Whilst basking on a rock in the sun I had a few niggling questions about the TIS and its commercialisation plans. Accordingly the snappingiguana fired up the carrier pigeons for some question and answer correspondence with the very accommodating Dr Mercer. There is nothing sneaky or inside about this info just alot of "gap filling" information.
Heres how it went...
Snapping: "You are in agreement to manufacture Vitrogro for both trials and commercial sales. How can you sell Vitrogro commercially if the product is yet to be approved?"
Dr Mercer: "We can sell VitroGro for cell culture media via our agreement with Invitrogen Corp. without health regulatory approval. The clinical trial results from Cardiff will be used for regulatory approval, initially in the EU, Canada, Australia, New Zealand and East Asia. With more than 8 years of published data, much of this with live human skin cells, the biologic activity and wound healing performance of VitroGro are not in doubt. Also, regulatory approval is not a prerequisite to doing a commercialisation partnership deal for wound healing products. Having commercial scale manufacturing in place improves our negotiating position with interested potential commercial partners and ensures that we will have material ready for sale."
Snapping: The potential commercial partnership you mention in your reports, does this involve Tissue therapies licensing a bandage manufacturer to use Vitrogro in their product or you co-producing products in partnership with them? Could any potential agreement involve direct royalty/funding made to tissue therapies at the beginning of the deal?
Dr Mercer: "The nature of the commercialisation deal we do for wound care products will be determined by the current negotiations but our preferred model is for Tissue Therapies to retain manufacturing rights and to therefore have a world wide exclusive sales agreement for a defined market segment eg. human wound healing therapeutics. This model usually involves royalty and milestone payments but this is also yet to be determined. Upfront payments in this type of arrangement have occurred in the past but are unusual now."
Snapping: "Will you be progressively releasing results and/or commentary on the current trials with Prof. Keith Harding or will it all be released at the end of the trial? Are you getting many people taking up the trial?"
Dr Mercer: "The release of results is still to be finalised with Prof Keith Harding and Cardiff University but it is likely that we will receive a final report, with no progressive release of results during the study. Our success in having topical VitroGro for wound healing classified as a device means that we only need 1 relatively small trial for regulatory approval. Our advice is that we only need to have 40 patients complete the study to satisfy the requirements. Under the control of Prof. Harding, we are planning to have multiple clinical sites involved to ensure that we get the target number of patients completed by the end of Dec. 2010"
so there you have it
SnappingIguana
TIS Price at posting:
21.5¢ Sentiment: LT Buy Disclosure: Held
