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.

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.

Cancer drug combo of Nexavar and Tarceva fails late-stage trial

Nexavar, the blockbuster cancer drug from Bayer HealthCare and Onyx Pharmaceuticals Inc., failed a late-stage trial that combined 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.

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.

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.

Astellas returns superbug-fighting drug to Theravance

Astellas Pharma Inc. ended its partnership Friday with South San Francisco’s Theravance Inc. around the antibiotic Vibativ.
The decision ends an up-and-down partnership between the companies, including production problems at a contractor manufacturer in Ohio in November that halted manufacturing and caused a shortage of the drug.

Manufacturing problems cause shortage of Theravance-developed superbug drug

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

Startup Cleave Biosciences raises $42M to develop cancer drugs

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

NeurogesX chief medical officer resigns, heads to Jazz Pharma

Dr. Jeffrey Tobias, chief medical officer of pain drug developer NeurogesX Inc. since 2005, will resign effective Oct. 16
It is the second high-level departure this year for San Mateo-based NeurogesX (NASDAQ: NGSX). President and CEO Anthony DiTonno said in April that he would retire by the end of the year.

Theravance superbug drug wins European OK

European regulators approved a drug developed by Theravance Inc. to treat the superbug MRSA in patients with hospital-acquired pneumonia.
The European Commission gave marketing approval Thursday to Astellas Pharma Europe Ltd., which signed a deal in 2005 with South San Francisco-based Theravance (NASDAQ: THRX). The drug, Vibativ, is a once-daily injectable to treat Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus, or MRSA.

Mid-stage Medivation prostate cancer trial doses 1st patient

Medivation Inc. and partner Astellas Pharma Inc. started a Phase II trial of an experimental prostate cancer treatment, the fourth study involving the drug.
The mid-stage study of the drug, MDV-3100, ultimately will enroll about 60 patients in Europe, San Francisco-based Medivation (NASDAQ: MDVN) said Monday. It will test the drug, taken once a day orally for 24 weeks, as the first hormonal treatment for patients with early-stage prostate cancer.

Medivation halves Q1 loss

Drug company Medivation Inc. cut its Q1 loss in half to $8.5 million.
A year earlier the San Francisco company (NASDAQ: MDVN) lost $17.5 million.
Revenue was about flat -- $14.7 million in the March quarter compared with $15.7 million a year earlier.

Astellas to buy out Maxygen interest in joint venture for $76 million

Astellas Pharma Inc. will buy out Maxygen Inc.’s interest in Redwood City joint venture Perseid Therapeutics Inc. for $76 million.
Astellas and Maxygen (NASDAQ: MAXY) of Redwood City set up the joint venture in summer 2009, with Maxygen transferring substantially all of its protein pharmaceutical programs and related assets and R&D personnel to Perseid. It granted Astellas an option to to buy all of Maxygen’s ownership interest in Perseid at exercise prices that increased each quarter until Sept. 18, 2012.

FibroGen lands $40M milestone from Astellas

FibroGen Inc. received a $40 million milestone payment from Astellas Pharma Inc. as its investigational anemia therapy for chonic kidney disease patients advanced to Phase IIb studies.