Friday, July 29, 2011

Merck to shutter Mission Bay R&D center

Merck & Co. will close its Mission Bay research center, eliminating 50 jobs and moving another 10 positions to other facilities.
Merck (NYSE: MRK) was the first large life sciences companies to move into San Francisco’s biotech enclave as it bought Sirna Therapeutics in late 2006 for $1.1 billion. Merck planned to double its Sirna unit’s footprint in Mission Bay, and its space reached as much as 66,000 square feet at Alexandria Real Estate Equities ’ 1700 Owens St.
But those growth plans were never fulfilled, Likewise, RNA interference technology, which essentially turns off genes that lead to disease, has yet to take off as hyped. Still, Merck spokesman Ian McConnell said Friday that the company continues to invest significantly in RNAi technology.

Thursday, July 28, 2011

Research Track: Gladstone scientist turns human skin cells into functional brain cells

A scientist at the Gladstone Institutes has discovered a novel way to convert human skin cells into brain cells, advancing medicine and human health by offering new hope for regenerative medicine and personalized drug discovery and development.
A paper being published online today in the scientific journal Cell Stem Cell, by Sheng Ding, PhD, reveals efficient and robust methods for transforming adult skin cells into neurons that are capable of transmitting brain signals, marking one of the first documented experiments for transforming an adult human's skin cells into functioning brain cells.

Wednesday, July 27, 2011

Growing Threshold, Nodality sublease Exelixis space

Exelixis Inc. is unloading more than 53,000 square feet in South San Francisco to two up-and-coming companies.
Exelixis (NASDAQ: EXEL), which once had a workforce more than 600, said it will sublease 28,180 square feet at 170 Harbor Way to cancer drug maker Threshold Pharmaceuticals Inc. and 25,110 square feet in the same building to Nodality Inc., which is working on clinical tests that can predict cancer and autoimmune diseases.

Federal judge dismisses suit over stem cell funding

A federal judge dismissed a lawsuit Wednesday against the Obama administration’s funding of embryonic stem cell research, a victory for stem cell researchers in California and elsewhere whose work has been under a cloud.
The suit, brought by two adult stem cell researchers who said funding violated the 1996 Dickey-Wicker law against taxpayer funding of projects that harm embryos, put a pall on stem cell research even as new facilities were built in California with state and private support.

Tuesday, July 26, 2011

BayBio COO leaves after 16 months, lands in D.C.

Jeremy Leffler has quietly returned to Washington, D.C., after just 16 months as chief operating officer and CEO-to-be at the life sciences trade group BayBio.
A self-described “political junkie,” Leffler is the new director of federal policy for drug developer Sanofi-Aventis. He had spent eight years in the nation’s capital, including four as manager of federal public policy with Eli Lilly and Co., before taking the BayBio post in February 2010.

Impax expects Parkinson's trial data by end of August

A late-stage trial of an Impax Laboratories Inc. drug, designed to control involuntary muscle jerks experienced by Parkinson’s disease patients, will report early results in late August.
Assuming positive results from the Phase III trial of Impax’s IPX-066, Hayward-based Impax (NASDAQ: IPXL) said it would file a new drug application with the Food and Drug Administration in the fourth quarter.

Monday, July 25, 2011

Raptor rare disease trial has good results, but stock drops

Shares of Raptor Pharmaceutical Corp.plummeted more than 28 percent Monday despite the Novato company reporting that its treatment for a rare metabolic disorder was as effective in a late-stage clinical trial as a currently marketed treatment.
Raptor (NASDAQ: RPTP) is betting that its drug, called Cysteamine or RP-103, is at least as effective as Mylan Laboratories Inc.’s (NASDAQ: MYN) Cystagon for the rare and potentially fatal genetic disease nephropathic cystinosis.

Anacor barks up right tree with neglected diseases focus

Anacor Pharmaceuticals Inc. is going to the dogs — and that’s just fine with CEO David Perry. The sooner it gets there, the faster the Palo Alto company can tackle more neglected human diseases.
It’s this simple: Some of the same parasites rampant in Fifi and Fluffy also cause some of the most devastating neglected diseases in humans. But while people willingly plunk down cash to acquire the latest drug to flush out a pet’s heartworm, poor people in developing countries must settle for older and cheaper — and, perhaps, less effective — treatments for tuberculosis, malaria or river blindness, for example.
The trick for a young drug-development company like Anacor (NASDAQ: ANAC) then is to come up with deals that balance those competing interests.
Anacor, whose website lists "neglected diseases" alongside its human commercial drug prospects, may have a few solutions.

Friday, July 22, 2011

Virtual companies add virtually little to overall economy

If Horace Greeley were alive today — and a venture capitalist to boot (work with me here) — he might turn to today’s life science innovators and say, “Go virtual, young man ….”
“Virtual” is all the rage. Farm out costly activities like clinical trial research and manufacturing, hire overseers to keep those activities in line, build up a contractor economy and get your company to a point (quickly and with little cash burn) where it can be sold.
But does the virtual (read: outsourcing) model make wider sense?

SARcode sees Phase III for dry eye drug

If SARcode Bioscience Inc.’s vision stays in focus, there won’t be a dry eye in the house.
Aiming to take advantage of a dearth of effective treatments on the market today, the Brisbane company closed a $44 million venture round that sees it through the first of potentially three late-stage trials for dry eye disease.
That is nearly as far as anyone else has reached with a dry eye drug over the past few years. “Nine have failed in dry eye, so there’s skepticism among investors,” said SARcode CEO Quinton Oswald.

Thursday, July 21, 2011

Research Track: Of worms, monkeys and research winners

You can’t win if you don’t play.
That’s not a direct quote from Regis Kelly, the head the University of California initiative QB3, but it might as well be. One of the issues with scoring outside funding for life sciences research, Kelly says, is just getting those potential financial backers to know what’s cooking at QB3’s three University of California campuses.
So, as I reported last week, QB3 and consulting firm Deloitte launched a competition that will spotlight some of that research. It also will land a researcher a $10,000 prize, but it could bring a lot of science to the attention of folks willing to fund it.
Minus the direct cash payout from me, that’s essentially the focus of our Research Track feature. I am compiling each week in one location — your friendly BiotechSF blog — medical research coming out of Bay Area institutions.
Use it, and perhaps you can win, too.

UCSF, Kaiser team with Affymetrix to unlock genetic data in 100K-person study

A collaboration between UCSF, Kaiser Permanente and Affymetrix Inc.genotyped the DNA of some 100,000 people in just 15 months, unlocking doors to medical researchers for years to come.
The $24.8 million project, funded by the National Institutes of Health’s federal stimulus program outlay, is significant in several ways.

Wednesday, July 20, 2011

Dynavax hepatitis B vaccine effective but lots inconsistent

Shares of Dynavax Technologies Corp.plummeted 19 percent Wednesday after the Berkeley company company said its hepatitis B virus vaccine bested a current treatment but said lots of the vaccine were inconsistent.

SuperGen closes deal with Astex; CEO wins $410K bonus

Overcoming shareholder criticism, SuperGen Inc. closed Wednesday on its acquisition of Astex Therapeutics Ltd. that won its CEO a $410,000 bonus and its new president a $449,000 salary.

Tuesday, July 19, 2011

Exelixis business development boss leaves company

Exelixis Inc.’s head of business development, Fran Heller, left the drug developer Monday, the company said in a Securities and Exchange Commission filing Tuesday.
The news of Heller’s departure as executive vice president of business development comes on the heels of Bristol-Myers Squibb’s decision earlier this month to return a cancer drug to Exelixis (NASDAQ: EXEL). While the company said it would not continue research on that drug, XL-218, it has concentrated on another cancer drug that BMS gave back a year ago, cabozantinib, which the company could partner with a larger drug developer.

Monday, July 18, 2011

South City reintroduces itself to Genentech

Dubbed an insider's look at the 2009 buyout of South San Francisco-based biotech giant Genentech by Roche, Genentech Chief Financial Officer Steve Krognes didn't disappoint at a BioExec Institute event last week.
But South San Francisco City Councilman Pedro Gonzalez may have provided the best insight into the fallout of the $47 billion deal and its impact on the Bay Area psyche.

Awaiting trial results, Sangamo pushes on with zinc finger technology

Sangamo BioSciences Inc. 's gene-editing technology could produce exciting commercial news on the horizon. But the Richmond company isn't resting on what may happen — it continues to gather scientific evidence around the technology.
The zinc finger technology has been described as a kind of "molecular scissors" that cuts and replaces pieces of a gene. So instead of treating a disease, Sangamo's work could provide a functional cure for some big-name diseases like AIDS and hemophilia.
Talk like that puts Richmond-based Sangamo (NASDAQ: SGMO) dead-center in the targets of potential investors and of doubters, too.

Talon latches on to accelerated approval for leukemia drug

Talon Therapeutics Inc. will seek accelerated approval from the Food and Drug Administration for its experimental treatment of a type of leukemia.
San Mateo-based Talon said Monday that it filed a new drug application for Marqibo, a capsule form of the FDA-approved anticancer drug vincristine, against adult Philadelphia chromosome negative acute lymphoblastic leukemia. Talon (OTC BB: TLON) said its drug could last longer in the blood and accumulate at the tumor site, increasing the amount of vincristine delivered to the tumor.

SARcode Bioscience nabs $44M second-round funding

SARcode Bioscience Inc., a Brisbane company developing eye treatments, raised $44 million in a second round of funding led by Sofinnova Ventures.
SARcode said it plans to use proceeds of the new funding for clinical development of a treatment for dry-eye syndrome.

Sleep drug rejection leads Transcept to cut jobs

Transcept Pharmaceuticals Inc. , whose middle-of-the-night sleep drug was rejected by regulators last week for a second time, said late Friday that it would lay off 45 percent of its workforce.
The Richmond company (NASDAQ: TSPT) didn’t say exactly how many employees would lose their jobs, but based on previous headcounts reported by Transcept, about 14 people will lose their jobs from a workforce of 31.

Friday, July 15, 2011

Genentech: Breast cancer drug hits its mark in late-stage trial

A late-stage breast cancer trial showed that a Roche Group drug, combined with the popular cancer fighter Herceptin and chemotherapy, hit its main goal in women with a form of breast cancer that has spread to other parts of the body.

Exelixis lands on its feet again with another cancer drug giveback

Leave it to Exelixis Inc. to (again) turn a negative into a positive.
Britol-Myers Squibb will return an early-stage cancer drug, which could have translated into $315 million in bio bucks plus sales performance milestones and double-digit royalties, to South San Francisco-based Exelixis (NASDAQ: EXEL).
Exelixis — now concentrating on cabozantinib, a drug that BMS gave back little more than a year ago — said it has no plans to further research and development or eventually commercialize the drug.
A bummer? Yeah, probably. A lost opportunity? Maybe. A total loss? No.

Executive Profile: Terry Hermiston, Bayer vice president of U.S. biologics research

As site head of Bayer’s U.S. innovation center in Mission Bay, Hermiston oversees 80 people focused on hematology, cardiology, oncology, women’s health care and diagnostic imaging research. Hermiston came to Bayer in its 2007 acquisition of Schering/Berlex, where he oversaw gene technologies.

Affymax preps for dialysis drug debut

After two decades, a name change for its lead product and damaging late-stage trial data a year ago, Affymax Inc. ’s first drug is ready for show time.
The Palo Alto company’s drug, called Peginesatide, could break Amgen Inc.’s virtual monopoly on treating anemia in kidney dialysis patients. In May, Affymax submitted its application for Food and Drug Administration approval of the drug.
In early or mid-August, the agency will say whether it accepts the 800,000-page application and set a target approval date, likely to be in early 2012.

Thursday, July 14, 2011

Bristol-Myers Squibb returns another cancer drug to Exelixis

Bristol-Myers Squibb is returning rights to an experimental cancer drug to Exelixis Inc. — the second time it has sent a drug back to the South San Francisco biotech company in little more than a year.

Transcent Medical's $51M leads life science funding roundup

Transcend Medical leads a list of recent financing action by Bay Area life sciences companies.
Transcend closed a $51 million Series B round, including a previously announced $35 million.

Wednesday, July 13, 2011

InSite Vision lands $22M from private placement

Eye drug maker InSite Vision Inc. will use most of the $22.2 million raised from a private placement to fund clinical trials and working capital.
The Alameda company (OCTBB: INSV) will issue 37 million shares of its common stock as well as warrants to buy about 14.8 million additional shares. Those warrants will be exercisable for five years at an exercise price of 75 cents per share.

Tuesday, July 12, 2011

FDA to reject middle-of-the-night sleep drug, Transcept says

Regulators are putting Transcept Pharmaceuticals ’ middle-of-the-night sleep drug to rest.
The Richmond company (NASDAQ: TSPT) said Tuesday that it expects the Food and Drug Administration to reject its tablet, called Intermezzo, for the second time in 21 months.
Transcept and the FDA met in a teleconference earlier Tuesday, the company said, during which the FDA had continued safety concerns about the drug.

Zogenix, Durect target J&J schizophrenia drug

Durect Corp. and Zogenix Inc. will develop a needle-free formulation of one of the best-selling schizophrenia treatments.
Johnson & Johnson ’s Risperdal Consta requires a large needle for twice-a-month injections into muscle. Cupertino-based Durect and Zogenix, which has research operations in Emeryville, said their Relday would be delivered just under the skin once a month without the use of a needle.
The potential market is big — Risperdal had sales of $1.5 billion last year.

Middle-income countries hurt in Gilead HIV drug deals, groups say

You can’t please everyone — that’s what the folks at Gilead Sciences Inc. must be muttering after announcing deals Tuesday morning that expand access to their life-saving HIV treatments in poor countries.
Good, say the international humanitarian organization Doctors Without Borders and Oxfam, but not good enough.

Gilead boosts low-cost HIV drug program for developing countries

Four Indian drug manufactures can make Gilead Sciences Inc.’s experimental “Quad” pill, and Gilead became the first drug maker to sign a deal with a newly formed patent pool, under deals that will deliver lower-cost HIV/AIDS drugs to the developing world.

Monday, July 11, 2011

Impax to pay $790K severance to former operations chief

Impax Laboraties Inc. will make a $790,434.50 severance payout to departed operations chief Charles Hildenbrand, according to a Securities and Exchange Commission filing by the company.

Big NIH grant awards show Bay Area still at center of HIV fight

The Bay Area continues to innovate at the center of the fight against HIV, winning a couple of major National Institutes of Health grants aimed at HIV reservoirs.
Dr. Steven Deeks and Dr. Mike McCune of the University of California, San Francisco , will work with Rafick-Pierre Sekaly of the Vaccine & Gene Therapy Institute of Florida to define the nature and location of reservoirs — cells where HIV may be undetectable for years — and how those reservoirs are created and maintained. What's more, researchers will develop and test targeted treatments that eliminate HIV reservoirs without broadly activating the immune system, which could activate the virus.
Sangamo BioSciences Inc. (NASDAQ: SGMO) of Richmond will work with the Fred Hutchinson Cancer Research Center in Seattle as part of a $20 million project to develop proteins that directly attack HIV reservoirs. Researchers also will study whether a patient’s immune cells can be made resistant to the virus.

PDL wins round in royalty suit against Genentech, Roche

A Nevada judge denied two motions from Genentech Inc. and parent company Roche to dismiss a PDL BioPharma lawsuit centering on royalties from a 2003 deal, PDL said.
Judge David Hardy also dismissed a claim by PDL (NASDAQ: PDLI), which was based in Redwood City before moving late 2008 to Incline Village, Nev., that Genentech breached an implied covenant of good faith and fair dealing.
The rulings are the latest in a court battle following an August 2010 letter from South San Francisco-based Genentech that claimed that PDL’s technique for humanizing an antibody does not apply to drugs Roche sells in Europe.

QB3 spotlights UC science, 'American Idol'-style

They aren’t exactly Simon Cowell or Randy Jackson, but a team of biotech pioneers is helping QB3 raise its scientific profile with an “American Idol”-like approach.
Former Genentech CEO Art Levinson, Chiron Corp. founder Bill Rutter and Five Prime Therapeutics founder Rusty Williams, as well as venture capitalist Robert Garland from New Enterprise Associates , are among 16 first-stage judges of a competition that will shave 38 entries to 10. That pack then will be whittled to five.
The ultimate prize? $10,000.

Friday, July 8, 2011

Genentech patent may hold key to cancer drug maker's IPO

One of the biggest biotech IPOs so far this year carries a significant Bay Area caveat and an important connection.
Cancer drug developer Merrimack Pharmaceuticals Inc. of Cambridge, Mass., said late Friday that it plans to sell about $173 million of common stock in an initial public offering. But the IPO is shrouded by a potential patent battle around its lead products, as well as two preclinical drugs, that involves South San Francisco biotech powerhouse Genentech Inc.

Mr. Hastings goes to Washington, fights for drug approvals

OncoMed Pharmaceuticals ’ Paul Hastings threw down some interesting facts and ideas to a House Energy and Commerce health subcommittee hearing Thursday. Whether committee chair Fred Upton and his counterparts will pick them up is another thing.
The hearing comes as Congress looks at reauthorizing the Prescription Drug User Fee Act, or PDUFA, which is designed to allow the Food and Drug Administration to decide in a timely manner whether a drug is safe and effective. The program is funded by drug company fees.

Biotech game planner: Sally Ann Reiss plays point guard for BioSF

Sally Ann Reiss loves playing point guard.
From her involvement in the early days of television technology pioneer TiVo leading efforts to raise millions of dollars for a Portola Valley community project, Reiss is all about turning game plans into victories. Now in her new job directing San Francisco’s biotech attraction and retention efforts, Reiss is hoping to build on the success of the city’s Mission Bay biotech enclave to score the economic development equivalent of a slam dunk.

Could 3 minutes reshape California's biotech future?

In just three minutes the other day, Maryland received more than 180 applications for its $8 million biotech tax credit program.
Apparently, all it takes is three minutes for many of those companies to access the state handout. Imagine how many applicants we’d have here.

Thursday, July 7, 2011

InterMune enrolls 1st patient in new lung disease trial

Jilted by the FDA in a previous attempt to win approval for its treatment for a fatal lung-scarring disease, InterMune Inc.said it has started a new Phase III study of its drug, called Esbriet.
The Brisbane company (NASDAQ: ITMN) said it enrolled the first patient in a roughly 500-patient trial designed to evaluate the safety and efficacy of Esbriet in people with mild to moderate idiopathic pulmonary fibrosis, or IPF.

Affymetrix stock dives on lower Q2 guidance

Affymetrix Inc. said Wednesday its preliminary second-quarter revenue declined to $64 million to $65 million because of lower academic and consumables sales.
The news sent the Santa Clara-based company's (NASDAQ:AFFX) stock down after hours almost 18 percent.

Wednesday, July 6, 2011

Exelixis delays report from thyroid cancer trial

Exelixis Inc. will unveil data from a late-stage trial of its cancer-fighting drug cabozantinib about three months later than originally expected.
The South San Francisco drug developer (NASDAQ: EXEL) said it needs more time to reach a pre-specified number of “events” — deaths or showing how long patients live without the disease progressing — with medullary thyroid cancer patients before it can unbind data and report top-line results of the study.

Biotech execs push to extend tax credits, grants program

Although the Bay Area was a big recipient from last year's biotech tax credits and grants, enthusiasm for an extension of the popular program is by no means just a California thing.

Tuesday, July 5, 2011

Biotech IPOs look strong — with haircuts

One of the many takeaways from BIO2011 was data from Elsevier Business Intelligence showing that biotech IPOs actually are doing quite well — up 42 percent post-IPO. Of course, that’s after many of those initial public offerings took significant price haircuts and remain down from where they originally wanted to be.