West Coast Editor

In the wake of a not-approvable letter and the loss of its partner for the targeted chemotherapy drug Marqibo, Inex Pharmaceuticals Corp. is trimming its work force again - this time from 57 to 22 employees, thus dropping monthly expenditures to less than $1 million and leaving the firm with about $16 million in cash, enough to last into the second half of next year.

The firm also is naming a new president and chief operating officer, Timothy Ruane, effective immediately. David Main, appointed president and CEO in July 1999, is leaving the company, along with Tom MacRury, senior vice president of technical operations, and Alexandra Mancini, senior vice president of clinical and regulatory affairs.

A spokeswoman for Vancouver, British Columbia-based Inex said company officials were busy meeting with employees Tuesday and could not be reached for comment.

This spring, two months after Marqibo was hit by a not-approvable letter on a unanimous thumbs-down vote by the FDA's Oncologic Drugs Advisory Committee, partner Enzon Pharmaceuticals Inc., of Bridgewater, N.J., pulled out of the January 2004 marketing deal. (See BioWorld Today, March 18, 2005.)

Developed from the off-patent cancer drug vincristine and encapsulated in Inex's sphingosomal drug delivery technology, Marqibo is designed to provide prolonged blood circulation, tumor accumulation and extended drug release at the cancer site.

In rejecting the new drug application for the compound, the FDA panel said the submission should have been based on results from a randomized, comparative Phase III study of Marqibo vs. other chemotherapy regimens, rather than on data from a single-arm Phase II trial. Two weeks after the panel's vote, Inex cut nearly two-thirds of its employees - 103 of 165 - and decided to slow other research efforts, reducing expenses by 40 percent. (See BioWorld Today, Dec. 15, 2004, and Jan. 20, 2005.)

The most recent round of cutbacks is the second shoe to drop, but Marqibo remains alive. Inex has reached agreement, in principle, with the FDA on a path to approval for first-line non-Hodgkin's lymphoma and first-line acute lymphoblastic leukemia based on Phase III trial designs that will use complete response rate as the primary endpoint, though the firm will not file a special protocol assessment until it gets a new partner for the compound.

Also in the area of targeted chemotherapy, Inex has been cleared by the FDA to start clinical trials of INX-0125 (sphingosomal vinorelbine) but, here again, the company plans to conserve cash and seek a partner or licensee to take the drug into Phase I. A third targeted chemotherapy product, INX-0076 (sphingosomal topotecan), also awaits partnering for clinical trials.

Ruane, new president and chief operating officer, joined Inex as senior vice president of corporate development late last year after his previous employer, San Antonio-based ILEX Oncology Inc., was bought by Genzyme Corp., of Cambridge, Mass., for $1 billion. (See BioWorld Today, March 1, 2004.)

In targeted immunotherapy, Inex has the monoclonal antibody INX-0167 at the early stage of development.

Inex's stock (TSE:IEX) closed Tuesday at C36 cents (US$0.29), down C3 cents.

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