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Biotec Pharmacon enters Phase III with the diabetic ulcers indication |
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12 Jun 2007 |
Biotec Pharmacon has during the past several months cooperated withand obtained scientific advice from the European Medicines Agency(EMEA) regarding the clinical development program for SBG fortreatment of diabetic ulcers
TROMSØ, Norway | June 11, 2007 | Biotec Pharmacon has during the past several months cooperated withand obtained scientific advice from the European Medicines Agency(EMEA) regarding the clinical development program for SBG fortreatment of diabetic ulcers.
Biotec Pharmacon has completed clinical phase II studies within thediabetic ulcers indication, and has recently initiated a new study inthe UK. EMEA has now confirmed that the company may be in a positionto file for marketing authorisation based on two positive,confirmatory phase III studies, of which the ongoing study in the UKwill qualify as one of these. The size of the second study will beapproximately of the same size as the current UK study, and bothstudies may be conducted in parallel.
The scientific advice from EMEA is very positive for Biotec Pharmaconsince it implies that time and costs associated with a marketingauthorisation application for SBG within the diabetic ulcerindication may be reduced compared to earlier estimates.
Biotec Pharmacon maintains an optimistic objective to file formarketing authorisation in Europe during 2009. A similar process isbeing planned with FDA for the US market.
The Board of Directors has not yet decided whether the company shallcomplete the final phase of the clinical development program by itsown. Value creation potential, competence and capacity as well ascapital requirements will be important factors to consider in thisrespect.
Biotec Pharmacon's concept for treatment of wounds is based on thecompany's pharmaceutical compound SBG which acts on immune cells inthe skin to support healing of ulcers. Diabetic patients often sufferfrom foot and leg ulcers due to dysfunctional immune cells in theskin. SBG stimulates and activates these immune cells in such a waythat new tissue develops. Chronic ulcers among diabetic patientsrepresent a severe medical problem. Within OECD, more than 3 milliondiabetics are believed to require treatment every year, and there areonly very few therapeutic alternatives available on the market today.
About Biotec Pharmacon
The biopharmaceutical company Biotec Pharmacon was founded in 1990and develops pharmaceutical products for treatment of immune relateddiseases. The company has developed the bioactive compound SBG, whichinitiates mechanisms that strengthen the ability of the immune systemto destroy cancer cells, repair wounds and fight infections. Inaddition the company manufactures and markets non-pharmaceuticalhealth- and diagnostics products. Biotec Pharmacon maintainscomprehensive collaborations with renowned institutions such as forexample Memorial Sloan-Kettering Cancer Center in New York. BiotecPharmacon today has 56 employees and offices in Tromsø, Oslo and LongBeach, USA. Further information can be found on www.biotec.no.
SOURCE: Biotec Pharmacon |
