Af­ter re­port­ing pos­i­tive da­ta in non-ra­di­ograph­ic ax­i­al spondy­loarthri­tis last month, No­var­tis’ block­buster Cosen­tyx was dealt a set­back on Fri­day.

In the 52-week EX­CEED tri­al in 800 bi­o­log­ic-naïve ac­tive pso­ri­at­ic arthri­tis pa­tients, the IL-17A drug was test­ed against Ab­b­Vie’s flag­ship Hu­mi­ra. The main goal of the study was to show Cosen­tyx was sta­tis­ti­cal­ly su­pe­ri­or us­ing re­sponse rates to ACR20, a stan­dard mea­sure that looks for a 20% re­cov­ery in the num­ber of ten­der and num­ber of swollen joints, and a 20% im­prove­ment in three oth­er cat­e­gories at week 52.

Al­though Cosen­tyx monother­a­py re­sult­ed in high­er re­sults ver­sus Hu­mi­ra, it “nar­row­ly” missed the main goal of sta­tis­ti­cal su­pe­ri­or­i­ty. De­tailed da­ta will be pre­sent­ed at a lat­er date.

Cosen­tyx — ap­proved for pso­ri­at­ic arthri­tis, plaque pso­ri­a­sis and anky­los­ing spondyli­tis — has been No­var­tis’ biggest sell­er in the first nine months of 2019, gen­er­at­ing about $2.6 bil­lion in sales over the pe­ri­od. It in­hibits a pro­tein called IL-17A from bind­ing to its re­cep­tor and was the first-ever ap­proved such ther­a­py to se­cure ap­proval, launch­ing in 2015.

Since then, ri­vals have emerged, in­clud­ing Eli Lil­ly’s IL-17A ther­a­py Taltz, and J&J’s an­ti-IL23 Trem­fya. Bausch Health’s (for­mer­ly Valeant’s) Siliq tar­gets IL-17RA and is ap­proved for plaque pso­ri­a­sis, but is cur­rent­ly be­ing eval­u­at­ed for pso­ri­at­ic arthri­tis.

For Ab­b­Vie, its TNF in­hibitor Hu­mi­ra — ap­proved for an ar­ray of au­toim­mune con­di­tions — has been the gift that keeps giv­ing. The drug — which hit a stu­pen­dous $20 bil­lion in sales last year, earn­ing it the crown of the world’s best sell­ing ther­a­py — has be­gun to see ero­sion in Eu­ro­pean sales due to biosim­i­lar com­pe­ti­tion, and a US patent cliff is loom­ing.

In Au­gust, Ab­b­Vie’s JAK in­hibitor upadac­i­tinib se­cured FDA ap­proval as part of the drug­mak­er’s post-Hu­mi­ra plans.  But the class of drugs has been blight­ed by safe­ty con­cerns — con­se­quent­ly, upadac­i­tinib’s ap­proval was ac­com­pa­nied by a black box warn­ing.  Mean­while, Ab­b­Vie has al­so planned for a post-Hu­mi­ra world with a $63 bil­lion deal to swal­low Al­ler­gan and its key­stone Botox fran­chise.

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).

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.

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

→ Less than a year ago Gilead’s antiviral remdesivir failed to make the cut as investigators considered a raft of potential drugs that could be used against an Ebola outbreak. But it may gain a new mission with the outbreak of the coronavirus in China, which is popping up now around the world.

Gilead put out a statement saying that they’re now in discussions with health officials in the US and China about testing their NUC against the virus. It’s the latest in a growing lineup of biopharma companies that are marshaling R&D forces to see if they can come up with a vaccine or therapy to blunt the spread of the virus, which has now sickened hundreds, killed at least 17 people and led the Chinese government to start quarantining cities.

Back at the beginning of 2015, Deerfield Management co-led a $10 million Series C for a private gene therapy startup, reshaping the company and bringing in new leaders to pave way for an IPO just a year later.

Fast forward four more years and the startup, AveXis, is now a subsidiary of Novartis marketing the second-ever gene therapy to be approved in the US.

For its part, Deerfield has also grown more comfortable and ambitious about the nascent field. And the investment firm is now putting down its biggest bet yet: a $1.1 billion contract development and manufacturing facility to produce everything one needs for cell and gene therapy — faster and better than how it’s currently done.