Released on = September 7, 2006, 3:51 am

Press Release Author = La Merie Business Intelligence

Industry = Biotech

Press Release Summary = Anti-TNF agents set the new gold standard of psoriasis treatment which could be outperformed by smarter next generation biologics and small
molecules in safety and convenience

Press Release Body = BARCELONA, Spain | September 07, 2006 | The Business
Intelligence firm La Merie S.L. reported today 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
findings of the search can be acquired at www.pipelinereview.com, La Merie's News
Center and Online Store.

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, the British 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 the topical 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, protein and 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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About La Merie
La Merie S.L. is a Business Intelligence enterprise fully dedicated to provide high
quality R&D information to the biopharmaceutical industry. La Merie offers
individual consultancy services and publishes reports and periodicals. For more
information visit www.lamerie.com.

SOURCE: La Merie Business Intelligence




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Contact Details = Jorge Márquez
La Merie Business Intelligence
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