Introduction to Drug Rediscovery

John LismanAttorney-at-lawLisman Legal Life sciences

Insert your logo in this areathen delete this text box.

Disclaimer

• The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.

• These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners.

2

Acknowledgements

• Most of this presentation is based on a study conducted by – Joris Langedijk, Utrecht University– John Lisman, Lisman Legal Life sciences– Pieter Stolk, Escher Project– Aukje Mantel-Teeuwisse, Utrecht University– Marie-Hélène Schutjens, Schutjens De Bruin

Acknowledegments c’tnd

• Under auspices of Utrecht University

• Financed through a grant of ZonMw

4

Agenda

• What is Drug Rediscovery?

• Why Drug Rediscovery?

• Why does Drug Rediscovery not happen?

• Political and Policy concerns

• The promotion of Drug Rediscovery

• Conclusion

What is Drug Rediscovery?

• Drug Rediscovery:– The development and authorisation of new

applications of existing, well-known, active substances.

Not: if medicinal is still protected by patent or any other IP-right

– Probably not by original manufacturer/patent holder

What is Drug Rediscovery? (3)

• 6-TG in IBD• Buformin in Lung Cancer• Numerous other treatments

8

Why Drug Rediscovery?

• Industry perspective– Pipe lines of drug companies are running dry– Development of NCE costs $ 1 billion

• Scientific perspective– Pharmacological activity in one indication

predicts other possible uses– Expected medical advance when better using

old molecules is huge

Why Drug Rediscovery? (2)

• Patient perspective– Many unmet medical needs– Many patients depend on new innovative

therapies still to be developed

• Society perspective– Outlook on affordable effective medicines– Generation of new innovative economic

activities

Why does Drug Rediscovery not happen?

• Because there is no return on investment to be expected;

• Because of the perception that no return on investment is possible;

• Common view is:– In pharmaceutical industry investments need to be

protected by IP rights– No investment is made in old off-patent molecules

Why does Drug Rediscovery not happen? (2)

• Because it is expensive to create the necessary dossier for a marketing authorisation

• Because investments in clinical evidence of new applications of old active substances seem to be a waste of money

• Because regulatory systems do not allow easy access for new indications for old active substances

Why does Drug Rediscovery not happen? (3)

But:

• Physicians want to treat their patients as well as possible;

• Patients find themselves entitled to the best possible treatment;

• Societies are looking for better allocation of scarce resources

Practical concerns

• The unauthorised use of medicinal products does not pose any problems:– Often medicinal products are used off-label– Often unauthorised medicinal products are being

used

• The authorisation process is bypassed, taking away the urgency of Drug Rediscovery– The good becomes the enemy of the better

15

Political and Policy concerns

• Barriers on a higher level– Current drug development paradigm – Patent and other IP is necessary for any

investment– Government takes a passive approach– Strict distinction between innovative and generic

industry– Drug development is not national, not even

regional, but global

The promotion of Drug Rediscovery

• Proposals (initially national)– Regulatory: start dialogue about clinical

development of new indication– Legal: create new regulatory pathway for Drug

rediscovery– Policy: Limit availability and reimbursement of

off-label used medicinal product– Practical: Create a Center for Drug Rediscovery

The promotion of Drug Rediscovery (2)

Promising developments

19

• National attention Drug Rediscovery in the Netherlands

• National attention in US

Promising Developments (2)

• Example from the Netherlands– 6-TG for IBD (presentation prof. Chris Mulder)

• Example from the US– Buformin for lung cancer (presentation prof.

Steven Lehrer)

20

Conclusion

• Drug Rediscovery may prove to be a hugely beneficial approach to innovation in the pharmaceutical industry

• Drug Rediscovery is an approach to meet unmet medical needs

• Drug Rediscovery requires efforts from Academia, Governments and Industry together.

22