Nektar to apply royalty windfall toward paying off debt

Nektar Therapeutics Inc. will use its $124 million windfall from the sale of its royalty interest in two drugs to help pay off a $215 million note due in September.
In a Securities and Exchange Commission filing Wednesday, the San Francisco-based drug developer (NASDAQ: NKTR) said it also is pursuing other “non-dilutive financing alternatives,” including the sale of other royalty interests, to pay off the convertible subordinated note.

Nektar reaps $124M from sale of Cimzia, Mircera royalties

Nektar Therapeutics Inc. scored $124 million by selling potential royalty revenue from two drugs marketed by Roche and UCB Pharma.
The San Francisco-based drug developer (NASDAQ: NKTR) said it sold to RPI Finance Trust all of its royalty rights from Jan. 1 onward for the Crohn’s Disease and rheumatoid arthritis drug Cimzia, marketed by UCB Pharma, and for the anemia drug Mircera, sold by F. Hoffmann-La Roche Ltd.
Nektar must pay RPI, a unit of New York-based Royalty Pharma, $3 million if worldwide net sales of Mircera don’t reach undisclosed thresholds in 2012 and up to $7 million if sales don’t hit certain levels for 2012 and 2013.

Aptus Endosystems hires new CEO

Aptus Endosystems said it has hired James Reinstein as its new president and CEO, as of Feb. 27.
Sunnyvale-based Aptus Endosystems specializes in technology for endovascular aneurysm repair.

Lawrence Berkeley Lab's JBEI spins out first biofuels company: Lygos

The Joint BioEnergy Institute of Lawrence Berkeley National Laboratory has spun out its first business, a cellulosic biofuel company named Lygos.
Emeryville’s JBEI is led by Jay Keasling, who is one of the five men who started Lygos. The JBEI itself was started in 2007 and will likely be moved from Emeryville into the lab’s new campus, now planned for the Richmond Field Station along San Francisco Bay.
Lygos has so far used sugar as a feedstock to create fuel -- or “petrochemical replacements” -- on a laboratory scale. The process it uses to make the chemicals is itself “nearly carbon neutral,” the lab said.

Napo Pharma, ex-partner battle over control of diarrhea drug

Nearly four months after a key partnership blew up, Napo Pharmaceuticals Inc . said Tuesday that the Food and Drug Administration will decide by June 5 whether to approve its drug to treat chronic diarrhea in HIV/AIDS patients on antiretroviral therapy.
The FDA will give priority review, but that does nothing to clear up just who controls the drug, called crofelemer, whose active ingredient comes from the South American medicinal plant Croton lechleri.
The new drug application was filed by Salix Pharmaceuticals (NASDAQ: SLXP) in December, a month after Napo ended a three-year collaboration with the Raleigh, N.C.-based company.

Ultragenyx lands orphan designation for 2nd drug

Ultragenyx Pharmaceutical Inc. won orphan drug designation from the Food and Drug Administration for an experimental treatment for a rare genetic metabolic disorder, called Sly syndrome.
UX-003 is the second drug from Novato-based Ultragenyx, started two years ago by BioMarin Pharmaceutical Inc. veteran Dr. Emil Kakkis, to be tagged as an orphan. The other drug, UX-001, is aimed at GNE myopathy, a severe muscle disease found in adults that weakens patients to the point of using a wheelchair.
UX-003 is designed as an enzyme replacement therapy for patients with Sly syndrome, or MPS 7, caused by a deficiency of the lysosomal enzyme Beta-glucuronidase. That enzyme is required to break down dermatan sulfate, which is found mostly in skin, and heparan sulfate, a carbohydrate expressed on the surface of all human cells.

One-on-One with Joe Belanoff of Corcept Therapeutics

Corcept Therapeutics Inc.’s Korlym is no Lipitor, and that suits CEO Dr. Joe Belanoff just fine for now.
While Vivus Inc.’s recently approved obesity drug Qnexa inspired talk that it would be a blockbuster like weight-loss drug Lipitor, Menlo Park-based Corcept’s Korlym won approval Feb. 17 for a drug aimed at roughly 5,000 to 10,000 patients with Cushing’s syndrome. That's a mere fraction of Qnexa's potential market.
Belanoff spoke with me recently about Corcept, its strategy for Korlym and how he celebrated Korlym’s approval, which earned him a $481,097 bonus.

The Pitch: Charisela Technologies aims to upset lab test kit market

Charisela Technologies Inc. makes test kits for life science researchers to test the concentration of certain molecular samples. Charisela says its kits are more accurate than those now being used and have fewer components, require less steps, don’t need to be repeated and are less expensive. The test can be done in an hour, compared to several hours with existing kits. Current products focus on diabetes research. The tests are now aimed at research but could have clinical uses in the future.

Affymax nabs $5M milestone payment from Takeda

Affymax Inc. said Monday it is expected to received a $5 million development milestone payment from Takeda Pharmaceutical Co.
The Palo Alto-based biopharmaceutical company (NASDAQ:AFFY) said the payment comes as a result of a global agreement between the two companies to develop and commercialize peginesatide — a drug aimed at treating anemia in dialysis patients with chronic kidney disease. It is being co-developed by the two companies.
The payment comes as a result of the European Medicines Agency accepting the Marketing Authorization Application for peginesatide.

Resotration Robotics' hair loss system to be marketed, sold in Canada

Restoration Robotics Inc. said Monday its branded Artas System has received a Canadian medical device license and can now be marketed and sold in Canada.
The private medical device company is based in Mountain View. Its minimally invasive robotic technology, controlled by the physician, offers the ability to identify and harvest healthy follicular units from the patient's scalp during hair transplantation.

Fluxion Biosciences adds sales, marketing, tech support

Fluxion Biosciences Inc. said Friday it has added four new senior management positions and globally expanded its sales and technical support.
The South San Francisco-based private company specializes in drug discovery tools, including the branded BioFlux system for studying cellular interactions and the trademarked IonFlux system for automated ion channel testing.

Vivus shares soar after FDA panel vote on obesity drug

Shares of Vivus Inc. soared more than 80 percent into late-afternoon trading Thursday, after a Food and Drug Administration panel recommended Thursday that the Mountain View-based company’s obesity drug be approved.
The panel voted 20-2 late Wednesday to recommend that the FDA approve Qnexa by April 17.
The FDA, which rejected the once-a-day oral drug from the Mountain View-based company (NASDAQ: VVUS) in October 2010, isn’t required to follow the panel’s recommendation but often does.

FDA targets October decision date for Impax Parkinson's drug

Impax Laboratories Inc.’s Parkinson’s disease treatment could be approved by late October, as the Food and Drug Administration accepted the Hayward company’s new drug application.
Impax (NASDAQ: IPXL), which last month said it will hire an undisclosed number of people as it prepares to sell the drug, said Thursday that its IPX-066 was given an FDA decision date of Oct. 21. The drug would be the first product from Impax's branded products unit, Impax Pharmaceuticals.

Amgen, Cytokinetics start early-stage study of oral heart drug

Cytokinetics Inc. and Amgen Inc. started an early-stage study of the oral form of a cardiac muscle-activating drug.
An intravenous formulation of the drug, called omecamtiv mecarbil, already is in a nearly 600-patient Phase IIb trial by Amgen (NYSE: AMGN).

Threshold dedicates pancreatic cancer drug results to late officer

Dedicating mid-stage drug trial results to its late chief medical officer, Threshold Pharmaceuticals Inc. said Tuesday its experimental treatment for deadly pancreatic cancer passed a significant test.
The South San Francisco company (NASDAQ: THLD) said Tuesday that patients with advanced pancreatic cancer who received a combination of TH-302 and gemcitabine in the Phase IIb trial lived 5.6 months — two months longer than those who got gemcitabine alone.
Threshold stock soared nearly 74 percent by mid-day trading, up $2.61 to $6.14 per share.

Melanoma drug from Roche, Plexxikon wins European approval

A metastatic melanoma drug developed by Roche and Plexxikon Inc. won approval Monday from European regulators.
Zelboraf, a twice-a-day pill that targets patients with a specific mutation in a protein called BRAF V600, was approved by the European Commission for adult patients with the most aggressive form of skin cancer.
It was approved in August by the U.S. Food and Drug Administration. A European panel in December recommended approval.

Codexis CEO Alan Shaw quits, interim boss steps in

Industrial enzyme business Codexis Inc. lost its CEO, Alan Shaw, who quit “to pursue other interests.”
The Redwood City company (NASDAQ: CDXS) named Peter Strumph, senior vice president and head of pharmaceuticals, as interim CEO while it looks for a permanent boss. He worked 10 years at CV Therapeutics before Codexis hired him in 2010.

Corcept's Korlym approved by FDA for Cushing's syndrome

Corcept Therapeutic Inc.’s Korlym was approved Friday by the Food and Drug Administration for patients with the orphan disease Cushing’s syndrome.
The agency said the drug can be used to control high blood sugar levels in adults with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or have not responded to prior surgery.
Korlym was developed by Menlo Park-based Corcept (NASDAQ: CORT).

Idea & Innovation: SanBio creates better odds for stroke recovery

A Mountain View-based biotech company could change how stroke patients are medically treated.
SanBio Inc. recently received approval from the U.S. Food and Drug Administration to test a regenerative cell therapy on patients who have become disabled as a result of ischemic stroke, or strokes caused by blocked blood vessels in the brain. This is the only clinical trial in the United States currently testing the regenerative potential of cell therapy in the brain, according to company officials.

Idea & Innovation: Pathology on fast track for ProteinSimple

Detecting antibodies that signal infection may become easier for doctors thanks to a Santa Clara-based bioscience company. ProteinSimple recently revolutionized a protein test considered the standard for more than three decades.
ProteinSimple, formerly called Cell Biosciences, introduced the Simon and the Simple Western assay last August. The new system is essentially an automated version of the Western blot test traditionally used to identify pathologies in tissue samples, which means less lab time and faster results.

Idea & Innovation: Nobel laureate Elizabeth Blackburn unlocks cells' aging secrets

Elizabeth Blackburn wants to help you read the warning signs that might be right on the tip of your chromosomes.
Blackburn, a professor at the University of California, San Francisco and Nobel laureate, essentially wrote the book on telomeres — DNA structures that cap human chromosomes and protect the genetic code from damage. These telomeres look much like antennas. Shorter telomeres, research suggests, could mean you’re at risk for diseases such as cancer and diabetes, and longer telomeres may be associated with longevity.
Now the Menlo Park company she co-founded, Telome Health Inc., is poised to offer a simple test to show how your telomeres are holding up.

The skinny on Vivus obesity drug: safety issues, FDA says

Ahead of a Feb. 22 advisory panel meeting for Vivus Inc. weight-loss drug Qnexa, a report from Food and Drug Administration staff cited safety concerns about the treatment.
The stock of Mountain View-based Vivus (NASDAQ: VVUS) was up 3 percent to $11.53 per share by late afternoon Friday.
If approved, Qnexa would be the first new prescription drug approved for weight loss in more than a decade.

Gilead shares slip on poor performance of hepatitis C drug

Shares of Gilead Sciences Inc. were down more than 14 percent in late-afternoon trading, after the drug developer said many patients relapsed after receiving a combination of its experimental hepatitis C drug and the antiviral ribavirin.
Six of eight patients receiving ribavirin and GS-7977, the centerpiece of its $11.2 billion acquisition of Pharmasset Inc., experienced a viral relapse after completing 12 weeks of treatment, said the Foster City-based company (NASDAQ: GILD).
Ten patients were in that group, Gilead said, but data was available for only eight of them so far.

UCSF chancellor blows up the boxes to remake campus, UC system

(SF Business Times subscription required.)

When UCSF Chancellor Susan Desmond-Hellmann started her Twitter account last month, she had two goals: do her own micro-blogging and never tweet about eating a tuna fish sandwich for lunch.
The University of California, San Francisco’s ninth chancellor runs little risk of inanity. Some 2-1/2 years into her tenure, Desmond-Hellmann has moved comfortably into her role as UCSF’s face. But more importantly, she is tackling head-on — and with some controversy — the way things are done on her campus and within the UC system.
How those initiatives fare is anyone’s guess. A plan to rework how grant applications are assembled has faced opposition from faculty. Questions also surround an ambitious idea that Desmond-Hellmann pushed at last month’s UC Board of Regents meeting for UCSF to largely split off from the 10-campus UC system.
Regardless, even skeptics applaud Desmond-Hellmann for her bold, pragmatic attempts to deal with an unsteady financial foundation and shake up traditional structures. She is, many say, the right person for the right job at the right time.

New wave of Bay Area companies tame DNA data storm

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Andreas Sundquist is no medical doctor, but his expertise in electrical engineering and computer science places him and technologists like him on the cusp of solving some of the knottiest human medical problems.
Sundquist’s DNAnexus Inc. is one of at least a half-dozen young Bay Area companies using computational biology and genetics to unleash exabytes of stored genome sequencing data into everyday health care. By blending their computer algorithms and software with medical know-how, experts say, clouds full of cheaper and cheaper DNA data could rain down treatments and new drugs for previously mysterious and common medical conditions.
The burgeoning industry of genome analysis — at the intersection of the Bay Area’s high-tech and biotech expertise — could make some visionaries very rich. On the other hand, easy-to-use genetic data could turn today’s diagnostics industry upside down.
But to Sundquist and other pioneers, their companies’ value lies in volume and the ability to turn Big Data into big-time answers.
“You can argue that social networks are for rich kids, that Twitter is for value seekers,” Sundquist said. “But everybody has DNA.”

Omicia frees VAAST data to find vital gene variants

(SF Business Times subscription required.)

From a narrow office in Emeryville, software engineers with experience designing systems like those that help retailers price products quickly are working on a way to allow medical researchers to rapidly identify gene variants.
VAAST — the Variant Annotation, Analysis and Selection Tool — was developed by Omicia Inc. and scientists at the University of Utah, with the help of a $400,000 federal recovery act grant from the National Human Genome Research Institute. It could be introduced commercially later this year.
“From the first day we wanted to focus on clinical management,” said Martin Reese, Omicia’s co-founder, chairman and CEO. “Researchers come in with a clinical question and you try to solve it.”

Retiring UCSF pharmacy dean leaves legacy of innovation

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Shortly after Christmas, Mary Anne Koda-Kimble, the dean of UCSF’s nation-leading pharmacy school, gathered her leadership team, their partners and some of her close friends and mentors at her San Francisco home.
As the catered dinner closed, Koda-Kimble stood and worked her way around the table, telling each person what they meant to her.
“She knew something cool to say about everyone,” said Jim Wells, chair of the department of pharmaceutical chemistry.
When she was done, Koda-Kimble announced that she would retire at the end of June. “And our hearts just went to our belts,” Wells said.
It was vintage Koda-Kimble, who will retire after 14 years heading and transforming the University of California, San Francisco’s School of Pharmacy. Known by students and faculty alike as “Mary Anne,” instead of “Dean Koda-Kimble,” she has translated care and understanding into a legacy that reaches beyond white lab coats counting pills behind a retail pharmacy counter.

Slew of Bay Area drugs awaiting approval

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A bounty of new drugs from the labs of Bay Area companies could win Food and Drug Administration approval in the next few months.
At least 10 drugs — from an obesity treatment to cancer drugs — are candidates for FDA approval by the end of June. Industry observers said they didn’t know how that number compares with any previous six-month period.
One thing is sure: After the economic downturn pushed many investors away from the capital-intensive drug-development business, the cadre of potential new drugs represents a victory of sorts. Many drug developers — especially smaller ones — have carried their drugs within sight of the finish line by sheer will or grit.

BioMarin posts loss, starts dwarfism drug trial

BioMarin Pharmaceutical Inc. started first-in-human testing of a drug for achondroplasia, the most common form of human dwarfism.
Novato-based BioMarin (NASDAQ: BMRN) said it started the Phase I safety and tolerability study of BMN-111 in 74 healthy volunteers. It expects to report results from the trial in the third quarter.

Stock offering nets Exelixis $65 million

Exelixis Inc. will net $65 million by selling 12.65 million shares of common stock, the South San Francisco biotech cancer drug developer said Wednesday.
The total includes 1.65 million shares that the underwriters opted to buy.

Counterfeit Avastin hits U.S. shores, Genentech warns

Counterfeit Avastin — the world’s best-selling cancer drug — is being distributed in the United States, Genentech Inc. and parent company Roche warned Tuesday.
Officials from South San Francisco-based Genentech could not say if patients had been directly harmed by counterfeit Avastin, which has been sold at least since December, or how much revenue the company had lost. But a Roche evaluation of the counterfeit vials showed that they did not contain the active ingredient in Avastin.

Going against AIDS group, FDA pledges quick review of Gilead drug to prevent HIV

A plan to use an approved HIV-fighting drug from Gilead Sciences Inc. as prevention to the AIDS virus will get priority review by the Food and Drug Administration, the agency said Monday.
The move means that the use of Truvada as a way to reduce HIV risk could be approved by June 15, rather than face a standard 10-month agency review.
If approved, Truvada would be the first drug for uninfected people to reduce the risk of acquiring HIV.
But Foster City-based Gilead (NASDAQ: GILD) faces a rough road on its way to winning approval of Truvada as a preventative treatment. At least one AIDS patient advocacy group, the AIDS Healthcare Foundation in Los Angeles, has opposed the plan.

Amyris gives up on biofuels for cosmetics

Amyris is giving up on making biofuels to focus on other, higher margin products.
According to Technology Review, Amyris CEO John Melo said in a conference call that the company was "humbled by the lessons we have learned" in trying to reach production volumes required for transportation fuels.
Amyris's technology, which converts renewable sugars into other molecules that can be converted into lots of things, still may be used in fuel production, but under the banners of joint ventures Amyris established with Total and Cosan, who must build their own production capacity, Technology Review reported.

For FDA, social media's still in trial phase

An army of tweeting thumbs and Facebook Inc.’s planned $5 billion IPO notwithstanding, Margaret Hamburg isn’t quite ready for social media.
“‘Social media’ is a scary term for me,” Hamburg, the top of the food chain in the Food and Drug Administration, told members of the Commonwealth Club this week.
That really comes as no surprise to those who have tracked the FDA’s laborious process for devising rules around how drug makers can communicate with patients using Facebook, Twitter and the like. Two years in, and all that’s emerged are very vague guidelines.

Former 49er, Buck Institute leader picks up ball for tech startup

Jim Kovach is still looking for a touchdown.
The former San Francisco 49ers linebacker was in Indianapolis for Super Bowl XLVI, not to play ball but to demonstrate his new company’s mobile technology, which can turn a stadium full of spectator smartphones into an instant social network, security alert system and direct-to-consumer marketing channel.
A seven-season player, mostly with the New Orleans Saints, Kovach managed to get both law and medical degrees during his playing career. He was later executive director of the Buck Institute for Age Research in Novato until June 2010, when he got the startup bug and left to run his own company, Athleticode, a venture using genetic testing to predict sports injuries.

Despite takeover talk, Onyx on rise with HQ expansion, drug portfolio

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As Onyx Pharmaceuticals Inc. preps for an expansion of its South San Francisco headquarters, one question naggingly persists in spite of the company’s success: Will it still be independent when it moves into the space?
Built around the liver and kidney cancer-fighting drug Nexavar and looking at the promise of two other anti-cancer agents, Onyx over the past year has consistently been the center of takeover rumors. That talk picked up late last year with the settlement of a lawsuit with Bayer AG and the continued progress of the two experimental cancer drugs.
For its part, the company has steadfastly played coy. It declined to comment on a November news report, for example, that it had hired Centerview Partners LLP to look at strategic alternatives.
Nonetheless, Onyx continues to move forward, with $600 million in cash, looking every bit like an independent company. It has leased 162,000-square-foot structure, on which BNBuilders Inc. soon will begin construction, next to Onyx’s East Grand Avenue headquarters. It initially will move into 90,000 square feet.
It also recently opened a European headquarters in Switzerland.

Exelixis to sell 10M shares to pay for R&D, other expenses

Cancer drug developer Exelixis Inc. plans to sell 10 million shares of common stock
The South San Francisco-based company (NASDAQ: EXEL), which has centered its drug-development efforts around the cancer-fighting drug cabozantinib, said in a Securities and Exchange Commission filing Thursday that it will use net proceeds from the offering for research and development, capital expenditures, working capital and other purposes.

FDA panel recommends agency reject NeurogesX HIV pain patch

An FDA advisory panel unanimously recommended Thursday that the agency reject an HIV pain patch from NeurogesX Inc. not be approved.
Qutenza, the patch from the San Mateo-based company (NASDAQ: NGSX), already is used for pain related to shingles, but NeurogesX is seeking Food and Drug Administration approval for its use in nerve damage associated with the AIDS virus.
The 12-member panel’s unanimous decision does not mean the FDA will reject the drug, but the agency typically follows the advise of its committees of experts.
The FDA is scheduled to make a final decision on the Qutenza on March 7.

Glaucoma drug developer Altheos adds $12.5M to Series A round

Altheos Inc. raised an additional $12.5 million — pushing its Series A round to a total of $32.5 million — as the South San Francisco company enters a mid-stage study of a glaucoma drug.

ChemoCentryx stock up 5% after IPO

ChemoCentryx Inc.'s stock was up nearly 5 percent in afternoon trading on Thursday, at around $10.50 per share. It opened at $10.75 per share.
The Mountain View-based biopharmaceutical company raised $45 million in its IPO on Wednesday, selling 4.5 million shares at $10 each. It is trading under the ticker symbol CCXI.

Vaccine developer PaxVax hires 3 officers

Oral vaccine developer PaxVax Corp. has hired a trio of officers as it prepares to take its lead cholera vaccine into Phase III trials.
The company, based in Menlo Park, hired Nima Farzan as executive vice president and chief operating officer, Dr. Thomas Monath as chief technology officer and Jonathan Smith as executive vice president and chief scientific officer.

FDA panel votes against Astex leukemia drug

An advisory panel did not recommend Thursday that the Food and Drug Administration approve a leukemia-fighting drug from Astex Pharmaceuticals Inc. and partner Eisai Co. Ltd.
The FDA’s oncology advisory committee voted 10-3 against recommending that Dacogen be approved for elderly patients with acute myeloid leukemia. One member abstained.
The recommendation is not binding, but the FDA typically follows a panel’s decision.
The FDA is scheduled to make its final decision March 6.

FDA pulls Impax generic antibiotic as it approves Mylan dose

Impax Laboratories Inc. lost market exclusivity for its generic rendition of the antibiotic Doryx as competitor Mylan Inc. won approval for its version.
The Hayward-based drug maker (NASDAQ: IPXL) said Thursday that the Food and Drug Administration has “forfeited” Impax’s exclusivity for its 150-milligram generic Doryx.

Impax factory not yet cleared by FDA, may delay some drug approvals

Impax Laboratories Inc. said Thursday that the Food and Drug Administration hasn’t yet inspected a Hayward factory and that approvals of some drugs may be held up as a result.
Hayward-based Impax (NASDAQ: IPXL) got a warning letter from the FDA last year about the way drugs are sampled and tested at the factory.
Although it is still able to use the factory - the FDA didn’t shut it down - the downcheck can affect approval of drugs that list the factory as a manufacturing site.

Bionovo looks to sell $10M in preferred stock, warrants

Botanical drug developer Bionovo Inc. plans to raise $10 million by selling convertible preferred stock and warrants to buy up to 240 million shares of common stock.
The Emeryville company (Pink Sheets: BNVI) focuses on using traditional Chinese medicines for women’s health and cancer indications. Its lead drug candidate, Menerba, is designed to treat “hot flashes” during menopause.

Pulmonx raises $10M

Pulmonx has raised $10 million, according to a regulatory with the U.S. Securities and Exchange Commission on Tuesday.
The Redwood City-based company sold equity to raise the funds. It makes what it says are minimally invasive medical devices and technologies for diagnosing and treating pulmonary disorders.

ChemoCentryx drops IPO target to $45M

ChemoCentryx, the next Silicon Valley initial public offering expected to debut on Nasdaq this week, lowered its IPO target early on Wednesday.
The Mountain View-based biopharmaceutical company has amended its IPO terms to 4.5 million shares at an offering price of $10 per share.

Velmedix gets $10.2M in Series B funds, adds CEO and VP

Velomedix said it has closed $10.2 million in Series B funding.
In addition, the Menlo Park-based development stage medical device company named Jeff Gold as CEO and Michael Moore and vice president of operations.

BayBio's Gail Maderis talks about new 2012 California biomed industry report

California’s biomedical industry employs nearly 270,000, generated revenue of more than $115 billion, captures $3.2 billion in National Institutes of Health grants and collects $2.7 billion in venture capital investment.
But, according to a report released today by Northern California trade group BayBio, the California Healthcare Institute and accounting-consulting firm PricewaterhouseCoopers, something is woefully amiss. The report contends that the state’s spot as the world’s intersection of innovation in medicine, devices, technology, academia and venture capital, is “balanced on a precipice.”

One-on-One with the Gladstone Institute's Michael Penn

Michael Penn is looking to make more of a deeper difference in his return to the Gladstone.
Penn, who spent the past eight years as a product and business development manager at biotech powerhouse Genentech Inc. in South San Francisco, was hired last month as the first vice president for strategy at the Gladstone Institutes.
His duties take in development, fundraising and communications for the San Francisco institute, which has units zeroed in on cardiovascular research, neurology and virology and immunology.

FDA review of NeurogesX HIV pain patch hits stock hard

FDA reviewers raised questions about a pain patch that NeurogesX Inc. wants to sell for HIV-associated nerve damage, sending the San Mateo company’s stock down 24 percent lower by mid-Tuesday.
The Food and Drug Administration’s staff said in briefing documents Tuesday that a study of the pain patch, called Qutenza,, failed to show superiority for the 60-minute application of the patch compared to low-dose capsaicin in a control group.
A 30-minute application was superior, the reviewers said.

FDA commits to quick review of new Genentech breast cancer drug

Genentech Inc.’s next-generation breast cancer drug will get priority review from the Food and Drug Administration.
The South San Francisco-based U.S. unit of drug giant Roche Group said Tuesday that the FDA said it would make a decision about the drug, called pertuzumab, by June 8.
Pertuzumab is a humanized monoclonal antibody designed to prevent the HER2 receptor — or human epidermal growth factor receptor 2, which promotes the growth of cancer cells — from pairing with other HER receptors. That may stop cancer cell growth or lead to the death of the cancer cell.
Researchers also believe when pertuzumab binds to HER2 that it may signal the body’s immune system to destroy the cancer cells.

Genomic Health's Randy Scott to lead human genome subsidiary

Longtime Genomic Health Inc. executive Randy Scott is leaving the company — sort of.
Scott will become CEO of a wholly-owned Genomic Health subsidiary that will focus on medical applications of the human genome. He will continue to serve on the Redwood City-based test developer’s board.

GSK 'finding' halts four trials of Anacor antibiotic

GlaxoSmithKline plc suspended enrollment in four trials of an Anacor Pharmaceuticals Inc. antibiotic after a “microbiological finding” in some patients in one of the studies.
The stock of Palo Alto-based Anacor (NASDAQ: ANAC) was down 36 cents, or nearly 5 percent, to $7.06 per share by mid-afternoon, after GSK said Monday that it suspended enrollment around GSK-052 in patients with complicated urinary tract infections.
The finding isn’t related to three other studies of the drug — a Phase IIb trial in complicated intra-abdominal infections and two Phase I trials — but GSK said it voluntarily suspended enrollment in those trials as well.

Cardica loses $3.2M in Q2, borrows $2M

Cardica Inc., which makes surgical devices, lost $3.2 million in the December quarter, its second, and borrowed $2 million from Century Medical Inc. on Dec. 27.
Redwood City-based Cardica (NASDAQ: CRDC) had an earlier secured debt deal with Japan’s Century Medical, an arrangement with $2 million left on it. Cardica made a distribution deal with Century Medical in September, and had already borrowed $2 million on the $4 million total allowed in the debt agreement.

Five Prime names founder Rusty Williams as president and CEO

Five Prime Therapeutics Inc. made Lewis Williams, M.D., president and CEO, thus confirming him in a job he’s held temporarily since August.
Williams has been temporary CEO of Five Prime since Julia Gregory quit as CEO last summer. Gregory herself had replaced CEO Gail Maderis in 2009.

Genentech, Singularity University ink deal

Genentech Inc. and Singularity University, a Mountain View institution focused on advancing technology, forged a deal aimed at the future of medicine.
South San Francisco-based Genentech will support Singularity University’s annual Summer Graduate Studies Program, a 10-week session blending various scientific and technology disciplines and become a leading sponsor of the institution’s 2012 FutureMed Program.
Financial terms of the deal were not disclosed.

Jobs Report: Biotech still selective in hiring

Still in shock from a drain-off of capital, life sciences companies will keep hiring selective, strategic and slim in 2012.
Early-stage companies still need cash to feed their growth, but more mature companies that are on the cusp of launching a product expect to hire, mostly in sales. Job cuts will continue in manufacturing, where excess capacity at contract manufacturing organizations has made it more attractive for companies to shut down their own drug-making shops.

Talon leukemia drug gets date with FDA advisory panel

Talon Therapeutics Inc. must hurdle a Food and Drug Administration advisory panel March 21 before its experimental leukemia drug can be approved.
San Mateo-based Talon (OTCBB: TLON) said Friday that its drug Marqibo will be assessed by the FDA’s oncology drugs advisory committee for treating adult Philadelphia chromosome-negative acute lymphoblastic leukemia, a rare blood cancer.

Early data show kidney cancer response to Exelixis' 'cabo'

Exelixis Inc.’s experimental cancer drug cabozantinib showed promise in patients with a form of metastatic kidney cancer, according to a preliminary report from an early-stage trial.
The South San Francisco-based drug developer (NASDAQ: EXEL), which will present the findings Saturday at the 2012 Genitourinary Cancers Symposium in San Francisco, said seven of 25 heavily pretreated patients with metastatic refractory renal cell carcinoma showed at least a partial response in the Phase Ib trial.
What’s more, 19 of 21 patients in the trial showed tumor regression after at least one assessment, the company said.

Threshold lands $25M upfront, possible $525M more, in cancer drug deal

Threshold Pharmaceuticals Inc. landed a $25 million upfront payment — with the potential of $525 million more in milestone payments — after inking a co-development and commercialization deal with Merck KGaA around an experimental cancer-fighting drug.
Threshold’s TH-302 is in a Phase III trial of patients with soft tissue sarcoma and a Phase II trial of patients with advanced pancreatic cancer.
The drug targets oxygen-deprived regions of tumors — so-called “hypoxic domains” — that are tough for drugs to reach effectively without serious side effects. Those regions are more prevalent in fast-growing and aggressive cancers like pancreatic tumors and sarcomas.

Gilead stock rises on potential hepatitis C cure

Gilead Sciences Inc.’s pricey acquisition of Pharmasset Inc. and its lead hepatitis C drug already may be paying off.
The Foster City-based drug developer (NASDAQ: GILD), known mainly for its drug that fight the AIDS virus, saw its stock rise nearly 10 percent by mid-day Friday after saying on Thursday that a combination of oral PSI-7977 and the anti-viral drug ribavirin cured a group of hepatitis C patients after just four weeks of therapy.
Gilead Chief Scientific Officer Norbert Bischofberger told analysts that the patients with genotype 1 hepatitis C had no detectable signs of the virus.

BioSF's new chief brings research, tech transfer background to job

San Francisco’s nonprofit resource for life sciences startups has hired its second leader in less than a year.
BioSF, a partnership between the mayor’s Office of Economic and Workforce Development, the nonprofit San Francisco Center for Economic Development and the University of California’s QB3 institute, in January hired cardiovascular researcher Ken Harrison as director.
Harrison will oversee a BioSF program that envelops several QB3 projects, including its new “startup-in-a-box” initiative that provides legal, banking and mentoring help to young companies.

Breast Cancer Action donations surge after Komen-Planned Parenthood fiasco

Believe it or not, there is a beneficiary of the controversial decision by Susan G. Komen for the Cure to not continue funding breast cancer screening at Planned Parenthood centers.
San Francisco-based Breast Cancer Action saw donations from its recent email alerts surge 30-fold from the average volume of click-throughs from the alerts, said spokeswoman Angela Wall. It sent out two alerts Wednesday about the change in Komen’s grant process, which Planned Parenthood has charged was based on pressure from antiabortion activists, and how the change affects Planned Parenthood.
“That’s huge for us,” Wall said about the surge in email alert responses.

FDA expands age range for Dynavax hepatitis B vaccine

Dynavax Technologies Corp. said the Food and Drug Administration agreed to expand the age range for use of the company’s Heplisav vaccine for hepatitis B.
Berkeley-based Dynavax (NASDAQ: DVAX) had expected it would only be able to use the vaccine on healthy adults 40 years old or older. But the FDA agreed to allow use in healthy adults age 18 to 70 years.
Dynavax, which has struggled to seek approval in the United States for Heplisav, called the change “a significant expansion.” It had once hoped to submit the application to the FDA in the third quarter of 2011.

StemCells gets FDA nod for eye trial using neural stem cells

An early-stage clinical trial using purified neural stem cells to treat dry age-related macular degeneration was approved by the Food and Drug Administration, said StemCells Inc.
Newark-based StemCells (NASDAQ: STEM) said the Phase I/II trial will administer the cells — extracted from fetal brain tissue — through a single injection in space beneath the retina of 16 patients. Those patients will be evaluated over one year and will be followed for another four years in a separate observational study.

Auxogyn raises $20 million

Auxogyn Inc., a Menlo Park startup aimed at helping in vitro fertilization clinics select fertilized eggs with the best chances to survive inside the mother, closed the final tranche of a $20 million Series A financing.
Spun out of the Stanford University lab of Renee Reijo Pera, Auxogyn’s algorithm-based Eeva system is designed to help IVF clinics place embryos into mothers on the third day after fertilization, rather than day five.

Hercules to gain $2M from selling Barrx Medical

Hercules Technology Growth Capital Inc. expects a net gain of about $2.2 million to $2.3 million in the first quarter of 2012 and a full repayment of its loan to Barrx Medical Inc., one of its portfolio companies.
Earlier this month, Hercules completed the sale of all its outstanding shares of Sunnyvale-based Barrx to Covidien plc (NYSE:COV) in a deal valued at $325 million.

Former Geron CFO gets $750K severance, $400-an-hour consulting gig

Longtime Geron Corp. employee David Greenwood, who served as interim CEO for seven months last year, received a lump sum severance payment of $750,000 and a two- to five-month consulting deal that will pay him $400 an hour.
Greenwood, who had been with Geron (NASDAQ: GERN) in various jobs since 1995, left the Menlo Park-based drug development company at the end of last year. He was appointed interim CEO on the departure of Thomas Okarma in February 2011.

Estech gets $7M loan from NXT Capital, Silicon Valley Bank

Estech Inc. on Wednesday received a $7 million venture loan package from the NXT Capital Venture Finance Group and Silicon Valley Bank.
San Ramon-based Estech makes medical devices that allow cardiac surgeons to perform minimally-invasive surgeries.

Medivation stock soars on strength of prostate cancer trial

More-detailed information about a late-stage prostate cancer study pushed Medivation Inc. stock higher Wednesday.
San Francisco-based Medivation (NASDAQ: MDVN) and Astellas Pharma Inc. said men in the Phase III trial who took their drug, called MDV-3100, lived a median of 18.4 months. That compares to 13.6 months for men who were given a placebo.
Medivation stock has skyrocketed 317 percent from Nov. 2, the day before Medivation reported initial results from the study, into mid-afternoon trading Wednesday. It was up $11.77 per share, or 21 percent, to $67.18 on Wednesday alone.

Sangamo's 'zinc finger' picks $13M payment from Shire for hemophilia

Shares of Sangamo BioSciences Inc. surged more than 25 percent after the Richmond-based company said it would work with Shire plc to develop drugs for hemophilia and other diseases.
Shire (NASDAQ: SHPGY) will pay Sangamo (NASDAQ: SGMO) $13 million upfront for exclusive worldwide rights to Sangamo’s “zinc finger” protein technology to target up to seven genes to stop the bleeding disorders hemophilia A and B.
The agreement, concluded Tuesday, will continue for six years.

Gilead gives CEO John Martin a $2.8M bonus

Gilead Sciences Inc. paid Chairman and CEO John Martin the highest bonus he was eligible for, $2.8 million, for his job performance in 2011.
Martin’s target bonus for 2011 was $1,859,000, and the maximum bonus he was eligible for was $2,788,500.
Foster City-based Gilead (NASDAQ: GILD) also set Martin’s 2012 salary at $1.5 million.

Impax nabs AstraZeneca migraine drug, will hire 20 people

Impax Laboratories Inc. will add 20 people to its sales force, it said Wednesday, after licensing the AstraZeneca migraine drug Zomig for $130 million.
The move beefs up the branded products pipeline of Hayward-based Impax (NASDAQ: IPXL), known more for marketing low-cost generic drugs. But the deal with AstraZeneca (NYSE: AZN) could tie in to Impax’s generic business — it has focused on controlled-release generics and could apply the same technology with Zomig.