Genmab's fast track with Roche

Danish drug company Genmab has been designated a Fast Track Product for its HuMax-CD4 by the US FDA. This designation covers patients with cutaneous T-cell lymphoma (CTCL) who have failed currently available therapy. This patient group includes those who are refractory as well as those who cannot tolerate currently available treatment. HuMax-CD4 is currently in two Phase II studies to treat CTCL.

Under the FDA Modernisation Act of 1997, designation as a Fast Track Product means that the FDA will facilitate the development and expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition, and it demonstrates the potential to address unmet medical needs for such a condition.

This fast track designation gives Genmab the opportunity to submit a Biologics License Application (BLA) in sequential sections, and have these sections reviewed as they are submitted, thus saving development time. A BLA is the biologic products' equivalent to a New Drug Application and is the final stage before a drug is approved for the market by the FDA. Fast track status also opens the possibility for receiving a priority review of the BLA where the review time would be halved to just six months.

'Fast Track status confirms there is a major unmet medical need for treatment of CTCL patients,' said Dr Lisa Drakeman, ceo of Genmab. 'We are encouraged by the results of the clinical trials to date and are looking forward to continued development.'

Roche collaboration

Genmab has also announced that Roche has selected two Genmab antibodies as candidates for clinical development. The antibodies, developed under a collaboration between Roche and Genmab which began in May 2001, are each designed to target a different disease area.

'The selection of these antibodies as clinical candidates underlines Genmab's skill in producing antibody product candidates as well as Roche's ability to identify valid disease targets,' said Dr Drakeman. 'Our partnership with Roche continues to be fruitful.'

Under the agreement, Genmab utilises its broad antibody expertise and development capabilities to create human antibodies to a broad range of disease targets identified by Roche. Roche has a proven track record in developing biologicals as innovative new products. Genmab receives milestone and royalty payments based on successful products, and in certain circumstances, Genmab may obtain rights to develop products based on disease targets identified by Roche. If all goals are reached, the value of the collaboration to Genmab could be $100m, plus royalties.

About HuMax-CD4

HuMax-CD4 is a high affinity human antibody that targets the CD4 receptor on T-lymphocytes. Genmab is running two Phase II studies concurrently using HuMax-CD4 to treat cutaneous T-cell lymphoma (CTCL), one in early stage patients and the other for patients with advanced disease.