Heartflow raises $65M in new funding round

Medical technology company Heartflow Inc. is raising $75 million, according to a Securities and Exchange Commission filing Friday.
The company has sold $65 million of the $75 million offering so far, the filing says.

Maya Medical raises $2.8M

Maya Medical Inc. raised $2.8 million, according to a regulatory filing with the U.S. Securities and Exchange Commission on Friday.
Founded in 2010, Maya is an early-stage firm developing a percutaneous catheter for treating hypertension.

Slideshow: Best Bay Area life sciences CEOs of 2011

It’s the most wonderful time of the year — slow news days that translate into “10 Best …” stories and other such lists summarizing the previous 12 months or predicting what’s going to happen during the next 12.
So, here’s my list of the best life sciences CEOs in the Bay Area. It’s a purely subjective undertaking, heavily weighted toward CEOs who managed through all or part of a year of adversity.

Industry view: Changes to business model come slowly to biotech

Entering the fifth year of a funding crisis, biotech’s business model is changing.
Slowly.
New sources of early-stage cash are stepping into the void left by fleeing venture capitalists. But whether those relatively small investments — or corporate venture capital, or grants from disease-specific foundations — are enough to build sustainable companies is an open question.
(San Francisco Business Times subscription required.)

Stanford, UCSF cancer researchers win grants

Two local pediatric cancer researchers, one each at Stanford University and UC San Francisco, have won $375,000 grants meant to “jumpstart” the careers of promising scientists.

Cytokinetics takes a swing at Lou Gehrig's disease

Cytokinetics Inc.’s 14-year history is marked by turns — out of cancer and into muscle programs — and a key heart failure drug partnership with biotech giant Amgen Inc. But the South San Francisco company (NASDAQ:CYTK) hasn’t yet taken a drug into the final of three phases of clinical trials, much less brought a drug to market.
Whether Cytokinetics reaches that ultimate goal could rest in the outcome of a mid-stage trials in a tough disease, amyotrophic lateral sclerosis — also known as Lou Gehrig’s disease. A strong showing would increase the chance of Cytokinetics finding a deep-pocketed partner to take the drug into Phase III trials.

Affymetrix acquisition of eBioscience hits delay

Affymetrix Inc.'s previously announced acquisition of San Diego-based eBioscience Inc. has been delayed, according to StreetInsider.com on Wednesday.
The deal was previously expected to close in the fourth quarter of 2011, but is now expected to wrap up in January 2012. The delay is due to additional work required to complete the merger's debt financing, StreetInsider reports.

Four Geron execs split more than $600K in cash bonuses

Geron Corp., which last month pulled out of the stem cell business, awarded four executives more than $600,000 in cash bonuses.

Gladstone, Bristol-Myers Squibb strike Alzheimer's research deal

The Gladstone Institutes will work with drug giant Bristol-Myers Squibb Co. in a basic research partnership to identify and validate Alzheimer’s disease targets.
Exact financial terms of the deal were not disclosed, but Bristol-Myers Squibb (NYSE: BMY) will fund Gladstone efforts to find targets that affect dysfunction of Tau, a protein that may help regulate the activity of brain cells.

BioMarin targets cancer as an orphan

BioMarin Pharmaceutical Inc. wants to do for cancer what it’s done for rare diseases.
After transforming the drug-development world with its focus on diseases with only a few thousand patients, BioMarin is using that same model to tackle cancer in subsets of patients. So instead of working on a drug aimed at the full population of ovarian cancer patients — many of whom won’t benefit from the treatment — it is zeroing in on a much smaller group with a specific genetic mutation.
“It turns cancer into an orphan disorder,” said BioMarin CEO Jean-Jacques Bienaime.
(San Francisco Business Times subscription required.)

Vivus takes heavy hit on obesity drug danger study

Vivus Inc. saw its shares plunge 15 percent Thursday after bad news about an ingredient in its Qnexa obesity drug, now under review by U.S. regulators.
Mountain View-based Vivus (NASDAQ: VVUS) tested topiramate, an ingredient in Qnexa, and found that babies born from moms taking the drug had a higher rate of cleft lip and cleft palate.

Exelixis reaps $12M up front in licensing deal with Merck

Merck & Co. will pay $12 million up front to license an anti-inflammatory drug program from Exelixis Inc. — a deal that ultimately could be worth up to $251 million.
The PI3K-delta program, led by the preclinical drug XL-499, targets transfer enzymes, known as kinases, that are expressed in immune system cells. When PI3K-delta is activated incorrectly, researchers believe, it contributes to inflammatory and allergic disorders, such as rheumatoid arthritis and allergic asthma.

Impax asks FDA for approval of Parkinson's drug

Impax Laboratories Inc., traditionally a maker of generic drugs, submitted an application for its new treatment for Parkinson’s disease symptoms.
The Hayward company (NASDAQ: IPXL) said Wednesday that its branded products unit made the application for IPX-066 to the Food and Drug Administration.

One-on-One with Transcept Pharma's Glenn Oclassen

It took two tries with federal regulators and a driving study in The Netherlands, but Transcept Pharmaceuticals Inc. is waking up plans for its middle-of-the-night sleep drug.
Transcept won’t be resting, though. In fact, 2012 is shaping up as an interesting year in terms of revenue growth (think royalties), hiring and acquisitions for the 18-employee company.
I talked to Transcept President and CEO Glenn Oclassen about Intermezzo, what the company gained and lost in the FDA approval process and its plans for next year.

Alexza explores sale, layoffs

Alexza Pharmaceuticals Inc. said late on Friday that it has hired Lazard Ltd. (NYSE:LAZ) to help it look into "strategic options that would enhance stockholder value." Lazard is a financial advisory and asset management company.
Strategic options could include "a possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions," according to a prepared statement released by Alexza.
The company has about 100 employees.

Burrill launches new life sciences fund, targets $500M by mid-2012

Burrill & Co. launched a life sciences fund — aiming at a $500 million goal by mid-2012 — to invest in a wide range of early- to late-stage companies.
Burrill Capital Fund IV LP initially aimed for $300 million in capital commitments, Steven Burrill, CEO of the San Francisco-based life sciences financial services firm, said in a press release. It launched at $313 million. Some $200 million in the fund is supplied by a Russian-owned corporation named Rusnano, according to MedCityNews.

ALS drug developer Neuraltus raises $9.6M toward $11M goal

Neuraltus Pharmaceuticals Inc., the Palo Alto developer of an experimental treatment for Lou Gehrig’s disease, has raised $9.6 million toward an $11.1 million offering, the company said Tuesday in a Securities and Exchange Commission filing.
Seven investors have ponied up for the round in the form of equity, option/warrants and preferred stock with warrants.

Ipsen to move North American HQ from Brisbane to New Jersey

Ipsen S.A. plans to move its Biomeasure Inc. unit’s headquarters from Brisbane to Bridgewater, N.J., by April.
The French drug company will also invest $45 million in a Biomeasure unit in Milford, Mass., focused on research and development.

InterMune to 'vigorously' fight German report on lung drug

InterMune Inc.’s drug to treat a deadly lung condition provides little benefit to patients, according to a German health organization.
The findings, published Thursday, could be a blow for Brisbane-based InterMune (NASDAQ: ITMN), which in February won approval in Europe for Esbriet as a treatment for the lung-scarring disease idiopathic pulmonary fibrosis. The company decided to launch Esbriet in Germany in the first half of 2012 and spread to other parts of the continent.
Saying it has “a number of important concerns” with the methodology used by the private Institute for Quality and Efficiency in Health Care, InterMune said it will “vigorously challenge” the assessment.

StemCells could gross $20M from offering of stock, warrants

StemCells Inc. could raise up to $20 million by selling 8 million units and an additional 8 million warrants at $1.25 per unit, the Newark company said Friday.
StemCells (NASDAQ: STEM), which is undertaking a Phase I/II study of its neural stem cells in patients with chronic spinal injuries, said Thursday that intended to make the public offering.

Plexxikon, Roche melanoma drug moves closer to European OK

A European drug review panel recommended that the melanoma treatment Zelboraf, developed by Berkeley-based Plexxikon Inc., be approved by regulators, the company said Friday.
Approval could come as early as February, said Swiss drug maker Roche, which is marketing Zelboraf.
The oral drug is aimed at metastatic melanoma patients who have a specific mutation of a protein called BRAF. That mutation is found in about half of all melanoma cases.

CIRM makes $30M deposit toward stem cell bank

California’s stem cell research funding agency wants to make a $30 million investment in the banking business.
The California Institute for Regenerative Medicine’s three-part strategy ultimately will create a stem cell bank for so-called pluripotent stem cells that can be manipulated to form skin, heart or other types of cells. It would allow researchers to more quickly and efficiently create “disease-in-a-dish” models of genetically complex diseases like diabetes, asthma, autism or heart disease.
Although the bank would house some embryonic stem cell lines, the project’s emphasis is on the fast-moving field of induced pluripotent stem cells, or IPS cells.

Raptor drug's big selling point — no stink, better compliance

On the verge of submitting a rare-disease drug for approval, Raptor Pharmaceuticals Corp. is counting on one major selling point: Its drug doesn’t stink.
The 14-person Novato company will file a new drug application early in first-quarter 2012 for delayed-release cysteamine, a treatment for a deadly inherited disease known as cystinosis. The drug uses the same active ingredient as Cystagon, approved in 1994 by the Food and Drug Administration.
The knock against Cystagon has been a putrid rotten egg smell and its every-six-hours dosing. That’s no small thing in a disease that can kill children by the age of 9 — parents must wake a child during the night to give the powder-filled capsule.

Mission Bay startups stay, grow at FibroGen digs

Startups are growing up in Mission Bay, but not moving away from home.
Early-stage life sciences and cleantech companies not only flocked to available incubator space in the FibroGen Inc. building, they’re sticking around. Biofuels company Siluria Technologies Inc. and clinical tools companies Locus Development, Ablexis Inc. and GigaGen are among a growing cadre of startups opting to stay put and grow rather than move to new digs, the usual path for incubated companies once they gain traction.

Gilead seeks approval of Truvada for HIV prevention

Gilead Sciences Inc. is seeking regulatory approval of its once-daily Truvada tablet as a way to prevent HIV.
The Foster City-based company (NASDAQ: GILD) said it submitted a supplemental application to the Food and Drug Administration. If successful, Gilead would be the first company to win FDA approval for a drug intended to prevent uninfected adults from getting infected with the AIDS virus, an approach known as pre-exposure prophylaxis, or PrEP.
But the move is controversial — even with some advocacy groups for AIDS patients — because opponents have said some gay men might engage in unprotected sex if they believe Truvada by itself protects them from getting the virus. Others have said that Truvada hasn’t proved that it can prevent transmission of HIV.

StemCells plans to sell more stock, shares fall

After announcing that the first group of spinal cord injury patients in an early-stage trial received its transplanted neural stem cells, StemCells Inc. said Thursday that it sell more common stock and warrants.
Newark-based StemCells (NASDAQ: STEM) said it would use the money for working capital and operations, including product development. The company did not say how many shares and warrants would be issued but said it is under a current shelf registration.

Innovation dies in the budget-cutting process

Give someone enough rope, my mother would say, and he’ll hang himself.
Now wrap that metaphor around California and a small investment/big return proposition around leukemia.
With an investment of only $290,633, the University of California Office of the President — or UCOP, as it’s known — will support research seeking a way to expand the population of stem cells in cord blood transplants for leukemia patients. Coupled with cash from GE Healthcare Life Sciences’ cell technologies unit, the UCOP Discovery Grant will take research teams led by UCSF’s Andrew Leavitt and Michelle Arkin to the starting line of essentially curing the deadly blood cancer.
These types of projects, however, are finding cash tougher to come by.

IntegenX raises $40M for human DNA ID system

IntegenX Inc. has raised $40 million in a Series C round of funding led by new investor Essex Woodlands.
Pleasanton-based IntegenX is focused on molecular biology and biotechnology.

One-on-One with Genomic Health's Steven Shak

Genomic Health Inc. will roll out another version of its Oncotype DX test this month, helping women with a less risky but tough-to-diagnose type of breast cancer avoid harmful radiation treatment.
The Redwood City company (NASDAQ: GHDX) said a recent study showed that the new test for patients with ductal carcinoma in situ of the breast, or DCIS, is better than traditional clinic and pathologic measures predicting recurrence of the localized cancer or the likelihood of developing a new invasive breast cancer.
It’s far from the only thing Genomic Health has been focusing on.
I spoke with Steven Shak, Genomic Health’s chief medical officer, last month about Oncotype Dx, Genomic Health’s strategy and what’s next in breast, colon and prostate cancer testing.

Anacor skin rash drugs scratch out mid-stage trial success

A mid-stage trial of two experimental skin rash treatments developed by Anacor Pharmaceuticals Inc. met their goals, the Palo Alto company said.
The drugs, known as AN-2728 and AN-2898, are designed to treat mild to moderate atopic dermatitis, a chronic rash that involves inflammation and itching. It affects about 40 million people in seven major countries, the company (NASDAQ: ANAC) said, including about 20 percent of children in the United States.

Former Genentech exec Marc Tessier-Lavigne elected to Pfizer board

Former Genentech Inc. chief scientific officer Marc Tessier-Lavigne was elected to Pfizer Inc.’s board of directors.
Tessier-Lavigne, who joined South San Francisco-based Genentech in 2003, but left last year to become president of Rockefeller University in New York. At Genentech, Tessier-Lavigne, 51, oversaw 1,400 researchers in Genentech Research and Early Development.

Amarantus hires strategic adviser

Amarantus BioSciences said it is bringing on Mark Benedyk as a strategic adviser.
The Sunnyvale-based biotechnology company said Benedyk starts immediately.

FDA won't give quick review to Onyx's multiple myeloma drug

Onyx Pharmaceuticals Inc. will have to wait in line for approval of its multiple myeloma drug — potentially adding weeks to the approval process — but reported results of another trial that ultimately could expand the treatment’s market.
South San Francisco-based Onyx (NASDAQ: ONXX) said the Food and Drug Administrated would review its new drug application for the drug, called carfilzomib, as it would any other drug. Onyx had sought accelerated approval based on a 266-patient Phase II trial.
What’s more, the FDA, which would complete its review by July 27, said in a letter to Onyx that its oncology drug advisory committee prefers Phase III trials. The agency also questioned whether carfilzomib’s benefit and risk are “appropriately balanced.”

Vertex, Alios start early-stage hepatitis C trials on 2 drugs

Alios BioPharma Inc. and partner Vertex Pharmaceuticals Inc. said Friday that they started two early-stage studies on separate hepatitis C drugs.
Alios, based in South San Francisco, and Cambridge, Mass.-based Vertex (NASDAQ: VRTX) said the safety and tolerability studies of ALS-2200 and ALS-2158 will return data in the second quarter of 2012.

A new biotech model? Cytokinetics rents space, expertise to Third Rock startup

When scientists at Cytokinetics Inc. have a question about contract research work they’re doing for a biotech startup, they don’t have far to go — just a few steps.
Biotech companies for years have taken on contract research projects, but the landlord-as-contractor arrangement between South San Francisco’s Cytokinetics and venture-backed Global Blood Targeting Inc. marks the latest model to bring money in the door while cutting costs.
For Global Blood, funded by Third Rock Ventures and working on a drug for sickle cell anemia, the move allows it to tap experienced researchers and reduce its startup costs. Publicly held Cytokinetics, meanwhile, keeps valued scientists busy and reduces its net cash burn, thanks to Global Blood payments for space and research work.

GE-UCSF stem cell program gets boost with grant program cut due to budget woes

A public-private partnership, funded in part by a grant program killed earlier this year by the state’s fiscal crisis, could within a decade help adult leukemia patients fight off the disease.
The $841,000, three-year project at the University of California, San Francisco, seeks to discover compounds that expand the number of stem cells found in umbilical cord blood and the placenta. If successful, that could increase the chances of adult leukemia patients receiving bone marrow transplants with blood-forming stem cells.
The cost of the project is covered by a “Discovery Grant” from the UC Office of the President and GE Healthcare Life Sciences’ cell technologies unit.
The UC grant program was set up to encourage projects between UC scientists and companies. In May, however, UC told researchers the program would be eliminated to help reduce a projected $500 million cut in state funding in fiscal 2012. Only the best of the best projects already in the pipeline would be funded, a UC spokeswoman said.

Hansen Medical secures $30M debt facility

Hansen Medical Inc. said Friday it secured a $30 million debt facility through Oxford Finance LLC and Silicon Valley Bank.
Mountain View-based Hansen (NASDAQ:HNSN) specializes in flexible catheter robotics and developing robotic technology for accurate 3D control of catheter movement. It plans to use the funds for general corporate financing.

CIRM puts up $5.6M to recruit stem cell researcher to UC Berkeley

UC Berkeley’s attempt to woo stem cell researcher Zhigang He from Children’s Hospital Boston got a $5.6 million boost from California’s stem cell research funding agency.
The six-year award, approved Thursday by the board overseeing the San Francisco-based California Institute for Regenerative Medicine, will help the University of California recruit He, whose research has focused on regenerating nerve projections that carry signals along the spine.

Stem cell board approves two research-centered programs totaling $27 million

California’s stem cell research funding agency will pump $27 million into various projects, including up to $12 million for disease-focused research teams, programs looking to move academic work into patients and for clinical trials.
The oversight board of the San Francisco-based California Institute for Regenerative Medicine voted Thursday to approve the programs, which are designed to accelerate stem cell research projects in the state.

Gilead selling $3.7 billion in notes for Pharmasset buyout

Looking for ways to finance its planned $11 billion acquisition of Pharmasset Inc. , biotech giant Gilead Sciences Inc. said it will sell $3.7 billion worth of bonds.
The four-part issuance consists of $750 million in bonds, due in 2014 and paying 2.4 percent interest, another $700 million at 3.05 percent interest and due in 2016, a third tranche of $1.25 billion 10-year notes at 4.4 percent interest and $1 billion at 5.65 percent interest due in 2041.

Gilead donates $8M of 'black sickness' drug to WHO

Gilead Sciences Inc. will donate 445,000 vials of AmBisome over five years to help the World Health Organization treat more than 50,000 patients with “black fever,” or visceral leishmaniasis.
Based on Gilead's no-profit price through its access program for developing countries, the donation is valued at more than $8 million.

Combo of Genentech's Herceptin, new drug delays spread of breast cancer - study

Combining the experimental Genentech Inc. antibody drug pertuzumab and the breast cancer drug Herceptin with docetaxel chemotherapy translated into metastatic breast cancer patients living more than a half-year longer without the disease progressing, according to results of a trial by the South San Francisco biotech giant.
Patients receiving the three-drug combination, who had received no previous treatment for HER2-positive breast cancer that had spread to other parts of their body, lived a median of 18.5 months without the disease progressing, compared to 12.4 months for patients on only Herceptin and chemo.

FDA panel backs Affymax anemia drug for dialysis patients

A federal advisory panel Wednesday approved Affymax Inc.’s once-a-month anemia drug for kidney dialysis patients.
The 17-member Food and Drug Administration panel of outside experts recommended that the agency approve peginesatide from Palo Alto-based Affymax (NASDAQ: AFFY) and partner Takeda Pharmaceuticals. Two Phase III studies showed that the drug is safe and effective for dialysis patients, but two other late-stage studies found that peginesatide could cause heart problems in kidney patients who weren’t yet on dialysis.
The FDA often follows an advisory panel’s recommendation but isn’t required to do so. The FDA is expected to approve or reject peganesatide by March 27.

CIRM names former iPierian exec as first CFO

The former chief financial officer of stem cell company iPierian Inc. was hired for the same job at California’s stem cell research funding agency.
Matthew Plunkett, who also has worked as a biopharma investment banker at Oppenheimer & Co. and predecessor CIBC World Markets, was named the California Institute for Regenerative Medicine’s first chief financial officer. He worked at iPierian in South San Francisco from August 2009 to this past April, when he, along with much of the management team and a couple of board members, exited the company.

UCSF, GE Healthcare program seeks to boost number of disease-fighting cord blood cells

A group of UCSF scientists will seek chemical compounds that can be added to blood-forming stem cells and progenitor cells in cord blood to increase their population and boost cord blood treatments for adult patients.
The $841,000, three-year program, funded by GE Healthcare Life Sciences’ cell technologies unit and the University of California’s Office of the President, initially will screen about 120,000 chemicals to find those that could expand the population of hematopoietic, or blood-forming, stem cells and progenitor cells.
The work is important because cord blood — a rich source of stem cells and progenitor cells — often doesn’t provide a large enough number of stem cells to treat adults with life-threatening diseases like lymphoma, leukemia or sickle cell anemia.

Science Exchange raises $1.5 million

Science Exchange, the online research marketplace launched earlier this year out of the Y Combinator incubator program, raised $1.5 million in a round led by Andreesen Horowitz.

Gilead HIV booster passes Phase III test

An experimental HIV therapy booster from Gilead Sciences Inc. — a key part of Gilead’s experimental four-in-one, once-a-day Quad pill — met the goal of a Phase III trial, the company said Monday.
The booster, named cobicistat, showed in the 96-week study that it was at least on par with ritonvair, or Norvir, from Abbott Laboratories (NYSE: ABT), Gilead (NASDAQ: GILD) said.

Gilead cancer strategy relies heavily on Yale collaboration

Gilead Sciences Inc. is best known for combining HIV-fighting drugs for AIDS patients, but it may draw on that experience as it pursues a two-pronged strategy in cancer.
After a decade away from the oncology space, Gilead’s buyouts of CGI Pharmaceuticals, Arresto Biosciences and Calistoga Pharmaceuticals over the past 18 months allow the Foster City-based biotech giant (NASDAQ: GILD) to hurdle some of the early cancer drug development challenges.
Given less attention, at least after the deal's initial announcement in March, is the company’s collaboration with heavy-hitting cancer researchers at Yale University. That $40 million, four-year effort is sequencing various types of tumors to identify new targets.

Manufacturing problems cause shortage of Theravance-developed superbug drug

Manufacturing problems at a third-party manufacturer have led to “critical” shortages of the serious skin infection drug Vibativ, developed by South San Francisco-based Theravance Inc.
Astellas Pharma US, which is marketing the drug, told wholesalers and distributors Friday that no new patients should be started on Vibativ, according to a Securities and Exchange Commission filing Friday by Theravance (NASDAQ: THRX).
Vibativ, a once-daily injectable drug to treat Gram-positive bacteria, including the MRSA “superbug,” was approved in the United States in September 2009. It won European approval this past September.

Genentech settles Rituxan whisteblower suit for $20M

Genentech Inc. will pay $20 million to settle a whistleblower lawsuit around off-label marketing of the cancer-fighting drug Rituxan.
The settlement, completed last month and first reported by Drug Industry Daily, will net $5.7 million for John Underwood, who was a senior manager of sales development from the start of Genentech’s oncology franchise in 1997.

You're so vain: Baby boomers, tech and lower risk for investors pump up aesthetics, vanity market

Kerry Pope wants to liberate women — and make some money in the process.
Pope’s Palo Alto company, Viveve Inc., is launching a product that promises to tighten vaginal tissue stretched by childbirth and return women’s sex lives to pre-child days. The half-hour radiofrequency technology procedure, already used to tighten saggy facial skin, allows women to return home or to work with nary anyone else the wiser for it.
“It’s all about her,” Pope said.
It also is about opportunity.
Vain baby boomers looking to suck, heat, squeeze or freeze their way toward the fountain of youth are pumping up a $10 billion-a-year market. Lower regulatory risk for companies and investors, a new wave of technologies and consumers willing to pay out of pocket are fattening up the industry as well.
Call it the aesthetics, personal care or vanity market, but one thing is sure: Even in a tough economy, a cadre of Bay Area companies with science-backed, minimally invasive methods for smoothing wrinkles, removing love handles or even restoring couples’ sex lives are tapping consumer lust for younger days.

Amyris, Total expand joint biofuels venture

Renewable fuels and chemicals company Amyris Inc. and French energy giant Total have expanded their partnership to produce renewable diesel products through a joint venture, to which Total will contribute an additional $105 million on top of the $180 million the companies already have committed, according to financial filings.
The 50-50 joint venture has the exclusive rights to produce and market renewable diesel and jet fuel worldwide. It also has a non-exclusive agreement to develop and market other non-fuel products. The venture will begin operations in the first quarter of 2012.

Transcept could land $90M after Purdue opts for sleep drug

Purdue Pharma LP exercised its option for U.S. rights to the middle-of-the-night sleep drug Intermezzo, developed by Richmond’s Transcept Pharmaceuticals Inc.
Transcept (NASDAQ: TSPT), which lost $30 million in potential Purdue payments after the Food and Drug Administration twice rejected the drug, now could receive up to $90 million in milestone payments.
The FDA finally approved Intermezzo last month. Purdue had until Dec. 8 to exercise its option on the lozenge, which is designed to help people go back to sleep for up to four hours after waking up in the middle of the night.

BioMarin buys back patents for rare disease drug for $81M

BioMarin Pharmaceutical Inc. bought the intellectual property at the core of the drug Naglazyme for $81 million cash, according to terms of a buyback deal disclosed Wednesday.
The Novato-based company (NASDAQ: BMRN), known for developing drugs to treat rare lysosomal storage diseases, said it paid the cash upfront to SA Pathology, a unit of the Central Adelaide Local Health Network in Australia. The patents are related to the purified form of Naglazyme and the method of using the enzyme to treat mucolpolysaccharidosis VI, or MPS VI.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.”

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.

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.

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.

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.

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.

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.

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.

NeurogesX hires Stephen Peroutka as chief medical officer

NeurogesX Inc. hired Stephen Peroutka, M.D., as chief medical officer. He replaces Jeffrey Tobias, M.D., who quit Oct. 16 but who still works as a consultant for up to $7,200 per month.
Peroutka has already started part time work at the San Mateo company (NASDAQ: NGSX) as a consultant, but will come on board full time Nov. 9.

Bay Area Science Festival kicks off Saturday, continues through Nov. 6

Aiming to get kids — and even adults — excited about science, the Bay Area Science Festival kicks off Saturday with the first of more than 100 events.
Geology, biology, music, hawk banding, genetics — and that’s just day one. In all, there are more than 100 free events, including lectures, exhibitions, concerts and a science pub crawl from San Jose to Santa Rosa, through Nov. 6.
Backers of the Bay Area Science Festival — ranging from the University of California, San Francisco, and the life sciences industry trade group BayBio to Chevron and the S.D. Bechtel Jr. Foundation — hope the festival is just the beginning of building excitement about the sciences. Many of those supporters already have been busy trying to beef up the region’s efforts around so-called STEM education, or science, technology, engineering and mathematics.

Peter Maag exits as Novartis Diagnostics president, interim named

Peter Maag, the Emeryville-based president and global head of Novartis Diagnostics for two years, is no longer with the company.
Carsten Schroeder, who has been Novartis Diagnostics’ vice president of commercial operations for Europe, the Middle East and Africa, was named as Maag’s replacement.

Fast 100: Discovery, deals boost Five Prime's bottom line

Five Prime Therapeutics Inc. is an anomaly.
A drug-development company without any drugs on the market, South San Francisco-based Five Prime has increased revenue in each of the past three years, reaching $23.7 million last year while hitting a three-year compound growth rate of more than 52 percent.
What’s more, Five Prime expects a double-digit percentage point jump in revenue in 2011.

Medivation pins hopes on prostate cancer drug

Medivation Inc. is getting another shot with another pill.
The San Francisco-based drug developer, which lost nearly 80 percent of its value after a highly touted Alzheimer’s disease treatment in March 2010 failed a late-stage clinical trial, will receive make-or-break data on an experimental prostate cancer treatment sometime over the next nine weeks.

Drug deal gives Biogen a stake in Portola Pharmaceuticals

Biogen Idec will license a family of drugs that could treat lupus or rheumatoid arthritis from Portola Pharmaceuticals Inc. for $36 million cash and $9 million in Portola equity.
The agreement could be worth up to $508.5 million more in development and milestone payments.
The deal links two of the biggest biotech dealmakers of the past several years, South San Francisco’s Portola and Biogen Idec’s George Scangos. Portola has negotiated deals with Novartis AG and Merck & Co. (though Merck returned the anti-clotting drug earlier this year), while Scangos cut a number of licensing deals — albeit on the other side of the fence — as CEO of South San Francisco’s Exelixis Inc.

Biotech's new normal: Innovation but no VC money, risk

If there’s a new normal in biotech — and some would argue that we’re still trying to find that base — it involves fewer people, a lot less cash, less risk taking and labs full of enthusiasm.
A few events this week in the Bay Area are pretty illustrative: the BIO Investor Forum, Peter Thiel’s new fund for off-the-grid researchers and Thursday’s QB3-Deloitte Award for Innovation.

Johnson & Johnson to fund awards for UC bio startups

An arm of Johnson & Johnson will fund University of California projects with a high potential to get to market.
The amount of money from J&J’s Corporate Office of Science and Technology was not disclosed by the California Institute for Quantitative Biosciences, or QB3.
The money will combine with cash from the Rogers Family Foundation of Oakland to support QB3’s Bridging-the-Gap program. The JJSI-QB3 Awards, a component of the program, will be given annually over the next three years.

Gilead, Bristol-Myers Squibb ink deal for HIV-fighting booster

Bristol-Myers Squibb Co. will develop a new HIV treatment combining its protease inhibitor Reyataz and Gilead Sciences Inc.’s new boosting agent cobicistat, according to a deal announced Wednesday.
Terms of the deal were not disclosed, except that Bristol-Myers Squibb (NYSE: BMY) will pay a royalty based on annual net sales of the product.
Foster City-based Gilead (NASDAQ: GILD) already has been studying Reyataz, or atazanavir, and cobicistat, a booster that increases the levels of certain HIV-fighting medicines, in Phase II and Phase III studies.

Stem cell agency CIRM, NIH to work together in pilot project

California’s stem cell research funding agency and the National Institutes of Health signed a memorandum of understanding for a pilot project to help medical researchers prevent, diagnosis and treat a wide range of diseases.
The two groups also are looking at ways that researchers funded by the San Francisco-based agency, the California Institute for Regenerative Medicine, and those supported by the NIH can collaborate in earlier translational or basic biology projects.

Bayer cancer drug does well in trial, Onyx stands to reap royalty

Two weeks after settling a lawsuit with Onyx Pharmaceuticals Inc., Bayer HealthCare Pharmaceuticals and Onyx said Wednesday that a late-stage trial of the cancer drug at the center of the suit met its main goal.
Details of the results of the 760-patient study of Bayer’s regorafenib in metastatic colorectal cancer were thin, but South San Francisco-based Onyx (NASDAQ: ONXX) will receive a 20 percent royalty on potential sales.

Peter Thiel launches Breakout Labs for startups with 'audacious ideas'

Startup guru Peter Thiel is spreading the love, announcing Tuesday that his foundation will offer $50,000 to $350,000 grants to help science and technology entrepreneurs blocked from traditional fund-raising paths.
Thiel, a co-founder of PayPal and early Facebook investor, unveiled the concept — called Breakout Labs — at a speech Tuesday to the Business Association of Stanford Entrepreneurial Students. The fund will have a website where advanced technology entrepreneurs can apply.
Ten or 20 high-tech, biotech, nanotech or other types of "convergence" projects could be funded next year, said Lindy Fishburne, executive director of Breakout Labs. In return, the Thiel Foundation will take a “modest” royalty on the startups’ products and a “small percentage” in warrants, Fishburne said, to fund fresh rounds of grants.

UCSF nabs $6M for seven-stage AIDS prevention project

UC San Francisco’s UCSF Center for AIDS Prevention Studies has won $6 million in federal funding over four years to lead a seven-state effort to help HIV-AIDS patients get diagnosed and receive continuing care.
The funds come from the U.S. Health Resources and Services Administration and its Special Projects of National Significance Program, UCSF said Tuesday. The grant is for $1.5 annually for four years.
The effort’s main goals are to improve access to care, optimize health outcomes and reduce HIV-related health disparities, UCSF said, mirroring some of the primary objectives of the national AIDS strategy. It targets individuals who haven't been tested or don't know their HIV status.

Gilead strikes deal with GlobeImmune on hepatitis B vaccine

Gilead Sciences Inc. will back GlobeImmune Inc.’s hepatitis B vaccine program through Phase Ia trials and then take full responsibility of the program.
Foster city-based Gilead (NASDAQ:GILD) will pay privately held GlobeImmune of Louisville, Colo., an undisclosed upfront payment plus additional milestone payments and, potentially, royalties.

On strength of Phase III data, Exelixis looks for cabozantinib submission in first-half 2012

After a strong Phase III trial of its cancer drug cabozantinib, Exelixis Inc. expects to file for approval of the drug in a type of thyroid cancer in the first half of next year.
The South San Francisco company (NASDAQ: EXEL) said cabozantinib registered progression-free survival — or the length of time it takes for a disease to worsen — a median of 11.2 months. Patients in a placebo arm had media progression-free survival of 4.0 months.

Hedge fund BVF takes 6.1% stake in Affymax

Biotechnology Value Fund has accumulated 6.1 percent of Affymax Inc., the hedge fund said in a filing Friday with the Securities and Exchange Commission.
BVF, with offices in Chicago and San Francisco, said it controls 2.15 million shares of Palo Alto-based Affymax’s (NASDAQ: AFFY) roughly 35.5 million shares. BVF had not previously stated a position in the anemia drug developer.

Intarcia inks diabetes treatment deal with Quintiles

Intarcia Therapeutics Inc. will work with biopharmaceutical services business Quintiles Transnational Corp. on a once-a-year treatment for Type 2 diabetes.
Durham, N.C.-based Quintiles has 14 facilities in the United States where it helps companies with clinical testing and other aspects of the pharmaceutical business.
Hayward-based Intarcia didn’t say what it will pay Quintiles for its help.
The two will work on ITCA 650, a matchstick sized pump that is implanted under a patient’s skin to deliver a drug for a whole year. It’s aimed at Type 2 diabetes and is about to start Phase III testing.

Video: UC Berkeley dedicates Li Ka Shing biomedical research center

Philanthropist Li Ka Shing, UC Berkeley Chancellor Robert Birgeneau and a standing-room-only crowd on Friday dedicated the campus’ new Li Ka Shing Center for Biomedical and Health Sciences.
The $267 million, six-level, 200,000-square-foot facility, which will feature the University of California, Berkeley’s stem cell program on the third and fourth floors, was funded in large part with a $40 million gift in 2005 from Hong Kong businessman Li. It also received $20 million from California’s taxpayer-supported stem cell research funding agency.
“I believe that investments in higher quality education are the best investments for improving the human condition,” Li said through an interpreter.

Dynavax to get $3M in expanded deal with GSK

Dynavax Technologies Corp. added a new target to a research deal with giant GlaxoSmithKline PLC, and will get a $3 million milestone payment as a result.
Berkeley-based Dynavax (NASDAQ: DVAX) and GlaxoSmithKline (NYSE: GSK) added a new “toll-like receptor,” TLR8, to their agreement. They plan to study TLR8 and seek an inhibitor of it to treat autoimmune and inflammatory diseases.

Med devices score more VC cash than biopharmas as venture dollars rise in Q3

Venture capital investment was up in the third quarter, with investors putting $8.4 billion into 765 deals for U.S.-based venture companies, according to a new report on Friday from Dow Jones VentureSource.
For the first time since 1998, medical device companies picked up more venture financing than biopharmaceutical companies, while consumer information services — which includes online search, entertainment and social media firms — garnered $1.3 billion for 104 deals in the third quarter.

Dermira raises $42M for dermatology work, buys Valocor

Dermira Inc. said Thursday it has raised $42 million in Series A funding.
The Redwood City-based company plans to use the funds for acquisition, development and commercializing dermatology-related therapeutics.
Its investors include Bay City Capital LLC, New Enterprise Associates and Canaan Partners.

WaferGen CEO Alnoor Shivji out in reorganization

WaferGen Biosystems Inc. brought in a consultant to “provide strategic guidance” and said its CEO and president, Alnoor Shivji, quit those jobs Wednesday as “part of his transition to a new role as a consultant.”
Shivji will stay at Fremont-based WaferGen (OTCBB: WGBS) as chairman and the company will pay him as a consultant. He’ll also get $262,500 in severance and his stock options have vested.
The company hired Steve Lombardi, former president and board member at Helicos BioSciences Corp. (Pink Sheets: HLCS), “to work with management and provide strategic guidance.”

Slideshow: Lab building groundbreaking starts remake of Gilead campus

Gilead Sciences Inc. broke ground Wednesday on a $140 million, 192,054-square-foot research lab building, part of a massive rebuild and expansion of its Foster City campus.
The event featured a handful of Bay Area politicians, including U.S. Rep. Jackie Speier (D-San Mateo) and the top brass of the HIV, hepatitis, cardiovascular and cancer drug developer.
In fact, Speier used the moment to highlight the fact that California, according to the most recent 2009 figures, received 40 percent of National Institutes of Health funds, much of that headed to the University of California, San Francisco. She then urged her state lawmaker colleagues, Sen. Leland Yee (D-San Francisco/San Mateo) and Assemblyman Jerry Hill (D-San Mateo), to at least maintain state funding levels for UCSF.

Amgen layoffs to include 37 in South S.F.

Amgen Inc. will lay off 380 research and development staffers in the United States and UK, the company said Wednesday. Those cuts will include 37 in South San Francisco.
A spokeswoman called the cuts, "strategic, targeted reductions" intended to reallocate resources in drug development.

Gladstone nabs $5 million from Roddenberry Foundation for new stem cell center

The Gladstone Institutes is boldly going where few stem cells have gone before.
With the help of a $5 million gift from Roddenberry Foundation — set up to honor late “Star Trek” creator Gene Roddenberry — the San Francisco-based J. David Gladstone Institutes will build off the stem cell work of part-time Gladstone researcher Dr. Shinya Yamanaka.
Gladstone officials scheduled a press conference for late Wednesday afternoon and did not provide details for publication prior to the event, but told the San Francisco Chronicle for a story in Wednesday morning’s paper that the Roddenberry Foundation’s gift would go toward a Roddenberry Center for Stem Cell Biology and Medicine.

Gilead breaking ground on 1st part of massive HQ campus rebuild

AIDS drug developer Gilead Sciences Inc. will break ground Wednesday afternoon on a $140 million, 192,054-square-foot R&D center on its Foster City campus.
It is the first in a major overhaul of Gilead’s longtime Lakeside Drive home that ultimately will double its footprint to 1.2 million square feet and push Gilead's local workforce from 1,700 to 3,400.
In all, plans call for razing eight one- or two-story buildings, constructing seven structures of two to 10 floors, and building one addition. The multi-year project, which Gilead (NASDAQ: GILD) unveiled in 2008, will result in a 16-building campus of up to 755,048 square feet of office space and at least 445,432 square feet of labs.

Cytokinetics to cut 18 jobs, focus on ALS trial

Cytokinetics Inc. will cut its workforce to 83 people as it focuses its cash on an experimental treatment for Lou Gehrig’s disease and a heart failure program partnered with Amgen Inc., the company said Tuesday.
Among the jobs cut was that of David Morgans Jr., the South San Francisco-based drug developer’s executive vice president of preclinical research and development. He will leave the company Oct. 31.

Johnson & Johnson, iScience sign supply deal

IScience Interventional said Tuesday it has signed a clinical and commercial supply agreement with Johnson & Johnson Pharmaceutical Research & Development LLC and its affiliates.
Menlo Park-based iScience specializes in therapies for anterior and posterior ocular diseases. It is expected to supply microcatheters to Johnson & Johnson for cell therapy clinical trials to treat retinal degeneration.

Topica raises $27M Series B round

Topica Pharmaceuticals Inc. closed a $27 million Series B financing.
The round led by Third Rock Ventures and existing investors Prospect Venture Partners and Yasuda Enterprise Development Corp. Ltd.

ChemoCentryx refiles IPO plans, seeks to raise $69M

ChemoCentryx Inc. has refiled plans for an initial public offering to raise $69 million, according to a regulatory filing with the U.S. Securities and Exchange Commission.
The Mountain View-based company, which develops oral drugs for autoimmune diseases, inflammatory diseases and oncology, filed for a $57.5 million IPO in 2007, but withdrew the registration citing market conditions. It had hoped to use most of the proceeds to develop treatment of inflammatory bowel disease, and for research and development of other candidates.

Sofinnova raises $440M life sciences-only fund

Amid the doom and gloom of venture investing in biotech, Sofinnova Ventures said Monday that it has raised a $440 million life sciences-focused fund.
Sofinnova's eighth fund is aimed at late-stage companies — including those spun out of drug-development programs acquired by Menlo Park-based Sofinnova — so it won’t necessarily help cash-hungry startups or other young companies. Yet Sofinnova general partner Mike Powell said the cash is earmarked for life sciences companies only.
“It’s clinically later-stage assets, but we’re the Series A investor in 80 percent of companies,” Powell said.

Berkeley Bionics changes name to Ekso Bionics

Berkeley Bionics, which makes technology to help paraplegics walk again, changed its name to Ekso Bionics this week.
The Berkeley business rebranded its line of “exoskeletons,” as it calls the wearable robots that let paralyzed people stand and walk.
A year ago, the company, started by Homayoon Kazerooni, made a splash as it unveiled its first set of mechanical legs.

Who is biotech's Steve Jobs?

Think of technology, and images of Steve Jobs, Bill Gates and a handful of others pop into your head.
Social media? Facebook’s Mark Zuckerberg and Google’s Larry Page or Sergey Brin.
Environmentalism? Al Gore.
Biotech? (crickets) Biotech?

Aduro, starting Phase II pancreatic cancer trial, sees promise in 2 'failed' cancer vaccines

Two cancer vaccines given up for dead — after killing two Bay Area biotech companies — together could breathe new life into a Berkeley company and earn a measure of redemption to boot.
Aduro BioTech Inc. of Berkeley this month dosed the first patient in a Phase II pancreatic cancer trial that uses its vaccine as a booster following a priming dose of another vaccine controlled by BioSante Pharmaceuticals Inc. Preliminary results could come as early as October 2012, but a full read on whether the combination is safe and effective likely will take years.

Depomed hot flashes drug fails in Phase III trial

Shares of drug developer Depomed Inc. tanked in after-hours trading Thursday after the company said a trial of its experimental hot flashes drug failed to decrease the number of attacks after 12 and 24 weeks of treatment.
The stock of Menlo Park-based Depomed (NASDAQ: DEPO) had closed Thursday up 22 cents at $6.28 per share, but after the company announced the results of the Phase III trial, shares were off $1.67 — or more than 26 percent — to $4.61 per share.
Depomed, however, said it would talk to the Food and Drug Administration about “possible pathways” for submitting the drug, called Serada, for approval. That meeting would likely come early next year, Depomed Chief Medical Officer Dr. Michael Sweeney said in a conference call Thursday afternoon.

Rules seen choking U.S. medical device makers

The most innovative new medical devices are being developed overseas because regulations in the U.S. are too strict, a panel of industry experts said Thursday at a Mountain View Chamber of Commerce “Life Sciences Summit” hosted at Fenwick & West LLP.
The panelists, including vascular surgeon and inventor Dr. Thomas Fogarty of Mountain View’s Fogarty Institute of Innovation, had some harsh words for the U.S. Food and Drug Administration, though they also said they’re starting to see a turnaround.
"The FDA has finally woken up and realized what is happening," Fogarty said.
Still, he said he continuously sees companies leave the U.S., and "they're not coming back."

Amarantus secures $10M in equity funding facility

Amarantus Biosciences said it closed a $10 million equity funding facility with Centurion Private Equity.
The Sunnyvale-based biotechnology company said it will be able to draw down on the facility over the next 36 months in tranches of up $750,000.
Amarantus Biosciences is developing biologics to treat Parkinson's and other human diseases.

Amgen 'evaluating' R&D unit, changes coming to South S.F.

Amgen Inc. told workers Wednesday it will reshape its R&D unit, which could mean big changes for the biotech company’s South San Francisco operations.
A spokeswoman for Thousand Oaks-based Amgen (NASDAQ: AMGN) said the world’s largest biotech company is “evaluating some changes within our research and development organization to improve focus and to reallocate resources to key pipeline assets and activities,” according to the Ventura County Star.
Amgen said it would give more details on the shakeup when it reports its third-quarter financial results on Oct. 24.
The changes will cut across all of Amgen's R&D operations in the United States and the United Kingdom, a spokeswoman told the San Francisco Business Times, but she wouldn't provide detail about the moves.

Onyx drops cancer drug suit against Bayer in return for $160M payment

Onyx Pharmaceuticals Inc. will drop litigation against its partner Bayer for a payment of $160 million and payment of possible royalties and other money in the future.
In exchange, South San Francisco-based Onyx (NASDAQ: ONXX) dropped all its claims against Bayer Corp., Bayer AG, Bayer Healthcare LLC and Bayer Schering Pharma AG in a fight over a cancer treatment.
Technically, Bayer is paying the $160 million for rights to sell Nexavar (sorafenib), a cancer drug, in Japan, without paying royalties to Onyx. Depending on how the drug is priced in Japan, Bayer might pay Onyx $15 million more in 2012 to 2013.

DNAnexus raises $15M from Google Ventures, TPG, others

DNAnexus has closed a $15 million second round of funding led by Google Ventures and TPG Biotech, the company said Tuesday.
Also joining in the round were institutional investors First Round Capital, SoftTech VC, K9 Ventures, and Felicis Ventures.

After strong results in one trial, Alvine readies another Phase II in celiac disease

A small trial by Alvine Pharmaceuticals Inc. indicated that its experimental celiac disease drug may reduce the effect of the intestinal disease, the company said Tuesday.
The 41-patient Phase IIa trial by San Carlos-based Alvine found that certain celiac disease patients taking ALV-003 over six weeks had less severe gluten-induced injury to the lining of their intestine.
Alvine Chief Medical Officer Daniel Adelman said in a press release that the company hopes to start a Phase IIb trial next year.

Codexis hires boss for Brazil and Latin American operations

Biofuel business Codexis Inc. hired Achilles Antonio Clement to direct its expanding operations in Latin America.
Redwood City-based Codexis (NASDAQ: CDXS) put Clement — a former DuPont employee — in charge of a new business, Codexis do Brasil Participacoes Ltda.

Startup Cleave Biosciences raises $42M to develop cancer drugs

Cancer survivor, surfer and longtime biotech executive Laura Shawver is back in the Bay Area, with a startup round of $42 million to develop cancer-fighting drugs that restore the balance of proteins in cells.
Shawver’s new company — Cleave Biosciences of Burlingame — raised the money from U.S. Venture Partners, 5AM Ventures, Clarus Ventures, OrbiMed Advisors and Astellas Venture Management LLC, the corporate venture arm of Japan’s Astellas Pharma, it said Tuesday.
With one of the largest drug-development startup hauls this year, Cleave will use the cash to discover and develop “multiple” small-molecule drugs that restore protein homeostasis, or the balance of proteins in cells. The pathways used in those processes, helping normal cells make proteins or dispose of unneeded proteins, can be hijacked by cancer cells.