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Pharma R&D Annual Review 2011

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May is the time when Citeline Drug Intelligence’s Annual Review of trends in pharmaceutical R&D is

traditionally conducted. It is a useful opportunity to pause and reflect on how the industry is continu-

ing to evolve, and is also the time when we take the annual snapshot of our data which provides a new

timepoint for our Trends data module in one of our database products, Pharmaprojects. In this article, we

examine the data for 2011, look at how it has changed since 2010, and try to put the information into some

sort of context.

Some of the key points covered in this report include:

• Growth of overall R&D pipeline flat • Few novel new active substances launched in past year

• 13% growth in drugs at Phase III status • Pfizer holds position as company with most drugs in development

• Cancer takes 28% slice of R&D pie • Poor year for newly-identified drug targets

Overall Decline in TOTal number Of acTive Drugs

The total number of Active drugs currently reported on the database is almost unchanged for 2011, with the figure of 9,713 representing a small but insignificant decline (0.2%) from the 2010 number of 9,737. This would appear to con-firm a trend, the beginnings of which were seen last year, of a plateauing off the longer-term trend of year-on-year increases. Figure 1 includes the totals reported at this time each year for every year since 2001, and clearly shows that the trend for most of the past decade was of slow annual growth (the step increase from 2007-2008 can be attrib-uted to the bringing together of drug data from our original database with that from the then newly-acquired Citeline database of clinical trials, TrialTrove).

Those who follow this figure more closely during the course of the year may have noticed considerable variations during the course of the year, with the total at one point appearing to show a considerable increase up to around the 10,600 mark. It is worth noting that many factors can affect the total week-to-week and month-to-month numbers, including the seasonality of scientific conferences and company reports, and changing editorial practices and priorities. However, we always ensure that the data is rigorously reviewed for this May timepoint, so this is the number which should be viewed as being the most reliable. We would counsel against concluding too much from the variations during the course of the year.

So should we be concerned at all about this apparent tapering off? In a year which has seen more R&D job losses and faltering recovery in many of the world’s economies, it is probably a comforting sign that the number of drugs in development has more-or-less held up. As we shall see when we come to dissect the R&D landscape more closely, there are some encouraging signs regarding the quality, if not the quantity, of the development pipeline. But before moving to this, let’s take a look at the success stories of 2010 – the new active substances which made their market debut during the year.

figure 1: Total size of the pipeline 2001-2011

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new acTive subsTance launches – nOT a vinTage year fOr nOvelTy

Table 1 lists all of the new active substances which we re-port as entering the market for the first time during calendar 2010, produced in conjunction with ScripIntelligence.com. There are 42 this year, slightly up on the 2010 figure of 36. However, last year’s figure was somewhat flattered by nine new anti-infective launches, mostly addressing the H1N1 in-fluenza pandemic, and this trick has been repeated this year with ten new anti-infective vaccines, of which seven are similarly for H1N1 or H5N1 influenza. The number of actual new chemical entities is again in the low twenties, and if we examine the list further for drugs with a new mechanism of action hitting the market for the first time, we come up with just three drugs.

Of these three, the one with the widest possible use is arguably Amgen’s denusomab (Prolia). This fully-human monoclonal antibody targets RANKL, also known as the osteoprotegrin ligand. Whilst the drug has thus far only been approved for use in osteoporosis, it is also under development for use in bone metastases in a wide variety of cancers, as well as for rheumatoid arthritis. Amgen has partnered with the larger multinational GlaxoSmithKline to bring this drug to the market in a number of non-US ter-ritories. Another of the innovative therapies of interest is Mitsubishi Tanabe’s fingolimod hydrochloride (Gilenya), a sphingosine-1 phosphate receptor agonist, approved for the therapy of relapsing-remitting multiple sclerosis, for which it is the first oral therapy. What both of these drugs have in common is that they have been successfully launched well ahead of their nearest rivals with the same mechanism of action, which are ALX-0141 (Phase I) and sonepcizumab (Phase II), respectively.

The final of these three debutantes is Santen’s diquafosol tetrasodium (Diquas), which, as the first purinoreceptor P2Y2 agonist to be launched, is notable for treating the

cause of xerophthalmia (dry eye syndrome), rather than the symptoms. However, despite gaining Japanese approval last year, the compound had already failed to impress the US FDA which had reviewed it twice but not approved it, leading to the drug’s original developer, Inspire, deciding to not develop it further.

On the novelty front, although they are not specific molecules, 2010 did see the innovative introduction of the first two autologous dendritic cell vaccines, CreaGene’s CreaVax-RCC and Dendreon’s Provenge, which were launched for the treatment of renal and prostate cancer, respectively. However, since these are therapeutics derived from the patient’s own cells, they are not pharmaceutical products in the traditional sense. Similarly, another interest-ing new cancer product, Agenus’ vitespen (Oncophage), shows innovation in the technology of utilizing heat shock protein (HSP) linked to an antigenic peptide, but both components are derived from the patient’s own cancer cells. Autologous products are something of a growth area, and we have recently widened our scope to ensure that we systematically track all those planned for commercialization.

Such successful use of biotechnological techniques feeds into a generally good year for biological NAS launches, with nineteen of the products in the table falling into this category versus 23 small molecules. However, aside from the aforementioned drugs, innovation in terms of new strategies is low, with the remaining small molecules all using strategies which have already been successfully employed. That’s not to say these other drugs don’t have therapeutic advantages, but it’s a fairly low hit rate in the area of novelty.

The US was, as always, the premier market of choice for first launch, with fifteen of the 42 NASs making their debuts in that territory. The UK eclipsed Germany this year as the most popular European market for a first appearance, with five first launches. There was an unusually high number of market entrances in Asia in 2010, with five in Japan, four in India (although three in the latter were ‘flu vaccines), two in South Korea and one in Taiwan. As far as the most suc-cessful companies for launches was concerned, there was no single company which had a spectacular year, with only Takeda originating more than one NAS.

The number of actual new chemical entities is

again in the low twenties, and if we examine the

list further for drugs with a new mechanism of

action hitting the market for the first time, we

come up with just three drugs.

Table 1: new active substance (nas) Drug launches 2010

generic name (branD name)

OriginaTing cOmpany

mechanism Of acTiOn

inDicaTiOn cOunTry(ies) Of firsT launch

alogliptin benzoate (Nesina)

Takeda DPP IV inhibitor Diabetes, Type 2 Japan

amifampridine phos-phate (Firdapse)

EUSA Pharma Potassium channel an-tagonist

Lambert-Eaton myas-thenic syndrome

The UK

bazedoxifene acetate (Viviant)

Ligand Selective estrogen recep-tor modulator

Osteoporosis Spain

cabazitaxel (Jevtana) Sanofi-Aventis Microtubule inhibitor Cancer, prostate The US

ChondroCelect TiGenix Not applicable (Cellular therapy)

Regeneration, cartilage Germany*

collagenase Clostrid-ium histolyticum (Xiapex)

Auxilium Collagenase stimulant Dpuytren’s disease The US

conestat alfa (Rhucin) Pharming Complement factor 1 inhibitor

Angioedema, hereditary Denmark

corifollitropin alfa (Elonva)

Merck & Co Follicle stimulating hor-mone receptor agonist

Infertility, female The UK

dalfampridine (Ampyra) Elan Potassium channel antagonist

Multiple sclerosis, general

Puerto Rico and the US

denosumab (Prolia) Amgen RANKL antagonist Osteoporosis The US

diquafosol tetrasodium (Diquas)

Santen Purinoreceptor P2Y2 agonist

Xerophthalmia Japan

ecallantide (Kalbitor) Dyax Kallikrein inhibitor Angioedema, hereditary The US

eribulin mesylate (Halaven)

Eisai Microtubule inhibitor Cancer, breast The US

fingolimod hydrochlo-ride (Gilenya)

Mitsubishi Tanabe Pharma

Sphingosine-1 phosphate receptor agonist

Multiple sclerosis, relapsing-remitting

The US

histamine dihydrochlo-ride, EpiCept (Ceplene)

EpiCept Histamine H2 receptor agonist

Cancer, leukaemia, acute myelogenous

The UK

iloperidone (Fanapt) Sanofi-Aventis 5-HT2A antagonist Schizophrenia The US

influenza vaccine (H1N1), Zydus Cadila (VaxiFlu-S)

Zydus Cadila Immunostimulant Infection, influenza virus prophylaxis

India

influenza vaccine, Baxter (PreFluCel)

Baxter International Immunostimulant Infection, influenza virus prophylaxis

Austria

influenza vaccine, Green Cro-2 (GC Flu)

Green Cross Immunostimulant Infection, influenza virus prophylaxis

S Korea

influenza vaccine, H1N1 (IM), Serum Institute of India (En-zavac)

Serum Institute of India Immunostimulant Infection, influenza virus prophylaxis

India

influenza vaccine, H1N1 LAIV, BioDiem (NasoVac)

BioDiem Immunostimulant Infection, influenza virus prophylaxis

India

*first patient received end of Dec 2009 but not included in last year’s list

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generic name (branD name)

OriginaTing cOmpany

mechanism Of acTiOn

inDicaTiOn cOunTry(ies) Of firsT launch

influenza vaccine, H1N1, ADImmune (AdimFlu-S)

ADImmune Immunostimulant Infection, influenza virus prophylaxis

Taiwan

influenza vaccine, H1N1, Bharat (HNVAC)

Bharat Biotech Immunostimulant Infection, influenza virus prophylaxis

India

iron isomaltoside, Phar-macosmos (Monofer)

Pharmacosmos Iron absorption stimulant Anaemia, iron deficiency The UK

Japanese encephalitis virus vaccine, Boryung (Jeimmugen)

Boryung Immunostimulant Infection, Japanese encephalitis virus pro-phylaxis

S Korea

laninamivir (Inavir) Daiichi Sankyo Neuraminidase inhibitor Infection, influenza virus Japan

meningococcal ACWY vaccine, Novartis (Menveo)

Novartis Immunostimulant Infection, Neisseria men-ingitidis prophylaxis

The US

mifamurtide (Junovan) Takeda Macrophage stimulant Cancer, sarcoma, osteo The EU

miriplatin hydrate (Miripla)

Dainippon Sumitomo Pharma

DNA inhibitor Cancer, liver Japan

pegloticase (Krystexxa) Mountain View Urate oxidase stimulant Hyperuricaemia The US

peramivir (Rapiacta) BioCryst Pharmaceu-ticals

Neuraminidase inhibitor Infection, influenza virus Japan

pneumococcal vaccine, 13-valent, Wyeth (Pre-venar 13)

Pfizer Immunostimulant Infection, pneumococcal prophylaxis

The US

prucalopride (Resolor) Johnson & Johnson 5-HT4 receptor agonist Constipation Germany

renal cancer vaccine, CreaGene (CreaVax-RCC)

CreaGene Immunostimulant Cancer, renal S Korea

roflumilast (Daliresp) Nycomed Pharma Phosphodiesterase IV inhibitor

Chronic obstructive pulmonary disease

Germany

romidepsin (Isodax) Astellas Histone deacetylase inhibitor

Cancer, lymphoma, T-cell The US

sipuleucel-T (Provenge) Dendreon Immunostimulant Cancer, prostate The US

tesamorelin acetate (Egrifta)

Theratechnologies Growth hormone releasing factor agonist

Lipodystrophy The US

velaglucerase alfa (Vpriv)

Shire Glucosylceramidase stimulant

Gaucher`s disease The US

vernakalant hydrochlo-ride (Brinavess)

Cardiome Voltage-gated sodium channel antagonist

Fibrillation, atrial The EU, Iceland and Norway

vinflunine ditartrate (Javlor)

Pierre Fabre Microtubule inhibitor Cancer, bladder The UK

vitespen (Oncophage) Agenus Immunostimulant Cancer, renal Russia

54

66

The 2011 pipeline by phase – encOuraging signs aT phase iii

So if 2010 was something less than vintage in terms of drugs successfully completing their development, what does the pipeline look like now in 2011 further back along the development cycle? Figure 2 compares this year’s data with last year’s, and, there are some encouraging signs. The number of drugs in Phase III has shown the biggest year-on-year jump so far recorded, with this year’s figure of 637 drugs representing a rise of 83 – or 13% - from the corresponding 2010 number. This is indeed a positive signal, as in recent years, there has been a noteworthy trend of increases in the numbers of Phase I and II drugs failing to translate through to Phase III. This indicated increas-ing attrition at Phase II, not what the industry was looking for as it sought to limit its expenditure on expensive clinical trials to drugs which had a better chance of success. This is shown more clearly in Figure 3, which focuses in on clinical stage development drugs but over a wider time period, from 2006-2011. It can be seen here how the Phase III figure was almost flat in the years 2008-2010, despite increases at Phases I and II in those years. While molecules can still fail in Phase III or have their approval applications turned down, the Phase II to III hurdle is a major one to overcome, so if this apparent improvement continues in the coming years, it should lead to an uplift in the numbers of drugs successfully reaching the market.

There are similar, although proportionally smaller, increases at Phase I and Phase II, and at pre-registration, continuing the trends seen in recent years. The counterbalance which has kept the overall pipeline size roughly static overall, is a decline at preclinical. Not too much should be read into this: the preclinical figure is the most subjective and volatile, and the decrease of 132 preclinical drugs can almost entirely be accounted for by an increase in 133 in the number of drugs moved to the No Development Reported status over the course of the year, a reflection primarily of more rigorous editorial reviewing policies. So overall, this particular analy-sis gives a more optimistic outlook than either the grand total or the number of NAS launches appear to.

figure 2: pipeline by phase, 2011 vs 2010 2010 2011

figure 3: clinical pipeline by phase, 2006-2011 2006 2007 2008 2009 2010 2011

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TOp cOmpanies – lack Of large m&as leaDs TO liTTle change

The first ‘league table’ which we consider annually is our Top 25 pharma companies by the size of their R&D pipe-lines. This is notable this year mainly by virtue of how little change is evident. Pfizer retains the top spot it acquired last year, albeit with a slightly reduced overall pipeline size. The gap between it and the runner-up, GlaxoSmithKline, remains the same though, as GSK’s portfolio size is also down by 20 drugs. Merck & Co posts a slightly smaller decline, but is still comfortably in third place. The Top 10 this year is in fact the very same ten companies as in 2010. The biggest material change within the ten is in the growth in Sanofi-Aventis’ pipeline size, which can be accounted for by its acquisition of Genzyme, causing the latter company

to disappear from this year’s table. And perhaps this is the big trend in big Pharma this year – aside from the Genzyme deal, and the smaller absorption of Alcon by Novartis, there has really been no sizeable M&A activity amongst the large multinationals this year. That is not to say that they are not acquiring companies; rather, their focus has shifted to acquisition of smaller, more niche concerns which aug-ment their existing pipelines, but avoid the wholesale and frequently traumatic events which a major merger inevitably brings. This more conservative approach could well be due to tighter conditions in the world economy, and is certainly in contrast to the frenzy of M&A activity and consolidation seen around ten years ago.

Table 2: Top 25 companies by pipeline size 2011

pOsiTiOn 2011 (2010) cOmpany nO Of r&D prODucTs 2011 (2010)

nO Of OriginaTeD prODucTs

1 (1) Pfizer 284 (304) 196

2 (2) GlaxoSmithKline 269 (289) 155

3 (3) Merck & Co 236 (249) 157

4 (6) Novartis 200 (164) 126

5 (5) Hoffmann-La Roche 183 (172) 134

6 (7) Sanofi-Aventis 182 (137) 92

7 (8) Johnson & Johnson 171 (134) 110

8 (4) AstraZeneca 167 (177) 113

9 (10) Bristol-Myers Squibb 149 (109) 119

10 (9) Eli Lilly 131 (128) 98

11 (13) Astellas 108 (87) 67

12 (12) Takeda 103 (90) 55

13 (11) Abbott 96 (99) 61

14 (15) Daiichi Sankyo 93 (70) 61

15 (14) Bayer 91 (84) 62

16 (16) Eisai 74 (66) 45

17 (17) Amgen 68 (54) 55

18 (18) Boehringer Ingelheim 67 (53) 41

19 (19) Merck KGaA 62 (53) 21

20 (-) Teva 48 (-) 18

21 (-) Mitsubishi Tanabe Pharma 45 (-) 27

22 (24) Dainippon Sumitomo Pharma 44 (47) 27

23 (20) Shionogi 43 (52) 24

24 (21) Kyowa Hakko Kirin 42 (52) 19

25 (-) Ligand 42 (-) 33

However, overall, the Top 10 has slightly tightened its grip on the industry this year, with 13.4% of all pipeline drugs being originated in these ten companies, up from 12.4% at the same point in 2010.

Japanese companies have not yet cracked open the Top 10, although Astellas is now getting very close as both it and Takeda break the 100 compound pipeline barrier for the first time. In fact there are a slew of Japanese firms queuing up outside the top tier, with Mitsubishi Tanabe being one of the entrants to the Top 25 this year. Whether next year will final-ly see an Asian company finally join the highest echelon of the world’s Pharma companies may in part depend on the Japanese economy’s ability to recover from the devastating natural disasters visited on that country earlier this year.

Aside from the acquired concern Genzyme, the two com-panies leaving the Top 25 this year are Isis Pharmaceuticals and Cancer Research Technology, with Teva and Ligand joining Mitsubishi in making their entrances.

While the largest companies consolidate their positions, there is still unrelenting growth in the numbers of com-panies at the other end of the scale. Once again, the total number of companies reported to be involved in R&D has increased, with this year, the figure reaching 2,387 (see Figure 4). This is a bigger rise than that seen in either of the two previous years, probably reflecting a combination of an increasing wealth of start-ups , and better detection of such companies by ourselves. This would again appear to be a sign of overall health in the industry.

We can further look at the lengthening ‘tail’ of the pharma industry by counting the number of com-panies with just one or two drugs in their pipelines – the true ‘niche’ companies. This year, this figure has swollen yet again to stand at 1,203 companies, up massively from 991 last year. In other words, now, over half of all pharma companies fall into this category, with 862 being single-drug concerns. This long tail hints at the wealth of innovation underway, which is currently outstripping both big pharma’s abil-ity to swallow it up, and industry success stories.

figure 4: Total number of companies with active r&D 2000-2011

The proportion of drugs classified as ‘Biotech’

(biologicals) has also risen and accounts for over

a quarter of all pipeline drugs now – another

metric which appeared to level off last year but

has resumed its increase markedly this year.

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TOp Therapies – cancer resumes iTs march

Turning to slicing the pipeline by therapeutic area, Figure 5 confirms that cancer has resumed its attempts to take an ever bigger portion of the R&D pie. Last year, for the first time in twenty years, it looked as though its onward march was faltering, as for the first time, the proportion of all drugs in R&D with an anticancer therapeutic aim had fallen back slightly, to 26.8%. This year, it is up to 28%, back to where it was in 2009, so it looks like the proportion is stabilizing rather than dropping back. The second biggest therapeutic area remains CNS (Neurological), and it too has an increased share this year at 21.4% compared to 19.9% in 2010 [NB: Drugs with activity in >1 Therapeutic Area will be counted in each group].

The proportion of drugs classified as ‘Biotech’ (biologicals) has also risen and accounts for over a quarter of all pipeline drugs now – another met-ric which appeared to level off last year but has resumed its increase markedly this year. The fact that most categories have increased this year despite the overall pipeline size remaining flat suggests that companies are increasingly looking to get their drugs developed for as wide a range of therapeutic activities as possible.

Trends in individual therapeutic categories are also exam-ined in Table 3, which lists the Top 25 of the 221 individual therapeutic categories which are used to classify drugs in our pipeline database. Unsurprisingly, cancer again domi-nates, and many of the trends in the previous graph are reflected in this more granular view. There is little wholesale change in this listing, but noteworthy are a 16% increase in the non-NSAID analgesic category (up to fourth in the table), a slip for antidiabetics, and a debut for multiple sclerosis treatments. Dropping out of the Top 25 this year is the Gene therapy category; the first time it has been absent and a long way from the peak of interest in this strategy, which at one point hit the heady heights of third in the table.

figure 5: pipeline by Therapy group 2010 2011

When the human genome sequence was first

published ten years ago, some predicted an

explosion in new drug targets over the next

decade, an explosion which has thus far failed

to occur.

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TOp mechanisms Of acTiOn (pharmacOlOgies) anD TargeTs – breaDTh increasing?

Ten years after the first publication of the human genome, where are we in terms of new ways to target and treat diseases? We can gain a glimpse into the answer to this question by looking at the numbers of terms in both the Mechanisms of Action and the Target classifications used on our database. Table 4 shows the Top 20 Mechanisms of Action ascribed to pipeline drugs this year, but as usual, this is dominated by some of the broader categories which are assigned to drugs with general activities or for which a more specific activity has not yet been identified. The most interesting movement in this table is perhaps the entrance of the PI3 kinase inhibitors, drugs under development for use in the treatment of types of cancer, into the table for

the first time. We have enhanced our Pipeline database this year to include a Mechanism of Action hierarchy, thus en-abling users to search for drug mechanisms at both a broad or very specific level as they choose.

However, looking at drug protein targets probably gives the more useful measure of innovation increase. When the hu-man genome sequence was first published ten years ago, some predicted an explosion in new drug targets over the next decade, an explosion which has thus far failed to occur. In the intervening ten years, we have first revised down the number of genes humans have to around 24,000, and then gained a glimpse into how many diseases are polygenic,

Table 3: Top 25 Therapeutic categories

pOsiTiOn 2011 (2010) Therapy nO Of r&D prODucTs 2011 (2010) TrenD

1 (1) Anticancer, other 1488 (1465) h

2 (2) Anticancer, immunological 773 (769) h

3 (4) Prophylactic vaccine, anti-infective 544 (513) h

4 (5) Analgesic, other 535 (461) h

5 (3) Antidiabetic 507 (536) i

6 (8) Anti-inflammatory 410 (385) h

7 (6) Recombinant vaccine 399 (420) i

8 (7) Cognition enhancer 382 (408) i

9 (9) Antiviral, other 377 (374) n

10 (10) Cardiovascular 351 (358) n

11 (12) Ophthalmological 342 (334) h

12 (13) Formulation, fixed-dose combinations 331 (313) h

13 (11) Immunosuppressant 326 (341) i

14 (14) GI inflammatory/bowel disorders 297 (293) n

15 (15) Recombinant, other 295 (289) n

16 (20) Neuroprotective 260 (249) h

17 (19) Monoclonal antibody, human 251 (249) n

18 (21) Monoclonal antibody, other 250 (249) n

19 (16) Antiasthma 245 (273) i

20 (17) Antiarthritic, other 243 (261) i

21 (22)( Symptomatic antidiabetic 234 (231) n

22 (18) Hypolipaemic/Antiatherosclerosis 228 (258) i

23 (24) Antiparkinsonian 224 (227) n

24 (-) Neurological 215 (-) h

25 (-) Multiple sclerosis treatment 214 (-) h

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affected by environmental factors, and affected also by the parts of the genetic code which don’t code for genes. How-ever, the concept of the ‘druggable genome’ has survived and estimates remain in the 3,500-6,500 targets region. Therefore, the number of targets investigated as potential drug targets remains an interesting measure of progress, and intriguingly, this year at first glance appears to have shown a much bigger increase than in any year so far. The total number of individual gene products which are, or have been, investigated as drug targets now stands at 2,205, an increase of 356 on the same figure from 2010. From 2009-10, the rise was only 97, and increases in preceding years were of the same order. However, this is unfortunately an artificial rise, as over the past year, we have widened the scope of our target coverage to include antibacterial targets, and these account for 289 of this uplift. So taking this out of the

equation, fewer new targets (67) have been reported this year than in the previous one, which is not an encouraging sign.

If we further examine the range of targets currently the focus of drugs only in active development, this figure stands this year at 1,323, up from 1,216, but again, the figures are hard to compare due to addition of bacterial targets. If we compare the 2011 figure to the 2010 figure adjusted to include the new bacterial targets and the drugs for which precise targets were identified during the course of the year, the figure has declined from 1,372. It’s difficult to draw any conclusion from this trend, since you would expect the current data set to include a greater proportion of drugs whose target remains at this point unidentified or undis-closed, but is interesting to note that this is the first year where a decline in this metric has been seen since 2004.

Table 4: Top 20 mechanisms of action

pOsiTiOn 2011 (2010) mechanism Of acTiOn (pharmacOlOgy)

nO Of r&D prODucTs 2011 (2010) % pr/r/l*

1 (1) Immunostimulant 1127 (1065) 8

2 (2) Angiogenesis inhibitor 206 (225) 7

3 (3) Apoptosis stimulant 180 (198) 8

4 (4) Immunosuppressant 148 (166) 24

5 (5) Cell cycle inhibitor 131 (155) 15

6 (6) Protein kinase inhibitor 131 (144) 13

7 (8) DNA inhibitor 98 (113) 15

8 (7) Protease/peptidase inhibitor 95 (114) 37

9 (9) Cyclooxygenase 2 inhibitor 95 (99) 28

10 (11) Opioid mu receptor agonist 93 (87) 26

11 (10) Tyrosine kinase inhibitor (TKI) 89 (88) 13

12 (15) Vascular endothelial growth factor (VEGF)receptor antagonist

79 (82) 11

13 (12) Mitotic inhibitor 73 (84) 14

14 (13) Cyclooxygenase 1 inhibitor 72 (83) 31

15 (14) DNA topoisomerase II inhibitor 72 (83) 31

16 (16) Tubulin inhibitor 69 (75) 12

17 (-) PI3 kinase inhibitor 69 (-) 0

18 (19) Sodium channel antagonist 68 (69) 21

19 (-) Opioid receptor agonist 64 (-) 25

20 (17) Insulin secretagogue 64 (75) 31

*% of drugs with this activity in Pre-registration, Registered or Launched

1110

a sTeaDy year

So overall, 2010-11 was a year which has seen little whole-sale change, which in the shadow of the world’s woes fol-lowing the financial crisis should arguably be seen as more of a comfort than a concern. It was certainly a quiet year in terms of corporate changes, which many would also see as a good thing, but was yet another disappointing one in terms of truly innovative product launches. Set against this, there are some undeniably encouraging signs. In particular, the rise in the number of drugs currently in Phase III trials could be a sign that of improving success rates of drugs completing Phase II, which is particularly important in the changing regulatory environment. The number of companies involved in the industry continues to climb, especially that of niche firms, although the number of potential drug targets under investigation appears to not have taken a significant step upwards yet. Ultimately, it will only be successful drug launches and subsequent portfolio management which will refuel the industry, but if the pot is not exactly boiling over yet, it looks like on a number of fronts, the ingredients are simmering away nicely.

— Ian Lloyd Editorial Director Citeline Drug Intelligence

As a Citeline Drug Intelligence Services subscriber, you can routinely perform some of the analyses discussed in this article. You can use them to observe trends over time, to keep an eye on competitors, and to aid business decisions. We have also added a seventeenth year of data into the Trends module of Pharmaprojects based on the 2011 data, to further assist you.

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