Healthcare Industry News:  head and neck cancer 

Biopharmaceuticals Oncology FDA

 News Release - January 3, 2006

Genmab's HuMax-EGFr Awarded Fast Track Status From FDA

COPENHAGEN, Denmark, Jan. 3 (HSMN NewsFeed) -- Genmab A/S (CSE: GEN ) announced today that HuMax-EGFr has been designated a Fast Track Product by the US Food and Drug Administration (FDA). This designation covers patients with head and neck cancer who have previously failed standard therapies. Genmab presented positive results from the Phase I/II study of HuMax-EGFr in May 2005.

Fast Track Product status allows the FDA to 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 if 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 or accelerated approval of the BLA where the review time would be halved to just 6 months.

"We are very pleased that HuMax-EGFr has been designated a Fast Track product and is now poised to move forward to pivotal studies which we hope to begin this year," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

About HuMax-EGFr

HuMax-EGFr is a fully human, high-affinity antibody targeted at the Epidermal Growth Factor receptor (EGFr). EGFr is a receptor molecule found on the surface of many cancer cells. Activation of EGFr by the appropriate growth factor molecule promotes the growth of tumor cells.

In September 2003, Genmab initiated an open label Phase I/II clinical trial using HuMax-EGFr to treat patients suffering from confirmed recurrent or metastatic squamous cell carcinoma of the head and neck who had previously failed standard therapies. Twenty-four patients were included in the initial trial, which was extended in October 2004 to include three additional patients. Patients were divided into six dose groups and received IV infusions of HuMax-EGFr at doses of 0.15, 0.5, 1, 2, 4, or 8 mg/kg. Twenty patients received all five infusions. The primary and secondary endpoints of the study were safety and efficacy of HuMax-EGFr.

Clinical and metabolic response was demonstrated by two types of scanning. Assessed by FDG-PET, which visualizes tumor metabolism, 7 of 18 evaluable patients achieved partial metabolic response (PMR) and 4 had stable metabolic disease (SMD) one week after their fifth and last infusion. In the two highest dose groups, 9 out of 11 patients obtained PMR or SMD.

Clinical response evaluated by computerized tomography (CT scan) supported the positive FDG-PET results. Two of 19 evaluable patients achieved partial response (PR) and 9 patients had stable disease (SD) according to RECIST criteria. The partial response was maintained at week 12 by one of the two patients. The other patient's disease progressed five weeks after the last treatment, but following additional HuMax-EGFr treatment at 8 mg/kg on a compassionate use basis, the patient re-obtained the partial response. In the two highest dose groups 7 out of 10 patients obtained PR or SD.

Results from the trial indicate that HuMax-EGFr is well tolerated by head and neck cancer patients. Furthermore, no patients experienced Dose Limiting Toxicity when treated with the highest dose of 8 mg/kg. The most frequent adverse event was acneiform rash demonstrating biological activity of HuMax- EGFr in 56% of the patients. The occurrence increased with dose, with 10 of 11 patients in the 4 and 8 mg/kg dose groups experiencing rash. Other adverse events included rigors, fatigue, pyrexia, nausea, flushing and increased sweating. One case of grade 3 rash was reported. One patient reported a serious adverse event considered related to treatment with HuMax-EGFr, grade 2 pyrexia, which developed during the first infusion. The patient recovered and completed the study.

About Genmab A/S

Genmab A/S is a biotechnology company that creates and develops human antibodies for the treatment of life-threatening and debilitating diseases. Genmab has numerous products in development to treat cancer, infectious disease, rheumatoid arthritis and other inflammatory conditions, and intends to continue assembling a broad portfolio of new therapeutic products. At present, Genmab has multiple partnerships to gain access to disease targets and develop novel human antibodies including agreements with Roche, Amgen and Serono. A broad alliance provides Genmab with access to Medarex, Inc.'s array of proprietary technologies, including the UltiMAb® platform for the rapid creation and development of human antibodies to virtually any disease target. Genmab has operations in Copenhagen, Denmark, Utrecht, the Netherlands, and Princeton, New Jersey in the US. For more information about Genmab, visit http://www.genmab.com.

This press release contains forward-looking statements. The words "believe," "expect," "anticipate," "intend" and "plan" and similar expressions identify forward-looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. Genmab is not under an obligation to update statements regarding the future following the publication of this release; nor to confirm such statements in relation to actual results, unless this is required by law.

UltiMAb® is a trademark of Medarex, Inc.

Genmab®; HuMax®; HuMax-CD4(TM) and the Y-shaped Genmab logo are all trademarks of Genmab A/S.


Source: Genmab

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