Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, today announced its financial results for the fourth quarter and full year ended December 31, 2009. The Company also highlighted recent pipeline progress and outlined expected 2010 milestones.
"With our lead product candidate blinatumomab expected to begin a European pivotal trial in mid-2010, a clinically validated next-generation antibody platform, and global rights to our two most advanced BiTE antibodies, we believe Micromet is in a strong position to continue to build value for all of our stakeholders in 2010 and beyond," said Christian Itin, Ph.D., Micromet's President and Chief Executive Officer. "We are on track to initiate two additional clinical trials later this year that will enable us to evaluate blinatumomab's utility in leukemia sub-types with high unmet medical need."
Fourth Quarter and Recent Pipeline Highlights:
- Reported results from a Phase 2 trial of blinatumomab in acute lymphoblastic leukemia (ALL) - At the December 2009 American Society of Hematology (ASH) Annual Meeting, the Company announced the presentation of data from a Phase 2 trial of blinatumomab in patients with ALL. 80 percent of evaluable patients (16 of 20) achieved MRD-negativity, the primary endpoint of the trial, all within the first treatment cycle. These data were selected by the American Society of Hematology for inclusion in the 2009 "Best of ASH."
- Reported interim results from a Phase 1 trial of blinatumomab in patients with B-cell non-Hodgkin's lymphoma (NHL) - At the December 2009 ASH Annual Meeting, the Company announced the presentation of interim data from its ongoing Phase 1 trial of blinatumomab in patients with relapsed/refractory NHL. At the therapeutic dose level (60 micrograms), 100 percent of evaluable patients (12 of 12) had an objective partial or complete response after their first four to eight weeks of treatment.
- Announced plans to expand clinical development of blinatumomab in leukemia - At its R&D Day in February, the Company announced its intent to initiate three blinatumomab trials in 2010, including a European pivotal trial in MRD-positive adult ALL, a Phase 2 trial in relapsed/refractory adult ALL and a Phase 2 trial in relapsed/refractory adult chronic lymphocytic leukemia. In addition, the Company expects to discuss its regulatory strategy for blinatumomab in pediatric ALL with the FDA and EMEA during the course of 2010. The Company has been working with the leading study groups for the treatment of ALL to plan and conduct the respective studies.
Fourth Quarter Corporate Highlights:
- Signed a global collaboration agreement with sanofi-aventis for a new BiTE antibody - In October, the Company announced that it had entered into a global collaboration and license agreement with sanofi-aventis to develop a new solid tumor BiTE antibody against an undisclosed target. Under the terms of the agreement, the Company has received an upfront payment of euro 8 million, and is eligible to receive additional payments of up to euro 312 million based on the successful achievement of future regulatory and sales milestones as well as up to a low double-digit royalty on worldwide product sales.
- Re-gained control of global commercial rights to blinatumomab - In November, the Company announced that it had acquired MedImmune's remaining North American commercial rights related to blinatumomab and had terminated the collaboration agreement signed in 2003.
- Entered into agreement with Lonza for the manufacture of blinatumomab - In November, the Company announced that it had entered into an agreement with Lonza AG for the process development and manufacture of blinatumomab. Under the terms of the agreement, Lonza will manufacture blinatumomab for clinical trials, develop the commercial scale process and supply blinatumomab for commercial sale, if regulatory approval is obtained and if so requested by Micromet.
- Initiated collaboration with Bayer Schering Pharma for a new BiTE antibody - In December, the Company announced that Bayer Schering Pharma had exercised its option to develop and commercialize a solid tumor BiTE antibody under an option, collaboration and license agreement entered into in January 2009. Under the terms of the agreement, the Company has received an option fee of euro 4.5 million and an option exercise fee of euro 5 million. In addition, Micromet is eligible to receive additional milestone payments of up to euro 285 million as well as up to double-digit royalties on net sales.
2010 Milestones:
During 2010, the Company intends to:
- Initiate a European pivotal clinical trial of blinatumomab in patients with MRD-positive adult ALL
- Initiate a phase 2 clinical trial of blinatumomab in patients with relapsed/refractory adult ALL
- Initiate a phase 2 clinical trial of blinatumomab in patients with chronic lymphocytic leukemia
- Discuss the regulatory strategy for blinatumomab in adult ALL with the FDA
- Discuss the regulatory strategy for blinatumomab in pediatric ALL with the FDA and EMEA
- Expand the safety and efficacy experience of blinatumomab in patients with relapsed/refractory non-Hodgkin's lymphoma
- Continue enrollment in an ongoing phase 1 clinical trial of MT110 in patients with solid tumors
- Present new data on the Company's pre-clinical BiTE antibodies
- Present updated results from phase 1 and phase 2 clinical trials of blinatumomab in patients with NHL and ALL at an upcoming medical meeting
- Present updated results from a phase 1 clinical trial of MT110 in patients with solid tumors at an upcoming medical meeting
Fourth Quarter Reported Results