jueves, 17 de diciembre de 2015

THE PIPELINE REPORT 2016 (III): Autoinmmune

Baricitinib Eli Lilly/Incyte 

Indication: RA (Ph.III) 
What the clinical trials found: The daily oral demonstrated superiority compared to placebo after 12 weeks based on ACR20 response (Ph. III RA-BEAM). The agent also proved superior to adalimumab on key secondary objectives of ACR20 response and improvement in DAS28-hsCRP score. A few occasional AEs were reported. 
Credit Suisse Success Probability and inThought Comment: 70%. The JAK inhibitor appears to have similar efficacy and safety to Pfizer’s Xeljanz. It was supposed to have a once daily vs. Xeljanz’s twice daily advantage, but Xeljanz’s once daily formulation will likely be approved soon. It’ll be interesting to see if Lilly/Incyte can do something with patient access and price to improve upon the poor performance of Xeljanz and expand the JAK inhibitor market. Expected launch: 2016 (Source: Credit Suisse) 
Credit Suisse forecast: $1.09 billion in global annual sales by 2020 
What the physicians are saying: Baricitinib is the most advanced competitor to first-in-class Xeljanz, which caters to patients who have failed anti-TNFs and/or methotrexate; an area where physicians have been awaiting more options. However, price could be a barrier to baricitinib uptake. With the biologic market’s expected growth by 2020, JAK inhibitors have room to develop in a market that seeks effective therapies to improve patient quality of life. —Anita Agier, head of Disease Atlas, GfK Healthcare 

Ozanimod Celgene 

Indication: Relapsing MS/ulcerative colitis (Ph.III) 
What the clinical trials found: Ozanimod in RMS reduced MRI brain lesion activity and met key secondary MRI-based endpoints (RADIANCE, Ph.II). Ozanimod in UC met all efficacy endpoints with statistical significance in patients on the 1mg dose after 32 weeks of treatment (TOUCHSTONE, Ph.II). No severe AEs observed to date. 
Credit Suisse Success Probability and inThought Comment: 25%. The drug looks similar to Gilenya in efficacy and perhaps better in safety. Surprisingly, Novartis never developed Gilenya in ulcerative colitis or Crohn’s disease, so ozanimod has a big advantage and will perhaps become an oral alternative to Humira and Entyvio. Expected launch: 2018 (Source: Credit Suisse) 
Credit Suisse revenue forecast: $900 million in annual global sales by 2020 
What the physicians are saying: Trial findings show ozanimod’s ability to reduce MS relapses and brain lesions. Early opinions indicate a similar safety profile to approved oral agents Tecfidera, Gilenya and Sanofi’s Aubagio, providing another oral option for needle-adverse patients. If results from ongoing Phase III studies show superiority to Biogen’s Avonex and similar or better safety to the current oral therapies, then neurologists could add a formidable weapon to the MS arsenal. —Paul Wojciak, research director, GfK

ABP 501 (adalimumab biosimilar) Amgen 

Indication: RA (Ph.III) 
What the clinical trials found: A Phase III trial in patients with moderate-to-severe RA met its primary endpoint of clinical equivalence between the adalimumab biosimilar and branded adalimumab groups, as measured by ACR20 assessment at week 24. The trial also met its key secondary endpoints, including ACR50, ACR70 and DAS 28-CRP. The safety profile was comparable to adalimumab. 
inThought Comment: There are at least 20 biosimilar adalimumab, etanercept and infliximab agents in global development, but the real question is how this will play out in major markets. We expect the market to support no more than four biosimilar versions of a given drug and believe that deals with payers will dictate winners and losers. 
What the physicians are saying: Despite concerns that these complex substitutes aren’t a perfect replacement, biosimilars will undoubtedly play a leading role in future RA treatment. Most physicians recognize that biosimilars lower costs and give access to a greater number of patients in need of more effective therapies. But a lack of product information and experience will impair their trust. Physician education is one of numerous hurdles the biosimilar will face upon launch as multiple other assets in late phase look to capture a piece of the Humira pie. —Anita Agier, head of Disease Atlas, GfK Healthcare

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