Washington Editor

In an attempt to stop the bleeding, executives at Inex Pharmaceuticals Corp. laid off more than 100 people and set a new development course for Marqibo, the company's lead cancer drug that recently received a unanimous thumbs-down from an FDA review panel.

"We've been focused on completing our restructuring plan," David Main, Inex's president and CEO, said during a conference call, "as this is the critical first step in moving forward."

In addition to the layoffs, which will reduce its head count from 165 to 62 employees, the company plans to slow research efforts in other programs to lower overall expenditures to about C$1 million (US$808,695) per month next year, about 60 percent of its current burn rate. After a one-time C$5 million charge related to the restructuring, Inex will enter next year with about C$27 million in reserves, a figure believed to be sufficient to fund operations through the end of 2006.

The conservation should give the Vancouver, British Columbia-based company enough wiggle room to undertake a new pivotal trial of Marqibo as soon as possible, and to eventually reapply for FDA approval. Inex's action follows a vote taken earlier this month by the agency's Oncologic Drugs Advisory Committee, which said it would not support accelerated approval for Marqibo as a treatment for relapsed, aggressive non-Hodgkin's lymphoma (NHL).

The review panel said the company should have based its new drug application on a randomized Phase III study to prove the drug's merits compared to others used in the same indication, rather than the single-arm trial submitted as the basis for accelerated approval. (See BioWorld Today, Dec. 2, 2004.)

Main pointed out that the panel's conclusion sharply contrasted with FDA guidance the company previously received.

"The trial design was reviewed by the FDA, and they agreed in principle that it would be sufficient for consideration under the accelerated approval guidelines," he said. "This was viewed as a significant advantage, because it provided a path to approval using clinical data from a single-arm trial, which meant that Marqibo did not need to be compared with other drugs. At the time, this regulatory strategy provided Inex the shortest path to seeking approval, and we still feel confident that it was the right way to go."

A day before the panel meeting, the FDA expressed in briefing documents its concerns about the drug and the conduct of studies underlying the company's NDA. (See BioWorld Today, Dec. 1, 2004.)

Marqibo is made of an off-patent cancer drug, vincristine, encapsulated in Inex's sphingosomal drug delivery technology. It is partnered with Enzon Pharmaceuticals Inc., of Bridgewater, N.J., per terms of a deal signed earlier this year that could be worth about $75million for Inex. The agreement calls for both companies to share development costs associated with Marqibo's North American marketing approvals. (See BioWorld Today, Jan. 21, 2004.)

Main indicated that Enzon remains committed to the partnership, but added that Inex's $1 million monthly burn rate going forward would remain unchanged should Enzon opt out. The partners plan to work together to finalize plans for the new study early next year, after considering a complete review letter they expect to receive from the FDA by Jan. 15. They do not expect the drug to receive approval.

"So instead of introducing Marqibo to the marketplace in 2005," Main said, "we now assume that obtaining FDA approval will require conducting at least one additional clinical trial, and we're assuming that the best path will include a Phase III, randomized, comparative clinical trial."

He said the partners are not yet sure which drug will be compared to Marqibo. Inex began submitting a rolling NDA last fall for the drug, which it formerly called Onco TCS. (See BioWorld Today, Oct. 1, 2003.)

Marqibo is being evaluated in several Phase II trials. It's being tested as a combination therapy treatment for first-line NHL, in relapsed Hodgkin's disease, relapsed acute lymphoblastic leukemia, relapsed NHL in combination with Rituxan (rituximab, from Genentech Inc. and Biogen Idec Inc.) and relapsed NHL in combination with etoposide, a generic chemotherapy agent.

As the company moves forward with Marqibo's development, it is reducing its emphasis on earlier-stage programs in its pipeline. In the next quarter, Inex expects to make a decision on whether to proceed with a Phase I trial of INX-0125 (liposomal vinorelbine). In the same time frame, formulation studies for INX-0076 (liposomal topotecan) will be completed to determine its future. The company also said it would consider various strategic initiatives to extract value from its Targeted Immunotherapy pipeline.

The staff restructuring is impacting employees at all levels of the company. Among Inex's upper management, Pieter Cullis is resigning from his positions as senior vice president of research and chief scientific officer, though he will remain a director and continue to oversee a collaboration with the University of British Columbia. Jeff Charpentier is resigning as vice president of finance and chief financial officer and being replaced by Ian Mortimer, who is being promoted from senior director of investor relations. Shelley McCloskey is resigning as vice president of human resources and information services.

Four executives remain on board. On Tuesday, Inex's stock (TSE:IEX) gained C1 cent to close at C70 cents.

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