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news.Roche has filed an investigational new drug application with the FDA for an antibody developed under the company's collaboration with biotech firm Genmab. If the FDA gives its approval Roche will be able to begin clinical testing of the drug.
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The filing represents the ninth milestone that the companies have achieved in the collaboration and triggers a milestone payment to Roche.
In the collaboration, Genmab utilizes its antibody development capabilities to create human antibodies to a broad range of disease targets identified by Roche. Genmab receives milestone and royalty payments based on successful products, and in certain circumstances 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 as much as $100 million, plus royalties. Roche has so far selected four Genmab antibodies as clinical candidates and this is the first of the four to enter the clinic.