Cheers! End­points News turns 1 to­day — and we're un­wrap­ping in­fo on a new sub­scrip­tion plan

To­day, End­points News is one year old. Like any thriv­ing in­fant, we’ve been grow­ing at a fast pace, out­grow­ing a hasti­ly craft­ed chris­ten­ing gar­ment.

Start­ing from scratch, with just so­cial me­dia and a lot of word of mouth to re­ly on, web traf­fic to End­points was less than 14,000 vis­its per week. To­day we notch 14,000 per day, with a to­tal of 139,000 unique read­ers com­ing to the web­site in May.

Email sub­scrip­tions — the most im­por­tant met­ric we track — grew from zilch to 16,000 dai­ly bio­phar­ma sub­scribers drawn to our in­de­pen­dent style of jour­nal­ism. This was a re­sult of or­gan­ic, word-of-mouth ad­vo­ca­cy from our biggest fans. End­points’ “open rate”, the per­cent­age of read­ers who ac­tu­al­ly open and read the email re­ports, has nev­er fall­en be­low 40% — far above in­dus­try av­er­ages and more than dou­ble the rate you see at sim­i­lar pub­li­ca­tions.

I’ve writ­ten — this is a rough ball­park fig­ure — more than 650,000 words on R&D over the past 12 months. And we con­tin­ue to grow our traf­fic month­ly at a dou­ble-dig­it rate.

I am es­sen­tial­ly at about 60% of the read­er­ship I had be­fore I de­cid­ed to do a boot­strap start­up pub­li­ca­tion for bio­phar­ma R&D. And be­lieve me, it’s the best 60%, as I’ve found dur­ing events we’ve host­ed along the way of our maid­en voy­age in San Fran­cis­co and Boston and Eu­rope. The rest will come along, and we’ll be ready to shoot past old mark­ers and fo­cus on achiev­ing big­ger goals in the year ahead.

So where do we go from here?

Com­mit­ment to open-ac­cess and high ex­pec­ta­tions for free con­tent

My part­ner, Ar­salan Arif, and I grew up in this on­line busi­ness me­dia world. We be­lieve that to get a big au­di­ence you need to con­cen­trate on an open-ac­cess mod­el.

In plain Eng­lish, the news must re­main free.

That hasn’t changed and it’s not go­ing to. But we are look­ing to grow the team here at End­points, adding con­tent as we ex­pand read­er­ship fur­ther. And that’s go­ing to take new rev­enue, on top of the ad­ver­tis­ing we’ve built up and con­tin­ue to grow.

A few weeks ago, we ran a read­er sur­vey ask­ing you whether you would con­sid­er pay­ing $200 a year for a sub­scrip­tion. Most said there wasn’t a chance. You have high ex­pec­ta­tions for free con­tent and you weren’t about to change. Some said they’d pay, but the fig­ure sound­ed high. And you were fine with the email blasts from ad­ver­tis­ers.

To all of you, we say thank you for spend­ing part of your work day with us. We’ll work for you every day of the week.

But about 20% of you felt that you would glad­ly pay that, ei­ther to sup­port the work we’re do­ing here or to pay for di­rect ac­cess to the re­port with­out any email blasts from ad­ver­tis­ers.

It was, in fact, about 50/50 on that score.

An­nounc­ing End­points In­sid­er

On Ju­ly 10, we’ll roll out End­points In­sid­er, our paid sub­scrip­tion mod­el. If you’d like to sup­port our work here — or sim­ply want all the con­tent with­out the ad­ver­tis­ing — please sign up here. The cost is $200/year (no pay­ment de­tails re­quired to­day).

End­points In­sid­er pre-reg­is­tra­tion
No pay­ment de­tails re­quired to­day

In ad­di­tion to sup­port­ing us and en­joy­ing an ad-free ex­pe­ri­ence, I’ll be mov­ing my opin­ion pieces be­hind the pay­wall, of­fer­ing eas­i­er ac­cess to the ed­i­to­r­i­al team for any queries you may have, and In­sid­ers can in­stant­ly down­load print-ready PDF ver­sions of all ar­ti­cles so you can print or share in­ter­nal­ly on your terms. Lat­er we’ll add a few oth­er sub­scriber-on­ly pieces, but all of the dai­ly bio­phar­ma news we pub­lish will re­main free and eas­i­ly ac­cessed to those of you who like things as they are. That is not go­ing to change and you don’t have to do any­thing to keep re­ceiv­ing End­points News and mes­sages from our ad­ver­tis­ers.

I’d like to thank you all for the lit­er­al­ly thou­sands of mes­sages of sup­port we’ve re­ceived along the way. When you start up your own in­de­pen­dent busi­ness in an in­dus­try like this, you find lots of sup­port for the en­tre­pre­neur­ial at­ti­tude we’ve adopt­ed. And if you would like to add your sub­scrip­tion to help sup­port that, we’d ap­pre­ci­ate that as well.

One way or the oth­er, we’ll keep work­ing 24/7 on your be­half. It’s been quite a ride, and we’re just get­ting start­ed putting can­dles on that cake. But with­out you, this all means noth­ing. — John Car­roll

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

No­var­tis is ax­ing 150 ear­ly dis­cov­ery jobs as CNI­BR shifts fo­cus to the de­vel­op­ment side of R&D

Novartis is axing some 150 early discover jobs in Shanghai as it swells its staff on the drug development side of the equation in China. And the company is concurrently beefing up its investment in China’s fast-growing biotech sector with a plan to add to its investments in local VCs.

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Democratic presidential candidate, U.S. Sen. Elizabeth Warren (D-MA) speaks during the Nevada Democrats' "First in the West" event at Bellagio Resort & Casino on November 17, 2019 in Las Vegas, Nevada (Getty Images)

Eliz­a­beth War­ren pro­pos­es us­ing com­pul­so­ry li­cens­ing, an­titrust ac­tions to break bio­phar­ma’s con­trol of drug pric­ing — and here are the block­busters she’s tar­get­ing first

Nancy Pelosi’s drug pricing bill may have sparked some industrial strength headaches on the money side of biopharma, but Elizabeth Warren seems determined to become biopharma’s Nightmare on Pennsylvania Avenue.
Warren, one of the top-ranked candidates for the Democratic presidential nomination backing Medicare for all, is circulating a new plan that promises to break the industry’s grip on drug prices — and she has some very specific examples of how she would do it.
The Warren plan would rely on the federal government’s compulsory licensing powers to seize the IP of blockbuster drugs like Truvada and Harvoni to provide them at a fraction of what Gilead sells them for in the US. And she would throw some antitrust actions in as needed to rein in the price of Humira, AbbVie’s cash cow that continues to dominate the list of the most profitable therapeutics on the market.
Notably, she plans to rely on the powers already vested in the federal government, rather than suggest remedies that would require the assent of a deeply divided Congress.
In addition to the blockbusters on the list, Warren sends a clear signal that the same tactics would be used to beef up the supply of cheap antibiotics, as needed. And the same action could befall any other therapy patients can’t afford.

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Mer­ck’s $1B cash gam­ble pays off with a sur­pris­ing PhI­II car­dio suc­cess for Bay­er’s heart drug veri­ciguat

More than 3 years after Merck stepped up and paid $1 billion in cold, hard cash to gain the US commercial rights to Bayer’s high-risk heart drug vericiguat in a broad-ranging cardio alliance, the partners say their Phase III study has come through with promising data and a date with regulators.
We don’t have the data, and won’t until they put it out at an upcoming scientific session, but Merck touted the results, saying that their big Phase III VICTORIA study hit the primary endpoint  — with vericiguat combined with available therapies reducing “the risk of the composite endpoint of heart failure hospitalization or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) compared to placebo when given in combination with available heart failure therapies.”
Depending on the hard data, and how it breaks out with the combinations used, this drug could pose a threat to Novartis’ blockbuster drug Entresto, currently at $1.6 billion while analysts expect peak sales to hit $4 billion.
The drug is a soluble guanylate cyclase (sGC) stimulator, which Bayer and Merck have had high hopes for. Evidently, so did cardiologists. Cowen’s last analysis set potential sales at $400 million in 2024, but that number could go up significantly now.
Cowen’s Steve Scala noted this morning:
Vericiguat could be a lucrative product for Merck, and one with potentially under-appreciated value. At Cowen’s Therapeutics Conference in September 2019, 80% of specialists anticipated a positive result from VICTORIA whereas only 51% of investors shared this optimism.
Investigators recruited more than 5,000 patients at more than 600 centers in 42 countries for this study — one of the most expensive propositions in R&D. Millions of people in the US suffer from heart failure with reduced ejection fraction when the failing heart fails to contract properly to eject blood into the system. Bayer holds ex-US rights to the drug and also stands to earn cash from the $1.1 billion in milestones Merck agreed on for their collaboration.
Remarkably, the drug was pushed into Phase III despite failing the mid-stage trial — though investigators flagged a success at the high dose of 10 mg. In VICTORIA, researchers started patients at 2.5 mg and then titrated up to 5 and then 10 mg.

Alk­er­mes forges $950M biotech buy­out deal in a bold bet on an ear­ly-stage CNS drug plat­form

Alkermes $ALKS is investing $100 million cash and committing up to $850 million more in milestones in a big wager on a very early-stage CNS discovery platform. And the biotech is adding $20 million more to fund next year’s new research work on the platform it’s acquiring in today’s buyout with an eye to expanding the research work in oncology.

The biotech, helmed by Richard Pops, is buying Rodin Therapeutics, which had focused early on Alzheimer’s disease. Pops’ buyout, though, isn’t focused solely on the most troublesome sector in pharma R&D.

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Left to right: Arthur Pappas, Robert Nelsen, Peter Kolchinsky Doug Cole and David Beier

In rare po­lit­i­cal for­ay, top biotech in­vestors urge Con­gress to re­ject drug pric­ing bill

Thirteen of the top biotech venture capitalists in the country wrote a letter last week warning lawmakers that if Congress passes a drug pricing bill House Speaker Nancy Pelosi has put before lawmakers, they won’t be able to invest in biomedical research at their current rate, and patients will suffer.

“If policies such as those included within H.R. 3, the Lower Drug Costs Now Act, are passed, our ability to continue to invest in future biomedical innovation will be severely constrained, thus crushing the hopes of millions of patient waiting for the next breakthroughs to treat or cure their cancers, rare genetic diseases, Alzheimer’s, or other serious and life-threatening conditions,” they wrote in a letter addressed to the highest-ranking Democrats and Republicans in the House and Senate and acquired by Endpoints News. 

Dicer­na scores broad, 'rest of liv­er' deal with No­vo Nordisk, bag­ging $225M in cash to hit some 30 tar­gets with RNAi plat­form

Turns out Dicerna wasn’t done with deals yet after locking in $200 million upfront from Roche for a hepatitis B cocktail two weeks ago.

Novo Nordisk has signed on as the latest partner to its GalXC RNAi platform, handing over $175 million in cash to claim any and all targets of interest in liver-related cardio-metabolic diseases that are not already reserved in previous pacts. The Danish drugmaker — which has signaled its interest to expand considerably beyond its core diabetes franchise into areas like NASH — is also purchasing $50 million worth of Dicerna’s equity at a 25% premium of $21.93 per share. More research payments and milestones extending to the billions are on the line.

Gene ther­a­py wins the in­side track at EMA; PPD files for IPO

→ Gene therapy maker Orchard Therapeutics has been granted an accelerated assessment for OTL-200 by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The gene therapy — in development in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy — being used towards the treatment of metachromatic leukodystrophy.

→ Pharmaceutical Product Development has announced that its parent company, PPD, Inc has submitted a draft to the SEC relating to the proposal of an IPO of the parent company’s common stock. Number of shares and price range have not yet been determined.

Pfiz­er gets biosim­i­lar ap­proved for Hu­mi­ra, set­ting up com­pe­ti­tion — in 2023

In the story lawmakers and drug pricing reform advocates have told about the drug industry, there are perhaps few greater villains than Humira and its maker AbbVie.

Between 2012 and 2018, AbbVie upped the drug’s annual after-rebates cost from $19,000 to $38,000 in the US, with sticker prices now over $60,000 per year — increases that led to accusations of price gouging, most recently from Democratic presidential frontrunner Elizabeth Warren.