Lonza achieves record quarter but receives FDA warning letter

Published: 6-May-2017

Lonza starts 2017 with outstanding first quarter results but a warning letter on 24 April 2017 from the US FDA has affected its Bioscience Solutions business

During the first quarter of 2017, Lonza achieved record quarter in terms of sales and earnings. The healthy overall company performance resulted from particularly strong performance in its Pharma and Biotech segment and continued robust growth in Specialty Ingredients.

“Following the record results last year, we have been able to continue our success into 2017. The major drivers were again the businesses along the entire healthcare continuum,” said Richard Ridinger, CEO of Lonza. "We are using this strong momentum to make the necessary investments into future-oriented projects that will continue to bring us closer to the goal of becoming a leading supplier within the healthcare continuum and our various specialty ingredients markets. The expected close of the Capsugel acquisition in Q2 will help us to get there faster.”

Its Pharma and Biotech segment’s sales growth was driven by strong demand in Mammalian Manufacturing and in Clinical Development and Licensing.

The year saw a strategic partnership with Sanofi in the first quarter of 2017 for the construction of a large-scale biologics production facility. The ground-breaking for the Lonza/Sanofi facility in Visp, Switzerland, is planned for the second half of the year.

The company said its Bioscience Solutions business was slightly softer due to quality issues at its Walkersville, MD (USA) facility; associated with these quality issues, Lonza received a warning letter on 24 April 2017 from the US Food and Drug Administration relating to technical issues involving for example validation and aseptic process simulations.

Lonza's clinical cell processing facility, inlcudes an ISO Class 7 (Class 10,000) cleanroom designed to meet US regulatory requirements as well as ISO Class 5 (Class B) suites designed for European regulatory needs.

Lonza said it takes this issue seriously, and has already started to address all issues raised by the FDA. It expects minimal financial impact on its overall 2017 pharma and biotech segment performance.

Lonza’s other divisions – Specialty Ingredients, Consumer Care, Hygiene business, Agro Ingredients Coatings and Composites and Industrial, Commercial, Municipal and Surface Water (ICMS) all delivered robust results in most markets.

With this positive start into 2017, Lonza is upgrading its outlook for 2017.

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