MBBS, my two are:
ACL - Very near to getting approval for their generic Fondaparinux (Arixtra - GSK Branded drug), Filed last year in March and average time taken is virtually now for approvals, all questions answered to the FDA many months ago and communications from the company are that they "expect" approval rather soon. Once approved they will be earning (projected) around $30m in profits, US only, Europe in 2012, they have 190m shares on issue. They will also be starting phase 3 trials for HA-irinotecan - colorectal cancer upon this approval.
TIS - Recent trials of their treatment VitroGro targets wound healing for diabetic, venous & pressure ulcer treatments. Trial results have been fantastic and the rate of healing far outdoes current treatments. The partnering is expected to be before the end of year, I think the below spells it out quite well, from the Directors Report in August:
3. Lead product VitroGro addresses a significant and growing unmet medical need:
VitroGro has been designed to provide simple, cost effective new treatments for diabetic, venous and pressure ulcers. This is backed by ten years of substantial laboratory and preclinical data, including multiple publications in peer-reviewed, scientific journals.
Current treatments for diabetic, venous and pressure ulcers are costly and are only moderately effective. These include compression dressings, moist wound healing products, vacuum dressings and antimicrobial dressings to
limit infection. Complete healing rates for diabetic, venous and pressure ulcers remain at approximately 25 50% following up to 20 weeks of treatment. (9, 10) Our target is to increase the incidence of complete healing
and substantially reduce healing time with VitroGro.
Worldwide, it is estimated that patients suffering diabetic, venous and pressure ulcers spent USD$4 billion in 2007 on wound dressings, with a compound annual growth rate of 11% 15%. (1, 2) World market growth is
being driven by an aging population, increased incidence of diabetes and increasing affordability of health care in developing countries. (1, 2) Consumer, retail and acute wound care products offer a substantially larger
opportunity.
Up to 70% of all lower limb amputations in the world are related to diabetic ulcers. A lower limb is lost to diabetic ulcers every 30 seconds. This represents more than 1 million amputations globally each year. (5)
4. Commercialisation Strategy
Tissue Therapies:
Is already using the exceptional clinical trial data in formal negotiations with identified potential healthcare partners.
Has successfully completed commercial scale GMP manufacturing.
Is proceeding with the final clinical trial necessary for approval for sale in most territorities outside the United States.
Is proceeding with development of other commercial applications for VitroGro and other technologies for the treatment of psoriasis, scar prevention and treatment and potential treatments for various cancers including those of the breast, colon and prostate.
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MBBS, my two are:ACL - Very near to getting approval for their...
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