While still a fully paid up member of the pharmaceutical industry, one of my great joys was the construction of a ‘competitor intelligence report’ after a conference. This was meant to be a pithy summary of the information gleaned on what the opposition might be doing, and was largely derived from three sources, of varying reliability, i.e. from trawling the scientific meeting rooms, speaking to consultants, and frequenting local bars. The assumption in the case of the latter was that industrial scientists and clinicians are alcohol-fuelled and loose-lipped. Unfortunately, in most cases their capacity for alcohol consumption tended to exceed their expense accounts well before reliable information would be forthcoming. On this basis, it is suspected that many reports submitted to senior managers in the pharmaceutical industry were based on somewhat less than tenuous speculation. A word of advice to the novice report writer is “never quote yourself” and “be original with the name of the source of the information” (given the location of the two major conferences this year, it is likely that in many reports GSK, Pfizer, etc. would be apparently staffed with a high proportion of Drs Eva Braun and M. Mouse).
The other source of information is from consultants. Often one company’s consultant is another company’s consultant, assuming they are any good. In general, consultants are eager to please with information “hot off the press” and sometimes forgetful of to whom, where and when they are speaking, and tend to attend many advisory boards (sometimes, magically, apparently simultaneously). The secret for a pharmaceutical company is to hold your own advisory board towards the end of the conference or, as in the case of one company, to organise a board on a product well past its ‘sell-by date’ on the day before the conference starts.
Finally, turning at last to the theme of this article, the most reliable source of information (short of true industrial espionage) is to be found in the debating chambers in the conference halls . You never find anything useful these days in the exhibition halls, as the companies have limits on gift value and the regulatory agencies take a dim view of advertising ‘coming next . . .’. A particularly useful venue is that of the unmoderated poster sessions, as there seems to be an inverse correlation between selection for podia presentation and/or moderated posters and high-quality original and early clinical development programmes. At least in the context of drug development, these, the perceived ‘more prestigious’ sessions, seem to have a relatively high proportion of presentations on already marketed products, dapoxetine, and those authored by Claus Roehrborn.
So what does scanning the programmes of this year’s EAU and AUA tell us about the future of urological and andrological drug development over the next few years? It could be pretty much summarised as more of the same. Several companies are still developing ‘novel’α-adrenoceptor antagonists, antimuscarinics, GnRH agonists/antagonists, phosphodiesterase inhibitors and testosterone-replacement therapy. The authors of MTOPS are still trying to persuade the healthcare economists/providers that combined therapy is best, and GSK are still committing to the case of dual isozyme 5α-reductase inhibitors for treating and preventing prostate cancer. The progress on minimally invasive therapy will be covered in a subsequent article.
In most of these cases the assumption is that all the drug classes cited above might be effective in the disease conditions for which they are marketed, e.g. BPH, overactive bladder (OAB), erectile dysfunction (ED), etc., and that there is still a large proportion of the patient population with that dysfunction who either do not present or remain untreated. The premise is that with improved therapy some of this refractory (or should it be DTC-resistant?) population would present to their physicians. However, we might have to accept that most patients might never be sufficiently ‘bothered’ to present, and what might be the deciding factor is not the availability of new drugs but pricing structure. This said, there is no real evidence that the availability of lower priced generics for several urological diseases has had any major impact on prescription numbers.
Is the pharmaceutical industry safe in assuming that a new drug of an established drug class will give a decent commercial return? The answer is (hopefully for shareholders) obviously ‘yes’, or they would not be doing it. If we look at the ED market, prescription analysis shows in terms of dollar sales that the market is actually flat (or possibly even declining) and the third arrival into this market (vardenafil) is barely reaching annualised sales of $300 million. By way of comparison, the most recent entrants into the OAB market (solifenacin and darifenacin) are generating annual sales of ≈ $200 million. Products given this level of return would hardly be considered ‘blockbuster’, where the definition is a drug generating annual sales of at least $1 billion.
The situation has changed over the last few years, with pharmaceutical companies needing, with an increasing degree of desperation, to fill their development pipelines. What makes urological drug development particularly attractive is that we know that the classes of drugs cited above work, and that they and novel members of these classes are relatively unlikely to show any major long-term safety issues (or at least less so than representatives of a novel mechanistic class). On this basis the risk to investment is relatively low and, although the commercial return is less than some other therapeutic areas, the development costs in many cases (urological oncology excepted) are relatively modest. As such, the return on investment is overall quite high and committed capital at risk is reduced.
Another part of the commercial equation is that the companies must continue fuelling the needs of established field forces. Although a $2–300 million/year product would not necessarily be attractive to a single product sales force, as a second or third detail to an established field force it becomes much more attractive. (The cost of the field force is already largely covered in selling the first product; a second product therefore affords the company a much higher percentage gross profit margin).
Based on the attendance of research scientists, several pharmaceutical companies still consider urology to be worthy of considerable R&D expenditure. Although over the years several alternative mechanistic approaches to urological disease have been evaluated in the clinic, and failed, there is some degree of optimism that novel mechanisms will be found and exploited. Should this be the case, as in other disease areas (the classical case being hypertension), the arrival of a new mechanistic type should result in considerable market expansion of at least the BPH and OAB markets. Perhaps we might learn about these when the AUA next returns to Anaheim!
My next article will be an analysis of progress in minimally invasive therapy for urological and andrological disease.