# Presentation: 700614

## Technology Transfer & Disruptive Innovation at NIH:  The Case of Taxus Express TM

- Steven M. Ferguson
- Director, Division of Technology
- Development & Transfer
- NIH Office of Technology Transfer
- HHS Email: sf8h@nih.gov

## Technology Source: National Institutes of HealthBasic Biomedical Research in Support of the Public Health

- Funding
- Training
- Basic Research

- Clinical Trials
-  Inventions
-  Policies

## NIH Licensing:  Transfer of Commercial Rights To Technology From Research Program

- Annual budget of $ 28 billion (2005)
- 8% of funding for intramural research
- 6,000 intramural scientists / 2,000 projects
- 212,000 extramural scientists /46,000 grants
- Basic & clinical research discoveries
- Partners commercialize into products

## How Could Just One Technology From the NIH Portfolio Be Disruptive?

- 400+ invention disclosures per year
- 2300 total pending/issued patents
- 1650+ active licenses (276 executed FY04)
- $56.3 million in royalties collected FY04
- >$456 million in royalties collected FY93-FY04
- 231 active CRADAs (1500 to date)
- ~200 products developed to date (20 vaccines and therapeutics)

## How Could Something So Small Be Disruptive?

## Cardiovascular Disease (circa 1996) 

- Stents (as part of balloon angioplasty) have revolutionalized atherosclerosis treatment.
- Johnson & Johnson controls the stent market in the U.S. and Europe.
- But 30% or more cases form scar tissue that re-closes arteries (restenosis).
- Incremental design changes in stents fail to solve the problem.

## That Was Then, This Is Now (2005) 

- “Most successful new medical product in history” launched by NIH licensee & corporate partners.
- >$2.6B estimated for first full year sales in U.S. and Europe.
- Johnson & Johnson no longer market leader in stents.
- What happened?

## Disruptive Innovation – Drug-Eluting Stents (DES) 

## Disruptive Innovation – Drug-Eluting Stents (DES) 

- Paclitaxel Coating

## Why Would DES Be Considered Disruptive? 

- Combination drug/devices uncommon approach.
- Double regulatory issues / double risk.
- NIH licensee (Angiotech) small innovative Canadian firm.
- Disruptive Partnering Strategy:  Angiotech unsuccessful with Market Leader (J&J) but partners with _multiple_ Market Trailers, including Boston Scientific.

## Why Would DES Be Disruptive At NIH? 

- Research came from National Institute of Aging (not typically focused on cardiovascular disease).
- Royalty income provides a sharp increase in NIA research budget.
- Royalty income not disruptive to inventors due to cap (unlike university paclitaxel synthesis).
- Licensing Issues:  Revisit standard license contract language for drug/device combos.
- Change in standard of healthcare.

## Why Would DES Be Disruptive At Angiotech? 

- Expected success but not market domination!
- Cash makes acquisition strategies possible.  Three subsidiaries!!
- Able to extend product concept to product platform to corporate mission (“Knowledgy”)
- Additional partnerships & product extensions based upon DES concepts.

- (from Angiotech Annual Meeting)

## Additional Paclitaxel Eluting Technology Applications Now In Development 

- Use in actual bypass surgery (Angiotech with CABG Medical).
- Treatment of emphysema (Angiotech with Broncus Technologies.
- Peripheral stents and wraps (Angiotech with Cook, Inc.)

## Conclusions Regarding Disruptive Innovation

- Disruptive Innovation brings changes to both marketplace as well as technology developer & provider.
- Disruptive Innovation appears to support notion that true innovation is increasingly driven by smaller firms – see for example ...

## Older NIH “Homerun” Licensed Products (All From Large Firms)

- Abbott 		HIVAB (AIDS Test Kit)
- BMS 		Videx (ddI)
- BMS		Taxol (paclitaxel)
- Schering		Fludara (fludarabine)
- GlaxoSKB	Havrix (hepatitis A)
- Roche		Hivid (ddC)

## More Recent  Product Approvals (All From Small Firms At The Time) 

- Angiotech	Taxus (paclitaxel-eluting stents)
- Genzyme 	Thyrogen (rTSH)
- Isis	                  Vitravene (antisense CMV)
- Medimmune	Synagis (RSV mab)
- Millennium     Velcade (myeloma drug)
- Biogen Idec	Zevalin (NHL I131 mab)
- Amgen		Kepivance (KGF)

## Sources Of Information On NIH Licensing And Technologies

- NIH Technology Transfer – ott.od.nih.gov
- NIH CRISP Database - nih.gov/grants
- Global TechnoScan – globaltechnoscan.com
- Pharmalicensing - pharmalicensing.com
- Technology Exchange - techex.com
- University Ventures - uventures.com
- Pharma-transfer - pharma-transfer.com
- Knowledge Express - keonline.com