AVI Biopharma has made some significant job cuts in Washington and Oregon after missing out on a potentially huge federal contract to make an RNA-based treatment against pandemic flu.

The Bothell, WA-based company (NASDAQ: AVII) is cutting the jobs of about 35 of its 125 employees—28 percent of the workforce—according to CEO Chris Garabedian. The company initially announced the job cuts at the bottom of a press release on Friday, without providing further explanation. The cuts will come from AVI’s Seattle-area operations, as well as its operations in Corvallis, OR, Garabedian says.

AVI Biopharma has sought to reinvent itself this year under the new CEO, who has brought in a new management team that has focused on its lead drug candidate for Duchenne Muscular Dystrophy (DMD), as well as biodefense programs to treat the deadly Ebola and Marburg viruses. But the company fell short in its bid to secure a long-term contract to make drugs against pandemic flu, which could have been worth as much as $500 million. Plus, AVI recently disclosed it was unable to overturn a European patent claim by Netherlands-based Prosensa, which claims it owns some intellectual property in AVI’s lead muscular dystrophy program.

“With our stock price at 52-week lows, and the recent disappointing news of not getting the flu contract, combined with Prosensa’s success in defending their patent in Europe related to Exon 51 (our lead program), we felt it was important to reprioritize / refocus on the primary value-driving programs of DMD, Ebola, and Marburg,” Garabedian said in an e-mail today.

AVI stock climbed 2 cents today to 73 cents a share, giving it a market valuation of just under $100 million. The company said in its most recent quarterly report that it expects to burn through about $30 million to $35 million of cash in 2011. AVI reported it had $46.3 million left in the bank at the end of September, in its most recent audited quarterly statement.

Comments (1) | Reprints | Share:          

Bothell, WA-based AVI Biopharma (NASDAQ: AVII) said today it has started dosing patients in a mid-stage trial of eteplirsen, an experimental RNA-based therapy for Duchenne Muscular Dystrophy. The study is expected to enroll 12 patients at Nationwide Children’s Hospital in Columbus, OH. Patients will get once-weekly intravenous infusions of the new drug, or a placebo, for 24 weeks, AVI said.

Comments | Reprints | Share:          

This week we had news from a couple of Seattle-area life sciences companies who appeared at a big cancer drug conference, a notable financing story, and a couple of in-depth profiles.

—Kirkland, WA-based Pathway Medical Technologies, the maker of a tiny drill that clears out blockages in leg arteries, provided me with a detailed update on how it is doing three years after winning FDA approval. Pathway grew its sales more than 50 percent last year without increasing the size of its salesforce, although the company still hasn’t yet turned the corner to become profitable.

—The American Society of Clinical Oncology, the big annual extravaganza for cancer R&D, came to a close earlier this week in Chicago. The local biotech standard-bearers—Dendreon (NASDAQ: DNDN) and Seattle Genetics (NASDAQ: SGEN) both presented important new findings for their cancer drugs, which I included in this national wrap up story.

—Seattle-based Adaptive TCR, a spinoff from the Fred Hutchinson Cancer Research Center, said it has raised $5.8 million in a new financing round from wealthy individuals. CEO Chad Robins says the goal is to use the money to develop clinical applications around its technology for profiling the immune repertoires of individual patients.

—Is it a nutty idea for biotech drug developers to think they can grow up to become fully integrated, independent, profitable enterprises without selling out to Big Pharma? A couple of years ago, most people would have said yes, but this week in the BioBeat column, I put forward the notion that maybe there is still a way to do this.

—The Bill & Melinda Gates Foundation has been soaking up lots of attention lately for a series of grand openings of its new $500 million headquarters near Seattle Center. I snapped a bunch of photos when I attended an evening reception with lots of local media and politicians.

—I took time to profile Chris Garabedian, the ambitious new CEO at Bothell, WA-based AVI Biopharma (NASDAQ: AVII). AVI may not have a high profile locally or nationally, but this former Gilead and Celgene exec has big plans to make AVI into a much bigger company built on its novel treatment in development for Duchenne Muscular Dystrophy.

—PATH, the Seattle-based global health nonprofit, said it has formed a collaboration with Netherlands-based Crucell and London-based GlaxoSmithKline to see if it can combine a couple of malaria vaccine candidates into a more effective strategy for protecting people from this deadly infectious disease. Terms weren’t disclosed.

Comments | Reprints | Share:          

Chris Garabedian took his first shot at being a CEO last December. Immediately, people thought this was a little bit crazy.

Friends wondered, why leave a job as an up-and-coming VP of corporate strategy at a biotech powerhouse like Summit, NJ-based Celgene (NASDAQ: CELG) to run an obscure little company like AVI Biopharma (NASDAQ: AVII)? AVI was built on a technology, antisense drugs, that few people in the industry believe in. The company’s track record is brutal—30 years spent on R&D with no FDA-approved drug to show for it. There was a leadership void, since a shareholder rebellion led to the ouster of the previous CEO. And, with labs in Corvallis, OR and headquarters in Bothell, WA, it’s a long way off the beaten path for most biotech industry executives and investors.

Garabedian, 44, admits he was skeptical at first. But when encouraged to take a look a year ago by the company’s largest investor, George Haywood, he looked. And the more Garabedian studied, the more he started to think it could be a classic diamond in the rough. It’s a bold, brash thing to say, but Garabedian told me a few weeks ago that the AVI of today reminds him of the 1990s version of Foster City, CA-based Gilead Sciences (NASDAQ: GILD) when it was worth about $500 million, long before it went on to become the world’s largest maker of HIV drugs, worth $32 billion today. Garabedian spent most of eight years in various roles at Gilead during its boom years, before joining another biotech success story in Celgene. Now he says it’s time to apply what he learned in those places.

“Those are experiences at Gilead and Celgene that shaped me, and helped me know what it takes to grow a breakout biotech,” Garabedian says. “I always felt that if I saw another opportunity to do that at another company, that’s something I could be excited about.”

Chris Garabedian

AVI, he says, is the place. There’s certainly room to grow. The stock closed yesterday at $1.55 a share, and the company has a little more than 110 employees, and a market valuation of about $210 million.

“We could make this a breakout biotech. It will take some time. It’s not going to happen in a year,” Garabedian says. “But I think this could be a company valued in the multi-billions in the next several years.”

Before diving into Garabedian’s blueprint for how he intends to lead AVI to that lofty perch, I wanted to know a little more about him. Unlike a lot of biotech CEOs, he never went on to get an MD, a PhD, or an MBA degree. He got a bachelor’s degree from the University of Maryland in marketing, and worked his way up in biotech through various marketing-related roles.

He did some consulting in his first real job out of college for a couple years. He says he “got the biotech itch” while consulting in the early ’90s. He caught on full time with Abbott Laboratories, where he worked on marketing, brand management, and product development in various parts of Abbott’s business in cardiovascular medicine and neurology, he says. “I started to learn how to work with R&D teams,” on things like when to hit the brakes on a new drug development program, when to press on the gas, and what it takes to get the ultimate prize—FDA approval to sell your new drug.

Garabedian’s first experience in a small, nimble biotech came in 1997 as a senior director of marketing for Gilead. He was brought in initially to help craft … Next Page »

Comments (1) | Reprints | Share:          

San Diego-based Regulus Therapeutics, the developer of mircoRNA therapies, said today it has named Neil Gibson as its new chief scientific officer. Gibson was most recently the chief scientific officer and oncology therapeutics head at Pfizer’s oncology research unit in La Jolla, CA. Gibson replaces Peter Linsley, who left last month to join Bothell, WA-based AVI Biopharma (NASDAQ: AVII).

Comments | Reprints | Share:          

Lots of little blurbs crossed the desk this week, along with one major blowup for a drug in the third and final stage of clinical trials.

—Seattle-based Omeros (NASDAQ: OMER) said it failed in a series of pivotal clinical trials with its anti-inflammatory drug to help patients undergoing arthroscopic knee surgery. The trials, which enrolled more than 1,000 patients from 2004 through 2010, were a big reason investors bought into the Omeros IPO of October 2009. The stock is down 39 percent since the news broke.

—An individual shareholder in Kansas kicked up a debate online after calling for a boardroom shakeup at Seattle-based Dendreon (NASDAQ: DNDN). Brad Loncar accused the company of failing to properly look out for the interests of small shareholders, and encouraged fellow readers of a popular stock message board, InvestorVillage.com, to urge the company to add one or two new board members to represent those interests. Loncar says he has received some support in his effort, along with plenty of vocal criticism.

—Bothell, WA-based Halosource, the maker of technology for purifying drinking water in the developing world, introduced three new products that consumers use at home. These are powered-water pitchers, or a gravity-based water container that use Halosource’s technology for killing viruses and bacteria. The company made its initial inroads into developing world markets by selling a replaceable cartridge with its technology that works with devices made by other companies.

—Vancouver, BC-based Tekmira Pharmaceuticals made headlines a few weeks ago when it accused its partner, Cambridge, MA-based Alnylam Pharmaceuticals (NASDAQ: ALNY) of misappropriating trade secrets related to the delivery of RNA interference drugs into cells. Now Alnylam has formally responded to the allegation in court, saying it plans to fully defend itself.

—Seattle-based Oncothyreon (NASDAQ: ONTY) said this week it has started a mid-stage clinical trial of drug for brain cancer, PX-866, which is designed to work against one of the high-profile molecular targets in cancer biology—the PI3 kinase. The study is enrolling 30 patients at seven sites in Canada.

—This week’s BioBeat column was about antibiotics, and why more biotech entrepreneurs should take this field seriously. I listed a few promising companies I’ve covered in this business all over the country, but couldn’t think of a single example of an antibiotics company from Seattle. If any readers out there have an idea why that is—or can alert me to some promising company I overlooked—please enlighten me at ltimmerman@xconomy.com.

—The University of Washington’s Center for Commercialization said last week it has added five new people to its roster of entrepreneurs-in-residence, who scout for university technologies with business potential. Ron Berenson, the former CEO of HemaQuest Pharmaceuticals, and Stephanie Amoss, formerly of Pathway Medical Technologies, are a couple of the new additions with expertise in biotech and medical devices, respectively.

—Bothell, WA-based AVI Biopharma (NASDAQ: AVII) said it has raised $30 million through a stock offering. The company followed up a few days later to say its underwriters exercised their options to buy extra shares, meaning that AVI netted about $32 million after paying expenses. AVI said previously that it entered this year with about $34 million of cash in the bank, and a plan to spend about $23 million to $28 million of its cash on operations.

Comments | Reprints | Share:          

AVI Biopharma (NASDAQ: AVII), the Bothell, WA-based developer of RNA-based therapies, said today it has raised $30 million through a stock offering. The company sold 20 million new shares at $1.50 apiece. The price represented a 19 percent discount to yesterday’s stock market closing price of $1.86. The underwriters of the deal—Lazard Capital Markets, Piper Jaffray, and ThinkEquity—were granted a 30-day option to buy more shares, which could raise an additional $4.5 million, AVI Biopharma said.

Comments | Reprints | Share:          

This was a pretty quiet news week for Seattle biotech except for one big decision that affects the hot cancer drug company in town.

—Seattle-based Dendreon (NASDAQ: DNDN) has produced enough evidence to win full reimbursement from Medicare for its $93,000 prostate cancer drug, sipuleucel-T (Provenge). This move was widely expected since Dendreon passed muster at a public hearing in November, but it’s still a pretty big win.

—Sage Bionetworks, the Seattle-based nonprofit seeking to spark an open-source movement for biology, said this week it has started working on projects for a couple of supporters—Japan-based Takeda Pharmaceutical and the CHDI Foundation. Both projects are about creating computational models for neurological disorders, which might help researchers do a better job of developing treatments. Sage also recently struck a deal with AstraZeneca to help with its cancer research.

—You’d never know it by driving by this nondescript warehouse in Bellevue’s Factoria neighborhood, but Clarisonic is fast becoming one of the biggest tech startup hits of the past few years in Seattle. The company, which makes a sonic wave brush that helps women get rid of dirt, oils, and makeup, surpassed $100 million in sales last year, its fifth year on the market, according to president Jack Gallagher. Who’s buying this device, which costs between $149 and $225? Pop sensation Lady Gaga and her mom, for starters.

—Seattle-based Frazier Healthcare Ventures completed its acquisition this week of a medical instrument repair and management company, OnSite Services, from San Diego-based Carefusion (NYSE: CFN). Terms weren’t disclosed.

—AVI Biopharma (NASDAQ: AVII), the Bothell, WA-based developer of RNA-based therapies, hired Peter Linsley as its new chief scientific officer. Most recently, Linsley was the chief scientist at San Diego-based Regulus Therapeutics, but he’s a familiar name in these parts, from his past experience with Merck/Rosetta Inpharmatics and Bristol-Myers Squibb.

—This week in BioBeat, I took aim at Big Pharma, saying it has grown too big and bureaucratic to develop innovative new drugs, and that it would be better off breaking up into nimbler, more manageable companies. I’d like to hear your comments on this, whether you think this is spot-on, dead wrong, or somehow beside the point.

Comments | Reprints | Share:          

AVI Biopharma (NASDAQ: AVII), the Bothell, WA-based developer of RNA-based therapies, said today it has hired Peter Linsley as its chief scientific officer. Linsley, 59, had previously been the chief scientist at San Diego-based Regulus Therapeutics, a company formed by Alnylam Pharmaceuticals and Isis Pharmaceuticals to develop microRNA treatments.

Comments | Reprints | Share:          

‘Twas the week before JP Morgan and all through the house…OK you get the idea. Not much biotech news was stirring this week as everybody is prepping for the big industry confab next week in San Francisco. I’ll be reporting there as always.

—We rang in the New Year on the biotech desk with a story titled “The Immunex Alumni: Where are they now?” It’s been more than eight years since the Seattle biotech bellwether was bought by Amgen, so I thought it would be interesting to track down where a lot of the Immunoids went. I’m getting a lot of great comments in my inbox, and please keep them coming. The list has 306 names at last count, and if you or someone you know is an alumnus that would like to be included, just send me a note at ltimmerman@xconomy.com

—One of the most prominent Immunex alumni, Doug Williams, made some news this week when he took a new job as the executive vice president of R&D at Weston, MA-based Biogen Idec (NASDAQ: BIIB). This means Seattle biotech can subtract one of its few bankable CEO candidates, as Williams is headed off to the East Coast.

—AVI Biopharma (NASDAQ: AVII), the Bothell, WA-based developer of RNA-targeted therapies, said it has formed an alliance with the Karolinska Institute in Sweden to look for new drugs against extensively drug resistant forms of tuberculosis. Financial terms weren’t disclosed, but the two parties will split research costs.

—Seattle-based Omeros (NASDAQ: OMER) said it has obtained an exclusive license from the University of California to a number of new drug candidates for trauma-related and surgical bleeding. Terms weren’t disclosed.

—Genentech, the biotech giant in South San Francisco, has taken a license to a number of antibacterial drug candidates from AMRI, the pharmaceutical service firm. AMRI did much of the work on these novel compounds, derived from natural product sources, at its lab in Bothell, WA.

—Leroy Hood added another major prize to his trophy case this week. Hood took home the Russ Prize, a $500,000 bioengineering honor presented by the National Academy of Engineering. Hood won for his most famous series of inventions in high-speed gene sequencing, which laid a critical foundation for the Human Genome Project and the wave of faster/cheaper genome sequencing that came after.

—We have had a bunch of guest editorials flowing into the Xconomy Forum lately, on a number of tech-related themes, and from a number of writers in our 5-city network. Here are two from the past couple weeks that are of most interest to Seattle biotech readers. Sue Siegel, a partner with Mohr Davidow Ventures, offered her view on five things to watch for in the coming year of healthcare and life sciences. And Larry Corey, the new president of the Fred Hutchinson Cancer Research Center, provided his thoughts on how vaccines were the big innovation story he saw in 2010.

Comments | Reprints | Share:          

AVI Biopharma (NASDAQ: AVII), the Bothell, WA-based developer of RNA-targeted therapies, said today it has formed a collaboration with leading scientists at the Karolinska Institute in Sweden to find new treatments for extensively drug resistant forms of tuberculosis known as XDR-TB. Funding and research support is provided by both parties, and intellectual property resulting from the work will be jointly owned, AVI said in a statement. AVI retains an exclusive right to acquire Karolinska’s interest in intellectual property, AVI said.

Comments | Reprints | Share:          

The medical meeting season has passed, and pretty soon Seattle biotechs will go into hibernation for the holidays. But here are a few headlines to catch up on you may have missed in the last week.

—Washington’s Life Sciences Discovery Fund had never invested in a corporation until October, when it agreed to pump $5 million into a drug discovery project at Seattle-based Omeros (NASDAQ: OMER). Like many people, I was under the impression that the state couldn’t really do things like this because of a constitutional prohibition against investing in companies. But executive director Lee Huntsman explained in this follow up interview how this deal was structured in a way that passed legal muster, and which he says could provide a significant return on investment for the state, and a nonprofit entity that may someday replace the Life Sciences Discovery Fund.

—We had the exclusive feature this week on Seattle-based Adaptive TCR, a spinoff from the Fred Hutchinson Cancer Research Center, that has made major strides as a business in its first full year of operations. The company, which is seeking to dominate a new industry in what it calls immune system profiling, has signed up more than 50 academic customers this year, CEO Chad Robins says.

—The future of ultrasound may be on an iPhone, if the folks at Redmond, WA-based Mobisante are correct. This was one of a couple of interesting life sciences startups that were featured last week at the Northwest Startup Demo conference, organized by the MIT Enterprise Forum of the Northwest.

—We announced the next big event on the calendar at Xconomy Seattle, a conference we are calling “Computing in the Age of the $1,000 Genome.” This event, set for February 7 at Swedish Medical Center’s James Tower Auditorium, will feature leading speakers at the nexus of computing and biology from around the West Coast. Today is the last day to get the “super saver” discounted rate, so if you plan on attending, this is the best time to get a ticket.

—Bothell, WA-based AVI Biopharma (NASDAQ: AVII), the developer of RNA-based therapies, named former Celgene executive Chris Garabedian as its new CEO this week. He steps in after former CEO Les Hudson was ousted in a shareholder revolt last April.

—OVP Venture Partners hadn’t had an IPO in a long time until last month, when Mountain View, CA-based Complete Genomics (NASDAQ: GNOM) pulled off that daring feat. I caught up with CEO Cliff Reid last week, and asked him about his company’s business plan to sequence complete human genomes specifically for cancer researchers.

—The Fred Hutchinson Cancer Research Center has been on a major push to boost its immunotherapy programs, and it got an assist from the community with donations from its annual Hutch Holiday Gala. This year, the center pulled in $5.6 million in donations, which was enough over a two-year period to trigger a full $10 million matching grant from the family of Amazon founder Jeff Bezos.

Comments | Reprints | Share:          

AVI Biopharma, the Bothell, WA-based developer of RNA-based therapies, said today it has hired Chris Garabedian as its new president and CEO. Garabedian, 44, previously was a vice president of corporate development with Summit, NJ-based Celgene (NASDAQ: CELG). AVI has had an opening for a permanent CEO since April, when Les Hudson was ousted in a shareholder uprising. Garabedian starts on January 1, and will replace AVI interim president and CEO David Boyle, who will continue with the company as chief financial officer and senior vice president.

Comments | Reprints | Share:          

Shire has got to be feeling a little extra bounce in its step, as one of its competitors (Genzyme) has wobbled recently, and today it’s continuing its bold push forward in the world of rare diseases in a big partnership with Cambridge, MA-based Acceleron Pharma.

Shire (NASDAQ: SHGPY), the U.K-based company that’s become an increasingly potent rival to Cambridge, MA-based Genzyme during that company’s recent manufacturing struggles, said today it has struck a deal in which it will pay Acceleron as much as $498 million to co-develop and co-market drugs that treat muscle disorders like Duchenne Muscular Dystrophy. Acceleron will get a $45 million upfront cash payment, and the two companies will move ahead with a mid-to-late stage development program. Shire gets the commercial rights outside North America, while Acceleron retains the commercial rights on this continent.

“The structure of this collaboration allows Acceleron to retain commercial rights in North America with the opportunity to build a highly valuable business while collaborating with an ideal partner,” said John Knopf, Acceleron’s CEO, in a statement. “Shire’s international presence and their proven leadership and dedicated focus on orphan diseases forms the basis for a successful collaboration.”

The key to the deal is Acceleron’s experimental protein drug, ACE-031, which is designed to build muscle by interacting with a receptor on cells known as activin receptor type IIB. The Acceleron drug is unusual, in that it’s a genetically engineered fusion protein that takes part of the receptor itself and combines it with a fragment of an engineered antibody that has targeting capability. While ACE-031 is the prime asset, Shire has also obtained rights to alternative molecules Acceleron has developed against the same target receptor, which could be useful for other muscle disorders.

The Acceleron drug has shown in animal studies that it can increase muscle mass and improve strength in animals, regardless of whether they have a specific genetic mutation. Other companies, like Bothell, WA-based AVI Biopharma and Netherlands-based Prosensa, have been pursuing RNA-based drugs to treat the disease in a different way. Genzyme, Shire’s main competitor, also formed a partnership two years ago with South Plainfield, NJ-based PTC Therapeutics which includes a treatment for Duchenne Muscular Dystrophy. That drug candidate failed in a mid-stage study last spring.

There is no FDA approved drug today that alters the course of muscular dystrophy, but all the biotech companies see big commercial potential in a treatment for this genetic disease. It primarily affects boys, and makes it difficult for them to walk, breathe, and otherwise play like normal kids. Duchenne Muscular Dystrophy is said to affect about one out of every 3,500 boys at birth.

For Acceleron, today’s deal isn’t the first validation it’s gotten from a big partner. The company, founded in 2004, has a partnership with Summit, NJ-based Celgene (NASDAQ: CELG) for a treatment against cancer-related bone loss. Waltham, MA-based Alkermes (NASDAQ: ALKS) has also invested $10 million in Acceleron to help it make a more convenient treatment for rheumatoid arthritis that could compete with Amgen’s multi-billion dollar hit drug etanercept (Enbrel). The financial support of its venture capitalists (Advanced Technology Ventures, Flagship Ventures, OrbiMed Advisors, and Venrock Associates to name a few), and corporate partners, has enabled Acceleron to build a staff of more than 150 employees and invest in manufacturing facilities at a time when few small biotechs can afford to pursue such bold plans. This new Shire deal certainly won’t discourage the company from thinking big.

Comments | Reprints | Share:          

The Ebola virus made a big appearance on the Northwest biotech scene this week, but it wasn’t nearly as ominous as that sounds.

—Tekmira Pharmaceuticals, the Vancouver, BC-based developer of drugs that silence specific stretches of RNA, said it has nailed down a U.S. defense contract that could be worth as much as $140 million over time to develop an RNA-based treatment for Ebola virus. News broke the next day that Tekmira wasn’t alone. Bothell, WA-based AVI Biopharma (NASDAQ: AVII) said it also secured a defense contract worth as much as $291 million over time if it can hit a series of milestones in development of an RNA-based Ebola treatment. While I’m sure the companies are happy to cash the checks, these are drugs that everybody hopes will never need to be used for biodefense.

—While Tekmira and AVI are going to enjoy living off Uncle Sam’s contracts for a while, many other biotech companies are having to adjust to a new stingy reality since the Wall Street-fueled housing bubble burst in 2008. Accelerator’s Carl Weissman offered some specific examples of how some companies have been pinching their pennies ever since.

—Here’s an interesting startup profile of a medical device company finding a way forward in this new era of austerity. Seattle-based Mirador Biomedical, armed with just $1.1 million in financing, has developed a simple device designed to prevent a common error in the hospital—when a catheter gets placed in an artery instead of a vein. With a little luck, Mirador could have an FDA-approved product before the end of 2010.

—A familiar name in Seattle biotech, Tom Ranken, has found a new mission as the head of the Washington Clean Technology Association. He’s been feeling some déjà vu lately, given that cleantech as an industry is in those heady early days like biotech was in the 1990s when he played a pivotal role in building the Washington Biotechnology & Biomedical Association.

—Bothell, WA-based MDRNA (NASDAQ: MRNA) delivered some news that’s sure to irritate a few shareholders. It announced a reverse stock split, in which shareholders will get one share for every four they own today. The company said this move was authorized by its board at the 2009 annual meeting, so it could be timed at the right moment in the future. MDRNA was worth 75 cents a share at yesterday’s close.

Comments | Reprints | Share:          

This was a big biotech news week with the annual extravaganza for cancer drug developers, the American Society of Clinical Oncology (ASCO). Nobody from Seattle stood out on the world stage this year, although we heard about some people laying important groundwork for future ASCOs.

—ZymoGenetics, the granddaddy of Seattle biotech, has had some bad luck the last couple years, and this year’s ASCO meeting was no exception. The company (NASDAQ: ZGEN) presented some promising data on a new treatment for melanoma that has spread through the body, although it was upstaged by a rival drug from Bristol-Myers Squibb.

—Calistoga Pharmaceuticals, one of the relative whippersnappers of Seattle biotech, presented some important data that shows its lead drug candidate is standing up to more rigorous clinical testing. Calistoga showed some intriguing results from the first dozen patients at last year’s ASCO, but this year, the same trend was apparent in a database of more than 100 patients.

—Seattle Genetics (NASDAQ: SGEN) has been on a roll with its “empowered antibody” for Hodgkin’s disease, although the company didn’t really have any groundbreaking scoops at ASCO this year. It presented some preliminary data that suggests its lead candidate might work when used in re-treatment cycles, which is an important thing for doctors who want to know they have options when a patient relapses.

—One of the interesting stories in medical devices this year has been the emergence of a Northwest angel investing network, supported by the Washington Biotechnology & Biomedical Association, called Wings. The mostly volunteer effort was led by EndoGastric Solutions founder Stefan Kraemer, who is leaving the Northwest for a job at C.R. Bard on the East Coast. But enough pieces were in place in the organization that a seasoned pair of medical device entrepreneurs—Kirby Cramer and Wayne Wager—have stepped in to fill the leadership void.

—Asemblon, a Redmond, WA-based developer of organic carrier molecules designed to make hydrogen fuel practical for the trucking industry, has picked up some renewed focus with its new CEO Michael Ramage and a partnership with Los Angeles-based Vision Industries, a hydrogen-powered truckmaker that has caught the eye of California Gov. Arnold Schwarzenegger.

—Bothell, WA-based Alder Biopharmaceuticals presented data at the ASCO meeting on its novel idea of treating cancer patients not by fighting the tumors, but by tamping down the excess inflammation that makes them feel so miserable. I offered an in-depth profile of this drug in a preview story before the big medical meeting.

—AVI Biopharma (NASDAQ: AVII), the Bothell, WA-based developer of RNA-based therapies, said it had lined up another contract from Uncle Sam potentially worth $18 million to develop a treatment for pandemic flu.

—Bothell, WA-based Ekos, the developer of ultrasound-based therapies, said it has received a $2.7 million grant from the National Institutes of Health to study its treatment for hemorrhagic strokes.

—Xconomy’s life sciences columnist, Sylvia Pagan Westphal, pointed out that in the decade since the genomics bubble burst, a lot of really interesting things are starting to happen again based on our deepening understanding of the genome. It may not show up on a quarterly earnings report yet, but genomics is on the comeback trail, Westphal writes.

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:          

[Update: 11 am Pacific] AVI Biopharma CEO Les Hudson has been ousted as part of a boardroom shakeup. The Bothell, WA-based biotech company (NASDAQ: AVII) said today that chief financial officer David Boyle will take his place as interim president and CEO through an agreement with activist shareholders.

AVI Biopharma director K. Michael Forrest is also stepping down from the board, and being replaced by Anthony Chase. That leaves AVI Biopharma with a seven-member board made up entirely of independent directors. Christopher Henney, the former CEO of Seattle-based Dendreon, and fellow director Michael Casey are not running for re-election at this year’s annual meeting, so two new faces will soon be joining the company’s board.

The shuffling at the top was part of an agreement with a group of shareholders composed of George Haywood, Cheryl Haywood, Rockall Emerging Markets Master Fund Limited, Meldrum Asset Management, Con Egan, and Conor O’Driscoll, according to an AVI statement. The company didn’t explain why the change was necessary, and only described it in the vaguest of terms.

“This agreement reflects the Board and management team’s focus on serving the best interest of all AVI shareholders and building on the strong foundation we have in place,” said Michael Casey, chairman of the AVI board, in a statement.

[Updated comment from spokesman, 11 am Pacific] David Walsey, a spokesman for AVI Biopharma, said the board plans to start a search for a new CEO soon, noting that it will consider internal and external candidates. That means Boyle is a candidate, Walsey says, adding “he has the support of the board now and he may in the future.”

AVI Biopharma has a long and somewhat tortured history. As I pointed out in a breaking news story last July, it is one of the oldest companies in biotech, having sputtered around since 1980 without ever developing an FDA-approved drug, burning through more than $250 million in investor cash, and never becoming profitable. But the company showed some new life last year, raising more than $50 million from investors during the year, adding capital from government grants, and moving to the Seattle area to recruit more staff.

Since Hudson joined in February 2008, he has pushed forward AVI’s technology for precisely blocking specific strands of RNA as a new mode of developing drugs. AVI is using this science to work on experimental treatments for Duchenne muscular dystrophy, and against really dangerous potential bioterrorist agents that conventional drugs can’t stop—Ebola and Marburg virus.

The company is eagerly awaiting detailed results from an early-stage clinical trial later this year for its Duchenne muscular dystrophy treatment, which I previewed in this feature back in February. But this hasn’t been enough to float the boat for investors. AVI Biopharma stock sold for $1.23 in early trading this morning, down just a penny on the news of Hudson’s departure, and still a far cry from the company’s 52-week high of $2.73.

Comments | Reprints | Share:          

The Seattle biotech beat is about to get a dose of drama over the next week, as one of the oldest companies in town prepares for a make-or-break moment in suburban Washington, D.C.

—Seattle-based Cell Therapeutics (NASDAQ: CTIC]) is getting ready for a critical decision next Wednesday, when a panel of cancer drug experts will advise the FDA on whether to approve pixantrone as a new treatment for relapsed, aggressive forms of non-Hodgkin’s lymphoma. I laid out what’s at stake in this preview story.

—AVI Biopharma (NASDAQ: AVII), a company that’s even older than Cell Therapeutics but a relative newcomer to Bothell, WA, has some important, albeit early-stage, clinical trial data to look forward to later this year. This story recaps what researchers, investors, and parents will be watching for from AVI’s lead drug candidate for Duchenne Muscular Dystrophy.

—Seattle-based HemaQuest Pharmaceuticals has raised $6 million in equity financing out of a round that could be worth as much as $12.7 million, according to a regulatory filing. This company, led by former Xcyte Therapies CEO Ron Berenson, is pursuing a new treatment for sickle cell anemia.

—NanoString Technologies, the Seattle-based maker of genetic analysis instruments, has added a big name to its board. William Young, the chairman of Biogen Idec and former chairman and CEO of Monogram Biosciences, has signed on as NanoString’s executive chairman. The company is still looking for a permanent CEO to replace Perry Fell, who stepped down last March.

—My colleague in Boston, Ryan McBride, wrote a story last week about Millennium: The Takeda Oncology Company has big ideas for how to capitalize on its new partnership with Bothell, WA-based Seattle Genetics (NASDAQ: SGEN]). This week, we saw one example of the strategy in action, as the two companies started a clinical trial of brentuximab vedotin for patients with newly-diagnosed Hodgkin’s disease, beyond the smaller group of patients with relapsed forms for whom the drug was initially developed.

—Bill Gates made some big biotech news this past week in Davos, Switzerland. His namesake foundation is pledging $10 billion over the next decade to research, develop, and deliver new vaccines against global health scourges. Biotech entrepreneurs on the fundraising trail, are you listening?

—Every March, the Washington Biotechnology and Biomedical Association tries to bring in big-time national investors for a conference where they can to scope out the local life sciences scene. And every year, they struggle. This year could be different, as Steve Burrill, the biotech jack-of-all-trades, is putting his money, organizational horsepower, and Rolodex into raising the profile of this year’s event, called Life Sciences Innovation Northwest.

—We published a thoughtful guest editorial from Richard Gayle about how to create an environment where people get out of their cubbyholes and start real, meaningful scientific collaborations. Just as a reminder, the space in the Xconomist Forum is open for you, our readers, not for me. So if you have an idea, an insight, or something you want to get off your chest that you think may have some value to other members of the local innovation community, just ping Greg and I at editors@xconomy.com

Comments | Reprints | Share:          

AVI Biopharma doled out an interesting little morsel of news on its muscular dystrophy drug right before Christmas that showed encouraging results in three boys. This year, the Bothell, WA-based biotech company is eagerly awaiting more meaningful follow-up data that could show it is on track with what could be the first treatment to fix the underlying molecular abnormality in boys with Duchenne Muscular Dystrophy.

I got the update on AVI’s game plan for 2010 when I met with a few senior executives, including chief financial officer David Boyle and chief medical officer Steve Shrewsbury, a couple of weeks ago in San Francisco. We talked a little bit about the company’s RNA-based treatments for hemorrhagic viruses like Ebola, as well as a new government-funded flu program. But there’s no doubt the main event this year will be what happens with the company’s treatment for Duchenne Muscular Dystrophy.

AVI Biopharma (NASDAQ: AVII) wants to be the first company to make a drug that silences a specific strand of RNA, and enables the body to produce a protein called dystrophin. This is a protein that’s essential for enabling muscles to rebuild themselves, and is lacking in boys with a birth defect known as Duchenne Muscular Dystrophy. This is a crippling disorder that affects about one out of every 3,500 boys born worldwide.

“Duchenne Muscular Dystrophy is certainly our lead program, and we think it has significant value,” Boyle says.

The AVI approach made some medical news in The Lancet last year, when the company showed that its RNA-based treatment was able to restore production of dystrophin proteins when injected directly into a foot muscle. That prompted the next step, in which AVI developed a version of the drug that could be delivered intravenously, and circulate throughout the body, where it could presumably have a much broader impact on muscles.

The first peek at data from this trial of the intravenous version came out in December. This initial slice of data was from the first nine patients who were enrolled in the four lowest dose groups. Researchers found that in three patients who got doses on the high end of that range, the molecular abnormalities dissipated. One boy was able to produce five-fold higher amounts of dystrophin. “These results suggest that we are on the right path,” said Francesco Muntoni, the trial’s lead investigator at University College London, in a statement.

I wanted to know about the next steps to watch for in the clinical development of this drug, called AVI-4658. It turns out that AVI has two major data releases planned for 2010, and both will be closely watched by parents, researchers, and shareholders.

The first release will be before the end of June. The trial, for those unfamiliar … Next Page »

Comments | Reprints | Share: