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.

Life Technologies buys DNA test developer Navigenics

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.

New wave of Bay Area companies tame DNA data storm

(SF Business Times subscription required.)

Andreas Sundquist is no medical doctor, but his expertise in electrical engineering and computer science places him and technologists like him on the cusp of solving some of the knottiest human medical problems.
Sundquist’s DNAnexus Inc. is one of at least a half-dozen young Bay Area companies using computational biology and genetics to unleash exabytes of stored genome sequencing data into everyday health care. By blending their computer algorithms and software with medical know-how, experts say, clouds full of cheaper and cheaper DNA data could rain down treatments and new drugs for previously mysterious and common medical conditions.
The burgeoning industry of genome analysis — at the intersection of the Bay Area’s high-tech and biotech expertise — could make some visionaries very rich. On the other hand, easy-to-use genetic data could turn today’s diagnostics industry upside down.
But to Sundquist and other pioneers, their companies’ value lies in volume and the ability to turn Big Data into big-time answers.
“You can argue that social networks are for rich kids, that Twitter is for value seekers,” Sundquist said. “But everybody has DNA.”

Scenes, thoughts from the J.P. Morgan Healthcare Conference

If the Occupy Wall Street folks wanted to shut down biotech’s biggest wheeling-and-dealing session, the 30th annual J.P. Morgan Healthcare Conference, couldn’t they just contact the San Francisco fire marshal?
The Occupy movement supposedly was the reason J.P. Morgan asked the Westin St. Francis for additional security for the conference this week. Badge-checkers were at their usual stations inside the hotel but also were moved outside of the hotel, creating more logjams than usual on the sidewalk along Union Street.
Folks staying at the hotel had to show their room keys, so the security crush significantly cut down “clock tower” meetings in the hotel’s lobby. Coupled with the unusually good January weather, Union Square became the preferred chat-up locale, to the point that the park was overrun by posses of (mostly) men in black suits.
All in all, the mood seemed less dreamy, more serious. Even last year, life sciences companies still in shock from the financial crisis seemed like zombies: “Must focus portfolio … arrrrrgh … Be virtual … ugh.” They walked the talk, but they didn’t really seem to mean it. This year, the companies indeed were focused, their milestones tangible.

Health care consumers start to use websites to make decisions

It’s not online nirvana yet, but websites that help consumers compare hospitals and other health care providers on cost, quality and customer satisfaction — which have been around for years — may finally be starting to gain some traction.
Paul Markovich, executive vice president and chief operations officer at Blue Shield of California, had been a skeptic — not so much about the quality of information being offered, but about how frequently consumers were using the data to make important decisions.
But now he appears to be seeing some light at the end of the transparency tunnel. By transparency, Markovich and others mean giving consumers, the public, and health care entities themselves access to specific quality and cost data that can help drive decisions and improve care.