NEWS - Centocor deal for new treatment for secondary amyloidosis

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Centocor deal for new treatment for secondary amyloidosis

Rheumawire

Jan 12, 2005

Zosia Chustecka

Malvern, PA - A novel therapy for secondary amyloidosis developed by

Neurochem Inc, which is still under development, will be distributed in most

countries worldwide by Centocor Inc ( & ).

Secondary amyloidosis occurs in patients with chronic inflammatory

conditions and is characterized by extracellular deposits of amyloid tissue,

which can eventually lead to destruction of organ function. The new drug,

1,3-propanedisulfonate (Fibrillex), is a glycosaminoglycan mimetic and

prevents the formation of the AA fibrils and their deposition in affected

tissues, as previously reported by rheumawire.

As manufacturer of the TNF inhibitor infliximab (Remicade), Centocor already

has a large presence in the rheumatology market. " Its commercial

organization in the field of rheumatoid arthritis [RA] will prove

invaluable, as arthritis is the most common underlying condition leading to

AA amyloidosis and because rheumatologists are very important to providing

care to these patients, " says Dr Francesco Bellini, chair and CEO of

Neurochem.

Neurochem has recently completed a phase 2/3 clinical trial with the

product, and results are due out on the second quarter of 2005. The 2-year

international trial involved 183 patients with amyloid A (AA) amyloidosis

confirmed by biopsy and renal involvement; nearly half of these patients

(49%) had rheumatoid arthritis and a further 19% had the inherited

inflammatory condition familial Mediterranean fever. The condition also

occurs in patients with other chronic inflammatory conditions, such as

ankylosing spondylitis, juvenile rheumatoid arthritis, and Crohn's disease,

as well as in patients with chronic infections.

The company hopes to file for regulatory approval before the end of the

year, and the drug already has orphan drug status in the US and orphan

medicinal product designation in Europe.

AA amyloidosis affects around 270 000 around the world and is both

progressive and fatal, Neurochem explains in a press release. Prognosis is

poorthe 5-year survival rate is approximately 50%. Left untreated, patients

gradually progress to end-stage failure, which is the cause of death in at

least 35% of cases. At present, there is no specific treatment.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org