Neurochem (International) Limited, a wholly-owned subsidiary of Neurochem Inc. has signed a definitive collaboration and distribution agreement, granting Centocor, Inc., a wholly-owned subsidiary of Johnson & Johnson exclusive distribution rights for Neurochem Inc.'s investigational product candidate, 1,3-propanedisulfonate (1,3PDS; Fibrillex), for the prevention and treatment of AA Amyloidosis.
The agreement includes up-front, regulatory and sales-based milestone payments valued at up to US$54 million. An escalating distribution fee will also be paid to Neurochem, the percentage of which will be based upon annual sales of Fibrillex over the life of the agreement. Distribution rights granted to Centocor are worldwide, with the exception of Canada, Switzerland, China, Japan, Taiwan and South Korea which remain with Neurochem. Under the agreement, Neurochem will be responsible for product approval activities in the US and EU, as well as for global manufacturing activities. Centocor and other affiliates will manage the marketing and sales of Fibrillex in the applicable territories. Centocor will also be responsible for worldwide safety surveillance, a release from Neurochem said.
"This agreement relating to Fibrillex with Centocor is a major achievement for Neurochem Inc. in its development," said Francesco Bellini, chairman and CEO of Neurochem Inc. "This agreement maintains Neurochem's participation in the potential financial success of this drug, preserves our access to selected markets and strengthens our financial position," he added.
"Moreover, we look forward to working with Centocor. Its commercial organization in the field of rheumatoid arthritis 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," Dr. Bellini said adding, "Centocor's in-depth knowledge of this field is expected to accelerate the availability of Fibrillex to patients who suffer from AA Amyloidosis, for which no specific treatment is currently available."
Fibrillex, an oral product candidate for the treatment of AA Amyloidosis, prevents amyloid fibril formation. Fibrillex belongs to the class of glycosaminoglycan (GAG) mimetics, better known as amyloid disease-modifiers. By mimicking GAGs, Fibrillex prevents formation of the AA fibrils and their deposition in affected tissues, which, when left untreated, leads to organ failure.
AA Amyloidosis is a progressive and fatal condition that affects some 270,000 people around the world and occurs in a proportion of patients with chronic inflammatory diseases, including rheumatoid arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, and Crohn's disease.
Neurochem Inc. recently announced that it has completed the phase II/III clinical trial of this product candidate. Neurochem Inc. anticipates filing for regulatory approval in 2005.