Washington Editor

Micromet Inc. stands to gain more than $72 million under a global agreement with German drugmaker Boehringer Ingelheim to research, develop and commercialize a new BiTE antibody to treat multiple myeloma.

Bethesda, Md.-based Micromet, which has retained U.S. co-promotional rights for the product candidate, will receive €5 million (US$6.6 million) cash up front, and could bank an additional $66 million.

The firm is eligible to receive a royalty comparable to profit split on the U.S. product sales and low double-digit royalties on ex-U.S. sales.

While the deal was good news for Micromet's bottom line, shares of the company slumped 7 percent Wednesday, likely due to the firm also reporting a loss of $16.3 million, or 23 cents per share, compared with a loss of $332,000 a year ago. Micromet's first-quarter earnings report also showed a revenue drop of 16 percent to $6.3 million from $7.5 million a year ago.

Shares of Micromet (NASDAQ:MITI) closed at $6.73, a loss of 51 cents.

Nonetheless, analysts noted that the company ended the quarter financially strong, with nearly $190 million in cash and equivalents, which Micromet CEO Christian Itin said was sufficient funding to carry the firm into late 2012.

He pointed to the $75.4 million Micromet raised in a March stock offering as providing the "necessary resources for future advance and expand our BiTE antibody development programs."

The deal with Ingelheim, Germany-based Boehringer, Itin told BioWorld Today, is "in line with our strategy to build a hematology franchise with BiTE antibodies in the U.S."

The collaboration's antibody, for which the companies have not disclosed the particular target in treating multiple myeloma, brings the number of BiTE antibodies Micromet is pursuing to three, he said.

Micromet is poised to start a Phase II pivotal registration study in Europe with its lead BiTE antibody blinatumomab (MT103) in adults with minimal residual disease (MRD) acute lymphoblastic leukemia (ALL), Itin said.

"We are moving with a sense of urgency to prepare for the study start in the third quarter of this year, and are now in the process of site selection, training the study staff, filing of the study with health authorities and IRB submissions," he told investors and analysts Wednesday during a conference call.

Key endpoints of the blinatumomab registration study include MRD activity and relapse survival rate, Itin explained. He noted that the registration trial plans to enroll about 130 patients.

"We view the initiation of this trial to be an important milestone in the development of blinatumomab, and a potential important driver of the company's future growth," he said.

While the study is intended to be used for blinatumomab's European application, "the data will be used obviously in the U.S." also, Itin said.

He noted that the BiTE antibody in the Boehringer deal is in "early discovery stages."

The BiTE antibody approach, with its demonstrated activity in blood, bone marrow and lymphatic tissue, "offers the potential for a differentiated product profile in multiple myeloma that will enable us to overcome some of the limitations of current therapies," Itin said.

While drugs like Millennium Pharmaceuticals Inc.'s Velcade (bortezomib) and Celgene Corp.'s Revlimid (lenalidomide) have improved response rates in patients with multiple myeloma, the disease "remains largely incurable and most patients will eventually die of the disease," he noted.

"Based on our understanding of the target for this BiTE antibody, we believe that it has the potential to offer improvement over existing treatment options, and therefore represents a potentially meaningful future royalty stream and revenue stream for the company," Itin said.

BiTE antibodies have been shown to bind T cells to tumor cells, ultimately inducing programmed cell death, according to Micromet.

Under the Boehringer deal, Micromet will be responsible for generating the BiTE antibody, while the firms will collaborate on preclinical development. Boehringer will be responsible for the worldwide clinical development of a product candidate and commercializing the BiTE antibody outside the U.S., Itin said.

As for the allocation of R&D and commercialization costs, Boehringer will be responsible for all costs of the program, except for costs related to Micromet's own initial preclinical activities "up to a specified amount and the cost of our own sales force used to co-promote the product in the U.S.," Itin pointed out.

During Wednesday's conference call, he also noted that Micromet recently achieved its first milestone under its partnership with Bayer Schering Pharma AG of reaching preclinical proof of concept for a BiTE antibody under investigation to treat solid tumors.

Analysts Wednesday noted that next up for Micromet is the release of updated Phase I data in June at the annual meeting of the American Society of Clinical Oncology in Chicago for MT110 in patients with advanced heavily pretreated coloric gastric and lung cancer.

"This will be an interim update and a phase of the trial where we continue to escalate the dose and explore the dosing schedule," Itin explained.

He noted that a further update on the Phase I trial for MT110, a recombinant bispecific single-chain antibody generated using Micromet's proprietary BiTE antibody technology, is planned in the fourth quarter.

The company also plans to report updated data in June in Barcelona, Spain, at the annual meeting of the European Hematology Association from ongoing studies of blinatumomab in patients with MRD positive ALL and non-Hodgkin's lymphoma, Itin said.