Praecis Pharmaceuticals Inc. continues to expect regulatory approval for Plenaxis despite an FDA decision to delay action on the new drug application by three months.

The agency recently informed the Waltham, Mass.-based company that instead of acting on the Plenaxis submission on Aug. 27, it would postpone the matter by 90 days. Praecis said the extension would allow the FDA to finalize its review of recently requested data, and also provide both parties time to finalize a risk-management program for Plenaxis.

"We're encouraged by our phone call as to the approvability of Plenaxis, and we expect it to be available to patients in the first quarter [of 2004]," Kevin McLaughlin, the company's chief financial officer, told BioWorld Today.

The application is a resubmission of a prior NDA that the agency originally rejected two years ago. The original submission was based on use of the drug in a broad patient population. At the time, the product was partnered with Amgen Inc., though the Thousand Oaks, Calif.-based company eventually exited the project. (See BioWorld Today, June 13, 2001, and Sept. 20, 2001.)

The company, which said its proposed risk-management program would need to include some form of controlled or managed distribution, plans to work with the FDA to iron out such modifications. McLaughlin declined to elaborate on specifics related to discussions with the FDA, but based on talks between both parties Friday, Praecis said Plenaxis is expected to be approved for a defined subpopulation of advanced prostate cancer patients by the end of November and available in the first quarter of next year.

"My estimate at this point is that our particular safety management program would be more focused at the level of physicians in ensuring that they are well aware of the label and the benefits and side effects of Plenaxis," William Heiden, the company's president and chief operating officer, said during a conference call. "We feel encouraged by the discussions with the FDA. The fact that we're talking about a risk-management plan is very encouraging at this phase."

A gonadotropin-releasing hormone antagonist, Plenaxis can be administered in a one-month, sustained-release formulation. Phase III trials showed that it could quickly reduce testosterone levels while avoiding the initial testosterone surge characteristic of leutinizing hormone-releasing hormone agonists, Praecis said.

The company, which also reported a three-month net loss of about $15.6 million for the period ended June 30, said its commercialization plans are coming together in advance of the expected regulatory ruling. As a result, hiring plans are laid out at Praecis, which expects to sell the drug in the U.S. through an internally developed sales force.

McLaughlin said that while the company does not plan to hire additional personnel before any FDA action, it has interviewed sales and marketing candidates and developed strategies for pushing the product's profile. Though Praecis expects to move forward on its own in the U.S., it plans to partner Plenaxis marketing rights in Japan and Europe, where last month it submitted the drug for approval to treat the broad population of hormonally responsive prostate cancer patients.

But because of the delayed regulatory action in the U.S., the company said it expects to burn about $65 million for the full year, $10 million less than previous guidance.

In its quarterly report, Praecis indicated that Plenaxis-related costs continued to grow as a result of such pre-commercialization spending, though such expenses are slightly offset by reductions in slowed research and development of the drug. The company reported no revenue for the quarter, a figure countered by its cash, cash equivalent and marketable securities holdings of about $166.8 million through June 30. Praecis said it would end the year with about $130 million in reserve.

In August, Praecis agreed to pay Amgen $13 million in a final settlement of all amounts payable under their terminated collaboration, initially signed more than four years ago and valued at up to $100 million. (See BioWorld Today, March 10, 1999.)

Beyond Plenaxis, development continues for Apan, its Alzheimer's disease drug candidate that entered a Phase Ib study last month. The dose-escalation trial is designed to test a single dose of Apan in Alzheimer's patients in order to determine its maximum tolerated dose.

Deeper in its pipeline, Praecis recently submitted an investigational new drug application for PPI-2458, its candidate for non-Hodgkin's lymphoma. The company said it expects to begin a Phase I trial of the compound during the second half of this year.

"Plenaxis is extraordinarily important, but we have two other drugs important to us as well," McLaughlin said. "We're excited about the overall product portfolio at Praecis at this time."

Praecis' stock (NASDAQ:PRCS) fell 41 cents Monday to close at $4.65.