Wednesday, November 30, 2011

Affymetrix to buy eBioscience for $330M

Affymetrix Inc. said Wednesday it signed an agreement to acquire eBioscience Inc.
Santa Clara-based Affymetrix (NASDAQ:AFFX) said the purchase price is $330 million in cash, subject to certain customary adjustments. Affymetrix makes products and services related to genetic analysis for the life science research and clinical health care markets.
San Diego-based eBioscience is a private company specializing in flow cytometry and immunoassay reagents for immunology and oncology research and diagnostics. EBioscience is expected to have 2011 sales of more than $70 million.

Tuesday, November 29, 2011

FDA accepts Onyx application for multiple myeloma drug

Federal regulators accepted Onyx Pharmaceuticals Inc.’s application for approval of the South San Francisco company’s multiple myeloma drug.
It is an important step in the approval process for carfilzomib, which Onyx (NASDAQ: ONXX) obtained in its November 2009 acquisition of Proteolix Inc. Onyx in late September completed its application to the Food and Drug Administration.

Monday, November 28, 2011

FDA clears $60M BioMarin drug-making plant expansion

BioMarin Pharmaceutical Inc.’s expanded manufacturing plant in Novato won approval from the Food and Drug Administration.
BioMarin (NASDAQ: BMRN) completed construction of the 21,800-square-foot “clean room” addition last year. It invested $60 million to expand the facility to about 70,000 square feet, including about 40,000 square feet of clean room space.
When production is up and running in the new space, a company spokesman said, BioMarin will have more than 100 new employees. Some of those new hires may already be on board, he said.

Report: Cancer drug developer Onyx looking at sale, other options

Onyx Pharmaceuticals Inc. is looking at options, including a possible sale, as it awaits an FDA decision on its multiple myeloma treatment carfilzomib, according to Bloomberg.
The stock price of the South San Francisco company (NASDAQ: ONXX) was up $5.62, or nearly 15 percent, to $43.46 in late-afternoon trading.

Exelixis, National Cancer Institute strike R&D deal around cabozantinib

The National Cancer Institute will study Exelixis Inc.’s experimental cancer-fighting drug cabozantinib in a variety of solid tumors, according to a research and development deal announced Monday.
South San Francisco-based Exelixis (NASDAQ: EXEL) and the NCI’s Cancer Therapy Evaluation Program will undertake clinical trials to evaluate the safety and efficacy of the drug, known as “cabo,” in several cancers. Earlier studies found “encouraging anti-tumor activity,” according to Exelixis.

Gilead wins European approval of HIV combo treatment

Gilead Sciences Inc. won European approval of a once-a-day tablet for HIV patients.
The drug, Eviplera, combines Gilead-developed Truvada — which itself is a combination of emtricitabine and tenofovir — and Tibotec Pharmaceuticals’ Edurant.
European approval allows the drug to be marketed in all 27 European Union countries to fight HIV-1 infection in adults with 100,000 copies or less per milliliter of blood and who have not previously been treated with antiretroviral drugs.

Genentech, Galena to combine breast cancer therapies in mid-stage trial

Genentech Inc. and Galena Biopharma will work together in a mid-stage trial of Galena’s breast cancer therapy NeuVax in combination with South San Francisco-based Genentech’s Herceptin.
Financial terms of the deal, which includes The Henry M. Jackson Foundation for the Advancement of Military Medicine, were not disclosed.

Saturday, November 26, 2011

Kaiser's next operation: Mission Bay

Kaiser Permanente is in contract to acquire a piece of land just southwest of Mission Bay and plans to build a roughly 200,000-square-foot medical office building there as part of a mixed-use development.
In addition to the medical office building, Walden Development, which owns four parcels along 16th and 17th streets, is seeking approval of 200 units of housing on a portion of the land. Under the proposed scenario, the site — now occupied by the office moving and storage company Corovan — would be divided into two parcels, with the Kaiser building on one portion and the residential project next door.

Jennerex advances cancer-killing vaccine

Jennerex Biotherapeutics Inc. has a trick up its sleeve to defeat cancer.
Using an altered version of the smallpox vaccine to deliver a hefty dose of the drug into a cancer cell, tiny Jennerex has vaulted to a lead position in the busy field of oncolytic viruses. In the space of a few months, the San Francisco company has shown that its drug, JX-594, is replicating inside cancer cells and that a protein slipped into the drug sets off an immune system response to those cells.
What’s more, the company said this month, a mid-stage trial showed that high doses of JX-594 more than doubled life expectancy for liver cancer patients, compared with patients given a low dose of the drug.

InSite envisions two drugs before FDA next year

InSite Vision Inc. is hoping for double vision.
The Hayward company, reduced last year to eight employees from a 2008 height of 55, enrolled the first patients in a rare two-for-one late-stage trial in an eyelid inflammation disease that could send two drugs in front of federal regulators within a year.

The birth of biotech

A reception for the launch of a book about Genentech’s early days attracted a technology and finance Who’s Who of the time — guys who ended up with their names on the door like David Morganthaler (Morganthaler Ventures) and Tom Perkins (Kleiner Perkins Caufield & Byers).
There were also Roberto Crea and Herb Heyneker, among Genentech’s first scientists. But there were notable absences, too: founders Herb Boyer, the former UCSF scientist whose work laid the platform, and the late Bob Swanson, the out-of-work VC who saw its potential. Boyer was suffering from a severe sinus infection. Swanson’s memory was well served by his widow, Judy Swanson.

Wednesday, November 23, 2011

One-on-One with Jim Knighton of AvidBiotics

AvidBiotics Corp. started work in human therapeutics several years ago, but it’s really taken a liking to food.
Just in time for the holidays, researchers at Harvard Medical School’s Brigham and Women’s Hospital and AvidBiotics said Monday that the South San Francisco-based company’s Avidocin proteins could prevent and treat E. coli-related diarrhea and intestinal inflammation in animals.
If the Thanksgiving table conversation turns staid, you can find the results of the study in the December issue of the journal Antimicrobial Agents and Chemotherapy.
I spoke with Jim Knighton, co-founder and president of the “nine-people-and-a-dog” company, about the company’s food safety program, a key partnership and the new study.

FDA approves Transcept middle-of-the-night sleep drug Intermezzo

Transcept Pharmaceuticals Inc.’s middle-of-the-night sleep drug won approval Wednesday from the Food and Drug Administration.
Now it is up to Purdue Pharmaceuticals, the partner of Richmond-based Transcept (NASDAQ: TSPT), to say if it will commercialize the lozenge, called Intermezzo. Purdue has until Dec. 8 to notify Transcept of its decision.

Tuesday, November 22, 2011

University of the Pacific snags SoMa building for $47M for dentistry school, other programs

University of the Pacific has closed its $47 million purchase of the former Wells Fargo office building at 155 Fifth St. and will establish a new San Francisco campus in the city’s South of Market district.
The 395,000-square-foot building will undergo a comprehensive $104 million renovation and is expected to open in mid-2014.
Five floors of the building will house the university’s Arthur A. Dugoni School of Dentistry, as well as classroom space for other university programs.

Lawrence Berkeley National Lab delays selection of 2nd campus to 2012

Lawrence Berkeley National Laboratory has pushed back the date when it expects to announce its selection for a proposed second campus to early 2012.
The lab, controlled by the University of California, had previously said the announcement would come by the end of November of this year.

Monday, November 21, 2011

Exelixis' cabo targets breast cancer in mid-stage trial

A mid-stage trial of Exelixis Inc.’s experimental drug cabozantinib in women with breast cancer that has spread to the bone has started at the Massachusetts General Hospital Cancer Center.
South San Francisco-based Exelixis (NASDAQ: EXEL) said the main point of the 50-patient trial is to see if cabozantinib has an affect on the bone cancers. Women will receive the drug once a day and be evaluated every 12 weeks until the drug’s toxicity proves unacceptable or the cancer progresses.

Impax sued over potential generic cancer pain drug

On the cusp of major legislation for generic drug makers, Impax Laboratories said Monday that it is being sued over its generic version of Cephalon Inc.’s cancer pain drug Fentora.
Hayward-based Impax (NASDAQ: IPXL) said Teva Pharmaceuticals-owned Cephalon and CIMA Labs Inc. filed the patent infringement suit — standard operating procedure in the generic drug world — on Friday in U.S. District Court in Delaware.

Going it alone, Portola raises $89M to work on blood thinner, antidote

Jilted by Merck & Co. earlier this year, Portola Pharmaceuticals Inc. said Monday that it will take its blood-thinning agent betrixaban into a Phase III trial on its own, thanks in large part to an $89 million preferred stock deal.
South San Francisco-based Portola also said the cash will be used to advance a companion antidote that reverses blood thinning for patients on so-called Factor Xa inhibitors, like betrixiban, who require surgery for major bleeds.
Portola plans to begin the Phase III trial of betrixiban in the first half of 2012.

Gilead to buy hepatitis C drug developer Pharmasset for $11 billion

Gilead Sciences Inc. will buy hepatitis C drug developer Pharmasset Inc. in a cash deal valued at about $11 billion that Gilead officials said is a “strong strategic fit.”
The $137-per-share offer from Foster City-based Gilead (NASDAQ: GILD) represents an 89 percent premium from Pharmasset’s (NASDAQ: VRUS) closing price on Friday. The deal, approved by Pharmasset’s board, is expected to close in the first quarter.

Friday, November 18, 2011

One-on-One with Dan Adelman, chief medical officer of celiac disease drug developer Alvine Pharmaceuticals

A gluten-free diet is great for celiac disease patients, but even the strictest adherents to dietary restrictions can experience flare ups or chronic symptoms.
That’s where Alvine Pharmaceuticals Inc. comes in with a drug that could make a huge impact. The San Carlos company earlier this month reported results of a Phase IIa trial that showed that its drug, ALV-003, could make a difference in helping patients with gluten-limiting celiac disease. It is the first mid-stage study to get positive results in modulating the immune system’s response to the storage protein.
The 15-employee company is backed by Sofinnova Ventures, InterWest Partners, Prospect Venture Partners, Flagship Ventures, Black River Asset Management and Panorama Capital.

FDA revokes Avastin OK for breast cancer

The Food and Drug Administration revoked approval for Genentech Inc.'s breast cancer drug Avastin, the agency said Friday.
In a statement, FDA Commissioner Margaret Hamburg said she is revoking the agency's approval of Avastin, also known as bevacizumab, after concluding the drug was not safe and effective in combatting metastatic breast cancer.
Avastin will remain on the market for types of colon, lung, kidney and brain cancer.

The risks of eliminating drug risks

Metabolex Inc. closed three big diabetes drug deals last year, lining up millions of dollars in upfront cash and potential milestone payments.
But now, even as the number of U.S. diabetics skyrockets beyond 20 million, the privately held Hayward biotech company wants little to do with the disease.
Instead, it is focusing on arthritis-like gout, with a patient population of about 6 million.
“Gout is viewed well by investors,” Metabolex President and CEO Harold Van Wart said. “There’s a large unmet medical need, and Phase III trials are manageable.”
Therein lies the rub: As the Food and Drug Administration weighs the benefits and risks of drugs — especially in areas like diabetes, cardiovascular and obesity — it is asking companies to undertake extraordinary, some say excessive, additional clinical trials to prove that the drugs are safe. As a result, drug developers and their venture capital backers are abandoning those diseases — or biotech — altogether.

Orphan drug backers seek rule changes

Emil Kakkis is a man on a mission to speed the way drugs get to people with rare diseases.
The former chief medical officer at BioMarin Pharmaceutical Inc. — one of the trailblazing companies of the so-called “orphan drug” industry — is leading efforts in Washington, D.C., to rewrite how those drugs are judged by the Food and Drug Administration. Why use a statistics-intensive process set up for diseases with millions of patients, Kakkis’ thinking goes, to divine the safety and effectiveness of the rarest of the rare diseases?
Changing the process to rely on markers in mid-stage trials rather than historical data, he said, will translate into less risk, more investment, more jobs and more treatments to patients faster.

Tiny Quanticel seeks big cancer impact

Steve Kaldor believes in “personalized medicine,” depending on your definition.
If it involves the idea of delivering customized treatment to individual patients, Kaldor is skeptical of the economics. But his Quanticel Pharmaceuticals Inc., a young San Francisco company emerging with backing from Versant Ventures and a $45 million deal with Celgene Inc., is readying a technology that at least could narrow the odds for cancer patients.
Spun out of the work of Stanford University scientists Stephen Quake and Michael Clarke, Quanticel’s technology allows researchers to analyze in “exquisite detail” individual cells from tumor samples, Kaldor said. That could give unique insight into how to target cancer-fighting drugs as well as speed up clinical trials and identify novel new drugs.

Thursday, November 17, 2011

Tom Perkins to government: Get out of the VC business

Vaunted venture capitalist Tom Perkins wants government out of his business.
Citing the Department of Energy’s $535 million loan guarantee to bankrupt solar panel manufacturer Solyndra Inc. of Fremont and plans for more of what he called government-led venture capital, Perkins predicted every Solyndra-like government investment would fail.
“It will all fail. Every one will fail,” Perkins said at a reception launching a new book about the early days of biotech giant Genentech Inc., which Kleiner Perkins Caufield and Byers initially financed in 1976 with a $100,000 investment.

Genentech's early days offer lesson for today's biotechs

We don’t do book reviews at the San Francisco Business Times — but at the risk of my email inbox flooding with requests, I must say that I found Sally Smith Hughes’ new book about the early days of biotech powerhouse Genentech fascinating.
Much of the story has been heard before — your typical boy-meets-technology story — ending up with scientist Herb Boyer and venture capitalist Bob Swanson hooking up to form the South San Francisco company that largely created a new industry and changed the face of drug development.
But there’s an underlying (unintentional?) message in the way Hughes, a historican of science at the University of California, Berkeley’s Bancroft Library, presents the story in the aptly named “Genentech: The Beginnings of Biotech.” It’s all about balance.

One-on-One with Deborah Bellush of Biotech Partners

Sometimes longevity says more than anything. Take Biotech Partners, the East Bay program started 19 years ago to steer at-risk high school students into Bay Area life sciences jobs.
But Biotech Partners is getting some important recognition as well. It was one of eight programs recognized recently with the Innovations in Life Sciences prize, sponsored by the Howard Hughes Medical Institute and backed by the Carnegie Foundation. The prize is designed to recognize programs that promote life sciences partnerships between scientists and science educators at middle schools and high schools.
The award is part of Ashoka Changemakers’ emphasis on so-called STEM — science, technology, engineering and math — education. It comes at a time when Bay Area educators and companies are pushing for more attention to STEM to provide a next-generation workforce for high-tech, biotech and cleantech jobs.
Biotech Partners, started as part of an agreement between Bayer HealthCare and the City of Berkeley, will receive $10,000.
I spoke with Deborah Bellush, the executive director of Biotech Partners, shortly after the nonprofit announced Wednesday that it had won the award.

Tuesday, November 15, 2011

Former Genentech CEO Art Levinson named chairman of Apple

Computer and popular electronics company Apple Inc. made Arthur Levinson non-executive chairman of its board of directors on Tuesday.
Cupertino-based Apple (NASDAQ: AAPL) also added Robert Iger, president and CEO of Walt Disney Co. (NYSE: DIS) to its board.
Levinson, who is chairman of South San Francisco-based Genentech and was its CEO in the past, has been on Apple’s board since 2000. Tim Cook, Apple’s CEO, said Levinson is the company’s “longest serving co-lead director.”

Monday, November 14, 2011

What Geron's stem cells exit means. (It ain't good)

Geron Corp.’s dismantling of its stem cell research on Monday puts the pressure on companies trying to discover or develop drugs by tapping into the cells that make us what we are.
Geron may have been trying to do too much too soon, but the real issue is that human embryonic stem cell drug development clearly was costing too much money for a publicly held company (NASDAQ: GERN).
That’s a shame in many ways. After all, Menlo Park-based Geron was in stem cells before stem cells were cool from a commercial point of view — not that they are more hip now. By being one of the first to harness embryonic stem cells as a potential treatment, it blazed a trail, enduring a Food and Drug Administration hold on its trial in acute spinal cord injuries.

Stem cell pioneer Geron to focus on cancer, cut 66 jobs

Pioneering stem cell drug developer Geron Corp. said it will axe 66 jobs, halt its stem cell R&D programs and seek buyers for those assets.
The Menlo Park company (NASDAQ: GERN) said it will concentrate on cancer treatments that could produce milestone events over the next 20 months. While researchers stress the promise of stem cells, treatments using embryonic stem cells could be several years in the future.

Friday, November 11, 2011

Mendel Biotechnology raises $11.8M toward $36M target

Mendel Biotechnology Inc., a Hayward company manipulating plant genes for the bio-agriculture and bioenergy fields, has raised $11.8 million, according to a Securities and Exchange Commission filing.
In all, Mendel is aiming to raise $36 million. It did not say how the money would be used.

Hospitals in line for Vascular Designs catheter as cancer treatment

A new type of catheter developed by a San Jose company to treat cancer patients is making its way into operating rooms.
The IsoFlow Infusion Catheter, developed by Vascular Designs Inc., is now being used to treat liver cancer patients at the University of California, Davis Medical Center. CEO Robert Goldman said he also has a “bunch of other hospitals about to come on line,” though he couldn’t disclose details.

Hansen Medical robot used to treat peripheral vascular disease

Hansen Medical Inc. said Friday it has clinically used its branded Magellan Robotic System for the first time to treat peripheral vascular disease, or a when blood vessels narrow and harden, often in the legs.
The condition affects more than 27 million people worldwide, with diabetes, hypertension, atherosclerosis and obesity being contributing factors.

Executive Profile: Bill Lis of Portola Pharmaceuticals

Bill Lis joined Portola Pharmaceuticals in 2008, became chief operating officer in August 2009 and was named CEO in May 2010. A Philadelphia native, Lis previously worked at Scios, COR Therapeutics/Millennium Pharmaceuticals, Rhone-Poulenc Rorer and Ethicon Endo-Surgery. He is one of many former COR employees, including several key scientists, to join Portola. The company last month struck a potential $553 million deal with Biogen Idec around so-called Syk inhibitors that play key roles in autoimmune and inflammatory diseases.

Thursday, November 10, 2011

Ekso Bionics makes big strides forward

Ekso Bionics is giving people with spinal cord injuries something that medical intervention and surgeries can’t — the ability to walk.
Hikers, military pilots and spinal cord patients have all benefited from Ekso Bionics’ weight-bearing frame, which supplements a person’s bone structure. Engineers at the Robotics and Engineering Lab at the University of California, Berkeley, first built the mechanical exoskeleton in 2005.

Wednesday, November 9, 2011

Xoma, partner Servier to expand eye disease trial

Xoma Ltd. and French drug partner Les Laboratoires Servier will broaden their late-stage clinical program to include patients diagnosed with a group of non-infectious eye maladies.
The Phase III trial of XOMA-052, also known as gevokizumab, had focused on Behcet’s uveitis, an eye disease that affects about 7,500 patients in the United States. By including several eye diseases categorized as non-infectious uveitis, including Behcet’s, the potential number of patients is increased to more than 150,000, the Berkeley-based company (NASDAQ: XOMA) said.

New president of Impax generic drug unit to make $470K

The new president of Impax Laboratories Inc.’s generic drug business will be paid a base salary of $470,000, plus a one-time $75,000 hiring bonus, and work out of company offices in suburban Philadelphia.
Carole Ben-Maimon, who the Hayward-based company (NASDAQ: IPXL) said in September it had hired to run its global pharmaceuticals division, also can participate in Impax’s management bonus program and received an option to buy 75,000 shares of common stock and 24,000 shares of restricted stock, according to a Securities and Exchange Commission filing Wednesday.

Tuesday, November 8, 2011

Dynavax raises $64M in stock sale, chairman buys 160,000 shares

Dynavax Technologies Corp. raised a net of $64.5 million in a stock sale in which its chairman, Arnold Oronsky, bought 160,000 shares.
Berkeley-based Dynavax (NASDAQ: DVAX) sold 27.6 million shares in the offering, including 3.6 million sold by the underwriters — Cowen and Co. and William Blair & Co. — to cover overallotments. They bought the shares from Dynavax at $2.35 each and sold them to the public at $2.50 each.

Thursday, November 3, 2011

Medivation shares soar on positive prostate cancer trial

Medivation Inc.’s late-stage prostate cancer drug showed in a study that it could help the sickest patients live a median 4.8 months longer, the company said Thursday.
The announcement, coming 1-1/2 years after its high-profile Alzheimer’s disease drug Dimebon flopped in a Phase III trial, sent shares of the San Francisco-based drug developer (NASDAQ: MDVN) sharply higher in pre-market trading Thursday. The stock, which closed Wednesday at $16.53, climbed 121 percent to $36.60.

Tuesday, November 1, 2011

Exelixis zooms past off-ramp on way to prostate cancer destination

Driving through Utah several years ago, my wife proclaimed as I missed an exit which we had planned miles back to take, “What were you thinking?”
My reply — “I wasn’t” — was all I could say.
Investors in South San Francisco-based biotech drug developer Exelixis Inc. (NASDAQ: EXEL) seemed to be asking my wife’s question. The stock lost nearly 40 percent of its value from Monday’s close to late Tuesday, trading down $3.05 to $4.68 per share.
The downturn came after Exelixis said late Monday that it would push forward on a Phase III trial of its heralded cancer-fighting medicine, cabozantinib, that focuses on relieving bone pain in men with advanced prostate cancer. These are the sickest of the sick — men whose cancerous lesions have spread to the bone and are causing excruciating pain.