Amylin Makes Move in Obesity Drug Race

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San Diego's Amylin Pharmaceuticals announced a deal this week with Japan-based Takeda Pharmaceuticals to develop and market experimental obesity drugs, making it the third San Diego-based biotech to make big news this year with potential weight loss therapies.

The deal calls for Amylin to get $75 million upfront, plus milestone payments based on whether the drugs make it through clinical trials and achieve certain revenues, according to Xconomy. It also gives the company a boost in its effort to keep up with San Diego-based Arena Pharmaceuticals and Orexigen Therapeutics, both of which are in late-stage clinical trials with their obesity drugs.

Here is what Xconomy had to say about the deal:

Amylin is betting it has found a way to breathe new life into one of the most overhyped biotech drugs of the 1990s -- Amgen’s leptin -- by packaging it in combination with its own pramlintide drug for diabetes. While the Amylin drug needs to be taken by injection and its rivals are oral pills, it has shown some strong promise that it can help people shed pounds in clinical trials, and the market has big potential. About two-thirds of people in the U.S. are considered overweight or obese, according to estimates from the Centers for Disease Control and Prevention.

This is an important year for both Amylin and Arena. Arena has had a bumpy ride with its obesity drug lorcaserin.

-- DAVID WASHBURN

Thursday, November 5 -- 7:09 pm

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Algae Guru Heading to UCSD

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Stephen Mayfield, a world-renowned researcher who studies the use of algae as a biofuel, is leaving his post as the dean of graduate studies at The Scripps Research Institute for a faculty job at the University of California, San Diego.

Mayfield, who is also a co-founder of locally based biofuel company Sapphire Energy, will join a dream team of biofuels experts at UCSD. It includes Steve Kay, who is dean of UCSD's Division of Biological Sciences; Steve Briggs, who was recruited from the San Diego biotech Diversa; as well as Susan Golden and James Golden from Texas A&M University.

Mayfield and Kay have worked together for year, co-founding the San Diego Center for Algae Biotechnology.

"Together with our colleagues at UCSD’s Scripps Institution of Oceanography, we have assembled one of the world’s leading centers for algae biotechnology research," Mayfield said in a UCSD news release. "I am very much looking forward to working with this team to make algae biofuels a reality."

In January, I reported on Mayfield's work, and the algae boom in general. And one of our top stories today by contributing writer Jonathan Parkinson examines jatropha, another plant that has received a lot of attention as a potential biofuel.

-- DAVID WASHBURN

Tuesday, November 3 -- 1:09 pm

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Ligand Buys Metabasis

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Metabasis, the San Diego-based biotech that created a run on the bank among its laid-off employees in May, has was recently purchased by Ligand Pharmaceuticals, another San Diego company.

Ligand was able to purchase Metabasis for just $3.2 million, according to the industry website FierceBiotech. In addition to the purchase price, Ligand agreed to spend $8 million to develop drugs in the Metabasis pipeline.

The deal comes less than two months after Metabasis CEO Mark Erion announced he was jumping ship for a job with pharma giant Merck.

In July we chronicled the Metabasis debacle, which included a mad scramble among employees to cash their last paychecks after senior management told them in May that they were laid off and the company didn't have enough money in the bank to pay them.

-- DAVID WASHBURN

Tuesday, November 3 -- 1:09 pm

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San Diego Researchers Win Stem Cell Grants

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Three San Diego-based research teams garnered a total of $55.6 million from the California stem cell institute today. The San Diego awards were among 14 totaling $230 million that the institute handed out statewide.

Here is a rundown of the local awards:

• A team led by University of California, San Diego researcher Dennis Carson was given $20 million for the use of stem cells in leukemia research. The UCSD team is partnering with a team for the University of Toronto.



• A team led by Emmanuel Baetge, chief scientist at San Diego-based Novocell, was awarded $20 million for research into using stem cells for diabetes research. Baetge is partnering with a team from the University of California, San Francisco.



• A team of Salk Institute for Biological Studies researchers were given $15.6 million for stem cell research focused on Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease. The Salk researchers will partner with UCSD and the locally based Ludwig Institute for Cancer Research.

-- DAVID WASHBURN

Wednesday, October 28 -- 7:24 pm

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Was Amylin's Drug Unethically Boosted Down Under?

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Xconomy has an item about a brewing controversy in Australia that revolves around San Diego-based Amylin's diabetes drug Byetta.

Reportedly, a study co-sponsored by Eli Lilly & Co., which partners with Amylin on Byetta, asserts that drugs in the same class as Byetta will do more to improve the health of diabetes patients than exercise.

A story in the Australia's national newspaper, The Australian, reports on concerns that the study is part of a marketing effort to win public subsidies for Byetta.

From the Xconomy post:

Although the study mentioned exenatide, the generic name for Byetta, only in a footnote, it asserted that drugs in the same class as exenatide could produce greater health improvements for diabetic patients than exercise or existing drugs. And that seems to have sparked a bit of a controversy Down Under.

The newspaper reports that some experts were concerned that the report was part of a marketing push to win public subsidies for the medication. Australia’s Public Benefits Scheme recommended the drug for inclusion last year, but the federal government has yet to respond. This means exenatide is available only on private prescription at a relatively high cost. Consequently, it is not widely used.

NATSEM defended the integrity of the research, saying the projected increase in type 2 diabetes was a legitimate concern.

-- DAVID WASHBURN

Tuesday, October 27 -- 7:16 pm

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Spotlight On: Sangart

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In 1971, with the Vietnam War still raging, the U.S. Army was intent on developing a blood substitute that could be used on battlefield casualties. The Army's goal was one of the primary reasons it established the Letterman Army Institute of Research in San Francisco.

The Army researchers working there tried for decades, but never produced a viable blood substitute. They couldn’t develop a safe product that replicates all the things our blood does for us, from coagulation to immune response.

While the institute was de-activated in 1995, Robert Winslow, a top researcher there, remained convinced that a product could at least perform one vital blood function -- the delivery of oxygen to trauma victims' organs and tissue.

Winslow dedicated his career to the effort, going so far as to climb Mount Everest to study the effects of oxygen deprivation on the body. In 1998, Winslow founded San Diego-based Sangart. The company subsequently developed the molecule MP4OX, which in clinical trials has shown the ability to deliver oxygen directly to capillaries without the side effects -- particularly high blood pressure -- that haunted previous blood substitutes.

If MP4OX gains approval for widespread use, Sangart CEO Brian O'Callaghan claims it will save thousands of lives annually. MP4OX could potentially take the place of blood transfusions in certain circumstances and allow paramedics to more quickly re-oxygenate trauma patients.

Winslow did not live to see his discovery come to full fruition -- he died in February at the age of 67 from complications of an inoperable brain tumor. But O'Callaghan said the world could soon reap the benefits of Winslow's work. MP4OX is now in clinical trials in Europe and the United States, with U.S. Food and Drug Administration approval possible within five years.

"His legacy lives through MP4," O'Callaghan said.

This is the first in an occasional look at potentially life-changing products being developed in the world of San Diego science and technology. Do you know of such a product? If so, shoot me an e-mail: david.washburn@voiceofsandiego.org

-- DAVID WASHBURN

Monday, October 26 -- 6:01 pm

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Update on H.M.'s Brain

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While reporting on my story about the Whole Brain Catalog, I had occasion to catch up with Jacopo Annese, the University of California, San Diego neuroanatomist who runs the Brain Observatory.

He told me that the much anticipated slicing of H.M.'s brain is scheduled to commence on Dec. 2, the first anniversary of the famous amnesiac's death.

If you recall from my story in December, Annese took possession of H.M.'s brain shortly after his death. H.M., who now can be identified as Henry Molaison, suffered a debilitating loss of short-term memory after undergoing experimental brain surgery in the 1950s. He became the most widely-studied brain patient in history.

Annese's plan is to slice H.M.'s brain into 3,000 fraction-of-a-millimeter thin sections that can be placed on oversized microscope slides and scanned into a computer. He and his colleagues will then construct the first ever three-dimensional, high-resolution digital map of a complete human brain, and make it available online.

Annese said everything is proceeding according to plan. Several MRI's have been taken of the famous cerebrum, and Annese and his colleagues have even done some practice runs on other brains in preparation of the big event.

"We've done the dress rehearsals to make sure everything is working well," Annese said.

-- DAVID WASHBURN

Friday, October 23 -- 1:47 pm

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Trying to Answer Venture Capital's Questions

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It seems inevitable that when the powers that be are faced with a crisis, or want money directed in a certain way, they form a task force.

The realities of San Diego's venture capital industry capture both of these scenarios at once: There is a crisis in the local innovation economy because money is not being invested venture capital funds. This is an issue we've covered extensively n reporting on both the dearth of traditional venture funding and new ideas for raising seed money for start-ups.

The task force is now at hand, Xconomy's Bruce Bigelow is reporting today. Organized by Connect chief Duane Roth and industry titan David Hale, the group is being led by David Titus, the managing director of locally based Winward Ventures. It will also include folks from Biocom, CommNexus, Cleantech San Diego, the San Diego Venture Group, San Diego Software Industry Council, and the San Diego Regional Economic Development Corporation.

Here are some things Titus had to say to Bigelow:

Titus says Windward raised its last venture fund in 2000, and the firm made its last new investment from that fund in 2007. Since then, Titus says, "We're managing our [existing] portfolio of companies -- like many others." And for at least the past two years, Windward has been unable to raise a new fund from pension funds, college endowments, and other institutional investors. As Titus put it, "The meltdown in the public equity markets and the global economy has really shut that door tight."

The situation, which was only compounded by the credit crisis that began last year, has created a void in funding for San Diego's early stage startups that was not immediately apparent -- largely because out-of-town venture firms continued to invest heavily in many of San Diego's mid- to later-stage startup companies.

With venture capital continuing to flow into the region, some San Diego business leaders questioned whether there was really a dearth of venture capital in San Diego, or even much need for San Diego-based VCs. Their argument, basically, is "if you build it, they will come." That is, if San Diego's early stage startups have truly innovative technology, then venture capital will come from far and wide to invest in it.

Titus doesn't see it that way. "I can only speak personally," he says, "but when you're talking about early stage companies, they don't get done by out-of-town venture capital firms. They just don't."

-- DAVID WASHBURN

Wednesday, October 21 -- 12:32 pm

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Another Guilty Plea in SPAWAR Bribery Case

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Kelly Alexander, a former SPAWAR official charged with participating in a bribery scheme centered at the agency, pleaded guilty Monday to wire fraud and filing false tax returns, the Union-Tribune reported today.

Alexander faces a maximum of 23 years in prison, and is scheduled to be sentenced on Feb. 8.

She is the third person to plead guilty in the decade-long scheme that was allegedly masterminded by her husband and high-ranking SPAWAR official Gary Alexander. The Alexanders steered nearly $5 million in military contracts to National City-based Technical Logistics Corp. in exchange for kickbacks totaling hundreds of thousands of dollars, according to federal prosecutors.

Technical Logistics owners Elizabeth Ramos and Louis Williams pleaded guilty in August and are cooperating with prosecutors in exchange for lesser punishment. We published a detailed account of the case in August that chronicled the alleged scheme from its beginnings in the late 1990s.

-- DAVID WASHBURN

Tuesday, October 20 -- 6:35 pm

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iPhone Apps for Biologists

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I just ran across an item on the Scientist.com site (requires free registration) that gives a rundown of 10 must-have iPhone apps for scientists.

The apps include a 3D protein structure viewer, an iTunes for scientific papers and one called The Chemical Touch that is essentially a souped-up mobile periodic table. Most of the apps are free, and the research paper app, at $9.99, is the priciest.

-- DAVID WASHBURN

Tuesday, October 20 -- 4:46 pm

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New Deals & Data

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Biocom’s Terri Somers is out with another issue of Deals & Data, the periodic rundown of the haps in the biotech world.

Among them are the liquidation of La Jolla Pharmaceuticals, which went out of business this year, and the patent infringement battle raging between San Diego biotech titans Illumina and Life Technologies.

I’m going to be looking into this suit in the coming days, so if you are following it feel free to e-mail me at: david.washburn@voiceofsandiego.org.

-- DAVID WASHBURN

Tuesday, October 20 -- 4:31 pm

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Update on Race for Obesity Drug

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The New York Times’ Andrew Pollack weighed in over the weekend on the race among three biotechs n two from San Diego -- to be the first to market with a safe and effective obesity drug.

As has been well-chronicled in our pages, locally based Arena Pharmaceuticals and Orexigen Therapeutics are tantalizingly close to applying for U.S. Food and Drug Administration approval for their drugs, lorcaserin and Contrave, respectively.

But the ride hasn’t been without its bumps, especially for Arena, which has been criticized for overhyping its clinical trial results. And I got the sense from Pollack’s story that both Arena and Orexigen are lagging behind Bay Area-based Vivus, at least when it comes to trial results. But questions surround that drug as well:

Vivus’s drug, Qnexa, provided the greatest weight loss, which is why that company’s stock is up 90 percent this year, more than that of the other two companies. But Qnexa’s ingredients may raise the biggest safety questions, although the clinical trials did not detect major problems.

--DAVID WASHBURN

Monday, October 19 -- 2:18 pm

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Does Tech Rate at City Hall?

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Over the past generation, the high technology and biotechnology industries have become pillars of the local economy. All told, the industries employ more than 100,000 and have a multi-billion dollar impact on the region.

But does their influence on policymakers at City Hall match their impact on the economy?

Tech and biotech leaders have at times during the city’s history wielded significant influence locally. In fact, the biotech cluster on the Sorrento Mesa exists because 50 years ago leaders of the fledgling industry pushed for zoning changes.

And in 2008, the industry successfully fought off an attempt by residential builders to rezone swaths of Sorrento Valley land from industrial to residential.

Yet in recent years the proposals for big public projects that have gained the most traction are those geared toward the so-called "old San Diego" industries of tourism and development -- things like convention centers and stadiums.

And there is a sense among many that the tech community could do more to push its agenda downtown, and downtown policymakers could do more to recognize the needs of tech industries when drawing up big public projects.

What do you think? Shoot me an e-mail at david.washburn@voiceofsandiego.org. Or a tweet at: twitter.com/davidwash.

-- DAVID WASHBURN

Friday, October 16 -- 4:27 pm

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Dissident Amylin Shareholder Cashes Out

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After spending half the year fighting to remake the board of San Diego-based Amylin Pharmaceuticals, dissident shareholder Eastbourne Capital has unloaded all of its shares, according to this Securities and Exchange Commission filing.

Eastbourne, along with Carl Icahn, spent much of the year waging a proxy battle against the Amylin board under the pretext that a series of bad decisions by the board had caused the company's stock to plummet.

In the end, Eastbourne and Icahn, who together had an ownership stake in Amylin of around 20 percent, were able to get two of their nominated directors on the board.

Eastbourne did not disclose what price it sold its stake for, but the stock has been hovering near its 52-week high of $15.90 in recent weeks. Shares in the company have traded as low as $5.50 over the past year.

A hat tip to Xconomy for news of the sale.

-- DAVID WASHBURN

Monday, October 12 -- 6:41 pm

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Sequenom Fires Top Brass After Investigation

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San Diego-based Sequenom Inc. today forced out its CEO and three other executives, including its research and development chief executive, after an in-house investigation into the mishandling of test results for its potentially breakthrough blood test for Down syndrome, the Associated Press is reporting.

The company, according to the AP story, fired CEO Harry Stylli, and Elizabeth Dragon, senior vice president for research and development. Sequenom's chief financial officer Paul Hawran and an unnamed executive resigned on Friday. Three lower-level employees were also fired.

The news caused shares of the company to plunge 44 percent -- from $5.69 to $3.21 -- in after hours trading Monday. Shares have been as high as $29.14 during the past year.

From the AP story:

"While each of these officers and employees has denied wrongdoing, the special committee's investigation has raised serious concerns, resulting in a loss of confidence by the independent members of the company's board of directors in the personnel involved," the company said in a statement.

The company did not say that any deliberate wrongdoing was discovered, but in a filing with the Securities and Exchange Commission, it said it did not put adequate protocols and controls in place. Some employees were not adequately supervised, it said.

Sequenom acknowledged on April 29 that employees had mishandled trial data on the test, which, because it is far less invasive than amniocentesis, could revolutionize how pregnant women are tested for the presence of Down syndrome in their babies.

As we chronicled in May, stock analysts and other industry watchers were shocked not only with the news that data had been mishandled, but also with the way the company managed the fallout. Since Sequenom's April admission, several class action lawsuits have been filed against the company on behalf of shareholders.

-- DAVID WASHBURN

Monday, September 28 -- 3:03 pm

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Salk Goes Digital

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If, after reading my story today on the biotech industry's aversion to social media, you are looking for a science organization that has embraced the new media landscape, look no further than the granddaddy of them all.

Salk Institute for Biological Studies has launched PolioToday.org, a site dedicated to sufferers of post-polio syndrome. The site includes videos, resource links and a real-time forum for former polio patients who have the syndrome, which is characterized by extreme fatigue and limb weakness.

Salk spokesman Mauricio Minotta said traffic on the site, which has not been written about in the mainstream media, has come largely via the institute's Twitter account and Facebook page.

"We are attracting an audience to our page that already has a built-in interest in our work," Minotta said.

The cause is of course near and dear to the institute, which was founded in 1960 by Dr. Jonas Salk, who developed the first safe and effective polio vaccine.

-- DAVID WASHBURN

Thursday, September 24 -- 11:16 am

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'Herd It' Goes Live

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Back in April I wrote about "Herd It," a next-level music search engine developed by University of California, San Diego professor Gert Lanckriet and doctoral students Luke Barrington and Damien O'Malley.

As a quick refresher, here is an excerpt:

For years now, computer-based song aggregators like Pandora and Last.fm have allowed people to compile playlists based on song names or artists. But Barrington's computer at the California Institute for Telecommunications and Information Technology takes things to a new level.

The "black box," as Barrington's professor Gert Lanckriet calls it, can listen to a song and decide, for example, whether it is a romantic song or a dance song. It can figure out what genre it falls into, and know what instruments are being played. And it puts the student/professor team at the forefront of the burgeoning field of machine listening. ...

They came up with what is best-described as a word/song association game in which players assign words to describe the songs they hear. Players score points based on how similar their answers are to those of other players. The scientists launched the game, called Herd It, on Facebook this week. The goal is to collect about 1 million word/song associations.

At the time I wrote the story, the game was still in its alpha launch phase while the guys worked out the bugs. Play time is over.

Today marks the official launch of "Herd It." So give it a whirl and let me know how it goes: david.washburn@voiceofsandiego.org.

-- DAVID WASHBURN

Thursday, September 24 -- 10:14 am

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Swine Flu Good For (Some) SD Biz

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At least five San Diego companies have seen their share prices jump since the World Health Organization declared in June that swine flu infection had reached pandemic levels, according to this Xconomy story.

The story gives a detailed rundown of the local companies benefitting from the outbreak. They include biotechs big and small, with products ranging from flu test kits to possible vaccines to a microbial germ killer.

Some local researchers, as we've reported, have also garnered extra attention thanks to the virus.

-- DAVID WASHBURN

Date: 9/22/09

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Panetta: Analysts Are Over-Analyzing Arena Results

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Wall Street's reaction Friday to Arena Pharmaceuticals' latest release of clinical trial data on its obesity drug lorcaserin wasn't as bad the last time it released data on the drug. But it wasn't exactly great either.

Biocom CEO Joe Panetta says the Street doesn't get it.

The stock closed up 5.5 percent following the release, which showed that lorcaserin met one of two weight-loss benchmarks set by the U.S. Food and Drug Administration regarding obesity drugs. The data was for the most part identical to data Arena released in March on the drug. Then, the stock dropped 28 percent on the news.

Word on Wall Street in March was that Arena CEO Jack Lief overhyped the results, which were good, but not great. Just more than 47 percent of patients taking the pill lost 5 percent or more of their body weight compared to 25 percent of patients who were on a placebo. Word now is that the data is still good, but not great, and FDA approval might be difficult.

"This data is just not that strong," said John McCamant, editor of the Bay-Area based Medical Technology Stock Letter.

Panetta said McCamant and other analysts are over-analyzing.

"This is a different kind of a product -- this isn't about the difference between 4 percent weight reduction and 5 percent," Panetta said. "It’s the degree to which it will help people move toward a goal. It is a very different product than others in that regard."

-- DAVID WASHBURN

Date: 9/18/09

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Arena Releases Data, Stock on Rollercoaster Ride

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San Diego-based Arena Pharmaceuticals this morning released the much-anticipated clinical trial data on its obesity drug lorcaserin. The data was basically the same than data in a smaller study it released earlier this year. But that didn't stop its stock price from going on a wild ride.

Data from the 4,008-person study showed the drug meeting one of two weight-loss benchmarks established by the U.S. Food and Drug Administration. Just more than 47 percent of patients taking the pill lost 5 percent or more of their body weight compared to 25 percent of patients who were on a placebo. That meets the FDA benchmark that requires weight loss among patients taking an obesity drug to be approximately double that of a placebo.

That was the good news. The bad news is that the drug didn't meet a second FDA benchmark. Patients' average weight loss after one year was 5.9 percent, which was 3.1 percentage points more than patients taking a placebo. The FDA benchmark requires at least a 5 percent difference between the drug and the placebo. The agency requires one of those two benchmarks to be met before it will consider approving the drug.

Company officials said this morning that they will submit lorcaserin for FDA approval in December.

The results were very similar to the results of the company's study in March, which caused its share price to drop precipitously and analysts to accuse Arena CEO Jack Lief of overhyping lorcaserin.

Arena's stock price shot up from $4.91 to over $6 in after-hours trading Thursday as the market anticipated the results. Shares slid back this morning and are now trading at $5.53, 12.6 percent higher than yesterday's close.

Arena is among three companies currently vying for FDA approval for new weight loss drugs. The others are La Jolla-based Orexigen Therapeutics and Bay Area-based Vivus. Stock in Orexigen, which in July posted trial results for its obesity drug Contrave that were similar to Arena's results, is down 1 percent. Shares in Vivus, which last week posted trial results for its drug, Qnexa, that were better than both lorcaserin's and Contrave's, are up nearly 8 percent.

Expect an update later after I make calls to analysts and try to get in touch with Lief. Meanwhile, you can check out this Bloomberg story for more details on the release.

-- DAVID WASHBURN

Friday, September 18 -- 11:53 am

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