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Amgen to Acquire Micromet

By Micromet, Press Release
Press Release.

 

Acquisition Includes a Novel Cancer Treatment in Clinical Trials for Hematologic Malignancies

Micromet’s Proprietary BiTE® Platform has Potential to Improve Treatment in Multiple Tumor Types

All-Cash Transaction Values Micromet at $1.16 Billion

THOUSAND OAKS, Calif., and ROCKVILLE, Md., Jan. 26, 2012 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Micromet, Inc. (NASDAQ:MITI) today announced that the companies have entered into a definitive merger agreement under which Amgen will acquire Micromet, a biotechnology company founded in Germany with its research and development (R&D) center in Munich and headquarters in Rockville, Md., for $11 per share in cash. The transaction, which values Micromet at approximately $1.16 billion, was unanimously approved by both the Amgen and Micromet Boards of Directors.

The acquisition includes blinatumomab, a Bispecific T cell Engager (BiTE) antibody in Phase 2 clinical development for acute lymphoblastic leukemia (ALL). Blinatumomab is also in clinical development for the treatment of non-Hodgkin’s lymphoma (NHL), and could have applications in other hematologic malignancies.

“The acquisition of Micromet is an opportunity to acquire an innovative oncology asset with global rights and a validated technology platform with broad potential clinical applications,”

said Kevin Sharer, chairman and CEO at Amgen.

“Blinatumomab will serve as an important complement to our oncology pipeline and is representative of our corporate strategy, which is focused on developing and successfully commercializing therapeutics to treat patients with grievous illness.”

Amgen will gain the following as a result of the acquisition:

■Blinatumomab, a BiTE antibody that has demonstrated encouraging single-agent activity in both adult and pediatric patients with ALL as well as adult patients with NHL, and is currently under investigation in five trials:
■Two Phase 2 trials for adult patients with relapsed/refractory ALL
■Phase 1/2 trial for pediatric patients with relapsed/refractory ALL
■Phase 2 trial for adult ALL patients with minimal residual disease (MRD)
■Phase 1 trial for adult patients with relapsed/refractory NHL
■Proprietary BiTE antibody technology which provides an innovative, validated platform for future clinical research
■Potential milestone and royalty payments from existing licensees of BiTE and other technologies
■Unencumbered rights to solitomab, a BiTE antibody in Phase 1 for patients with advanced solid tumors
■Micromet’s Munich site, which will operate as an Amgen R&D center of excellence
“We believe that this transaction represents an attractive opportunity for Micromet, its stockholders and cancer patients,” said Christian Itin, Ph.D., Micromet’s president and CEO. “Amgen’s extensive resources and experience in the development and commercialization of biologics promise to speed blinatumomab’s path to market, expand its development across a broader range of B-cell malignancies and maximize the full potential of our novel BiTE technology.”

Terms of the Transaction

Under the terms of the merger agreement, a subsidiary of Amgen Inc. will commence a tender offer to acquire all of the outstanding shares of Micromet’s common stock at a price of $11 per share in cash. Following the purchase of shares through the tender offer, Amgen will complete the transaction by acquiring all remaining shares not acquired in the offer through a merger at the same price as the tender offer. The consummation of the tender offer is subject to various conditions, including a minimum tender of at least a majority of outstanding Micromet shares on a fully diluted basis, the expiration or termination of the waiting period under the Hart Scott Rodino Antitrust Improvements Act and other customary conditions. The tender offer is not subject to a financing condition. The transaction is expected to close in the first quarter.

Amgen is advised by Moelis & Company LLC and Sullivan & Cromwell LLP. Goldman, Sachs & Co. and Cooley LLP are acting as financial and legal advisors, respectively, to Micromet.

Amgen will discuss the transaction as part of its fourth quarter earnings conference call today with the investment community at 2:00 p.m. Pacific Standard Time.  The previously scheduled conference call will primarily address Amgen’s fourth quarter and full year financial results.  Live audio of the conference call will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public. The conference call, including the question and answer session, is expected to last approximately one hour.

The webcast of the conference call, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar.

About Amgen
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. To learn more about our pioneering science and vital medicines, visit www.amgen.com.

About Micromet, Inc.
Micromet is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Micromet is advancing a robust pipeline of novel therapeutics based on its proprietary BiTE® technology. Micromet’s lead product candidate blinatumomab is currently the subject of a European trial in patients with minimal residual disease positive acute lymphoblastic leukemia. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including Amgen, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, MedImmune, Merck Serono, Nycomed and Sanofi.

About Blinatumomab

Blinatumomab is a Bispecific T cell Engager (BiTE antibody) designed to direct a patient’s cytotoxic T cells to eliminate cancer cells that express CD19. CD19 is a protein expressed on the surface of B-lymphocytes including acute lymphoblastic leukemias and non-Hodgkin’s lymphomas.  Data on blinatumomab demonstrating a high complete remission rate in adult patients with relapsed/refractory B-precursor ALL was recently reported at the American Society of Hematology (ASH) Annual Meeting, held in December 2011.

About BiTE Technology

BiTE antibodies are designed to direct the body’s cytotoxic, or cell-destroying, T cells against tumor cells, and represent a new therapeutic approach to cancer therapy. Typically, antibodies cannot engage T cells because T cells lack the appropriate receptors for binding antibodies. BiTE antibodies have been shown to bind T cells to tumor cells, ultimately killing the tumor cells.

Amgen Forward-Looking Statement

This news release contains forward-looking statements that are based on Amgen’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described.  All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements about the planned completion of the tender offer and the merger, estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results.  Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen’s most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K.  Please refer to Amgen’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen’s business.  Unless otherwise noted, Amgen is providing this information as of Jan. 26, 2012 and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects.  Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product.  Further, preclinical results do not guarantee safe and effective performance of product candidates in humans.  The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models.  The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures.  Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen’s products after they are on the market.  Amgen’s business may be impacted by government investigations, litigation and products liability claims.  Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development.

In addition, sales of Amgen’s products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement.  Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of Amgen’s products.  In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products.  Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen’s products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products.  In addition, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen’s ability to obtain or maintain patent protection for its products or product candidates.  Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products.  Amgen’s stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates.  Further, the discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen’s business and results of operations.

The scientific information discussed in this news release related to product candidates is preliminary and investigative.  Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.  Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated.  Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.

Additional Information

The tender offer described in this communication (the “Offer”) has not yet commenced, and this communication is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Micromet, Inc. (“Micromet”) or any other securities. On the commencement date of the Offer, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed with the United States Securities and Exchange Commission (“SEC”). The offer to purchase shares of Micromet common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. The tender offer statement will be filed with the SEC by Armstrong Acquisition Corp., a wholly owned subsidiary of Amgen formed for the purpose of making the Offer, and Amgen, and the solicitation/recommendation statement will be filed with the SEC by Micromet.  Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to Georgeson Inc., the information agent for the Offer, at (888) 877-5360 (toll free).

Micromet Safe Harbor Statement

Statements in this announcement that relate to future results and events are forward-looking statements based on Micromet’s current expectations regarding the tender offer and transactions contemplated by the merger agreement. Actual results and events in future periods may differ materially from those expressed or implied by these forward-looking statements because of a number of risks, uncertainties and other factors. There can be no assurances that a transaction will be consummated. Other risks, uncertainties and assumptions include the possibility that expected benefits may not materialize as expected; that the transaction may not be timely completed, if at all; that, prior to the completion of the transaction, if at all, Micromet may not satisfy one or more closing conditions; that the merger agreement may be terminated; and the impact of the current economic environment; risks related to Micromet’s ongoing development activities and clinical trials; and other risks that are described in Micromet’s most recent Form 10-Q for the quarter ended Sept. 30, 2011. Micromet undertakes no obligation to update these forward-looking statements except to the extent otherwise required by law.

Contacts
Amgen, Thousand Oaks
Mary Klem, 805-447-6979 (media)
Arvind Sood, 805-447-1060 (investors)

Micromet
Jennifer Neiman, 240-235-0246 (media and investors)
Andrew Cole/Lesley Bogdanow
Sard Verbinnen & Co.
212-687-8080

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SOURCE Amgen

Micromet’s Blinatumomab Induces Durable Remissions in Patients with Relapsed Non-Hodgkin’s Lymphoma

By Micromet, Press Release
Press Release.

 

Durable responses ranging up to 30 months observed

 

BETHESDA, Md., – Micromet, Inc. (Nasdaq: MITI) today announced the presentation of updated results from a Phase 1 trial of the Company’s lead product candidate blinatumomab (MT103) in patients with relapsed non-Hodgkin’s lymphoma (NHL). A high objective response rate was maintained among patients treated with blinatumomab using an adapted schedule, comparable to that previously reported in patients receiving constant dosing. Blinatumomab is the first in a new class of agents called BiTE(R) antibodies, designed to harness the body’s T cells to kill cancer cells.

The findings were presented on June 12, 2010 in an oral presentation (abstract # 0559) at the 15th Annual Congress of the European Hematology Association (EHA) in Barcelona, Spain.

“Blinatumomab continues to demonstrate a long duration of response in heavily pre-treated non-Hodgkin’s lymphoma patients,”

said Professor Ralph Bargou, Division of Hematology and Oncology, Department of Internal Medicine II, Wuerzburg University Hospital, and the study’s principal investigator.

“Results of the expanded Phase 1 experience suggest that blinatumomab has the potential to alter the clinical course of disease in patients with a variety of NHL sub-types.”

Phase 1 Study Design
This multi-center Phase 1 study evaluates the safety and tolerability of blinatumomab in adult patients with relapsed non-Hodgkin’s lymphoma (NHL). The key objectives of the study are to assess safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-lymphoma activity. Patient response is assessed using the Cheson criteria by independent radiologic review.

Patients initially received blinatumomab at dose levels ranging from 0.5 to 90 micrograms per meter squared per day over a four or eight week cycle. Based on findings in the ongoing study, a new dosing schedule was designed to mitigate the occurrence of neurological adverse events observed at the onset of treatment. Recently enrolled patients received a “step-dose approach” including a lower starting dose (5 or 15 micrograms per meter squared per day) of blinatumomab for one week, with subsequent escalation up to the target dose of 60 micrograms per meter squared per day.

Updated Phase 1 Results
The analysis presented at EHA included 52 patients, mainly with diagnoses of follicular lymphoma (FL) (42%) and mantle cell lymphoma (MCL) (42%). The majority of enrolled patients received three or more prior lines of chemotherapy. Of eight evaluable FL and MCL patients treated with constant dosing at a dose level of 60 micrograms per meter squared per day, 100% (8 of 8) achieved an objective response. The median response duration is 21 months. Three patients currently have ongoing responses ranging from 24 up to 30 months.

Among patients treated using constant dosing, the most common clinical adverse events were pyrexia, headache and fatigue. The most common adverse events were early, transient, fully reversible and did not require discontinuation of treatment. The clinically most relevant cause of treatment discontinuation was neurologic events. These were observed in a sub-group of patients with an identified prognostic factor. All events resolved without sequelae following treatment discontinuation.

Data presented on six patients with an identified risk factor for neurologic events who were treated with blinatumomab using a “step-dose approach” indicates that the new treatment schedule appears to mitigate neurological events and maintain clinical activity. There was no occurrence of grade 3 or higher neurological events and five objective responses were achieved among the six patients treated.

“Our goal is to safely and effectively treat indolent and mantle cell lymphomas using a uniform treatment schedule irrespective of patient characteristics,”

said Jan Fagerberg, M.D., Ph.D., Micromet’s SVP, Chief Medical Officer.

“We look forward to continuing to advance enrollment in the on-going study using the adapted treatment schedule and broadening the eligible patient population to include other non-Hodgkin’s lymphoma subtypes.”

Conference Call and Webcast
Micromet management will host a conference call on Tuesday, June 15 at 8:30 AM EDT to review the data presented at EHA. To participate in the conference call, please dial 866-770-7120 (domestic) or 617-213-8065 (international) and reference the access code 28465583.

A replay of the call will be available from 11:30 AM ET on June 15, 2010 until midnight on June 22, 2010. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international) and reference the access code 87529369. The archived webcast will be available for 30 days in the Investor Relations section of the Micromet website at www.micromet-inc.com.

About Blinatumomab
Blinatumomab (MT103) is a novel, next-generation monoclonal antibody designed to direct the body’s cell destroying T-cells against CD19, a protein expressed on the surface of B-cell derived acute lymphoblastic leukemias and non Hodgkin’s lymphomas. Micromet received orphan drug designation from the European Medicines Agency for blinatumomab for the treatment of acute lymphoblastic leukemia, mantle cell lymphoma and chronic lymphatic leukemia and from the Food and Drug Association for the treatment of acute lymphoblastic leukemia, chronic lymphocytic leukemia, indolent B cell lymphoma, hairy cell leukemia and prolymphocytic leukemia.

About Micromet, Inc.
Micromet, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Its product development pipeline includes novel antibodies generated with its proprietary BiTE(R) technology, as well as conventional monoclonal antibodies. Two of Micromet’s BiTE antibodies and three of its conventional antibodies are currently in clinical trials. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including sanofi-aventis, Bayer Schering Pharma, Merck Serono, Boehringer Ingelheim, MedImmune and Nycomed. Additional information can be found at www.micromet-inc.com

Safe Harbor
This press release contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from historical results or from any future results expressed or implied by such forward-looking statements. These forward-looking statements include statements regarding the development of blinatumomab and its use in the treatment of cancer. 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 our preclinical data is not confirmed in clinical trials with our product candidates. This factor and others are more fully discussed in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2010. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

SOURCE Micromet, Inc.

Micromet’s Blinatumomab Achieves Primary Endpoint in Phase 2 Study with Acute Lymphoblastic Leukemia Patients

By Micromet, Press Release
Press Release.

 

German Multicenter ALL Study Group Presented Data at the 14th Congress of the European Hematology Association Showing High Response Rate in Patients with Minimal Residual Disease

 

BERLIN, June 8 /PRNewswire-FirstCall/ — Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, announced that the German Multicenter ALL Study Group (GMALL) presented phase 2 clinical data of the BiTE® antibody blinatumomab (MT103) at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany, showing a high response rate in acute lymphoblastic leukemia (ALL) patients with minimal residual disease (MRD)(1). Blinatumomab is a novel therapeutic antibody that activates a patient’s T cells to seek out and destroy cancer cells.

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.

The primary endpoint of the phase 2 study is MRD response within four cycles of treatment. MRD response is defined as the elimination of ALL cancer cells in patients with MRD below the limit of detection. The achievement of the primary endpoint requires that at least 22% of 21 patients have an MRD response. Currently, 13 of 16, or 81% of evaluated patients have shown an MRD response, thus qualifying the trial as having met its primary endpoint before the completion of the study. Patients in all subgroups responded to treatment with blinatumomab, including bcr-abl positive patients after failure of treatment with bcr-abl inhibitors, and patients with t(4;11) translocations. Side effects were observed primarily in the first 24 to 48 hours with transient pyrexia and lympho-/leukopenia being the most frequent adverse events.

“Blinatumomab is one of the most active agents the GMALL has tested in the adult ALL consolidation setting,”

said Dr. Ralf Bargou, principal investigator of the trial.

“We are excited about the significant activity of blinatumomab in ALL and the favorable safety profile observed in this study. These results are particularly important for these patients who are in a disease stage with extremely poor prognosis and for which we lack treatment options except for patients eligible for allogenic stem cell transplantations.”

“The ALL interim data showing an MRD response rate above 80% significantly exceeds the rate which was considered to be clinically meaningful and was set as the hurdle for the achievement of the primary end point,”

said Micromet’s Senior Vice President and Chief Medical Officer, Carsten Reinhardt, M.D.

“We are now looking forward to discussing a pivotal ALL program with the regulatory authorities later this year.”

(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

 

Webcast/Conference Call

Micromet will host a webcast/conference call this morning from 9:00 am to 11:00 am U.S. Eastern time to discuss the blinatumomab data presented at the 14th Congress of the European Hematology Association. The webcast will be available on the company’s website at www.micromet-inc.com. To participate in the conference call, dial 866-543-6403 (U.S.) or 617-213-8896 (international), passcode: 12594792.

A replay of the call will be available from 1:00 pm Eastern Time on June 8, 2009 (7:00 pm Central European Time) through June 15, 2009. The replay number is 888-286-8010 (U.S.) or 617-801-6888 (international), passcode: 67386852.

 

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. Four 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.

In addition, Micromet has established a collaboration with Nycomed for the development and commercialization of 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. Nycomed has filed a clinical trial application and is expected to commence a phase 1 clinical trial of MT203 in the first half of 2009. 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 also 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.

Micromet’s preclinical product pipeline includes several novel BiTE antibodies generated with its proprietary BiTE antibody platform technology. BiTE antibodies targeting CEA, 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 blinatumomab and other 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.

 

CONTACT:
US Media, Andrea tenBroek or Chris Stamm, +1-781-684-0770, micromet@schwartz-pr.com; European Media, Ludger Wess, +49 (40) 8816 5964, ludger@akampion.com; US Investors, Susan Noonan, +1-212-966-3650, susan@sanoonan.com; European Investors, Ines-Regina Buth, +49 (30) 2363 2768, ines@akampion.com, all for Micromet, Inc.