Lonza successfully develops a manufacturing process for Arzerra (ofatumumab), a new biopharmaceutical from GSK and Genmab

 

Basel, Switzerland, 10 November 2009 - Lonza announces that GlaxoSmithKline (GSK) and Genmab's antibody ArzerraTM, which has just been approved for use in patients with chronic lymphocytic leukemia (CLL) by the US Food and Drug Administration (FDA), will be manufactured by Lonza.

Under agreements with GSK and Genmab, Lonza carried out a program of process development and cGMP manufacturing services to support the licensure. Lonza will supply ArzerraTM drug substance to GSK under the terms of a long-term supply agreement. Financial details of the agreement were not disclosed.

"We are looking forward to a long-term relationship between Lonza and GSK. We expect that ArzerraTM will be a key biopharmaceutical for both companies, and we are proud that we could bring together the expertise of both companies to develop a state-of-the-art manufacturing process," said Dr. Stephan Kutzer, COO Lonza Custom Manufacturing APIs.

About CLL
CLL is a cancer of the lymphocytes, a type of white blood cell. The lymphocytes can grow too quickly and live too long (disease usually gets worse slowly), and in time, overtake healthy white blood cells, red blood cells and platelets in the bone marrow. CLL is the most common adult leukemia and one of the most common malignant lymphoid diseases.

About ofatumumab
ArzerraTM is a monoclonal antibody that causes the body's immune response to fight against normal and cancerous B-cells. ArzerraTM attaches to the small and large loop epitopes - on a molecule called CD20, which is found on the surface of B-cells, the type of cell which becomes cancerous in CLL.

About Lonza
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 2008, Lonza had sales of CHF 2.937 billion. Further information can be found at www.lonza.com.