Your fast-pass to the news, insights, and storylines you need to know. Watch the full webinar here http://ow.ly/4mOGmk Hosted by Master of Ceremonies Ian Lloyd, senior director of Pharmaprojects and data integration, this webinar spotlights the blockbuster trends and rising stars of global R&D 2016 as seen in this year’s Annual Review. During this presentation, Ian Lloyd & Scrip Managing Editor, Alex Shimmings cover: >> Year-on-year growth >> Clinical phases trends >> Top companies and the shape of the industry >> Mergers and acquisitions >> Trending therapies, diseases, drug types and delivery routes >> Mechanisms and drug targets This webinar is the essential pharma R&D trend and forecast overview you need to be positioned for success in 2016. Watch the full webinar here http://ow.ly/4mOGmk

1. Citeline Pharma R&D
Annual Review 2016
Moderators
Ian Lloyd - Senior Director,
Pharmaprojects and Data Integration
Alexandra Shimmings - Managing Editor,
Scrip Intelligence

2. Pharma intelligence | informa2
Citeline Pharma R&D Annual Review Agenda
• Change in the number of active drugs in the pipeline
• New Active Substance Launches 2015 – overview and standout products
• Trends in R&D by development phase
• The Top 25 R&D players – how the rankings have changed
• Top indications, mechanisms, targets
• Outlook and what to watch for in 2016

3. Pharma intelligence | informa3
Pipeline Grows Again: 11.5% increase

4. Pharma intelligence | informa4
Total Pipeline Size: Key Facts
• No. of active drugs in development hits 13,718
• 11.5% increase bests 2014’s 8.8% rise
• Maintains trend of ever-increasing rises
• Increase mainly from fewer discontinuations
• Editorial changes
• Sustainable?

5. Pharma intelligence | informa5
New Active Substance Launches 2015
• No. of NAS launches 2015 vs preceding years
• Top companies for NAS launches
• Top therapy areas for NAS launches
• Most popular countries to debut drugs
• A review of the first-in-class NASs

6. Pharma intelligence | informa6
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7. Pharma intelligence | informa7
NAS Launches in 2015 – Key Points
• NAS launched drop by nearly one third to 43
• Even so, 2015 was the third best on record
• 14 were first-in-class – a higher % than in 2014
• More than half (24) are orphans
• Biologicals accounted for 39% (similar % to 2014)

8. Pharma intelligence | informa8
Top Companies By NAS Launches 2015

9. Pharma intelligence | informa9
NAS Launches By Therapy Area

10. Pharma intelligence | informa10
NAS Launches By Market

11. Pharma intelligence | informa11
The (First-In-)Class of 2015 Part 1
•Oncology:
• Five of the 14 were for cancer indications:
• AbbVie and Bristol-Myers Squibb’s Empliciti (elotuzumab)
SLAMF7 antagonist for multiple myeloma
• Genmab and Johnson & Johnson’s Darzalex (daratumumab)
CD38 antagonist for multiple myeloma
• United Therapeutics’ Unituxin (dinutuximab)
Chimeric MAb against ganglioside antigen GD2 for pediatric glioblastoma

12. Pharma intelligence | informa12
The (First-In-)Class of 2015 Part 2
Oncology (continued):
• The final two anticancers were small-molecule kinase inhibitors:
• Eisai’s Lenvima (lenvatinib)
FGF receptor-2 and -4 tyrosine kinase for metastatic thyroid cancer
• Pfizer/Amgen’s Ibrance (palbociclib)
Cyclin-dependent kinase-4 and -6 inhibitor for breast cancer
• Honorable mention:
Amgen’s Imlygic (talimogene laherparepvec) for recurrent melanoma

13. Pharma intelligence | informa13
The (First-In-)Class of 2015 Part 3
•Cardiovascular:
• Two hypolipemic PCSK9 inhibitors:
Regeneron/Sanofi’s Praluent (alirocumab) and Amgen’s Repatha (evolocumab)
• The first specific reversal agent for a NOAC:
Boehringer Ingelheim’s Praxbind* (idarucizumab)
• The first new agent for heart failure in 20yrs
Novartis’s Entresto (valsartan + sacubitril**)
*not strictly novel but noteworthy **The NAS in this product

14. Pharma intelligence | informa14
The (First-In-)Class of 2015 Part 4
•Respiratory:
• GlaxoSmithKline’s Nucala (mepolizumab)
Interleukin-5 antagonist
• Enzyme Replacement Therapies:
Alexion’s Strensiq (asfotase alfa) and
Kanuma (sebelipase alfa)
• Sexual Dysfunction:
Sprout Pharmaceuticals’ Addyi (flibanserin)
Dopamine D4 antagonist (among other mechanisms)

15. Pharma intelligence | informa15
Dissecting The 2016 R&D Pipeline
•By Phase
•By Company
•By Therapy Area
•By Mechanism of Action And Target

16. Pharma intelligence | informa16
Pipeline By Phase

17. Pharma intelligence | informa17
Clinical Phases Continue To Rise

18. Pharma intelligence | informa18
Top 10 Companies by Pipeline Size
Source: Pharmaprojects®, January 2016

19. Pharma intelligence | informa19
Top Companies By Pipeline Size Cont.

20. Pharma intelligence | informa20
Number Of Companies In R&D
Year-on-year Increase grows:

21. Pharma intelligence | informa21
Distribution Of Companies by Country HQ

22. Pharma intelligence | informa22
Pipeline By Therapy Area – Cancer’s Domination Continues

23. Pharma intelligence | informa23
Pipeline By Therapy Area – Key Facts
• 30.4% of pipeline drugs have a cancer target
• Cancer growth rate hits 16% (cf 11.5%)
• Cardiovasculars (4.6%), Neurologicals (7.7%) and Anti-infectives (6.2%)
all underperform
• Immuologicals (11.8%) and Sensory (13.5%) outperform

24. Pharma intelligence | informa24
Top 10 Indications

25. Pharma intelligence | informa25
Small Molecules V Biologicals

26. Pharma intelligence | informa26
Top 10 Mechanisms Of Action

27. Pharma intelligence | informa27
Top 10 Targets

28. Pharma intelligence | informa28
MoAs And Targets - Key Facts
• Anticancer immunotherapy – a new class taking R&D by storm
• Only 4 of the top 10 targets are against cancer – target diversity
• 1,518 individual proteins are being targeted
• 113 new targets identified (77 previous year)

29. Pharma intelligence | informa29
Orphans Continue To Rise

30. Pharma intelligence | informa30
Key Points And What to Look Out For In 2016 – The Pipeline
• Another record rise in pipeline size
• Increases across all phases and therapeutic areas
• Cancer strengthens its lead
Will these trends continue?

31. Pharma intelligence | informa31
Key Points And What to Look Out For In 2016 – NASs
• Number of NAS launches drops
• But levels in keeping with recent years
• Orphans and oncology NASs increasing
• Reimbursement rears head in the US
• 2016 looks less exciting for NAS novelty

32. Pharma intelligence | informa32
NAS To Look Out For In 2016
• Early disappointments:
• BioMarin's Kyndrisa (drisapersen) and Sarepta's eteplirsen
for muscular dystrophy
• CTI BioPharma and Baxalta's pacritinib for myelofibrosis
• Recently approved in the US:
• Eli Lilly's Taltz (ixekizumab) for psoriasis
• Teva's Cinqair (reslizumab) for asthma

33. Pharma intelligence | informa33
NAS To Look Out For In 2016
• PDUFA dates later this year:
•AbbVie/Roche's venetoclax for chronic lymphocytic leukemia
•Acadia's Nuplazid (pimavanserin) for Parkinson's disease
•Portola's andexanet alfa for anticoagulation reversal
•Sanofi/Regeneron's sarilumab for rheumatoid arthritis

34. Thank you very much for joining
us today.
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