Pharma R&D Annual Review 2016 Webinar

Citeline Pharma R&D Annual Review 2016

Moderators

Ian Lloyd - Senior Director, Pharmaprojects and Data Integration

Alexandra Shimmings - Managing Editor, Scrip Intelligence

Pharma intelligence | informa 2

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


Pipeline Grows Again: 11.5% increase


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?


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


<<

<<


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)


Top Companies By NAS Launches 2015


NAS Launches By Therapy Area


NAS Launches By Market


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



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



•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



•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)


Dissecting The 2016 R&D Pipeline

• By Phase

• By Company

• By Therapy Area

• By Mechanism of Action And Target


Pipeline By Phase


Clinical Phases Continue To Rise


Top 10 Companies by Pipeline Size

Source: Pharmaprojects®, January 2016


Top Companies By Pipeline Size Cont.


Number Of Companies In R&D

Year-on-year Increase grows:


Distribution Of Companies by Country HQ


Pipeline By Therapy Area – Cancer’s Domination Continues


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


Top 10 Indications


Small Molecules V Biologicals


Top 10 Mechanisms Of Action


Top 10 Targets


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)


Orphans Continue To Rise


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?


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


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


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

Thank you very much for joining us today. If you have any further questions or comments, please email them to [email protected]

Healthcare

Pharma R&D Annual Review 2016 Webinar