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Biotech / Medical : Isotechnika -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (65)	5/26/2003 2:40:28 PM
From: Icebrg	Read Replies (1) \| Respond to of 285

Oral Pimecrolimus Thanks Peter. That appears to be something relatively similar to ISA247 even if the molecule and its origin is different. It is also a calcineurin inhibitor. I checked PubMed and found two abstracts that are of interest. It appears as if they are slightly behind as far as Psoriasis goes, but that they are planning to overtake. There is no mentioning of transplants. When I see things like ISA247 and Pimecrolimus I have to wonder why the biotechs bother. If these two drugs are as good as they appear to be, there will be very little space left for Amevive, Raptiva, Humana, Embrel et.al. Erik Pimecrolimus identifies a common genomic anti-inflammatory profile, is clinically highly effective in psoriasis and is well tolerated. Rappersberger K, Komar M, Ebelin ME, Scott G, Burtin P, Greig G, Kehren J, Chibout SD, Cordier A, Holter W, Richter L, Oberbauer R, Stuetz A, Wolff K J Invest Dermatol. 2002 Oct ; 119(4): 876-87 The ascomycin macrolactam pimecrolimus is a novel inflammatory cytokine release inhibitor that so far has not been administered systemically to humans. In this phase I/II randomized double-blind, placebo-controlled, multiple rising dose proof of concept study psoriasis patients were treated with oral pimecrolimus or placebo. Gene profiling identified a common genomic profile with a downregulation of genes associated with inflammation but no changes in gene expression linked to drug-related side-effects. A steady state of pimecrolimus was reached after 5-10 d, Cmax, and area under the curve (0-24) was 54.5 ng per ml and 589.9 ng h per ml, respectively, at steady state at the highest dose. There was clear clinical efficacy in patients receiving 20 mg pimecrolimus twice daily and 30 mg twice daily with a reduction of Psoriasis Area and Severity Index by 60% and 75%, respectively. Histopatho logically and immunopathologically there was a reversion of the psoriatic phenotype towards normal. There were no notable clinical, laboratory, kidney function, or immunologic side-effects. We conclude that pimecrolimus taken orally is highly effective in a concentration-dependent manner in patients with psoriasis and on a short-term basis it is well tolerated and this is confirmed by its pharmacogenomic profile. The latter also indicates that pimecrolimus should be equally effective in other inflammatory skin diseases. and Pimecrolimus. Novartis. Schopf RE Curr Opin Investig Drugs. 2002 May ; 3(5): 720-4 Pimecrolimus, an ascomycin macrolactam derivative, is an inhibitor of T-cell and mast-cell activation, developed and launched by Novartis for the potential treatment of psoriasis and allergic, irritant and atopic dermatitis. The topical formulation had been launched in the US by February 2002 for mild-to-moderate atopic dermatitis in patients aged two years and older. At that time, an oral formulation was in development for which launch was anticipated for 2006. In March 2002, pimecrolimus was approved in Denmark, becoming the first non-steroid prescription cream approved for patients from as young as 3 months of age through to adulthood. At this time, Novartis planned to seek approvals in other European countries during 2002 under the Mutual Recognition Procedure, and elsewhere around the globe. In December 2000, Merrill Lynch predicted sales of SFr 100 million in 2002, rising to SFr 330 million in 2004, and in February 2001, the analysts predicted sales of SFr 120 million in 2002, rising to SFr 574 million in 2005. Later in August 2001, Deutsche Bank estimated sales of SFr 150 million in 2002, rising to SFr 550 million in 2005. Following FDA approval in 2002, Morgan Stanley Dean Witter cautiously predicted sales of SFr 60 million rising to SFr 860 million by 2007. and finally an article on macrolides (Both cyclosporin and pimecrolimus are macrolides). The macrolide immunosuppressants in dermatology: mechanisms of action john-libbey-eurotext.fr