Dems fire off a sil­ly pric­ing bill; What's wrong with No­var­tis?

End­points as­sess­es the big bio­phar­ma sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.

The De­moc­rats field few good ideas in a drug pric­ing bill that is DOA

Any Sen­ate bill that re­lies on a long list of De­moc­rats for its sup­port doesn’t have much chance of be­com­ing law. But the Dems’ pro­posed law does help il­lus­trate what Par­ty lead­ers are think­ing these days, and where Pres­i­dent Trump may find com­mon ground if the ul­tra con­ser­v­a­tive wing of the Re­pub­li­can Par­ty can’t be brought back in­to the fold.

At the top of the list of things-phar­ma-com­pa­nies-hate is a re­quire­ment to break out de­vel­op­ment costs for each new drug. The un­end­ing de­bate over the cost of R&D gen­er­al­ly re­volves around glob­al R&D bud­gets com­pared to ap­provals. The De­moc­rats want to see some hard num­bers for each new pro­gram, prob­a­bly so they can start sham­ing man­u­fac­tur­ers for ex­ces­sive pric­ing.

Medicare ne­go­ti­a­tions are back, of course. Al­ready sup­port­ed by Trump, gov­ern­ment an­a­lysts have con­clud­ed that Medicare price ne­go­ti­a­tions as such wouldn’t like­ly cre­ate much in the way of sav­ings. That would take a for­mu­la­ry, and the threat of kick­ing off drugs priced too high, an idea which caus­es angst in phar­ma cir­cles.

In this new bill Medicare would be al­lowed to use VA prices or a price list from some oth­er agency if of­fi­cials can’t ne­go­ti­ate a “fair” price. We al­ready know from the Cal­i­for­nia bill that drug­mak­ers would fight this to the last lob­by­ist. There’s al­so a spe­cial ex­cise tax in the event a phar­ma com­pa­ny push­es up the price of drug more than med­ical in­fla­tion.

In­ter­est­ing­ly, there’s $2 bil­lion “prize” mon­ey for new an­tibi­otics. Giv­en the need here, and the low cost, it’s un­like­ly to spur much op­po­si­tion. And there’s $10 bil­lion to pay for drug tri­als at the NIH. Al­so, not so con­tro­ver­sial, but right now the fo­cus in the new ad­min­is­tra­tion is on cut­ting the NIH bud­get, not adding to it.

Bot­tom line: Aside from Medicare ne­go­ti­a­tions, there isn’t much here for a bi­par­ti­san ap­proach. It’s DOA, like most every­thing else in the Capi­tol these days.

Num­bers be­fore peo­ple. It’s the in­dus­try stan­dard.

Over the past week we’ve cov­ered sev­er­al new re­or­ga­ni­za­tion sto­ries. Am­gen led the way, with its planned move push­ing about 10% of its Thou­sand Oaks staff out of HQ. The cuts or re­lo­ca­tions in­volve mov­ing po­si­tions and re­searchers to the two big hubs of the Bay Area and Cam­bridge/Boston. Ver­tex, we learned from an SEC fil­ing, is shut­ter­ing its Cana­di­an R&D fa­cil­i­ty in a con­sol­i­da­tion. R&D sources tell us they’ve al­so been root­ing out pock­ets of the “Old Guard” in what are re­ferred to as “stealth lay­offs.” And Take­da gave us an ex­am­ple of the M&A va­ri­ety of job cuts, with their de­ci­sion to ax 180 of about 300 jobs at the new­ly ac­quired Ari­ad (with some axed staffers go­ing to a CRO).

With biotech val­u­a­tions be­ing what they are, it shouldn’t sur­prise any­one to see buy­ers cut as deep as they pos­si­bly can af­ter an ac­qui­si­tion. It’s one way to make num­bers work. That’s a sim­ple, though painful, re­al­i­ty.

Am­gen, for all its biotech his­to­ry, is now a Big Phar­ma and it will look for ef­fi­cien­cies wher­ev­er it can find them. Like all the Big Phar­mas, the on­ly con­stant in R&D is change.

Ver­tex gets a black star next to its name. Not for the Cana­di­an re­treat — every­body is con­sol­i­dat­ing in des­ig­nat­ed hubs — but for its re­fusal to be hon­est about the stealth lay­offs. You don’t have to be down­siz­ing to note when you are lay­ing peo­ple off from their jobs.

I was asked by a Roche em­ploy­ee at Nut­ley a few years ago what I thought about job se­cu­ri­ty in R&D. I told her I didn’t see much of it. The fact is com­pa­nies will do what’s in the best in­ter­est of their share­hold­ers every time. For rank-and-file em­ploy­ees, that takes a will­ing­ness to stay flex­i­ble and move as need­ed and de­sired.

The con­stant churn helps with new com­pa­ny cre­ation, but the me­chan­ics of this new re­al­i­ty are un­for­giv­ing at a per­son­al lev­el.

You can’t fight a trend like this. But you can de­ter­mine the best way to man­age a ca­reer in which job se­cu­ri­ty is a thing of the past — if it ever ex­ist­ed.

What’s wrong with No­var­tis?

I have no in­side knowl­edge why Karen Walk­er is leav­ing her se­nior po­si­tion in charge of cell ther­a­py man­u­fac­tur­ing for No­var­tis. Seat­tle is a nice place to live, or so I hear, and for all I know Seat­tle Ge­net­ics made her an of­fer she couldn’t refuse. That’s her busi­ness.

But her tim­ing, leav­ing two days af­ter the FDA ac­cept­ed No­var­tis’ ap­pli­ca­tion for its pi­o­neer­ing CAR-T, couldn’t have been worse for the com­pa­ny. Man­u­fac­tur­ing is a crit­i­cal el­e­ment in this field, more than most oth­ers, and she would have played a key role in its re­view.

It’s an­oth­er ex­am­ple of the ex­o­dus of tal­ent from No­var­tis over the past year. Some of that is self-in­flect­ed, like No­var­tis’ ques­tion­able de­ci­sion to dis­solve an in­de­pen­dent cell and gene ther­a­py unit, which led Oz Azam to leave the com­pa­ny. But bleed­ing tal­ent the way No­var­tis has is in­dica­tive of deep prob­lems.

The up­side here is that lots of these ex­pe­ri­enced ex­ecs — like Azam and Walk­er — are tak­ing new jobs in a boom­ing biotech sec­tor. But what’s wrong with No­var­tis?

Third Rock’s lat­est start­up launch­es in style, with an am­bi­tious set of goals

While turnover re­mains high, the in­dus­try re­mains vi­brant be­cause new com­pa­ny cre­ation in biotech is strong. One of our top sto­ries this week fo­cused on a clas­sic Third Rock start­up, Tan­go Ther­a­peu­tics. I en­joyed cov­er­ing the sci­ence they will be ex­plor­ing, as the team grows in­to the mid-20s.

This com­pa­ny has every­thing a start­up wants: Brains, mon­ey and am­bi­tion. And it’s carv­ing out new ter­ri­to­ry in drug de­vel­op­ment, go­ing big.

It’s com­pa­nies like these that make my job fun. Whether it works or not, it cer­tain­ly looks like they de­serve a shot. And it keeps the big hubs like Boston/Cam­bridge teem­ing with new ideas for old, im­pos­si­ble tar­gets. Thumbs up, in­deed.

Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

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Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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The FDA will hus­tle up an ex­pe­dit­ed re­view for As­traZeneca’s next shot at a block­buster can­cer drug fran­chise

AstraZeneca paid a hefty price to partner with Daiichi Sankyo on their experimental antibody drug conjugate for HER2 positive breast cancer. And they’ve been rewarded with a fast ride through the FDA, with a straight shot at creating another blockbuster oncology franchise.

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Sean Parker, AP

Sean Park­er helps cre­ate a CRISPRed cell ther­a­py 2.0 play — and he’s got a high-pro­file set of lead­ers on the team

You can rack up one more high-profile debut effort in the wave of activity forming around cell therapy 2.0. It’s another appealing Bay Area group that’s attracted some of the top hands in the business to a multi-year effort to create a breakthrough. And they have $85 million in hand to make that first big step to the clinic.

Today it’s Ken Drazan and the team at South San Francisco-based ArsenalBio that are coming from behind the curtain for a public bow, backed by billionaire Sean Parker and a collection of investors that includes Beth Seidenberg’s new venture investment operation based in LA.
Drazan — a J&J Innovation vet with a long record of entrepreneurial endeavors — exited the stage in 2018 when his last mission ended as he stepped aside as president of Grail. It wasn’t long, though, before he was helping out with a business plan for ArsenalBio that revolved around the work of a large group of interconnected scientists supported by the Parker Institute for Cancer Immunology.

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CSL ac­cus­es ri­val Pharm­ing of par­tic­i­pat­ing in a scheme to rip off IP on HAE while re­cruit­ing se­nior R&D staffer

Pharming has landed in the middle of a legal donnybrook after recruiting a senior executive from a rival R&D team at CSL. The Australian pharma giant slapped Pharming with a lawsuit alleging that the Dutch biotech’s new employee, Joseph Chiao, looted a large cache of proprietary documents as he hit the exit. And they want it all back.
Federal Judge Juan Sanchez in the Eastern District Pennsylvania court issued an injunction on Tuesday prohibiting Chiao from doing any work on HAE or primary immune deficiency in his new job and demanding that he return any material from CSL that he may have in his possession. And he wants Pharming to tell its employees not to ask for any information on the forbidden topics.
For its part, Pharming fired off an indignant response this morning denying any involvement in extracting any kind of IP from CSL, adding that it’s cooperating in the internal probe that CSL has underway.

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Eli Lil­ly’s first PhI­II show­down for their $1.6B can­cer drug just flopped — what now?

When Eli Lilly plunked down $1.6 billion in cash to acquire Armo Biosciences a little more than a year ago, the stars seemed aligned in its favor. The jewel in the crown they were buying was pegilodecakin, which had cleared the proof-of-concept stage and was already in a Phase III trial for pancreatic cancer.

And that study just failed.

Lilly reported this morning that their cancer drug flopped on overall survival when added to FOLFOX (folinic acid, 5-FU, oxaliplatin), compared to FOLFOX alone among patients suffering from advanced pancreatic cancer.

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UP­DAT­ED: Alex­ion pays $930M to buy out Achillion and its promis­ing com­pan­ion drug to Soliris

After a series of stock-crunching setbacks over the years, Achillion enjoyed a turn in the sun a few weeks ago as the FDA blessed their lead drug danicopan (ACH-4471) — a complementary therapy for PNH patients taking Alexion’s Soliris — with a breakthrough drug designation after taking a look at some solid supporting Phase II data.

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