Wyeth settles suit, will give FDA bone-drug info

NEW YORK (Reuters) - U.S. drugmaker Wyeth on Thursday said it tentatively settled a class-action lawsuit attempting to block its merger with Pfizer and would provide the FDA information needed to gain approval of its long-delayed osteoporosis drug.

Wyeth said in a Securities and Exchange Commission filing that it and Pfizer had tentatively settled an action filed in the Delaware Court of Chancery.

But the filing did not describe the status of separate class-action suits filed in federal and state courts in New Jersey, which also sought to block the proposed merger.

Wyeth said it and Pfizer entered a memorandum of understanding with plaintiffs in the Delaware case on June 10 that obliges the companies to provide certain disclosures related to their deal. Should the settlement be approved, the Delaware action will be dismissed, according to Wyeth. It said the proposed deal was offered to avoid delaying the merger and to minimize the expense of litigation.

Also in a SEC filing, Wyeth said it would provide the U.S. Food and Drug Administration later this year with requested information about its osteoporosis drug, Viviant.

The FDA had declined to approve Viviant, saying it first needed analyses concerning the incidence of stroke and serious blood clots associated with the drug.

The FDA told Wyeth it would convene an advisory panel to review the medicine, the drug company said in the filing.

"We expect that the FDA-requested advisory committee meeting will be scheduled following submission of our complete response" to the FDA, Wyeth said.

Wyeth, which is slated to be acquired by Pfizer Inc this year, also said that it now expects to seek approval of a related osteoporosis drug called Aprela no sooner than the first half of 2010.

Before submitting the marketing application, Wyeth said it needed to complete additional work on Aprela, including its proposed commercial formulation of the drug. The drug combines the active ingredient of Viviant, called bazedoxifene, with estrogen.

(Reporting by Ransdell Pierson, editing by Leslie Gevirtz)