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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It’s Editor’s Picks time at the end of the year, which is a sure sign that your local journalists are looking to stick something on the site you can read during a slow week so we can spend time with our families.

Seriously, this has been a fascinating and typically frenzied year for us at Xconomy Seattle. The biggest story for me personally has been the hiring of our new senior editor Curt Woodward. I introduced him in these pages as “one of the best all-around reporters in our state” when he joined us in mid-February, and he has delivered the goods on the local technology beat. You can see for yourself by checking out Curt’s 2012 preview story, which ran yesterday.

The other significant news for us is that we are planning to move into new digs in early 2012, at 1551 Eastlake Avenue East, the former headquarters of the Bill & Melinda Gates Foundation. Curt and I are psyched about this move into the high-rent district, from our (cough, cough) humble startup abode. We are looking forward to inviting readers over for a happy hour/open house once we are settled in, probably sometime in February.

With that, I thought it would be worth reflecting a bit on the biggest life sciences stories of the year in Seattle. These aren’t necessarily the biggest traffic generators, or the biggest earth-shaking events of the year. Instead, these picks represent the kind of original, in-depth coverage that we believe makes us a must-read for news and analysis in the local innovation community. These are my personal favorites from the biotech side of this operation in 2011—see Curt’s story to get a feel for his faves on the tech beat.

As always, if you have ideas of interesting people and companies that I should check out, just send me a note at ltimmerman@xconomy.com. See you out there in biotechland in 2012. And above all, thank you for reading.

“Dendreon Wounds are Self-Inflicted, Not the Start of a Biotech Industry Virus“

“Lady Gaga’s Favorite Seattle Tech Startup, Clarisonic, Cracks Big-Time With $100M Sales“

“Gates Foundation Makes First Equity Investment in a Biotech Startup, Liquidia Technologies“

“How ZymoGenetics Coulda Been a Contender: The Big Break That Came Too Late“

“Ken Stuart, the Working Class Kid Who Built a Global Health Hotspot at Seattle Biomed“

“Seattle Genetics: The Next Big Litmus Test for High-Priced Cancer Drugs“

“NanoString Nails Breast Cancer Prognosis Study, Challenging Genomic Health“

“Exclusive: Pathway Medical Technologies to be Acquired by Bayer’s Medrad Unit for $125M“

“Light Sciences Oncology Stumbles in Clinical Trial, Layoffs Loom“

“Mobisante Wins FDA Approval for Ultrasound on a Smartphone Technology“

“Blaze Bioscience, Fred Hutch Spinoff With Zymo Vet at the Helm, Seeks to Paint Tumors“

“The Immunex Alumni: Where Are They Now?“

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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 »

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Seattle Genetics and its partner, Millennium: The Takeda Oncology Company, are following one of the well-traveled roads in cancer drug development. It’s about first gaining experience in the market by treating a small group of the very sickest patients, then working backwards until your drug eventually becomes part of the standard of care for more people who are newly diagnosed.

If the drug proves super-effective and safe over time, it could end up as part of “maintenance” therapy to keep the cancer from coming back.

It’s all part of the long-term strategy at Seattle Genetics (NASDAQ: SGEN), which will be on display next week at the American Society of Hematology‘s big annual meeting in San Diego. The company will have a handful of presentations this year about its antibody drug, brentuximab vedotin (Adcetris), for lymphomas. The treatment was initially cleared in the U.S. for patients with relapsed and treatment-resistant forms of Hodgkin’s lymphoma and anaplastic large cell lymphoma. But now Seattle Genetics and Millennium are preparing to release some results at ASH from a small trial of patients with a much healthier prognosis—those getting their first line of therapy for Hodgkin’s disease.

Genentech followed a similar strategy with its hit rituximab (Rituxan) for non-Hodgkin’s lymphoma, says Seattle Genetics CEO Clay Siegall. It started with relapsed, treatment-resistant patients, moved into the standard of care for newly diagnosed patients, and became part of maintenance therapy. If Seattle Genetics can duplicate the feat, it will significantly expand the potential market for its drug, and provide the first advance for this group of patients since the existing chemo regimen was established in 1977.

Clay Siegall

“After 34 years of there being no advances in front-line therapy, our goal is to increase the efficacy and decrease the toxicity,” Siegall says.

About 9,000 patients in the U.S., and a similar number in Europe, are diagnosed with Hodgkin’s each year, and are generally prescribed a cocktail of four chemotherapy drugs that essentially effective for 80-90 percent of patients, Siegall says. The bet for Seattle Genetics and Millennium is that the new antibody drug can raise the bar even higher on effectiveness, while reducing some of the nastier side effects of chemotherapy, including lung scarring.

The standard of care is a combination of chemotherapy drugs Adriamycin, bleomycin, vinblastine, and dacarbazine, known as ABVD. Based on feedback from top researchers, Seattle Genetics is testing the idea that the “B” in that regimen (bleomycin) might be the nastiest ingredient in the mix. The idea is to swap out bleomycin, and swap in the Seattle Genetics drug, Siegall says.

Researchers are keen to test this idea based on how the Seattle Genetics drug has performed in the sickest patients. The Seattle Genetics drug provided significant tumor shrinkage in 75 percent of patients with relapsed forms of Hodgkin’s disease in a clinical trial, and in about 86 percent of patients with anaplastic large-cell lymphoma. Researchers are still following patients to see how long those responses really do last, and to what extent they may help people live longer. The most common side effects found … Next Page »

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Life sciences investing is up against the ropes. The sector has been beset by such high capital costs and such long paths to market that many venture partners don’t seem to want early- and mid-stage biotech companies tarnishing their portfolios anymore. Hence the news last week that Menlo Park, CA-based Morgenthaler Ventures and Boston-based Advanced Technology Ventures are shedding their life science investing teams and merging them into a new independent biotech fund—and the news today that Scale Venture Partners of Foster City, CA, is ceasing new healthcare investments altogether.

The ScaleVP announcement came this morning in the form of a blog post and press release. Kate Mitchell, ScaleVP’s managing director, said that after long discussion with limited partners, the firm decided that healthcare investing—where the unpredictable rigors of FDA review are making it harder to get new treatments to patients—is not compatible with the firm’s focus on mid-stage investing.

As its name indicates, ScaleVP generally focuses on identifying companies that have early revenues and helping them scale up until they’re ready for an IPO or acquisition. The firm has successfully shepherded a few life sciences and healthcare companies to that stage, including Seattle Genetics, Cellective Therapeutics, IPC The Hospitalist Company, and National Healing. But for other companies in its portfolio, the process has become too expensive and unpredictable, largely due to the “vagaries” of the regulatory review process for new drugs, Mitchell says.

“In the last four years, our companies have filed seven NDAs [new drug applications]; five of them have been approved and two are pending—something we are proud of,” she writes in today’s post. “Unfortunately, they took longer and used more capital than planned from the start…The partners believe that the vagaries of the FDA and the resulting increase in time and capital needed to take these companies through to a real exit doesn’t fit our mid-stage fund strategy any longer.”

Mitchell (who is an Xconomist) has been active in efforts to remove regulatory barriers to growth for emerging healthcare and technology companies. She’s a past president of the National Venture Capital Association, which puts part of its lobbying energy into Washington lobbying into promoting streamlined FDA regulations. More recently, she chaired an “IPO Task Force” that issued a report last month calling on Congress, the White House, and the Treasury Department to ease rules that make it prohibitively complex and expensive for emerging companies to go public.

But Mitchell says that none of these changes will happen fast enough for ScaleVP’s purposes. “Our team has been closely watching the regulatory environment in the healthcare field for years, and we are heartened by the dialog that is beginning to take place between our industry and the regulators,” she writes. “We will continue to be active in that conversation but think that the timing of a resolution that benefits emerging companies tackling important healthcare issues will be beyond our investing horizon.”

Mitchell hastened to add that ScaleVP’s decision is “not a signal of the end of healthcare investing for VCs. Healthcare should and will continue to be a good place to invest for many of our peers who have earlier or later stage mandates.”

Since May 2009 ScaleVP has been investing out of its $255 million Fund III. Managing directors Lou Bock and Mark Brooks oversee the healthcare part of the portfolio, which includes Alimera Sciences, Ascenta Therapeutics, LivHome, National Healing, New Century Hospice, Oraya Therapeutics, Sonexa Therapeutics, and Spinal Kinetics. They’ll stay on with the firm, according to Mitchell’s announcement, in order to “support their portfolio companies and maximize return to investors.”

ScaleVP has already changed the front page of its website to indicate that it invests primarily in Internet, software-as-a-service, mobile, and cloud computing companies. Reflecting the new focus, the firm announced that Stacey Bishop, who led ScaleVP’s investments in ExactTarget and Omniture, has been promoted to managing director.

Xconomy is scheduled to talk with Mitchell later this morning, and we’ll update this story as warranted.

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Groupon raked in so much cash through its initial public offering last week that it could buy the entire class of life sciences companies that have gone public in 2011.

For those of you who aren’t following the Groupon melodrama, the Chicago-based online daily deals site raised $700 million last week in its IPO after overcoming serious questions about its accounting practices. Groupon shrugged that off and saw its stock (NASDAQ: GRPN) boom 31 percent on the first day of trading. TV news commentators cheered, just like when social networking site LinkedIn (NYSE: LKND) went public in May.

The biotech IPO market, by comparison, has been about as exciting as the average Seattle Mariners game was this year.

Not everybody thought it would be this dull. Heading into 2011, market prognosticator Steve Burrill predicted there would be at least 25 biotech IPOs this year in the U.S. The final tally will be nowhere close to that. Renaissance Capital of Greenwich, CT, says there have been 13 healthcare IPOs this year, compared with 37 from the tech industry. Even by reaching for the loosest definition possible of the “life sciences” industry, there have been 16 life sciences IPOs so far this year, as tallied in August by The Burrill Report. But if you get rid of specialty chemical/biofuel companies, and you whittle out a Tibetan medicine company and a health IT player, that brings the group down to 10 true life sciences IPOs by my count. Six are drug developers, leaving a couple of medical device companies, a diagnostics company, and an instrument maker.

Here’s a quick rundown of the life sciences IPO class of 2011 that I put together. Three have gained value this year, two are basically treading water, and five have declined. The grand total of IPO money that went to these 10 companies is a paltry $640 million—less than a single online daily deals site raised last week. Just as worrisome, I’m almost certain that when scientific eyes look at this list, they glaze over with boredom.

It’s a sad state of affairs today that some daily deals website, which produces nothing of lasting value and will probably end up the poster child of another tech bubble gone bad, can generate so much attention and actual money.

Don’t get me wrong, I don’t think investors should just start taking fliers on unproven biotech companies. The vast majority of people who try that would surely get burned, like I’m guessing most people will get burned by Groupon.

This dynamic isn’t going to change anytime soon. The biotech VC world is in crisis, pharma companies are cutting their R&D capabilities, and the federal government is contemplating budget cuts that would put a dent in basic academic research. Hardly anybody, other than a few focused philanthropies, seems to be stepping up to invest in the risky, messy business of biomedical discovery that keeps the whole industry moving forward. Certainly IPO investors have made clear the past few years they want no part of that kind of risk.

Ironically, this same abundance of caution is coming during the same year of some major biotech home runs. There has been a string of outstanding innovation this year in life sciences from … Next Page »

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[Update: 2:55 pm PT] Seattle Genetics handily beat Wall Street expectations by selling $10 million worth of its new lymphoma drug in its first 30 business days on the market.

The Bothell, WA-based company (NASDAQ: SGEN) said today it generated $10 million in net product sales in the quarter ended Sept. 30, according to its quarterly financial report. The sales came from the company’s first FDA-approved product, brentuximab vedotin (Adcetris) for patients with a couple rare blood cancers—Hodgkin’s lymphoma and anaplastic large cell lymphoma. The drug was first cleared for sale in the U.S. on Aug. 19.

Seattle Genetics is going after a small group of patients with this new drug, and expectations on the street were low in recent weeks, although they have been building. Analyst Thomas Wei of Jefferies & Co. said in mid-October that he pegged Seattle Genetics’ third quarter sales at $5.7 million, which was way above Wall Street consensus at the time of just $1.9 million. In an updated report on Nov. 2, Wei said that expectations among buyside funds had climbed to $7 million. The drug, which has shown strong effectiveness in this narrow population in clinical trials, costs $13,500 a dose, and is given via an intravenous infusion every three weeks.

The company’s expenses naturally climbed in its debut quarter of being a marketing organization. Total expenses grew to $61.6 million in the quarter, up from $51.3 million in the same quarter a year earlier. Seattle Genetics reported a net loss of $40.7 million in the most recent period.

Seattle Genetics didn’t release any sales forecast for the rest of 2011, or for 2012, in its quarterly report today. It did, however, offer some explanation for its bang-up commercial debut.

[Updated with info from conference call] About 200 patients were getting the Seattle Genetics drug free on a “compassionate use” basis from January through August during the FDA review process, and more than 80 percent of those patients converted into paying customers once the Seattle Genetics product was cleared for sale Aug. 19, said Bruce Seeley, the company’s executive vice president of commercial operations. Quite a few doctors were aware of the company’s FDA deadline at the end of August, and also lined up additional patients in the queue, Seeley said.

Partly because Seattle Genetics isn’t sure how many of those $13,500 per dose infusions patients will get in real-world use, and partly because there have been some delays on insurance reimbursement, Seattle Genetics declined to offer a sales forecast for the fourth quarter or beyond. The company has also gone out of its way to ask its distributors to stop disclosing order reports to prescription tracking services like IMS Health, which many investors count on to provide transparency on commercial progress.

The lack of information clearly annoyed analysts on today’s conference call.

Seattle Genetics CEO Clay Siegall’s response was that the company is still trying to better understand the dynamics of its market before it makes forecasts, and that it is trying to block third-party information services because it wants to keep competitors in the dark about its strategies to broaden use of the drug to additional patient groups.

“We’re not trying to hide anything. We’re trying to understand our launch,” Siegall said on the conference call. He added: “We have a very exciting product with Adcetris. For competitive reasons, we are working with distributors to prevent the release of information.”

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Seattle Genetics only had 30 full business days in the last quarter to sell its first drug, and at least one analyst says the company nailed the early days of its commercial rollout.

The Bothell, WA-based biotech company (NASDAQ: SGEN) won FDA approval to start selling brentuximab vedotin (Adcetris) as a new treatment for Hodgkin’s disease and anaplastic large cell lymphoma on August 18. Based on a report from market research firm Wolters Kluwer, the company appears to have generated $5.7 million in sales through the end of the third quarter, on Sept. 30, says Thomas Wei, an analyst with Jefferies & Co. That’s way above the modest $1.9 million consensus forecast on Wall Street, Wei said.

Seattle Genetics plans to formally announce its third quarter financial results on Nov. 3, so until then, there will be a lot of educated guesswork going on. Many investors try to predict quarterly sales numbers based on weekly prescription data trends from research firm IMS Health. But in this case, investors haven’t been able to get access to IMS data, Wei said. Given how many biotech drug introductions have fallen short of expectations in recent years, and the lack of tracking data, many investors have continued to hold bearish positions in the company, betting its stock will fall, Wei said.

Still, that doesn’t appear to be a majority opinion, at least today, anyway. Shares of Seattle Genetics climbed as high as $20.92 today, giving it a valuation of almost $2.4 billion. The stock is up more than 45 percent since Adcetris won FDA approval.

“We would continue to be buyers of SGEN at current levels as we and the Street have likely underestimated the near-term uptake of Adcetris,” Wei wrote in a note to clients Oct. 19.

The data from Wolters Kluwer comes from institutional sales, which are recorded from wholesalers to physician offices and hospitals, Wei said. That’s different than the usual prescription tracking method used by IMS, which is part of what the analyst said makes him bullish about how Seattle Genetics is doing. “We have heard from investors that the Wolters Kluwer institutional sales audit generally underreports actual reported sales by companies,” Wei wrote.

Seattle Genetics spokeswoman Peggy Pinkston confirmed that the company has tried to block market research firms from tracking its progress the usual ways. “We have taken steps to ensure that our distributors do not disclose our proprietary sales information. As a result, Adcetris sales data from IMS and similar services are not informative. There are other companies interested in this space, and we don’t want to enable others to use our data for competitive reasons.”

Sales of the Seattle Genetics drug can add up pretty quickly, based on its high price per infusion. 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. If a patient gets the maximum number of 16 doses described in the FDA-approved label, it will cost $216,000 per patient.

Seattle Genetics has contended its product is worth the price because of the value it brings to patients. The drug was able to significantly shrink tumors in about 75 percent of patients with Hodgkin’s disease, and in about 86 percent of patients with anaplastic large cell lymphoma (ALCL). The treatment’s side effects include a depletion of infection-fighting white blood cells, nerve damage in the fingers and toes, fatigue, nausea, and other adverse events. About one-third of Hodgkin’s patients and one-half of ALCL patients went into complete remission in clinical trials, but researchers still don’t know how much longer patients can expect to live on the new drug, compared with existing chemo regimens.

David Miller, who covers Seattle Genetics for Biotech Stock Research, said he’s projecting $12.2 million in sales for the company in 2011, followed by $223 million next year.

“Despite the very high cost, this is a very effective drug even in late-stage disease. It doesn’t surprise me the demand would be high,” Miller says.

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Football season is getting started this week, and I’m pumped. This is the time millions of people test their wits against friends (and strangers) in fantasy football. For fellow biotech nerds who aren’t familiar, this is a little bit like the stock market—you try to pick a diversified portfolio of pro football players who you think are going to have great seasons. And you try to avoid the losers.

Since I just finished drafting my fantasy team, I thought it would be fun this week to evaluate biotech a bit like I analyze football players. So here goes, with a somewhat tongue-in-cheek set of awards and predictions about the ups and downs to watch this season among the companies, players, and drugs that make biotech so darn interesting.

Reggie Bush don’t-believe-the-hype award: Brisbane, CA-based Intermune (NASDAQ: ITMN). The former Heisman Trophy winner from USC had a dazzling college career, but has been a dud in the pros. Intermune, too, saw a monster wave of enthusiasm earlier this year, and its stock briefly topped $50 in April. The company has already dropped back into the mid-$20s, but it still has a market valuation of about $1.5 billion. All of this excitement has been for one new drug that was rejected by the FDA, and then approved in the European Union for patients with idiopathic pulmonary fibrosis. It all looks to me like investors have gotten carried away. This disease is a rare condition, Intermune is blazing a new trail on its own with physicians and patients, and quite a few European countries are basically broke.

LaDainian Tomlinson fading superstar award: Amgen’s erythropoietin anemia drug franchise. The future Hall of Famer did amazing things for the San Diego Chargers, but now he’s 32, near the end of his career. He’s given up the starting tailback job with the New York Jets to Shonn Greene, which means LT won’t have to carry the load all by himself, which could lengthen his career. Thousand Oaks, CA-based Amgen (NASDAQ: AMGN) had a similarly spectacular run with its erythropoietin anemia drug franchise, but after battling years of safety controversies, this product’s best years are behind it. Fortunately for Amgen, it has the equivalent of Greene’s fresh legs with its new antibody drug denosumab, which it is marketing as Prolia for osteoporosis and Xgeva for cancer-related bone loss. But just like Shonn Greene is no LT, d-mab is no EPO.

Packers-Bears best rivalry: Vertex-Merck. The Green Bay Packers and Chicago Bears have the oldest and one of the most intense rivalries in football, and there are few things I enjoy more than watching my World Champion Packers beat the Bears. I don’t have a rooting interest in the battle between Vertex Pharmaceuticals and Merck in the hepatitis C field, but this has the elements of a great rivalry. Vertex has superior data for its drug from clinical trials, but Merck’s drug is also a big step up over the old hepatitis C regimen, and it has money, manpower, and sales history with doctors that can’t be dismissed. To add another layer of intrigue, Vertex founder Josh Boger and CEO Matt Emmens both worked earlier in their careers at Merck, so these are familiar enemies.

Tom Brady sleeper pick of the year: Richmond, CA-based Sangamo Biosciences (NASDAQ: SGMO). The legendary 3-time Super Bowl-winning quarterback was the ultimate sleeper pick coming out of college, and the New England Patriots were able to grab him in the sixth round of the 2000 draft. Sangamo has been around for a long time with a technology for specifically silencing genes, which investors aren’t giving much value. But Sangamo is expecting some clinical trial results this fall from a mid-stage clinical trial of its new drug for patients with diabetic neuropathy. If the data are positive, it could propel this company from the bench to stardom.

Tedy Bruschi comeback player of the year: South San Francisco-based Exelixis (NASDAQ: EXEL). The former Patriots linebacker and 3-time Super Bowl champion suffered a rare heart condition that caused a stroke, which looked like it would send him into retirement in 2005. But he beat the odds, coming back to play some more great football. Exelixis, too, looked like it was in big trouble just a year ago after it made some big layoffs, one of its partners (Bristol-Myers Squibb) threw in the towel on its lead drug candidate, and its CEO left for a new job. But Exelixis’ lead drug, cabozantinib, has shown an impressive ability to treat the debilitating bone pain that strikes men with advanced prostate cancer. Investors have heard researchers rave about this drug, and have pumped new life into the stock, which enabled Exelixis to raise a lot more money. Now Exelixis needs to prove the results in more rigorous studies, but it is certainly back in the game.

Baltimore Ravens defensive team of the year: The FDA’s division that reviews obesity and diabetes gets this award in a landslide. Like the NFL’s notoriously violent defender, Ravens linebacker Ray Lewis and his teammates, the FDA has … Next Page »

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Seattle Genetics made waves both locally and nationally this week with an FDA approval that’s a historic step for the antibody drug business, and raises some interesting questions about the economics of cancer.

—Seattle Genetics (NASDAQ: SGEN) nailed down FDA approval of its first product on Friday. The drug, brentuximab vedotin (Adcetris) is designed to treat people with a couple of rare diseases, Hodgkin’s lymphoma and anaplastic large cell lymphoma. After 14 years in business and more than $500 million of R&D investment, Wall Street was betting this highly effective drug would command a premium price of about $110,000 per patient. And sure enough, Seattle Genetics came out with a high price of $13,500 per dose. It could end up costing anywhere between $108,000 per patient or $216,000 per patient, depending on how many doses patients get in the real world. CEO Clay Siegall did his best to defend the price when he was interviewed on Monday by CNBC. I argued in the BioBeat column this week that Seattle Genetics is in the rare position where it can justify a six-figure price tag. But if it really ends up costing $216,000 per patient … that might be worth another column.

—Seattle-based Dendreon (NASDAQ: DNDN), another cancer drug developer that knows all about the consternation surrounding high-priced therapies, had a small but noteworthy personnel announcement. Dendreon added John H. Johnson, the CEO of Savient Pharmaceuticals (NASDAQ: SVNT) and the former CEO of ImClone Systems, to its board of directors. Johnson was the CEO who turned ImClone around in the late 2000s, as its cancer drug became a $1 billion hit, and the company was acquired by Eli Lilly for $6.5 billion.

—Before all that news hit, I dug up an Xconomy exclusive on how Bayer’s Medrad unit has bid $125 million to acquire Kirkland, WA-based Pathway Medical Technologies. The deal still needs shareholder and regulatory approval before it can be finalized.

—Seattle-based Theraclone Sciences has been toiling away the past few years on broadly neutralizing antibodies against the HIV virus, and last week we saw some fruits from that labor. Theraclone, with support from the International AIDS Vaccine Initiative, was part of a national scientific collaboration that discovered 17 new broadly neutralizing antibodies which could become important new tools for AIDS vaccine R&D. The research was published in Nature.

—Seattle Children’s Hospital CEO Tom Hansen is deeply passionate about a simple, low-cost ventilator that he thinks can save the lives of premature infants around the world, and now he’s got some more support to take this idea through critical early tests. The Bill & Melinda Gates Foundation agreed to pump $2.3 million into the ventilator program.

—Lastly, we had an Xconomist Forum guest post from Steve Dickman at CBT Advisors in Boston, who argues that the latest social networking platform, Google+, has the potential to transform healthcare in ways that Google Health couldn’t. As always, your own trenchant observations about various biotech topics are welcome here. If you have an idea you’d like to write about for the Xconomist Forum that’s either local or national in scope, ping me at ltimmerman@xconomy.com.

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Seattle Genetics is making news all over the Web today, in the first full business day since it won FDA approval for its new targeted antibody drug for rare lymphomas.

While the drug won FDA approval a little bit earlier than expected, the company kept everyone in suspense until today on one critical fact—how much the drug is going to cost. The company announced earlier today that it will charge $13,500 for each dose of brentuximab vedotin (Adcetris) for patients with Hodgkin’s lymphoma and anaplastic large cell lymphoma.

What does that mean? The drug is given as an intravenous infusion once every three weeks, for about 30 minutes. Experience from clinical trials says patients got between 7-9 infusions. If you estimate the average patient gets eight infusions, it will cost $108,000 per patient. If you estimate that patients will get the maximum of 16 infusions as outlined under the FDA prescribing information, then the price jumps to $216,000 per patient. The company says it doesn’t know exactly how many infusions patients will get in real-world experience.

There is a ton of debate out there in healthcare circles about the cost/benefit ratios of cancer drugs, as anybody knows if they’ve been following the Dendreon saga, and the stories about Genentech’s bevacizumab (Avastin) for breast cancer. So Seattle Genetics is wading into some sensitive territory here.

I came out in support of the six-figure price tag for the Seattle Genetics drug in today’s BioBeat column. Over at Pharmalot, veteran industry writer Ed Silverman is polling readers about whether this is an appropriate price. Based on the assumption that patients will get about eight infusions, Sally Church at the Pharma Strategy Blog points out that the Seattle Genetics drug costs less than the $120,000 that Bristol-Myers Squibb is charging for its new melanoma drug, ipilimumab (Yervoy). Brett Chase over at Minyanville notes that the price may make some investors nervous about Seattle Genetics running into trouble with insurers, like Dendreon (NASDAQ: DNDN).

CEO Clay Siegall had to see all the questions coming about price, and naturally, this was a main theme the folks at CNBC asked him about when he appeared on the financial TV network this morning. Still, Siegall looked a little bit nervous when asked about how he can justify the high price of the new drug, but he has been consistent that the price is based on the value the drug is bringing to patients.

To catch Siegall’s CNBC appearance from this morning, check out the video below. And if you’ve got your own views on the price of this new product, please leave a comment on this story below, or send me a note at ltimmerman@xconomy.com

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Seattle Genetics is now in position to start selling its first new drug, and it won’t be cheap.

The Bothell, WA-based biotech company (NASDAQ: SGEN), fresh off its FDA approval of brentuximab vedotin (Adcetris) on Friday, said it will charge $13,500 per dose for the new drug for Hodgkin’s lymphoma and a related disease, anaplastic large cell lymphoma. The product is given as an intravenous infusion every three weeks.

Seattle Genetics says it doesn’t know how many doses patients will get in real world use, but if you assume an average of eight doses, it will cost $108,000 per patient. The average patient in clinical trials got 7 to 9 doses, CEO Clay Siegall said today on a conference call with analysts. If that’s how much patients will actually use, then Seattle Genetics’ price is in line with Wall Street expectations, which were about $110,000 per patient, according to a survey of five analysts Xconomy conducted last week. But the actual cost could be a lot higher. If a patient gets the maximum number of 16 doses described in the FDA-approved label, it will cost $216,000 per patient.

Seattle Genetics said it expects “some reimbursement issues” during the early days of the new product’s introduction, but that it based the price on extensive conversations with doctors, patients, and insurers.

“This drug has a superb value to patients,” Siegall told analysts.

In clinical trials, the Seattle Genetics product was able to significantly shrink tumors in about 75 percent of patients with Hodgkin’s disease, and in about 86 percent of patients with anaplastic large cell lymphoma (ALCL). The drug’s side effects include a depletion of infection-fighting white blood cells, nerve damage in the fingers and toes, fatigue, nausea, and other adverse events. The drug prompted about one-third of Hodgkin’s patients and one-half of ALCL patients to go into complete remission in clinical trials, but researchers still don’t know how much longer patients can expect to live on the new treatment, compared with existing chemo regimens.

Seattle Genetics, like all makers of expensive new cancer medicines, said it has set up a financial assistance program for people who are uninsured, underinsured, or who need help with making co-pays.

Cambridge, MA-based Millennium: The Takeda Oncology Company has the rights to market the product in the European Union, and it has sought approval from regulators there as well. Seattle Genetics didn’t comment on today’s call about what kind of price the product might fetch overseas.

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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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Seattle Genetics’ big day has arrived, as it has won FDA clearance to start selling its first new drug on the U.S. market after 14 years in business.

The company has received FDA clearance to start marketing brentuximab vedotin (Adcetris) as a new treatment for U.S. patients with a pair of rare lymphomas—Hodgkin’s disease and anaplastic large-cell lymphoma. The drug was given approval under the faster-than-usual six-month review cycle the FDA sometimes grants to potentially lifesaving therapies, and the official word came a little bit faster than the agency’s legal review deadline of Aug. 30. The regulatory action was really no surprise, since Seattle Genetics won a 10-0 approval recommendation from an FDA advisory panel last month.

“Early clinical data suggest that patients who received Adcetris for Hodgkin lymphoma and systemic anaplastic lymphoma experienced a significant response to the therapy,” said Richard Pazdur, the director of the FDA’s cancer drug review office, in a statement.

The FDA approval is the biggest moment in the history of Seattle Genetics (NASDAQ: SGEN), a company that was founded in 1997 and has run up a deficit of more than $546 million to get to this point, according to its most recent quarterly report.

The company’s new drug represents a significant step ahead for both the science of antibody drug development, and for patients with these two lymphomas. The drug combines the targeting capability of a genetically engineered antibody with an attached toxin that gives the antibody much more potent tumor-killing punch. This sort of “empowered antibody” approach has been pursued by scientists for more than three decades, but Seattle Genetics is only now in position to create what could be the first commercial hit from this class.

Clay Siegall

The drug showed startling effectiveness in clinical trials, providing significant tumor shrinkage in 75 percent of patients with relapsed forms of Hodgkin’s disease in a clinical trial, and in about 86 percent of patients with anaplastic large-cell lymphoma. Researchers are still following patients to see how long those responses really do last, and to what extent they may help people live longer. The most common side effects found in clinical trials were a depletion in infection-fighting white blood cells, nerve damage in the fingers and toes, fatigue, nausea, and anemia, among other effects, according to today’s statement from the FDA.

Seattle Genetics issued a brief statement today after the FDA announcement. “Bringing a new product to the market is a significant milestone for Seattle Genetics in fulfilling its mission to improve the lives of people with cancer,” said Clay Siegall, the company’s co-founder and CEO.

The company didn’t discuss one of the key facts investors will want to know immediately about the new product—its price. Most analysts expect that the drug will end up costing more than $100,000 per patient, as it is given to patients in a series of intravenous infusions once every three weeks. Seattle Genetics said it plans to discuss more of its commercial plans on a conference call with investors at 8:30 am ET/5:30 am PT on Aug. 22.

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This was the week Seattle Genetics passed an important milestone on its way to bringing its first product to the U.S. market.

—Seattle Genetics (NASDAQ: SGEN) won unanimous endorsement from an FDA advisory panel for its new drug for rare lymphomas, brentuximab vedotin (Adcetris). The FDA’s committee of cancer drug experts voted 10-0 in favor of approving the drug for Hodgkin’s disease, and voted 10-0 again later in the day for its use against anaplastic large cell lymphoma. The stock traded down after the votes, however, partly because of some hostile comments from the panel, and from FDA’s Richard Pazdur, who said an ongoing study known as Aethera isn’t designed properly to confirm the benefit seen in prior trials. The FDA, which will make the final decision, has a deadline of August 30 to complete its review of the Seattle Genetics applications.

—Ken Stuart, the founder and president of Seattle Biomedical Research Institute, sat down for an extensive interview for a profile that ran here yesterday. Stuart’s life journey is a fascinating one. Growing up in a working class home in Boston, he wasn’t sure he was even college material in his senior year of high school. He got hooked on biology in college, and went on to build a mini-global health empire over 35 years at Seattle Biomed, which now has 365 employees and a $52 million annual budget.

—This week in the BioBeat column, I wrote about how people should stop obsessing about the next big biotech company to get acquired. A Reuters story featured Seattle-based Dendreon (NASDAQ: DNDN) and Seattle Genetics as a couple prime takeover candidates, and I took the occasion to point out that while this might benefit investment bankers and shareholders in the short term, it would hurt this region’s biotech cluster, just like other regions would be hurt if their leading companies were taken out.

—Lastly, we had a thought-provoking guest editorial from Thane Kreiner, who leads the Center for Science, Technology, and Society at Santa Clara University. Kreiner, the former CEO of Seattle-based Presage Biosciences, is urging investors to work on setting up a VC-style investment framework to tackle what he calls “stubborn social problems like food security, safe drinking water, or energy access.”

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Given what investment bankers did to the financial system just a couple years ago, it surprises me how many people still accept what they have to say at face value. But quite a few people in biotech are still lapping up all sorts of short-sighted, destructive advice from the financial powers that be.

The latest bit of wisdom passed down from Wall Street came in a Reuters story this past week. It speculated about 11 publicly traded biotech companies that various investment pros consider to be takeover candidates. These companies have the kind of novel drugs that Big Pharma needs to replenish its empty pipelines. If you’re a shareholder in one of these little companies, this sounds exciting. Just hold onto your shares a little while longer, or buy some now while you can, and wait a couple quarters for a suitor to pay a 30, 40, or 50 percent premium. Instant returns! That will make everybody happy, right?

What stories like this usually fail to mention is who really stands to gain, and who loses, in these deals. Investment bankers, C-level executives, lawyers, accountants, certain consultants—they all pocket big money. Bench scientists, lower-level management, and entire regional economies can get whacked as hundreds or thousands of people lose their jobs.

The so-called winners in these deals often end up with a pyrrhic victory. While the quarterly and annual financial reports of the acquiring company might look good for a while, they often are left with an organization that is too bloated to really do the innovative work of developing new drugs. What happens a year later? These same fee-seeking investment bankers start whispering in the ears of executives, and reporters, about the next crop of biotechs that need to be harvested to fill up Big Pharma’s empty hopper.

Don’t get me wrong, some acquisitions can work out well for everybody involved. This tends to be true with small, private, venture-backed biotech companies that are essentially built to create a single drug, or maybe two, with a small team that can be easily integrated. Recent examples that made sense were Daiichi Sankyo’s purchase of Berkeley, CA-based Plexxikon; Gilead Sciences’s buy of Seattle-based Calistoga Pharmaceuticals; and Amgen’s takeover of Woburn, MA-based Biovex. These were cases of little companies that needed the resources of a bigger enterprise to make the most of their drug candidates. They also were able to provide healthy returns to their venture backers. And because the little company didn’t have many employees, the acquirer had fewer integration headaches and didn’t need to make mass layoffs.

What’s more problematic is when the bankers aren’t satisfied with the puny fees they get from those $500 million to $1 billion acquisitions. So they start beating the drum for multi-billion dollar mega-mergers. These are the kind of deals that can generate monster fees, like the potential takeovers listed in the Reuters report. The target list includes Biogen Idec (NASDAQ: BIIB), Vertex Pharmaceuticals (NASDAQ: VRTX), Dendreon (NASDAQ: DNDN), Seattle Genetics (NASDAQ: SGEN), Exelixis (NASDAQ: EXEL), and Intermune (NASDAQ: ITMN), along with some smaller players.

Most in the financial crowd sees these companies as nothing more than any other liquid security, like a pork belly or a securitized mortgage. They don’t care … Next Page »

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Seattle Genetics batted a clean 2-for-2 today in its appearances in front of an FDA advisory committee.

The FDA’s Oncologic Drugs Advisory Committee voted 10-0 to recommend that Seattle Genetics’ brentuximab vedotin (Adcetris), be cleared for sale as a new treatment in the U.S. for anaplastic large cell lymphoma. That decisive vote came after a morning session in which the panel voted 10-0 in favor of the same drug for a related malignancy, Hodgkin’s lymphoma.

Both of these conditions are quite rare. About 8,500 patients in the U.S. get Hodgkin’s each year, and while about two-thirds get cured by standard chemotherapy, about one-third relapse. About 2,000 new cases of anaplastic large cell lymphoma are diagnosed each year, half get effectively treated with chemo, but once it recurs, patients are only expected to live a little more than three months, according to Barbara Pro, a researcher at Fox Chase Cancer Center in Philadelphia, who studied the Seattle Genetics drug in clinical trials.

The data for the Seattle Genetics drug in this group of patients was striking. The drug completely or partially shrank tumors in 86 percent of the patients studied in a mid-stage trial (50 of 58). Most of the patients (57 percent) went into complete remissions, with no sign of their tumors anywhere on imaging scans. The complete remissions lasted for a median time of 13.2 months, before the tumors began to re-appear, Seattle Genetics said. The main side effect was peripheral neuropathy, a form of nerve damage in which patients feel numbness and tingling in their fingers and toes.

“This drug is wildly active in this rare population. The toxicity is concern, but not a dealbreaker for patients without other options,” said Mikkael Sekeres, an oncologist at the Cleveland Clinic, in explaining his vote at the afternoon hearing.

The FDA has a deadline of August 30 to complete its review of the Seattle Genetics application to start marketing the drug for patients with Hodgkin’s and anaplastic large cell lymphoma. If approved, the new therapy will be Seattle Genetics’ first marketed product after 14 years in business, and it would be in position to be the first commercially successful version of an “empowered antibody” that specifically zeroes in on tumors, mostly spares healthy tissues, and unleashes a potent toxin against tumors.

Trading in Seattle Genetics stock (NASDAQ: SGEN) was halted today during the FDA panel’s deliberations, and is expected to resume tomorrow.

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Seattle Genetics (NASDAQ: SGEN) passed its first big test with an FDA advisory panel today with flying colors. An FDA panel of cancer drug experts recommended in a 10-0 vote that the company’s drug for Hodgkin’s lymphoma should be cleared for sale in the U.S.

The vote came this morning by the FDA’s Oncologic Drugs Advisory Committee, which gathered in Silver Spring, MD to review the safety and effectiveness of brentuximab vedotin (Adcetris). The panel is also meeting later today to discuss another use of the drug for another rare disease, anaplastic large cell lymphoma.

The FDA isn’t required to follow the advice of its advisory panels, but it usually does. The agency’s deadline to complete its review of the Seattle Genetics drug is August 30. But there was no real debate about the drug’s safety and effectiveness profile. A study of 102 patients showed that 75 percent had complete or partial tumor shrinkage, which lasted a median time of 6.7 months, even after patients failed all prior rounds of therapy.

About 8,500 patients get Hodgkin’s disease each year in the U.S. and about two-thirds are cured with standard chemotherapies, but the rest eventually relapse.

“Brentuximab works and it works well. People with Hodgkin’s lymphoma will have another option for treating a terrible disease,” said Mikkael Sekeres, an oncologist at the Cleveland Clinic, in explaining his vote at the public hearing.

Wyndham Wilson, the chairman of the panel and a cancer researcher at the National Cancer Institute, added that “this drug has extremely exciting activity.” Even the often critical head of the FDA’s cancer drug officer, Richard Pazdur, said “we think this is an active drug and would like to see it out and available for the American public.”

Questions at the panel centered on issues like what further trials will be necessary to confirm the benefit of the drug, which patient populations it is most appropriate for, and its long-term safety profile. The most common adverse event was peripheral neuropathy, a form of nerve damage in the fingers and toes, which researchers said could be managed by reducing the dose.

If the FDA approves the drug for sale, it will be Seattle Genetics’ first marketed product after 14 years in business and more than $500 million of investment. It will also have a chance to be the first commercially successful version of an “empowered antibody” which combines the targeting ability of an antibody with a toxin to give it extra tumor-killing punch.

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This week, all eyes in Seattle biotech are on Seattle Genetics. If you don’t know why, here’s a chance to catch up. If nothing else, this will provide plenty of fodder for conversation at today’s WBBA Summer Social, which I plan to attend this afternoon.

—Seattle Genetics (NASDAQ: SGEN) is making its case today in front of an FDA advisory panel that’s reviewing the company’s lead drug candidate, brentuximab vedotin (Adcetris). If the FDA ends up clearing this drug for sale in the U.S., it will not only be Seattle Genetics’ first marketable product after 14 years in business, it also has a chance to be a trailblazer in a new category of therapy, as the world’s first commercially viable “smart bomb” for cancer. The FDA staff review, in documents posted online Thursday, was benign to say the least. I plan to listen to the proceedings via webcast, and report on the FDA panel’s vote and commentary later today.

—Seattle-based Allozyne is seeking to go public through the backdoor route, a reverse merger with a shell of a public company—Poniard Pharmaceuticals (NASDAQ: PARD). CEO Meenu Chhabra talked about all the steps that she’s taking to generate interest in Allozyne on Wall Street, and how this is different from the traditional IPO route.

—Not all the news this week from Seattle Genetics was of the happy variety. Zishen Fan, the brother of a former Seattle Genetics employee, pleaded guilty to federal charges that he traded on inside information about the company in order to pocket more than $700,000 in profits. Fan could face as much as 20 years in prison, according to a statement from the U.S. Attorney’s Office for Western Washington.

—The Fred Hutchinson Cancer Research Center said this week it has secured a $20 million grant from the National Institutes of Health to investigate a new HIV prevention strategy, along with collaborators at the University of Washington, and Richmond, CA-based Sangamo Biosciences (NASDAQ: SGMO), among others.

—The biotech industry today is facing lots of problems, and one them is a lack of guts. That’s the position I took in this week’s BioBeat column. So far, I can say the response has been overwhelmingly positive to this column—apparently biotechies still have thick skins, which I consider a good thing.

—Fate Therapeutics, the San Diego-based company that was co-founded by University of Washington stem cell researcher Randy Moon, disclosed that it has cut back on its small-molecule discovery work and laid off a handful of employees, to concentrate on developing biotech drugs. John Mendlein, the executive chairman, explained the moves in this Xconomy exclusive report.

—Lastly, we had a couple of guest editorials of interest to the local life sciences scene. Stewart Parker, now the CEO of the Infectious Disease Research Institute, offered up some insights into what she saw during her time as a commercialization consultant at the WBBA. And Melinda Moree, the CEO of BIO Ventures for Global Health, provided a fascinating case study on how biotech and global health organizations can work together in really productive ways.

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Zishen Fan, of Chino Hills, CA, pleaded guilty today in U.S. District Court in Seattle to charges that he traded on insider information on Seattle Genetics (NASDAQ: SGEN) in 2010, according to a statement from the U.S. Attorney’s Office for Western Washington. Fan’s brother, Zizhong “James” Fan, now deceased, was at the time a manager of clinical programming at Seattle Genetics, and was accused by securities regulators of providing tips to Zishen that enabled the brothers to make more than $700,000 on the nonpublic information, officials said. Zishen Fan could face up to 20 years in prison when he faces sentencing on Oct. 7.

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