Pharma R&D Annual Review 2018 Ian Lloyd Senior Director - - PowerPoint PPT Presentation

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Pharma R&D Annual Review 2018 Ian Lloyd Senior Director - - PowerPoint PPT Presentation

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Pharma R&D Annual Review 2018 Ian Lloyd Senior Director Pharmaprojects & Data Integration Alexandra Shimmings Executive Editor Scrip, Pink Sheet and In Vivo Wednesday May 16 th 2018 Agenda The total drug R&D pipeline size in

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Pharma R&D Annual Review 2018

Ian Lloyd Senior Director Pharmaprojects & Data Integration Alexandra Shimmings Executive Editor Scrip, Pink Sheet and In Vivo Wednesday May 16th 2018

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Agenda

  • The total drug R&D pipeline size in 2018
  • New active substance launches 2017
  • The drug pipeline in 2018, and how it is

changing

  • What to expect in the year ahead
  • Q&A
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Total pipeline size in 2018

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Total pipeline size has grown by 2.7%

2.7%

increase

Source: Pharmaprojects

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Key Facts – Total pipeline size

Source: Pharmaprojects

3,807 drugs entered pipeline during the year, but net increase

  • f just 395

The 2018 growth rate of 2.7% well down on the 2017 rate of 8.4% Growth has picked up again for 2018 in some indications Therefore, 3,412 left development during the year – a churn rate

  • f over 20%

Continuing growth is a cost, so only a good thing if it's matched by new drug launches

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New active substance launches 2017

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Source: Pharmaprojects

2017 was a good year for New Active Substance launches

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Key Facts – NAS launches in 2017

Source: Pharmaprojects

32% increase

  • n the 41 NAS

launches in 2016 54 New Active Substances were launched Pushes mean up to 46 for this decade Second- highest tally since 2000 Increase in first-in-class products launched

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Selected New Drug Launches 2017 – A Year of Firsts

First 2 CAR-T cell therapies launched

  • Novartis’ Kymriah (tisagenleucel-t)
  • Gilead’s Yescarta (axicabtagene ciloleucel)
  • Spark Therapeutics’ Luxturna (voretigene neparovec)
  • Sanofi/Regeneron’s Dupixent (dupilumab)

First US approval for a gene therapy First systemic therapy for atopic dermatitis More success in immuno-oncology Poised to become a blockbuster

  • AstraZeneca’s Imfinzi (durvalumab)
  • Merck KGaA/Pfizer’s Bavencio (avelumab)
  • GSK’s shingles vaccine Shingrix

Biggest first year sales in recent years

  • Roche’s Ocrevus (ocrelizumab) for MS, generating

~US$1 billion in nine months

Source: Pharmaprojects

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Top Companies By NAS Launches 2017

Source: Pharmaprojects

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NAS Launches 2017 By Therapeutic Group

Source: Pharmaprojects

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NAS Launches 2017 By Region

Source: Pharmaprojects

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Other First-In-Class Products In 2017 – Part 1

CELL AND GENE THERAPIES

  • Holostem and Chiesi Farmaceutici’s Holoclar

– an autologous corneal epithelial cell transplant therapy

  • TissueGene and Kolon Life Science’s

Invossa for osteoarthritis – the first TGF-ß1 agonist

  • Puma Biotechnology’s Nerlynx (neratinib)
  • BioCryst Pharmaceuticals/Mundipharma’s

Fodosine (forodesine)

CANCER ANTI-INFECTIVES

  • AiCuris/Merck & Co.’s Prevymis (letermovir)
  • Maruhi Co.’s Amenalief (amanamevir)
  • Merck & Co.’s Zinplava (bezlotoxumab) in

Clostridium difficile infections

Source: Pharmaprojects

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Other First-In-Class Products In 2017 – Part 2

RESPIRATORY

  • AstraZeneca’s Fasenra (benralizumab) for

severe asthma – an IL-5 receptor antagonist

  • Roche’s Hemlibra (emicizumab) – a

bispecific antibody to Factors IXa and X

HEMOPHILIA ENZYME REPLACEMENT THERAPIES

  • BioMarin Pharmaceuticals’ Brineura

(cerliponase alfa)

  • Ultragenyx Pharmaceuticals’ Mepsevii

(vestronidase alfa)

Source: Pharmaprojects

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The drug R&D pipeline in 2018, and how it is changing

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Breakdown of pipeline by phase

Source: Pharmaprojects

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Trends in clinical phase drug R&D

Source: Pharmaprojects

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Pipeline quality assessment of late stage drugs

Source: Biomedtracker

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Top 10 pharma companies by pipeline size

Posi:on 2018 (2017) Company No of Drugs in Pipeline 2018 (2017) No of Originated Drugs 2018 1 (1) Novar's 223 (251) 138 2 (5) Johnson & Johnson 216 (214) 116 3 (6) AstraZeneca 205 (213) 117 4 (3) Pfizer 192 (232) 126 5 (7) Roche 191 (206) 114 6 (2) GlaxoSmithKline 191 (250) 111 7 (4) Merck & Co. 191 (229) 109 8 (8) Sanofi 179 (193) 78 9 (10) Takeda 164 (141) 96 10 (9) Bristol-Myers Squibb 134 (144) 96

Source: Pharmaprojects

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Top 10 pharma companies – are they delivering new drugs?

Posi:on 2018 (2017) Company No of Drugs in Pipeline 2018 (2017) No of NAS Launches 2017 (2016) 1 (1) Novar's 223 (251) 4 (0) 2 (5) Johnson & Johnson 216 (214) 1 (0) 3 (6) AstraZeneca 205 (213) 3 (1) 4 (3) Pfizer 192 (232) 3 (0) 5 (7) Roche 191 (206) 2 (2) 6 (2) GlaxoSmithKline 191 (250) 1 (1) 7 (4) Merck & Co. 191 (229) 3 (2) 8 (8) Sanofi 179 (193) 2 (0) 9 (10) Takeda 164 (141) 1 (0) 10 (9) Bristol-Myers Squibb 134 (144) 1 (0)

Source: Pharmaprojects

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Total companies involved in pharma R&D

Source: Pharmaprojects

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Big pharma companies vs small – how the balance is shifting

Source: Pharmaprojects

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Locations of pharma companies worldwide

Source: Pharmaprojects

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The R&D pipeline by Therapeutic Area

Source: Pharmaprojects

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Cancer taking an ever bigger slice of the R&D pie

Source: Pharmaprojects

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Ongoing clinical trials by Therapeutic Area

Source: Trialtrove

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Top 10 diseases/indications

Posi:on 2018 (2017) Disease

  • No. of Ac:ve drugs

2018 (2017) Trend 1 (1) Cancer, breast 727 (654) ↑ 2 (2) Cancer, lung, non-small cell 544 (477) ↑ 3 (3) Cancer, colorectal 503 (476) ↑ 4 (6) Cancer, ovarian 434 (386) ↑ 5 (4) Cancer, pancrea'c 430 (416) ↑ 6 (5) Diabetes, Type 2 407 (415) ↔ 7 (9) Cancer, prostate 381 (362) ↑ 8 (7) Alzheimer's disease 381 (376) ↔ 9 (10) Cancer, brain 361 (322) ↑ 10 (8) Arthri's, rheumatoid 352 (372) ↓

Source: Pharmaprojects

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Top diseases/indications – 11-25

Posi:on 2018 (2017) Disease

  • No. of Ac:ve drugs

2018 (2017) Trend 11 (11) Cancer, melanoma 346 (312) ↑ 12 (12) Cancer, leukaemia, acute myelogenous 326 (285) ↑ 13 (15) Cancer, liver 272 (264) ↔ 14 (14) Pain, nocicep've, general 262 (268) ↔ 15 (19) Cancer, head and neck 258 (227) ↑ 16 (13) Psoriasis 256 (283) ↓ 17 (17) Cancer, myeloma 254 (246) ↔ 18 (18) Parkinson's disease 252 (246) ↔ 19 (21) Cancer, gastrointes'nal, stomach 242 (213) ↑ 20 (16) Asthma 224 (254) ↓ 21 (22) Cancer, renal 218 (197) ↑ 22 (20) Cancer, lymphoma, non-Hodgkin's 215 (217) ↔ 23 (23) Chronic obstruc've pulmonary disease 179 (192) ↔ 24 (25) Pain, neuropathic, general 178 (169) ↔ 25 (24) Infec'on, HIV/AIDS 177 (183) ↔

Source: Pharmaprojects

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Top 10 Mechanisms of Action (pharmacologies)

Posi:on 2018 (2017) Mechanism of Ac:on (Pharmacology)

  • No. of Ac:ve

Compounds 2018 (2017) % of Compounds PR/R/L 1 (1) Immunos'mulant 1501 (1736) 10.0 2 (2) An'cancer immunotherapy 1332 (889) 1.6 3 (-) Immune checkpoint inhibitor 211 (-) 3.3 4 (3) Immunosuppressant 208 (215) 26.4 5 (4) Angiogenesis inhibitor 169 (179) 17.8 6 (5) Vascular endothelial growth factor (VEGF)receptor antagonist 138 (123) 14.5 7 (7) Apoptosis s'mulant 116 (115) 14.7 8 (6) DNA inhibitor 111 (120) 20.7 9 (9) Opioid mu receptor agonist 110 (114) 40.9 10 (-) Radiopharmaceu'cal 108 (-) 10.2

Source: Pharmaprojects

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Top 10 Drug protein targets

Posi:on 2018 (2017) Target

  • No. of Ac:ve

compounds 2018 (2017) Trend 1 (1)

  • pioid receptor, mu 1

140 (143) ↔ 2 (4) erb-b2 receptor tyrosine kinase 2 [Her-2] 120 (113) ↔ 3 (6) vascular endothelial growth factor A 119 (105) ↑ 4 (2) nuclear receptor subfamily 3, group C, member 1 (glucocor'coid receptor) 113 (123) ↓ 5 (3) tumour necrosis factor 113 (123) ↓ 6 (5) prostaglandin-endoperoxide synthase 2 (prostaglandin G/H synthase and cyclooxygenase) [COX-2] 107 (106) ↔ 7 (7) epidermal growth factor receptor 107 (104) ↔ 8 (8) insulin receptor 99 (94) ↔ 9 (9)

  • pioid receptor, kappa 1

88 (87) ↔ 10 (10) glucagon-like pep'de 1 receptor 80 (82) ↔

Source: Pharmaprojects

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New drug protein targets identified by year

Source: Pharmaprojects

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Biologicals advance towards 40% of R&D

Source: Pharmaprojects

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Orphan drug designations and expedited reviews granted by year

Source: Pharmaprojects

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Key Trends – The drug R&D pipeline in 2018 – Part 1

Source: Pharmaprojects

2017 was a good year for new drug launches, with some notable firsts The R&D pipeline is still growing, although the growth rate has slowed Top 10 pharma companies all delivered new drugs, but their share of the

  • verall pipeline

is in decline Little change in drugs at clinical stages – in quantity or quality

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Key Trends – The drug R&D pipeline in 2018 – Part 2

Source: Pharmaprojects

The immuno-

  • ncology boom

shows no sign

  • f ending

Cancer now taking over a third of all pipeline drugs, and all of the top 5 indications Companies still focusing on rare diseases, despite stumbling innovation levels Biologicals advance towards 40% of the R&D portfolio

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What to expect in the year ahead

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Selected drugs approved in 2017 due for early 2018 launch

Source: Pharmaprojects

Spark Therapeutics’ Luxturna (voretigene neparvovec) for biallelic RPE65 mutation- associated retinal dystrophy Pfizer’s Steglatro (ertugliflozin) for Type 2 diabetes Novo Nordisk’s Ozempic (semaglutide) for Type 2 diabetes Aerie Pharmaceuticals’ Rhopressa (netarsudil) for glaucoma

Launched Q1 Launched April Launched February Launched January

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Important approvals so far in 2018

  • Gilead’s Biktarvy (bictegravir in FDC with

emtricitabine/TAF) [February]

  • Theratechnologies/TaiMed Biologics’

Trogarzo (ibalizumab) [March]

  • Rigel’s Tavalisse (fostamatinib) [April]

Further anti-HIV drugs Immune thrombocytopenic purpura Non-metastatic castration-resistant prostate cancer Moderate-to-severe plaque psoriasis

  • J&J’s Erleada (apalutamide) [April]
  • Merck & Co & Sun’s tildrakizumab [March]

Source: Scrip

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Important approvals due later in 2018

  • Amgen/Novartis’s Aimovig (erenumab) [17

May]

  • Teva’s fremanezumab [15 June]
  • Lilly’s galcanezumab [October]
  • AbbVie’s elagolix [was due in May but now

Q3]

Anti-CGRP monoclonals for migraine Endometriosis and uterine fibroids Hairy cell leukemia Moderate-to-severe rheumatoid arthritis

  • AstraZeneca's moxetumomab [PDUFA

September]

  • Eli Lilly/Incyte's baricitinib [mid-year]

Source: Scrip

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Phase III Results to look out for in 2018

PD-1/PD-L1 inhibitors and CTLA-4 inhibitors in indications beyond melanoma

  • AstraZeneca’s study of Imfinzi (durvalumab) with tremelimumab in

NSCLC

  • Bristol-Myers Squibb’s study of Opdivo (nivolumab) with Yervoy

(ipilimumab), also in NSCLC

  • Phase III ECHO 301 trial of Merck & Co’s Keytruda (pembrolizumab) in

combination with IDO inhibitor epacadostat

Vascular Biogenics’ gene therapy for GBM, ofranergene

  • badenovec

Oncology Neuroscience Cardiometaboli c

Further Phase III trial read-outs in Alzheimer’s

  • Roche’s amyloid-targeting crenezumab and gantenerumab in AD
  • vTv Therapeutics’ RAGE inhibitor azeliragon in AD – STEADFAST trial

J&J’s esketamine for treatment-resistant depression in Phase III Esperion’s bempedoic acid in elevated LDL-cholesterol as add-

  • n to ezetimibe

Source: Scrip

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What to look out for in 2018

Generic competition

  • Lifting barriers to generic drug competition will be a priority of the US

government and FDA

New pricing mechanisms for combination therapies

  • New formulae for reimbursing combinations where elements come from

different manufacturers

Brexit

  • Continued uncertainty on harmonization and ex-UK recruitment into UK

pharmas

Source: Scrip

Pricing and policy

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What to look out for in 2018

Personalized Medicine

  • Improvements in cost-effectiveness and sensitivity of genomic analysis

meaning a wide range of tests are beginning to emerge

  • PM will improve response rates dramatically and make treatments much

more effective and efficient

The rise of Artificial Intelligence

  • Companies will significantly scale their use of AI via applications such as

predictive customer engagement

Tech companies become industry disruptors?

  • Amazon and Google could enter the pharma fray

Technology

Source: Scrip

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What to look out for in 2018

  • Takeda acquiring Shire and TiGenix
  • Sanofi outbid Novo Nordisk to buy Ablynx
  • Bioverativ also to be acquired by Sanofi
  • Celgene buying cancer drug developer Impact Biomedicines
  • Biocryst and Idera set to merge

Source: Scrip

Selected M&A activity already announced in 2018

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Thank you for your attention

Questions?

pharma@informa.com