Alex Howarth via Lycera

As it shops for new deals, Akcea hires for­mer GSK ex­ec as COO

In an un­ex­pect­ed twist in Sep­tem­ber, a tri­fec­ta of se­nior ex­ec­u­tives run­ning Akcea — CEO Paula Soteropou­los, pres­i­dent Sarah Boyce and COO Jef­frey Gold­berg — left the Boston drug­mak­er in one fell swoop.

Damien McDe­vitt

The board of the Io­n­is ma­jor­i­ty-owned spin­off swooped in to place Damien McDe­vitt — the chief busi­ness of­fi­cer of the Cal­i­for­nia com­pa­ny — in the in­ter­im chief spot. He will now be joined by Alex Howarth who will take on the role of COO.

When the un­cer­e­mo­ni­ous de­par­tures were an­nounced ear­li­er this year, no ex­pla­na­tion was ini­tial­ly pro­vid­ed by the com­pa­ny. Even­tu­al­ly, it emerged that the ex­its were un­re­lat­ed to the launch­es of Akcea’s two drugs, Tegse­di and Waylivra, but were in fact dri­ven by the need to go shop­ping for deals to ex­pand its ar­se­nal of drugs-in-de­vel­op­ment as the next big tri­al read­outs are on­ly ex­pect­ed by 2021.

Howarth, who will take charge of cor­po­rate strat­e­gy, busi­ness de­vel­op­ment, man­age­ment of stake­hold­er al­liances, le­gal and com­pli­ance, has a re­sumé that suits the evolv­ing strate­gic goals of Akcea.

He spent over ten years at GSK in a va­ri­ety of roles, in­clud­ing lead­ing GSK Ven­ture Part­ner­ships. He has al­so pre­vi­ous­ly worked at the ac­count­ing firm KP­MG, and is qual­i­fied as a char­tered ac­coun­tant and holds an hon­ors de­gree in bio­chem­istry.

Kyle Jenne Akcea

Un­der the re­vamped man­age­ment team, which al­so in­cludes the pro­mo­tion of Akcea’s chief com­mer­cial of­fi­cer Kyle Jenne, Akcea and Io­n­is clinched a col­lab­o­ra­tion with phar­ma gi­ant Pfiz­er. In Oc­to­ber, Akcea and Io­n­is signed the deal, which gave them $250 mil­lion up­front, and up to $1.3 bil­lion in mile­stone pay­ments, in ad­di­tion to dou­ble-dig­it roy­al­ties for their car­diometa­bol­ic drug, AKCEA-ANGPTL3-LRx.

Akcea re­mains broad­ly fo­cused on rare dis­ease med­i­cines and oth­er ther­a­pies which com­ple­ment their in­fra­struc­ture/ex­pe­ri­ence. What’s clear, in our view, is that Akcea‘s new man­age­ment team is mo­ti­vat­ed to ex­pand the pipeline from here,” Stifel’s Paul Mat­teis wrote in a note last month.

The com­pa­ny — fo­cused on rare dis­eases — is de­vel­op­ing a range of an­ti­sense drugs, which are en­gi­neered to in­ter­rupt the pro­duc­tion of dis­ease-caus­ing pro­teins by tar­get­ing the spe­cif­ic cor­re­spond­ing mes­sen­ger RNA (mR­NA) that en­codes that pro­tein, there­by ma­nip­u­lat­ing pro­tein pro­duc­tion.

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

Endpoints News

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Bernie Sanders, AP Images

Bernie Sanders goes af­ter Bio­Mar­in's shot at a record drug price, threat­en­ing to break the patent

Bioregnum Opinion Column by John Carroll

Last week at JP Morgan, BioMarin CEO JJ Bienaimé laid out his thoughts on pricing the leading gene therapy for hemophilia A at $2 million to $3 million a shot. Payers would support that, he said, putting the biotech on track to launching a treatment that could top the price of Novartis’s $2.1 million gene therapy for spinal muscular atrophy.

And with that, he earned some high-level attention from a would-be president of the United States.

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Hal Barron and Emma Walmsley, GSK

GSK’s ‘break­through’ BC­MA can­cer drug gets a pri­or­i­ty re­view — and a big win for the on­col­o­gy R&D team

After largely whiffing the past 2 years on the pharma R&D front, GlaxoSmithKline research chief Hal Barron has seized boasting rights to a key win that puts them back in the cancer drug development game.

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Who are the young bio­phar­ma lead­ers shap­ing the in­dus­try? Nom­i­nate them for End­points' spe­cial re­port

Two years ago, when we did our first Endpoints 20-under-40, we profiled a set of up-and-comers who promised to help reshape the industry as we know it. Now we’re back and once again looking for the top 20 biopharma professionals under the age of 40. We’ll be profiling folks who have accomplished a lot at a young age but seem on the verge of accomplishing so much more.

And we need your help.

John Oyler, Endpoints

BeiGene lines up its first shot at crack­ing the megablock­buster PD-1 mar­ket for lung can­cer. But can they over­come un­der­dog sta­tus?

BeiGene took another big step towards challenging Merck, Bristol-Myers Squibb, AstraZeneca and some other Big Pharma heavyweights for a share of the lucrative lung cancer market for the PD-(L)1s racking up billions in annual revenue.

The China-based biotech $BGNE run by CEO John Oyler posted positive top-line progression-free survival results for their pivotal Chinese study on their PD-1 antibody tislelizumab combined with chemo for squamous non-small cell lung cancer in frontline cases. Squamous NSCLC accounts for about 30% of the overall lung cancer market.

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David Ricks (Eli Lilly via YouTube)

Eli Lil­ly re­serves $470M for new man­u­fac­tur­ing plant — and North Car­oli­na is more than pleased

Eli Lilly is adding an eighth site to its network of manufacturing plants in the US, investing $470 million to begin production of injectable products and delivery devices at Research Triangle Park, North Carolina.

Anchored by three of the state’s top research universities, RTP is also home to some of the world’s top contract research organizations as well as a growing group of biopharma companies.

Tim Walbert (via Twitter)

UP­DAT­ED: FDA hands off its lat­est whirl­wind drug OK as Hori­zon hus­tles would-be block­buster to the mar­ket

The FDA isn’t letting its foot off the gas pedal just because it’s January.

The agency came through with an approval for Horizon Therapeutics’ $HZNP new thyroid eye drug Tepezza (teprotumumab), close to two months ahead of the PDUFA date — which was already set early in the year due to a priority review designation. But that sort of thing is becoming routine at the agency, especially if it has a designated “breakthrough therapy” on its hands.

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