Genmab to start Phase III studies of HuMax-CD20 in rheumatoid arthritis

06.18.07, 9:18 AM ET

COPENHAGEN (Thomson Financial) - Genmab AS said it expects to initiate Phase III studies of ofatumumab (HuMax-CD20) in rheumatoid arthritis (RA) by the end of 2007.

HuMax-CD20 is is being developed under a worldwide co-development and commercialisation agreement between Genmab and GlaxoSmithKline (nyse: GSK - news - people ).

Genmab said the group also plans to expand the development programme through a Phase II study in relapsing remitting multiple sclerosis (RRMS) in the first quarter of 2008.

There is potential to pursue indications in a wide range of autoimmune disease settings,' Genmab said.

The Danish pharma group added the development plans for ofatumumab will be described at GSK's Oncology Seminar.

Ofatumumab is currently in late stage development for chronic lymphocytic leukemia (CLL), follicular non-Hodgkin's lymphoma (NHL) and in Phase II for RA.

Genmab said a clear demonstration of the efficacy and safety of ofatumuamb in two late stage trials for CLL and follicular NHL could provide the initial regulatory applications.

The company has received a Fast Track designation for the CLL study.

Under these circumstances, it said, 'ofatumumab could potentially enter the market in 2008 first for the treatment of refractory CLL and subsequently for rituximab-refractory follicular NHL.'

The group has planned initiation of clinical studies for ofatumumab in diffuse large B-cell lymphoma (DLBCL) by the end of 2007 and randomised Phase III studies in CLL and follicular NHL in the first half of 2008.

michael.delaine@thomson.com

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Glaxo China R&D centre to target neurodegeneration

Thu May 24, 2007 12:34 PM BST


LONDON, May 24 (Reuters) - GlaxoSmithKline Plc (GSK.L: Quote, Profile , Research) said on Friday it had appointed Dr. Jingwu Zang to head a major new research and development centre in Shanghai, which would focus on neurodegenerative diseases.

The centre aims to create new drugs for disorders like multiple sclerosis, Parkinson's and Alzheimer's disease. It will eventually direct global discovery and development activities in its therapeutic area, from drug-target identification to late-stage clinical studies.

Zang, the founding director and a professor at the Institute of Health Sciences in Shanghai, will take up his position in June.

Glaxo's research head Moncef Slaoui, who told its annual meeting on Wednesday that an announcement on building a fully integrated R&D centre in China was imminent, said the move marked a significant expansion of the group's research effort.

"We intend to be part of a future in which the phrase 'discovered in China' is heard as often as 'made in China' is heard today," he said in a statement.

Glaxo already has an R&D presence in China via collaborations with the Shanghai Institute of Materia Medica, the drug research institute of the Chinese Academy of Sciences.

Its new move mirrors efforts by other major drugmakers to tap into the country's skills in life sciences.

China is rapidly growing in importance for the pharmaceuticals industry -- as a centre of research, production and future sales.

The country is set to become the world's fifth-largest medicine pharmaceuticals market by 2010, with sales nearly doubling to $25 billion from $13 billion in 2005, Boston Consultancy, an independent consulting group, said last year.

In the past Western drugmakers have been wary of investing in China because of a reputation for weak patent protection. But industry executives say patent enforcement is now improving.

© Reuters 2007. All Rights Reserve