BioWorld Today Contributing Writer

Amgen Inc. has joined a long list of pharma companies eager to capitalize on Micromet's BiTE antibody platform, which showed unusual promise in recent Phase II studies. The agreement tallies up to $976 million including an up-front payment of €10 million (US$14 million), plus milestones, royalties and development funding.

At nearly $1 billion, it's the largest preclinical deal in 2011, but $14 million up front is on par with others during the first half of the year, according to BioWorld Today's analysis.

In exchange, Micromet will provide discovery and preclinical development of BiTE antibodies against three solid tumor targets. Amgen will take over costs for development and commercialization of antibodies advanced to the investigational new drug application stage.

Micromet stock (NASDAQ:MITI) gained 7.3 percent, or 42 cents, to close at $6.18 on Monday, reflecting investor appreciation of the near-billion-dollar deal.

"The terms we've achieved here exceed industry norms," Micromet spokeswoman Jennifer Neiman told BioWorld Today. "It speaks to the interest in our technology and an appreciation of its potential application in the treatment of solid tumors."

Some comparable recent deals include Epizyme Inc. and GlaxoSmithKline plc's January multitarget deal for $20 million up front, $630 total, and a six-target deal between Avila Therapeutics Inc. and Sanofi in December 2010 for $40 million up front, $770 million total. (See BioWorld Today, Dec. 21, 2010, Jan. 11, 2011, and July 8, 2011.)

Micromet's $976 million deal total tops those deals (although the up-front payment is on the lower end), as well as the company's own previous BiTE technology deals.

Micromet received $6.6 million up front from German drugmaker Boehringer Ingelheim to develop and commercialize a new BiTE antibody for multiple myeloma, with a potential deal total of $66 million. (See BioWorld Today, May 6, 2010.)

In December 2009, Bayer Schering Pharma AG exercised an option to develop a preclinical BiTE antibody for cancer, locking in a $7.5 million fee, with a potential for $426 in future milestones. Bayer originally paid $6 million for the option. (See BioWorld Today, Dec. 2, 2009.)

Earlier in 2009, Micromet shook hands with Sanofi for $11.9 million up front and potential milestones up to €312 million. (See BioWorld Today, July 31, 2009.)

All of those numbers add up to a promising upward trend in Micromet's history, and within the biotech industry.

Micromet's BiTE antibody technology is a new class of drugs that are "mobilized T cells," according to Neiman. BiTE antibodies enable the T cells to detect and destroy normally unrecognizable cancer cells by binding with one arm to cell surface protein CD3.

The other arm of the antibody binds to the tumor target of interest. Micromet will develop BiTE antibodies against three different solid tumor targets brought forward by Amgen.

The Amgen deal marks Micromet's fifth large partnership. The company already had relationships with Sanofi, Boehringer Ingelheim, Bayer Schering Pharma and Astrazeneca plc, through Medimmune LLC.

According to Micromet, two factors are driving partnering interest. First, its most advanced product, blinatumomab, showed a high level of activity in a Phase I trial in patients with relapsed/refractory non-Hodgkin's lymphoma, a Phase II trial in patients with front-line acute lymphoblastic leukemia (ALL) at high risk of relapse, and more recently a Phase II trial in patients with refractory acute lymphocytic leukemia.

ALL is a typically aggressive blood cancer, and the 12 patients in the trial had a refractory form of the disease with a very poor prognosis. Interim data from the study showed that 75 percent of the patients (nine out of 12) achieved a complete remission (CR) or CR with partial recovery of blood counts (Crh). Those patients had a complete molecular response with no trace of leukemic cells in the bone marrow.

A smaller group of four within the trial had genetic abnormalities typically associated with poorer outcomes, and they all achieved CR or Crh. The interim results were presented at the European Hematology Association meeting in London in June.

"I think the compelling clinical activity that has been demonstrated to date with blinatumomab has certainly garnered interest among a number of leading biopharma companies," Neiman said.

Second, Micromet's BiTE antibodies and similar next-generation antibodies represent a potential way of plugging looming revenue leaks due to patent expirations. Moving into biologics, either through internal research and development or acquisition, is a way to replace that lost revenue.

Antibodies have been some of the biggest successes in biologicals in recent years. Herceptin and Avastin have established without a doubt that antibodies can become highly successful.

"What technologies like ours offer is potential to improve potency of marketed monoclonal antibodies, which is why we now have five large biopharmaceutical companies that have engaged Micromet to develop BiTE antibodies across a range of different cancer types," Neiman explained.

Joseph Pantginis, of Roth Capital Partners, commented on Micromet's sizable deal. "The latest deal with Amgen continues to be a testament, in our belief, to the potential of the BiTE platform, evidenced by the strong financial terms for drug candidates, which currently do not even exist yet."

Roth rated MITI as Buy with a price target of $11.