"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
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