Wednesday, January 30, 2008

Pfizer license AIDs drug to non-profit

Pfizer have taken what some may consider to be a bold step in licensing Selzentry to the International Partnership of Microbicides to see if it can be converted into a drug that will prevent transmission of the HIV virus in women ( WSJ, 30th January 2008). What a terrific idea. It is a risky idea from a scientific perspective because the whole area of prevention in HIV/ADIS has been fraught with troubles - who can forget Merck's failed vaccine trial? However, I believe that this shows the way for pharma to effectively manage one of its biggest problems - how to make drugs available to the developing world without getting crucified for the high prices it has to charge.

The non-profit world has enormous potential for assisting healthcare delivery in the developing world. Already, in many parts of the world, the majority of healthcare delivery is managed by non-profits of one kind or another. Whether it is volunteer physicians giving their time to run clinics, or huge organizations running fully developed programs, the non-profit organizations are already playing a huge role.

Why not then take a bigger role in drug development? A number of disease specific groups are already directly owning and funding drug development (the Cystic Fybrosis Foundation is a leader in this field), and people like the Bill & Melinda Gates Foundation are pouring huge amounts into specific disease areas. Why not then take it to the next stage? Directly acquire licensing rights to develop and distribute drugs. With the shortage of funding in early stage research that we see today, the opportunity for non-profit organizations to step up and fund development of new science that one day turns into drugs over which they have some IP control could fundamentally change the way in which developing world diseases are managed.

In addition, pharma can surely find ways to protect their developed world rights whilst also granting free access to drugs for the developing world - just as Pfizer are doing with Selzentry. Isn't this a massive win-win?

There is much more to say on this - but I have to go to a meeting.

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Tuesday, January 29, 2008

Election Year - A Good Time to Get Back in the Saddle

2007 was a very busy year for me and this blog suffered. No more.

We start 2007 with the potential for more change in the industry than probably any previous year. FDA is massively underfunded and so far behind it is truly worrying The New York Times; most major pharma companies are closing plants and laying off staff; significant issues are being raised regarding drug trials and drug promotion, and the industry is at an all time low in terms of public perception.

At the same time the political trends appear to be shifting towards the Democrats, and all the candidates from that party are lauding their credentials as someone who will end special interest politics in Washington - especially the drug companies. This is a risky time to be in the drug business.

The business shifts occurring in pharma are seismic, and we are only just getting the initial tremors. I am convinced that we are about to see a major transformation in the ways in which pharma does business and the ways the industry is structured. The steady increase in the licensing business is evidence of the shift away from in-house R&D to in-licensed R&D. It can only be a matter of time before one of the big pharma companies off-loads its entire R&D function. Divesting large divisions that were previously thought to be core has been a trend in other industries for some time and I think it is only the higher margins of the pharma industry that have prevented it occurring here too.

I'm off to the BioPartnering North America Conference this weekend (I do business development consultancy for a couple of small biotech companies). There are going to be over 500 companies at the meeting, with around 700 products being represented - and this is one of the smaller partnering meetings. R&D is alive and well - but not in big pharma, where the in-licensing teams are typically talking to over 100 potential partners at any given time. The Hollywood model is coming and soon we shall see at least one top-20 company shift entirely to a D&M model (development and marketing), and a new category of company will have been formed.