Roche and My­lan set­tle a scrap over Her­ceptin, clear­ing path to a glob­al launch of a knock­off drug

Heather Bresch, CEO of My­lan

Two weeks ago Roche shares jumped on the news that the phar­ma gi­ant had scored win­ning Phase III da­ta sup­port­ing the com­bi­na­tion of Her­ceptin and Per­je­ta in fight­ing ear­ly-stage breast can­cer. And to­day, Roche and My­lan are an­nounc­ing that they’ve agreed to a set­tle­ment of their long-run­ning dis­pute over a biosim­i­lar of Her­ceptin, leav­ing My­lan with boast­ing rights for its shot at be­com­ing the first com­pa­ny to get a knock­off on­to the US mar­ket.

My­lan and Roche ham­mered out a glob­al li­cens­ing pact that gives My­lan launch dates for mar­kets around the world. But the com­pa­nies are keep­ing the sched­ule un­der wraps. As part of the set­tle­ment, My­lan is drop­ping a le­gal chal­lenge to two of Genen­tech’s patents.

From the state­ment:

Fol­low­ing this set­tle­ment and the re­cent ac­cep­tance of My­lan’s ap­pli­ca­tion for its pro­posed biosim­i­lar trastuzum­ab with the U.S. Food and Drug Ad­min­is­tra­tion (FDA), My­lan an­tic­i­pates po­ten­tial­ly be­ing the first com­pa­ny to launch a biosim­i­lar to Her­ceptin in the US.

My­lan is fac­ing a Sep­tem­ber 3rd PDU­FA date on their knock­off of Her­ceptin, a megablock­buster for Roche that brought in $6.7 bil­lion last year. The com­pa­ny has man­aged to stall com­peti­tors to its big fran­chise drug, though, giv­ing it time to ma­neu­ver for­ward with a com­bo suc­ces­sor that should help keep it high­ly com­pet­i­tive. Just a week ago Roche lost a three-year run­ning fight with My­lan and Bio­con over its at­tempt to break in­to the key In­di­an mar­ket.

Roche’s Dan O’Day said ear­li­er that he didn’t be­lieve a biosim­i­lar of Her­ceptin would reach the US mar­ket be­fore the fall of this year.

Roche’s po­si­tion now will lean heav­i­ly on da­ta from its APHIN­I­TY study, which demon­strat­ed pos­i­tive da­ta for the com­bi­na­tion of Per­je­ta and Her­ceptin in post-surgery pa­tients.

Am­gen and No­var­tis, mean­while, have been spar­ring over the rules on in­tro­duc­ing new biosim­i­lars. Leg­is­la­tion re­quires a 180-day no­tice of sales be­fore biosim­i­lar mar­ket­ing can start, and No­var­tis wants to sup­ply the no­tice ahead of a for­mal ap­proval to al­low for a quick start. Am­gen and op­po­nents, though, ar­gue that the no­tice should be on­ly al­lowed af­ter an ap­proval, in or­der to avoid mar­ket “chaos.” And both sides are tak­ing the case, which in­cludes a dis­pute over re­quir­ing biosim­i­lars man­u­fac­tur­ers to dis­close ap­pli­ca­tions, to the Supreme Court next month.

The set­tle­ment is big news for My­lan, which de­vel­oped the biosim­i­lar with In­dia’s Bio­con. My­lan has sole mar­ket­ing con­trol in the US, Cana­da, Japan, Aus­tralia, New Zealand and in the Eu­ro­pean Union and Eu­ro­pean Free Trade As­so­ci­a­tion coun­tries, with Bio­con hold­ing co-sales rights in the rest of the world.

My­lan CEO Heather Bresch com­ment­ed:

There is an un­met need for ac­cess to more af­ford­able ver­sions of bi­o­log­ic prod­ucts such as trastuzum­ab. We look for­ward to en­hanc­ing ac­cess to this im­por­tant treat­ment op­tion, which com­ple­ments our com­pre­hen­sive can­cer care of­fer­ings, in the U.S. and around the world. With 16 biosim­i­lar prod­ucts in de­vel­op­ment, we be­lieve My­lan has one of the in­dus­try’s broad­est port­fo­lios of biosim­i­lars and that we will be a leader in bring­ing high-qual­i­ty biosim­i­lar prod­ucts to mar­ket giv­en our abil­i­ty not on­ly to de­vel­op and man­u­fac­ture such com­plex prod­ucts, but al­so to nav­i­gate the in­tri­cate reg­u­la­to­ry and le­gal en­vi­ron­ment and suc­cess­ful­ly com­mer­cial­ize these prod­ucts on a glob­al ba­sis.

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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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?

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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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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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.

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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