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Tuesday, July 19, 2016

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, your daily dive into the world of biotech. Need more? Visit statnews.com and follow us on Twitter.

 

23andMe is a full-fledged biotech now

23andMe is using genetic information from about 1 million people, harvested from their spit, to develop drugs. (23andme)

Spit from strangers could turn out to be pretty lucrative. Or so 23andMe hopes.

The Silicon Valley genetic-testing startup, led by CEO Anne Wojcicki, recently added a 16-person team to develop new antibody therapeutics, “prioritizing targets for diseases of significant unmet needs” involving cardiovascular ailments, cancer, and asthma, Erik Karrer, who heads the effort, told STAT West Coast editor Charles Piller.
 
Nearly 1 million customers have permitted their genetic profiles to be used for research, and Karrer's team is mining that data in search of links to diseases.
 
Seven antibody programs are in early development. The company plans to move strong candidates through phase 2 clinical trials, then partner with bigger companies for large-scale testing. And it's preparing for growth: 23andMe intends to expand its drug-discovery team to 25 this year and 50 next year, Karrer said.
 

Could an antibiotic block the Zika virus?

Specialty pharma companies: Rev up those license-seeking engines. STAT's Helen Branswell writes that a new study suggests the antibiotic duramycin may help temper the damage caused to fetuses by the Zika virus.

Prior research has suggested that duramycin can prevent dengue and West Nile viruses from attaching to the cells. Researchers found the drug is also active against Zika, at least in test tubes, where it significantly reduces the virus's ability to infect cells

In the US, duramycin is primarily used among livestock -- chickens in particular. It has been tested in US clinical trials for cystic fibrosis; beyond that, there's been minimal study in humans.  So it'll take a spate of trials, first in animal models and then in people, to determine if the antibiotic is safe and effective in preventing Zika complications.

That's a long haul, but it could happen faster than a Zika vaccine. So it wouldn't be unreasonable for a pharma company to begin exploring licensing rights.

What’s next for brodalumab?

Valeant's very bad year could soon get even worse. (Richard Drew/AP)

Today's a big day for Valeant Pharmaceuticals, famous for buying up discarded drugs — and infamous for jacking up their prices.

The back story: As recently as last year, partners Amgen and AstraZeneca were barreling toward the market with a new treatment for psoriasis that looked like a winner. The drug, brodalumab, cleared plaques better than standard therapies then on the market, and AstraZeneca figured it would eventually top $1.5 billion in annual sales.

Then it all came apart. In May 2015, Amgen cut its ties to the drug altogether after noting "events of suicidal ideation and behavior" in its clinical trials. AstraZeneca kept the faith, at least publicly, as it looked for another company to take the reins. It found one in Valeant.

Now comes the big test: A panel of FDA advisers will convene today to discuss whether those suicide risks rule out an approval for the psoriasis drug. In documents released ahead of the meeting, FDA staff disclosed there were six suicides in brodalumab's clinical development program among 6,243 patients. For comparison, there were just four suicides among more than 18,000 patients treated with similar therapies.

The FDA will make its final determination by Nov. 16, and Valeant will find out whether its latest bet is a bust.

Getting creative with clinical trial recruitment

ClinicalTrials.Gov may be a comprehensive resource of the medical research going on around the country, but it's rarely user-friendly enough to help companies enroll the right patient populations. That's a costly and difficult task. 

That's why biopharma companies are looking for new ways to recruit patients into clinical trials, as the Wall Street Journal writes

One method? Offer them free rides. Drugmaker Axovant Sciences is using ride share company Lyft to ferry trial participants to and from clinics taking part in an Alzheimer's study.

Another company with an interesting clinical trial recruitment service? It's 23andMe again, actually -- which is allowing outside drug companies plumb the depths of its database to "recruit exquisitely targeted participants."

More Reads

  • The FDA has rejected Novartis's application for a biosimilar version of Amgen's blockbuster Neulasta. (FierceBiotech)
  • Genomics pioneer J. Craig Venter has led a study digging deep into more than 10,000 genomes, trawling for links between genotypes and phenotypes. (San Diego Union-Tribune)
  • Brexit could cost the UK about $1.3 billion in research funding a year. (Bloomberg)
  • PatientsLikeMe recruited former FDA official Marni Hall to serve as its head of research and policy. (Press release)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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