Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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The Biotech Devil's Dictionary: A Guide to Biotech Buzzwords & Other Inane Jargon

The Biotech Devil's Dictionary: A Guide to Biotech Buzzwords & Other Inane Jargon | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Biotech can be a breeding ground for jargon, coded language, and outright nonsense, as investors and scientists probe the depths of linguistic absurdity to explain why the thing they do is just that much more special than all the other things out there. We wanted to celebrate this proud tradition — and so, like a canny capitalist repurposing an old drug, we stole an idea.

Ambrose Bierce began “The Devil’s Dictionary” in the late 1800s, creating a satirical lexicon he updated weekly before wandering off to Mexico to die. We sought to replicate at least part of that story — hence, The Biotech Devil’s Dictionary. Entries appear semi-regularly in The Readout, our free daily biotech newsletter. (Shameless plug: Subscribe here!)

Here, in one place, are the entries we’ve compiled so far. If they offend you, just remember that Bierce defined a reporter as “a writer who guesses his way to the truth and dispels it with a tempest of words.” So there’s that.

Pharma Guy's insight:

Pretty funny!

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Biotech Dreams of Drugging the ‘Undruggable’ (Not What You Think)

Biotech Dreams of Drugging the ‘Undruggable’ (Not What You Think) | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pills have served biopharma pretty well over the years. Easy to design and cheap to produce, the so-called small-molecule therapies that fit in a capsule have made billions of dollars for their inventors and treated millions of patients in the process.

 

Now, however, as yesteryear’s swallowable blockbusters go generic, the industry is running into diseases for which pills can find no quarter.

 

“This is a classic lament in the drug development business, that all the low-hanging fruit has been plucked and eaten already,” said Michael Gilman, CEO of a newfangled biotech called Arrakis Therapeutics.

 

But Gilman’s company is among a growing number of startups hoping to challenge the conventional wisdom on small-molecule drugs, relying on advances in science and exuberance from investors in hopes of writing a second act for the humble pill.

 

Arrakis, borrowing its name from the Dune universe, just raised $38 million in venture funds with a plan to move upstream in the process of disease. While the majority of small-molecule therapies are designed to latch onto problematic proteins, Arrakis’s goal is to attack the RNA molecules that direct protein production in the first place.

 

Beyond being a novel approach in itself, setting sights on RNA could also allow for the treatment of what scientists call undruggable targets, proteins that are impervious to any kind of therapeutic intervention.

Pharma Guy's insight:

Arrakis CEO @michael_gilman admits on Twitter: "I am loving the Dune references in my feed this morning. But must acknowledge I am only reading it now for the first time."

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Consultants Advise Pharma to Act More Like Biotech to Revive ROI for New Drugs

Consultants Advise Pharma to Act More Like Biotech to Revive ROI for New Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The an­a­lysts at De­loitte con­tinue to cal­cu­late a dwin­dling re­turn for Big Pharma’s R&D dol­lars. Their lat­est num­ber crunch­ing for the world’s top 12 bio­pharma com­pa­nies con­cludes that ROI on their in­vest­ment cash has shrunk to 3.7%, the low­est level yet after hit­ting 10.1% in 2010.

What’s killing these com­pa­nies’ num­bers, De­loitte says, is that while de­vel­op­ment costs on new drugs has plateaued at about $1.5 bil­lion on each pro­gram, their rev­enue keeps falling. There’s been an 11.4% drop in rev­enue year-on-year over 6 years, which has now fallen to $394 mil­lion in av­er­age peak an­nual sales.

A hunt for any sil­ver lin­ing in this new re­port can be des­per­ately hard. The De­loitte guys — Colin Terry and Neil Lesser — con­clude that the num­ber of block­busters pro­duced by this crowd has dwin­dled by more than half, so they keep spend­ing big in search of smaller drugs. And as they focus more and more on their own pipeline, they are ig­nor­ing the ex­ter­nal pro­grams that can de­liver bet­ter re­turns — set­ting up a push, per­haps, for a surge in M&A as the re­al­iza­tion sinks in that they are on the wrong track.

The best ap­proach, they add, is to think and act like a biotech. Smaller biotech groups sim­ply do bet­ter than Big Pharma at R&D. And the big com­pa­nies that stay fo­cused on core dis­eases do far bet­ter than the com­pa­nies that keep shift­ing R&D spot­lights.

Pharma Guy's insight:

What's the best way to emulate biotech companies to increase ROI? Raise prices like Gilead did, of course (read, for example, “Gilead Dodges Taxes While Gouging Prices, Says Advocacy Group”; http://sco.lt/7IjyXR). Or hire consultants to be CEO like Valeant did.

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Questions Trump Should Ask Biotech CEOs Today

Questions Trump Should Ask Biotech CEOs Today | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It’s the biotechnology industry’s turn to dazzle Donald Trump — or at least to try — in a meeting at the White House on Monday. Top on the agenda: the hot debate over federal funding for biomedical research.

 

  1. Will Trump ask his guests why they charge so much for drugs?

 

Vertex Pharmaceuticals CEO Dr. Jeffrey Leiden is coming to the event, as per a guest list obtained by Bloomberg. Why do we mention that? Because Vertex’s cystic fibrosis drug Orkambi has a list price of $259,000 a year.

 

Executives from Celgene are slated to attend, too. Their blood cancer drug Revlimid lists at about $130,000 a year (read “Orphan Drugs Are ‘Wicked Hot’ & Profitable for Pharma to Boot!”; http://sco.lt/5f0Fer).

 

Trump, of course, has famously accused drug makers of “getting away with murder.” (He also called the entire industry “disastrous.”) But when he met with key representatives from the biopharma world in late January, he was much more temperate.

 

If Trump does decide to come out swinging, he may find an unexpected ally in the room, in Regeneron CEO Dr. Len Schleifer. He has taken on his fellow CEOs on pricing, accusing them of letting greed darken the reputation of the industry (“Regeneron CEO Len Schleifer vs Pfizer CEO Ian Read on Drug Prices”; http://sco.lt/9CRiEr). Schleifer famously got into a public shouting match with Pfizer’s chief executive at a health care conference last fall as he railed against yearly price increases for old drugs (“Oh Snap! Regeneron CEO Says What to Pfizer CEO Ian Read???”; http://sco.lt/8ZED0T).

 

  1. Will the president of Stanford explain why he needs taxpayers to pay the light bill in his labs?

 

  1. Will Trump’s guests dare to bring up the NIH budget?

 

  1. Will Trump promise miracles?

 

  1. Will the talk turn to cash stashed abroad?

 

At least one of the companies represented at the meeting — Celgene — has a lot of money stashed overseas: $6.1 billion, to be exact.

 

President Trump has talked about giving companies in that situation a big tax break if they bring their wealth back to US shores. Treasury Secretary Steven Mnuchin recently said he’s working with Congress to come up with a “very competitive” plan for repatriating the money. But no details have been released.

 

The industry has promised that a tax break would help them create thousands of American jobs. But last time they got such a tax break, it didn’t pan out that way. Instead, drug makers used the tens of billions they brought back to the US in the mid-2000s to enrich their CEOs and drive up their stock prices. They also laid off thousands of workers.

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Leaders of U.S. Biotech Call Trump’s Ban “Misguided.” Big #Pharma Still Stands Mutely Behind Trump!

Leaders of U.S. Biotech Call Trump’s Ban “Misguided.” Big #Pharma Still Stands Mutely Behind Trump! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

We the undersigned, founders and leaders of biotech companies, write to express our deep concern and opposition to the executive order signed by President Donald Trump on January 27, 2017, barring the entry of citizens from seven countries into the United States1.

 

The United States is the world’s greatest developer of medicines and new inventions to ameliorate and cure intractable diseases, a status achieved through massive investment in private and public companies, academia and R&D. Most importantly, our success has been founded on the creativity and dedication of our most precious resource—our people.

 

Our people include researchers, clinicians, entrepreneurs and business executives from all over the world. They are colleagues in our laboratories, management teams and boardrooms. They discover and develop therapies that drive US biomedical innovation and deliver new medicines to patients, not only in America, but also across the globe. And they start companies that drive the economic growth and employment provided by biotech. Many of our colleagues from abroad ultimately become Americans, all to the great benefit of the United States. Indeed, a study found that in 2014, 52% of the 69,000 biomedical researchers in the United States were foreign-born.

 

If this misguided policy is not reversed, America is at risk of losing its leadership position in one of its most important sectors, one that will shape the world in the twenty-first century. Indeed, it will harm an industry dominated by smaller companies and startups, the very kind of industry the administration has said it wants to support. It will slow the fight against the many diseases that afflict us, as well as carry negative economic consequences for the United States.

 

From STATnews: “Entirely missing are representatives of Big Pharma, which has been comparatively silent on the issue (“Pharma's Top Execs React to Trump Immigration Ban With Near Universal Silence”; http://sco.lt/8fzALh). Among the world’s largest drug makers, only one, Allergan, has criticized the executive order. The likes of Johnson & Johnson, Pfizer, Merck, and Novartis have either stayed silent or issued statements that expressed support for affected employees but took no stance on the order itself.”

 

Further Reading: “Big Pharma (@PhRMA) Stands Behind Trump Even As He Vows to Lower Prices to Medicare”; http://sco.lt/5461NB

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New, Pricey Biotech Cholesterol Drugs Aren't Selling.

New, Pricey Biotech Cholesterol Drugs Aren't Selling. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It looked like a surefire way to make billions.

 

A year ago, two new drugs that used a novel mechanism to drive down cholesterol levels came on the market, and were promptly crowned as blockbusters in waiting. Analysts estimated sales at more than $3 billion a year.

 

But the two drugs have been commercial flops, in part due to a complicated reimbursement system that has frustrated doctors, confused patients, and left the biotech industry worried about the implications for other high-priced drugs in the pipeline.

 

“These launches so far are close to, if not the biggest, wastes of development and commercial investment in recent industry history,” said Geoffrey Porges, a biotech analyst at Leerink.

 

The companies behind the drugs — Amgen and the partnership of Sanofi and Regeneron — are spending hundreds of millions to promote their products but have reaped a mere fraction of that in revenue. “You don’t need to be in finance to know that that’s not a sustainable business proposition,” Porges said.

 

The problem boils down to doctors who are reluctant to write prescriptions, insurers who are unwilling to pay for them, and drug companies that have failed to understand a fast-changing marketplace.

 

Docs won’t prescribe pricey new cholesterol meds unless they lower heart risks.

 

The failures could send a chill through the still-booming biotech business, which relies on the idea that the risky, expensive process of developing new drugs can one day pay off big.

 

Cardiologists say the drugs could save lives. An estimated 15 percent of the roughly 74 million Americans with high cholesterol have alarmingly high LDL levels despite taking other drugs. Many would be candidates for the new treatments.

 

[But cardiologists may be biased. See my insights.]

 

And yet the new therapies have only been prescribed about 120,000 times, according to data from QuintilesIMS, grossing just above $150 million combined in the past year.

Pharma Guy's insight:

Dr. Robert Eckel, former American Heart Association (AHA) president and co-author of certain cholesterol-related AHA guidelines, received nearly $33K in industry payments in 2014. Over $14K came from drug maker Sanofi Aventis.. Express Scripts’ Chief Medical Officer Dr. Steve Miller wrote in July 2015 that the company’s new cholesterol-lowering drug, Praluent, and other “PCSK9-inhibitors” like it, could cost U.S. payers and patients more than $100 billion per year if not managed properly. More here: http://sco.lt/8fqEmf

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