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.

IPierian turns its stem cell technology on Alzheimer's, antibody drugs

After fits and starts, iPierian Inc. will focus on developing monoclonal antibodies targeting Alzheimer’s disease and other neurodegenerative conditions, the company said Monday.

The South San Francisco stem cell technology and drug development company -- whose top-drawer investors include Kleiner Perkins Caufield & Byers    , Google Ventures and venture groups tied to GlaxoSmithKline and Biogen Idec -- said its antibody drugs will zero in on tau protein and the Complement pathway.

IPierian’s goal over the next six months is to identify a suite of antibodies for the tau and Complement programs, said CEO Nancy Stagliano, and to raise another round of financing by the end of the year.

Ultimately, iPierian is aiming to begin a human trial with one of those potential drugs in 2014, Stagliano said.

Cytokinetics takes a swing at Lou Gehrig's disease

Cytokinetics Inc.’s 14-year history is marked by turns — out of cancer and into muscle programs — and a key heart failure drug partnership with biotech giant Amgen Inc. But the South San Francisco company (NASDAQ:CYTK) hasn’t yet taken a drug into the final of three phases of clinical trials, much less brought a drug to market.
Whether Cytokinetics reaches that ultimate goal could rest in the outcome of a mid-stage trials in a tough disease, amyotrophic lateral sclerosis — also known as Lou Gehrig’s disease. A strong showing would increase the chance of Cytokinetics finding a deep-pocketed partner to take the drug into Phase III trials.

Changing the course of disease, one tweet or 'like' at a time

"New media” or “social media” is helping recruit to clinical trials and maybe — potentially — even reshaping the way trials are done. But take a look at the companies making this happen: Apple Inc. of Cupertino, Twitter Inc. of San Francisco, WordPress developer Automattic Inc. of San Francisco, YouTube of San Bruno.
These Bay Area technologies are connecting people — whether they are fomenting revolution in the Middle East or trying to revolutionize treatment of a deadly disease — are largely due to Bay Area innovators and entrepreneurs.

Patients tap the Net to enlist in fight against ALS

Ben Harris is taking on Lou Gehrig’s disease, one Internet message board at a time.
Harris and a band of fellow patients with the fatal muscle-wasting disease are actively recruiting others into a mid-stage trial of a new drug for amyotrophic lateral sclerosis, or ALS, by Neuraltus Pharmaceuticals Inc.
The movement shows the growing role that the Internet, particularly social media, is playing in filling key clinical trials, especially those focused on rare diseases like ALS. That has implications for cash-hungry companies as well: The faster Neuraltus can enroll patients in its Phase II study, for example, the faster it can discover whether the drug actually does what leaders of the Palo Alto company believe it will do — slow or stop ALS from gradually tightening its suffocating grip.

Neuraltus ALS drug wins fast track, orphan status

An experimental treatment for Lou Gehrig’s disease won fast track and orphan drug designations from the Food and Drug Administration, potentially speeding the drug’s development by Neuraltus Pharmaceuticals Inc.
NP-001, the Palo Alto company’s treatment for amyotrophic lateral sclerosis, or ALS, received those designations last week, Neuraltus CEO Andrew Gengos told the San Francisco Business Times on Tuesday.

Amunix, Biogen Idec in research deal

Amunix Inc. on Wednesday announced an agreement with Biogen Idec to research and develop novel, fully-recombinant blood factors with improved therapeutic properties.
The partnership will combine Mountain View-based Amunix's protein half-life engineering expertise and Biogen Idec's research, manufacturing and clinical development of recombinant blood factors for hemophilia.