Imbruvica, approved by the US Food and Drug Administration (FDA) in November last year for the treatment of patients with mantle cell lymphoma, was granted three Breakthrough Therapy Designations - a first for an oncology drug - designed to expedite the development and review of drugs for life-threatening conditions.
Contract manufacturing organisation (CMO) Lonza had been contracted by Pharmacyclics during the clinical trial stage and, according to spokesman Dominik Werner, is now the primary CMO partner for commercial supply of the small molecule active pharmaceutical ingredient (API).
“We have been partnered with them since Phase I of the drug development,” he told Outsourcing-Pharma.com, and though contract terms were only announced yesterday, the firm has been providing commercial supplies of the API since September 2013.
Lonza’s experience in manufacturing the API in clinical quantities was the key factor behind yesterday’s agreement - of which financial details have not been divulged - with the firm being able to work with the manufacturing process for a number of years, Werner told us.
“[The optimization and scale-up] experience along with the in-depth knowledge of Pharmacyclics has allowed us to successfully manufacture for this intricate and robust process,” he added.
This is Lonza’s second contract win announced so far this year, with Index ventures selecting the firm to develop and manufacture biologics for a number of biotech companies in its portfolio last week.
Working with Catalent
Pharmacyclics is also working with Catalent to manufacture Imbruvica both for clinical and commercial supplies. Catalent, a CMO that does not manufacture APIs, produces the finished drug from its Kansas City, Missouri facility and in November the firm said it was building dedicated space to service commercial supply.
The expansion - set to be completed in mid-2014 - came after the FDA inspected 450,000sq ft at the site and reported zero observations.
The site, we were told at the time, “provides a wide range of fully integrated support services from formulation development and analytical testing to clinical supply services as well as clinical and commercial manufacturing for oral dose forms.”