cherokeeyou asked:"When Shire paid 750MM for them what was their...

cherokee

you asked:

"When Shire paid 750MM for them what was their FDA status and if they had already gotten FDA approvals i would like to know how long the trials took and most importantly----what was their sales prior to there being acquired. THIS IS IMPORTANT TO KNOW."

well here are some facts...

- Advanced BioHealing (ABH) purchased the global rights to Dernagraft and Transcyte in 2006 - both were already FDA approved

- the UK company they bought from had already discontinued manufacturing and marketing - in other words, the products were sitting on the shelf and not being commercialised at all

- Dermagraft is the spearhead product, treating slow healing Diabetic Foot Ulcers (DFU)

- There are 538,000(7) cases of slow healing DFU annually in the US

- The World Health Organisation estimates an increase in incidence of diabetes of 43% in North America and 55% worldwide from 2007-2025, and diabetic patients have a 15%-25% lifetime risk of developing a DFU

- As of June 2011, DERMAGRAFT's share of the slow healing segment of the DFU market was 5% of something like a $3 billion market.

- When ABH acquired Dermagraft they spent 9 months building the manufacturing and marketing from scratch

- Sales began in February 2007

- Now ABH can produce up to 300,000 units of Dermagraft annually

- the company conducted a 2009 study to see whether Dermagraft could be successfully used on Venous Leg Ulcers (VLUs), but after a review of headline data they chose to discontinue any further development in that area

- June 2011 they were acquired by Shire

as for how long Dermagraft were in FDA trials, you need to reach back into the original R&D performed by the UK company Smith & Nephew.

trust this helps


good luck