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Friday, August 5, 2016

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, your daily peek into the world of biotech. Follow us on Twitter for more: @damiangarde@megkesh, and @statnews.

Cuba's biotech industry is drawing new attention

in july of 2011, Mick phillips' odds of surviving five years were basically zero. but here he is. (SARA STATHAS/STAT)

Typically, it’s cigars that are smuggled into the US from Cuba.

In the case of Mick Phillips, the hot item is a cancer vaccine, which he packs in an insulated lunch box to sneak from Havana to Wisconsin.
 
When Phillips ran out of options to treat his stage 3 lung cancer in 2011, he sought out a vaccine — called CimaVax — that’s approved in Cuba and Peru, but not stateside. It's an EGFR inhibitor, but it works differently from US drugs like Erbitux or Iressa. Instead of revving up the immune system to kill cancer cells, the Cuban vaccine revs it up to deplete EGF from the bloodstream, thereby slowing the proliferation of malignant cells. Experts say it's an example of the Cuban biotech industry's ingenuity in the face of long-running sanctions. The drug’s been remarkably effective for Phillips: 

“Outside of divine intervention, this guy shouldn’t be living right now,” said Dr. Timothy Goggins, who is Phillips’ oncologist. “If you believe in God, it’s God. If you believe in science, it’s CimaVax.”

CimaVax has been used in patients since 1994. Now, researchers at the Roswell Park Cancer Institute in Buffalo, N.Y. are planning a 70-patient safety trial in hopes of getting it FDA approved.

Read more.

Biopharma mergers are ruining everything, study says

Drug companies, they’re always buying other drug companies. And when they do, they tend to cut staff and drug programs, which has a well-established negative effect on research.

But a new study suggests that, when two biopharma companies merge, it drags down R&D for their competitors, too. The study looked at 65 buyouts in the drug business — and at the companies that compete against those newly merged firms. Over four years, those competitors reduced their R&D budgets and number of patent filings by 20 percent on average, the authors found.

Why? Competition, or the lack thereof. If you’re trying to make new cancer drugs, and one of your biggest rivals gets cannibalized by another, your incentive to innovate gets reduced, according to the study’s authors.

The piece, published in Harvard Business Review, urges global antitrust regulators to take this phenomenon into account when vetting mergers, considering not only whether a deal will create a monopoly but also how it will affect the pace of scientific progress.

To share or not to share? Data is the question

elizabeth warren likes to share. (CHIP SOMODEVILLA / GETTY IMAGES)

The case for publicly sharing the data generated by clinical trials has a high profile new backer. Senator Elizabeth Warren of Massachusetts has penned an editorial for the New England Journal of Medicine arguing that the “stakes are too high” to continue keeping data private. 

Her view is getting some pushback, though, from consortium of nearly 300 researchers, who wrote their own NEJM opinion piece. They fear making trial data public would give outside scientists a way to discredit the work of rivals. The consortium believes that researchers should be able to keep their data private for as long as five years, or in some cases forever. And that's getting some pushback of its own:

“It’s a massive ass-covering move as far as I can tell,” one open data advocate told STAT.

Read more.

Today in insider trading

Biotech insider trading is a great source of reader engagement for this newsletter, and the latest allegations serve as a reminder that it can come in many forms.

They center not on an executive, a business development professional, or a hedge fund manager. Instead, they involve a cardiologist who, the SEC claims, did something he shouldn’t have.

Back in 2014, the now-defunct Regado Biosciences was developing a new anticoagulant. As is standard, the company required all doctors involved in its clinical trial to sign an agreement that they wouldn’t disclose or exploit any proprietary information. After signing the agreement, one doctor bought up about $250,000 worth of Regado’s stock, according to the SEC, apparently confident the drug would work.

It didn’t. In June, the doc got an email that the trial was being put on hold after a series of severe allergic reactions in patients — news that wouldn’t become public for three days. So he dumped all 40,000 of his shares, the SEC alleges, averting about $160,000 in losses. That, if true, is very illegal.

Now the government wants him to give back all his earnings and pay a fine, and it’s demanding a jury trial to compel him to do so.

Don’t insider trade.

More reads

  • Kite and Novartis take the lead in CAR-T after Juno falters. (Endpoints)
  • Investing in a startup? Follow the data, not the herd. (STAT)
  • The National Institutes of Health is planning to lift its ban on funding research into human-animal hybrids. (STAT)
  • Juno Therapeutics expanded its arsenal of CAR-T therapies, licensing a project targeting multiple myeloma. (Press release)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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