MedImmune Returns BiTE Compound To Micromet With An Option To Jump Back In
This article was originally published in The Pink Sheet Daily
Executive Summary
Partners will start an all-new BiTE project and continue working on another, while Micromet takes over worldwide development of blinatumomab, for which MedImmune retains a commercialization option.
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Although MedImmune has changed its relationship with Micromet, stepping back from their co-development deal for the BiTE antibody blinatumomab, the news is not necessarily bad for the U.S./German biotech. AstraZeneca subsidiary MedImmune returned its U.S. license for blinatumomab, but it has agreed to complete development of the commercial-scale manufacturing process for the antibody, also known as MT103, at its cost and to supply blinatumomab for clinical trials. Further, it retained a one-time option to reacquire U.S. commercialization rights if the experimental immunotherapeutic is approved. Also a plus, the two companies plan to develop a new BiTE program aimed at the same goal as MT103: treatment of hematological cancers. The new arrangement gives Gaithersburg, Md.-based MedImmune exclusive license to develop and commercialize the new compound in the U.S., while Micromet has rights in the rest of the world, which is the way the original deal started out. Micromet, which has its U.S. base in Bethesda, Md., will generate and conduct preclinical studies on the new compound at MedImmune's expense, and MedImmune also will pay development milestones, as well as royalties on U.S. sales if the therapy reaches market. None of the terms were disclosed. The relationship between the two companies on a third BiTE compound, MT111/MEDI-595, which targets carcinoembryonic antigen (implicated in colorectal cancers) has not changed. Micromet anticipates that MedImmune will initiate clinical trials for the antibody in 2010, CEO Christian Itin said during a March 13 analyst call to report Micromet's 2008 earnings and field questions on the realignment. Blinatumomab is a product of Micromet's bispecific T-cell engager (BiTE) technology platform. The novel single-chain antibodies act by tethering resting T-cells to tumor cells, where the immune system cells then deliver their cytotoxic proteins, triggering cell death. Blinatumomab targets the C19 antigen expressed on B cells. MedImmune, which was responsible for development in the U.S., never started any clinical trials for blinatumomab, though an IND was approved by FDA in early 2007. The compound has shown promise in Micromet's European studies. Phase I data from a non-Hodgkin's lymphoma trial were published in Science magazine last August (1 (Also see "Micromet/MedImmune’s Blinatumomab Shows Early Promise Of BiTE Antibodies" - Pink Sheet, 18 Aug, 2008.)). Data from a German Phase II study in adult patients with acute lymphoblastic leukemia - which Itin said is recruiting faster than expected - and a Phase I study in relapsed NHL are being presented in June at the European Hematology Association meeting in Berlin. The holdup might be due to AstraZeneca's Big Pharma attitude about small-market indications. "I think it not too unusual that this is a path that may not be at the center of focus for large pharma companies," Itin said. Blinatumomab isn't the first MedImmune project AstraZeneca has given back to a partner on pretty good terms. In another case of apparent evolutionary incompatibility, MedImmune returned control to Infinity Pharmaceuticals of its Phase III injectable heat shock-90 inhibitor, as well as a Phase I oral compound, in December (2 (Also see "Infinity Regains Rights To Its Lead Program" - Pink Sheet, 11 Dec, 2008.)). The difference for Micromet is the company can't repartner U.S. rights to blinatumomab so long as MedImmune/AstraZeneca's option remains outstanding. -Shirley Haley ([email protected]) |