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A go-go FDA is poised to break the all-time record on new drug ap­provals. Is this the new stan­dard for bio­phar­ma suc­cess?

Last year at this time, the FDA was beginning to reach into Q1 of 2018 to hurry up a slate of new drug approvals that pushed the agency to a new record high, both a current-generation agency best as well as an overall spike that broke into virgin territory for the first time in 20 years — provided you added a group of major new biologics to the new therapeutics list.

This year, it looks like the FDA will have the luxury of breaking through the finish line at the end of December after putting the old record — set in 1996 — to shame just by sticking with the PDUFA dates on hand. And they’ve proven beyond doubt that they’re not likely to do that.

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Glob­al reach: The top 25 bio­phar­ma com­pa­nies in the world

Everyone likes to see a quick update on the list of the top companies in the industry, and the latest breakdown on big biopharma from GlobalData marked an opportunity I’m not going to let pass.

Of note, the data outfit flagged the debut of a Chinese company in the top 25 list. Chances are, we’ll be seeing others join it as the industry undergoes a tidal shift toward Asia.

Other highlights include a significant drop in market cap for Celgene $CELG as it lost favor with investors and now tries to win some market respect back.

For those of you who like comparisons, you would have to add the top 4 companies on the list — the global players J&J, Pfizer, Roche and Novartis — to come up with one company big enough to rival Apple’s $1 trillion market cap.

We did slightly rearrange this list to include a chart with updated market caps, so you could give it all some careful thought. Add them all up, and the sum of the 25 parts comes to $2.9 trillion. The distance from top to bottom marks a Grand Canyon of financial scale and reach. But what’s interesting is how this list could change in the next 5 years.

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The biotech mood at the halfway mark of 2018? Bois­ter­ous, fo­cus­ing more at­ten­tion on Chi­na and look­ing for ac­cel­er­at­ed progress

Our Endpoints 100 group is in a feisty mood here in the summer of 2018.

We asked for their views on some of the biggest headlines in healthcare, and came away with some clear impressions on how industry execs view the latest developments on drug prices, FDA supervision of drug development and approvals and their company policies related to the controversial “right-to-try” legislation. We also tracked opinions on the explosion of biotech growth in China and, as always, monitored opinions on key financial and hiring trends for the industry that affect everyone.

We even asked for a report card on Endpoints News content at our second anniversary. And while we enjoyed some high marks, if you think this crowd was going to let us off without a few sharp critiques, well, you don’t know the Endpoints 100. The one common trait you can apply to all biotech execs is that they are intelligent, extremely well educated and unafraid to voice an opinion. That goes double for this group.

Let’s start with their thoughts on the recent round of vows by Big Pharma to swear off price increases through the end of the year, which started with a reversal by Pfizer and swiftly became an industry standard at most of the big players in the industry.

The drug price freeze may be a cynical dodge, but overall change is coming

We gave the 100-plus in our group — with 82 responses — a chance to score this as a simple dodge by pharma to escape criticism, a meaningful turning point in the industry or some “other” position they could explain.

A slight majority, 52%, concluded it was a simple dodge. Another 28%, though, see a significant inflection point for biopharma that shouldn’t be missed. And 20% were somewhere else in the mix.

Here’s a sampling of opinions, which reflect a more nuanced collection of their thoughts than the simple percentages may imply:

I hate Trump as our President for MANY reasons, but the actions he/Alex Azar are taking will likely result in fundamental and favorable changes to biopharma pricing going forward. We’re heading toward a rebate-less world, which could actually create greater sustainability for innovation and needed rewards to attract capital going forward. — Anonymous

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Who are the most pro­duc­tive drug de­vel­op­ers in bio­phar­ma? Our top-20 list has lots of sur­pris­es

When you play the game of blockbusters, you win or you buy.

Now, let me explain what that means.

Mike Rea at IDEA Pharma tracked all the drugs approved from 2013 through 2017, adding their cumulative sales to find out which biopharma companies have had the greatest successes. There are always plenty of caveats in what you find with these numbers — not least of which is how some recent R&D successes at companies like Roche and AstraZeneca (painfully dead last among the majors below) are likely to vault them up the list.

I did some number crunching and drew some conclusions that might interest you. And there are some key takeaways that are impossible to ignore.

One comment: Big research spending doesn’t translate into big innovation or productivity. While 14 of the world’s top 15 R&D spenders in the industry dominate this list of 22 companies — with only Amgen absent in the tally, with PCSK9 still twisting in the headwinds — the amount they spent on research doesn’t necessarily reflect where they rank on this scale of commercial success. At times, you’ll see they can diverge wildly, raising some fresh questions about how some analysts come up with the average cost of developing a new drug.

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Top 10 pipeline blowups, set­backs and sna­fus in H1 2018

We’ve had no shortage of epic disasters in H1. Some of them are legendary. They all offer lessons about this industry we’d be wise to pay attention to, and will be talking about for years to come.

Looking over the rubble, we can see how one unicorn buyout led to painfully bad data, the Next Big Thing in cancer went pffft in one day and a once-confident industry leader was hobbled by a jarring mistake.

And that’s just a start.

To boil it all down to 10 forced me to overlook the extinction-level events that beset a string of small cap companies. Once the industry starts turning back to shell companies to get on the market, there should be no problem picking one up cheap.

And that day is certainly ahead of us. I just don’t know when, exactly. Hindsight is 20/20 vision, as they say, and the rearview mirror in biotech is always cluttered with snafus and fiascos.

One moment Incyte had the next big thing in cancer therapy, and the next moment it didn’t

Based: Wilmington, DE
YTD: $INCY -31%
CEO: Hervé Hoppenot

The scoop: Everyone knew that the ECHO-301 readout came with high stakes. But few could have foretold the level of destruction its failure would bring in a matter of days. 

The study itself was a disaster, which Incyte was quick to acknowledge. Epacadostat combined with Keytruda failed to improve progression-free survival in metastatic melanoma, and there was virtually no chance of success for overall survival. So they scrapped it.

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12 top Chi­na VCs you need to know who are mak­ing a transpa­cif­ic splash (Part 2)

This is Part 2 of a two-part series on Fundraising in China. Check out Part 1 — 7 things you should know about raising biotech cash in China — here

Money is rushing into biotech at breakneck speed this year, and one part of the globe is accounting for much of the uptick: China.

VC deals were teeming with Chinese investors in the first half of the year, with China-based firms participating in US biotech investment rounds worth $5.1 billion, according to data from PitchBook. For some perspective, that beats 2017’s total figure of $4 billion — and we’re only six months into the year.

This is a trend that started last year, with Chinese investors participating in a third of all biotech funding rounds in 2017. Local investors teaming up with Chinese funds say the region has an insatiable appetite for biotech, with money flowing less and less to areas like real estate in favor of the returns in healthcare.

In a recent interview, Duane Kuang from China-based Qiming Ventures said biotech was the most exciting new area for investment.

“We had this phenomenal run in healthcare, from devices to targeted diagnostics and lately we’ve spent quite a bit of energy on biotech — on the more innovative drug discovery part of healthcare investment,” Kuang said. “That’s one area we continue to be excited about, and we’re likely to (dedicate) additional manpower to this area.”

Total biotech investment dollars are booming like we’ve never seen before. In the first half of the year, we’ve counted at least 12 mega-rounds totaling more than $100 million. That’s including massive rounds like Grail’s $300 million raise, which was studded with numerous Chinese investors and led by Hong Kong-based Ally Bridge Group alongside Hillhouse Capital Group and 6 Dimensions Capital.

With all this activity and interest from the region, we decided to track down the most important people you should know in China’s VC scene. We polled connections over to the globe to pare our list down to these 12 investors. Check out what we know about each below.

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The un­der-40s: How does the next gen­er­a­tion of bio­phar­ma ex­ec­u­tives view the fu­ture?

A group of outstanding up-and-coming biopharma professionals under 40 talk about their jobs, their plans and their dreams — and some of the things that just have to change about this industry.

The young standouts featured here have worked hard to get where they are, and they’re nowhere near finished. If you’re looking for a common theme, it’s about making a difference — in a big way — in how people will deal with disease in the future. Together, they are thinking about groups of millions that all have to be stripped down to one single case at a time.

Mentors figure prominently for many on the list, with gratitude for the help and positive guidance in mapping careers that have decades to run. And it’s influencing how they deal with the generation coming up from behind.

No one is denying the risks involved. They’re not keen on tradition. And they all like to surround themselves with smart, savvy colleagues.

But more than anything, this is a story about working to change biopharma for the better — both a revolution and an evolution. That may be about pushing new tech that can deliver dramatic improvements in R&D and development programs, new attitudes about work and life, or working toward the day when thorny issues like gender diversity are dealt with once and for all.

None of it will be easy. But they have decades to fulfill their dreams.

  • Yasir Al-Wakeel: CFO, Neon Therapeutics
  • Laura Deming: Founder & general partner, The Longevity Fund
  • Chris Gibson: Co-founder & CEO, Recursion Pharmaceuticals
  • David Giljohann: CEO, Exicure
  • Michael Gladstone: Principal, Atlas Venture
  • Arjun Goyal: Co-founder & managing director, Vida Ventures
  • Julie Papanek Grant: Partner, Canaan Ventures
  • Rachel Haurwitz: CEO, Caribou Biosciences
  • Christina Isacson: Chief business officer, Magenta Therapeutics
  • Cigall Kadoch: Co-founder, Foghorn Therapeutics; Associate professor, Dana-Farber Cancer Institute and Harvard Medical School; Member, Broad Institute
  • Samarth Kulkarni: CEO, CRISPR Therapeutics
  • Neil Kumar: CEO, BridgeBio
  • Timothy Lu: CEO, Senti Biosciences
  • Kush Parmar: Managing partner, 5AM Ventures
  • Armon Sharei: CEO, SQZ
  • Alok Tayi: Co-founder & CEO, TetraScience
  • Geoffrey von Maltzahn: Partner, Flagship Pioneering
  • Feng Zhang: Co-founder, Editas Medicines & Arbor Biotechnologies; Professor in neuroscience, McGovern Institute for Brain Research at MIT; Core member, Broad Institute

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Ele­phants can't jump? IDEA's Mike Rea says some Big Phar­ma play­ers are crush­ing old be­liefs

This is an industry that typically says ‘innovation’ when what it means is ‘invention.’ Innovation, as most purists will argue, is about return on invention, an ability to derive value from pipeline. That is what our Pharmaceutical Innovation Index measures — a company’s ability to launch successfully, to add more value to pipeline molecules than another company would. It is objective, and about how well the past 5 years have gone, regardless of how well the story has been spun.

12 block­busters: The surg­ing list of $1B-plus drugs rolling out on the mar­ket this year might sur­prise you

What exactly qualifies as a success in drug R&D may be discussed and disputed in many ways, but nothing lays an argument to rest quite as decisively as the real possibility of blockbuster status.

The data analysts at Clarivate Analytics have just assembled their annual list of all the drugs that are rolling out onto the market this year with a solid shot at breaking the one billion-dollar annual barrier by 2022, and their roster — 12 likely blockbusters which I’ve detailed below — provides some interesting insights into the state of drug R&D today.

The good, the bad and the ug­ly for the top 15 spenders in the glob­al drug R&D busi­ness: 2018

As a general rule, the top 15 R&D groups in biopharma are known for keeping a very steady hand on spending. I’ve been following this group for more than a decade now, and it hasn’t been unusual seeing little year-to-year variations in the total spend.

But that’s no longer the case.

Four giant companies — J&J, Bristol-Myers Squibb, GlaxoSmithKline and Celgene — all increased R&D spending last year by more than a billion dollars each, according to their recent year-end tallies. That represents some big bets on late-stage efforts during an intense and growing rivalry to score bigger markets in oncology and other key disease focuses. And several will continue to wager fresh billions in the year to come, as analysts now keenly wait to see which of these big players — such as Amgen or Pfizer — pull off some new acquisitions in 2018.

The very biggest players, such as Basel-based Roche and Novartis, will likely keep hunting those bolt-ons they like best.

As we’ve been tracking in our ongoing survey of biotech execs, this is all playing out at a time that experimental drug valuations are at an all-time high, showing few signs of stagnating now. Bristol-Myers just helped prove that with its record pact to partner with Nektar.

Over the past year we’ve seen a continued pullback from brick-and-mortar ops in China, as GlaxoSmithKline helped illustrate with its retreat from Shanghai. But J&J is helping blaze a path toward new alliances with Chinese upstarts, just as Celgene did when it partnered with BeiGene on PD-1. China is becoming a huge new influence on drug development, and they have the scientific capability to make some stunning advances with the help of a reenergized CFDA making it easier to gain an approval there.

Along the way, Chinese biotechs are becoming so prolific that some categories could become commoditized by a slew of me-toos.

Reorganization never stops in Big Biopharma, either. That can mean increased spending at a company like GSK, which tore up its US ops several years ago to knit something new in the Philadelphia area. Lilly has made some deep cuts, presumably ahead of new dealmaking. Amgen keeps trimming staff. And Pfizer demonstrated its zeal for the ax when it cut off neurosciences in a brutal stab. Takeda has undergone a complete remake over the past two years, and like the rest of the pack, it’s building more externalization into the research structure.

The race for PD-1/L1 domination is far from over, even though a tsunami of experimental meds would seem to be setting up some cheaper alternatives. As a result, the leaders are distinguishing themselves with new combos that can top any single therapy. And we’ve moved from pioneering approvals in CAR-T to a race for CAR-T 2.0, with aggressive players like Gilead and Celgene stepping in to fight it out with a powerhouse team at Novartis.

In this field, scoring two or three significant new drug approvals in one year is good, maybe even great. But with old franchises fading fast, it’s the companies that can stay ahead with dominant late-stage pipelines that promise a steady stream of blockbuster OKs that earn the most respect. That requires round-the-clock vigilance, a keen ability to design and execute the right trials and one eye to look over your shoulder to see who’s catching up. All while the industry’s ROI for the giants continues to shrink.


And without more ado, here are the top 15 companies by R&D budgets.

This is Endpoints News’ third annual look at the top 15 spenders in the global R&D business. Read the 2016 edition and 2017 follow-up here.

Get instant access to this report with a paid Endpoints News subscription. Includes a detailed analysis of each top spender and the players involved.

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