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The Readout Damian Garde

Good morning! Don't forget to join STAT's Adam Feuerstein today for a live chat on the biggest upcoming news in biotech. It starts at noon ET, and you can find it right here.

Why is 23andMe demanding secrecy from its customers?


It’s typical for companies to email their customers asking to survey them for internal research purposes, often in exchange for a gift card. What’s less typical is the secrecy demanded by consumer genetics giant 23andMe for a study and a survey it recently invited its customers to participate in.

23andMe customer Charles Warden tipped us off about a couple of emails he received from the company last week. One invited him to take part in a laboratory quality test to “help us affirm accuracy and precision of our testing process for a wide range of customers”; if selected to participate in the study, he’d be sent 20 spit kits and would be expected to mail them back with his saliva samples. He was interested — until he was asked to agree not to publicize the study or share details about his involvement on Twitter, Facebook, or on a blog.

Similarly, an invitation to participate in a 30-minute interview “to help us improve our products and services” came with terms and conditions requiring him to keep silent about all concepts and ideas presented in the interview for five years or until that information became public through other means. And if he spoke out before then? 23andMe may seek an injunction against him, the agreement says.

Asked for comment, 23andMe spokesperson Liza Crenshaw said that participation in these studies is voluntary and does not impact a customer’s experience. The restrictions on speaking out are in place “to protect confidential information that may be shared with the customer, including new product concepts or designs or validation activities, in the course of the customer’s participation,” Crenshaw said.

Warden said he hopes the company changes its mind about the confidentiality requirements and “would be happy to participate” if it does so.

Illumina’s $3 billion problem


The nice thing about completely dominating a market is you don’t have to worry much about competition. The only downside is that if you want to actually grow your business, you can’t just beat your rivals; you have to expand the market.

That, as STAT’s Matthew Herper reports, is the quandary facing Illumina, the $43 billion company that has come to own the market for machines that read genetic code. This week, Illumina signed a 15-year deal with the diagnostics company Qiagen, an agreement that could expand the use of its banner technology. But the reaction from investors has been muted.

That’s because despite its more than $3 billion in annual revenue, Illumina seems to be reaching a plateau. The company has become synonymous with genomic analysis, but the demand for its services seems to have a limit.

Read more.

How the FDA thinks about those ‘N-of-1’ studies


Among the wonders of modern medicine are truly personalized treatments, invented exclusively to help a single patient with an otherwise untreatable genetic disease. Fitting those so-called N-of-1 therapies into a decades-old regulatory framework, however, presents some challenges for the likes of the FDA.

That hasn’t escaped the notice of Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research. Because these single-patient therapies don’t need to be approved for sale, the standard FDA review process doesn’t apply. But if the future brings more N-of-1 success stories, the agency will need to figure out a replicable policy.

“We’ll have to develop policies and procedures if this becomes more common — which we suspect it will be,” Woodcock said. “We need to have a standardized approach to this that’s fair to everybody.”

Read more.

Puma breaks the ‘social contract’


About three years ago, amid a now-familiar fervor over drug prices, Allergan CEO Brent Saunders committed to what he called a pharmaceutical “social contract,” promising not to increase prices by double digits more than once a year. Since then, grudgingly or otherwise, major drug makers have by and large followed suit, ushering in the age of the annual 9.9% hike.

Then there’s Puma Biotechnology. As STAT’s Ed Silverman reports, the one-product company has increased the price of the breast cancer drug Nerlynx by 20% over the course of nine months.

The Puma situation is an interesting case study. The company is struggling to meet its revenue targets and had to scale back its 2019 guidance. The prospects of expanding the label for Nerlynx are fairly limited. Thus, as Cowen analyst Chris Shibutani put it, “price increases would appear to be the familiar tool to reach for, unfortunately.”

Read more.

More reads

  • Ginkgo Bioworks raises $350 million fund for biotech spinouts. (Reuters)
  • Andreessen Horowitz just promoted a VC rising star to figure out how software will transform healthcare. (Business Insider)
  • Rebuilding Neil Woodford’s reputation ‘could take a decade.’ (Financial News)
Correction: Yesterday's issue mischaracterized the side effects of Novartis's new treatment for ocular disease. The drug led to four times as much eye inflammation as seen with Regeneron Pharmaceuticals' competing Eylea, not four times as much as placebo.

Thanks for reading! Until tomorrow,

Thursday, October 10, 2019

STAT

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