West Coast Editor

The Sanofi-Aventis Group's decision to bail out of developing Phase II-stage Uvidem for melanoma leaves IDM Pharma Inc. with all rights to the compound, as the firm continues to explore strategic options under a plan disclosed in mid-December - but plans now also include a restructuring and staff reduction, to be finalized in the first quarter of this year.

IDM's stock (NASDAQ:IDMI) sank 15 cents on the latest news, closing Monday at 79 cents.

Paris-based Sanofi entered the potential €616 million (US$899 million) deal about six years ago, gaining first right of refusal on up to 20 drugs emerging during a 10-year period from IDM's immunotherapy platform. Uvidem was the first selected. (See BioWorld Today, Jan. 23, 2002.)

The drug has undergone three Phase II trials, but "probably didn't get the right amount of focus or leadership, because it seemed to be stagnating for a while," said Timothy Walbert, president and CEO of Irvine, Calif.-based IDM, adding that the product seemed to get lost in the summer 2004 merger of Sanofi-Synthelabo SA, of Paris, and Aventis SA, of Strasbourg, France.

"It's one of the stories you see in biotech often," Walbert said.

With Uvidem, dendritophages derived from the patient's blood cells are exposed to tumor cell antigens in IDM's production facility and then re-injected. The company provided more results in November from a Phase II trial showing the vaccine provided evidence of clinical benefit in nine of 33 patients, and duration of response ranged from 7.2 months to 29.7 months.

IDM plans to conclude the Uvidem collaboration within three months, as specified in the agreement with Sanofi, which owned about 7.9 percent of the firm's outstanding shares as of Sept. 30.

During a mid-December pipeline update, IDM said JMP Securities was enlisted to study strategic alternatives, as IDM works with European regulators and the FDA on approval of Junovan (mifamurtide, also known as L-MTP-E), the macrophage activator for osteosarcoma.

Gatekeepers overseas had questions about the marketing authorization request, and IDM said their decision is due late this month. In the U.S., the firm is working with external experts and advisors to gather patient follow-up data from the Phase III trial conducted by the Children's Oncology Group, and to respond to questions in the not approvable letter, so an amendment to the new drug application likely will not be finished until the second half of this year.

In May, the FDA's Oncology Drug Advisory Committee agreed with agency reviewers by a 12-2 vote that IDM had not shown a substantially effective profile with the drug. (See BioWorld Today, May 10, 2007.)

IDM provided more data in November from its Phase II trial in patients with non-small-cell lung cancer who were vaccinated with IDM-2101, compared to a parallel external control group of nonvaccinated patients. Updated one-year survival in patients treated with IDM-2101 topped out at 60 percent, compared to 49 percent in a group of 72 patients who were HLA-A2 negative but otherwise were comparable. Median survival for patients treated with the drug was 17.3 months compared to 12.0 months for patients in the comparator group.

The drug came to IDM by way of the 2005 merger with San Diego-based Epimmune Inc., and plans for the next clinical step are under way. (See BioWorld Today, March 17, 2005.)

Also in IDM's hopper: Bexidem, based on activated macrophages, which the company calls MAK cells, for Monocyte-derived Activated Killer cells, activated in the patient's white blood cells ex vivo, and re-injected. Bexidem is in Phase II/III development for bladder cancer.

IDM now owns rights to all of its candidates, an advantage when studying the possibility of a merger or acquisition, though all options are being studied, said Walbert, who joined the company at the end of May "after some of the company had taken some stumbles and brought in a new management team." Officials then "made the decision to re-evaluate the overall business, given the events over the last several years, he said.

At the third-quarter's end, IDM had about $33.1 million in cash and cash equivalents.