Biologics define new standard of therapy in psoriasis
La Merie S.L. reported that the advent of anti-TNF biologicals has set a new standard of treatment in moderate to severe plaque-type psoriasis. Systemic anti-TNF biologics etanercept followed by infliximab, adalimumab and certolizumab pegol have raised the level of efficacy in an unprecedented manner, but which next generation biologics such as Centocor's CNTO 1275 directed against interleukin-12/-23 also achieved in phase II. The more than 13 biologics and 31 small molecule projects in the full clinical stage pipeline will have to be smarter than anti-TNF and achieve at least the same efficacy but offer an advantage in avoiding the serious side effects of anti-TNF biologics. These results and more were found in a competitor analysis conducted by La Merie Business Intelligence.
The four anti-TNF biologics already approved or in late stage clinical development achieved a 75% reduction of the psoriasis area and severity index (PASI) in about 70% of patients. An almost complete clearance of psoriasis (PASI 90) was achieved in about half of the patients. Despite annual treatment costs of about US$ 10,000 to 20,000, theBritish NICE issued guidance for the use of targeted biological therapies to treat adult patients with severe plaque psoriasis. However, the high efficacy is at the cost of severe anti-TNF typical side effects such as cardiac failure, infections (tuberculosis), lymphoma risk and neurological events. More targeted therapies or topical administration of anti-TNF agents may overcome this downside of anti-TNF therapy. Several small molecule and small biological anti-TNF projects are exploring thetopical use in psoriasis.
The most validated and promising new target in psoriasis is under development by Centocor with competitors from other companies. The fully human antibody targeting the common p40 subunit of interleukin-12 (IL-12) and IL-23 is in phase III studies and achieved phase II efficacy results comparable to those of anti-TNF agents without uncommon side effects. Other categories of biologics include, apart from the predominant antibodies, vaccine, DNA, RNA, proteinand peptide projects.
Nearly half of the small molecule based projects in clinical development are improved molecules against validated targets. The most recent introduction of the combination product of calcipotriene and beclomethasone as a once-daily gel or ointment from LEO Pharma and Warner Chilcott has the potential to challenge the biologicals as it also achieves a high level efficacy at a cost of only about EURO 100 per year. New data also indicate that the steroid containing gel may be safely administered over one year.
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Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
