Seattle Genetics is getting some new warnings, including one new language about a potentially deadly brain infection, put into the FDA-approved prescribing information of its lone marketed product.

The company (NASDAQ: SGEN) said today it is working on an update to the label for brentuximab vedotin (Adcetris), which will include a boxed warning about the risk of patients on the lymphoma drug getting a potentially fatal brain infection called progressive multifocal leukoencephalopathy (PML). Seattle Genetics’ original drug label, cleared by the FDA in August, said there had been a case of PML in clinical trials, but now that the drug has been used more widely on the market, Seattle Genetics discovered a second case last fall, and said today it has learned of a suspected third case of PML. That information is prompting new warning language that’s supposed to help doctors spot signs of PML.

Several new biotech drugs have been linked to cases of PML, including Roche and Biogen Idec’s hit lymphoma drug rituximab (Rituxan). The Seattle Genetics drug is designed to hit a different target on cancer cells, and it is approved for use in a couple of rare malignancies—Hodgkin’s disease and anaplastic large cell lymphoma. The new treatment has shown strong ability to shrink tumors in clinical trials in the majority of patients who have essentially run out of options, and it has beaten Wall Street’s initial sales expectations. Now Seattle Genetics is looking to expand use of the drug to larger groups of patients. One of those label-expansion studies showed that the new drug shouldn’t be used in combination with a chemotherapy agent known as bleomycin, because of an elevated rate of lung toxicity, so a warning about that is also being incorporated into the Adcetris label.

The bleomycin warning isn’t much of a concern, because even though it’s part of a typical chemo regimen, Adcetris was never approved to be used in combination with that drug, and researchers are hopeful that Adcetris might be able to replace bleomycin for use in some patients, because the new drug has a milder side effect profile when used on its own.

“Our first priority is patient safety. By developing these agreed upon label updates with the FDA regarding PML and the contraindication with bleomycin, we aim to heighten awareness among healthcare professionals in order to most safely treat their patients with Adcetris. Although PML in lymphoma patients can be caused by factors such as underlying disease and prior therapies that affect the immune system, a contributory role of Adcetris cannot be excluded,” said Tom Reynolds, the chief medical officer of Seattle Genetics, in a statement.

Previous studies have said patients with blood cancers have about a 0.07 percent chance (1 in 1,400) of getting PML. Seattle Genetics didn’t say what the ratio is for patients getting Adcetris, but it has had two confirmed cases, and one suspected case, out of more than 2,000 patients worldwide who have gotten the new drug.

Shares of Seattle Genetics fell about 6.3 percent to $17.28 at 10:14 am Eastern time.

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[Update: 9:20 am ET] Dendreon ran into a buzz saw of opposition last year when it priced its new prostate cancer drug at $93,000 per patient. Genentech has loads of critics who say it has overreached on price with its antibody drugs for cancer, especially in cases where the data supporting the drug is controversial, as with bevacizumab (Avastin) for breast cancer. But despite all the pressure from insurers, elected officials, patients, and doctors, drugmakers are showing no signs of backing off.

Many times, I’d say the critics are right to complain about excessively high drug prices. But in a few cases, the drugmakers are right to stand firm, and today we’re going to see an interesting test case.

Today, we’ll see a new player emerge in the great cancer drug price debate: Seattle Genetics (NASDAQ: SGEN). The company won FDA clearance on Friday to start selling its new antibody drug for Hodgkin’s disease and another rare lymphoma. [Updated 9:20 am ET, with pricing info] Seattle Genetics revealed the price of this new drug, called brentuximab vedotin (Adcetris), on a conference call with analysts this morning. The company set the price at $13,500 per dose, given intravenously every three weeks. If patients get eight infusions on average, consistent with clinical trial experience, then it will cost $108,000 per patient. Wall Street was expecting it to cost about $109,800 per patient for a course of treatment, based on the average estimate of five Wall Street analysts I surveyed last week.

Most Americans will never make that much money in a single year of their life, so this could be an easy target for critics of high drug prices. But this is one case in which a drug is worth a six-figure price tag.

Here’s why: For starters, the Seattle Genetics drug is being aimed at a small group of patients. About two-thirds of the 8,500 patients diagnosed in the U.S. with Hodgkin’s disease are successfully treated with chemotherapy, leaving about one-third who eventually get relapsed, treatment-resistant forms that make them candidates for the Seattle Genetics drug. The other group of anaplastic large cell lymphoma patients who are eligible is even smaller. Insurance companies do most of their watchdogging on price with much more common medicine. They usually, or at least should, have better things to do than mess with a tiny handful of customers in their risk pool.

Those who are afflicted with this disease aren’t just dealing with some minor annoyance, or theoretical risk. Many patients with relapsed Hodgkin’s disease are in their primes (their 30s and 40s), and are being threatened with an illness that offers a life expectancy of just two to three years. These patients have no other options left. The Seattle Genetics drug is bringing innovation to a moribund field of cancer drug development. It is the first product approved for Hodgkin’s disease since 1977, and the first ever for anaplastic large cell lymphoma.

And most importantly, the data to support this drug’s approval was simply superb. About 75 percent of patients with Hodgkin’s disease had significant tumor shrinkage, and 86 percent did that well with anaplastic large cell lymphoma (ALCL). About a third of the Hodgkin’s patients and more than half of the ALCL patients went into complete remissions. These are the kinds of tumor shrinkage rates that you rarely see in the cancer drug business.

There’s no major rub here in terms of side effects, which are pretty typical for other compounds in this drug’s class. Patients get depletion of infection-fighting white blood cells, nerve damage in the fingers and toes, fatigue, nausea.

One big question here is still about survival. Nobody knows … Next Page »

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[Updated: 6:50 am PT] This is the week Seattle Genetics, a 14-year-old company, will have its biggest coming-of-age experience on its way to becoming a real grown-up.

The company (NASDAQ: SGEN) is getting ready to make its best possible argument for FDA approval of its new “empowered antibody” drug aimed at a pair of rare lymphomas. The evidence so far for this treatment, brentuximab vedotin (Adcentris), was posted in staff briefing documents on the FDA website, in advance of an FDA advisory committee meeting of cancer drug experts on Thursday in Silver Spring, MD.

The FDA panel’s review represents a huge moment for Seattle Genetics, and also could send a ripple effect through the biotech industry, and the Northwest’s local biotech cluster. If Seattle Genetics can persuade the expert panel to recommend its drug, and the FDA formally approves the treatment by its Aug. 30 deadline, then it will be the company’s first marketable product after spending 14 years and more than $500 million. It will also clear the way for what could be the first commercial success with a “smart bomb” antibody that zeroes in on tumors, while unleashing a potent toxin that hits the cancer and mostly spares healthy tissues.

For Seattle’s biotech community, it would mark the second time in two years that a local company has been able to blaze a trail with a new class of cancer drug, following last year’s FDA approval of an immune-boosting cancer fighter from Dendreon (NASDAQ: DNDN). And while about two-thirds of the 8,500 patients diagnosed in the U.S. with Hodgkin’s disease are successfully treated with chemotherapy, one-third eventually get relapsed, treatment-resistant forms that provide a grim prognosis-a life expectancy of just two to three years. If Seattle Genetics can win approval, it will start selling the first new drug for Hodgkin’s since 1977.

Eric Dobmeier

“We think this is very important for the industry and for cancer patients,” says Eric Dobmeier, Seattle Genetics’ chief operating officer. The combination of antibodies fused to potent toxins, sometimes called antibody-drug-conjugates, “have the potential to impact the way many cancers are treated. They are more targeted, and less toxic than chemotherapy,” Dobmeier says.

The evidence from clinical trials that Seattle Genetics has put together is “spectacularly positive,” says David Miller, president of Biotech Stock Research, an independent research firm. Seattle Genetics has been careful not to get overly confident in its public statements, but Dobmeier did say in an interview last week, “we believe we are on strong ground.” The debate, Miller says, is most likely to hinge on which specific patient populations ought to be included in the prescribing information.

The FDA and its expert panel are looking at data from more than 300 patients in clinical trials, and especially at two late-stage studies for Hodgkin’s lymphoma and … Next Page »

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Just glance at the name, Seattle Genetics, and you get the drift this is a science-based company. But Seattle Genetics is morphing into something bigger and more valuable, which creates a whole new challenge: How do you maintain an inspired scientific culture from the early days, while living up to the cold market reality to start producing real sales and profits?

Seattle Genetics (NASDAQ: SGEN) has been thinking hard about how to manage this transformation over the past year. Almost 14 years after its founding, the company is now just weeks away from what analysts expect will be a slam-dunk FDA approval of its first marketed product—a drug for rare lymphomas. Expectations are sky-high, as Seattle Genetics stock closed last week above $20 a share, making it worth more than $2.3 billion. To maximize this opportunity, Seattle Genetics has spent months vetting, hiring and training a new commercial team of 100 employees, bringing its total staff up to 450 people. Manufacturing, sales, marketing, supply chain logistics, and insurance reimbursement are just a few of the skills the company has had to add.

It’s hard to overstate how important managing this growth is to Seattle Genetics’ future as a company. If they do it right, this new commercialization crew will help the R&D groups realize their early vision of helping patients and blazing a new trail for “smart bomb” antibody drugs for cancer—a type of drug that has eluded scientists for three decades. But if the new commercial folks botch the product rollout, or engage in unseemly marketing practices to hit their numbers, then Seattle Genetics is asking for trouble. As Josh Boger, the founder and CEO of Vertex Pharmaceuticals said in a speech last week at the Biotechnology Industry Organization’s convention, “it will tear your company apart if commercial has its own set of values. Commercial plans have to be consistent with company values.”

The co-founder and CEO of Seattle Genetics, who is like Boger a scientist by training, has definitely been thinking hard about how to maintain the science-based culture as the company grows up.

Seattle Genetics CEO Clay Siegall

“We were very careful to select commercial folks who were very excited and passionate about a company that is led by the scientific discoveries and the clinical data we have,” says Seattle Genetics CEO Clay Siegall. “We wanted sales reps that didn’t just want talking points to sell the product. They want to know how the product works, and what kind of patient populations it works in. They wanted to understand CD30 [the drug's biological target] and its expression profile. When you have commercial folks asking about underlying science questions, and not just things like, ‘What are the sales targets?’ that’s the kind of person we wanted.”

A little science background is required to see why this matters. Other biotech companies have had a lot of success with targeted therapies over the past decade, making genetically engineered antibodies that specifically zero in on markers on tumor cells, while mostly sparing healthy cells—unlike typical chemotherapy.

Seattle Genetics has gone a step further, by turning genetically engineered antibodies into what amounts to a “smart bomb” against cancer. The company’s technology links the targeting antibody to a potent toxin, which gets unleashed on the tumor.

Most of these efforts to soup-up antibodies have failed over the years, but Seattle Genetics proved it had solved the puzzle last year in a pair of clinical trials. They showed that the new Seattle Genetics drug, brentuximab vedotin (Adcetris) could … Next Page »

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The big boys of Seattle biotech made some news this week, but the town was humming with activity from little companies you haven’t heard of, who appeared at Life Science Innovation Northwest. More on that later.

—Seattle-based Dendreon (NASDAQ: DNDN) confirmed this week that it has signed leases on a new headquarters at the Russell Investments Center downtown, and a new home for its R&D at the Earl Davie Building, formerly occupied by ZymoGenetics. Dendreon also released its annual report, which showed it has grown from 198 employees two years ago to 1,497 companywide at last count, as of February 15. At that kind of rate, it makes you wonder how long it will be before Dendreon looks to expand again.

—Seattle Genetics (NASDAQ: SGEN), the other emerging public company on the local biotech scene, said this week it had reached an important milestone by filing its new drug application with the FDA. This is a big deal for Seattle Genetics, because if the FDA clears brentuximab vedotin (SGN-35) for sale as a new treatment for Hodgkin’s disease and anaplastic large cell lymphoma—which most analysts expect it will—then the company will have its first product that it can actually sell on the U.S. market.

—Bothell, WA-based Alder Biopharmaceuticals made its name with an antibody designed to fight cancer and autoimmune disease—pretty familiar territory in the biotech business. But this week Alder stepped out and did something that’s pretty offbeat for an antibody drug maker. Alder talked publicly for the first time, in an exclusive interview with Xconomy, about how it has created two new antibody drugs to treat migraine headaches and high cholesterol—diseases that have always been the realm of small-molecule treatments.

—Venture capital investment levels are still basically in the toilet, compared to where they were pre-downturn, but angel investment continues to reach record levels, according to a recent report from the Seattle-based Alliance of Angels. I talked about some of the basics of angel investment and the impact it can have on our region during a 5-minute segment this week on “The Conversation” with Ross Reynolds of KUOW-94.9 FM.

—Physio-Control, the Redmond, WA-based unit of Medtronic that makes heart defibrillators, said this week it bought a Swedish company called Jolife, which is developing a mechanical device for cardiopulmonary resuscitation. Terms weren’t disclosed.

—My new national column on national biotech issues, BioBeat, debuted this week. This feature started off by taking aim at Big Pharma companies who are preying on the financial weakness of biotech companies.

—Last, we had a guest editorial from Tobin Arthur, the founder and CEO of Seattle-based iMedExchange, a social network for physicians. Based on insights picked up at a recent conference, Arthur says health records are going to the cloud, going mobile, and the feds are still paying.

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Seattle Genetics had some great news for shareholders and cancer patients last September, and now federal securities regulators say it was too good for one of the company’s managers and a member of his family.

The Securities and Exchange Commission has accused Zizhong (James) Fan, an employee of Seattle Genetics, of tipping off his family member Zishen (Brandon) Fan in advance about positive clinical trial results that were eventually made public in September. The SEC has obtained a court order to freeze a bank and brokerage account which it says contains $800,000 in illegal profits, according to an SEC statement. Here’s the full complaint from the SEC, filed in the U.S. District Court for Western Washington.

The big clinical trial news at Seattle Genetics first came to light in public on September 27. That’s when the company issued a press release saying its “empowered antibody” for patients with relapsed forms of Hodgkin’s disease was able to shrink tumors by 50 percent or more for a startling 75 percent of the 102 patients who enrolled in a pivotal trial. That success, and a second, even more promising trial of the drug for another form of lymphoma that was later presented at a medical meeting, caused Seattle Genetics stock to climb more than 60 percent last year.

Zizhong Fan, through his role as a manager of clinical programming at Seattle Genetics, knew about the results as they were coming in and being prepared for presentations to senior management, the SEC alleges in its complaint. On September 24, three days before the public announcement of positive results, Fan’s family member made his biggest purchases of Seattle Genetics derivative securities and bought $150,000 worth of stock.

The SEC says it contacted both members of the Fan family on January 13. Almost immediately after that contact, Zishen sought to wire several hundred thousand dollars to a bank in China, while Zizhong informed Seattle Genetics that he was leaving unexpectedly for China, according to the SEC statement.

The SEC said the Chicago Board Options Exchange assisted in its investigation, and that Seattle Genetics has cooperated. Seattle Genetics spokeswoman Peggy Pinkston said this in an e-mailed statement to Xconomy:

“We are surprised by the allegations and, if proven true, we are shocked and disappointed. Seattle Genetics takes compliance and insider trading laws seriously, and we have a strong compliance culture. We believe this is an isolated incident, and that the authorities are focused solely on this one employee. We have no reason to believe the authorities suspect wrongdoing by any other Seattle Genetics employee, officer or director, or the company itself. The employee is on administrative leave, but we otherwise can’t comment on the allegations and the ongoing investigation.”

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One emerging biotech company in Seattle gets a lot of national attention, and it isn’t Seattle Genetics. So while the regional drama king (Dendreon) grabbed headlines again today by raising $540 million, the lesser known folks at Seattle Genetics (NASDAQ: SGEN) took their turn in the limelight this week, in an appearance on CNBC.

The cable TV cameras were pointed at Seattle Genetics CEO Clay Siegall this week while he was attending the JP Morgan Healthcare Conference in San Francisco. Seattle Genetics stock has climbed more than 60 percent in the past year, based on some clinical trial results that showed its “empowered antibody” has a potent ability to shrink tumors in patients with Hodgkin’s disease and anaplastic large cell lymphoma.

Clay Siegall

Seattle Genetics is now working on an application to seek FDA approval of the drug. It’s possible Seattle Genetics will be able to start selling the treatment on the U.S. market in 2011.

You can watch Siegall’s appearance on CNBC below or at CNBC’s site. At one point, host Larry Kudlow tried to ask Siegall how much SGN-35 (brentuximab vedotin) might cost if it were cleared for the U.S. market, and while Siegall didn’t answer directly, it’s fair to conclude it won’t be cheap.

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This is the time of year for counting blessings, so I have to say we consider ourselves fortunate as journalists to have what is sometimes called the front row seat to history.

That’s how I feel when I look back at the year’s mix of features, breaking news stories, scoops, and up-close profiles. We feel privileged to get to know the people in our community creating things like powerful new smartphones, software, cancer drugs, and the $1,000 genome. Even better, we get to share these stories with our readers on a daily basis.

So, in what’s becoming an annual tradition around here, we have pulled together our favorite 10 technology and top 10 life sciences stories from the past calendar year. We will certainly make sure to keep up with the fast-twitch nature of news on the Web in 2011, but at the same time, we also promise to deliver these kind of in-depth features. The whiteboard in my office, which I scribbled on when we opened this bureau in June 2008, still has a line that says “News You Can’t Find Anywhere Else.” You can count us to deliver more stories like that in the year to come.

Top 10 Tech Stories

“Geoff Entress, the Go-To Startup Investor, Weaves Himself Deeper Into Seattle Tech Community“

“GlobalScholar’s Kal Raman, Fresh off $160M Deal, Seeks to Build an Oracle for K-12 Schools“

“Beaming Power to UAVs, Space Elevators, and Someday Earth: The LaserMotive Story“

“UW Building $20M Fund to Back University Startups, Following the Utah Model“

“Amazon’s Cloud Computing Service Sees Opportunity in Genomic Data Overload“

“How Seattle Startups Could Lead the World: Five Technology Themes to Watch“

“Andy Sack, Flush With $6M, Builds Revenue Based Financing Company that Could Disrupt Venture Capital Startup Ecosystem“

“How to Predict Whether a Startup Will Succeed or Fail: Testing the Disruptive Innovation Model“

“Google, Amazon Play Catch Up in Group Buying: Analysis and Reactions from BuyWithMe, Tippr“

“Cowboys Like Us: Investor Nick Hanauer on How to Think About Breakthroughs in Business and Society“

The Top 10 Life Sciences Stories

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

“Dendreon Makes History: FDA Approves First Immune Booster to Fight Cancer“

“Seattle Genetics, Millennium Report Groundbreaking Results of Drug for Hodgkin’s“

“How Emerald Biostructures Was Saved from the Decode Genetics Bankruptcy by Boston VCs“

“Leroy Hood’s Personalized Medicine Vision Enters Proving Ground at Ohio State“

“How Michael French, a Military Brat Turned Dealmaker, Kept Marina Biotech Alive“

“ZymoGenetics CEO Doug Williams Exits the Stage, Mulls Next Free Agent Move“

“Lee Hartwell, at 70, Tackles Personalized Medicine, Education in Latest Career Phase“

“Seattle Children’s CEO, Between Meetings, Invents Cheap Ventilator to Save Babies Worldwide“

“Larry Corey, Virus Hunter With Midwest Roots, Seeks to Unleash Health Innovation at Hutch“

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Seattle biotech was popping up on this site all over the weekend—when we don’t usually publish—so here’s the place to catch up on some significant news you may have missed.

—Seattle Genetics (NASDAQ: SGEN) was one of the belles of the ball at the American Society of Hematology (ASH) meeting in Orlando, FL over the weekend. The company showed off some truly remarkable results for its “empowered antibody” against both Hodgkin’s disease, and anaplastic large cell lymphoma. Wall Street has been bidding up Seattle Genetics shares for months in anticipation, so there was a predictable buy-on-the-rumor-sell-on-the-news phenomenon. There is some reasonable debate going on now about how much sales potential this drug really has. But don’t be fooled into thinking that some red on a stock chart means something bad just happened. Doctors are buzzing about this potent new cancer drug, and eager to get their hands on it.

—NanoString Technologies, the Seattle-based maker of a digital genetic analysis instrument, said this week it has obtained some key intellectual property that will pave the way for the company’s first serious commercial push into the molecular diagnostics business. The company hopes to use its instrument to look for a 50-gene signature which is thought to help doctors classify the severity of certain forms of breast cancer, and help them make better individualized treatment decisions.

—PATH, the Seattle-based global health nonprofit, has been getting a lot of attention this week for its push to deliver to some of the poorest countries in Africa a new meningitis vaccine, which it developed along with its partners at the World Health Organization and private companies in the Netherlands and India. PATH president Chris Elias helped explain the long and creative journey his organization took, with about $70 million of support from the Bill & Melinda Gates Foundation, to create a vaccine without help from any of the classic Big Pharma players.

—Seattle Genetics may have taken the starring role at the ASH meeting, but Seattle-based Calistoga Pharmaceuticals turned some heads as well. Calistoga released some more follow-up data to show that its CAL-101 compound is standing up to the test of time as a potent new agent against chronic lymphocytic leukemia and slow-growing “indolent” non-Hodgkin’s lymphoma. This study has laid the foundation for a pivotal trial Calistoga plans to start late this year or early next year, which could clear the way for FDA approval. Sally Church, the prolific cancer consultant and blogger who goes by the MaverickNY handle on Twitter, singled this drug out as one of her favorite compounds to watch at ASH.

—Instead of flying to ASH over the weekend, I hopped a shorter flight down to San Francisco for an exclusive event for life science leaders called Convergence. There were a number of thoughtful panels and chats about the state of biotech, and I summed up one of the panels which focused on how to raise money for an honest-to-god innovative biotech startup. There were a number of great insights, and a few zingers to pass along.

—Lastly, we had a guest op-ed from Diane Bieri, the executive vice president and general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA). She weighed in with her view on how potential changes to patent litigation could harm innovative biotech companies like those in Seattle.

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Seattle Genetics generated buzz at a medical meeting over the weekend with its new souped-up antibody drug for Hodgkin’s disease, and today it is coming out with an encore that tops the original performance.

The biotech company (NASDAQ: SGEN) and its partner, Cambridge, MA-based Millennium: The Takeda Oncology Company, are presenting results today from a study of 58 patients who got the targeted drug for a rare and deadly malignancy called anaplastic large cell lymphoma (ALCL). More than half of the patients (53 percent) had their tumors completely eradicated after getting dosed with brentuximab vedotin, and a total of 86 percent had their tumors shrink by half or more, according to findings being presented today at the American Society of Hematology (ASH) meeting in Orlando, FL.

The most common severe side effect, in one-fifth of patients, was neutropenia, in which infection-fighting white blood cells get knocked out. Doctors don’t know how long the remissions are lasting, because more than half of patients are still in remission after six months of follow-up.

“Nearly all patients in this trial had reductions in tumor volume, including a remarkable rate of complete remissions,” said Dr. Andrei Shustov, a hematologist at the University of Washington, in a Seattle Genetics statement. Another researcher, Pier Zinzani of Seràgnoli University of Bologna, Italy, noted that since this drug was given by itself, with no other chemotherapy combinations, it was particularly impressive. “Single-agent activity of this magnitude is rarely seen in oncology,” he said in a statement.

This is the second important batch of clinical trial results for this drug at this year’s hematology meeting. On Sunday, researchers reported that the new drug generated complete remissions in about one-third of patients with Hodgkin’s disease, and shrank tumors by half or more in another 40 percent of patients. Those results, combined with the new findings among patients with the related malignancy known as ALCL, have given Seattle Genetics the confidence to seek FDA approval before the end of March for brentuximab vedotin for both forms of cancer. If approved, it will be the first marketable product for Seattle Genetics, and it will be the only drug available that combines the specific tumor-targeting capability of an antibody with an extra-potent dose of a toxin to give it extra tumor-killing kick.

Seattle Genetics CEO Clay Siegall

Investors have been hotly anticipating this data set ever since Seattle Genetics offered a basic preview press release on the trials, back in September and October. Since investors already bid up Seattle Genetics shares more than 56 percent heading into the weekend’s detailed data dump, there was a sell-on-the-news reaction yesterday, in which the stock dropped about 4 percent.

“Overall, we believe the results are very good, and that this drug is exceedingly likely to be approved in the second half of 2011,” said Cory Kasimov, an analyst with JP Morgan, in a note to clients after the Hodgkin’s data was reported on Sunday. “However, considering that prevailing expectations were already quite high, we suspect it will be difficult for this weekend’s update to trigger near-term upside in Seattle Genetics shares.”

Here’s what the latest study showed of the new drug. The 58 patients who enrolled had relapsed or treatment-resistant forms of … Next Page »

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Seattle Genetics is reporting today on a batch of clinical trial results that represent a watershed moment for the company, its technology for creating “empowered antibodies” against cancer, and which could provide a new source of hope for patients with Hodgkin’s disease.

The company (NASDAQ: SGEN) and its partner, Cambridge, MA-based Millennium: The Takeda Oncology Company, are presenting detailed results today from a study of 102 patients who got brentuximab vedotin (SGN-35) as a treatment for relapsed forms of Hodgkin’s disease. Researchers found that one-third of the patients (34 percent) had their tumors completely eliminated after getting the new drug, while another 41 percent had their tumors shrink by half or more, and a total of 94 percent had at least some observable tumor shrinkage. All kinds of nitty gritty details on how long the remissions lasted, and the drug’s side effect profile, are being disclosed today at the American Society of Hematology (ASH) meeting in Orlando, FL.

Seattle Genetics plans to package this data in an application to the FDA by the end of March, in which it will seek clearance to start selling the product in the U.S., where it holds 100 percent of the commercial rights. Millennium, which has a lot of experience in blood cancers with its $1 billion hit bortezomib (Velcade), holds the rights to this drug in Europe and plans to seek regulatory clearance there in 2011. If the FDA allows the drug on the market next year, it will mean Seattle Genetics will be transformed from an R&D-only operation into a more diversified commercial organization. The drug is also being closely watched in the biotech industry, because it could be the first time anyone has been successful with an “empowered antibody”—a molecule that’s designed to zero in specifically on cancerous cells, carrying a potent tumor-killing toxin.

While about two-thirds of the 8,500 patients diagnosed in the U.S. with Hodgkin’s disease are successfully treated with chemotherapy, one-third eventually get relapsed, treatment-resistant forms that provide a grim prognosis—a life expectancy of just two to three years. The new Seattle Genetics drug could be the first treatment for this patient population in more than two decades. Seattle Genetics already released some of the results to investors in September, and its stock has soared 56 percent this year on the news, but this is the first time the data will get scrutinized in detail at a medical meeting with more than 20,000 people in attendance.

Clay Siegall

“I’ve been a part of many clinical trials before, and this is one of the best results I’ve ever seen,” says Robert Chen, a hematologist at the City of Hope in Duarte, CA, and an investigator on the study who will present to his peers at the ASH conference. “I’m very excited for patients with Hodgkin’s disease.”

Clay Siegall, the CEO who co-founded Seattle Genetics a dozen years ago, says he sees the new drug as a cornerstone in a plan for the company to become a much bigger force than it is today in cancer drug R&D. “We want to be the next Celgene, the next Genzyme, the next really important biotech company,” Siegall says. “We have the nucleus, and we have the technology to do it.”

Before going deep into the clinical trial results, a little science … Next Page »

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Seattle Genetics broke new ground in the field of cancer drug development last month, and now evidence is mounting from a second clinical trial that suggests it wasn’t a fluke.

Seattle Genetics (NASDAQ: SGEN) and its partner, Cambridge, MA-based Millennium: The Takeda Oncology Company, are reporting today that 50 out of 58 patients (86 percent) with a rare, deadly malignancy called anaplastic large cell lymphoma had complete or partial shrinkage of their tumors after taking their experimental “empowered antibody” drug in a clinical trial. Side effects associated with the drug, brentuximab vedotin (SGN-35), were consistent with prior studies. Full data for this study, and another groundbreaking trial of this drug for Hodgkin’s disease, will be presented at the American Society of Hematology annual meeting in Orlando, FL in December.

The results are eye-opening for a number of reasons. Patients who enrolled in this study had seen their disease worsen after at least one prior round of chemotherapy, meaning they had about a 25 percent chance of responding to another round of chemo, and a life expectancy of one to two years, says Seattle Genetics CEO Clay Siegall. While many cancer drugs only help one-fourth of patients, the new drug from Seattle Genetics has now shown an ability to shrink tumors in more than three-fourths of patients with two types of cancer—anaplastic large cell lymphoma and Hodgkin’s disease. Plus, patients in this study only got the Seattle Genetics drug by itself, which means they got the tumor shrinkage benefit without being subjected to the nasty side effects of chemotherapy. The data are compelling enough that Seattle Genetics plans to seek FDA clearance in the first half of 2011 to start selling the product for both forms of cancer.

“The data are superb,” Siegall says. “I’ve been doing this kind of work for 25 years, and data like this are what make it all worthwhile.”

Clay Siegall

About 2,000 adults in the U.S. each year are thought to have anaplastic large cell lymphoma, roughly 3 percent of the 65,540 people diagnosed with non-Hodgkin’s lymphoma in the U.S. each year.

While tumor shrinkage was the primary goal of this study, doctors will want to comb through the data that will come out in December in much greater detail. This study was designed to follow patients to see how long they stayed in remission, how long tumors were prevented from spreading, and how long patients actually lived. None of those important measurements are being made available in today’s announcement, and it will take more follow-up time to get those answers. Seattle Genetics also hasn’t said what proportion of patients had complete remission versus how many had partial remission. (That’s important, because doctors might be less impressed if the 86 percent response rate was achieved through 2 percent getting complete remissions, and 84 percent experiencing partial remissions).

Still, the data has important implications for more than just patients. It will help Seattle Genetics make a stronger case to the FDA to approve what could be the company’s first marketable cancer drug. Scientifically, it provides more evidence that says it’s a good idea to aim a targeted antibody drug against a protein found on cancer cells called CD30, which brentuximab vedotin is designed to hit. And it provides further validation for the new paradigm of “empowered antibodies” which seek … Next Page »

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Seattle Genetics is making history today, after a dozen years of effort, with groundbreaking clinical trial results in the field of cancer drugs. The results pave the way for the first successful “empowered antibody” drug for cancer, and a new therapy for people who have run out of options for fighting Hodgkin’s disease.

The Bothell, WA-based company (NASDAQ: SGEN) and its Cambridge, MA-based partner, Millennium: The Takeda Oncology Company, are reporting today that Seattle Genetics’ lead drug candidate, brentuximab vedotin, was able to partially or completely shrink tumors for 75 percent of the 102 patients with Hodgkin’s disease who enrolled in a pivotal clinical trial. Most cancer drugs shrink tumors in fewer than 30 percent of patients. That means Seattle Genetics unequivocally surpassed the usual definition of success, and is now in a position to seek FDA approval to market the drug in the U.S.

“I’ve been doing cancer research and making cancer drugs for 25 years, and these are the kind of data you dream of,” says Clay Siegall, the co-founder and CEO of Seattle Genetics. “We are going to have an amazing impact on patients.”

Even though the patients were the sickest of the sick, their tumors were kept in check for at least six months. Doctors will continue to follow the patients to see how long the tumors remain stable, and ultimately how long the drug helps the patients live. Detailed results from the study will be presented at an upcoming medical meeting.

Armed with this new batch of results, Seattle Genetics now plans to seek FDA clearance in the first half of 2011, and to ask for a faster-than-usual six-month regulatory review that is sometimes granted for lifesaving therapies.

Clay Siegall

The results are important for several reasons. If the FDA gives the green light, brentuximab vedotin (formerly known as SGN-35) will become a transformative asset for Seattle Genetics, as the company will morph from an R&D-only operation into a more fully integrated company that discovers, develops, and sells pharmaceuticals. Scientifically, the drug is potentially the first of a new class of drugs designed to zero in specifically on cancerous cells, with a potent toxin to give them extra tumor-killing punch. Medically, the drug could offer a new option for many of the 8,500 patients in the U.S. diagnosed with Hodgkin’s each year, as well as other patients with lymphomas that overexpress a protein marker called CD30, which brentuximab is designed to hit.

Millennium, which last year paid Seattle Genetics $60 million upfront to obtain rights to the product outside North America, said its next move will be … Next Page »

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Raising her son in a middle class home in the Detroit area in the ’50s and ’60s, Larry Corey‘s mother dreamed he’d become a doctor. Now he’s set his sights much higher, as the new president and director of one of the world’s leading biomedical research institutes, a place that seeks to do no less than eliminate cancer as a cause of suffering and death.

Corey, 63, was introduced Friday at a press conference in Seattle as the new president of the Fred Hutchinson Cancer Research Center. Doug Walker, the chairman of the “Hutch” board said Corey was the guy with the “impeccable scientific and leadership credentials” needed to run a center that’s home to three Nobel laureates and 2,600 employees, and which has an annual budget of more than $390 million.

Corey found himself in position to take on such a hefty responsibility at the Hutch after arriving in Seattle 35 years ago for a postdoctoral fellowship “on a lark.” He ended up putting down roots in the Northwest, and building his career as a leading physician-scientist in the battles against viral invaders, particularly HIV and genital herpes. He’s built alliances among scientists throughout his career. The work hasn’t led to an HIV vaccine, or a cure for cancer. But Corey’s job over the coming years will be create the medical and scientific environment where other people can make breakthrough discoveries and help deliver them into the real world.

“Great ideas make for great scientific opportunities. And great scientific opportunities will provide large programs,” Corey says. “The major thing is that whatever we do, we do world class, and that we make an impact on human health.”

As you’d expert, the new president is getting started with a lot of public votes of confidence. Walker, the chairman of the Hutch board, said Corey is “uniquely poised” to form new partnerships to help the center reach its goals. Fred Appelbaum, the director of the clinical research division at the Hutch, noted at the press conference that “a lot of people have vision,” but that Corey was the right man for the job because he has not just vision, but the ability to follow through on it. And Robert Nelsen, the managing director of Arch Venture Partners in Seattle and a member of the center’s board, said, “he is great choice—very sharp and creative. He will bring a fresh and forward-looking leadership to the Hutch.”

Once the press conference was over, I had a chance to follow up with Corey in more detail by phone, to learn more about him as a person and the approach he intends to take in this new job.

Corey started on his journey toward such a lofty position from “a middle-class family of humble means.” He was born in Detroit, as the youngest of three, with two older sisters. His father ran a scrap rag business for a time before that ran into financial hardship, and then managed a produce section at a grocery store. His mother was a homemaker.

The modest upbringing helped light a fire in Corey, which was partly out of necessity. The family didn’t have a lot of money, and he relied on a series of scholarships to help pay his way through school. And he didn’t intend to waste the time or the money. He was the classic young man in a hurry—skipped a grade in school, graduated from the University of Michigan at 20, and got into a fast-track medical program at the university that allowed him to get an MD in three years rather than four. When he got his medical degree, he enrolled in postgraduate training at the Centers for Disease Control and Prevention, and was able to shave a full year off that usual training program. He became a tenured professor at the University of Washington at 37.

“I was always the young one,” Corey says. “I have to say probably more motivated by financial issues to move forward in life.”

All that restless energy had to be directed somewhere, and it wasn’t immediately obvious where it would go when Corey stepped onto the University of Michigan campus in Ann Arbor. He picked up much of his passion for medicine in his early 20s from … Next Page »

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Summertime may be officially here, but we are a long way from the dog days. This week, the Seattle biotech desk had reports on cancer drugs, drug discovery tools, and antibiotics, as well as a few sharp guest editorials.

—Seattle Genetics (NASDAQ: SGEN) has generated a lot of buzz about its drug candidate, an “empowered antibody” for Hodgkin’s disease. But a lesser-known drug candidate, a more traditional “naked” antibody that hits tumor cells without packing an extra toxic payload, is also nearing a key turning point in which the company will learn whether it can help leukemia patients live longer.

—Quite a bit has happened in the last few months at Presage Biosciences, a Seattle-based spinoff from the Fred Hutchinson Cancer Research Center. The company topped off a $4 million angel investment round, hired a new CEO, and has found a couple paying customers from Big Pharma that are using its technology to help sift out the winners from the losers in cancer drug development.

—Gilead Sciences (NASDAQ: GILD), the Foster City, CA-based company with significant operations in Seattle, said that its inhalable antibiotic for cystic fibrosis beat a competing drug from Novartis in a head-to-head study. This trial compared patients who mostly had three prior cycles of the Novartis drug and who were getting a fourth round, or a new round of the Gilead drug. The Gilead drug, originally developed by Corus Pharma in Seattle, won FDA approval in February.

—Seattle-based Oncothyreon (NASDAQ: ONTY) was able to breathe a sigh of relief late last week. The company said its partner, Germany-based Merck KGaA, was cleared to re-start two of three pivotal trials of an immune-boosting treatment for cancer called Stimuvax that was first developed at Oncothyreon.

—A familiar face to many local biotechies, Tom Ranken, is taking on a new challenge as the first full-time CEO of the Washington Clean Technology Alliance. This may seem like déjà vu for Ranken, who in the mid-90s, took the helm of a loosely affiliated trade association at the time, the Washington Biotechnology & Biomedical Association, and made it into a much bigger organization with more impact for the local life sciences industry.

—The Vancouver, BC, biotech cluster had a big financing to report last week. Aquinox Pharmaceuticals pocketed $25 million in a Series B venture round to advance its drug candidates against cancer and inflammatory diseases.

—We had a flurry of guest editorials built around life sciences themes. The first was from Thong Le of WRF Capital, who contends that Silicon Valley needs to invest in truly innovative people and companies if it wants to be a more stable hub. Next was a piece from Dan Vorhaus, well known as @genomicslawyer on Twitter, with a piece on how consumer genetics needs more transparency instead of heavy-handed regulation. And, we had a post from WBBA chief Chris Rivera on how biotech must have more capital, more talent, and predictable regulations to thrive. Thanks to all for your contributions, and anyone else who wants to chime in, shoot me a note at ltimmerman@xconomy.com.

—Last, but not least, we had some good news around the Xconomy Seattle office this week. I’m happy to introduce our newest team member, Thea Chard, who is covering all kinds of technology here in the Northwest. She is replacing the co-founder of this bureau, Greg Huang, who is moving to run Xconomy’s editorial shop in Boston. Greg will continue to cover national themes in IT, so his byline will still appear from time to time on these pages.

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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.

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Seattle Genetics (NASDAQ: SGEN) and Cambridge, MA-based Millennium: The Takeda Oncology Company said today that their “empowered antibody” for blood cancers showed promising results in a small study of patients who were re-treated following a relapse. The study found that seven of 11 patients with Hodgkin’s disease or anaplastic large cell lymphoma had at least partial tumor shrinkage after getting re-treated with brentuximab vedotin. The drug is unusual in that it combines the targeting ability of an antibody with a toxin to make it more potent against tumors. Results were presented today at the American Society of Clinical Oncology meeting in Chicago. We wrote a detailed story last month about the commercial potential Seattle Genetics and Millennium see in this emerging field of cancer treatment.

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Seattle Genetics has spent more than a decade thinking about cutting-edge biology, chemistry, and clinical trials to prove its drug candidates work. Then last week, for the first time in nine years I’ve been reporting on CEO Clay Siegall, he talked with passion about things like manufacturing, inventory, quality assurance, quality control, and insurance reimbursement.

It all might sound awfully boring. But it’s a sure sign that Bothell, WA-based Seattle Genetics (NASDAQ: SGEN), with help from its partner Millennium: The Takeda Oncology Company, is learning fast what it takes to be a mature, commercial biotech company. And while it may be a slow news period for Seattle Genetics (NASDAQ: SGEN), it has to grow up in a hurry, because it is only a few months away from finding out if it has really struck gold with a new therapy for Hodgkin’s disease and related lymphomas.

The big story at Seattle Genetics and Millennium centers on brentuximab vedotin, an “empowered antibody” that specifically seeks out cancer cells and unleashes a potent toxin on them for extra tumor-killing punch. This concept has not lived up to its hype over the past 30 years, but by the second half of 2010, Seattle Genetics and Millennium will learn from a pivotal clinical trial of 100 patients how well this therapy really helps sick patients. If successful, the companies will be able to seek FDA approval in early 2011, and potentially get a faster-than-usual six-month review that the agency sometimes gives to drugs with lifesaving potential. Patients, employees, investors, and an entire field of research is counting on Seattle Genetics and Millennium to deliver the goods. So Siegall & Co. are quietly trying to lay the groundwork now to make sure they are truly ready to make sure this drug is a hit.

Clay Siegall

“Our drug has a chance to be a very important drug for patients,” Siegall says.

For those just getting up to speed on this story, here’s a quick refresher. Seattle Genetics, founded in 1998, had its breakout moment in June 2008 at the American Society of Clinical Oncology meeting. That’s when the company released preliminary results showing its experimental treatment was able to completely wipe out or partially shrink tumors for 12 of 38 patients, with mild to moderate fatigue, cough, and nausea as side effects. Results only got better when researchers enrolled a few more patients, and longer-term follow-up data arrived.

A lot of things have fallen into place for Seattle Genetics as a business ever since that appearance at ASCO. It raced to the FDA in early 2009 with a proposal for a pivotal clinical trial, and won the agency’s blessing for the study design. The company got this trial up and running at 27 locations in North America and Europe, and completed enrollment six months ahead of schedule—a lightning pace in oncology, where it’s extremely difficult to enroll patients on time. The company raised more than $200 million from investors in 2009, during a dark period in the overall biotech financial market. In December, Millennium wrote a $60 million upfront check to Seattle Genetics to form a partnership, which left the smaller company with 100 percent of the commercial rights to the experimental drug in the North American market.

Much of what has happened since then has been the sort of behind-the-scenes blocking and tackling that biotech companies need to do, and often fail to do, as they prepare to commercialize a new drug. Part of that effort is in hiring new types of people, with skills in things like … Next Page »

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Seattle Genetics, the developer of antibody treatments for cancer, said today it has received a new patent which will extend its proprietary rights to its lead drug for Hodgkin’s disease until at least 2025. The U.S. patent covers technology for a linker that selectively unloads a potent toxin called auristatin on the target cell of interest. This is the technology Seattle Genetics uses in its lead “empowered antibody” program called brentuximab vedotin (SGN-35), and which several of its partners use under licenses. Seattle Genetics expects to seek FDA approval of brentuximab vedotin to treat Hodgkin’s disease in the first half of 2011.

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Seattle Genetics (NASDAQ: SGEN) and its partner, Millennium: The Takeda Oncology Company, said today they are starting a clinical trial of the brentuximab vedotin “empowered antibody” for patients newly diagnosed with Hodgkin’s disease. The drug has been shown effective in a small study for patients with relapsed forms of Hodgkin’s, and is currently being tested in a pivotal study among that sicker patient group. The new study among newly diagnosed patients will enroll about 40 people at multiple sites in the North America. Patients will get the experimental treatment in combination with a common chemotherapy regimen.

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