- Contract covers the production of ENB-0040, a bone-targeted enzyme replacement therapy under investigation for treating metabolic bone disease hypophosphatasia (HPP)
- Lonza will manufacture ENB-0040 at its large-scale biopharmaceutical facilty in Portsmouth, NH (USA)
Lonza today 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 (HPP). 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.
“We are pleased that Enobia places confidence in Lonza’s manufacturing capabilities and has entrusted us to support the launch and commercial supply of their lead drug candidate" said Dr. Stephan Kutzer, COO Lonza Custom Manufacturing. “We very much look forward to a long and successful collaboration.”
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.
About Enobia Pharma Inc.
Enobia Pharma Inc. is a private Montreal-based company focused on the development of therapeutics to treat serious bone disorders for which there are no drug therapies currently approved. ENB-0040, an investigational drug for the treatment of hypophosphatasia, is the Company’s lead program. For more information, please visit www.enobia.com.
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers’ needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets.
Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2010, Lonza had sales of CHF 2.680 billion. Further information can be found at www.lonza.com.
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