Drug Delivery Report

Introduction

As the drug delivery sector develops, there will be an increasing choice of technologies to be used to administer therapies. Drug delivery technologies are enabling drugs to be launched  that  would otherwise  have been terminated
in development because  they could not be delivered effectively. They have also helped in lowering the amount of drug that  needs to be administed,  thus giving improved safety profiles. Moreover, these  technologies have been crucial to the life cycle management of therapies. A clear example of this is the approval of Exubera, where a drug that  was only available by injection is now approved for inhalation.  This approval has importance on several levels, mainly to improve the lives of many diabetics, but
it is the first approval of a protein-based drug to be used systemically delivered via the lungs.

Trends within the Drug Delivery  Sector

This is the third in a series of articles discussing the trends within the drug delivery sector. The first article (Drug Delivery Report Autumn/Winter 2005) discussed the trends
relating to deal types and company types involved with drug delivery deals. The second article (Drug Delivery Report Spring/Summer 2006) takes this further,  providing analysis of the trends and therapy focuses of the drug delivery sector. The aim of this article is to build on the previous articles breaking the available data down further to analyse whether there are any significant trends relating to therapy focus versus the deal types within the drug delivery sector. Taking the total number  of healthcare related deals recorded  within PharmaDeals® Agreements, there is a clear trend - year on year the number  of deals recorded  is increasing; over 3,000  deals are now recorded  each year. This is mirrored in the number  of deals relating to drug delivery; there is a similar general increase . When considering drug delivery deals as a proportion of total deals the value is around  10%,  although there might be a slight decrease. The identification  of the trend that  the number  of drug delivery deals is increasing should not be surprising as drug delivery systems are key for certain new therapies  and business models. However, what is perhaps  interesting  is the fact that  the proportion of drug delivery deals relative to total deals is not increasing. As therapies  become more complex and the need to manage product  lifecycles becomes  a key strategy,  should it not be expected  for the proportion of drug delivery deals relative to the total deals to increase, and not decrease?
Within this article, the aim is to focus analysis on drug delivery deals that  involve elements  of licensing, collaborative research and development (R&D), and co- development. The number  of transactions recorded  for the other deal types is very low and, therefore, it is not possible to interpret  any meaningful  trends.  For each of the three deal types - licensing, collaborative R&D and co-development - further analysis has been conducted assessing the therapy areas of cancer, cardiovascular, anti- infective and respiratory. Again, due to low numbers  of deals in the other therapy areas, it is not possible to analyse these  further.

Licensing

When considering drug delivery agreements, it is not surprising that  a large proportion of them involve an However the trend in the licensing drug delivery deals relating to cardiovascular is less clear. In the year 2000, the level of deal activity dropped to its lowest point. This was also the year when there was a peak in the number  of signed drug delivery agreements and there was the highest proportion of drug delivery deals relative to total deals. The deal trends for anti-infective and respiratory broadly follow the same trend as cancer, where a gradual increase is observed,  although the trends are less consistent 

Collaborative Research and Development (R&D) Deals

As with licensing deals, there is a general increase in collaborative R&D deals which have an element  of drug delivery. Within this series, however,  there is an outlier, this being the year 2000,  where more deals were recorded  than  would have been predicted  from the general trend. Considering drug delivery collaborative R&D deals that focus on cancer, a similar increase can be seen to that  of the total number  of deals. The problem with the analysis of this group is the number  of actual deals is fairly low and any small changes  give the impression of a trend.  However, there does appear  to be a similar increase in the year 2000 as discussed in the licensing deals. The
same trend is observed when considering drug delivery collaborative R&D deals relating to the anti-infective
sector, but there is a more pronounced peak for the deals announced in the year 2000.
Assessing the two other therapy sectors under analysis within collaborative deals - cardiovascular and respiratory - there is no visible peak for the year
2000,  but again the number  of deals is low and one or two deals will disguise a trend.

Co-development Deals

Assessing the total co-development deals that  involve drug delivery, the trend does not follow the same pattern as licensing and collaborative R&D. Up to and including the year 2004,  it appeared there was a general decrease  in the number  of drug delivery co-development deals announced. There was a peak within 2000 which gradually declined until 2004.  However, in 2005 there was an increase where 57 deals were recorded.  Therefore, looking at the number  of drug delivery collaborative deals between 1997 and 2005,  there has been little change  in the average number  of deals per year. Breaking these  deals down into the four sections as before reveals some interesting  observations  although it is difficult to define a trend due to the low number  of  actual deals recorded.  Prior to 2005,  there was a general decrease  in the number  of co-development deals relating to cancer and drug delivery. However, as with the overall drug delivery co-development agreements, there was a relatively large increase in 2005 (from 1 to 7 deals). A very similar observation  is evident relating to the anti-infective deals; a general decline until 2004 followed by a relatively large increase in 2005. For the other two sectors, cardiovascular and respiratory, there is no real observations  as the deal numbers are low, except for respiratory and the year 2000, which again appears  to be an outlier.
A further observation  relating to the four sectors of analysis is that  the increase seen in 2005 for the deals relating to cancer, anti-infective and respiratory is not seen in cardiovascular deals.

Summary

In analysing the deal types described in certain cases,
for example licensing and collaborative R&D, there is an increase in the number  of announcements each year. Other sectors, such as co-development, the level of deal activity
on average is fairly static. Breaking these  sectors down further,  the main identifiable trend is often that  there was a relatively high number  of deals announced in 2000 relating to certain deal types and certain therapy sectors. For example, this increase is seen in co-development and collaborative R&D deals but is not evident in licensing agreements. Even breaking the deals down further into deal types and therapy area, the peak is not seen in deals relating to licensing. However, breaking the co- development and collaborative R&D deals down into therapy areas the peak is not seen in all therapy areas. For collaborative R&D, the peak is evident relating to cancer and anti-infective and for co-development it is only evident in deals focusing on cancer.