Patients' tales, biotech legends add weight to BayBio awards

Genentech co-founder Herb Boyer.

When two or more biotechs are gathered, you hear the usual phrases, including the old standby, “We're serving patients with unmet medical needs.”
Box checked, move on to other things and the phrase quietly floats away.

BayBio, Northern California’s life sciences industry trade group, has been beating the “for the patients” drum for the past couple of years especially -- and it didn’t stop at the organization’s annual Pantheon event Thursday night. Problem is, when you hear rote phrases so often, they start to bounce off of you.
That is, until something like this year’s Pantheon ceremony. Many of the companies winning BayBio's DiNA awards brought patients with them to accept their plaques; some actually let patients tell their stories.
Putting patients in front of corporate slide decks is needed by the biotech industry, which has been wringing its collective hands over cuts in research funding and the drought of venture capital cash. Telling those stories, or actually helping patients tell their own stories outside of industry settings, could win over leery legislators and a weary public that feels bombarded with stories of unsafe drugs and failed clinical trials.

One-on-One with Medivation CEO David Hung

Medivation's David Hung.

The story of Medivation Inc. could belong in the collection of biotech’s greatest comebacks. The San Francisco company (NASDAQ: MDVN), partner Pfizer Inc. (NYSE: PFE) and investors pinned many of their hopes on Dimebon, but even before that drug failed, Medivation was working on what now is called Xtandi in prostate cancer. I spoke with Medivation President and CEO David Hung about Xtandi, the competition in the prostate cancer drug arena, Medivation’s pipeline and the likelihood of bringing Dimebon back as an Alzheimer's-fighting drug.

Medivation prostate cancer drug wins FDA approval

Medivation's David Hung.

A prostate cancer drug from Medivation Inc. was approved Friday by the Food and Drug Administration. Under the brand name Xtandi, the drug's approval came three months sooner than expected for metastatic, castration-resistant prostate cancer that has spread or recurred. The approval represents a victory for San Francisco-based Medivation (NASDAQ: MDVN), not only for coming in ahead of the planned Nov. 22 decision date but also because Medivation only two years ago tumbled on the late-stage failure of its experimental Alzheimer's disease treatment Dimebon.

Medivation to take 2-for-1 split of soaring stock Sept. 21

Medivation CEO David Hung.

Medivation Inc., whose stock has soared more than 500 percent since early November, will take a 2-for-1 split of its common stock, the company said Tuesday. Due to the promise of its late-stage experimental prostate cancer drug enzalutamide, the San Francisco-based drug developer (NASDAQ: MDVN) has seen its stock rise to a 52-week high of $103.89, from $16.10 per share less than 10 months ago.

Researchers: Medivation's failed Alzheimer's drug deserves another shot

Medivation Inc.'s failed Alzheimer's drug Dimebon deserves a second chance, a group of researchers say. Dimebon in March 2010 flamed out in a Phase III trial that disappointed Alzheimer's disease patients and their advocates, leading San Francisco-based Medivation (NASDAQ: MDVN) to squash a planned space expansion and lay off employees. Medivation, which was working with Pfizer Inc. (NYSE: PFE) on Dimebon, has bounced back in spectacular style under CEO David Hung. Its prostate cancer drug enzalutamide is under priority review by the Food and Drug Administration, and its stock has crested $100 per share, a 520 percent increase in the past nine months. Now an international team, led by researchers at Mount Sinai School of Medicine in New York, believes that Dimebon, too, may be in line for a comeback.

Biotech Day: Wednesday morning's national biotech news wrap

From the 40 business journals of American City Business Journals …

Bluebird Bio raises $60M with Shire for gene therapies (Boston Business Journal)
Cambridge biotech Bluebird Bio has raised $60 million in a Series D financing, the company reports. Shire plc (Nasdaq: SHPGY) was a strategic investor on the round, which brought in Deerfield Partners, RA Capital, Ramius Capital Group and two undisclosed "blue chip public investment funds," Bluebird announced in a news release.

Gladstone, film maker Jesse Dylan collaborate as research institute rebrands (San Francisco Business Times)
The times they are a-changin’ at the Gladstone Institutes, thanks in part to a Dylan. The San Francisco biomedical research organization said Tuesday that it is launching a new website, tweaking its name and teaming with award-winning film maker Jesse Dylan on a series of short films about Gladstone scientists, supporters and patients who benefit from research. Dylan, the son of legendary singer-songwriter Bob Dylan, with his film company Wondros won an Emmy Award for its 2008 “Yes We Can” presidential campaign ad about Barack Obama. 

BioCryst gets good news on gout treatment (Triangle Business Journal)
Durham-based drug company BioCryst on Tuesday announced positive clinical trial results for its proposed gout treatment ulodesine. The phase two trials of ulodesine were consistent with previously reported findings and that means BioCryst will continue to push the drug forward – but the company may not be doing it alone.

Medivation nets $10M as prostate cancer drug moves toward approval (San Francisco Business Times)
Medivation Inc. landed $10 million from partner Astellas Pharma Inc. after the Food and Drug Administration said the San Francisco drug developer's late-stage experimental prostate cancer treatment will get a priority review. The milestone payment to San Francisco-based Medivation (NASDAQ: MDVN) is based on the FDA's acceptance of the company's new drug application, Medivation said Tuesday.

Medicago earns $1M milestone payment for flu vaccine (Triangle Business Journal)
Canadian drug company Medicago has earned a $1 million milestone payment after producing more than 10 million doses of the H1N1 flu vaccine in one month – a feat accomplished at its Durham facility. The product completion was a key milestone under an agreement with the Defense Advanced Research Projects Agency to test capabilities in the event of a deadly flu outbreak.

Cynosure hits 52-week high on record revenue (Boston Business Journal)
Aesthetic medical device company Cynosure (Nasdaq: CYNO) saw its shares surge more than 12 percent, to a new 52-week high, on news that the company’s revenues for the second quarter grew 50 percent year over year. The Westford, Mass., company booked revenue of $39.6 million in the second quarter of 2012, up from $26.3 million for the same period in 2011.

Genentech's Lucentis restores diabetic vision loss, FDA says (San Francisco Business Times)
Genentech Inc.'s eye drug Lucentis improved the vision of people with a type of blindness associated with diabetes, drug regulators said in a report Tuesday, according to the news agency Bloomberg. The report came in advance of a Food and Drug Administration advisory committee meeting Thursday in which Genentech hopes to expand the use of Lucentis from wet age-related macular degeneration to patients with diabetic macular edema.

Life sciences company bringing 25 jobs to Florida (South Florida Business Journal)
Life science company Somahlution will move from Fargo, N.D., to Jupiter, where it could create 25 jobs over three years, the Business Development Board of Palm Beach County announced Tuesday. The developmental-stage company has secured a 13,000-square-foot facility for its headquarters, research and development and laboratory space.

Emergent Technologies-based Caisson Biotech names CEO (Austin Business Journal)
Caisson Biotech LLC, a company funded and managed by Austin-based Emergent Technologies Inc., has named a new president and CEO. Glenn Nedwin has been tapped to lead the Oklahoma City-based biopharmaceutical company that creates patented drug delivery technology, according to a press release.

Medivation nets $10 million as prostate cancer drug moves toward approval

Medivation Inc. landed $10 million from partner Astellas Pharma Inc. after the Food and Drug Administration said the San Francisco drug developer's late-stage experimental prostate cancer treatment will get a priority review. The milestone payment to San Francisco-based Medivation (NASDAQ: MDVN) is based on the FDA's acceptance of the company's new drug application, Medivation said Tuesday.

Biotech Day: Tuesday morning's national biotech news

From the 40 business journals of American City Business Journals …

Shareholders seek to block Human Genome Sciences buyout (Baltimore Business Journal)
Two shareholders of Human Genome Sciences Inc. have filed a lawsuit to blockthe acquisition by GlaxoSmithKline. The class-action complaint says the company failed to give stockholders a “meaningful chance to review material information” about the offer, according to documents filed in the U.S. District Court in Delaware. The lawsuit also seeks a temporary restraining order on the deal.

Alzheimer's drug bapineuzumab fails late-stage trial (San Francisco Business Times)

A closely watched Alzheimer's drug trial failed a late-stage test, Pfizer Inc. said Monday. The trial is the first of four with bapineuzumab by Pfizer partner Janssen Alzheimer Immunotherapy R&D LLC of South San Francisco. The trial of the intravenous drug focused on patients with mild-to-moderate Alzheimer's disease who carry a specific genotype called ApoE4.

Cerulean Pharma launches ovarian cancer trial (Boston Business Journal)
Cerulean Pharma Inc., a privately held developer of cancer drugs delivered by tiny nanoparticles, has launched a Phase 2 study of its lead drug candidate in ovarian cancer patients who are resistant to some other drugs. The ovarian cancer study is targeting patients whose cancer has advanced despite treatment with standard platinum therapy.


Chronic-pain drug developer Relmada raises $3 million (Philadelphia Business Journal)
Relmada Therapeutics raised $3 million in a private stock sale, according to documents filed with the Securities and Exchange Commission Monday. The Blue Bell, Pa., clinical-stage pharmaceutical company is specializing in developing prescription products used to manage chronic pain.

Cancer drug combo of Nexavar and Tarceva fails late-stage trial (San Francisco Business Times)
Nexavar, the blockbuster cancer drug from Bayer HealthCare and Onyx Pharmaceuticals Inc., failed a late-stage trial that looked at combining the drug with the Genentech-developed Tarceva in patients with advanced liver cancer. Onyx and Bayer said in a press release Monday that combining Nexavar and Tarceva tablets in the 720-patient, Phase III trial did not improve overall survival of patients with hepatocellular carcinoma, or HCC. The trial compared the combination therapy to Nexavar alone.

Jeffrey Boily.

Up Close: Jeffrey Boily, CEO of the Center for Animal Health Innovation (Kansas City Business Journal)
Jeffrey Boily is CEO of the Center for Animal Health Innovation, an Olathe research advocate the Kansas Bioscience Authoritycreated last year to help academic and private-enterprise researchers identify the most promising animal health breakthroughs and turn them into saleable products. (Kansas City Business Journal subscription required.)

Integra Group bought by Ohio-based NAMSA (Minneapolis/St. Paul Business Journal)
The Integra Group, a medical research firm with about 50 employees, has been sold to North American Science Associates Inc. for an undisclosed amount. Northwood, Ohio-based NAMSA has about 550 employees, including those from Integra. The company provides testing and consulting services to medical-device makers.

Halo signs license agreement with University of North Dakota (Los Angeles Business)
Halo Healthcare Inc. has signed a definitive license agreement with the University of North Dakota to develop biomarkers for the early detection of breast cancer.

OneWorld Health's Ponni Subbiah.

Pfizer veteran to lead nonprofit drug developer OneWorld Health (San Francisco Business Times)
OneWorld Health named Dr. Ponni Subbiah as its first global program leader, responsible for the South San Francisco nonprofit's drug development portfolio. Subbiah is a 15-year veteran of Pfizer Inc., where she most recently was vice president of global access within the world's largest drugmaker's emerging markets business unit. She will join OneWorld Health on Aug. 1.

BioHealth Innovation adds staff, space in quest to help Maryland companies win more funding (Baltimore Business Journal)
BioHealth Innovation Inc. is adding staff and office space to expand its operations in central Maryland. The Rockville-based organization has created a new position, director of innovation programs, to lead the organization’s effort to help Maryland companies get a greater share of federal funding intended for near-commercialization projects.

Arizona biotech leader Jeff Morhet dies in plane crash in Colorado (Phoenix Business Journal)
Jeff Morhet, 43, who was active in Arizona’s biotechnology industry, died in a plane crash July 21. He was flying his CJ-6A airplane with his oldest son Jack, 9, when the plane crashed and both were killed.

St. Pete medical device company wins $4M patent infringement verdict (Tampa Bay Business Journal)
A St. Petersburg medical device company won a $4 million jury verdict in a patent case where the Ohio Willow Wood Co. was found to have willfully broken patents on 13 different products. Since the infringement was willful, the judge has an option to increase the jury’s verdict to as much as $12 million to ALPS South LLC.


KV Pharma receives another delisting notice (St. Louis Business Journal)
KV Pharmaceutical Co. officials said the company has been notified by the New York Stock Exchange that it is below listing standard criteria due to the company’s average market capitalization being less than $50 million over a 30-day trading period and its stockholder’s equity being less than $50 million.

Alzheimer's drug bapineuzumab fails late-stage trial

A closely watched Alzheimer's drug trial failed a late-stage test, Pfizer Inc. said Monday. The trial is the first of four with bapineuzumab by Pfizer partner Janssen Alzheimer Immunotherapy R&D LLC of South San Francisco. The trial of the intravenous drug focused on patients with mild-to-moderate Alzheimer's disease who carry a specific genotype called ApoE4.

Exelixis seeks 'cabo' approval in thyroid cancer, but big target is prostate cancer

(San Francisco Business Times subscription required.)

Exelixis Inc. believes it can finally see its future, and it’s in cabo.

Cabonzantinib, a cancer drug that potentially could target multiple forms of the deadly disease as well as tumor-related bone pain, was submitted last month for Food and Drug Administration approval for a form of thyroid cancer. The treatment, known as “cabo” for short, takes South San Francisco-based Exelixis the closest to selling a drug after 18 years and a cumulative deficit of $1.1 billion.

Medivation, Astellas submit prostate cancer drug for FDA OK

Medivation Inc. and partner Astellas Pharma Inc.    could win approval of their experimental prostate cancer drug within six months, after the companies on Monday filed a new drug application with the Food and Drug Administration.

The filing isn't unexpected, but it's a big step forward for San Francisco-based Medivation (NASDAQ: MDVN). Only two years ago, the company's experimental Alzheimer's disease drug Dimebon fizzled in a Phase III trial. But a nearly 1,200-patient, late-stage study of the prostate cancer drug -- called enzalutamide, or MDV-3100 -- showed strong results.

Sniffing out investments, Medivation to sell $175M in notes

Medivation Inc. hopes to raise about $175 million through a convertible senior note offering.
The San Francisco-based drug developer (NASDAQ: MDVN), whose stock has shot up more than 300 percent since it disclosed results of a successful Phase III trial of a prostate cancer drug in November, said Monday it could use proceeds of the offering to invest in other products, technologies or businesses.
Medivation said in a press release that it mainly will use the money for working capital and to fund further development and potential commercialization of its drugs.

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.

After failed trial, Pfizer, Medivation shut down Alzheimer's drug program

Dimebon is done.
The experimental Alzheimer’s disease drug from San Francisco-based Medivation Inc. (NASDAQ: MDVN) failed a late-stage trial, the company said Monday, and Medivation and partner Pfizer Inc. (NYSE: PFE) said they will discontinue development in all diseases.
Dimebon’s demise also will shut down another ongoing study of the small, green tablet in Alzheimer’s patients.
Dimebon failed a high-profile Alzheimer’s trial in 2010 and a late-stage trial in Huntington’s disease last year.

Medivation bounces back with new drug, new lease

The second time may be a charm for Medivation in downtown San Francisco.
Nearly two years ago the San Francisco biotech terminated a 63,817-square-foot lease at 345 Spear St. following a disappointing Phase III trial for Dimebon, the Alzheimer’s drug the company was developing with Pfizer. Now Medivation has a new promising drug ­— this one a late-stage cancer drug — and a big new lease to go along with it.

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.

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.

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.

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?