EVENTS | VIEW CALENDAR
Taking a BiTE out of multiple myeloma
INGELHEIM, GermanyŚBoehringer Ingelheim (BI) and Bethesda, Md.-based biopharmaceutical Micromet Inc. have joined forces for the research, development and commercialization of a new BiTE antibody for the treatment of multiple myeloma, a blood cancer disease that is largely incurable.
In the United States, Micromet and BI will jointly co- promote the BiTE antibody with commercial terms commensurate with a profit split, according to the joint company announcement on May 5.
Micromet will be responsible for discovery of the BiTE antibody and will jointly conduct with BI further preclinical studies, while BI will be responsible for all manufacturing activities, clinical development and worldwide commercialization subject to Micromet's co-promotion right in the United States.
Micromet will bear the costs up to a pre- defined amount for its preclinical activities.
During commercialization, Micromet will solely bear the costs for its sales force in the United States. All other costs for research, development, manufacturing and commercialization of the BiTE antibody will be borne by BI.
Under the terms of the agreement, BI will pay Micromet an upfront cash payment of approximately $6.6 million. Micromet is eligible to receive development and regulatory milestone payments of up to approximately $66 million and tiered low double-digit royalties on product sales outside the United States.
Wolfgang Rettig, head of corporate research at BI, says the company recognizes the advantage of combining Micromet's BiTE antibody platform with BI's target identification and development expertise. Kate O'Connor, executive director of public relations at BI's Ridgefield, Conn. facility, says the companies have a "long-standing relationship" on a senior management level.
"The respective projects that resulted in the collaboration represent a perfect fit of BI's interest in developing innovative approaches to target specific biologically relevant structures in the area of multiple myeloma and BI's expertise in the central nervous system research field."
Myeloma is a tumor involving specialized white blood cells in the bone marrow. The cells that are affected are plasma cells, which are our antibody-producing cells. The disease myeloma is called "multiple" since there frequently are multiple patches or areas in bone where tumors or lesions have developed.
The commercial opportunity for treatments for multiple myeloma is reflected in the growing numbers of mostly elderly adults worldwide inflicted with the disease. The American Cancer Society estimates that about 20,580 new cases of multiple myeloma were diagnosed during 2009 in the United States, where the lifetime risk of getting multiple myeloma is one in 161. More than 14,000 new cases a year are expected in the United States alone.
Despite recent advances in the treatment of multiple myeloma, the disease remains largely incurable, O'Connor says. While the majority of patients initially respond to treatment, almost all will eventually relapse. The five-year relative survival rate for multiple myeloma is around 35 percent.
BI and Micromet believe BiTE antibodies will help more individuals survive longer since the antibodies are designed to direct the body's cytotoxic, or cell-destroying, T cells against tumor cells, thus representing a new and more powerful therapeutic approach to cancer therapy.
Jennifer Neiman, Micromet's director of corporate communications, says that typically, antibodies cannot engage T cells because T cells lack the appropriate receptors for binding antibodies. However, BiTE antibodies have been shown to bind T cells to tumor cells, ultimately inducing a self-destruction process in the tumor cells referred to as apoptosis or programmed cell death. In the presence of BiTE antibodies, T cells have been demonstrated to serially eliminate tumor cells, which explains the need for BiTE antibodies at very low concentrations, Neiman explains.
The BiTE antibodies actually represent a new class of antibodies that activate the T cells of a patient's immune system to eliminate cancer cells, she said. T cells are considered the most powerful '"killer cells'" of the human immune system.
"We believe that treating multiple myeloma represents a potentially meaningful future revenue stream for the company," Neiman says. "Based on our understanding of the target for this BiTE antibody, we believe that it has the potential to offer an improvement over existing treatment options."
Christian Itin, Micromet's president and CEO, says he is "very pleased to collaborate with Boehringer Ingelheim, an industry leader with a proven track record of successful partnerships."
In line with the strategic importance of hemato- oncology for Micromet, "we have retained U.S. co-promotion rights for this product candidate consistent with our goal of building a commercial hematology franchise in the United States," Itin says.
The deal with BI was timely. In announcing Micromet's financial results for the first quarter ending March 31, 2010, Itin said: "With the proceeds from our recent financing, we are well-positioned to conduct the planned European pivotal study of blinatumomab in patients with acute lymphoblastic leukemia and other studies intended to support its use as a key component of the standard of care in this indication."
"Our new collaboration with Boehringer Ingelheim is an important step toward our goal to develop a hemato-oncology franchise, with now three BiTE antibodies in research and development that have the potential to address the majority of hematological cancers," he now adds.