisition — Privately held Celldex Therapeutics acquired a majority stake in publicly traded Avant Immunotherapeutics for $66.7 million in stock. The release is here.

The deal effectively takes Celldex public via a form of reverse merger. Although the combined company will be known as Avant, Celldex shareholders will own 58 percent of it. Avant’s current CEO, Una Ryan, will remain in that position in the combined company, which will be worth an estimated $115 million following the merger. The new Avant will pursue a number of immune-related treatments for cancer, infectious disease and autoimmune disease.

High-Throughput Genomics raises $10M for gene-expression tools — Tuscon’s High-Throughput Genomics, a biotech focused on tools that measure gene activity, raised $10 million in a third funding round. Investors included Merck Capital Ventures, Solstice Capital, Valley Ventures and Arcturus Capital.

HTS, founded a decade ago as a subsidiary of a combinatorial-chemistry company called Systems Integration Drug Discovery Company, spun out as an independent company in 2001. The company provides tools that let researchers study the activity of genes and proteins in laboratory samples.

Ablynx aims at €99.2 million IPO for “mini-antibodies” from llama DNA — Belgium’s Ablynx, a biotech focused on developing new therapies using miniature antibody molecules derived from llama DNA, said it hopes to raise as much as €99.2 million ($141.5 million) in an IPO. (Its release is here.)

The offering will be launched on Eurolist by Euronext Brussels. You can find our previous coverage of the company here and here.

OTHER HEADLINES OF NOTE:

• DNA-testing co. Orchid Cellmark acquires ReliaGene Technologies for $8.6M (release)
• VisEn Medical raises $7.5M for imaging (PE Hub)
• Genomas pulls in $2.5M for “DNA-guided medicine” (PE Hub)
• TransMolecular names Nicholas Nicolaides chairman (release)

(UPDATED at 5:55pm PT: See below.)

Featured companies: Sierra Surgical Technologies, HerbalScience Nutraceuticals, Topigen Pharmaceuticals, EKR Therapeutics, Molecular Partners, Celsense, Glucose Sensing Technologies, Falcon Genomics, Waters, Calorimetry Sciences, Parion Sciences, Gilead Sciences, Isto Technologies, Fluidnet, NABsys

Sierra Surgical raises $7.1M — Palo Alto, Calif.-based Sierra Surgical Technologies, a developer of female sterilization technology, raised $7.1 million in a first funding round, PE Hub reports, citing a regulatory filing. Alta Partners and De Novo Ventures provided the funding.

Singapore’s HerbalScience raises $28M for natural extracts — HerbalScience Nutraceuticals, a Singapore-based natural-extracts company with offices in Naples, Fla., raised $28 million from the private-equity firms Aisling Capital and Weston Presidio, VentureWire reports (subscription required). The investment purchased a 25 percent stake in HerbalSciences, which makes purified extracts from various natural substances, valuing the company at $112 million.

Topigen Pharma pulls in $25M against lung disease — Montreal’s Topigen Pharmaceuticals, a biotech developing inhalable drugs to treat asthma and other lung diseases, raised $25 million (C$26 million) in a third funding round. Investors included NovaQuest, MMV Financial, BDC Venture Capital, Desjardins Venture Capital, Caisse de Dépot et Placement du Québec (Caisse), T2C2/BIO 2000 and Lothian Partners 27 (sarl) SICAR.

The funding will “accelerate” mid-stage human trials for Topigen’s leading drug candidates, a small-molecule treatment for chronic obstructive pulmonary disease and an RNA inhibitor for asthma.

EKR receives over $13M, licenses opiod drug — EKR Therapeutics, a Cedar Knolls, N.J., specialty pharmaceutical company, raised more than $13 million in a private placement. Investors included Quaker BioVentures, NewSpring Capital, and ESP Equity Partners. EKR also acquired rights to DepoDur, an extended-release opioid, from Pacira Pharmaceuticals.

Switzerland’s Molecular Partners gets $15.6M for novel binding proteins — Zurich-based Molecular Partners, a biotech developing drugs based on a new class of binding proteins, raised $15.6 million (CHF18.5 million) in a first funding round. Investors included Index Ventures, BB Biotech Ventures, Johnson & Johnson Development Corp. and Endeavour.

Molecular Partners is focused on developing therapeutics proteins it calls “DARPins,” which the company says offer the same ability to stick selectively to other molecules as monoclonal antibodies, but with greater stability and ease of manufacturing. DARPins are based on the notion of “repeat proteins,” which as the name suggests are modular proteins that contain repeated elements — something like posts spaced at regular intervals along a barbed-wire fence. (See the image at left.) The protein itself ends up looking something like a string that’s been knotted at regular intervals, only much more complicated.

Repeat proteins are found in almost all species, and in nature serve to bind other proteins in order to facilitate protein-protein reactions. By shuffling the modular elements in these proteins, they can be engineered to stick to specific molecules such as cell-surface proteins, potentially making them useful as drugs. The company has a more detailed description here.

Although Molecular Partners likes to play up the advantages of DARPins (the acronym stands for “designed ankyrin repeat proteins”) over antibodies — here, for instance — there are a few disadvantages the company doesn’t mention. As large molecules, DARPins most likely won’t get inside cells, limiting their potential as drugs to interactions with free-floating and cell-surface proteins. (Monoclonal antibodies have the same limitation.) Potentially more important, however, is the fact that the effectiveness of many antibody-based drugs results from their ability to stimulate a particular immune response, not just to stick to the appropriate target. DARPins, which aren’t immune-system molecules the way antibodies are, seem unlikely to do the same.

Pittsburgh-area biotechs, device makers get $350K — The Pittsburgh Life Sciences Greenhouse, a public-private life-sciences investment partnership, invested $350,000 in three Pittsburgh-area life-science startups. Falcon Genomics, a developer of chip-based cancer-detection diagnostics, received $150,000. Another $100,000 went to Celsense, which uses an MRI tracing agent to image transplanted cells. The final $100,000 was invested in Glucose Sensing Technologies, which is developing a catheter-based glucose sensor for continuous blood-sugar monitoring in intensive-care units.

Waters acquires Calorimetry Sciences — Milford, Mass.-based Waters, a laboratory-instrument maker, acquired Calorimetry Sciences of Linden, Utah. Terms of the deal weren’t announced. Calorimetry Sciences, which makes high-performance devices intended to measure the heat produced or absorbed by chemical reactions, will be merged into Waters’ TA Instruments division.

Fedora Commons wins $4.9M grant for open collaboration software — Fedora Commons, a non-profit organization devoted to open-source technologies for creating and sharing digital content, received a $4.9 million grant from the Gordon and Betty Moore Foundation. From the release:

With this funding, Fedora Commons will foster an open community to support the development and deployment of open source software, which facilitates open collaboration and open access to scholarly, scientific, cultural, and educational materials in digital form. The software platform developed by Fedora Commons with Gordon and Betty Moore Foundation funding will support a networked model of intellectual activity, whereby scientists, scholars, teachers, and students will use the Internet to collaboratively create new ideas, and build on, annotate, and refine the ideas of their colleagues worldwide. With its roots in the Fedora open-source repository system, developed since 2001 with support from the Andrew W. Mellon Foundation, the new software will continue to focus on the integrity and longevity of the intellectual products that underlie this new form of knowledge work. The result will be an open source software platform that both enables collaborative models of information creation and sharing, and provides sustainable repositories to secure the digital materials that constitute our intellectual, scientific, and cultural history.

Parion licenses lung-disease drug to Gilead for up to $146M — Parion Sciences, a Durham, N.C., biotech focused on diseases of the mucous membranes, struck a licensing and co-development deal with Gilead Sciences for its drug P-680 worth up to $146 million. The drug, an epithelial sodium-channel inhibitor, could potentially be useful in a variety of lung diseases, including cystic fibrosis. The companies will also work to identify other similar drug candidates.

Isto Tech raises $8.8M, prepares to launch synthetic bone grafts — St. Louis’ Isto Technologies, a developer of cell-based cartilage and bone regeneration technology, raised $8.8 million in a fifth funding round as it prepares for its first product launch, VentureWire reports. Investors included Ascension Health Ventures, Alafi Capital, Life Sciences Partners, Mid-America Transplant Services and private individuals. Isto’s leading product, InQu, is a synthetic biomaterial intended to help tissues heal and bones to regenerate; Isto expects FDA approval later this year.

Fluidnet rises from ashes, raises $6.4M for IV pumps — Portsmouth, N.H.-based Fluidnet, a “reincarnation” of its bankrupt predecessor FluidSense, raised $6.4 million in a first funding round to launch a new intravenous-infusion pump next year, VentureWire reports. Cardinal Partners and Rockport Venture Partners provided the funding.

NABsys raises $750K for high-speed genome sequencing — NABsys, a Providence, R.I., startup focused on high-speed gene-sequencing technologies, raised $750,000 in seed funding, VentureWire reports. Slater Technology Fund and individual investors provided the funding, which closely follows a $1.3 million grant from the National Institutes of Health.

UPDATE (10:55am PT): Added items on Molecular Partners and the Pittsburgh Life-Sciences Greenhouse investments.

UPDATE REDUX (5:55 pm PT): Added items on Waters/Calorimetry Sciences, Fedora Commons, Isto Technologies, Fluidnet, NABsys.

(UPDATED at 6:40pm PT: See below.)

Featured companies: Nereus Phramaceuticals, KFx Medical, NeuroMed Pharmaceuticals, Adnexus Therapeutics, Masimo, Biofisica, Aegera Therapeutics, LymphoSign, InfuScience, Palmetto Infusion Services

Nereus Pharma raises $45M for ocean-derived cancer drugs — San Diego’s Nereus Pharmaceuticals, a biotech that searches for cancer drugs in marine microbes, raised $45 million in a follow-on to its fourth funding round.

The company features an all-star lineup of investors, which includes BankInvest, Roche Venture Fund, Astellas Venture Management, Boston Life Science Venture Corporation, Taiwan Global Biofund, Eminent Venture Capital, HBM BioVentures, Alta Partners, Forward Ventures, Advent International, GIMV, InterWest Partners and Pacific Venture Group.

From the press release:

The proceeds from the financing will be drawn down in two tranches and used to complete Phase I and begin Phase II clinical trials for Nereus’ two drug candidates. The first compound, NPI-2358, is being evaluated for the treatment of solid tumors and lymphomas in Phase I clinical trials. It is a potent, selective tumor vascular disrupting agent (VDA), a class of compounds that represents a novel approach to disrupting the intrinsic tumor blood flow, which leads to tumor cell death. NPI-2358 has favorable preclinical characteristics, such as a longer duration of action on tumor blood flow, activity against multi-drug resistant tumor cell lines and a favorable preclinical toxicology profile. The compound is one of 200 analogues that were produced after finding activity and novel chemistry from a marine fungal extract.

Nereus’ proteasome inhibitor NPI-0052 is in Phase I trials for solid tumors, lymphomas and multiple myeloma. Preclinical studies indicate that this next generation compound may be superior to Velcade(R), with broader target inhibition, faster onset of action, higher potency, oral and intravenous availability, and activity against myeloma cells resistant to Velcade(R) (bortezomib, Millennium), Thalomid(R) (thalidomide, Celgene Corporation), Revlimid(R) (lenalidomide, Celgene Corporation) and steroid therapy. NPI-0052 was derived from a marine-obligate gram-positive actinomycete (Salinispora tropica).

Rotator-cuff specialist KFx Medical raises $10M — San Diego’s KFx Medical, a Carlsbad, Calif., developer of minimally invasive repair systems for rotator-cuff injuries, raised $10 million in a second funding round. Investors included Alloy Ventures, Charter Life Sciences, Arboretum Ventures, Montreux Equity Partners, and MB Venture Partners.

It’s pretty difficult for a non-surgeon to figure out exactly how KFx’s system works better than current medical practice, but if you’re interested in a look, check it out here.

NeuroMed Pharma drops Merck work on pain drug, raises $36M — Vancouver-based NeuroMed Pharmaceuticals, a biotech focused on new pain meds, discontinued Merck-funded work on an experimental pain drug called MK-6721. The Merck collaboration, valued at as much as $475 million, will continue.

Separately, NeuroMed has raised $36 million toward a fifth funding round, VentureWire reports (subscription required). That round isn’t yet complete, and the investors haven’t been disclosed. The funding is designed to pay for completing late-stage human trials of a separate pain drug the company recently licensed from a J&J subsidiary.

Adnexus raises $15.5M against cancer — Adnexus Therapeutics, a Waltham, Mass., biotech developing a new class of drugs against cancer and other diseases, raised $15.5 million in a third funding round. Investors included HBM BioVentures (Cayman), Atlas Venture, Flagship Ventures, Polaris Venture Partners and Venrock. The company intends to use the proceeds to further clinical development of its lead candidate, Angiocept, which is currently in early-stage trials in cancer.

Masimo IPO raises $233 million, jumps 23% on first day — Irvine, Calif.-based Masimo, a major developer of non-invasive patient monitors, priced its IPO in the middle of its predicted range of $16 to $18 per share, raising as much as $232.9 million — just shy of the quarter-million-dollar mark we discussed here. Since the offering involved a hefty chunk of shares sold by existing shareholders, however, the company can only pocket up to $55.9 million of the proceeds. Investors received the offering warmly, pushing the stock up to $20.90 yesterday, a rise of 23 percent.

Biofisica raises $2M in venture debt for wound healing — Atlanta’s Biofisica, a medical-device maker focused on wound healing, raised $2 million in debt financing from Leader Ventures. The company makes an electrical-stimulation device designed to speed the healing of wounds, and currently sells it in the United Kingdom.

Aegera acquires LymphoSign, uniting two Canadian oncology biotechs — Aegera Therapeutics, a Montreal biotech focused on cancer, acquired Toronto’s LymphoSign, another cancer-specialized biotech, for undisclosed terms. Several shareholders also made additional investments in Aegera’s previously announced third funding round.

InfuScience acquires Palmetto Infusion Services — InfuScience, a Chicago provider of drug-infusion therapy, acquired Palmetto Infusion Services of Beaufort, S.C., for an undisclosed sum.

UPDATE (6:40pm PT): Added KFx Medical item.

Although I try to stay on top of events in the life sciences, announcements do sometimes manage to slip through the cracks. Some days, in fact, I end up triaging. Because the roots of this site — not to mention many of its readers — are in Silicon Valley, Bay Area events are a priority. Then come announcements from the rest of the U.S., then Asia, then Europe. Also, smaller or partial fundings tend to take a backseat.

Looking back over my notes — it’s the only way I keep anything straight — I see quite a few of these orphans have piled up. So for the sake of completeness, I’m inaugurating this occasional feature to recap the fundings, mergers and IPOs that got away from me. I’ll put all the details below the fold, so only forge ahead if you’re really interested. RSS subscribers, unfortunately, are going to get the whole thing anyway.

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Santa Monica, Calif.-based Agensys, a biotech focused on new cancer drugs, raised $41 million in a fourth funding round. Duquesne Capital Management and JAFCO led the round, joined by Innovis Investments, Nextech Venture, Bear Stearns Health Innoventures, Alta Partners, HBM BioVentures, Lombard Odier Darier Hentsch & Cie, H&Q Life Sciences Investments, and Orbimed Associates.

Agensys develops monoclonal antibodies designed to target surface proteins or other molecules that specifically identify tumor cells. Its first drug candidate, AGS-PSCA, targets a protein known as prostate stem-cell antigen, which the company claims is found in a majority of patients with prostate, pancreatic and bladder cancer. In conjunction with Merck, Agensys launched an early stage phase I trial of AGS-PSCA in 2005 that apparently demonstrated the drug’s safety, although the company hasn’t had much to say about the drug since.

In January, the company also struck an agreement with Seattle Genetics to co-develop “antibody-drug conjugates,” which combine a toxic chemotherapy drug with an antibody designed to help it hone in on a targeted tumor.

Agensys was founded in 1997 as UroGenesys, but updated its name in 2001. It had previously raised $62.1 million in three rounds.

(UPDATED: See below.) Paracor Medical, a Sunnyvale, Calif., startup developing a mesh restraint designed to support failing hearts, raised $44.35 million in a fourth round of funding. The company is vying with another device startup, Acorn Cardiovascular, to prove that this sort of device works and to bring it to market.

The idea behind Paracor’s device, which it calls HeartNet, is simple. In heart failure, a general term for a variety of similar conditions with different causes, the heart muscle grows progressively weaker and loses the ability to pump enough blood through the body. In many cases, the heart reacts to its reduced pumping strength by enlarging, which temporarily makes it possible to contract more strongly. Over time, however, the enlarged heart tires again, triggering a new cycle of enlargement and weakness.

Paracor’s HeartNet is an elastic metal-alloy mesh designed to wrap around the heart and support it, theoretically improving its efficiency and slowing or stopping failure-related expansion of the muscle. (See the photo above.) Doctors stretch this mesh over a still-beating heart via a less-invasive form of the surgery known as a thoracotomy, which Paracor calls a “mini-thoracotomy.” (For some mildly gory photos, see this research abstract, which is a PDF file.)

In early clinical trials, heart-failure patients who received the mesh were able to walk farther, reported fewer symptoms and witnessed improvement in a variety of heart-related measurements such as oxygen transport and utilization. Paracor is currently enrolling volunteers in a large, randomized study of the device in 272 patients, which company officials hope will allow them to apply for FDA approval by 2010, according to VentureWire (subscription required).

Acorn’s experience, however, provides a cautionary tale. The St. Paul, Minn., company is developing a similar polyethylene mesh wrap called CorCap, which it already markets in Europe (see its PDF brochure here). CorCap requires a full open-chest surgery (see slide #8 in this PowerPoint deck) and can complicate subsequent heart surgeries.

In a 300 patient trial, CorCap appeared to improve a variety of outcomes for patients who received it. Last December, however, an FDA dispute-resolution panel said the company would need to conduct an additional clinical trial before the agency would consider U.S. approval, after an FDA advisory panel recommended against approval in 2005. Some panel members called the study a “quagmire” because of its poor design and statistical anomalies. Acorn hovered on the brink of dissolution until this May, when it reached an agreement with the FDA to conduct a 50 patient confirmatory trial for which it is currently raising $15 million, the company told VentureWire.

Paracor’s funding round was led by Aberdare Partners, joined by Montagu Newhall Associates and existing investors Delphi Ventures, Pequot Ventures, InterWest Partners, Alta Partners, De Novo Ventures, Saratoga Ventures, and Palo Alto Investors. The company said the new funds will support its pivotal trial of HeartNet.

UPDATED: Expanded and rewritten throughout.

(UPDATED: See below.)

Ceregene, a San Diego biotech at work on a gene therapy for Parkinson’s disease, has so far raised $28 million in a third funding round and last week struck a development partnership with Genzyme that resulted in a $25 million up-front payment and potential payments of another $125 million plus royalties.

Those are some surprisingly large numbers for gene therapy, the experimental practice of inserting new genes into the human body in hopes that their activity will make up for a defective or malfunctioning natural gene. The technique once served as a poster child for biotechnology’s promise of curing genetic disease, but crashed and burned when early efforts failed or, in a few tragic cases, proved harmful to patients. One infamous trial involving a rare genetic disease led to the 1999 death of 18-year-old Jesse Gelsinger, after which interest in the field dropped precipitously.

Now enthusiasm for gene therapy may once again — tentatively, at least — be on the upswing. Ceregene’s focus lies in genes that can deliver so-called neurotrophic factors, which are naturally occuring proteins that protect brain, spinal and nerve cells against damage, prevent programmed cell death, and stimulate the growth of new neurons.

While researchers have long considered neurotrophic factors a possible way to treat degenerative neural diseases such as Parkinson’s disease and Alzheimer’s disease, the proteins themselves don’t make promising drugs — largely because they’re too large to cross the blood-brain barrier. Some researchers have experimented with delivering similar proteins directly into the brain via invasive shunts or catheters, but the results have been unimpressive and the cost and difficulty of the procedure would likely limit its widespread use in any case.

Ceregene’s technology involves adeno-associated viruses that have been modified to carry genes for particular neurotrophic factors and disabled from reproducing naturally. These viruses are designed to carry the genes into at-risk cells — say, dopamine-producing neurons in Parkinson’s patients — and then “install” the carried gene into cellular DNA, where the cell’s own natural machinery will activate the gene and begin to produce neurotrophic factors.

In an early-stage trial involving just 12 Parkinson’s patients, administration of Ceregene’s gene therapy CERE-120 was associated with a 36 percent reduction in symptoms 12 months after the gene-loaded virus was injected into the volunteers’ brains. That trial didn’t have the most rigorous controls necessary to protect against investigator bias and placebo effect, so it’s impossible to draw too many conclusions from it. Ceregene is currently at work on a 51-patient follow-up trial that may produce data by the fall of 2008.

The promising results still intrigued Genzyme, an early pioneer in gene therapy for cystic fibrosis, who two years earlier had bought out much of the gene-therapy business of the struggling biotech Avigen, which also has a gene-therapy treatment for Parkinson’s disease.

Last week, Genzyme agreed to pay Ceregene 50 percent of the late-stage development costs for CERE-120 plus up to $150 million in cash in exchange for all rights to the treatment outside the U.S. and Canada. That’s a fairly hefty sum for a treatment that hasn’t even completed mid-stage trials and which also depends on such a relatively untested technique as gene therapy. Genzyme has other irons in the gene-therapy fire as well; today, Applied Genetic Technologies announced that it received $2 million from the big biotech as a milestone payment for its development of a gene therapy for a particular form of blindness.

Meanwhile, Ceregene has also raised $28.1 million in an open third funding round, VentureWire reports (subscription required). Investors in the round include Investor Growth Capital, Alta Partners, California Technology Ventures, Hamilton BioVentures, MPM Capital and Cell Genesys, Ceregene’s former corporate parent.

UPDATE: Added MPM Capital to the investors list, per Ceregene CEO Jeff Ostrove’s comment.