+Timos Papagatsias

Tuesday, 9 August 2011

Trials, trials everywhere!

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Taking a look at what the large pharma companies are doing in terms of clinical trials that they have currently underway or planned to start in the near future one can get a feel of the current status of pharma and biotech R&D.


Looking a bit deeper at what is happening with vaccine- and gene therapy-related trials and who the major players are in these fields at the moment perhaps would allow for an estimate of where some really innovative and rsik-taking companies are being active. So, let's have a look at the graphs and tables below...
(All data is publicly available through clinicaltrials.gov; search parameters were "Open Studies | Industry", "Vaccine | Open Studies | Industry" and "Gene Therapy | Open Studies | Industry". Search results valid on 15th of July 2011.)
Novartis, Pfizer, Roche and GSK are the leaders in the number of open studies with each one of them having ~250 and above studies currently ongoing or planned to initiate soon. Altogether, the Top 10 companies account for approximately 16.5 % of the current/planned studies at the moment. 


But this only tells half the story, as you can see below...
Sanofi, #10 in terms of ongoing/planned studies (86), is recruiting ~940,000 volunteers into its studies (a large proportion of which involve vaccine candidates) and is followed by GSK who will be involving approximately 700,000 patients in its 248 trials. As you can see, GSK features in the Top 5 in terms of both number of studies and patients recruited. Pfizer and Novartis can be found further down the list with ~220,000 patients and ~110,000 patients to be recruited respectively.


So, no real surprises so far, with the "usual suspects" appearing at high positions in the lists and with GSK justifying its strong reputation amongst big Pharma. 


Time to look a bit more in detail on what is happening with studies involving vaccine and gene therapy candidates.


In terms of number of vaccine-related studies (see chart below), GSK tops the list with more than double the number of studies from its three followers, Pfizer, Novartis and Sanofi. Some interesting companies also appear on the list, such as Intercell, Bavarian Nordic, Crucell and Dendreon (going through some rough times at the moment).
Looking at the number of patients involved in vaccine-related studies, no real surprise there-Sanofi leads the pack with almost 900,000 patients. However, GSK is again in the picture, claiming a second place with almost 650,000 patients enrolled or planned to be enrolled in its vaccine studies. Pfizer is #3 in this list with only 90,000 patients in its studies.

So far, GSK has almost dominated the different lists, but the situation is somewhat different when we take a look at companies who are active in the Gene Therapy field. Names such as Oxford Biomedica, Sibiono Genetech, Genzyme, Introgen and Diamyd dominate the Top 10 list.
In terms of numbers of patients recruited in these studies, Sibiono is a clear winner, with 2,400 patients recruited in its 3 studies with its recombinant adenovirus p53 candidate. NovaRx, with its candidate for treatment of NSCLC Lucanix (which is in fact merging the concepts of Gene Therapy and Vaccine) is second in the list with ~500 patients enrolled in its single study.   
So here it is, a view of the current status of clinical trials and what the large (and small) pharma and biotech companies are doing at the moment. Obviously, I had to rely on the search engine within clinicaltrials.gov, so it is quite likely that a few trials have been omitted from these results, however, I do not believe that the results are significantly affected by this.


Overall, GSK is really strong and very active, both in terms of number of trials and numbers of patients enrolled. I believe that this is to be expected. GSK's strategy seems to be aligned with expansion in all therapeutic areas either through partnerships and collaborations but also through acquisitions. And the company now seems to be establishing itself as the dominant player in the vaccines field. Obviously, big names such Sanofi and Pfizer still maintain a strong presence; and let's not forget about Novartis, one of the most innovative biotech companies around.


Although some big names dominate the lists in terms of clinical trials as a whole and in terms of trials involving vaccine candidates, the situation is strikingly different when it comes to Gene Therapy trials. Smaller in size companies appear to be active in this field, something which should perhaps be expected due to the higher than average risks involved in development of gene therapy candidates and the higher versatility and focus that small companies exhibit. Sibiono is the clear leader at the moment, being the first company to market a Gene Therapy product (Gendicine, a recombinant adenovirus expressing the p53 gene for treatment of  head-and-neck cancer on top of radiotherapy). Oxford Biomedica appears on the list, with its Parkinson's treatment candidate, ProSavin.


One company not mentioned in this list, but worth having a look at, is Scancell, a UK-based company with its pioneering ImmunoBody technology which has applications both in the treatment of cancer and in infectious diseases.


It will be interesting to repeat this analysis in one or two years' time, when R&D restructuring and process optimization by the major pharma companies will have taken place and when, hopefully, more funds will have been available for development of innovative treatments.
However, I would predict that more medium sized players will be featuring in these lists, either on their own, but more likely in partnership with one (or more) of the big pharma companies, who will be looking to bring "innovation" into their pipelines.









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