A toothsome BiTE
August 2011
by Jeffrey Bouley  |  Email the author


ROCKVILLE, Md.—There are smiles to be had over BiTE antibodies for Micromet Inc. with the recent signing of a collaboration agreement with Amgen Inc. for research directed at using such antibodies against three undisclosed solid tumor targets. With the promise of some $14 million upfront and a maximum deal value of around $976.3 million, plus royalties and development cost reimbursement, the deal could mean as much as $1.01 billion for Micromet over the long run.
Under the terms of the agreement, Amgen will have the right to pursue development and commercialization based on Micromet's proprietary BiTE technology for as many as two of the three targets, to be selected by Amgen. For one of the programs, Micromet could receive roughly $480.2 million in clinical and commercial milestone payments if various goals in indications and tumor type are achieved, and Micromet would also be eligible to receive up to double-digit royalties on worldwide net sales.
For the second BiTE program, Micromet is eligible to receive an additional cash payment upon initiation of the program, as well as milestones, royalties and development funding that would be more or less comparable to the first program.
The initial development plan assumes about $35 million in funding of Micromet research and development activities if two BiTE antibodies are advanced to the (Investigational New Drug) IND stage. All expected costs associated with the research, development and commercialization of the BiTE antibodies will be borne by Amgen. Micromet will be primarily responsible for the discovery and preclinical development of the BiTE antibodies. Amgen will lead the clinical development, manufacturing and commercialization of any products resulting from the collaboration.
"The BiTE antibody provides an innovative approach to cancer therapy," said Dr. Roger M. Perlmutter, executive vice president of research and development at Amgen, in a press release about the deal, noting that the antibodies are designed to direct the body's cytotoxic, or cell- destroying, T cells against tumor cells.
Typically, antibodies cannot engage T cells because T cells lack the appropriate receptors for binding antibodies. BiTE antibodies reportedly can 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 shown evidence of the potential to serially eliminate tumor cells, which the companies say explains the activity of BiTE antibodies at very low concentrations. Through the killing process, T cells start to proliferate, which leads to an increased number of T cells at the site of attack.
Although Micromet declined to share any details about the origin of the relationship between the two companies nor the process of the deal coming together, Jennifer Neiman, director of corporate communications, tells ddn, "from a strategic standpoint, this deal enables us to gain entrée into additional large solid tumor indications with support from a partner while also generating substantial non-dilutive capital for the company."
This echoes the comments of Dr. Christian Itin, Micromet's president and CEO, in the news release about the deal, who called Amgen "an industry leader with a proven track record of success in oncology and biologics" and noted that this collaboration "aligns well with our strategy to expand development of BiTE antibodies into solid tumor indications."
Micromet has ongoing collaborations with a number of leading pharmaceutical and biotechnology companies other than Amgen, including Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, MedImmune, Merck Serono, Nycomed and Sanofi, and Neiman adds that "the growing number of partnered BiTEs is adding significant long-term value in future milestones and royalties with no investment required by Micromet. "
The company generated approximately $141.4 million in cash from 2006 to the first quarter of 2011 from corporate partnerships, she notes, including five BiTE antibody collaborations now in place, and points out that "Amgen has long been a leader in the development and marketing of antibodies, making them an ideal collaboration partner."
Amgen likewise had no further comment on the details of the deal itself or its genesis, but Kristen Davis of the company's corporate communications department notes that Amgen is keenly focused on developing innovative cancer therapies and adds that the BiTE antibody technology will explore new targets for treating solid tumors.
"BiTEs are an extension of antibody technology and are an excellent fit with Amgen's expertise," she adds.
Micromet focuses on antibody-based therapies for the treatment of cancer, and its product development pipeline includes novel antibodies generated with its BiTE technology as well as conventional monoclonal antibodies. The company's lead product candidate blinatumomab (MT103) is currently the subject of a pivotal European trial in patients with minimal residual disease positive acute lymphoblastic leukemia.
Code: E081101

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