Micromet Receives European Orphan Drug Designation for Treatment of Acute Lymphoblastic Leukemia with BiTE Antibody Blinatumomab

BETHESDA, Md., Aug. 3  /PRNewswire-FirstCall/ -- Micromet, Inc. (NASDAQ: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today announced that it has received Orphan Drug Designation from the European Medicines Agency (EMEA) for BiTE antibody blinatumomab (MT103) for acute lymphoblastic leukemia (ALL).  Blinatumomab is a novel therapeutic antibody that activates a patient's T cells to seek out and destroy cancer cells.

In June, Micromet announced that the company had achieved its primary endpoint in an ongoing Phase 2 study of ALL patients. The company presented data at the the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany, showing an 81% response rate in acute lymphoblastic leukemia (ALL) patients with minimal residual disease (MRD)(1).

The patients included in this phase 2 clinical trial were in complete hematological remission following intense chemotherapy regimens, but retained a detectable level of ALL cancer cells in their bone marrow - so called minimal residual disease (MRD). Various studies have confirmed that ALL patients with MRD following chemotherapy have a significantly worse prognosis than patients without MRD.

According to the EMEA, "orphan" medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

The aim of the EU legislative framework for orphan medicines is to stimulate research and development of medicinal products for rare diseases by providing incentives to the pharmaceutical industry such as simplified access to EMEA's scientific consulting resources.  This initiative helps to give patients suffering from rare diseases access to the same quality of treatment as other patients.

(1) Topp, M.S. et al (2009). Blinatumomab (anti-CD19 BiTE ) for targeted therapy of minimal residual disease (MRD) in patients with B precursor acute lymphoblastic leukemia (ALL): Update of an ongoing Phase II study. 14th Congress of the EHA 2009, abstract no. 482

About Micromet, Inc.

Micromet, Inc. is a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. Its product development pipeline includes novel antibodies generated with its proprietary BiTE  antibody platform, as well as conventional monoclonal antibodies. BiTE antibodies represent a new class of antibodies that activate the T cells of a patient's immune system to eliminate cancer cells. Five of Micromet's antibodies are currently in clinical trials. Its BiTE antibody blinatumomab (MT103) is in a phase 2 clinical trial for the treatment of patients with acute lymphoblastic leukemia (ALL), and in a phase 1 clinical trial for the treatment of patients with non-Hodgkin's lymphoma (NHL). A second BiTE antibody, MT110, is in a phase 1 clinical trial for the treatment of patients with solid tumors. MT110 binds to the epithelial cell adhesion molecule, or EpCAM, which is overexpressed in many solid tumors. Micromet's human monoclonal antibody adecatumumab (MT201) also binds to EpCAM and is being developed under a collaboration with Merck Serono. Adecatumomab is in a phase 2 clinical trial in colorectal carcinoma patients after complete resection of liver metastases, and a phase 1b clinical trial evaluating adecatumumab in combination with docetaxel for the treatment of patients with metastatic breast cancer. Micromet's monoclonal antibody MT293, also known as TRC093, is licensed to TRACON Pharmaceuticals, Inc., and is in a phase 1 clinical trial for the treatment of patients with cancer.  MT203, a human antibody neutralizing the activity of granulocyte/macrophage colony stimulating factor (GM-CSF), which has potential applications in the treatment of various inflammatory and autoimmune diseases, such as rheumatoid arthritis, psoriasis, or multiple sclerosis, is in a phase 1 clinical trial conducted by Micromet's collaboration partner Nycomed.  Micromet's licensee Morphotek, a wholly-owned subsidiary of Eisai, is also expected to initiate a first phase 1 clinical trial with Micromet's glycolipid-binding human antibody MT228 for the treatment of melanoma.

Micromet's preclinical product pipeline includes several novel BiTE antibodies generated with its proprietary BiTE antibody platform technology. A BiTE antibody targeting CEA for the treatment of solid tumors is being developed in collaboration with MedImmune. In addition, Micromet has entered into an option, collaboration and license agreement with Bayer Schering Pharma AG under which Bayer Schering Pharma was granted an exclusive option to license a specified BiTE antibody against an undisclosed solid tumor target. Other BiTE antibodies targeting MSCP, CD33, HER2, EGFR and other targets are in various stages of preclinical development.

Forward-Looking Statements

This release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. These forward-looking statements include statements regarding the efficacy, safety and intended utilization of our product candidates, the conduct, timing and results of future clinical trials, and expectations of the future expansion of our product pipeline and collaborations. You are urged to consider statements that include the words "ongoing," "may," "will," "believes," "potential," "expects," "plans," "anticipates," "intends," or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that product candidates that appeared promising in early research, preclinical studies or clinical trials do not demonstrate safety and/or efficacy in subsequent clinical trials, the risk that encouraging results from early research, preclinical studies or clinical trials may not be confirmed upon further analysis of the detailed results of such research, preclinical study or clinical trial, the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data, the risk that we or our collaborators will not obtain approval to market our product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborators, including MedImmune, Merck Serono, TRACON and Nycomed, for the funding or conduct of further development and commercialization activities relating to our product candidates. These factors and others are more fully discussed in Micromet's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2009, filed with the SEC on May 11, 2009, as well as other filings by the company with the SEC. 

DATASOURCE: Micromet, Inc.



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