Pharma R&D Annual Review 2011

ay is the time when Citeline Drug Intelligences 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 13% growth in drugs at Phase III status Cancer takes 28% slice of R&D pie Few novel new active substances launched in past year Pfizer holds position as company with most drugs in development 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 confirm 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 attributed 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 worlds 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, lets 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

new acTive subsTance launches nOT a vinTage year fOr nOvelTy

Table 1 lists all of the new active substances which we report 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 years figure was somewhat flattered by nine new anti-infective launches, mostly addressing the H1N1 influenza 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. 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 drugs 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, CreaGenes CreaVax-RCC and Dendreons Provenge, which were launched for the treatment of renal and prostate cancer, respectively. However, since these are therapeutics derived from the patients own cells, they are not pharmaceutical products in the traditional sense. Similarly, another interesting 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 patients 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. Thats not to say these other drugs dont have therapeutic advantages, but its 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 successful 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.
Of these three, the one with the widest possible use is arguably Amgens 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 territories. Another of the innovative therapies of interest is Mitsubishi Tanabes 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 Santens diquafosol tetrasodium (Diquas), which, as the first purinoreceptor P2Y2 agonist to be launched, is notable for treating the

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

generic name (branD name) alogliptin benzoate (Nesina) amifampridine phosphate (Firdapse) bazedoxifene acetate (Viviant) cabazitaxel (Jevtana) ChondroCelect collagenase Clostridium histolyticum (Xiapex) conestat alfa (Rhucin) corifollitropin alfa (Elonva) dalfampridine (Ampyra) denosumab (Prolia) diquafosol tetrasodium (Diquas) ecallantide (Kalbitor) eribulin mesylate (Halaven) fingolimod hydrochloride (Gilenya) histamine dihydrochloride, EpiCept (Ceplene) iloperidone (Fanapt) influenza vaccine (H1N1), Zydus Cadila (VaxiFlu-S) influenza vaccine, Baxter (PreFluCel) influenza vaccine, Green Cro-2 (GC Flu) influenza vaccine, H1N1 (IM), Serum Institute of India (Enzavac) influenza vaccine, H1N1 LAIV, BioDiem (NasoVac)

OriginaTing cOmpany Takeda EUSA Pharma Ligand Sanofi-Aventis TiGenix Auxilium

mechanism Of acTiOn DPP IV inhibitor Potassium channel antagonist Selective estrogen receptor modulator Microtubule inhibitor Not applicable (Cellular therapy) Collagenase stimulant

inDicaTiOn Diabetes, Type 2 Lambert-Eaton myasthenic syndrome Osteoporosis Cancer, prostate Regeneration, cartilage Dpuytrens disease

cOunTry(ies) Of firsT launch Japan The UK Spain The US Germany* The US

Pharming Merck & Co Elan Amgen Santen Dyax Eisai Mitsubishi Tanabe Pharma EpiCept Sanofi-Aventis Zydus Cadila

Complement factor 1 inhibitor Follicle stimulating hormone receptor agonist Potassium channel antagonist RANKL antagonist Purinoreceptor P2Y2 agonist Kallikrein inhibitor Microtubule inhibitor Sphingosine-1 phosphate receptor agonist Histamine H2 receptor agonist 5-HT2A antagonist Immunostimulant

Angioedema, hereditary Infertility, female Multiple sclerosis, general Osteoporosis Xerophthalmia Angioedema, hereditary Cancer, breast Multiple sclerosis, relapsing-remitting Cancer, leukaemia, acute myelogenous Schizophrenia Infection, influenza virus prophylaxis Infection, influenza virus prophylaxis Infection, influenza virus prophylaxis Infection, influenza virus prophylaxis

Denmark The UK Puerto Rico and the US The US Japan The US The US The US The UK The US India

Baxter International Green Cross Serum Institute of India

Immunostimulant Immunostimulant Immunostimulant

Austria S Korea India

BioDiem

Immunostimulant

Infection, influenza virus prophylaxis

India

*first patient received end of Dec 2009 but not included in last years list

generic name (branD name) influenza vaccine, H1N1, ADImmune (AdimFlu-S) influenza vaccine, H1N1, Bharat (HNVAC) iron isomaltoside, Pharmacosmos (Monofer) Japanese encephalitis virus vaccine, Boryung (Jeimmugen) laninamivir (Inavir) meningococcal ACWY vaccine, Novartis (Menveo) mifamurtide (Junovan) miriplatin hydrate (Miripla) pegloticase (Krystexxa) peramivir (Rapiacta) pneumococcal vaccine, 13-valent, Wyeth (Prevenar 13) prucalopride (Resolor) renal cancer vaccine, CreaGene (CreaVaxRCC) roflumilast (Daliresp) romidepsin (Isodax) sipuleucel-T (Provenge) tesamorelin acetate (Egrifta) velaglucerase alfa (Vpriv) vernakalant hydrochloride (Brinavess) vinflunine ditartrate (Javlor) vitespen (Oncophage)

OriginaTing cOmpany ADImmune

mechanism Of acTiOn Immunostimulant

inDicaTiOn Infection, influenza virus prophylaxis Infection, influenza virus prophylaxis Anaemia, iron deficiency Infection, Japanese encephalitis virus prophylaxis Infection, influenza virus Infection, Neisseria meningitidis prophylaxis Cancer, sarcoma, osteo Cancer, liver Hyperuricaemia Infection, influenza virus Infection, pneumococcal prophylaxis Constipation Cancer, renal

cOunTry(ies) Of firsT launch Taiwan

Bharat Biotech Pharmacosmos Boryung

Immunostimulant Iron absorption stimulant Immunostimulant

India The UK S Korea

Daiichi Sankyo Novartis

Neuraminidase inhibitor Immunostimulant

Japan The US

Takeda Dainippon Sumitomo Pharma Mountain View BioCryst Pharmaceuticals Pfizer

Macrophage stimulant DNA inhibitor Urate oxidase stimulant Neuraminidase inhibitor Immunostimulant

The EU Japan The US Japan The US

Johnson & Johnson CreaGene

5-HT4 receptor agonist Immunostimulant

Germany S Korea

Nycomed Pharma Astellas Dendreon Theratechnologies Shire Cardiome Pierre Fabre Agenus

Phosphodiesterase IV inhibitor Histone deacetylase inhibitor Immunostimulant Growth hormone releasing factor agonist Glucosylceramidase stimulant Voltage-gated sodium channel antagonist Microtubule inhibitor Immunostimulant

Chronic obstructive pulmonary disease Cancer, lymphoma, T-cell Cancer, prostate Lipodystrophy Gaucher`s disease Fibrillation, atrial Cancer, bladder Cancer, renal

Germany The US The US The US The US The EU, Iceland and Norway The UK Russia

The 2011 pipeline by phase encOuraging signs aT phase iii

So if 2010 was something less than vintage in terms of There are similar, although proportionally smaller, increases drugs successfully completing their development, what at Phase I and Phase II, and at pre-registration, continuing does the pipeline look like now in 2011 further back along the trends seen in recent years. The counterbalance which the development cycle? Figure 2 compares this years data has kept the overall pipeline size roughly static overall, is a with last years, and, there are some encouraging signs. decline at preclinical. Not too much should be read into this: The number of drugs in Phase III has shown the biggest the preclinical figure is the most subjective and volatile, and year-on-year jump so far recorded, with this years figure the decrease of 132 preclinical drugs can almost entirely be of 637 drugs representing a rise of 83 or 13% - from the accounted for by an increase in 133 in the number of drugs corresponding 2010 number. This is indeed a positive signal, moved to the No Development Reported status over the as in recent years, there has been a noteworthy trend of course of the year, a reflection primarily of more rigorous increases in the numbers of Phase I and II drugs failing editorial reviewing policies. So overall, this particular analyto translate through to Phase III. This indicated increassis gives a more optimistic outlook than either the grand ing attrition at Phase II, not what the industry was looking total or the number of NAS launches appear to. for as it sought to limit its expenditure on expensive clinical trials to drugs which had a better chance of success. This is shown figure 2: pipeline by phase, 2011 vs 2010 2010 2011 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.

figure 3: clinical pipeline by phase, 2006-2011

2006 2007 2008 2009 2010 2011

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 pipelines. 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 GSKs 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 years 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 augment 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) 1 (1) 2 (2) 3 (3) 4 (6) 5 (5) 6 (7) 7 (8) 8 (4) 9 (10) 10 (9) 11 (13) 12 (12) 13 (11) 14 (15) 15 (14) 16 (16) 17 (17) 18 (18) 19 (19) 20 (-) 21 (-) 22 (24) 23 (20) 24 (21) 25 (-)

cOmpany Pfizer GlaxoSmithKline Merck & Co Novartis Hoffmann-La Roche Sanofi-Aventis Johnson & Johnson AstraZeneca Bristol-Myers Squibb Eli Lilly Astellas Takeda Abbott Daiichi Sankyo Bayer Eisai Amgen Boehringer Ingelheim Merck KGaA Teva Mitsubishi Tanabe Pharma Dainippon Sumitomo Pharma Shionogi Kyowa Hakko Kirin Ligand

nO Of r&D prODucTs 2011 (2010) 284 (304) 269 (289) 236 (249) 200 (164) 183 (172) 182 (137) 171 (134) 167 (177) 149 (109) 131 (128) 108 (87) 103 (90) 96 (99) 93 (70) 91 (84) 74 (66) 68 (54) 67 (53) 62 (53) 48 (-) 45 (-) 44 (47) 43 (52) 42 (52) 42 (-)

nO Of OriginaTeD prODucTs 196 155 157 126 134 92 110 113 119 98 67 55 61 61 62 45 55 41 21 18 27 27 24 19 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 finally see an Asian company finally join the highest echelon of the worlds Pharma companies may in part depend on the Japanese economys ability to recover from the devastating natural disasters visited on that country earlier this year. Aside from the acquired concern Genzyme, the two companies 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 companies 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.

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.

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

We can further look at the lengthening tail of the pharma industry by counting the number of companies 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 pharmas ability to swallow it up, and industry success stories.

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].

figure 5: pipeline by Therapy group

2010

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. 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.

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.

Trends in individual therapeutic categories are also examined 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 dominates, 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.

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 enabling 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 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. 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) 1 (1) 2 (2) 3 (4) 4 (5) 5 (3) 6 (8) 7 (6) 8 (7) 9 (9) 10 (10) 11 (12) 12 (13) 13 (11) 14 (14) 15 (15) 16 (20) 17 (19) 18 (21) 19 (16) 20 (17) 21 (22)( 22 (18) 23 (24) 24 (-) 25 (-)

Therapy Anticancer, other Anticancer, immunological Prophylactic vaccine, anti-infective Analgesic, other Antidiabetic Anti-inflammatory Recombinant vaccine Cognition enhancer Antiviral, other Cardiovascular Ophthalmological Formulation, fixed-dose combinations Immunosuppressant GI inflammatory/bowel disorders Recombinant, other Neuroprotective Monoclonal antibody, human Monoclonal antibody, other Antiasthma Antiarthritic, other Symptomatic antidiabetic Hypolipaemic/Antiatherosclerosis Antiparkinsonian Neurological Multiple sclerosis treatment

nO Of r&D prODucTs 2011 (2010) 1488 (1465) 773 (769) 544 (513) 535 (461) 507 (536) 410 (385) 399 (420) 382 (408) 377 (374) 351 (358) 342 (334) 331 (313) 326 (341) 297 (293) 295 (289) 260 (249) 251 (249) 250 (249) 245 (273) 243 (261) 234 (231) 228 (258) 224 (227) 215 (-) 214 (-)

TrenD h h h h i h i i n n h h i n n h n n i i n i n h h

10

affected by environmental factors, and affected also by the parts of the genetic code which dont code for genes. However, 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 200910, 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. Its 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 undisclosed, 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) 1 (1) 2 (2) 3 (3) 4 (4) 5 (5) 6 (6) 7 (8) 8 (7) 9 (9) 10 (11) 11 (10) 12 (15) 13 (12) 14 (13) 15 (14) 16 (16) 17 (-) 18 (19) 19 (-) 20 (17)

mechanism Of acTiOn (pharmacOlOgy) Immunostimulant Angiogenesis inhibitor Apoptosis stimulant Immunosuppressant Cell cycle inhibitor Protein kinase inhibitor DNA inhibitor Protease/peptidase inhibitor Cyclooxygenase 2 inhibitor Opioid mu receptor agonist Tyrosine kinase inhibitor (TKI) Vascular endothelial growth factor (VEGF)receptor antagonist Mitotic inhibitor Cyclooxygenase 1 inhibitor DNA topoisomerase II inhibitor Tubulin inhibitor PI3 kinase inhibitor Sodium channel antagonist Opioid receptor agonist Insulin secretagogue

nO Of r&D prODucTs 2011 (2010) 1127 (1065) 206 (225) 180 (198) 148 (166) 131 (155) 131 (144) 98 (113) 95 (114) 95 (99) 93 (87) 89 (88) 79 (82) 73 (84) 72 (83) 72 (83) 69 (75) 69 (-) 68 (69) 64 (-) 64 (75)

% pr/r/l* 8 7 8 24 15 13 15 37 28 26 13 11 14 31 31 12 0 21 25 31

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

11

a sTeaDy year
So overall, 2010-11 was a year which has seen little wholesale change, which in the shadow of the worlds woes following 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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