Evo­lus cel­e­brates green­light for Botox ri­val while Al­ler­gan coun­ter­at­tacks with a com­plaint of stolen trade se­crets

De­spite a months-long de­lay, Evo­lus has over­come man­u­fac­tur­ing faults FDA pre­vi­ous­ly found and man­aged to se­cure a nod to be­gin mar­ket­ing its Botox ri­val. And you can count on Al­ler­gan to mount a le­gal coun­ter­at­tack to block the US en­try of a bi­o­log­ic that can threat­en its $3.5 bil­lion fran­chise.

David Moataze­di

The ap­proval came just af­ter mar­ket close on Fri­day for Jeu­veau, a 900 kDa pu­ri­fied bot­u­linum tox­in type A for­mu­la­tion that re­duces frown lines — or “glabel­lar lines as­so­ci­at­ed with cor­ru­ga­tor and/or pro­cerus mus­cle ac­tiv­i­ty in adults” if you pre­fer the aca­d­e­m­ic term.

In a head-to-head Phase III tri­al in­volv­ing 540 Eu­ro­peans and Cana­di­ans, in­ves­ti­ga­tors re­port­ed re­spon­der rates of 87.2% in the group re­ceiv­ing Evo­lus’s drug, 82.8% in the Botox group, and 4.2% in the place­bo group. Oth­er Phase III tri­als con­duct­ed in the US es­tab­lished su­pe­ri­or­i­ty over place­bo, the com­pa­ny says.

Per­haps more per­ti­nent to its plan to dis­rupt a mar­ket cur­rent­ly dom­i­nat­ed by Botox, Evo­lus “an­tic­i­pates a 20-25% dis­count to mar­ket leader,” a com­pa­ny rep­re­sen­ta­tive tells End­points News in an email, with more de­tails to come.

In a trade com­plaint filed two days be­fore the ap­proval, though, Al­ler­gan claims that the ri­val wrin­kle ther­a­py pig­gy­backs on R&D se­crets stolen by a for­mer staff sci­en­tist at its part­ner Me­dy­tox.

The em­ploy­ee then al­leged­ly hand­ed the “metic­u­lous, time-con­sum­ing, and ex­pen­sive re­search” on how to con­vert the dead­ly bot­u­linum tox­in in­to a treat­ment to Dae­woong, which lat­er out-li­censed its drug, DWP-450, to Evo­lus, ac­cord­ing to a Bloomberg re­port of the fil­ing. Dae­woong al­ready mar­kets the prod­uct in South Ko­rea as Nab­o­ta.

The com­plaint, filed at the US In­ter­na­tion­al Trade Com­mis­sion in Wash­ing­ton, fol­lows 2017 com­plaints in Ko­rea that Me­dy­tox filed against Dae­woong. The cas­es are on­go­ing.

Even if Al­ler­gan gets its way this time — which is high­ly un­cer­tain — ri­val of­fer­ings from Re­vance Ther­a­peu­tics and Hugel will still be fast on its heels.

And if it doesn’t, Evo­lus be­lieves that it can move in­to the num­ber 2 share po­si­tion with­in a few years, Leerink’s Marc Good­man notes, giv­en an EU ap­proval ex­pect­ed in mid-2019 and launch in Cana­da be­fore that.

Whether achiev­ing the num­ber 2 po­si­tion hap­pens or not, we do be­lieve that in­vestors should ex­pect a no­tice­able im­pact to the Botox Cos­met­ic growth rate from new com­pe­ti­tion. We mod­el US mar­ket growth of ~9% with Botox sales growth of ~6% in 2019E and mar­ket growth of ~8% and Botox sales growth of ~5.5% in 2020E. Giv­en that Botox is the most im­por­tant as­set for Al­ler­gan, we would al­so ex­pect sig­nif­i­cant in­vestor at­ten­tion fo­cused on this share dy­nam­ic and some ex­tra volatil­i­ty in the stock, just as we saw dur­ing pre­vi­ous Botox com­peti­tor launch­es.

Hav­ing de­nied al­le­ga­tions against them, Evo­lus and Dae­woong are al­ready at work build­ing out a spe­cial­ty sales team — which Evo­lus en­vi­sioned (when it went pub­lic) to con­sist of 65 reps at launch this spring and grow to 150 over time.

Evo­lus CEO David Moataze­di — ex-aes­thet­ics chief at Al­ler­gan — has this to say in his toast to the news:

Evo­lus is the first com­pa­ny in near­ly a decade to en­ter the fast-grow­ing US aes­thet­ic neu­ro­tox­in mar­ket […] The launch of Jeu­veau will be pow­ered by our tech­nol­o­gy plat­form de­signed to elim­i­nate the fric­tion points that ex­ist for cus­tomers to­day.

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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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 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.
The biotech started by putting together an “arsenal” of technologies aimed at making cell therapies for cancer much, much better than the rather crude first-generation drugs that hit the market from Novartis and Kite.
Their drugs have become the baseline against which all others are being measured.
“The technology set we’re developing is independent of the chassis,” Drazan tells me. “It doesn’t have to be autologous (extracted from the patient) or allogeneic (off the shelf). It doesn’t have to be a T cell, it could be a B cell.” But they are starting out on the autologous side, where they have the most knowledge and insight into manufacturing techniques.
It also doesn’t have to be close to the clinic.
Drazan expects the biotech will be working its way through preclinical operations for “a few years,” with enough money from the $85 million launch round to get into humans.
By today’s superheated fundraising standards, that’s not a huge amount of cash. Lyell, another cell therapy 2.0 startup we featured last week, raised $600 million in a year, including a big chunk of cash from GlaxoSmithKline. Drazan is interested in dealmaking as well, but he also knows he has the cash necessary to support the company for a good run — a key part of what it takes to bring together a stellar team of top players.

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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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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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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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From left to right: Lilian Kim, Associate Director Business Development; John Moller, CEO; Yooni Kim, Executive Director, Asia Operations; Michelle Park, Director South Korea Operations.

Novotech CRO sees 26% growth in Asia tri­al ac­tiv­i­ty from biotechs, but still plen­ty of ca­pac­i­ty

As the Asia-Pacific clinical trials sector continues to grow rapidly, Novotech the Asia-Pacific-based CRO is seeing biotech clinical activity up by 26%. But says there is still plenty of capacity in the region that features advanced medical facilities, supportive regulatory environments, and more than 2.3 billion people, largely treatment naïve, living in urban areas.

China, South Korea and Australia have the most studies registered as recruiting or about to recruit according to ClinicalTrials.Gov.