Ardelyx raises $30M in financing, hires chief business officer

Ardelyx Inc. said Wednesday it closed a $30 million Series B preferred stock financing.
This included previous investors Menlo Park-based New Enterprise Associates Inc., San Francisco-based CMEA Capital, unnamed individual investors, and new investor San Francisco-based Amgen Ventures LLC.

Xoma's Steven Engle quits as chairman, president, CEO

Xoma Ltd. Chairman, President and CEO Steven Engle stepped down Wednesday from all of the positions as the company struggles to move past disappointing results from a diabetes trial earlier this year.
The Berkeley company (NASDAQ: XOMA) said current board member John Varian will become interim CEO and W. Denman Van Ness, Xoma’s lead independent director, will become chairman. Xoma will start looking for a permanent CEO.

Impax challenges patents of treatment for laughing, crying fits

Generic drug maker Impax Laboratories Inc. is challenging the patents of Avanir Pharmaceuticals Inc.’s Nuedexta as it tries to launch a lower-cost version of the drug.
Alameda-based Impax (NASDAQ: IPXL) said Wednesday that it has filed an abbreviated new drug application with the Food and Drug Administration for its version of Nuedexta, which treats pseudobulbar affect. PBA, as it is known, appears in some people with underlying neurologic conditions, causing involuntary, sudden and frequent episodes of laughing or crying.

FDA: Repackaged Avastin blinds eye patients in Florida

Doses of the Genentech Inc. cancer drug Avastin repackaged at a Florida pharmacy for patients with an eye disease caused blindness and other serious eye infections, according to the Food and Drug Administration.
The news could boost the contention of South San Francisco-based Genentech that Avastin should not be broken down into smaller doses for off-label use against wet age-related macular degeneration. The drug, though designed to fight various forms of cancer, is the most-prescribed treatment for that eye disease because its mechanism of action is the same as a more-expensive Genentech drug, Lucentis.

Neuraltus ALS drug wins fast track, orphan status

An experimental treatment for Lou Gehrig’s disease won fast track and orphan drug designations from the Food and Drug Administration, potentially speeding the drug’s development by Neuraltus Pharmaceuticals Inc.
NP-001, the Palo Alto company’s treatment for amyotrophic lateral sclerosis, or ALS, received those designations last week, Neuraltus CEO Andrew Gengos told the San Francisco Business Times on Tuesday.

Air Xpanders to start breast reconstruction device trial, raise $5M-$7M

AirXpanders Inc. will start a clinical study of its breast tissue expansion device in mastectomy patients — and seek additional financing — after the Food and Drug Administration on Monday granted a key exemption.
The Palo Alto company said it will seek $7 million-$10 million to help pay for clinical and commercial work for AeroForm, its device for women undergoing breast reconstruction. That work includes regulatory clearance in the United States and Europe, increased manufacturing and limited commercialization in Europe and Australia.

New Deloitte digs focuses life sciences colleagues

As Deloitte moved into its new space at 555 Mission St. this summer, its biotech team was salivating.
After all, within the 182,000 square feet that Deloitte leased, its biotech practice leaders saw a chance to bring all of their services together for their clients. Some 60 biotech-related practitioners in consulting, tax, audit and financial advice would have a better opportunity to collaborate in what Deloitte is calling a life sciences incubator.

For CIRM, there's no place like home

California’s stem cell research funding agency may be unpacking its bags. At last some of them.
When Gov. Jerry Brown called for state agencies to cancel unnecessary out-of-state travel in light of the state’s ongoing fiscal problems, the California Institute for Regenerative Medicine told Brown that all its impending trips — including to Australia, Japan, Paris and Amsterdam — were “mission critical.”
In fact they were, in CIRM’s view, virtually a matter of life and death.

Angel investors push for California tax credits

A group of angel investors is urging state legislators to offer tax credits on investments, claiming California is missing out on startups lured away by other states’ incentives.
Twenty-six other states offer angel investment tax credits and nine states have no income tax at all, said Sarosh Kumana, a spokesman for Technology Angel Investors of California. The group is leading the charge to convince California legislators to implement a program of their own.

Varian to buy back $250 million in shares

Medical device company Varian Medical Systems Inc. said Friday it agreed to buy back $250 million of its common stock under an accelerated share repurchase program.
Palo Alto-based Varian (NYSE:VAR) said the company also amended its revolving credit facility with Bank of America N.A. to increase its borrowing capacity from $225 million to $300 million.

Lab worker shortage threatens hot molecular diagnostics industry

A tug-of-war for hiring specialized, hard-to-find lab workers could pull a potential growth industry out of California.
Molecular diagnostic test companies — part of the personalized medicine boom — are competing with hospitals and reference labs for master’s degree-level clinical laboratory scientists, or CLSs. That conflict is driving wages higher, company leaders say, as underfunded job-training programs can’t keep up with demand.
But leaders in the life sciences industry and academia will launch a program in September that could alleviate the supply-demand crush. Tapping federal economic stimulus program cash, the program will narrow the scope of CLS training for molecular diagnostics companies, helping them land the workers they need to quickly send test results back to doctors and patients.
At the same time, the new program could allow hospitals to hold onto more broadly trained lab workers.

Shrinking biotechs peddle space to deal-seekers

Sometimes the search for quality biotech real estate along the Peninsula is simply a waiting game.
As tight venture capital checkbooks, the weak economy and risk-averse capital markets continue to squeeze cash-intensive biotech companies, deals on subleases for even freshly built space can be found.
It’s the proverbial win-win for companies — one sheds costs, the other gets top-drawer space for a fraction of the market price.
Sublease deals are nothing new, but the amount of ready-to-move-in, biotech-centric sublease space is strong for companies jumping into the lease market.

HCP bets on labs, not cubicles, in Redwood City

HCP Inc. is placing a $43 million bet on Redwood City and the conversion of cubicles to labs.
The real estate investment trust in March returned 88,000 square feet of space in Seaport Centre to the market after converting it for biotech or other life sciences companies.

Google fined $500M for illegal drug ads

So much for making money without doing evil.
Google Inc. has agreed to forfeit $500 million to the U.S. government for helping Canadian companies illegally market and send prescription drugs to U.S. consumers.
The settlement, announced by the U.S. Justice Department, includes an admission by Mountain View-based Google of wrongdoing and the imposition of compliance and reporting measures to prevent similar conduct in the future. Google acknowledged it let online Canadian pharmacies place advertisements through its AdWords program targeting U.S. consumers, "resulting in the unlawful importation of controlled and non-controlled prescription drugs," the DOJ said.

Complete Genomics grabs $8 million for pediatric cancer sequencing

Complete Genomics Inc. will be paid $8 million to sequence the genomes of about 500 children with cancer.
The Mountain View company has already sequenced genomes from 50 children in the first phase of this project. It’s working for SAIC-Frederick Inc., which is in turn working for the National Cancer Institute under a contract paid for by stimulus funding from the U.S. government.

Relievant Medsystems names DiNello president and CEO

Relievant Medsystems named Alex DiNello president, CEO and a member of the board.
Redwood City-based Relievant said DiNello has more than 20 years of experience in the medical device industry, including 18 years focusing on spinal therapies and related medical devices.

Vivus to raise $45M in stock sale

Drug developer Vivus made a deal with institutional investors, who agreed to buy 6.889 million shares at $6.65 per share. The company will net a little more than $45 million after expenses of about $562,000.

The Pitch: Vascular Access Technologies offers safer vein access

THE BUSINESS: Vascular Access Technologies Inc. offers a device and method that it says transforms how central veins are accessed by medical professionals.
BUSINESS/TECHNOLOGY IT COULD DISRUPT: Vascular Access Technologies’ technology replaces the essentially blind “outside-in” method commonly used today.
MANAGEMENT TEAM: CEO Patrick Burt was previously the founder and CEO of Acteron Inc., which was acquired by Flextronics in 2010.

Holdout Celera shareholder sells stock to Quest Diagnostics

A large hedge fund investor in Celera Corp. surrendered its 19.3 million shares to Quest Diagnostics Inc. , which bought the Alameda genetic test developer in May.
Biotechnology Value Fund LP withdrew its demand for an appraisal of its shares and accepted the same $8-per-share payout Quest (NYSE: DGX) made to other Celera shareholders. BVF general partner Mark Lampert had said in March that the Quest deal didn't adequately value Celera.

FDA: No advisory meeting needed for Corcept drug

Corcept Therapeutics Inc.’s route to approval for its drug to treat Cushing’s Syndrome just got a little easier.
The Food and Drug Administration told the Menlo Park company (NASDAQ: CORT) that there will be no advisory committee meeting to review Corcept’s new drug application for Corlux, or mifepristone. That eliminates one step of the process toward winning FDA approval, though it does not change the Feb. 17 date that the agency must make a decision about Corlux.

Corcept hires new CFO

Corcept Therapeutics Inc. hired Gary Robb as chief financial officer.
Robb takes over from the Menlo Park’s previous CFO, Caroline Loewy, who told the company in May she was leaving.

Roots of new melanoma drugs run deep in Bay Area

Zelboraf, the melanoma treatment approved Wednesday by the FDA, is a great Bay Area story — developed by Berkeley’s Plexxikon Inc., marketed by South San Francisco’s Genentech Inc. and accelerated by a diagnostic test developed by Pleasanton’s Roche Molecular Diagnostics.
You can’t get much more Bay Area than that.
But Zelboraf isn’t the only new melanoma drug with a Bay Area connection. Bristol-Myers Squibb’s Yervoy, approved by the Food and Drug in March, largely owes its development to research done by Dr. James Allison and colleagues in the mid-1990s at the University of California, Berkeley.

Lawrence Berkeley Lab opens biofuels test center in Emeryville

Lawrence Berkeley National Laboratory opened a 15,000 square foot biofuels research center in Emeryville this week.
The Advanced Biofuels Process Demonstration Unit, or ABPDU, will allow large scale tests of processes developed in laboratory work. The biofuels in the center are made from “cellulosic biomass” -- i.e. bits of plants that aren’t useful for food or animal feed -- and the lab hopes their development will create a new energy industry in the United States.

Four BioTime embryonic stem cell lines OK'd for NIH registry

Four embryonic stem cell lines developed by a subsidiary of BioTime Inc. were approved by the National Institute of Health for use by stem cell researchers in federally funded research, the company said Friday.

Omniox bets on oxygen-binding proteins

Stephen Cary doesn’t mind failure. He doesn’t invite it, either.
Omniox Inc., Cary’s young San Francisco company, is testing oxygen-binding proteins as treatments for aggressive cancers, heart attacks, strokes and battlefield wounds. It is the proverbial “multiple shots on goal” that is the aim of biotech company executives: You can miss wide with several indications, the thinking goes, as long as you score big with one.
The range of possibilities could be a boon for Omniox as it chats up potential venture backers, especially if proof-of-concept brain cancer and heart attack studies in animals over the next six months prove that the company is more than an extended research project.

Biotech seedlings flourish with SBIR grants

Bay Area biotech entrepreneurs working in their nascent ventures are turning to two long-running federal grant programs designed to spur research by small businesses.
Small Business Innovation Research, which debuted in 1982, and the Small Business Technology Transfer Program, which was modeled after the SBIR when it was created in 1992, provide grants for research that targets a specific product or commercial application. The grants are made through 11 participating government agencies.
The programs’ supporters argue that the grants are financing innovation and job creation at a time both are sorely needed.

Comparative effectiveness a challenge for drugmakers

Call it “comparative effectiveness research” or a piece of “Obamacare,” but a plan to help health insurers, doctors and patients pick the best and most cost-effective treatment options could reshape drug makers’ business models.
That is, if it ever happens as originally envisioned. Confusion and questions reign, even as health care costs continue to escalate.
What data standards will payers — Medicaid and private health insurance plans, in particular — want to see from comparative effectiveness research? When will they want to see the data? How big of a clinical difference between one drug and a competitor’s drug will be needed to get payers to cover all or a portion of its use? And how big of an impact will such studies have on the bottom line?

Report: Five Prime CEO departs, Rusty Williams takes over

Five Prime Therapeutics founder Lewis “Rusty” Williams has replaced Julia Gregory as CEO, Elsevier Inc.’s In Vivo Blog reported.
A Five Prime spokeswoman confirmed that Gregory is no longer with the company, the blog reported. A Five Prime spokeswoman did not return a phone message left by the San Francisco Business Times.
Gregory replaced Gail Maderis as CEO in 2009, coming from Lexicon Pharmaceuticals.

Genentech melanoma drug, Roche companion diagnostic win FDA approval

A groundbreaking drug-diagnostic combination for metastatic melanoma patients was approved by federal regulators, nearly two months before approval was expected.
Zelboraf, developed by Berkeley’s Plexxikon Inc. and marketed by South San Francisco’s Genentech Inc. , will treat patients with the deadly skin cancer who have a specific mutation, known as BRAF V600E. That mutation, found only in cancerous tumors and in a vast majority of malignant melanomas, is detected in a test developed by Roche Molecular Diagnostics of Pleasanton.

One-on-One with Roche Molecular Diagnostics' Paul Brown

In the personalized medicine revolution, Roche Molecular Diagnostics is positioned to be the major arms supplier.
The Pleasanton-based unit of Swiss drug maker Roche developed, for example, a diagnostic test that helped Berkeley drug maker Plexxikon find melanoma patients who had a specific genetic mutation for clinical trials. Targeting those skin cancer patients using RMD’s test helped Plexxikon accelerate its trials and show strong results.
RMD and Roche-owned Genentech , which is marketing the drug, on Wednesday won Food and Drug Administration approval of the drug and the companion diagnostic.
What’s more, RMD is central to Roche’s mandate that the development plan for every therapeutic include a companion diagnostic or biomarker.
Paul Brown, a 25-year veteran of Roche’s pharma division, about 14 months ago joined RMD as CEO. He oversees about 500 people at the Pleasanton site as well as 170 or so at a facility outside Zurich.
Brown sat down with me last month to talk about the company’s efforts, the FDA and the role of diagnostics in improving health care.

Bay Area Science Festival campaign kicks off

A consortium of Bay Area business, research, academic and government leaders want to “unleash your inner scientist” with the week-long Bay Area Science Festival.
The inaugural event kicked off planning for the festival Tuesday with a news conference featuring Rep. Nancy Pelosi, San Francisco Mayor Ed Lee and University of California, San Francisco , Vice Chancellor Keith Yamamoto.
In all, 100 free events from Oct. 29 to Nov. 6 will try to get kids and adults excited about science and what it means for the Bay Area. Think biotech. Think high-tech. Think engineering.

Gilead's HIV-fighting Quad pill effective in Phase III trial

Gilead Sciences’ four-in-one HIV treatment was more effective than its three-in-one tablet in a late-stage study of patients new to a drug regimen to combat the AIDS virus.
However, the Foster City-based company’s stock traded lower, presumably because the company didn’t release deeper safety data from the Phase III trial.
The so-called Quad pill combines four Gilead compounds in a once-a-day tablet. The drugs are emtricitabine and tenofovir — combined in Gilead’s Truvada and as two of the three drugs in Gilead’s Atripla — along with an experimental drug, elvitegravir, and a new boosting agent, cobicistat.
The Quad pill’s ease of use, effectiveness and safety are key to Gilead (NASDAQ: GILD) winning approval from the Food and Drug Administration and holding on to its position as the top developer of HIV treatments. It could offer an alternative to people who can’t tolerate Atripla.

Intersect sinus treatment gets FDA approval

Intersect ENT Inc. on Monday announced that the U.S. Food and Drug Administration has approved its premarket application for a sinusitis treatment.
Palo Alto-based Intersect focuses on treatment for ear, nose and throat patients.
The company's product, Propel, is an implant that offers controlled drug delivery for chronic sinusitis.

Nile reduces Q2 loss

Nile Therapeutics Inc. lost $880,530 in the June quarter, down from a loss of $1.5 million a year earlier in the same period.
San Mateo-based Nile (Pink Sheets: NLTX) had $346,000 in revenue in the most recent quarter, compared with no revenue in the second quarter of 2010.

Impax touts success of Parkinson's drug in late-stage trial

Impax Laboratories Inc. said a treatment for Parkinson’s Disease that it is testing with GlaxoSmithKline did well in a Phase III clinical trial.
Hayward-based Impax (NASDAQ: IPXL) has been working since December with GlaxoSmithKline (NYSE: GSK) on the drug, IPX-066.
Impax, which typically focuses on generic drugs, is developing IPX-066 through its “branded products unit,” Impax Pharmaceuticals.

Cancer drug shortages threaten trials

Gearing up for a pivotal late-stage study of its lead tumor-fighting drug, Threshold Pharmaceuticals has checked all the boxes with regulators, investors, doctors and patients.
Yet one nagging question remains: Will it have enough vials of an essential generic chemotherapy drug to last throughout the trial?
Threshold isn’t alone. A national shortage of key generic cancer drugs — often used in combination with treatments like Threshold’s or to provide statistical backdrops in studies — is threatening clinical trials.
The shortfall is forcing a handful of Bay Area drug developers to develop backup plans, including stockpiling supplies.

Jennerex raises $8.6M in private placement

Cancer drug company Jennerex Inc. raised $8.6 million in gross proceeds from a private placement.
The San Francisco company didn’t say what it is likely to net after expenses.
Jennerex, led by CEO and President David Kim, M.D., is testing a treatment for liver cancer which is in mid-stage clinical development. It plans a Phase IIb test of that treatment “in the coming months.”

Gilead wins FDA approval of new HIV combo treatment

The Food and Drug Administration approved a new combination HIV treatment that includes Gilead Sciences ’ Truvada and another antiretroviral drug, Edurant.
Foster City-based Gilead (NASDAQ: GILD) makes Truvada, which is a combination of two drugs -- emtricitabine and tenofovir disoproxil fumarate. In this new treatment, Truvada is combined with Edurant (rilpivirine) in a single tablet aimed at HIV-1 patients who are “treatment-naïve,” meaning they have not taken HIV treatment before.
The new combination pill is called Complera.

Prenatal diagnostic testing firm Verinata Health raises $46.5M

Verinata Health Inc. has raised $46.5 million in a third round of funding with an additional $2 million expected to close on August 31, the company said Tuesday.
The new round was led by existing investors Mohr Davidow Ventures, Sutter Hill Ventures and Alloy Ventures.

Gut feeling: Corey Goodman-led startup lands $5M investment

A gut feeling for microbes and a small amount of venture cash could help a San Francisco startup unleash a new, faster way to identify diseases and uncover personalized treatments.
Second Genome Inc., whose founders include serial biotech entrepreneur Corey Goodman and two of Lawrence Berkeley National Laboratory scientists, said Tuesday morning that it received $5 million in a Series A round co-led by new investors Advanced Technology Ventures and Morgenthaler Ventures.

Genentech to pay $28M in cancer drug deal with Array

Genentech will pay $28 million next month as a downpayment for Array BioPharma to develop two cancer drugs designed to disrupt a tumor cell’s natural repair mechanism.
The deal centers on an oral drug developed by Boulder, Colo.-based Array to inhibit Checkpoint kinase 1, or ChK-1, but also includes a Phase I oral drug from South San Francisco-based Genentech, GDC-0425.

Gilead to buy Genentech manufacturing facility

Gilead Sciences Inc. will buy a clinical manufacturing facility in southern California from Genentech, moving 55 workers from one Bay Area life sciences powerhouse to another.
The companies did not say how much Foster City-based Gilead (NASDAQ: GILD) will pay for 70,000-square-foot plant and other assets in Oceanside, which makes biologic compounds for Phase I and Phase II clinical trials and toxicity studies for South San Francisco-based Genentech.
The deal is expected to close in the third quarter.

Genentech: Keep Avastin available for 'appropriate' breast cancer patients

Avastin should remain available to patients who need it most while Genentech undertakes another trial, the South San Francisco-based biotech company wrote in what amounts to the final argument in its appeal to maintain Food and Drug Administration approval in metastatic breast cancer.
In paperwork submitted Thursday to the FDA, Genentech said Avastin in combination with the chemotherapy drug paclitaxel should continue to be available while new labeling directs doctors to the “most appropriate” cases where breast cancer has spread to other parts of the body. It also said officials emphasize to doctors and patients the drug’s efficacy and safety data, “thus supporting informed decision-making regarding Avastin.”
Ultimately, FDA Commissioner Margaret Hamburg will decide yet this year whether to end approval of the world's best-selling cancer drug for women with metastatic breast cancer.

Corcept stakes future on Cushing's orphan drug

A drug with a social stigma — yet one that could transform patients with a disfiguring but little known disease — has tiny Corcept Therapeutics Inc. on the cusp of its first approval instead of on the edge of shutting down.
The 12-year-old Menlo Park company said the Food and Drug Administration accepted its application for Corlux, a treatment for Cushing’s syndrome. The disease often is triggered by steroids that cause the body to build up excessive cortisol, a hormone that influences metabolism.

Medivation says prostate cancer drug also blocks breast cancer cell growth

Medivation Inc. said a preclinical test of its drug MDV3100 -- aimed at prostate cancer -- showed it also blocked the growth of breast cancer cells.
San Francisco-based Medivation (NASDAQ: MDVN) tested the drug with partner Astellas Pharma Inc. at the University of Colorado in Denver.

MAP Pharma gets $20M payment for FDA filing

MAP Pharmaceuticals Inc. will be paid $20 million by partner Allergan Inc. for filing a drug application with the Food and Drug Administration.
Mountain View-based MAP (NASDAQ: MAPP) said the FDA accepted its application for the inhaled migraine drug Levadex. The successful submission of that application triggers a $20 million milestone payment under MAP’s deal with Allergan.
The “goal date” for the FDA to review the application is March 26, 2012.

Intuity Medical raises $12M to add to Series D funding

Intuity Medical Inc. said Monday it secured an additional $12 million in funding, bringing its Series D round to a total of $76 million.
The Sunnyvale-based company previously announced it had raised $64 million of the round in January 2010.

Impax profit falls in Q2

Generic drug maker Impax Laboratories Inc. reported lower sales and profits in the second quarter than a year ago.
The Hayward company (NASDAQ: IPXL) earned $12.5 million in the June quarter, down from $31.3 million a year earlier. Sales fell to $125.9 million, down from $153.1 million a year earlier.