Cell Therapeutics suffered an embarrassing defeat the last time it appeared in front of an FDA advisory panel and today the company made a move that will enable it to avoid another public shellacking, at least for a while.

The Seattle-based biotech company (NASDAQ: CTIC) said today it has withdrawn its application to start selling pixantrone (Pixuvri) as a new lymphoma drug in the U.S. after saying today it needed more time to prepare for a Feb. 9 meeting of the FDA’s cancer drug advisory panel. The company said it asked the FDA to allow it to present at the March meeting instead, but when the agency said no, Cell Therapeutics withdrew the application. That means the agency’s April 24 deadline to complete its review of the application has been voided, although Cell Therapeutics said today it plans to resubmit its application later in 2012.

The last time Cell Therapeutics appeared at the FDA’s Oncologic Drugs Advisory Committee (ODAC), in March 2010, the panel voted 9 to 0 against the company’s pixantrone application. The chair of the FDA panel at the time, Gail Eckhardt of the University of Colorado at Denver, said the Cell Therapeutics application was “disturbing,” partly because it only enrolled 140 of the 320 patients needed to generate a statistically valid result. The head of the FDA’s cancer drug office, Richard Pazdur, said at the time that the Cell Therapeutics application depended on “a single incomplete trial.” The initial application was turned down by the FDA in April 2010.

By withdrawing the application just before the next advisory panel, Cell Therapeutics contradicted one of its own statements from less than a month ago, when it said it believed it had addressed the concerns raised by the FDA.

“We are pleased the Office of Oncology Drug Products (OODP) chose to bring our pixantrone new drug application back to ODAC for review now that we have provided additional information and data recommended by the Office of New Drugs (OND) that we believe addresses the issues raised in the OODP Complete Response Letter of April 2010,” James Bianco, the company’s CEO, said in a Jan. 3 statement.

Shares of Cell Therapeutics fell 18 percent today to $1.09 in early trading.

Comments | Reprints | Share:          

This was a great year for Seattle biotech if you measure success through sheer number of acquisitions. But if you prefer to measure the health of an innovation community by the number of exciting new startups it hatches, then this was most certainly a down year.

That’s the mixed bag of returns that I saw when looking back at the news of 2011 from the Seattle life sciences scene. This was the year of the acquisition for Calistoga Pharmaceuticals, Pathway Medical Technologies, Calypso Medical Technologies, SonoSite (NASDAQ: SONO), Amnis, Geospiza, and Pacific Biosciences Labs (the maker of the Clarisonic skin brush.)

While those companies got harvested, not a whole lot of new seeds got planted. The list of notable Seattle biotech startups this year includes Cardeas Pharma, Oncofactor, Blaze Bioscience, Aquedect Neuroscience and Cardiac Insight.

Who else made headlines in Seattle biotech in 2011? Seattle Genetics emerged. Dendreon crashed. Marina Biotech, Omeros, and AVI Biopharma all had years they’d like to forget. Cell Therapeutics somehow managed to stay in business. New leaders emerged at the global health nonprofits, as Alan Aderem moved in to run the Seattle Biomedical Research Institute, Stewart Parker took over at the Infectious Disease Research Institute, and Chris Elias created a vacancy at the top of PATH by leaving for a new gig at the Bill & Melinda Gates Foundation. The foundation’s head of global health, Tachi Yamada, left for a new venture capital gig, and was replaced by a former Novartis executive, Trevor Mundel.

Here’s a company-by-company rundown of the major events at Seattle biopharmaceutical and global health organizations we keep tabs on here at Xconomy. Tomorrow, I’ll follow up with the rundown of rundown of medical device, diagnostic, and others in fields like Bio-IT or Health IT.

Seattle Genetics (NASDAQ: SGEN). This was a transformative year for Seattle Genetics. The company broke through in August by winning FDA approval of its first product, a souped-up antibody for rare lymphomas. The drug validated a new target on the surface of cancer cells, CD30, and provided hard proof that Seattle Genetics’ proprietary chemistry can successfully link toxins to antibodies—a feat that has eluded scientists for 30 years. Big Pharma companies have beaten a path to Bothell to get licenses to the antibody-drug linking technology, and Seattle Genetics has exceeded Wall Street expectations in the early days of its drug rollout.

Dendreon (NASDAQ: DNDN). Dendreon was the star of local biotech in 2010, and this year it fell flat on its face. The company failed to live up to its first full year sales forecast with its immune-boosting drug for prostate cancer, and burned its shareholder base in the process. The company lost more than $3.5 billion in market valuation, and had to cut 500 jobs, largely because it sparked controversy and confusion by pricing its cancer drug too high—at $93,000 per patient. It remains to be seen this year whether Dendreon can pick up the pieces, as the disastrous screw-up of 2011 has created a gaping opportunity for emerging competitors like Johnson & Johnson’s abiraterone (Zytiga) and Medivation’s MDV-3100.

Amgen (NASDAQ: AMGN). The Thousand Oaks, CA-based biotech company, which has significant R&D in Seattle, said at the end of the year that longtime CEO Kevin Sharer … Next Page »

Comments (3) | Reprints | Share:          

One of the Accelerator graduates made news last week (Allozyne) and this week another alumnus from the Seattle biotech startup propeller took its turn making headlines.

—Seattle-based Theraclone Sciences (an Accelerator grad) said it has formed an alliance with the world’s largest drugmaker, New York-based Pfizer (NYSE: PFE). Pfizer will get access to Theraclone’s antibody discovery platform to develop new drugs against certain targets for cancer and infectious diseases. The total value of this deal is $632 million over time, and as much as 30 to 40 percent of the cash could come from “near-term” milestones, says acting president Steve Gillis.

—Seattle-based Dendreon (NASDAQ: DNDN) continued to seize its momentum by snapping up a debt financing worth $540 million, which it plans to use as part of its strategy to take its immune-booster for prostate cancer into Europe. If Dendreon stock continues its bull run of 2010 throughout 2011, it’s possible that much of the debt could be wiped off the books and converted into stock.

—The other public biotech company in town that’s on a hot streak, Seattle Genetics (NASDAQ: SGEN), took its turn in front of the national TV cameras of CNBC last week. CEO Clay Siegall talked about the clinical trial results that support its “empowered antibody” for certain lymphomas. He also shed a little light on how he’s thinking about pricing this drug if it wins FDA approval, which many investors are expecting to happen this year.

—Ekos, the Bothell, WA-based developer of ultrasound technology for treating blockages in blood vessels, said this week it has won clearance to start marketing its Ekosonic product in the European Union for patients with clots in the lungs. As the FDA approval process looks ever more uncertain for med device makers, we are seeing more and more announcements like this, where new medical devices here get introduced first in Europe.

—We have wrapped up our series of Xconomist editorials that look ahead at the big trends to watch in infotech, biotech, and cleantech. I compiled the list of editorials we’ve run across our 5-city national network, and I’m pretty sure a few of these are of interest to folks in the Seattle biotech community.

—Arzeda, the University of Washington spinoff that uses computers to make custom-built enzymes, has achieved a technical milestone as part of its collaboration with DuPont’s Pioneer Hi-Bred business unit. Arzeda has developed a novel enzyme that is “showing activity toward a trait of interest” in corn and soybeans, Pioneer says.

—We’ve already hit the theme “Biotech’s Back in Seattle” through one of our Xconomy events from November, but I came back to this theme during a talk at the University of Washington‘s South Lake Union campus. Here’s the link to (most of) the archived webcast of the talk for those who couldn’t be there in person.

—Seattle-based Cell Therapeutics (NASDAQ: CTIC) said this week it raised $25 million from a single investor, whose name wasn’t disclosed.

—We had an intriguing guest post from Stewart Lyman, who posed the question on whether biotech suffers from information overload, or underload. Essentially, biotech startups can’t afford to have access to a lot of the high-priced peer-reviewed journals they might have been able to read in yesteryear, so Lyman wonders what kind of impact that might have on their ability to innovate. As always, you are welcome to add your comments. Believe me, I read them, and sometimes get good ideas for follow-up stories from our readers, so keep them coming.

—On Friday, I banged out a quick wrapup of my whirlwind trip to the JP Morgan Healthcare Conference in San Francisco. I gathered a ton of news from contacts around the country there, and also snapped a few pictures along the way of people well known to local biotechies. One of the shots was of Keith Crandell of Arch Venture Partners teasing his fellow partner Bob Nelsen.

Comments | Reprints | Share:          

Seattle-based Cell Therapeutics (NASDAQ: CTIC) said today it has raised $25 million by granting preferred stock and warrants to a single institutional investor. The investor, whose name isn’t being disclosed, also obtained the right to buy more shares in the company for an additional $25 million at a future date. Cell Therapeutics, a cancer drug developer founded in 1991, has accumulated a deficit of about $1.54 billion through its history, according to its most recent quarterly report. The investor will now have about a 9.7 percent ownership stake in the company. Cell Therapeutics said it may use the new money to pay down some old debt, or acquire new technologies. Shares of Cell Therapeutics closed yesterday at about 39 cents.

Comments | Reprints | Share:          

Cell Therapeutics (NASDAQ: CTIC), the Seattle-based developer of cancer drugs, said today it has filed an application for approval to start selling a new lymphoma drug in the European Union. The company is asking the European Medicines Agency to allow sales of pixantrone (Pixuvri) to adult patients with relapsed forms of non-Hodgkin’s lymphoma. The company’s application for U.S. approval was turned down by the FDA in April.

Comments | Reprints | Share:          

We had a hodgepodge of news this week on the biotech scene, with financings, an FDA approval, and an exclusive feature on what Nathan Myhrvold’s invention shop is doing in the medical device business. Get caught up here.

—Cell Therapeutics (NASDAQ: CTIC), the Seattle-based cancer drug developer, raised $21 million through the sale of preferred stock and warrants. It’s just the latest sign that one should never underestimate this company’s fundraising prowess. It can still raise money, even though after 19 years in business, and burning through $1.5 billion of investor money, it doesn’t have any cancer drugs currently on the market.

—OncoGenex Pharmaceuticals (NASDAQ: OGXI), the Bothell, WA-based cancer drug developer, is not exactly an Internet chat room cause celebre like Cell Therapeutics, but it raised a lot more money this week. OncoGenex pulled in $50 million to help advance its drug development programs.

—PATH, the Seattle-based sparkplug for global health, said this week it has secured a $1 million grant from the U.S. Department of Agriculture to take its “Ultra Rice” technology to Africa for the first time. The fortified rice will be made available through a pilot project, in collaboration with Federal Way, WA-based World Vision, to malnourished children in the central African nation of Burundi.

—Geospiza, the Seattle-based maker of software for genetic analysis, said this week it has added well-known drug developer Bruce Montgomery to its board of directors. Geospiza is hoping that Montgomery will provide advice to help it branch out from its traditional base of academic research customers, and start making bigger waves in the pharmaceutical industry.

—Intellectual Ventures, the Bellevue, WA-based invention firm founded by famed polymath Nathan Myhrvold, gets most of its attention for far-out ideas it pushes for zapping mosquitoes or producing clean nuclear power. But according to a couple of new medical device dealmakers on staff, IV is actually in position to start making an impact in medical devices, with stuff like self-sanitizing touch screens that could cut down infections in hospitals.

—One cool little entrepreneurial success story in Seattle emerged this week by the name of Mirador Biomedical. The company won FDA approval for a device that will help doctors to tell the difference between when they are about to puncture an artery or a vein, which has potential to prevent quite a few life-threatening screw-ups that happen in hospitals every year. The company got to this point after less than two years of work and after raising a little more than $1 million.

—Stewart Lyman chimed in this week with a delightful guest editorial which pokes holes in a lot of the doubletalk and flabby thinking that often passes as insight in the biotech industry. This is a fun piece you don’t want to miss.

Comments | Reprints | Share:          

Cell Therapeutics (NASDAQ: CTIC), the Seattle-based developer of cancer drugs, said today it has raised $21 million through a securities offering to four institutional investors. The investors will get preferred stock worth the equivalent of 56.7 million shares of common stock, and warrants to buy another 22.7 million shares of common stock. Cell Therapeutics struck the agreement a little more than a month after shareholders authorized further stock sales, just as the company said it was in danger of running out of money.

Comments | Reprints | Share:          

This week, I profiled a person in his 70s and someone in her 20s. It really reminded me how covering the life science innovation beat leads to a lot of fascinating people at different stages of their careers.

—Lee Hartwell, the Nobel Prize-winning biologist who is stepping down as president of the Fred Hutchinson Cancer Research Center, talked in depth about what he plans to do in the next phase of his career. It’s a fascinating blend of personalized medicine, global sustainability, and science education. Hartwell also chimed in with an op-ed to specifically outline his ideas around science education.

—The other profile was about Dana Lewis, a person just starting her career at 22 as the social media ace at Swedish Medical Center. She told the story of how her interest in finding information online about her Type 1 diabetes morphed into a job, in which she coaches doctors on how to engage with patients and peers through Twitter, Facebook, YouTube and any other form of social media.

—Seattle-based Cell Therapeutics (NASDAQ: CTIC) survived yet another cliffhanger moment, as the company was able to persuade shareholders to authorize the sale of another 400 million shares. The company was running low on cash, and now expects to be able to raise more money.

—Stewart Lyman kept the conversation going about ZymoGenetics, noting that he’s sad to see one of the strongest players in Seattle biotech disappear. While others have suggested the region doesn’t need a so-called “anchor tenant,” Lyman points out why he thinks this is important for the region’s future as a biotech hub.

—Paying down debt is a fashionable thing to do in 2010, and that’s what Vancouver, BC-based Tekmira Pharmaceuticals did this week. Tekmira agreed to accept a $5.75 million payment from Hana now, in exchange for reduced payments in the future from a drug development licensing agreement. Tekmira then sent the $5.75 million to debt holders to wipe out its remaining debt.

Comments | Reprints | Share:          

[Updated: 6:20 pm Pacific] Cell Therapeutics isn’t ready to close its doors just yet, even after suffering what could have been a fatal setback this year. The Seattle-based biotech company (NASDAQ: CTIC), which had a new drug application soundly rejected by the FDA in April, said today that shareholders have given it the green light to sell up to another 400 million shares to raise more money to stay in business.

This was the fifth time Cell Therapeutics tried to rustle up enough shareholder votes in favor of issuing new shares after it tried, unsuccessfully, at previous shareholder meetings scheduled on April 9, May 14, June 4, and June 29. The company needed this vote badly, because it had already issued or reserved almost all of the 810 million shares that it had previously been allowed to offer. Since the company has no money-generating products on the market, it continues to burn cash. So Cell Therapeutics management told shareholders it was necessary to keep issuing more shares—something stockholders often detest because it dilutes the value of existing shares. But without selling more stock, the company said in its most recent quarterly report, it didn’t have enough cash to last beyond the end of this year.

“We are gratified by the support from our shareholders and of our mission to make cancer more treatable,” said Dan Eramian, a company spokesman, in an e-mailed statement.

Cell Therapeutics, in a recent letter to shareholders filed with the SEC, made clear that this was an urgent matter and that it needed help.

“We are committed to bringing our drugs to cancer patients, but CTI needs your support,” wrote Louis Bianco, the company’s chief financial officer, in a letter to shareholders dated Sept. 3.

“Your vote can help us make a difference in the potential success of these drugs and in the lives of the patients who could someday benefit from them,” Bianco added. “Without your voting support, CTI may not be able to continue this research.” [Editor's Note: Cell Therapeutics used the bolded text in its letter to shareholders.]

What the letter didn’t go into was the string of events that put Cell Therapeutics into such a predicament. The company, which has burned through about $1.5 billion of investors’ money since it was founded in 1991, has no marketed products and nothing else in the pipeline with a chance of generating sales anytime soon. Cell Therapeutics failed to win FDA approval of its latest lymphoma drug, pixantrone (Pixuvri), back in April. The drug was slammed by FDA cancer drug boss Richard Pazdur at an advisory panel meeting a few weeks earlier, in which he said  the company’s application depends on a “single incomplete trial.” That’s because the Cell Therapeutics trial was supposed to enroll 320 patients over 36 months, but was halted after 45 months, when only 140 patients had enrolled.

Pazdur added that only eight of the 140 patients enrolled at sites in the U.S., even though the company had arranged for 28 U.S. sites to enroll patients. The enrollment was poor because many patients opted for other combination treatments, simple pain relief at the end of life, or a competing drug, rituximab (Rituxan), Pazdur said. The lack of U.S. patients means there’s a question of whether the results are generalizable to a patient population in the U.S., Pazdur said. After the presentation, the FDA’s expert panel of cancer drug advisors stated clearly, in a 9-0 vote, that the drug shouldn’t be cleared for sale in the U.S.

Discouraging as that might seem, the company has sought to give shareholders a reason to keep the company going. Cell Therapeutics, in the recent letter from its finance chief, said it is “moving toward” seeking approval of pixantrone in the European Union. And earlier this week, the company said it plans to appeal the FDA’s decision to reject the pixantrone application.

Cell Therapeutics has another drug in development, paclitaxel poliglumex (Opaxio, formerly known as Xyotax), which failed to show it could help lung cancer patients live longer in trials that enrolled 1,900 patients, according to a company fact sheet. The company is now hoping to revive the drug candidate based on an ovarian cancer study conducted by the Gynecologic Oncology Group, which has enrolled about 700 of the intended 1,100 patients, according to the most recent Cell Therapeutics quarterly report. The cooperative physician group may perform an interim analysis “as early as 2011,” according to the filing. “If successful, we could utilize those results to form the basis of a New Drug Application for Opaxio,” the company said in its quarterly filing.

[Updated with analyst comment] Today’s shareholder vote is a matter of “postponing the inevitable,” demise of the company, says analyst David Miller of Biotech Stock Research. Even with the new ability to sell 400 million shares, the company is unlikely to be able to raise enough cash to get data from a new pivotal trial of pixantrone, or to stick around long enough to get an answer from European regulators. Miller adds “pixantrone might actually work, but if you really believe in it, you should want it in the hands of a management team that can get a drug approved by the FDA.”

The company’s shares were worth 37.5 cents at the close of trading today.

Comments (2) | Reprints | Share:          

The drug discovery and development process is a difficult one that takes considerable expertise in both the research and business realms. Seattle currently has approximately 103 biotechnology companies, 21 of which are publicly traded. The area also has a number of non-profit research organizations that participate in a variety of efforts to find new medicines. Biotech companies have been operating here for some 30 years now, during which time some 42 companies have either been acquired or gone out of business. So what are the prospects for developing new drugs here in Seattle? To address this question, I thought it might be helpful to look back at the track record of our local biotechs. Just how many drugs have we developed locally?

Deriving an answer to this question turned out to be anything but simple. Some drugs were discovered and developed here, some drugs were discovered elsewhere but were developed for new clinical indications by Seattle companies, and some drugs were simply acquired and then sold by our local biotechs. There are a few other caveats I should point out. A majority of these drugs were developed with the help and financial assistance of big pharma partners. Biotechnology also formed the technological basis for several companies that developed medical devices that went on to become FDA approved and treat patients, as noted below. Finally, I want to acknowledge that there have been a number of successes locally in medical devices, agricultural biotech, diagnostics, and biocomputing software applications. However, my focus today is on drug discovery and development. Let’s take a look back and see where we’ve been:

Seven Drugs Discovered and Developed by Seattle Biotechs

Leukine (sargramostim) was developed by Immunex and was FDA approved in 1991 to stimulate the proliferation of white blood cells in patients recovering from bone marrow transplants. Leukine only captured a small share of the market due to stiff competition from Amgen’s competing drug filgrastim (Neupogen), which was approved a month earlier by the FDA for a much wider clinical indication. Amgen’s purchase offer for Immunex led to the divestiture of Leukine to Berlex, the US subsidiary of Schering AG, for antitrust reasons. Berlex was in turn acquired by Bayer in 2006, who subsequently sold Leukine to Genzyme in 2009.

Enbrel (etanercept) was originally developed by Immunex for use in the treatment of sepsis, but it failed in its clinical trials. While most companies would have buried a failed drug, Immunex resurrected Enbrel by testing it in clinical trials with rheumatoid arthritis patients. Strongly positive results led to FDA approval in 1998. Subsequent clinical trials expanded its use for a number of disorders, including juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Acquiring Enbrel was the primary reason Amgen purchased Immunex in 2002. Enbrel went on to become the best selling biologic drug in the world, with worldwide sales in 2008 of $7.4 billion. Amgen’s purchase of Immunex also brought on board the monoclonal antibody that would become panitumumab (Vectibix), and prevented a nasty patent war between the companies over intellectual property that led to the newly approved osteoporosis drug denosumab (Prolia).

Cialis (tadalafil) was initially discovered by … Next Page »

Comments (4) | Reprints | Share:          

This week we had a few of the usual small deals to cover, but there were a few moments to take a deep breath and look at the big-picture trends underway in the Northwest biotech community.

—Seattle Genetics is practically invisible compared to the drama queen across Lake Washington, otherwise known as Dendreon. But while few may have noticed, Bothell, WA-based Seattle Genetics (NASDAQ: [[ticker:SGEN]) is working methodically to make sure it is ready to commercialize its own potentially groundbreaking cancer drug.

—Once in a while, I dig into a tale from the nearby Vancouver, BC, biotech cluster, and this week’s story was about Valocor Therapeutics. This startup, a spinoff from QLT, is developing a light-activated, locally-delivered acne medication that it hopes will be safer than a widely used medication that has been linked to birth defects.

—If you run a nonprofit with a mission to provide an amorphous benefit to society, like improving science education, how do you justify your existence in a data-driven world? The Northwest Association for Biomedical Research, as part of the 10th anniversary of its Student BioExpo, tracked down some of the living, breathing people it inspired in its early years who are now pursuing careers in science.

—Who Needs VCs? Apparently Steven Quay, the former CEO of Sonus Pharmaceuticals and Nastech Pharmaceutical, doesn’t think he does. He’s started a new company, Atossa Genetics, that is seeking to pull off a $15 million IPO to commercialize a new tool for breast cancer screening.

—In good times and in bad, Seattle-based Cell Therapeutics (NASDAQ: CTIC) never fails to raise more cash from investors. This time, the company raised $21 million from three institutional investors a little more than a month after the FDA rejected its only drug candidate with a chance of reaching the U.S. market anytime soon. This new cash will be used partly to pay off some of the debt that has been threatening to drive the company out of business.

—There’s been a lot of buzz about the federal government’s new plan to spread $1 billion worth of tax credits and grants around the biotech industry, and Stewart Lyman took some time to bust a few popular myths about the program in a guest editorial.

—The Fred Hutchinson Cancer Research Center has secured $10 million worth of federal stimulus grants to buy some more sophisticated equipment and establish a high-powered computing center on its Seattle campus.

—GenoLogics, the Victoria, BC-based maker of life sciences software, raised $1 million in equity out of a round that could be worth as much as $1.5 million.

—Bellevue, WA-based RF Surgical, a medical device maker, raised $2.5 million out of a total financing round worth as much as $5 million, according to a regulatory filing.

Comments (1) | Reprints | Share:          

Cell Therapeutics (NASDAQ: CTIC), the Seattle-based developer of cancer drugs, said today it has raised $21 million through an offering of preferred stock to three institutional investors. The company’s lead drug candidate, pixantrone for non-Hodgkin’s lymphoma, was rejected by the FDA last month. Cell Therapeutics said it plans to use the new financing to pay down some of its debt, finance R&D, prepare new drug applications, and for other corporate purposes.

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:          

Cell Therapeutics (NASDAQ: CTIC), the Seattle-based biotech company, said it has cut 36 jobs to conserve cash. The move comes less than a week after the company’s application to sell a new drug for non-Hodgkin’s lymphoma was rejected by the FDA. The company says it now expects to spend about $60 million on operations this year, down 21 percent from its previous forecast.

Comments | Reprints | Share:          

One of Seattle’s oldest biotech companies was rejected by U.S. drug regulators in the past week, while another is on pins and needles awaiting what most analysts expect will be an imminent FDA approval.

—How much will people pay for a new prostate cancer drug that will help men live a median of four months longer than a placebo? That’s one of the big questions at Seattle-based Dendreon (NASDAQ: DNDN) as it enters the final days before the FDA says whether the drug, sipuleucel-T (Provenge), is ready for the market or not. I polled seven analysts on their price projections, and dug into some of the factors that Dendreon has to consider when it sets the price.

—The FDA rejected Seattle-based Cell Therapeutics‘ application to sell a new drug for non-Hodgkin’s lymphoma, pixantrone. This was the obvious outcome, since the FDA’s cancer boss, Richard Pazdur, gave the company a public dressing down at an advisory committee hearing last month, and the panel of cancer experts voted 9-0 against it. Cell Therapeutics (NASDAQ: CTIC) hoped to get out of this jam by holding a shareholder meeting where it would win authorization to sell millions of more shares, but it postponed that meeting, probably because it was unable to get a quorum of shareholders—a problem that has dogged the company in the past. A subsequent conference call about the company’s future plans struck me as so absurd I chose to Tweet about it in real-time, but not spend more time writing. If you really want to follow this in more depth, read a blistering opinion piece from TheStreet.com’s Adam Feuerstein.

—We had some encouraging news from Eastern Washington this week. Waltham, MA-based PerkinElmer said it agreed to acquire Spokane, WA-based Signature Genomic Laboratories for $90 million in cash, to strengthen its genetic testing and molecular diagnostics business.

—The University of Washington has confirmed what a top commercialization official predicted a year ago—that the university has been awarded $300 million in federal stimulus money. I gathered that fact from a Technology Alliance talk by one of UW’s leading genome scientists, Debbie Nickerson. But she talked in more depth about her “new Corvette”—a $25 million gene-sequencing center that her team hopes will prove it was worth Uncle Sam’s investment.

—I promised myself that I’d avoid cheesy puns like “fledgling” when describing the latest angel investment network in the Northwest, but it can now be said that it is starting to take flight (that’s a little better isn’t it?). This was a story about Wings, the new angel network for medical device investors, which got started at its inaugural meeting yesterday, in which it reviewed business plans of three startups.

—Dendreon had one other nugget of news this week. It hired Varun Nanda as the senior vice president in charge of commercialization of sipuleucel-T (Provenge). Nanda has a ton of experience with cancer drugs, having previously worked at the Genentech unit of Roche. He better be a quick study, because Dendreon is awaiting word from the FDA by May 1 on whether it has the green light to start selling the product.

—Fate Therapeutics, the San Diego-based company that counts University of Washington stem cell researcher Randall Moon as a scientific co-founder, is expanding its mini-empire into Canada with the acquisition of Verio Therapeutics.

—Liberty Dialysis, a Mercer Island, WA-based company that operates more than 100 dialysis clinics around the U.S., received an undisclosed amount of financing from a group of investors that includes Ignition Partners.

—As the dust settles on healthcare reform, Stewart Lyman helped show readers one of the overlooked elements of the new law that will provide a windfall of tax benefits for biotech companies.

Comments | Reprints | Share:          

Cell Therapeutics (NASDAQ: CTIC) apparently has had enough humiliation for one day. The Seattle-based biotech company postponed a special shareholder meeting this morning at its headquarters along Elliott Bay, after announcing that the FDA rejected the application for its only cancer drug with a shot at reaching the U.S. market anytime soon.

About a dozen shareholders showed up at 10 am Seattle time on the third floor of Cell Therapeutics’ stylish headquarters, which features track lighting, pastel wall colors, and sweeping views of Elliott Bay. The meeting, in which shareholders will be asked to authorize the company to sell as many as 1.2 billion shares, has been rescheduled for the same time on May 14. Cell Therapeutics usually has trouble getting a quorum of shareholders to vote on matters like these, because it has a lot of shareholders in Italy who don’t turn in their ballots. So it wouldn’t surprise me if the company failed to get a quorum to vote on that question.

Cell Therapeutics founder and CEO James Bianco didn’t show up to face the shareholders this morning, although company spokesman Dan Eramian told me in the hallway that the company is planning a conference call for 4:30 pm Eastern/1:30 pm Pacific today. We had to chat in the hallway because the company barred me from attending this meeting as a member of the press, saying it was open only to shareholders of record. As many of you who follow me on Twitter know, I offered some pocket change to buy a share so I could attend, but they could not accommodate me on the spot. (TheStreet.com’s columnist Adam Feuerstein cheekily offered to start a pledge drive to help me get in the door, but alas, the meeting adjourned in a just a few minutes.)

Seriously, though, I have a few questions that I couldn’t get answered. Like why shareholders would allow the company to issue as many as 1.2 billion shares, further diluting their existing stakes in a stock that’s already worth less than a buck? Who are the people who invested $20 million in Cell Therapeutics after it was shot down 9-0 by a panel of FDA cancer drug experts last month? Did those people listen to the same brutal critique that I heard? In what way do they think Cell Therapeutics can generate positive returns? Do they think the company can afford the time and expense of another clinical trial to support approval of pixantrone for non-Hodgkin’s lymphoma? Or do they think that paclitaxel poliglumex (Opaxio), a drug that already failed three pivotal clinical trials in 2005, will rise from the dead?

I will listen in to today’s conference call (dial-in number is here), but I’m not holding my breath for any substantive answers.

Comments | Reprints | Share:          

Cell Therapeutics suffered what I called a “humiliating public beatdown” last month in front of an FDA advisory committee, and now the FDA has made it official in writing. The Seattle-based biotech company said its application to market a new lymphoma drug in the U.S. has been formally turned down by the FDA.

The FDA apparently didn’t need to wait until its statutory deadline of April 23 to deliver the bad news in its “complete response” letter to the company. The agency said that if Cell Therapeutics wants clearance to start marketing pixantrone (Pixuvri) in the U.S. for patients with non-Hodgkin’s lymphoma, it will need to run another clinical trial to prove it is safe and effective. Cell Therapeutics said it has had some preliminary talks with the FDA about what such a trial would look like, and that it plans to pursue an “expanded access” program to make pixantrone more widely available to patients even without being able to sell it.

The FDA’s rejection is no surprise, given the harsh public comments made last month at a panel of the Oncologic Drugs Advisory Committee. The panel voted 9-0 against recommending approval of pixantrone. The FDA’s chief cancer drug reviewer, Richard Pazdur, slammed the application in his remarks, noting that Cell Therapeutics was seeking approval on the basis of a “single, incomplete trial.” The chair of the FDA panel, Gail Eckhardt of the University of Colorado at Denver, said the Cell Therapeutics application was “disturbing,” partly because it only enrolled 140 of the 320 patients needed to generate a statistically valid result the way the trial was originally designed.

Cell Therapeutics took the unusual step of quoting a cancer researcher in its press release who took a critical shot at the FDA.

“This is a sad outcome for our patients with relapsed/refractory aggressive NHL,” said Dr. Stanley Marks, chief medical officer for the University of Pittsburgh Cancer Centers, in a Cell Therapeutics statement. “I was disappointed that an agency charged with providing treatment hope for patients with life threatening diseases like relapsed/refractory non-Hodgkin’s lymphoma would ignore clinically meaningful improvements in overall response rate and progression-free survival, let alone complete responses, something we all wish for our patients, but with existing treatments rarely achieve.”

Cell Therapeutics, as I noted in an analysis after the FDA panel, still says it hopes … Next Page »

Comments | Reprints | Share:          

At the pace of today’s news, it can be hard to maintain perspective on what all the important stories are. Sure, the iPad is dominating headlines today, but remember when Google bought Picnik just a month ago? That deal is still resonating in the startup community. What’s more, headlines fly off the page so fast that not everyone can catch them the first time. Luke and I wanted to find a way to help readers discover more of the stuff we’ve been busily producing for the past few months.

The first quarter of 2010 is in the books. So we thought it would be fun and useful to recap our favorite stories of the year so far—everything from Alder to Z2Live, with Amazon, Apple, Cell Therapeutics, Dendreon, and Microsoft in between. These were sometimes our most popular pieces, but not always. In every case, they highlight the kind of in-depth analysis and exclusive reporting that we are bringing to bear on the Seattle-area innovation community. Enjoy.

.

Greg’s Top 10 technology stories:

Cowboys Like Us: Investor Nick Hanauer on How to Think About Breakthroughs in Business and Society (Part 1)

Nick Hanauer, a “High-Functioning Contrarian,” on How to Think About Breakthroughs in Business and Society (Part 2)

Bill Gates’s Nuclear Miracle? John Gilleland Says TerraPower Needs Discipline, Not Divine Intervention

Picnik CEO on Getting Bought by Google, and How It Affects Startups and Consumers

How Amazon Innovates: Lessons in Strategy for Microsoft and Others

How to Win the Future of Social Mobile Gaming: The Z2Live Story

The Apple iPad’s Impact on Mobile, Gaming, and E-Books: Local Techies and Startups React

Friend or Foe: How Apple Is Forcing Microsoft, Amazon, Google, and AT&T to Raise Their Game

MIT MBA Students: Amazon, Google, and T-Mobile Are Hiring, Expedia Isn’t; Microsoft “Super Interesting,” Apple Is “Sterile”

Stephen Wolfram Talks Bing Partnership, Software Strategy, and the Future of Knowledge Computing

.

Luke’s Top 10 biotech and life sciences stories:

The Dendreon Alumni: Where Are They Now?

Joe Eichinger, Top Medical Device Entrepreneur and UW Volunteer, Dies From Cancer

Cell Therapeutics Offers Bigger Cash Bonuses for 2009 While Stock Languishes

Ekos, Swedish Aim to Shake Up Stroke Treatment with Ultrasound Brain Clot Buster

Geospiza Runs in the Black as Scientists Turn to Software to Help Crunch Genomes

Microsoft Fleshes Out Health-IT Portfolio, Waits (and Waits) for Market to Materialize

Medical Device Entrepreneurs Converge on Wings, a New Angel Investing Network

Dendreon’s New Operations Man, Hans Bishop, Aims to Keep Provenge Trains Running on Time

Halosource Nails Down $10M for Global Expansion of Water Purifying Technology

Alder Rises from Ashes of Layoffs, Overcomes Skeptics to Become Seattle Biotech Force

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:          

It’s time to talk about survival strategy if you’re Seattle-based Cell Therapeutics. The company (NASDAQ: CTIC) suffered a humiliating public beatdown yesterday from an FDA advisory panel, which said unanimously that the company’s lymphoma drug, pixantrone, isn’t ready for the U.S. marketplace.

Even though the FDA doesn’t have to make a formal decision on this application until April 23, the agency didn’t hide its feelings about the application. FDA’s cancer drug boss, Richard Pazdur, issued a blistering critique, saying Cell Therapeutics was essentially asking for approval of pixantrone based on “a single incomplete trial.” He added that the PIX301 trial looked more like an exploratory mid-stage study than the kind of rigorous proof from a Phase III trial the FDA demands before it will approve a new cancer drug.

If the application is rejected, what’s next for Cell Therapeutics? The company, which has burned through more than $1.4 billion of investors’ money since 1991, has no marketed products and nothing else in the pipeline with a chance of generating sales anytime soon. Cell Therapeutics had a little more than $37 million in cash in the bank heading into this year, which isn’t quite enough to run the business through September, according to the company’s annual report.

“After spending $1.4 billion of shareholders’ money, maybe it’s best for Cell Therapeutics to return what’s left to shareholders and call it a day,” says David Miller, president of Seattle-based Biotech Stock Research, an independent firm that specializes in covering small public biotech companies.

There isn’t much room to maneuver. Cell Therapeutics lost about half of its stock market valuation yesterday after the FDA panel vote, so it will be much more difficult and expensive if it wants to raise new capital by selling new shares to investors. The company has a whopping 616 million shares outstanding already, valued at 47 cents apiece at yesterday’s close, giving it a market valuation of $290 million. That valuation probably isn’t sustainable for long, Miller says. He notes that the stock opened at 12 cents a share immediately after the FDA panel vote, and climbed after that, which was probably the result of derivatives traders exiting their positions in the company, rather than a valuation that’s based on the company’s cash in the bank plus its technology. When those forces return to the stock, the company’s market valuation will likely fall below $100 million, Miller says.

So, if you’re CEO James Bianco, how do you get your company out of this jam? He has shown the ability to pull an 11th hour escape once before, keeping the company alive last year when it was down to its last few weeks of cash by selling off a key asset, closing down a facility, resorting to layoffs, and raising more cash.

The company didn’t respond to an interview request yesterday, so I figured I’d try to assess Cell Therapeutics’ options by sorting through the company’s documents and previous public statements. Here’s what I gathered about its other drug candidates, largely from the company’s annual report:

—Pixantrone in Europe. The company hasn’t yet applied for approval of pixantrone in the European Union, although it has shown interest in doing so. The company plans to file the equivalent of a new drug application to market pixantrone in Europe for relapsed or aggressive forms of non-Hodgkin’s lymphoma in mid-2010, according to its annual report.

But this isn’t a quick fix. European regulators tend to take … Next Page »

Comments | Reprints | Share: