One of our local billionaires made a couple of significant biotech investments this week, while one of the venerable names from the biotech scene faded away.

—The Bill & Melinda Gates Foundation made its first-ever direct equity investment in a for-profit biotech company last week, when it plunked down $10 million on Research Triangle Park, NC-based Liquidia Technologies. As the foundation’s Doug Holtzman explained to me in an exclusive interview, this deal was crafted to provide maximum flexibility so Liquidia can build out its technology for making vaccines against various scourges of the developing world—instead of being hemmed in to carry out work on one specific project. Separately, my Boston colleague Ryan McBride reported on how Gates personally invested in Cambridge, MA-based Nimbus Discovery, which is seeking to use computer models to improve drug discovery.

—Seattle-based Targeted Genetics is no longer Seattle-based Targeted Genetics. The venerable gene therapy company is now based out of London, goes by the new name AmpliPhi Biosciences, and is primarily focused on anti-bacterial drugs. It’s the end of an era for one of the region’s important companies of the 1990s and early 2000s.

—Calypso Medical Technologies looked to be on the cusp of big things when it raised $50 million in venture capital in September 2009, but it was actually going through hard times, as I explained in a feature story this week. The Seattle-based medical device company struggled through a tough couple of years when hospitals were unwilling to spend big bucks for its radiation-pinpointing technology for prostate cancer, although the new CEO says hospitals are feeling more confident about spending now that the federal healthcare reform law has passed and the stock market is up.

—The Seattle-based Institute for Systems Biology struck yet another collaboration this week, this time through a partnership with Covance to study brain tumors. Terms weren’t disclosed.

—About 1,000 people turned out for the big Life Science Innovation Northwest conference last week put together by the Washington Biotechnology & Biomedical Association, making this the biggest local biotech event in years—or maybe ever. I didn’t have any one major scoop from this confab, but I put together a half-dozen mini-scoops of new information on small companies presenting at this year’s conference. Here are a few companies that I paid close attention to—PhaseRx, Cardiac Insight, Acqueduct Neurosciences, and Integrated Diagnostics.

—This week’s edition of the BioBeat column, now a regular Monday feature, focused on the state of dysfunction in the IPO market for new biotech companies.

—Lastly, we had a guest editorial from Stewart Lyman about how biotech companies sometimes seek advice for all the wrong reasons. If you don’t already, this post will make you think twice about whether to be impressed when a company brags about how it has a Nobel Laureate or two on its scientific advisory board.

Comments (1) | Reprints | Share:          

Targeted Genetics has been a shell of its former self for a couple years now, but today it’s officially no longer the same old Targeted Genetics.

The Seattle-based company, a one-time trailblazer in the field of gene therapy, said today it has made a slew of changes to its business, including ditching the old name in favor of a new one—AmpliPhi Biosciences (pronounced like the thing that cranks up the sound coming from a guitar).

The re-invented company, traded on the Pink Sheets, is now headquartered out of London, the home of new CEO Edward Cappabianca. AmpliPhi is the creation of the merger of Targeted Genetics and London-based Biocontrol—although the emphasis in today’s release is focused on what Biocontrol brought to the table. The new company is going to focus on bacteriophage therapies, designed to fight stubborn antibiotic-resistant bugs like Pseudomonas aeruginosa. AmpliPhi says it has nailed down research grants for part of its drug development programs, including support from the Cystic Fibrosis Foundation of America.

The new entity is still holding onto some old Targeted Genetics intellectual property, and it stands to collect royalties if any partners like Amsterdam Molecular Therapeutics, San Diego-based Celladon and Cambridge, MA-based Genzyme (NASDAQ: GENZ) are able to create new drugs that use Targeted’s techniques for delivering specific gene therapies where they need to go in cells.

Targeted Genetics had been struggling to stay afloat for two years now, as it ran out of cash and was unable to keep raising more as investors lost interest in the once highflying field of gene therapy in the 1990s. It burned through more than $315 million in investor capital during its 19-year history, leaving many investors with holdings that were basically worthless. The company did, however, leave a profound mark on the Seattle biotech community as a training ground for a generation of scientific and managerial talent. Founder and longtime CEO H. Stewart Parker recently landed a new gig as the CEO of the Infectious Disease Research Institute, bringing her business experience to the prolific global health nonprofit organization.

I’ve personally covered Targeted Genetics for almost 10 years now, and seen it experience a few highs, like the time its gene therapy showed an effect against a congenital form of blindness. There were also plenty of lows, like the time a clinical trial showed its most advanced gene therapy failed to help patients with cystic fibrosis, and when a patient died in a rheumatoid arthritis trial, raising suspicion that Targeted’s therapy was responsible (ultimately, it wasn’t).

AmpliPhi Biosciences will retain a Seattle office focusing on finance, business development, investor relations, and capitalizing on the remaining gene therapy assets, says David Poston, the longtime finance chief for Targeted Genetics. Former CEO Susan Robinson “is pursuing other Seattle-based biotech projects, which may include forming her own company,” Poston says. The new company strategy, he says, amount to “exciting times, indeed.”

We don’t have a London bureau so this will probably be my last post about the company now known as AmpliPhi.

Targeted, R.I.P.

Comments (3) | Reprints | Share:          

This week the Seattle life sciences beat was all people coming and going from high-profile jobs, which may say something about where the action is heading.

—Steve Burrill, the biotech jack of all trades from San Francisco, likes to say he’s a “geographic agnostic” when it comes to looking around for the best investments in biotech. Since he’s nobody’s hometown homer, I asked him why he’s coming back to keynote our city’s big local biotech conference for the second year in a row.

—H. Stewart Parker, the founder and longtime CEO of Seattle-based Targeted Genetics, has found a new job as the CEO of the Infectious Disease Research Institute. This means that IDRI, one of the “best-kept secrets” in the Seattle global health research community, will be taking on a new direction with someone who has loads of biotech business experience and connections.

—NanoString Technologies, the Seattle-based maker of a digital genetic analysis instrument, added a new VP of sales, and a VP of marketing, to complete the makeover of its senior management team.

—Tachi Yamada, the president of the Bill & Melinda Gates Foundation’s global health program the past five years, said he’s stepping down from that role in June. Yamada, a former chairman of R&D at GlaxoSmithKline, still has local ties through his role as a senior advisor to Frazier Healthcare Ventures. He has dropped hints about wanting to stay in Seattle, and also to make his next career move in his native Japan.

—Seattle-based Mirador Biomedical, the maker of a device to help doctors avoid dangerous needle puncture errors in hospitals, said it has hired a new VP of sales to pitch its new FDA approved product.

—Bothell, WA-based Marina Biotech (NASDAQ: MRNA) raised $5.1 million in a stock offering this week to finance clinical trial work on its lead RNA-based drug candidate.

—We even had a personnel move to report on here at Xconomy Seattle, which I raved about in these pages on Monday. We’ve hired Curt Woodward, former Olympia reporter for the Associated Press, to cover the Northwest technology, venture capital, and cleantech scene. I will stay here as the editor of this bureau, and national biotech editor. For me, it means I will still edit stories about things like Cheezburger, but I should have more time to write stories about Seattle biotech that’s really in my wheelhouse.

—Here’s one last guest editorial which comes from a Seattle tech entrepreneur, Dan Shapiro, which I’m sure will resonate across disciplines into the local biotech community. This is a hard-hitting post about the sticky issues surrounding non-disclosure agreements, which Shapiro says often amount to nothing more than “NDA terrorism.” If you’re one of those people curious about what it takes to write a good guest editorial for Xconomy, read this and take note.

Comments | Reprints | Share:          

[Updated: 2:15 pm] H. Stewart Parker did some soul-searching after her dreams fizzled out at Seattle-based Targeted Genetics, but now the well-known biotech executive has found herself a big new challenge at the Infectious Disease Research Institute.

Parker, 55, the founder and longtime CEO of Targeted Genetics, has agreed to sign on as the CEO of IDRI, the nonprofit global health research center on Seattle’s First Hill. She starts on March 1.

IDRI is pretty much invisible in its hometown, but it is well-known in global health circles as a bustling center for R&D. The nonprofit, founded by immunologist Steve Reed in 1993, now has 94 employees, and an annual budget of about $25 million—half of which comes from the Bill & Melinda Gates Foundation, according to president Curt Malloy. The institute has seen about five-fold growth in the past six years, adding capabilities for vaccine research and development, low-cost diagnostics, and early-stage drug discovery—particularly a tuberculosis treatment program supported by Eli Lilly.

Reed will remain the head of R&D at IDRI, while he continues in his other work as CEO of Seattle-based Immune Design, a vaccine spinoff from IDRI and Caltech that has raised more than $50 million in venture capital. By adding Parker, IDRI is getting its first full-time CEO in the two years that have passed since interim CEO Steve Davis stepped down. Parker, with her experience at Targeted Genetics, knows all about the perils of taking promising science through the clinical development process, and all the money and collaborations it takes to support that enterprise.

“We really pride ourselves on how well we work with the for-profit sector, and she will bring a lot of experience in that area,” Malloy says. “She has product development focus, and operational expertise.” When I asked if Parker will help IDRI raise its public profile, and help improve community fundraising, Malloy didn’t answer directly, but it sounded like a yes. “We’ve kept our heads down too long, we really are a story that hasn’t been told,” Malloy says.

[Updated comment from Parker] “IDRI is the best kept secret in town,” Parker says. “This felt like a natural fit for me. I can’t wait.”

The fit was good, Parker says, because IDRI has an entrepreneurial spirit and an understanding of how things work in industry, which is rare in a nonprofit. Reed, who she has known for years since he was a co-founder of Seattle-based Corixa, personally called her to talk about the position almost a year ago, Parker says. She says she envisions working as a “co-captain” in which Reed continues to drive the R&D effort, while she focuses on key business functions like business development, strategy, fundraising, and “creating the opportunity for our scientists to excel,” she says. She adds: “Our skills are complementary.”

Since she left Targeted Genetics in November 2008, Parker took some time off to think about her next move, as I discussed in this December 2009 feature. She eventually took a part-time role with the Washington Biotechnology & Biomedical Association as a mentor for budding biotech entrepreneurs. It was a role she had unusual qualifications for, as one of the first employees at Immunex in 1981, and as the head of Targeted Genetics from the time it spun off from Immunex in 1992. Parker says she plans to step down from the WBBA role after a transition period.

Like any job, this will involve a learning curve, but it has a new wrinkle for Parker. Her past two jobs were basically with companies that were just getting started, where the culture was being created. IDRI is different in that it has an established culture which Parker will learn. This will be a little like some of her past experience as a board member, in which she has had to get up to speed on established organizations.

“I’m a good listener, I believe in teamwork, I think it will be OK,” she says.

Comments | Reprints | Share:          

Seattle’s hot biotech company of the moment survived an unusual public hearing this week that could have put a serious crimp in its ability to sell its drug.

—Seattle-based Dendreon (NASDAQ: DNDN) dodged a bullet at a public hearing this week held by the Centers for Medicare and Medicaid Services. The government-run health insurance plan for the poor and people 65 and older convened a panel of physicians and researchers to weigh the evidence for Dendreon’s sipuleucel-T (Provenge). The panel expressed an intermediate degree of confidence that the drug does prolong lives of men with prostate cancer when used according to its FDA-approved label, although the panel disapproved of use for unapproved “off-label” uses.

—Swiss pharmaceutical giant Roche made big news this week when it announced a global R&D restructuring program, and specifically said it plans to terminate its efforts to discover and develop RNA interference drugs. This was a surprise given that Roche is the world’s biggest spender on pharma R&D, and a prominent benefactor of two leaders in this emerging field of therapy—Cambridge, MA-based Alnylam Pharmaceuticals (NASDAQ: ALNY) and Vancouver, BC-based Tekmira Pharmaceuticals (NASDAQ: TKMR). Alnylam stock fell 5 percent on the news, while Tekmira dropped almost 14 percent.

—Allozyne, the Seattle-based developer of new techniques to engineer protein drugs, said this week that its second drug candidate for autoimmune diseases has passed a couple important animal tests and is being primed for clinical trials. This treatment, a “bispecific” antibody designed to hit two targets on inflammatory cells instead of just one, is starting to generate just as much interest among Big Pharma partners as Allozyne’s lead candidate for multiple sclerosis, which has already completed a clinical trial, CEO Meenu Chhabra said in this Xconomy exclusive.

—Arch Venture Partners, the largest life sciences venture investor in Washington state, came close, but wasn’t able to grab the proverbial cigar last week through an IPO of Ikaria. Arch was in line to see its early investment in Ikaria transformed into liquid holdings worth more than $50 million, until, at the last moment, the company withdrew its IPO when it didn’t find the kind of investor demand it wanted to see. Arch’s Bob Nelsen acknowledged he was disappointed, in an exclusive interview with Xconomy, but said Ikaria will still go on as one of those rare birds in biotech—a profitable company.

—Since I like to mix things up around here, I took some time to learn about what Redmond, WA-based Physio-Control is doing to generate some interest among docs attending this week’s American Heart Association meeting in Chicago. The company, part of medical device giant Medtronic, rolled out the latest iteration of its vision for smooth wireless transmission of heart data from ambulances to the hospital. Part of this plan involves a partnership with a hot health IT company, San Antonio, TX-based AirStrip Technologies, which makes a high-resolution iPhone app that cardiologists can use to examine a patient’s vitals.

—Todd Patrick, one of the more successful life sciences entrepreneurs of the past decade in the Northwest, has taken a new gig as the CEO of Los Angeles-based C3 Jian.

—Another well-known CEO around town, Ron Berenson, made his exit from HemaQuest Pharmaceuticals, as he is being replaced by John Longenecker.

—And lastly, Seattle-based gene therapy pioneer Targeted Genetics, which has been gradually fading away over the past couple years, said this week it is seeking to merge with London-based Biocontrol. Shareholders at Biocontrol are being asked to OK this deal.

Comments | Reprints | Share:          

Targeted Genetics, the Seattle-based gene therapy company that has struggled to survive the past two years, said today it has agreed to merge with London-based Biocontrol. The deal seeks to combine Biocontrol’s science with Targeted Genetics’ technology for using adeno-associated viruses to deliver gene therapies inside cells. The deal must be approved by Biocontrol shareholders.

Comments | Reprints | Share:          

There’s a changing of the guard happening over at one of the historic addresses in Seattle biotech—1100 Olive Way. This former car dealership, which for more than 15 years was home to Targeted Genetics’ leading-edge gene therapy work, is now going to be the center of a new initiative in pediatric cancer studies at Seattle Children’s Research Institute.

This story jumped out at me literally, as I noticed a brand new paint job and set of Children’s logos plastered on the door, just off the corner of Olive Way and Boren Avenue. (For all of you who wonder where I get my story ideas, this one came from the seat of my bicycle as I pedaled by yesterday morning on my way to the office.)

It turns out that Children’s, which already occupies a state-of-the-art research building at 9th and Stewart just a few blocks away, is spiffing up the former Targeted Genetics facility to turn it into a pediatric cancer research center led by Michael Jensen, a newly recruited scientist from City of Hope in Duarte, CA. Jensen will lead a team there that studies immunotherapy techniques, in which scientists seek to stimulate the body’s own immune system to fight cancer cells as a foreign invader like a virus or bacteria. The old facility, which used to house Targeted Genetics’ gene therapy manufacturing plant, will eventually house new labs. It will also become home for a “T-cell re-engineering and production factory” in which T-cells of the immune system are harvested from the blood and re-programmed to fight cancer, says Teri Thomas, a spokeswoman for Seattle Children’s.

Targeted Genetics, meanwhile, has shrunk down to just four employees and some part-time consultants, with a headquarters downtown at 601 Union Street, the Two Union Square building. The company terminated its lease on the old 1100 Olive Way facility in November, and then consolidated some offices in the neighboring Metropolitan Park West building until the end of July, when it moved its remaining employees to the downtown building.

The 1100 Olive building has a lot of sentimental value to an entire generation of Seattle biotech talent, who learned the industry ropes there under longtime CEO H. Stewart Parker. Targeted Genetics has had well-documented financial struggles the past couple years. It received a critical lifeline last September when Cambridge, MA-based Genzyme (NASDAQ: GENZ) agreed to acquire some of its most valuable intellectual property, used for manufacturing certain viruses for gene therapy experiments, for $7 million.

With no need for its own manufacturing space anymore, Targeted Genetics has been able to downsize further. The company still has a couple of proprietary drug development programs—one for a rare eye disorder called Leber’s congenital amaurosis, and another for Huntington’s disease. The clinical trials for those gene therapy programs are being run elsewhere, at University College London and the University of Iowa, respectively. Another program that Targeted Genetics is watching very closely, and which could generate some milestone payments, is a heart failure treatment in development by San Diego-based Celladon.

Targeted Genetics’ last statement about its financial health came out on June 1, and CEO Susan Robinson told me in a phone call yesterday that she wasn’t going to offer any further update. The company said in that statement it had $5.1 million in cash and investments left on Dec. 31, 2009. In that release, Robinson said she was evaluating options, like selling the company, or liquidating assets while sending future royalty streams to shareholders. Much of the value of that royalty stream will depend on what happens to Celladon’s heart failure program, which yielded some promising results at a medical meeting in May.

Even if that program advances with the key modified viral delivery vector from Targeted Genetics to help heart failure patients, the manufacturing will be done somewhere else. And it’s possible that a new generation of immune-based treatment for kids with cancer will emerge from 1100 Olive Way. It may not be much consolation for Targeted Genetics employees who lost their jobs or shareholders who lost their money, but Robinson saw something positive about that for the Seattle biotech community.

“I’m glad to see that the building is now being occupied by an institution in Seattle that will use it for what it’s been used for the past 15 years, and that’s research and development,” says Robinson.

Comments | Reprints | Share:          

Gene therapy has never lived up to two decades of hype, but some intriguing new evidence for the technology emerged over the weekend at a medical meeting in Berlin. That was where San Diego-based Celladon unveiled results from a clinical trial—albeit a small one—that offers the first sign that gene therapy might help people suffering from heart failure.

Celladon hinted about what was coming in late April when it issued a vague statement saying that its gene therapy hit the main goal in a trial of 39 patients, demonstrating its superiority over a placebo. It turns out the trial, called “Cupid,” showed that a high dose of Celladon’s gene therapy offered a 50 percent lower risk of serious cardiovascular event like death, or a heart transplant, when compared with those who got a placebo. The Celladon treatment, called Mydicar, didn’t appear to cause any serious side effects, researchers said. Details were presented at the Heart Failure Association of the European Society of Cardiology.

“To see a signal like this in a small number of patients is promising,” says Barry Greenberg, a researcher at UC San Diego and an investigator on the study. “But you have to be realistic and say it is a small number of patients. It still needs to be re-produced in a larger study.”

That said, this data is sure to stir up hope in a long-struggling field. Gene therapy was hyped in the early 1990s as a cure-all for diseases that resisted conventional drug treatment. The idea is to deliver properly functioning copies of genes into cells where they can replace missing or faulty genes at the root cause of certain diseases. The field was plagued by safety concerns, and many companies abandoned the field over the past decade. After all those years, no gene therapy has won FDA approval.

Celladon, as I explained back in April, had a clear strategy on why it thought its approach would work. Older gene therapy techniques used common adenoviruses or retroviruses to deliver genes into cells, which often failed. Celladon sought out what it thought was a better delivery tool with adeno-associated virus technology from Seattle-based Targeted Genetics, which engineered the viruses to shuttle genes into cells without causing illness. Congestive heart failure was thought to be a promising field to study, partly because it’s a gravely serious illness that kills 300,000 people a year, who have few treatment options other than beta-blockers and diuretics. And Celladon’s therapy can be delivered via a direct infusion to the heart, and doesn’t need to circulate through the body-a distribution challenge that has plagued gene therapies before.

So what did researchers really learn from this “Cupid” study? The primary goal of the study looked at a whole kitchen sink of important questions … Next Page »

Comments | Reprints | Share:          

H. Stewart Parker, the founder and longtime CEO of Seattle-based Targeted Genetics, has agreed to join the Washington Biotechnology & Biomedical Association as a part-time commercialization adviser to local life sciences researchers and entrepreneurs. Parker, who has inspired and mentored a generation of biotech professionals in Seattle, resigned from Targeted Genetics in November 2008 after the company suffered a number of setbacks. In a December interview, she said she was itching to return to biotech. “We are thrilled to have Stewart join us,” said WBBA president Chris Rivera, in a statement.

Comments | Reprints | Share:          

Celladon has some tantalizing news today for the world of gene therapy. The San Diego-based biotech company is announcing that its experimental treatment, which delivers a gene to help people with heart failure pump blood more efficiently, has met its primary goal of showing the treatment is more effective than a placebo.

The trial enrolled 39 patients with advanced heart failure who were randomly assigned to get a single-shot infusion of Celladon’s gene therapy, called Mydicar, or a placebo. The study, called Cupid, was designed to compare the drug to placebo on a mixture of important factors, like whether patients on the drug could get out of the hospital sooner, how often they need heart transplants or implants, how far they could walk for six minutes, and how long they lived. Patients were followed for as long as a year.

Celladon isn’t revealing any details in today’s announcement about how much better its treatment performed versus placebo, so it’s impossible to say with certainty how big a deal this is. But CEO Krisztina Zsebo said her company’s drug showed a statistically significant advantage over the placebo group on the study’s primary goal. And there was no greater rate of adverse events among patients who got the gene therapy than those in the placebo. Detailed results will be presented at European Society of Cardiology’s Heart Failure Congress in Berlin on May 30, and will be published soon in a top peer-reviewed journal, Zsebo says.

“We’re very excited. This has been a long, tough program, and a lot of translational science has gone into making it a success,” Zsebo says.

If the European cardiologists agree that this is an important finding, it will be a major milestone for gene therapy and for heart failure patients. Gene therapy was hyped in the early 1990s as a cure-all for diseases that resisted conventional drug treatment. The idea is to deliver properly functioning copies of genes into cells where they can replace missing or faulty genes at the root cause of certain diseases. The field was plagued by safety concerns in the late 1990s, and many companies abandoned the field altogether. Even today, no such treatment has yet won FDA approval.

Krisztina Zsebo

But Celladon likes its chances for a few reasons: Older gene therapy techniques used common viruses as the delivery mode to get those genes inside cells, which often failed. Celladon sought out what it thought was a better delivery tool with adeno-associated virus technology from Seattle-based Targeted Genetics, which engineered the viruses so they would be efficient without causing illness. Congestive heart failure was thought to be an ideal testing ground for gene therapy, partly because it’s a serious illness that kills 300,000 people a year, who have few treatment options other than beta-blockers and diuretics. And Celladon’s therapy can be delivered via a direct infusion into the heart, and doesn’t need to circulate effectively through the body—a distribution challenge that has tripped up other gene therapies of the past.

The Celladon program began about five or six years ago, Zsebo says. The concept was to deliver a gene called SERCA2a into heart muscle cells. Once in the heart cells, it produces an enzyme that improves the heart’s ability to pump blood.

Everything is riding on the outcome of this trial for tiny Celladon, which … Next Page »

Comments | Reprints | Share:          

There was more than the usual amount of carnage this week on the Seattle biotech beat.

—AVI Biopharma (NASDAQ: AVII) ousted CEO Les Hudson as part of a boardroom coup. The board installed chief financial officer David Boyle as the interim CEO, and a company spokesman says Boyle has the board’s confidence and is a candidate for the top job on a permanent basis. AVI is eagerly awaiting data this year on a novel drug for Duchenne Muscular Dystrophy, and is also developing specific RNA-based therapies for Ebola and Marburg virus.

—CombiMatrix (NASDAQ: CBMX), the Mukilteo, WA-based maker of genetic analysis instruments, said it is making a deep round of cuts at its local facility and betting the future of the company on its diagnostics unit in Irvine, CA. CEO Amit Kumar will stay at the helm until a replacement can be found sometime before the end of June.

—Seattle-based Targeted Genetics said it was eliminating three people from its board of directors as part of its ongoing efforts to conserve cash.

—Cell Therapeutics (NASDAQ: CTIC) said it is handing out pink slips to 36 workers in order to save money now that its lymphoma drug, pixantrone, has been rejected by the FDA.

—But not all the local biotech news was so grim. Seattle-based HemaQuest Pharmaceuticals said it nailed down the second half of a Series B venture capital round that totals $12 million.

—Seattle Genetics, the developer of “empowered antibodies” to fight cancer, said the Genentech unit of Roche has extended a partnership to continue using the smaller company’s antibody technology. Seattle Genetics (NASDAQ: SGEN) will get a $9.5 million payment as part of the extension.

—Mirabilis Medica, the Bothell, WA-based developer of ultrasound technology for treating uterine fibroids, has received $1 million in debt and options financing out of a round that could be worth as much as $2 million.

—We also reminded readers earlier in the week of a big event we are planning about the future opportunities in health IT on May 12. This event will bring together a stellar list of speakers, including Swedish Medical Center CEO Rod Hochman; Stephen Friend of Sage Bionetworks; Don Listwin of the Canary Foundation; and David Cerino, who oversees Microsoft’s HealthVault platform.

—I’m also happy to say Xconomy’s life sciences team just got a little bigger this week with the addition of new columnist Sylvia Pagan Westphal. Her first column raises some provocative issues about how things might be different if the world of finance were regulated to the same degree that the FDA oversees new medicines. She is based in Boston, but Sylvia’s column will discuss national issues and run regularly on the Seattle site. You can reach her at swestphal@xconomy.com

—Last, but not least around here, Xconomy made a little news of our own. Xconomy founder Bob Buderi announced the addition of our next new bureau, in Detroit. I will contribute occasional life sciences stories to the mix of stories that are percolating in the state of Michigan. Want to know one obvious Seattle to Michigan connection I’ve already found? Steve Gillis of Arch Venture Partners is a board observer at Lycera, a company founded by University of Michigan professor Gary Glick to treat autoimmune disease. I’m sure we’ll find more interesting connections like these over time.

Comments | Reprints | Share:          

Targeted Genetics, the Seattle-based developer of gene therapies, said today that three of the six members of its board of directors have stepped down. They departures aren’t because of a boardroom disagreement, but are intended to help save costs, Targeted said in a statement. Joseph Davie, Roger Hawley, and Nelson Levy have left the board, while Jeremy Curnock Cook, Michael Perry, and CEO Susan Robinson are keeping their board seats. The company has also made layoffs, and de-listed from the NASDAQ as part of its efforts to save cash.

Comments | Reprints | Share:          

The days are getting longer, spring is in the air, and hope is springing eternal for the Mariners. But a couple of Seattle biotech companies got clobbered this week.

—Seattle-based Cell Therapeutics (NASDAQ: CTIC) suffered a humiliating public beatdown this week at a long-awaited FDA advisory panel. The FDA committee voted 9-0 against the company’s application to market pixantrone for patients with non-Hodgkin’s lymphoma. FDA cancer drug boss Richard Pazdur—whose body language practically screamed that this was a waste of his time—said the company was essentially asking him to approve the drug based on “a single incomplete trial.” Cell Therapeutics isn’t saying what its fallback plan is, but one analyst suggested that after nearly 20 years, and burning through $1.4 billion of investor’s money, it may be time to shut the doors.

—Cell Therapeutics wasn’t the only cancer drug company in town to feel a kick in the ribs. Seattle-based Oncothyreon reported that its partner, Merck KGaA, has halted all clinical trials of its experimental immune-booster for cancer after a patient in an exploratory trial developed encephalitis, an inflammation of the brain. Oncothyreon (NASDAQ: ONTY) will have to wait a while to find out if the adverse event was caused by the drug or something else, but many investors didn’t want to wait for the answer: The company’s stock immediately lost more than one-fourth of its value.

—In between breaking news, we at Xconomy are getting ready for a big event we’re organizing at the University of Washington next Monday that will bring together biotechies and computer people. It’s called “What’s Your Breakthrough Idea?” Lee Hood and Nathan Myhrvold are keynoters at this event, and I took a moment to show how these two big thinkers have forged a close relationship over the years to stay on the leading edge of their respective fields.

—President Obama and Congress made history this week by enacting healthcare reform into law, but few of the analyses coming out of the other Washington have had much to say about how this will affect the business of developing innovative new drugs. Richard Gayle dove into the bill and offered up a shrewd analysis about how biotech essentially got more of what it wanted in this bill than the President himself.

—It seems like a month ago already, but I ran a wrapup piece on Seattle biotech’s marquee gathering of the year—Life Science Innovation Northwest. This piece offered a preview of coming attractions from Alder Biopharmaceuticals, Tekmira Pharmaceuticals, Acucela and other companies that don’t make the headlines all that often—yet.

—OncoGenex Pharmaceuticals (NASDAQ: OGXI), the Bothell, WA-based developer of cancer drugs, added a couple familiar names to its board of directors. Jack Goldstein, the former president of Chiron, is the new chairman, while H. Stewart Parker, the founder and longtime CEO of Seattle-based Targeted Genetics, is taking another seat on the board.

—MDRNA (NASDAQ: MRNA), offered up its fourth quarter financial report (which, by the way, is pretty darn late at this point in March). The report said that MDRNA was down to just $1.7 million in cash heading into 2010. Even though it raised $7.5 million in January, it only has enough on hand to operate “well into the second quarter of 2010.”

—Theraclone Sciences, the Seattle-based developer of antibody drugs, disclosed in a regulatory filing that it has collected another $1.5 million for its drug development programs from an undisclosed investor. Theraclone followed up that disclosure with a press release that said its Japanese partner, Zenyaku Kogyo, exercised an option to develop one of Theraclone’s antibodies in Japan for pandemic and severe seasonal flu. Theraclone said it has received $9 million so far under the collaboration, which could be worth as much as $18 million through early-stage clinical trials, and more milestones and royalties if the antibody becomes a marketed product.

Comments | Reprints | Share:          

OncoGenex Pharmaceuticals (NASDAQ: OGXI), the Bothell, WA-based developer of cancer drugs, said today it has named Jack Goldstein as its new chairman, and H. Stewart Parker as a member of its board of directors. Current board members Dwight Winstead and Michael Martino plan to step down at the company’s upcoming annual meeting on June 8. Goldstein was president and chief operating officer of Chiron when that company was acquired by Novartis in 2006, while Parker was the founder and CEO of Seattle-based Targeted Genetics until she left the company in November 2008.

Comments | Reprints | Share:          

Hope sprang eternal at this year’s JP Morgan Healthcare Conference, the annual kickoff event for the biotech industry. A few Seattle biotech companies offered some reasons for people to think a little hope may be justified.

—VentiRx Pharmaceuticals said it raised $25 million to further develop its drugs that stimulate the innate immune system against cancer and allergies. A pair of local investors, Arch Venture Partners and Frazier Healthcare Ventures, chose to re-invest in the Seattle and San Diego-based company, while MedImmune Ventures, a unit of AstraZeneca, led the new round.

—Stephen Friend is at it again. The visionary founder of Sage Bionetworks said he struck a partnership with the world’s largest drugmaker, Pfizer, to support Sage’s effort to spark an open-source-style movement for biology. Pfizer is paying to support research at Sage to find new cancer drug targets and predict which patients are likely to respond to therapies in development. Terms weren’t disclosed.

—Gilead Sciences (NASDAQ: GILD), the world’s largest maker of HIV medications, is deepening its roots in the Seattle area with a $50 million respiratory disease research center looking out over Lake Union. The company hasn’t yet seen U.S. product sales to justify its $365 million acquisition of Corus Pharma in 2006, although it is hoping to get the green light from the FDA next month to start selling Corus’s inhalable antibiotic for cystic fibrosis.

—ZymoGenetics (NASDAQ: ZGEN), the granddaddy of Seattle biotech companies, closed on a financing that netted about $90.9 million. The company plans to use the cash to support R&D, and to boost sales of its lone marketed product, recombinant thrombin (Recothrom) for surgical bleeding.

—Seattle-based Targeted Genetics (NASDAQ: TGEN) said it is allowing itself to be de-listed from the NASDAQ exchange in order to save cash. The longtime gene therapy stalwart is down to the equivalent of six full-time employees.

—The Institute for Systems Biology was found to have the highest scientific impact of any research center in the U.S., and the third highest in a global survey of more than 2,100 research centers, according to an analysis by Spain-based SCImago Research Group. The report looked at total research output, how much each institute collaborates with other centers, the influence of its publications, how often they are cited by other scientists, and other factors.

—SonoSite (NASDAQ: SONO), the Bothell, WA-based developer of portable ultrasound machines, said it plans to spend $100 million to buy back shares of its stock.

—Kineta, the Seattle-based biotech company, raised $942,000 in new capital, according to a regulatory filing. The company is developing anti-viral therapies, as well as drugs for autoimmune diseases.

Comments | Reprints | Share:          

Targeted Genetics, the Seattle-based developer of gene therapies that went public back in 1994, said today it has decided to allow its stock (NASDAQ: TGEN) to be delisted from the Nasdaq in order to conserve cash. The company has the equivalent of just six full-time employees, and the company is planning to further reduce costs by switching CEO Susan Robinson and David Poston, the chief financial officer, to part-time status, the company said. Targeted Genetics had $4.5 million in cash on hand heading into this year, the company said. The stock closed trading yesterday at 32 cents.

Comments | Reprints | Share:          

Well, 2009 did not turn out to be the biotechnology disaster here in Seattle that many people had predicted.

By my reckoning, only four of the local biotech companies that I track on my website went bust in 2009 (Eden Biosciences, VizX Labs, Northstar Neurosciences, and Rosetta Inpharmatics). This last blow was softened when Microsoft bought some of Rosetta’s assets from Merck (it’s biosoftware division) and hired a number of its employees. Many of the VizX employees (along with its GeneSifter software) were absorbed by Geospiza. The loss of four companies put Seattle on a roughly equal footing with Boston, which saw at least five companies fold, and San Diego, where at least six companies went under.

Although we didn’t lose quite as many companies, it was still a very tough year locally for those employed in the biotech sector. At least nine companies reported significant layoffs, including Cardiac Science, CMC Icos, Trubion Pharmaceuticals, Cell Therapeutics, Poniard Pharmaceuticals, Amgen, Targeted Genetics, ZymoGenetics, and VLST.

On the positive side, Dendreon moved much closer to being able to sell sipuleucel-T (Provenge), their novel treatment for prostate cancer, and has been on a hiring frenzy. OncoGenex Pharmaceuticals had a breakout year with its own prostate cancer treatment. Partnerships were both formed and broken at a dizzying pace, with Seattle Genetics, ZymoGenetics, MDRNA, Alder Biopharmaceuticals, Arzeda, Ikaria, Kineta, Trubion, and Nanostring among the notable participants. Amgen won its long running patent fight with Roche and was able to block them from selling generic erythropoiesis stimulating drugs in the U.S. Some top executives moved around, with Immune Design gaining part-time help from ex-Zymo CEO Bruce Carter, and with Peter Thompson leaving Trubion and Stewart Parker departing Targeted Genetics.

Other notable events: PATH won the $1.5 million Hilton Prize, the world’s biggest humanitarian award, for it’s work improving health in poor countries, and local biotech Omeros was successful in launching their IPO (although the stock price has dropped some 25 percent since then).

A number of new companies launched or moved into the area, including Arrowsmith Technologies, Beat Biotherapeutics, Qwell Pharmaceuticals, ImaRx, Novo Nordisk, AVI Biopharma, Covance, Arzeda, Xori, Presage Therapeutics, Integrated Diagnostics, Sage Bionetworks, and Genzyme (via its acquisition of Leukine from Bayer). Chris Rivera got off to an excellent start as he took over the head job at the Washington Biotechnology & Biomedical Association. The State’s Life Sciences Discovery Fund expenditures were cut by 41 percent to help balance out the state budget deficit.

In 2010, at least three companies that operate in Seattle will hope to have their drugs approved: Dendreon’s sipuleucel-T (Provenge) for prostate cancer, Amgen’s denosumab (Prolia) for osteoporosis, and Cell Therapeutics’ pixantrone for non-Hodgkin’s lymphoma. Here’s hoping that they all fair well.

Health care reform is sure to bring numerous changes to the industry. One key change likely to be enacted via legislation in 2010 will define a regulatory pathway for the approval of follow-on biologics, which are generic versions of biologic-based drugs. This has the potential of providing significant savings for consumers, although such benefits will depend on the period of market exclusivity awarded to innovator drugs.

Continuing economic problems indicate to me that 2010 will also be a very challenging year for biotech companies in Seattle and beyond. I expect to see many more deals for the acquisition of product candidates, but not so many acquisitions of companies. I wish all of you on the local biotech scene a productive and successful year in 2010.

Comments | Reprints | Share:          

‘Tis apparently the season to cram in as much biotech news as possible before taking a holiday breather.

—Dendreon (NASDAQ: DNDN) snapped up a total of $409 million through a stock offering. The Seattle-based biotech company sold 15 million shares in an initial piece of the financing that brought in $356 million, and secured the rest when underwriters bought another 2.25 million shares. The cash is going toward manufacturing and marketing of sipuleucel-T (Provenge), which is aiming to become the first FDA-approved treatment to stimulate the immune system against cancer.

—Who will decide how to spend all that cash at Dendreon? Some of that day-to-day oversight responsibility will fall to Hans Bishop, who Dendreon hired this week as its new chief operating officer. Bishop previously worked at Bayer Healthcare.

—Seattle Genetics (NASDAQ: SGEN) had a roller coaster of a week. The Bothell, WA-based biotech company said that Roche terminated a partnership to co-develop dacetuzumab as a new antibody treatment for lymphoma. But investors didn’t have a lot of time to stew over that. Seattle Genetics followed that up a few days later with a new partnership with Millennium: The Takeda Oncology Company, to co-develop and commercialize its lead drug candidate, brentuximab vedotin, for Hodgkin’s disease and related lymphomas. Importantly, Seattle Genetics retains full commercial rights in the U.S. and Canada, and has found a partner with a lot of experience in blood cancers with bortezomib (Velcade).

—We’ve been asking a bunch of the Xconomists and other technology leaders in all three of our cities for their impressions on the top five innovations in their respective fields this past decade, or what they think will be the top five disruptive technologies of the coming decade. Seattle Genetics CEO Clay Siegall wrote back fast with this interesting take on the big changes he saw in biotech.

—H. Stewart Parker, one of the pioneers of Seattle biotech, told me how she recharged her batteries during a year off after her departure from Targeted Genetics, the company she founded and led for 17 years. She’s now “antsy” to get back into biotech, she says, either as a … Next Page »

Comments | Reprints | Share:          

H. Stewart Parker’s biotech dream came to an end a little more than a year ago. The company she founded back in 1992, Seattle-based Targeted Genetics, had essentially run out of time and money for its quest to develop groundbreaking new gene therapies. It’s still around, but it never developed a cure, and it is much smaller than it was in its earlier days.

That experience—in which she recruited, mentored, and inspired a generation of Seattle biotechies—sapped an enormous amount of her energy. It was obviously humbling, and heartbreaking, when it ended. “I love Targeted Genetics,” Parker says. “It was a real roller coaster ride. We did some great work that I’m proud of, but it was a tough row to hoe.”

So Parker, 54, took a year off. She only had a couple of nonprofit board responsibilities to tie her down to Seattle, with the University of Washington’s College of Arts and Sciences and the local YMCA. So she got about as far away from Seattle and biotechnology as one can get.

She brushed up on her Russian language skills she learned back in her undergraduate days at the University of Washington, and she went on a monthlong journey in Russia. She passed through the global cities of Moscow and St. Petersburg, hopped on the Trans-Siberian railway, ending up in Ulaanbaatar, the capital of Mongolia. She visited with friends and family back home in the U.S. She went fishing near her second home in Montana, and hiking in Yellowstone and Grand Teton National Parks. And when she sat down to catch up with me last week at a coffee shop in Seattle’s South Lake Union, she said that after this year of soul-searching, she decided she wants back into biotech.

“I got re-energized,” Parker says. “I wondered if I’d get the passion back. But I find that I miss it. I miss the people. I want to get back in.” She adds, “I grew up in it. The people are really passionate about what they do. And I don’t care what anybody says, they have the best interests of patients at heart. They are not money grubbers.”

Exactly what role she’ll take is still to be determined. She could end up taking on another full-time CEO role at a biotech startup. Or, rather than get consumed in another intense day-to-day operating job, she might join a number of boards where she can share her experience and advice more broadly. Joining a venture capital fund is another option, in which maybe she could serve on boards, and occasionally dive more deeply as an interim CEO for companies that are going through a change of some kind.

That sounded to me a lot like what one of Parker’s mentors, Steve Gillis, is doing these days at Arch Venture Partners. “That would be ideal,” Parker says.

Of course, she’s trying to get back into the game at a time when there aren’t as many opportunities as there once were. But we talked a fair bit about the state of local biotech, and how it’s far from dead. Many Seattle companies have gotten much stronger in the past year, including Dendreon, Seattle Genetics, OncoGenex Pharmaceuticals, Calistoga Pharmaceuticals, and Alder Biopharmaceuticals, to name a few. Biotech pioneer Leroy Hood has started a new company, Integrated Diagnostics, with $30 million in committed venture capital. But even while those positive things have occurred, I’ve noticed that those organizations are watching their pennies more closely than ever, and not doing very much hiring.

Parker wasn’t about to tip her hand on where she might go. She obviously has deep Seattle roots, and would like to do something here, but she’s also nationally known through her past work with the Biotechnology Industry Organization, and as a pioneer among women biotech executives. Wherever she goes, she sounds to be motivated by the same thing that convinced her to start a gene therapy company in the early 1990s. She wants to see a compelling technology with potential to make a big impact on patients’ lives.

“It’s all about passion,” she says. “If it’s an opportunity, an idea that I could fall in love with, then it’s something I could see doing for another 20 years.”

Comments (1) | Reprints | Share:          

Seattle’s biotechnology industry is in significantly better financial shape than it was six months ago. The turnaround has been nothing short of amazing, thanks to a frantic run of dealmaking, cost-cutting, and remarkable clinical trial results that have made local companies some of the best-performing stocks this year on the NASDAQ.

Indeed, while our first analysis of the Northwest’s public life sciences companies, published last November, showed that six of 10 companies had less than a year’s worth of cash on hand at that point, only one—Seattle-based Northstar Neuroscience—actually folded.

And when we took a look at the most recent quarterly reports filed with the Securities and Exchange Commission by the 12 companies we’re following right now (11 of them public, one preparing for its IPO), we found that seven of them were actually in a stronger position at the end of June than they were at the start of the year. What’s more, three of the companies that were classified by this analysis as worse off (Seattle-based Trubion Pharmaceuticals and Targeted Genetics and Bothell, WA-based OncoGenex Pharmaceuticals) have recently struck partnerships or completed financings that aren’t yet reflected in the federal filings, but have clearly improved their financial futures.

Read on for a complete rundown of all 12 companies, listed in alphabetical order. To purchase a much expanded version of this report, in PDF format, click the “Add to Cart” button below. The expanded version, available for $95,* includes an assessment of each company’s financial position at the end of June compared to six months earlier, the projected length of time it can survive on its existing cash reserves, and an analysis of the strategic moves it has made to stay afloat in the current environment. Click here to see a sample entry. *Price is subject to change without notice.

We intend to repeat this analysis regularly to monitor the financial health of the life sciences companies we follow in San Diego, Seattle, and Boston. Please send feedback to editors@xconomy.com.

AVI Biopharma (NASDAQ: AVII)
Cash on hand: $20.2 million
Related Xconomy coverage:
“AVI Biopharma Bolts from Portland to Seattle to Tap Biotech Talent”
“AVI Biopharma Out to Reinvent Itself, Making RNA-based Drugs for Ebola and Other Nasty Things”
“Ebola Fighter AVI Biopharma Gears Up for Biodefense Contracts”

Cell Therapeutics (NASDAQ: CTIC)
Cash on hand: $12 million
Related Xconomy coverage:
“Cell Therapeutics Teeters on the Brink as Cash Runs Out on Promising Cancer Drugs”
“Cell Therapeutics Taps Stock Market Again, Seeks $40M or More”
“Cell Therapeutics Files Cancer Drug Application, In Nick of Time”
“Cell Therapeutics Lymphoma Drug Boosts Remissions, Shares Boom”
“Cell Therapeutics Reports Severe Cardiac Events in Drug Trial”
… Next Page »

Comments (1) | Reprints | Share: