J&J ad­vances through PhII with a promis­ing hep C triple and 100% cure rate

Cur­ing he­pati­tis C is a done deal now. But J&J is step­ping through the clin­ic with a new com­bo that the phar­ma gi­ant hopes will prove it can do it all faster, and pre­sum­ably cheap­er, than what’s avail­able now.

Achillion CEO Milind Desh­pande

In a new batch of da­ta put out Fri­day morn­ing by J&J part­ner Achillion $ACHN, J&J’s team scored a 100% cure rate in three co­horts of pa­tients get­ting a triple com­bi­na­tion of odalasvir, AL-335 and Oly­sio (simepre­vir). A fourth co­hort that ex­clud­ed simepre­vir achieved a 90% cure rate at SVR12, 12 weeks af­ter treat­ment. And one of the triplet co­horts achieved 100% cure for 20 pa­tients af­ter just 6 weeks of treat­ment.

That last fig­ure could be cru­cial, says Baird’s Bri­an Sko­r­ney:

Suc­cess at six weeks has the po­ten­tial to make this reg­i­men a se­ri­ous com­peti­tor to Gilead’s reg­i­mens, which cure in eight to 12 weeks.

The Phase IIa re­sults fixed the dose that J&J $JNJ will use in the next step, a Phase IIb that will en­roll both treat­ment-naive and treat­ment-ex­pe­ri­enced non-cir­rhot­ic pa­tients chron­i­cal­ly in­fect­ed with he­pati­tis C virus which runs the slate of geno­types 1, 2, 4, 5, and 6. In­ves­ti­ga­tors will al­so ex­pand the IIa to in­clude a broad­er mix of pa­tients as they push ahead to­ward piv­otal stud­ies and what looks like a prob­a­ble ap­proval.

Gilead, as we know, changed the treat­ment stan­dard with its break­through hep C drugs, be­gin­ning with So­val­di and con­tin­u­ing with Har­voni. Gilead al­so has a triple in the works, and has a rep­u­ta­tion as a tough com­peti­tor in any mar­ket it plays in. Gilead’s suc­cess was al­so fol­lowed up by new com­bos from Mer­ck and Ab­b­Vie, which fur­ther com­pli­cate the ar­rival of any new ther­a­pies. While whole­sale prices have been drop­ping, putting Gilead past the peak rev­enue stage, J&J still sees some big com­mer­cial up­side in a world where mil­lions of these slow-burn­ing cas­es have yet to be di­ag­nosed.

That strat­e­gy drove a deal to li­cense in Achillion’s NS5A drug odalasvir (ACH-3102) in a $1.1 bil­lion pact. The phar­ma gi­ant al­so bought out Alios for $1.75 bil­lion, gain­ing the nu­cleotide NS5B in­hibitor AL-335, which was added to a port­fo­lio that al­so in­clud­ed the NS3/4A pro­tease in­hibitor Oly­sio.

It’s not all good news for the hep C team, though. Jef­feries’ Bri­an Abra­hams was quick to note that there are still unan­swered ques­tions on how this sec­ond-wave ri­val­ry will play out, and whether J&J can suc­cess­ful­ly carve out a piece of the mar­ket. And he not­ed:

Based on two vi­ral re­bounds ob­served in the 8 week dual NS5A arm, we have con­firmed that ACHN/JNJ will no longer pur­sue a dual-reg­i­men — slight­ly dis­ap­point­ing, giv­en re­sults of the pi­lot “proxy” odalasvir-so­fos­bu­vir study, which had shown 100% SVRs with an odalasvir con­tain­ing dual-reg­i­men with both 8- and even 6-week treat­ment du­ra­tions, and could have been a dif­fer­en­ti­at­ing fea­ture. (We spec­u­late this may be due to ei­ther AL-335 be­ing less po­tent than so­fos­bu­vir, or to odalasvir dos­ing/ex­po­sure still be­ing op­ti­mized). The 6 week triple-reg­i­men showed promis­ing 100% EoT sup­pres­sion, and giv­en JNJ’s plan to ex­plore a 6 week reg­i­men in ph.IIb, we be­lieve SVR da­ta avail­able at the meet­ing in 2 weeks could look promis­ing and in­di­cate a po­ten­tial fu­ture path for the cock­tail.

Not­ed Achillion CEO Milind Desh­pande:

“Based on these in­ter­im re­sults, Janssen plans to ad­vance a phase 2b pro­gram for the triple com­bi­na­tion to fur­ther un­der­stand the po­ten­tial of this 3DAA drug com­bi­na­tion to short­en the du­ra­tion of treat­ment for pa­tients suf­fer­ing from HCV. De­spite re­cent ther­a­peu­tic ad­vances, we be­lieve there re­mains a sig­nif­i­cant un­met need in ad­dress­ing the glob­al bur­den of he­pati­tis C virus in those liv­ing with the dis­ease.”

Mer­ck is tak­ing the ax to its US op­er­a­tions, cut­ting 500 jobs in its lat­est re­or­ga­ni­za­tion

Merck is cutting 500 jobs in its US sales and headquarters commercial teams in its latest effort to find new ways to streamline the operation.

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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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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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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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Flu Virus (Source: CDC)

FDA ex­pands Xofluza ap­proval as Roche strug­gles to catch loom­ing flu mar­ket

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

EMA backs sev­en ther­a­pies, in­clud­ing Mer­ck­'s Ebo­la vac­cine

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.

Ronald Herb­st fol­lows Med­Im­mune ex­o­dus to Pyx­is CSO post; Jeff God­dard to suc­ceed CEO of AIT Bio­science

→ The outflow of top execs from MedImmune continues to fill the leadership ranks of smaller biotechs. The latest to take off is Ronald Herbst, the head of oncology research, who’s assuming the CSO post at Pyxis Oncology.  

Herbst was part of the old MedImmune organization AstraZeneca CEO Pascal Soriot restructured earlier this year, reorganizing the company and eliminating the storied subsidiary as a separate organization.

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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?

UP­DAT­ED: J&J's Xarel­to, Amar­in's Vas­cepa are cost-ef­fec­tive, not bud­get friend­ly — ICER

ICER, an increasingly influential cost-effectiveness watchdog in the United States, has concluded in its review of treatments for cardiovascular disease that while the cost of J&J’s Xarelto and Amarin’s Vascepa meet its benchmark for value pricing — the two treatments will not likely treat as many patients as hoped without surpassing the annual budget threshold calculated by ICER for each therapy.