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Annual round up of all drugs entering Phase I

Small molecules still leading the way into the clinic

By Mike Nagle , 20-Dec-2007

DrugResearcher.com brings you its annual round up of all the drugs that entered clinical development in 2007.

Although increasing numbers of pharma firms are making noise about boosting their biological pipelines, it seems the more-traditional small molecule approach is still leading the way in terms of numbers of drugs entering first-in-man clinical trials. Throughout 2007, DrugResearcher.com has been compiling a list of drugs entering Phase I trials. Given that companies tend to announce this type of clinical trial at different stages, those in the list could be there through the acceptance of a Investigational New Drug (IND) application to US regulators at the Food and Drug Administration (FDA), or perhaps through starting or completing enrolment. Unfortunately, many companies - especially the pharma heavyweights such as Merck & Co - often don't announce the trials at all and so this list can't claim to be complete. But among those firms that do divulge the movement of drugs through their pipeline, here's what we found out. More and more pharma firms are decrying the fact that they don't have enough biological drugs and although this market is clearly growing, it still has some way to go before it usurps small molecule drug development as drug developers' technique of choice. Most popular types of drug entering clinic Type of drug Number of drugs Small molecules 135 Of which: Prodrug 3 Biologic /Biopharma 61 Of which: Antibody 29 Protein 13 Cell therapy, incl stem cells 6 Gene therapy 4 Other 9 Vaccines 23 Peptides, Antisense and siRNA 18 Undisclosed 15 There are more than twice as many small molecules entering the clinc as biologic drugs. Of those, however, by far the biggest group is antibodies. This covers monoclonal antibodies (MAb), mini-antibodies and antibody-drug conjugates. So what are all these drugs aiming to treat? It's no real surprise that top of the disease list is cancer. This year the number of drugs that could potentially tackle tumours was double that of any other therapeutic category. Some drugs could also potentially work across multiple indications (number given in brackets below). Top Indications Indication Number of drugs Oncology 88 (6) Anti-infectives and Vaccines 44 (5) Central Nervous System 41 (1) Cardiovascular 26 (1) Alimentary and Metabolism 23 (1) Respiratory 9 Ophthalmology 8 Dermatological 6 Musculoskeletal diseases 6 Other 6 Of all the companies in the list, the US biotech Exelixis is leading the way into the clinic with a staggering nine drugs. Touted by industry insiders as the 'new Genentech', the firm has had a mixed year. Many of its drugs are partnered with GlaxoSmithKline (GSK) and the pharma giant has pulled out of co-development of one of those drugs. On the up side, there's plenty more cancer drugs in its pipeline and GSK is still helping them develop at least seven other drugs. Top Seven Most Productive Firms (not including big pharma) Company Number of drugs Exelixis 9 Medarex 5 Array BioPharma 4 Pharmacopeia 4 Enzon Pharmaceuticals 3 Genmab 3 NeuroSearch 3 Amazingly, Exelixis' haul is only 2 less than Pfizer has managed this year. Although it will come as no surprise to most that most of these drugs have come from companies headquartered in the US. The following table gives a continental breakdown. Naturally there will be a bias on those countries more likely to release the information in English (many Chinese or Japanese pharma firms do not for example). Most productive pharma regions Region Number of drugs North America 176 Of which: US 161 Canada 15 Europe 61 Of which: Denmark 14 UK 8 France 6 Austria 5 Germany 5 Israel 5 Sweden 5 Switzerland 4 Ireland 2 Italy 2 Belgium 2 Finland 1 Asia and Australia 17 Of which: Australia 6 Japan 6 Singapore 2 India 2 China 1 Of the 253 drugs that entered the clinic in 2007, only around one in ten can be expected to make it to market. That's around 25 drugs that started their clinical life this year will eventually be prescribed by doctors. Time to start hedging those bets... If you would like a free copy of the complete dataset, then just email me with your name, company and job title and I'll send the info right back (also, let me know whether you want an Excel file or an Access database file). Consider it your Christmas present from everyone at DrugResearcher.com.

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