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.

Biotech Day: Friday's national biotech news

From the 40 business journals of American City Business Journals …

'Biohackers' go solo in quest to find cures (San Francisco Business Times)

Ryan Bethencourt is hacking his way toward saving lives. Working one day a week on shared lab equipment snatched up for pennies on the dollar, Bethencourt and a growing wave of do-it-yourself biotechnologists, or “biohackers,” are zeroing in on some of life sciences’ thorniest questions from the cozy confines of their kitchen tables, hallway closets or hand-me-down lab benches. (San Francisco Business Times subscription required.)

'Supertemps' reshaping biotech workforce (Boston Business Journal)
Local life sciences companies are increasingly hiring workers — often those with high-level expertise — on a temporary, rather than a permanent, basis. (Boston Business Journal subscription required.)

Vertex and city celebrate topping off at Fan Pier (Boston Business Journal)
Developer Joseph Fallon, Mayor Thomas M. Menino and a crowd of construction workers watched as the final beam for the first of two Vertex Pharmaceuticals (Nasdaq: VRTX) office towers on Fan Pier was hoisted to the top of the 18-story building on Thursday. Work on the 1.1 million square foot global headquarters for Vertex is expected to be completed late next year.

Couple buys drug candidate, raising $25M betting it works (Triangle Business Journal)

The leaders of Sprout Pharmaceuticals are banking $25 million on a drug aimed at treating sexual dysfunction in women, even though federal regulators did not approve the medication when it was held by another company. The husband-wife team of Cindy Whitehead and Bob Whitehead bought the drug, called flibanserin, for an undisclosed sum in 2011. Flibanserin was available when Raleigh-based Slate Pharmaceuticals, which Bob Whitehead helmed at the time, was sold to Lake Forest, Ill.-based Actient Pharmaceuticals. (Triangle Business Journal subscription required.)

Seed firms sprouting around UC Davis (Sacramento Business Journal)

A year-old nonprofit is aiming to transform the Sacramento region into the Silicon Valley of seed science and technology. At least 50 seed and seed-related companies already have set down roots in the region, so now it’s a matter of getting those companies to “behave like they are in a cluster,” said François Korn, one of Seed Central’s founders. “It’s all about energizing the seed cluster.” And developing a significant economic engine for the region. (Sacramento Business Journal subscription required.)

Medtech startups increasing in Sacramento region (Sacramento Business Journal)

Industry insiders say the region’s small medical technology cluster is on its way to becoming an important part of the economy. They point to a growing base of companies and industry partnerships with theUniversity of California Davis as key drivers of the region’s med-tech sector. (Sacramento Business Journal subscription required.)

Human Genome Sciences' sale to GlaxoSmithKline: What it means for the D.C. area (Washington Business Journal)

After an ugly, feuding courtship, Human Genome Sciences Inc. and GlaxoSmithKline PLC are finally tying the knot. The two drugmakers announced July 16 the consummation of a takeover process that officially began in April, when London-based Glaxo first offered to buy its partner of two decades for $3.6 billion, a deal Rockville-based Human Genome Sciences declined as too cheap. (Washington Business Journal subscription required.)

Whopper deal more of a whimper (Washington Business Journal)

A company’s multibillion-dollar sale is normally the apex of its journey, the peak of its existence. But I gotta tell you, this one’s a bit anticlimactic. (Washington Business Journal subscription required.)

Colorado bioscience sector welcomes FDA reforms (Denver Business Journal)

Colorado’s bioscience industry expects good things from reforms of U.S. Food and Drug Administration regulations signed into law July 13. Passage of the FDA Safety and Innovation Act capped more than 18 months of work by Denver-area executives and U.S. Sen. Michael Bennet, D-Colo., to pass the bill. The industry supports the reforms even though they result in large FDA fee increases. (Denver Business Journal subscription required.)

Medical device makers brace for excise tax (Memphis Business Journal)

When the U.S. Supreme Court ruled the Affordable Healthcare Act was constitutional in late June, device and pharmaceutical companies began looking at the calendar. The reason? On Jan. 1, 2013, the 2.3 percent excise tax on device and drug manufacturers such as Pfizer Inc., Medtronic Inc., Wright Medical Group Inc. and Smith & Nephew Inc. is scheduled to take effect. (Memphis Business Journal subscription required.)

Study: Non-core work ordered by pharmas driving up costs (Triangle Business Journal)

Drug companies ask for non-core trials to be conducted by contract research organizations at a cost of as much as $5 billion per year, a factor that drives up the ultimate cost of developing new drugs, concludes a new study. While that’s bad news for patients and further contributes to rising health care costs, it can be taken as good news for the Triangle, where CROs employ more than 10,000 workers. (Triangle Business Journal subscription required)

Shower Shirt's sales volume nearly triples (Orlando Business Journal)

In 2009, Lisa Crites was standing in the shower after a double breast mastectomy with a white plastic trash bag with cut-out arm holes draped over her to keep her surgical site dry, when the idea hit: This could be fixed. Five prototypes and a year later, Crites formed The Shower Shirt Co. LLC and invented the Shower Shirt. The $85 waterproof, turtle neck-style jacket allows a patient to shower after a mastectomy and keep the site dry, replacing the old methods of using a plastic bag or Saran wrap. “It’s comical now,” Crites said, looking back. (Orlando Business Journal subscription required.)

Mobile heart monitor doesn't skip a beat (San Francisco Business Times)
San Francisco-based AliveCor’s new iPhone electrocardiogram isn’t on the market yet, but it may have already saved a life. (San Francisco Business Times subscription required.)

Executive Profile: Astex Pharmaceutical CEO James Manuso (San Francisco Business Times)
Manuso, a self-described “Euro mutt,” joined SuperGen Inc. as a director in 2001 and became chairman and CEO of Astex Pharma after SuperGen’s acquisition last summer of Astex Therapeutics Ltd. in the U.K. The 140-employee company has three cancer drugs in mid-stage clinical trials, but the FDA in March rejected expanding its blood cancer drug Dacogen to elderly patients with acute myeloid leukemia. Manuso’s eclectic career has taken him from counseling heroin addicts in Bedford-Stuyvesant, part of his domestic service as a conscientious objector during the Vietnam War, to buying, fixing up and selling Manhattan properties. (San Francisco Business Times subscription required.)


Wake Forest Nano Center digging deeper to boost startups (The Business Journal)
Seeking to boost the pace of commercialization coming out of his labs at Wake Forest University, the director of the school’s Center for Nanotechnology and Molecular Materials has set up a partnership with an outside firm designed to mine early-stage research looking for potential money-makers. (The Business Journal subscription required.)


Drug maker donating to Franklin Institute brain exhibit (Philadelphia Business Journal)
Pharmaceutical giant Teva will donate $2.5 million toward the Franklin Institute’s fundraising campaign. The money will be put toward the museum’s planned “Your Brain” exhibit, which will explore neuroscience and the human brain.


Up close: Roger Cubicciotti (The Business Journal)
Roger Cubicciotti has lived and worked in biotech hotspots all over the country, but he chose the Piedmont Triad Research Park when it came time to settle his company, NanoMedica. Since arriving in 2010, Cubicciotti has also thrown his efforts behind building up fellow entrepreneurs and helping to organize the all-volunteer support group VentuRealization. (The Business Journal subscription required.)


Targacept exec to head biotech committee (The Business Journal)
Karen Hicks, the vice president of human resources at drug discovery firm Targacept, will chair the 24-member Advisory Committee for Biotechnology, under the auspices of N.C. Biotechnology Center.

Anthera seeks $33 million from stock offering (San Francisco Business Times)

Anthera Pharmaceuticals Inc. will use $33 million from the sale of 33 million shares for general corporate purposes, the company said Thursday.

CTRC tapped for clinical trial of ovarian cancer drug (San Antonio Business Journal)
Viral Genetics has selected the Cancer Therapy & Research Center at the University of Texas Health Science Center to conduct a Phase I clinical trial for an investigational ovarian cancer drug.

Biotech Day: Tuesday's national biotech news

From the 40 business journals of American City Business Journals …

Biogen to fund mapping of ALS genome (Boston Business Journal)
Biogen Idec (NASDAQ: BIIB) has entered into a research collaboration with Duke University and the HudsonAlpha Institute for Biotechnology designed to sequence the genomes of up to 1,000 patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The goal is to gain a better understanding of the genetic causes of ALS, in order to come up with better potential treatments.

Navigenics' Vance Vanier.

Life Technologies buys DNA test developer Navigenics (San Francisco Business Times)

Life Technologies Corp. bought genetic-information company Navigenics Inc., the company said Monday, giving the testing equipment giant an inroad to process lab tests for doctors. Carlsbad-based Life Technologies (NASDAQ: LIFE) did not disclose the value of the deal, but it said it is its "first step" toward building out its molecular diagnostics business through internal development, partnerships and select acquisitions. Foster City-based Navigenics, run by San Francisco Business Times 40 Under 40 award winner Vance Vanier, develops DNA tests that tell doctors if patients have genetic markers for certain diseases. It is one of a handful of companies that have taken advantage of faster, more accurate systems, like those offered by Life Technologies, to tap into consumers' interest in predicting and preventing diseases.


NuPathe resubmits migraine patch to FDA (Philadelphia Business Journal)

NuPathe is ready to take another shot at getting its migraine patch Zelrix approved. The company (NASDAQ:PATH) said it has resubmitted the treatment to the Food and Drug Administration. Last year the FDA raised chemistry, manufacturing and safety questions about the product.

Johnson & Johnson firm seeking new use for Simponi (Philadelphia Business Journal)
Janssen Biotech and Janssen Biologics are requesting Food and Drug Administration and European Medicines Agency approval to make their Simponi drug a treatment for "adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy."



A watershed moment in the fight against HIV (Boston Business Journal)

I caught my breath as I opened an email from the FDA Monday. The agency had for the first time approved a drug to prevent the spread of HIV, made by California biotech Gilead Sciences Inc (Nasdaq: GILD). This day is a day that has been the dream of patients, family members, activists, and medical providers throughout my entire adult life.

Related story: FDA approves Gilead's Truvada as first pill for HIV prevention (San Francisco Business Times)

Human Genome Sciences CEO Tom Watkins

Unknown future for Human Genome Sciences, execs after GlaxoSmithKline buyout (Washington Business Journal)

British pharmaceutical company GlaxoSmithKline PLC (NYSE: GSK) is snapping up Rockville-based Human Genome Sciences Inc. (Nasdaq: HGSI) for $3.6 billion, raising a host of questions over the local biotech’s future along the Interstate 270 corridor. It’s yet unclear how Glaxo plans to reshape its longtime partner, whether it will keep management in place or clean house — as in other recent big pharma acquisitions — and whether it will maintain Human Genome Sciences’ Maryland facilities.

MedImmune will open new center, shift 40 jobs to Hayward (San Francisco Business Times)

The South Bay's loss of MedImmune will be the East Bay's gain. The vaccine and infectious diseases drug developer said it plans to open a new translational sciences area for applied immunology and microbiology in Hayward as it closes facilities in Mountain View and Santa Clara.

Related story: MedImmune closures in Mountain View, Santa Clara will ax hundreds of jobs (San Francisco Business Times)

Moody's downgrades Thermo Fisher on Lamba acquisition (Boston Business Journal)

Moody’s Investors Service announced it would downgrade $6.6 billion of Thermo Fisher Scientific’s (NYSE: TMO) debt, just hours after the life sciences tools company said it would acquire California diagnostics firm One Lambda for $925 million in cash. Moody’s lowered the credit rating for Waltham, Mass.-based Thermo Fisher one notch to Baa1 from A3. The outlook is stable, Moody’s said.

Med-tech devices may get barcodes (Minneapolis-St. Paul Business Journal)

How do you place a unique identifying number on a medical device? That’s a question many med-tech companies will be considering in the coming years, thanks to proposed guidelines issued last week by the Food and Drug Administration. The FDA wants medical-device companies to use barcodes or other techniques to label each of their products. The program’s goal is to make it easier for the agency to determine whether particular devices are malfunctioning or otherwise harming patients. The FDA estimates the effort will cost the medical-device industry about $68.4 million a year.

Repros Therapeutics files protocol for mid-stage study of drug on clinical hold (Houston Business Journal)

Repros Therapeutics Inc. (Nasdaq: RPRX) said Monday it plans to submit to the Food and Drug Administratio  protocol for a phase 2 study of Proellex. Proellex is an oral drug intended to treat endometriosis and uterine fibroids. The FDA said it would change the drug’s full clinical hold to a partial clinical hold once the phase 2 protocol is approved.

Fast 100: Discovery, deals boost Five Prime's bottom line

Five Prime Therapeutics Inc. is an anomaly.
A drug-development company without any drugs on the market, South San Francisco-based Five Prime has increased revenue in each of the past three years, reaching $23.7 million last year while hitting a three-year compound growth rate of more than 52 percent.
What’s more, Five Prime expects a double-digit percentage point jump in revenue in 2011.

FivePrime inks potential $500M cancer drug deal with Human Genome Sciences

FivePrime Therapeutics Inc. will get $50 million upfront and as much as $445 million in future payments from Human Genome Sciences Inc. in a deal around FivePrime’s cancer-fighting genetically engineered protein drug.
The early-stage drug, called FP-1039, could be used against many types of cancers. It is in a Phase I trial but patients are being screened for a Phase II trial against a form of gynelogic cancer that attacks the lining of the uterus.