Date: 2011-03-15
Type of information: Production agreement
Compound: ENB-0040 (asfotase alfa)
Company: Lonza (Switzerland) Enobia (Canada)
Therapeutic area: Bone diseases - Genetic diseases - Metabolic diseases
Type agreement: manufacturing
production
Action mechanism:
Disease: hypophosphatasia
Details: Lonza has announced an exclusive contract for the commercial production of Enobia’s bone-targeted enzyme replacement therapy ENB-0040 (asfotase alfa), under investigation for the treatment of hypophosphatasia. Under the agreement, Lonza will provide process validation and commercial manufacturing at its large-scale biologics site in Portsmouth, NH, with an option to extend production to a second Lonza site.
Enobia recently announced that its successfully completed phase 2 juvenile study has met its primary endpoint, demonstrating a statistically significant improvement in rickets when compared with historical matched cohort controls (p=0.002). Rickets, a softening and weakening of the bones, is often seen in children with HPP and can lead to fractures, pain and deformity. The positive data follow the successful completion of an earlier trial in infants, in which participants continue to demonstrate functional and respiratory improvements in longer-term follow-up. A phase 2 study in adolescents and adults with HPP is ongoing.
Financial terms: Financial details of the agreement were not disclosed.
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