Friday, October 14, 2016

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we bring you the latest in biotech. Follow us on Twitter: @damiangarde@megkesh, and @statnews. And for those of you interested in delivery of health care, we're excited to announce that our new hospitals newsletter, On Call, will be debuting on Monday. Sign up here.

The insulin market is getting a shake-up

ABOUT 6 million AMERICANS with diabetes use insulin (GETTY IMAGES)

You probably already knew that insulin prices have been skyrocketing. Now with the first follow-on insulin set to launch in December and more expected in the coming months, the insulin market is poised for a shakeup.

But the coming wave of knockoff insulins probably isn't likely to help patients much, especially not in the short term, experts say. Some of the reasons: It's hard to copy complex biologic drugs. Middlemen wield significant power in the tussle over the real cost of a drug. And the system isn't designed to bring relief to patients hurting the most from high insulin prices — those with high deductibles or no insurance.

STAT's Rebecca Robbins explains how we got here and what to expect. 

Read more.

The Clinton campaign ‘vetted’ Theranos, too

Back in March, when the Theranos scandal was still in the upper DEFCONs, the Hillary Clinton campaign agreed to let company CEO Elizabeth Holmes host a fundraiser featuring Chelsea Clinton. The move raised eyebrows in politics and business alike, and, now, thanks to WikiLeaks, we know the issue came up within the campaign.

“I don’t think it was wise to have Elizabeth Holmes host a Clinton event,” Clinton donor Herbert Sandler wrote in an email to campaign chairman John Podesta a week before the fundraiser. “There are significant questions concerning Holmes and her company. She may come out alright, but it is certainly possible that everyone associated with her venture will be embarrassed.”

But that warning went unheeded.

“We vetted her and her company and also raised it to Chelsea’s team,” Clinton fundraiser Dennis Cheng replied. “As of now, everyone is still comfortable with her.”

As of now now, one assumes that has changed.

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BioMarin mulls a Duchenne do-over

BioMarin is going around telling analysts that it might ask the FDA to reconsider its once-rejected treatment for Duchenne muscular dystrophy in light of the controversial approval of a drug from rival Sarepta Therapeutics.

Such a move would test the hypothesis that the FDA's Sarepta decision has in some way eroded the agency’s ability to say no to questionable drugs. Sarepta presented scant, uneven data in support of its DMD treatment, but the combination of public pressure and severe patient need led regulators to approve it anyway. BioMarin seems to be hoping that if it can gin up some of the same passion, it might convince the FDA to give it the green light, too.

But consider two sizable caveats. 

For one, Sarepta’s drug, despite its murky efficacy, was safe (like “a scientifically elegant placebo,” as one FDA scientist put it). BioMarin doesn’t have the same luxury, as its drug was tied to serious skin ulcers, kidney injury, and damage to blood vessels. 

For two, Sarepta’s approval removes much of the immediacy that galvanized all that public outcry. In the run-up to the FDA’s decision on Sarepta’s drug, parents, protesters, and amenable lawmakers rallied around one point: Kids with DMD had no drugs to offer them hope. That’s not true anymore, making BioMarin’s case that much tougher to make.

But, hey, you never know.

Bad news and good news for biotech VC

The latest PwC MoneyTree Report (based on data from Thomson Reuters) is out, and it presents yet another opportunity to assess the full/empty ratio of the glass that is biotech venture capital.

Half-empty take: In pure dollar terms, the first three quarters of 2016 are pacing more than 10 percent behind the same period last year. The actual number of deals is faring even worse, lagging the first nine months of 2015 by nearly 20 percent.

Half-full take: Last year’s $7.8 billion in biotech VC was the largest sum in PwC’s 20-year history of tracking private investments. And this year is still on pace to eclipse 2014, despite notching fewer individual deals. Three of the third quarter’s biggest rounds went to biotech companies, PwC notes, continuing a trend that has been evident all year.

More reads

  • New treatments for Alzheimer's disease are targeting patients in earlier and earlier stages of the disease, presenting clinicians with a challenge: When is run-of-the-mill memory loss a sign of oncoming dementia? (MedPage Today)
  • As companies rush to develop novel therapies for depression, scientists are still figuring out just how the disease works. (The Economist)
  • Flex Pharma's in-development treatment for leg cramps came up short in a clinical trial. (FierceBiotech)
  • UK regulators are planning to fast-track the approval of new medicines based on their cost-effectiveness. (Reuters)

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Have a good weekend! We'll be back on Monday.

Damian & Meghana

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