Micromet terminates agreement with MedImmune for MT103 (MEDI-538)

Under the terms of the termination agreement, Micromet has now regained MedImmune's remaining rights relating to blinatumomab as well as any other BiTE antibodies binding to antigens relevant for hematological cancers that had been reserved for MedImmune. Micromet will make upfront, milestone and royalty payments to MedImmune related to the development and North American net sales of blinatumomab.

As a result of this transaction, Micromet now controls global rights to develop and commercialize blinatumomab.

Update on March 12, 2009:

Micromet has signed an agreement to regain the North American rights to its BiTE antibody candidate, blinatumomab (MT103), from its partner MedImmune.

Under the agreement, MedImmune has retained an option to reacquire the right to commercialize blinatumomab in North America.

In Europe, Micromet is conducting a phase II clinical trial with blinatumomab for the treatment of patients with acute lymphoblastic leukemia and a phase I clinical trial for the treatment of patients with non-Hodgkin's lymphoma.

In addition, Micromet and MedImmune plans to initiate a research program for the development of a new BiTE antibody for the treatment of hematological cancers.

Update On June 12, 2008:

Micromet and MedImmune, announced that the first patient has started treatment in a multi-center, phase II trial conducted in Germany investigating BiTE antibody blinatumomab (MT103/MEDI-538) in patients with adult acute lymphoblastic leukemia (ALL).

Blinatumomab is a T cell engaging antibody targeting the CD19 antigen, which is only expressed on B cells. The clinical development program for blinatumomab was expanded to include ALL as an additional indication after data from an ongoing phase I clinical trial showed potent single-agent activity of the BiTE antibody in patients with late-stage non-Hodgkin's lymphoma (NHL).

Update On April 23, 2007:

Micromet announced the achievement of a milestone in its research collaboration with MedImmune for the development of new BiTE molecules targeting carcinoembryonal antigen, a validated tumor- associated antigen frequently expressed on various human carcinomas. Preclinical data showed that CEA-BiTE molecules can prevent subcutaneous tumor growth and formation of lung metastases. Achievement of the preclinical proof-of-concept milestone in the CEA-BiTE program triggers a payment from MedImmune to Micromet.

Update On August 21, 2006:

MedImmune and Micromet announced that MedImmune has filed an investigational new drug application with the U.S. Food & Drug Administrationfor MT103 (also known as MEDI-538) for the treatment of patients with B-cell-derived non-Hodgkins lymphoma not eligible for curative therapy. MT103 is a recombinant single-chain bispecific T-cell engager, or BiTE, molecule. It targets the CD19 antigen, which is uniquely expressed on B cells.

Update On July 21, 2006:

MedImmune and Micromet present a BiTE molecule (bscEphA2xCD3) targeting the tyrosine kinase receptor EphA2, which is frequently overexpressed on solid tumors. The compound has been generated in the context of the companies' research collaboration for the development of therapeutics based on Micromet's BiTE technology. In in vitro studies, bscEphA2xCD3 was observed to kill tumor cells at low nanogram/ml concentrations, which is considerably below dose levels currently required by classical monoclonal antibody-based therapies. Tumor cell lysis approached 100 percent even at low ratios of effector T cells to target cells. In mice, the BiTE compound redirected unstimulated human T cells to inhibit transplanted human tumor outgrowth without the apparent need for co-stimulation of T cells.

Under the terms of the companies' collaboration agreement, MedImmune holds the rights to bscEphA2xCD3. Micromet is entitled to receive milestones and royalties in case of successful development and commercialization of the compound and has the option to receive co-promotion rights in Europe.

Update On November 21, 2005:

Micromet AG has achieved a milestone in its collaboration with MedImmune, Inc. for the development of new BiTE therapeutics. In the context of the collaboration, Micromet generated BiTE molecules against an oncology target proprietary to MedImmune. Both companies successfully tested them for anti-tumor activity in preclinical studies. The preclinical milestone triggered an undisclosed proof-of-concept payment from MedImmune to Micromet.

Under a separate arrangement, Micromet and MedImmune are also collaborating on the development of MT-103, a BiTE molecule being developed to treat B-cell non-Hodgkin's lymphoma. MT-103 specifically targets the CD19 antigen present on B cells, but not on other types of blood cells or healthy tissues.

Update On May 09, 2005:

Micromet AG reports preclinical data on its drug candidate MT103, a representative of the Company's proprietary class of antibody derivatives called BiTE. MT103 is currently in a phase I trial for the treatment of non-Hodgkin's Lymphoma. It is being co-developed with MedImmune, Inc., a leading U.S.-based biotechnology company focused on infectious diseases, immunology and oncology.

The new study published in the recent issue of the International Journal of Cancer (1) investigates the mode of action of MT103 using video-assisted microscopy. The results demonstrate that minute doses of MT103 can direct cytotoxic T cells to conduct multiple rounds of target cell killing. Even at a ratio of one T cell facing five tumor cells, complete target cell elimination was achieved within 24 hours. Cells that did not carry the CD19 target antigen for MT103 were completely spared from T cell attack.

Announcement (June 9, 2003):

MedImmune and Micromet have signed an agreement to jointly develop Micromet's B cell tumor drug, MT103. In addition, the parties agreed to create up to six drug candidates using Micromet's proprietary Bi- Specific T Cell Engagers (BiTE) product platform.

Micromet has initiated two European phase I studies of MT103 in non- Hodgkin lymphoma (NHL) and plans to initiate a phase I study in chronic lymphocytic leukemia (CLL) later this year.

Under the terms of the agreement, Micromet would receive milestone payments based on the successful development, filing, registration and marketing of MT103, as well as royalties on MedImmune's North American sales of the product. Furthermore, MedImmune Ventures, Inc., a wholly owned venture capital subsidiary of MedImmune, would make an investment in Micromet.

MedImmune receives Micromet's product rights to MT103 in North America and would assume responsibility for clinical development, registration and commercialization of the product in that region. As part of the agreement, MedImmune would develop the commercial manufacturing process and supply clinical trial material as well as commercial products for all markets. Micromet retains rights to MT103 outside of North America.

In addition to the MT103 co-development agreement, the parties would collaborate to create and develop up to six new products based on the BiTE platform. Micromet is entitled to receive milestones and royalties on future product sales of all resulting BiTE products.

In addition, Micromet has the option to obtain exclusive European rights for BiTE compounds based on targets non-proprietary to MedImmune and the option to receive co-promotion rights in Europe for BiTE compounds based on MedImmune's proprietary targets. For each new BiTE molecule MedImmune would cover full development costs up to phase I. Micromet would be responsible for the generation of the new BiTE molecules. The parties expect to initiate the first joint BiTE program within the next six months.

Deal Type    Partnership
Sub-Category Co-development,Marketing,Sales,Commercialization
Deal Status  Terminated: 2009-11-05

Deal Participants

Partner 1 (Company) MedImmune, LLC
Partner 2 (Company) Micromet AG
Partner 3 (Company) Micromet, Inc.
Partner 4 (Company) AstraZeneca PLC

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