THE PIPELINE REPORT 2016 PIPELINE 2014 AUTOIMMUNE PRODUCTS GENERATING BUZZ OTHER KEY PRODUCTS IN THE PIPELINE BIG-TIME Baricitinib Eli Lilly/Incyte Indication: RA (Ph.III) Romosozumab Amgen/UCB Sirukumab Janssen Biotech RA What the clinical trials found: The daily oral demonstrated superiority Osteoporosis (Ph.III) (Ph.III) compared to placebo after 12 weeks based on ACR20 response (Ph. Avatrombopag Astellas Pharma Anifrolumab Medarex/Med­ III RA-BEAM). The agent also proved superior to adalimumab on ITP/thrombocytopenia (Ph.III) Immune Systemic lupus erythema- tosus (Ph.III) key secondary objectives of ACR20 response and improvement in Elobixibat AstraZeneca CIC and DAS28-hsCRP score. A few occasional AEs were reported. IBS-C (Ph.III) Odanacatib Merck Osteoporosis (Ph.III) Credit Suisse Success Probability and inThought Comment: 70%. Lesinurad AstraZeneca Gout (Ph. III) Tildrakizumab Merck Psoriasis The JAK inhibitor appears to have similar efficacy and safety to (Ph.III) Pfizer’s Xeljanz. It was supposed to have a once daily vs. Xeljanz’s Alicaforsen Atlantic Healthcare Pouchitis/ulcerative colitis (Ph.III) Siponimod Novartis MS (Ph.III) twice daily advantage, but Xeljanz’s once daily formulation will likely be approved soon. It’ll be interesting to see if Lilly/Incyte Rituximab biosimilar Boehringer Infliximab biosimilar Pfizer RA Ingelheim RA (Ph.III) (Ph.III) can do something with patient access and price to improve upon Mongersen Celgene/Nogra RHB 104 RedHill Biopharma the poor performance of Xeljanz and expand the JAK inhibitor Pharma Crohn’s disease (Ph.III) Crohn’s disease (Ph.III) market. Expected launch: 2016 (Source: Credit Suisse) Etanercept biosimilar Coherus Sarilumad Regeneron RA (Ph.III) Credit Suisse forecast: $1.09 billion in global annual sales by 2020 Biosciences/Daiichi Sankyo/ Etrolizumab Roche Ulcerative A peek at 159 aspiring agents, with profiles on 17 that could shoot to stardom. Baxalta Plaque psoriasis/RA (Ph.III) What the physicians are saying: Baricitinib is the most advanced colitis (Ph.III) UPSIDE competitor to first-in-class Xeljanz, which caters to patients who Ixekizumab Eli Lilly Psoriasis Rebecca Mayer Knutsen has the forecast Adalimumab biosimilar Sandoz (Pre-reg.) have failed anti-TNFs and/or methotrexate; an area where physicians Plaque psoriasis (Ph.III) Etrolizumab Genentech Ulcerative have been awaiting more options. However, price could be a barrier Plecanatide Synergy Chronic colitis/Crohn’s (Ph.III) to baricitinib uptake. With the biologic market’s expected growth by constipation/IBS-c (Ph.III) Guselkumab Janssen Biotech he most-promising late-stage pipeline drugs are CETP inhibitors have been making headlines 2020, JAK inhibitors have room to develop in a market that seeks Laquinimod Teva MS (Ph.III) a varied bunch: cancer therapies employing the in the cardiology sector, though not in a good way. effective therapies to improve patient quality of life. —Anita Agier, Psoriasis (Ph.III) T immune system, PCSK9 inhibitors targeting THERAPEUTIC Following the lead of Roche and Pfizer, Eli Lilly head of Disease Atlas, GfK Healthcare cholesterol and biosimilars angling to upset biologics’ CATEGORIES became the latest company to halt development. market share. Some will hit the market with a splash, Whither Merck’s anacetrapib? Ozanimod Celgene others will crash and burn due to safety/efficacy issues Autoimmune p. 33 Among PCSK9 inhibitors, analysts are waiting to Indication: Relapsing MS/ulcerative colitis (Ph.III) ABP 501 (adalimumab biosimilar) Amgen and the rest could fade into obscurity if competitors Cardiology p. 34 see if Pfizer’s bococizumab can replicate Lipitor’s What the clinical trials found: Ozanimod in RMS reduced MRI brain Indication: RA (Ph.III) win the race to market. tardy—but huge—splash in the market. lesion activity and met key secondary MRI-based endpoints (RADI- What the clinical trials found: A Phase III trial in patients with Metabolic p. 35 When judging the future of clinical candidates, the In two pivotal studies Roche’s ocrelizumab ANCE, Ph.II). Ozanimod in UC met all efficacy endpoints with moderate-to-severe RA met its primary endpoint of clinical equiva- only important criterion is whether they will change Oncology p. 36 showed remarkable improvements over an MS statistical significance in patients on the 1mg dose after 32 weeks of lence between the adalimumab biosimilar and branded adalimumab therapy when approved, notes Bernard Munos, senior standard of care. The humanized mAb could make treatment (TOUCHSTONE, Ph.II). No severe AEs observed to date. groups, as measured by ACR20 assessment at week 24. The trial also Respiratory p. 37 fellow at FasterCures. Of a potential drug, Munos a real difference if approved. Credit Suisse Success Probability and inThought Comment: 25%. met its key secondary endpoints, including ACR50, ACR70 and asks, “Will patients and physicians clamor for it, as Other p. 38 And R&D dollars are making their way into the The drug looks similar to Gilenya in efficacy and perhaps better in DAS 28-CRP. The safety profile was comparable to adalimumab. they clamor for [Gilead’s hep.-C pill] Sovaldi or orphan-disease space at a greater clip, including Bio- safety. Surprisingly, Novartis never developed Gilenya in ulcerative inThought Comment: There are at least 20 biosimilar adalimumab, some of the new cancer drugs?” Marin’s agent to generate the muscle protein miss- colitis or Crohn’s disease, so ozanimod has a big advantage and will etanercept and infliximab agents in global development, but the real These days, changing the standard of care comes ing in patients with Duchenne muscular dystrophy. perhaps become an oral alternative to Humira and Entyvio. Expected question is how this will play out in major markets. We expect the with a hefty price tag: The year 2015 saw more industry pricing Advancements in diabetes drugs also grabbed our attention, launch: 2018 (Source: Credit Suisse) market to support no more than four biosimilar versions of a given controversy than ever before—and with the arrival of biosimilars including Sanofi’s lixisenatide/insulin glargine combination. Credit Suisse revenue forecast: $900 million in annual global sales drug and believe that deals with payers will dictate winners and losers. prices may go haywire. Perhaps the biggest lingering R&D question involves late-stage by 2020 What the physicians are saying: Despite concerns that these complex Nonetheless, oncology boasts the most noteworthy R&D innova- biosimilars like Merck/Samsung Bioepis’s MK-1293. What the physicians are saying: Trial findings show ozanimod’s ability substitutes aren’t a perfect replacement, biosimilars will undoubtedly tion of late. “PD-1/L1 inhibitors are the most remarkable accom- “We’re still figuring out . what the pricing structure will look to reduce MS relapses and brain lesions. Early opinions indicate a play a leading role in future RA treatment. Most physicians recognize plishment in years,” says Richard Evans, founder of SSR Health. like for biosimilars in the US,” Evans says. similar safety profile to approved oral agents Tecfidera, Gilenya and that biosimilars lower costs and give access to a greater number of Roche is looking to add its PD-L1 inhibitor atezolizumab to the The candidates profiled in this report are based on consultation Sanofi’s Aubagio, providing another oral option for needle-adverse patients in need of more effective therapies. But a lack of product mix, getting a boost with FDA’s breakthrough therapy designa- with inThought, Adis R&D Insight, GfK HealthCare and others. patients. If results from ongoing Phase III studies show superiority information and experience will impair their trust. Physician educa- tion for NSCLC. And Eli Lilly’s CDK 4/6 inhibitor abemaciclib Each therapeutic area includes the latest in clinical data, revenue to Biogen’s Avonex and similar or better safety to the current oral tion is one of numerous hurdles the biosimilar will face upon launch has shown promise for refractory HR+ advanced or metastatic forecasts, expected launch dates and success likelihood, where avail- therapies, then neurologists could add a formidable weapon to the as multiple other assets in late phase look to capture a piece of the breast cancer. able, of featured products. MS arsenal. —Paul Wojciak, research director, GfK Humira pie. —Anita Agier, head of Disease Atlas, GfK Healthcare 32 MM&M x DECEMBER 2015 x mmm-online.com mmm-online.com x DECEMBER 2015 x MM&M 33 BIG-TIME UPSIDE PIPELINE 2014 CARDIOLOGY METABOLIC PRODUCTS GENERATING BUZZ PRODUCTS GENERATING BUZZ OTHER KEY PRODUCTS IN THE PIPELINE OTHER KEY PRODUCTS IN THE PIPELINE Bococizumab (RN316) Pfizer LixiLan (lixisenatide/insulin glargine) Sanofi Indication: CV disorders/hypercholesterolemia/hyperlipidemia Indication: Type 2 diabetes (Ph.III) Revusiran Alnylam FAC (Ph.III) Volanesorsen Isis Pharmaceuti­ Etelcalcetide/AMG416 Amgen O62175C Novo Nordisk T1\2 (Ph.III) cals hypertriglyceridemia What the clinical trials found: In a Phase-III trial vs. Sanofi’s Lantus, Secondary hyperparathyroidism diabetes (Ph.III) What the clinical trials found: Patients with hyperlipidaemia who Beperminogene perplasmid lixisenatide/insulin glargine combination met the primary endpoint (Pre-reg.) AnGes MD PAD (Ph.III) Vanoxerine Laguna Pharmaceuti­ Pradigastat Novartis FCS (Ph.III) were on concurrent statin therapy saw significantly reduced LDL-C cals Atrial fibrillation (Ph.III) of statistically superior reduction in HbA1c (LixiLan-L). The Phase Candesartan cilexetil/nifedipine