Kevin Sharer will not go down in history as one of biotech’s most successful, or beloved, CEOs. But how well did Sharer really perform during his decade running the industry’s biggest company?

For those who missed it, Thousand Oaks, CA-based Amgen (NASDAQ: AMGN) said last week that Sharer, 63, will be retiring as CEO in May. In a move that didn’t surprise anybody, he will be succeeded by one of his deputies, Robert Bradway, the company’s president and chief operating officer.

Since becoming CEO in 2000, Sharer has lived through the ups and downs that go with the territory in this most volatile of industries. He graced the cover of Forbes magazine in January 2005 for leading the “Company of the Year,” getting credit for revitalizing a long stalled R&D engine. Two years later, Sharer was the industry goat, as Amgen lost $29 billion of its stock market value when safety concerns cast a cloud over its cornerstone products for the treatment of anemia. At various times, Sharer has been slammed in the press for being one of the nation’s most overpaid CEOs, raking in $21.2 million in total compensation last year.

Amgen’s official statement last week noted that the company had $3.6 billion in revenue when Sharer became CEO, and now has revenues approaching $16 billion. Vance Coffman, the chairman of the board’s nominating and governance committee said in the statement that during Sharer’s time, “Amgen grew significantly in every dimension and is well positioned for the future.”

Still, shareholders had little to cheer about the past decade under Sharer. Investors have gotten by with a 0.5 percent annual stock growth during his tenure, according to Bloomberg News. Even after giving in to shareholder demands to boost the stock price via share buybacks, dividends, and cost-cutting, investors have assigned Amgen stock a price-to-earnings ratio of under 15—not exactly a ringing endorsement of wondrous go-go days to come.

Kevin Sharer

I’ve covered Amgen throughout Sharer’s tenure, and have interviewed him several times. While many executives in this industry come from geeky backgrounds in science or medicine, Sharer is a different kind of cat. A graduate of the U.S. Naval Academy, he got some of his formative experience working on nuclear submarines, and later in the telecom industry. He has the tall, upright bearing, silver hair, and poise that make him look like Hollywood’s idea of a Fortune 500 CEO. He also has a forceful voice that seems to contain no doubt, and sounds like it was born to bark orders and instill fear into subordinates.

Sharer seemed to relish the image of himself as a businessman with military discipline. He famously hung a picture of General Custer on his office wall, he has said, to remind himself of the dangers of overestimating his own abilities, and underestimating the enemy. Yet despite his serious and commanding demeanor, he could be charming: I remember him once calling me a few years ago on my cell phone with that piercing voice, “This is Kevin Sharer…” and I thought, “Oh boy, this could be nasty.” Instead, he wanted to let me know he liked something I had just written about Amgen, while also pointing to one line in the story he didn’t like. He ended by saying how he appreciated the interest and coverage of Amgen. Point taken, handled with class.

Evaluating anyone’s performance is an inherently subjective task, but to come away with a grade for how Sharer performed at Amgen, I’ve tried to look at how Sharer performed in some key areas that are important for leaders of all major biotech companies.

Here goes:

Company leadership: A great leader of a biotech company has to surround himself with stars from all kinds of disciplines—research, development, legal, lobbying, marketing, manufacturing. Amgen has long enjoyed a reputation for top-notch patent lawyering and political muscle, but one of Sharer’s most important early moves was hiring former University of Washington immunologist and Merck executive Roger Perlmutter to be his head of R&D. Perlmutter, who is stepping down in February, led a decade-long mission to improve R&D productivity at Amgen. He did have some success, although it will take a few more years to get a final verdict because of the long nature of product development cycles. But even more importantly, a great CEO has to pick a good successor. Bradway joined the company five years ago, has worked his way up from VP of operations, and will take over as CEO after a six-month transition process. Those are good signs that Sharer was smart enough to put an orderly succession plan in place. Most analysts are expecting no big strategic changes under Bradway. Grade: B+

New Product Development: Former Apple CEO Steve Jobs told his biographer that the company lost its way under CEO John Sculley because it focused too much on maximizing profits, and didn’t focus enough on first making amazing products. Sharer’s one big hit in the product development department was … Next Page »

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Word came out of Amgen last week that it was looking to overhaul its R&D operations, and today the biotech giant confirmed the overhaul is translating into job cuts for 380 people across the company.

Thousand Oaks, CA-based Amgen (NASDAQ: AMGN) notified 380 employees internally today that their jobs are being eliminated as part of the company’s effort to improve focus and re-allocate R&D resources, according to company spokeswoman Mary Klem. Amgen isn’t closing any of its research sites around the world, but people are being laid off at its major U.S. R&D sites in Thousand Oaks, Seattle, San Francisco, and Boston, Klem says.

No sites are being closed, and Amgen isn’t eliminating any therapeutic areas from its research portfolio, she says. Amgen plans to discuss the cuts in some more detail next Monday on its quarterly financial conference call, she says.

“We will continue to invest significantly in R&D,” Klem says. But she added the company needs to shift resources around to support more expensive late-stage development projects. “We will continue to allocate resources in a focused manner,” she says.

Amgen generated about $15.1 billion in revenue last year, and spent what’s generally considered a healthy 19 percent proportion of that revenue ($2.9 billion) on R&D. The company is actively pushing the biggest new innovations from its internal pipeline in years—denosumab, marketed for osteoporosis patients as Prolia, and for cancer-related bone loss as Xgeva. The company has had as many as 20,000 employees in the past, but its latest worldwide headcount is down to about 17,000, according to a recent company fact sheet.

Amgen’s full-year profit was $5.02 billion in 2010, essentially flat compared to $5.01 billion the prior year. In the most recent quarterly report, Amgen said its profits declined about 3 percent compared with the same period a year ago.

Klem didn’t say how much the company expects to save by making the cutbacks.

Here’s the breakdown of job losses at each major Amgen site, according to Klem.

—Thousand Oaks, CA (226)

—Seattle/Bothell, WA (69)

—South San Francisco (37)

—Cambridge, and Woburn, MA (32)

—United Kingdom (the remainder, about 15)

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Amgen, the world’s largest biotechnology company, just sent a signal to its staff that cuts could be coming soon to its R&D operations.

Amgen (NASDAQ: AMGN) is based in Thousand Oaks, CA, and has R&D operations in Seattle, South San Francisco, and Cambridge, MA. News of potential cuts to Amgen’s R&D operations were reported earlier today by the Ventura County Star. Amgen isn’t yet saying specifically what it plans to do, but company spokeswoman Mary Klem confirmed that something’s up:

“As we discussed with our R&D staff today we are currently evaluating some changes within our Research & Development organization to improve focus and to re-allocate resources to key pipeline assets and activities.

“We will provide additional details on the Q3 earnings call on October 24.”

Klem didn’t provide any further comment on how the re-allocation of resources may affect individual Amgen sites in Seattle, San Francisco, or Boston. I’m checking with sources to see if I can get any more details.

Amgen generated about $15.1 billion in revenue last year, and spent what’s generally considered a healthy 19 percent proportion of that revenue ($2.9 billion) on R&D. The company is also actively pushing the biggest new innovations from its internal pipeline in years—denosumab, which is being marketed for osteoporosis patients as Prolia, and for cancer-related bone loss under the name Xgeva. The company has had as many as 20,000 employees in the past, but its latest worldwide headcount is down to about 17,000, according to a company fact sheet.

The company, under R&D chief Roger Perlmutter, has been making a decade-long push in cancer drug development, and it also has been seeking to seize some of the momentum in bone disorders through a “son of denosumab” program that I profiled earlier this year. I’ll be watching to see which programs stay, which get jettisoned, and how many people are affected in the end.

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Today marks a major milestone in Cambridge, MA-based Radius Health’s long quest to enter the multibillion-dollar osteoporosis market. The company announced that it has raised $91 million in a third financing round, which includes $66 million in equity. What’s more, upon the closing of the financing, Radius merged with an unlisted shell company (“MAC”), so that it can take on the status of an SEC-reporting company and apply to be listed on a national stock exchange. The financing will be used to complete pivotal Phase 3 clinical trials.

CEO C. Richard Lyttle says Radius was able to make a convincing case to investors that its treatment will break new ground in osteoporosis, the gradual loss of bone that affects many aging people, especially women. “Investors want to put money towards products with really good data behind them, and we had Phase 2 data showing this drug is able to build bone in women,” he says. “We believe we’ll be able to offer women a new agent to treat osteoporosis.”

Radius is developing a novel “anabolic,” or bone-building drug, called BA058, which is an analog of human parathyroid hormone-related protein. In early studies of the drug—which Radius is formulating both as an injection and a skin patch—patients have re-grown some bone, while facing little risk of hypercalcemia, or too much calcium in the blood, which can be a side effect of current treatments.

The treatment is so promising that Radius has had little trouble raising cash in what has been an extremely challenging fundraising environment for most life sciences companies. Prior to today’s financing, the company had raised $106 million in venture capital from an A-list group of investors including MPM Capital, BB Biotech Ventures, MPM Bio IV NVS Strategic Fund, the Wellcome Trust, HealthCare Ventures, and Scottish Widows Investment Partnership.

The new round includes those investors, along with newcomers BB Biotech, Brookside Capital, Saints Capital, Nordic Bioscience, and Ipsen Pharma. It also includes a commitment to a $25 million loan facility from GE Capital, Healthcare Financial Services, and Oxford Finance. Nordic will also manage the Phase 3 trials of BA058—a coup, says Harvey, because Nordic is a renowned leader in osteoporosis, having been involved in trials of Amgen’s (NASDAQ: AMGN) recently approved denosumab (Prolia) and other osteoporosis treatments.

No doubt those investors were attracted to what is becoming an incredibly rich market opportunity. The aging of the population has led to a rapid increase in osteoporosis around the world. According to a recent study by Global Industry Analysts of San Jose, the annual market for osteoporosis treatments will reach $8.8 billion by 2015, even though many of the most popular treatments are losing their patent protection and going generic. Radius’s CFO, Nick Harvey, points to a Cowen & Co. report estimating … Next Page »

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The financial crowd who follows Amgen may be talking all about dividends or techniques to boost the stock through share buybacks, but the medical and scientific world will be chirping today about an interesting new finding the company has made for treating osteoporosis.

Amgen (NASDAQ: AMGN), the Thousand Oaks, CA, biotech giant with R&D operations in Seattle, South San Francisco, and Cambridge, MA, said today an experimental drug met its goal of improving bone mineral density in a study of 400 postmenopausal women. Details are being saved for a medical meeting, but Amgen said its drug, AMG785, beat a placebo and two comparison drugs, after 12 months of follow-up. The rate of side effects was “generally balanced” between those patients on the new drug and those in the control groups, Amgen said.

The new treatment, being developed in collaboration with Belgium-based UCB, will now advance into the third and final stage of testing, Amgen said.

“Despite available osteoporosis therapies, there remains a significant need for additional treatment options that form new bone in women with postmenopausal osteoporosis,” said Roger Perlmutter, Amgen’s executive vice president of R&D, in a statement.

Amgen made the AMG785 announcement as its management team is meeting with analysts in New York to talk about the company’s long-term financial outlook. After years of prodding from shareholders, Amgen confirmed in a separate statement that it will introduce its first dividend for shareholders, starting next quarter.

While dividends are usually for old fuddy-duddy stocks for widows and orphans, Amgen has sought to hold onto some of the perception that it still has high growth potential. And Amgen has generated a lot of attention in the past year for its new bone treatment denosumab, which is now FDA-approved for treating osteoporosis and cancer-related bone fractures. The company projects that drug in its two marketed forms will generate $3 to $4 billion in sales by 2015.

But while denosumab works to stop the excessive breakdown of bone, the new drug, AMG785 is designed to work differently, so that the body can build up stronger, more dense bone material, as Amgen chief medical officer Sean Harper explained in an interview earlier this year. If the new drug passes the final stage of clinical trials, Amgen could be in position to capture a bigger share of the $9 billion-plus osteoporosis market as some older drugs turn generic. An estimated one out of five women over 50 in the U.S. have osteoporosis.

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The San Francisco Bay Area has a storied tradition as the birthplace and leading hub of biotechnology, but something curious has happened the past couple years. Most of the scientifically groundbreaking, medical-textbook rewriting, financially lucrative new biotech drugs of the 21st century are coming from somewhere else.

This dawned on me last week as I started thinking about the 20-year outlook for the Bay Area life sciences cluster, in advance of the Bay Area Life Sciences 2031 event I’m organizing in San Francisco on Wednesday evening. It forced me to think about the really innovative drugs that still have a chance to generate billions of dollars in revenue two decades from today, that will help people live longer and better lives, and that are blazing new scientific trails. I’m talking about drugs that are a scientific, clinical, and business trifecta—drugs like Gleevec, Avastin, Herceptin, and Enbrel.

Plenty of molecules in the hopper today have that kind of potential, but for the purposes of this subjective parlor game I wanted to focus on the ones that have generated proof through pivotal clinical trials, and have either recently won FDA approval or are clearly on the verge of approval. That makes for a pretty short list:

• Vertex Pharmaceuticals’ new drugs for hepatitis C and cystic fibrosis

• Human Genome Sciences’ treatment for lupus

• Dendreon’s immunotherapy for prostate cancer

• Seattle Genetics’ “empowered antibody” for rare lymphomas

• Amgen’s antibody for osteoporosis and cancer

• Plexxikon and Roche’s genetically tailored treatment for melanoma

• Genentech’s souped-up version of Herceptin for breast cancer

A couple of things jump out at me right away. Of these eight new molecules, two are coming from Boston, two are from Seattle, one is from Washington, D.C., one is from greater Los Angeles, and only the last two are from the San Francisco Bay Area. These products are important not just for shareholders, patients, and scientists, but also for their respective regions, because they stir up … Next Page »

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We’re starting to see a little—just a little—bit of life get injected into the IPO market for life sciences companies. Nothing much to get too excited about yet, but it’s worth monitoring.

—South San Francisco-based Fluidigm had an epic yarn of a story when it first IPO attempt was botched during the financial crisis of 2008. But the company, which makes microfluidic instruments for biological researchers, bounced back this week with a $75 million IPO, setting its initial price at $13.50 a share. Fluidigm (NASDAQ: FLDM) saw a modest 3.9 percent uptick in its shares on Day 1 as a public company, closing yesterday at $14.02.

—Palo Alto, CA-based Anacor Pharmaceuticals (NASDAQ: ANAC) said this week it formed a collaboration to discover and develop new drugs for acne along with Scottsdale, AZ-based Medicis Pharmaceutical (NYSE: MRX). Medicis knows a little something about the skin business, as the maker of the hit anti-wrinkle product marketed as Restylane.

—Steve Burrill, the man who wears many hats in the biotech industry, likes to say he’s “geographically agnostic” when it comes to seeking out hot new biotech companies. So it was interesting to hear the San Francisco-based banker talk this week about why he’s beating a trail to my hometown, Seattle, to keynote a local biotech confab for the second straight year.

—Geron (NASDAQ: GERN), the Menlo Park, CA-based developer of stem cell therapies, said this week its longtime CEO Thomas Okarma is stepping down and leaving the board of directors. David Greenwood, the chief financial officer, is stepping up to be president, interim CEO, and a member of the board.

—Biotech giant Amgen (NASDAQ: AMGN) captured a lot of attention the last couple years with its novel antibody for bone disorders, called denosumab, or ‘Dmab’ for short. What fewer people realize is that the company, which has R&D operations in South San Francisco, has a second antibody in the pipeline that works to strengthen bones in a different way than Dmab that has the bone research world abuzz.

—Fast/cheap gene sequencing is here and it is starting to transform the business models for molecular diagnostic companies, according to Rowan Chapman, a partner with Mohr Davidow Ventures. Like most any VC, she talked up her firm’s portfolio, pointing to Bay Area companies like Sequenta, Artemis Health, Tethys Bioscience, and Crescendo Bioscience as organizations that are taking advantage of advances in genomics, and biomarker analysis, to come up with new diagnostics that they hope the healthcare system will find to be a lot more valuable than diagnostics of the past.

—Before I jet on to the next story, there’s one last word about the IPO market. My San Diego colleague Bruce Bigelow chimed in with a report on the market from Ernst & Young. The consulting firm counted 57 IPOs in the final three months of last year, and counted 56 more in the queue. Like I said at the top, we’ll keep an eye out for signs of life—like whether more companies go out, and whether stock prices climb for the fortunate ones able to make it on the NASDAQ.

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We saw headlines from health IT firms and drug developers in New England this week.

—Cambridge, MA-based drug developer Stromedix is looking to kick off a mid-stage clinical trial of its lead drug, and has attracted some debt-based financing to cover the costs, Ryan wrote. CEO Michael Gilman says the firm has also gotten interest from potential pharmaceutical partners for the drug, STX-100, a treatment for the lung disorder idiopathic pulmonary fibrosis.

—Alexandra Drane, founder and president of Beverly, MA-based health IT firm Eliza, teamed up with Google chief health strategist Roni Zeiger to launch a website called Seduce Health for discussing hot health topics in a more provocative way. They’re looking to YouTube clips featuring high profile people in the healthcare field to help inspire people to make healthier decisions.

—Lebanon, NH-based stealth mode biotech startup Arsanis raised $9.6 million in equity-based funding, according to an SEC filing. The firm has Tillman Gerngross, CEO and co-founder of Lebanon-based antibody discovery firm Adimab, as a director and executive. The filing also lists Adimab backers from Polaris Venture Partners, SV Life Sciences, and OrbiMed Advisors as members of the Arsanis board of directors.

—Todd Park, the chief technology officer of the U.S. Department of Health and Human Services, took the stage as keynote speaker at our Xconomy Xchange on the future of health IT in Cambridge on Wednesday night. He also sat on a panel with other veteran health IT investors and execs.

—Luke took a look at the work Amgen (NASDAQ: AMGN), a Thousand Oaks, CA based firm with significant R&D operations in Cambridge, is doing on a drug follow up its hit antibody drug for bone disorders, denosumab. If the new treatment, AMG785, succeeds in clinical trials, Amgen could snap up a bigger share of the more than $9 billion osteoporosis market.

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Folks who follow Amgen closely know there’s really been one main theme to this story the past couple years—Dmab, Dmab, Dmab. Also know as denosumab, this is the targeted antibody drug Amgen developed for bone disorders that is supposed to be biggest thing to emerge from its internal R&D pipeline in about 20 years (although that’s not saying much because there were a lot of lean times).

The Thousand Oaks, CA-based company (NASDAQ: AMGN), which has significant R&D operations in South San Francisco, Seattle, and Cambridge, MA, won two coveted FDA approvals for denosumab last year—the drug is now sold under the name Prolia for osteoporosis, and as Xgeva to fight bone fractures in cancer patients. Combined sales could reach $2 billion in 2013, according to analyst Eun Yang of Jefferies & Co. That’s real money even to a company as huge as Amgen, with $15.1 billion in sales last year.

Still, there’s another side to the bone R&D story at Amgen that fewer people have noticed. Amgen has a drug that you might call the “son of Dmab” advancing through its clinical trial pipeline. It’s made to work in a completely different way than denosumab, and could offer physicians with a one-two punch against bone disorders. If clinical trials for this drug, AMG785, pan out this year, Amgen could be in position to grab an even greater share of the $9 billion-dollar-plus osteosporosis market as some of the old workhorse drugs turn generic.

“It’s appropriate to focus on Dmab because of the impact it will have on patients and the company in two big indications, but it has taken away focus from everything else we’re doing, and everything else we’re doing is very interesting,” says Amgen’s chief medical officer, Sean Harper. He adds: “Between dmab and this sclerostin program, we dominate the excitement in the bone field. To the key opinion leaders in the bone field, dmab is old hat for them. They are all focused on sclerostin.”

Sean Harper

It takes a little bit (not much, I promise) of science to understand what Harper is talking about with sclerostin, and why it matters.

First off, healthy people maintain a constant balance of what scientists call bone remodeling, in which bone is broken down and rebuilt in response to both injuries and normal wear and tear. Cells known as osteoclasts work to break down bone, while another kind of cell, osteoblasts, build up new bone. The two cell types have a yin-yang relationship, but when that cycle falls out of balance, it can lead to bone loss, Amgen scientist Bill Dougall explained in this October 2008 feature story.

Denosumab is designed to work by blocking a protein called RANK Ligand which activates the osteoclasts. So essentially, the drug works by preventing excessive breakdown of bone, and giving osteoblast cells enough breathing space to do their thing and build up bone.

But Amgen has long been interested in the other side of the equation—the osteoblasts themselves. That’s where the protein called sclerostin comes into the picture. Sclerostin works against … Next Page »

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Roger Perlmutter, the guy who runs R&D at the largest biotech company in the world, is an immunologist by training. So it shouldn’t be any surprise that he’s fascinated by recent advances in which scientists have shown they can harness the immune system to fight tumors. Now he’s acting on that emerging knowledge of cancer immunology in a big way, through Amgen’s potential $1 billion acquisition of Woburn, MA-based BioVex.

Thousand Oaks, CA-based Amgen (NASDAQ: AMGN), which has significant R&D centers in South San Francisco, Seattle, and Cambridge, MA, made headlines yesterday with its big bet on a novel cancer treatment in development at BioVex. Perlmutter, the executive vice president of R&D at Amgen, has his fingerprints all over this deal, since he’s been working to transform Amgen into a more aggressive developer of anti-tumor drugs over the past decade. I’ve known Perlmutter for almost the entire time he’s been at Amgen, so I was eager to hear his thoughts the day after the big BioVex deal was struck.

Scientists have been dreaming for decades about alternatives to traditional chemotherapy, radiation, or surgery—particularly those that can harness the body’s immune system to fight tumors as if they were a foreign invader like a virus. Most of these efforts went down in flames, until Seattle-based Dendreon (NASDAQ: DNDN) won FDA approval last year for the first treatment of this kind—which analysts say now has multi-billion dollar annual sales potential. One variation on this theme is through what BioVex and others have done, utilizing what are known as oncolytic viruses. These viruses are designed to specifically replicate inside tumors, causing them to burst, while also sending signals that alert the immune system to seek and destroy any residual cancer cells that might have been able to evade the virus.

Roger Perlmutter

Neither BioVex, nor anybody else, has proven that it can fight tumors well enough to win FDA approval, but Amgen’s bet is that BioVex will validate the oncolytic virus approach much like Dendreon proved cancer immunotherapy a year ago.

“I’ve looked at this field for a long time and found it to be rather discouraging,” Perlmutter said of oncolytic viruses. But over the last couple of years, after seeing what BioVex has done in clinical trials, Perlmutter says he was impressed by not just the company’s engineered virus, but the immune system effect it was able to trigger. “It seemed to me it was more and more likely they were seeing an effective immune response. It looked more and more promising.”

BioVex has been pursuing this challenge for a long time, having been founded in 1999 by Robert Coffin, a virologist from University College London. A dozen years later, Amgen snapped it up as BioVex was pushing its lead program, OncoVex GM-CSF, through the third and final stage of clinical trials normally required for FDA approval. The company is enrolling patients with both melanoma, a deadly form of skin cancer, and head and neck cancer.

The science is really interesting here, and Perlmutter was clearly happy to talk about what interested him (maybe he was bored with poring over spreadsheets on yesterday’s earnings call?).

Here’s the basic idea. The BioVex team has … Next Page »

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Top innovative news from 2010:

• Amgen’s 147 trial was the first study to ever show a delay in the onset of bone metastases in men with prostate cancer, for the denosumab (Xgeva) investigational clinical program. This result showed that you can prevent or delay skeletal metastases by making the bone microenvironment an inhospitable place for tumor cells to spread.

Trends we’ll be watching in 2011 and beyond:

• Research in cancer treatment will continue into the next decade with novel approaches for targeting tumor growth including treatments that aim to inhibit angiogenesis (the formation of new blood vessels required by many cancers to survive and grow).

• The study of growth hormones on tumor growth. Growth through regulation of the IGF-1R is an area of interest for many companies right now. IGF-1R plays an important role in the release of growth hormone, which can cause cancer cells to proliferate and grow. By blocking signals from reaching the IGF-1R, it may be possible to rein in the growth and spread of cancer cells.

• The expanded use of biomarker analysis in clinical settings using next-generation gene sequencing technology will help the understanding of clinical research and drug efficacy.

• Developing new treatments lies at the start of the journey to help patients. At the end of the road, regulatory environments in emerging markets will continue to evolve, paving the way for innovative therapies to reach more patients in new markets around the world.

[Editor's Note: This is part of a series of posts from Xconomists and other technology and life sciences leaders from around the U.S. who are weighing in with the top surprises they've seen in their respective fields in the past year, or the major things to watch for in 2011.]

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The year that was 2010 was another year on the rollercoaster. We had our ups and our downs. But throughout, we continued to be at the forefront of innovation. From mature companies to emerging technologies, 2010 was an exciting year. Here are BayBio’s top five stories for 2010.

1. Amgen secures approval for two new treatments in 2010. In June, the FDA approved denosumab (Prolia) for the treatment of postmenoposaul women with osteoporosis who are at high risk for fracture. And in November, the FDA approved the same drug under a different name (Xgeva) for a different use, as the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. The treatments were developed in South San Francisco and are another indication of the maturing market space for Northern California biotechnology companies.

2. Bay Area takes the lead on the next wave of sequencing technology. Menlo Park, CA-based Pacific Biosciences (NASDAQ: PACB) and Mountain View, CA-based Complete Genomics (NASDAQ: GNOM) were the first of next generation of sequencing companies to go public. Pacific Biosciences’s platform provides real-time analysis of biomolecules with single molecule resolution, enabling a deeper understanding of biological systems. Many believe this could lead to more affordable human genome sequencing. Complete Genomics enables researchers to conduct large-scale complete human genome studies.

3. Mission Bay becomes a magnet for BioPharma. Bayer HealthCare in May announced its U.S. Innovation Center to be located in Mission Bay. In addition, Nektar Therapeutics opened its new headquarters right next door. Then to add icing to the cake, Pfizer announced an $85 million partnership agreement with UCSF.

4. Amyris IPO paves way for fuel alternatives. In September, Emeryville, CA-based Amyris raised a modest $85 million in its initial public offering. With several competitive synthetic and alternative fuels emerging, Amyris’s offering represents the first steps to finding true alternatives to petroleum. We’ll have to wait and see what becomes of competitors like Solazyme, Codexis, and LS9, among others.

5. Stem cell treatments move closer to reality. Menlo Park, CA-based Geron (NASDAQ: GERN) began the first human trial in the U.S. with an embryonic stem cell treatment. The trial will attempt to repair a patient’s injured spinal cord. SanBio received FDA clearance in June for clinical testing of the company’s regenerative medicine for cerebral stroke.

[Editor's Note: This is part of a series of posts from Xconomists and other technology and life sciences leaders from around the U.S. who are weighing in with the top surprises they've seen in their respective fields in the past year, or the major things to watch for in 2011.]

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This was a short holiday week, and so we have an appropriately short biotech roundup.

—Seattle-based Dendreon (NASDAQ: DNDN) said last week that its top sales and marketing executive, Varun Nanda, left the company effectively immediately. Nanda was hired back in April to lead the market introduction of Dendreon’s first product, sipuleucel-T (Provenge), and stayed in that job less than a year.

—Nanda wasn’t the only executive departure we reported on in the past week. Light Sciences Oncology, the Bellevue, WA-based maker of a drug/device combo treatment for cancer, said its CEO, Llew Keltner, has left to take a job at another biotech company. A replacement hasn’t been named.

—Omeros (NASDAQ: OMER), the Seattle-based developer of neurological drugs, said this week it had completed its acquisition of drug discovery technology that it hopes will help it develop new therapies aimed at G-protein coupled receptors—some of the most lucrative targets in the pharmaceutical business today.

—Amgen (NASDAQ: AMGN), the biotech giant with operations in Seattle, said it won FDA clearance to start selling denosumab (Xgeva) as a to fight bone fractures in cancer patients. The drug was approved earlier this year as a treatment for osteoporosis, but this anti-cancer usage, long championed by Bill Dougall at Amgen Seattle, might be equally or even more lucrative, analysts say.

—Lastly, we had a national op-ed piece from Lisa Suennen of Psilos Group, who recently moderated an Xconomy Forum in San Diego. She takes on health IT data security in this post.

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Amgen (NASDAQ: AMGN), the world’s largest biotech company, said today it has won clearance from the FDA to start marketing denosumab (Xgeva) to reduce fractures in cancer patients with solid tumors that have spread to the bones. This is the second major approved use of the drug, which was first cleared in June as a treatment for osteoporosis. Xconomy described Amgen’s strategy for fighting cancer in the bones, and the role of Seattle-based scientist Bill Dougall, back in this story from October 2008.

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Amgen (NASDAQ: AMGN) and Abbott Laboratories (NYSE: ABT) took home a couple of the top prizes last night at the BayBio Pantheon Awards. Amgen received honors for the best therapeutic with denosumab (Prolia) for osteoporosis, while Abbott won for the outstanding medical device—a product called MitraClip that repairs leaky heart valves without requiring surgery, which it acquired from Menlo Park, CA-based Evalve. Other winners included Solazyme, the South San Francisco-based developer of biofuels; Pacific Biosciences, the DNA sequencing toolmaker in Menlo Park, CA; and Emeryville, CA-based cancer drug developer Onyx Pharmaceuticals (NASDAQ: ONXX), among others. The event drew a record-high 700 attendees, according to BayBio. For a complete list of the winners, click here.

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

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

Seven Drugs Discovered and Developed by Seattle Biotechs

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

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

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

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Quite a few Seattle biotechies are quietly gearing up for the always-important American Society of Clinical Oncology meeting from June 4 to 8 in Chicago. Combine that with a holiday weekend, and the local life sciences news was a little light for Xconomy Seattle.

—One of the big national headlines this week came when Amgen (NASDAQ: AMGN) won FDA approval, ahead of schedule, to start selling denosumab (Prolia) for women with osteoporosis. This is big news for the world’s largest biotech company. But it’s not the end of the story. The company is also vying for FDA approval to market the product for cancer-related bone loss, a quest that one of Amgen’s local scientists has been pursuing for about 15 years.

—SonoSite (NASDAQ: SONO), the Bothell, WA-based maker of portable ultrasound machines, made an important strategic move last week when it gobbled up Toronto-based Visualsonics. CEO Kevin Goodwin explained in detail what this new technology will mean for portable ultrasound, and how the company plans to use the new capabilities to crack open some new markets.

—Sometimes a startup is born after a couple old friends bump into each other after years of going their separate ways. That’s how Seattle Sensor Systems got an infusion of new vision and enthusiasm early this year, when Dendreon veteran Carole Spangler re-connected with UW researcher Clem Furlong on a portable technology for spotting pathogens.

—Genomics pioneer J. Craig Venter made international news a couple weeks ago when he engineered the first bacterial cell with an entirely synthetic genome. But he actually had a lot of help. One of the key players he relied on behind the scenes was a privately held company in Bothell, WA, called Blue Heron Biotechnology.

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Amgen (NASDAQ: AMGN) has received clearance from the U.S. FDA to start selling denosumab (Prolia) as a treatment for women with osteoporosis. The drug, an injection taken every six months, works to decrease the destruction of bone and increase bone mass and strength, according to an FDA statement. The drug was approved ahead of schedule, as the agency’s deadline to complete its review was July 25. Amgen is also seeking FDA approval of the new drug for cancer-related bone loss, another potentially big market that I described in detail back in an October 2008 feature.

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

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

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

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

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

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

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

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

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

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This week we were jamming on our big event on the 20-year outlook for Seattle’s life sciences hub, but we still found a way to squeeze in a lot of news and features.

—Biotech pioneer Chris Henney offered an insightful and entertaining talk about how to invest in biotech at a recent speech before the CFA Society of Seattle. I included his six tips on how to spot a winning biotech in last week’s roundup, but that piece didn’t include the sequel on the five red flags investors should watch out for. The In Vivo Blog did a fun follow up on this story, too.

—If Seattle wants to grow as a biotech hub over the next 20 years, it could use a few more bars, and less university red tape. That’s according to Stephen Friend, the Rosetta Inpharmatics founder who’s now trying to ignite an open source movement for biology, in comments he made at the Xconomy event Monday evening on the 20-year outlook for Seattle life sciences. I summed up some of the other great insights I heard from his fellow panelists Ben Shapiro and Steve Gillis, and also posted a big photo gallery here that captured the energy in the room.

—Kirkland, WA-based Pathway Medical Technologies is one of the big success stories of the past year in the local medical device community, but even it has had to endure a few lessons from the school of hard knocks. CEO Paul Buckman offered a candid look at how the company is adjusting to the new reality of the medical device business.

—Amgen (NASDAQ: AMGN), the giant biotech company with 900 employees in Seattle, said its experimental drug for osteoporosis, denosumab (Prolia), was delayed by FDA requests for more information. That didn’t seem like much of a big deal at first glance because the FDA didn’t ask for any new clinical trials, and it has been missing a lot of deadlines lately. But then Amgen said yesterday in its earnings release that the FDA is asking for more clinical trials to demonstrate safety of denosumab for cancer patients. Ouch.

—Sonosite, the Bothell, WA-based maker of portable ultrasound machines, got a lift this week when it settled all of its patent litigation with General Electric over ultrasound devices that weigh less than 10 pounds. Sonosite (NASDAQ: SONO) will get $21 million upfront and an undisclosed royalty on sales of GE’s portable ultrasound machines until 2016.

—Seattle-based Calistoga Pharmaceuticals released some preliminary, but encouraging, results over the weekend from a small leukemia trial. The company’s experimental drug was able to shrink tumors for 29 percent of patients in the trial, but based on some secondary findings, the company thinks it might be able to do much better than that in combination with other treatments, or with longer follow-up.

—San Diego-based Fate Therapeutics, the company co-founded by a group of top stem cell scientists that includes Randall Moon of the University of Washington, announced over the weekend that it has taken a big step toward “industrialized” production of stem cells for drug discovery. The advance for inducing adult cells into a pluripotent, stem-cell like state, came from the lab of Fate co-founder Sheng Ding, a professor at The Scripps Research Institute in San Diego.

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