Monday, September 25, 2017

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we keep you on top of the latest in biotech. For more in-depth coverage of biopharma, subscribe to STAT Plus. On Twitter: @damiangarde@megkesh, and @statnews.

Biotech buyouts don’t work how you think

We often talk about biotech dealmaking like it’s some sort of fashion trend, blowing in and out with the seasons like a flared pant or cuffed sleeve. But actually, that’s entirely wrong-headed — and probably counterproductive, according to data.

Analysts at Cowen combed through 10 years of biotech buyouts — some $420 billion worth — and found that there is no clustering, no seasonality, no quote-unquote good or bad takeout climate. “Rather,” they write in an analyst note, “the data support the view that there is a constant, basal level of M&A discussions coupled with a certain randomness to whether somewhat more or fewer deals are consummated in any given year.”

Further confounding the sort of armchair economics you find in free newsletters like this one, the Cowen counters also found no correlation between number of M&A deals and sector-wide stock performance. In fact, the biotech index did worse in the five busiest buyout years than in the five quietest ones, they observe.

In other news, investor sentiment was incrementally positive on the notion the fourth quarter will be good for M&A and thus drive up the broader market.

Who's going to win the Nobel Prize in medicine?

Will it be Jim Allison in Houston with CTLA-4? Gordon Freeman and Dr. Arlene Sharpe in Boston with PD-1? Or perhaps Dr. Bert Vogelstein in Baltimore with BRCA?

We'll find out come Oct. 2, but in the meantime, chatter abounds. Among the intel picked up by STAT's Sharon Begley: Concern that the whole field of oncology has been unfairly ignored. And a simmering certainty that another snub for Jacques Miller, a towering figure in immunology, "will go down in the annals of Nobel prizes as a huge oversight."

What do you think? Vote in our poll.

PTC's date with (probable) despair

When you have no clinical data to prove your drug helps patients, can you nonetheless convince a group of FDA-appointed experts to recommend approval?

Seems highly unlikely, but that’s exactly what PTC Therapeutics will try to do on Thursday, when an FDA advisory panel reviews the company’s Duchenne muscular dystrophy drug Translarna.

Without a positive clinical trial to prove Translarna improves muscle function in DMD patients, PTC will be forced to make its case using slices of data that hint at the drug’s efficacy. Or it could take a page from Sarepta and pack the room with patients pleading for approval.

The FDA has already expressed doubts about Translarna, but that was before Dr. Scott Gottlieb was appointed commissioner, bringing a more drug approval-friendly attitude to the agency. 

To quote Lloyd Christmas, “So you’re telling me there’s a chance? Yeah!”

STAT biotech reporters Adam Feuerstein and Damian Garde will be following the PTC story all week, starting tomorrow morning when the FDA’s clinical review of Translarna is posted to the agency’s web site. On Thursday, they'll post live updates from the FDA advisory panel and host an interactive chat, exclusively for STAT Plus subscribers.

A close look at pharma's wish list

The world of drug makers is hardly homogenous and certainly not immune to infighting. But pharma execs do tend to agree on at least a few things: Fewer taxes, please, and an end to those pesky patent challenges that have led to tribal creativity. More freedom to tout off-label uses for medicines would be nice, too. 

But how likely is pharma to get what it wants? Join STAT’s Ed Silverman and Damian Garde today at noon ET for a chat on pharma’s wish list — and some insight as to whether an industry once implicated for “murder” can eke out a win in this tough political climate.

Register here and check out Ed's analysis here.

More reads

  • Hurricane Maria halts drug production in Puerto Rico. (USA Today)
  • The FDA rejected Johnson & Johnson's rheumatoid arthritis treatment sirukumab. (Reuters)
  • Novartis's $475,000 CAR-T price tag is running into more resistance. (Bloomberg)
  • Pharma executives are wary of value-based deals but see the potential benefits. (FiercePharma)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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