Trophos Granted Orphan Drug Status for TRO19622


Trophos Granted Orphan Drug Status for TRO19622 for the Treatment of Amyotrophic Lateral Sclerosis in Europe

MARSEILLE, France, Sept. 5, 2006 - Trophos SA, a biopharmaceutical company specializing in the discovery and development of drugs for neurodegenerative diseases, announced today that the European Commission granted the company an Orphan Medicinal Product designation for Cholest-4-en-3-one, oxime, (TRO19622) as a treatment for Amyotrophic Lateral Sclerosis (ALS). The decision follows the favorable opinion of the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA).

Trophos has already been granted orphan drug designation for TRO19622 for the treatment of ALS by the U.S. Food and Drug Administration in the USA. TRO19622 is currently being evaluated in a Phase Ib clinical trial in ALS patients at two centers in France. Trophos expects to initiate a pivotal Phase II/III clinical trial for the ALS indication in Europe in Q1 2007.

"The orphan drug designation in the EU signifies another important step for Trophos in the development of TRO19622," said Antoine Beret, CEO of Trophos. "We appreciate the EMEA's recognition of our efforts in developing TRO19622 for the potential benefit of patients with this debilitating and rapidly fatal disease." Béret added: "We are also excited by recent preclinical data showing the potential benefit of this molecule, and others in its series, in neuropathic pain and cardiovascular disorders. These results confirm that the 'first-in-class' mechanism of action of TRO19622 will be useful in the treatment of other diseases in addition to ALS."

About ALS (Amyotrophic Lateral Sclerosis): ALS, more commonly known as Lou Gehrig's disease in the USA, is a progressive and fatal neurological disease that is estimated to affect approx. 100,000 people worldwide. There is no cure for ALS. The only drug approved for ALS is riluzole (Sanofi-Aventis), which has been demonstrated to give some survival benefit to ALS patients. For more information about ALS, see http://www.alsa.org.

About Orphan Drug Designation Status: The granting of orphan drug designation status is intended to promote development of drugs to treat rare diseases or conditions, which would otherwise be unprofitable to pursue. The designation provides EU market exclusivity for a particular indication against drugs with the same structural features and which act via the same mechanism for a 10-year period, if the sponsor complies with certain EMEA specifications. In addition to marketing exclusivity, designation as an orphan drug provides other incentives including EMEA protocol assistance in preparing a drug development dossier that will meet regulatory requirements. For more information about the EMEA orphan drug designation process, see http://www.emea.eu.int

About Trophos: http://www.trophos.com. Trophos is a biopharmaceutical company developing drugs to treat neurodegenerative diseases. These are severely debilitating, often fatal, disorders with few effective drugs and tremendous unmet medical needs. In preclinical studies, compounds with similar effects as TRO19622 have been shown to prevent the neuronal degeneration that is involved in the onset or progression of motor neuron disease. Trophos was founded in 1999, is based in Marseille, France and currently has 35 employees.

Neil Hunter ANDREW LLOYD & ASSOCIATES
http://www.ala.com
neil@ala.com

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