FDA's inspection of Wyeth's Guayama, Puerto Rico, manufacturing facility, currently underway, is going to take at least "several more weeks" to complete, Chief Financial Officer Kenneth Martin announced Feb. 28 in a conference call alerting investors.

"The situation right now is that the inspection has been conducted by a single inspector, so rather than a typical situation, where you might expect two to three inspectors for two to three weeks, obviously, it's going to take longer," Martin said.

The evaluation includes an inspection of Wyeth's pharmaceutical facility, as well as its consumer facility at the same site and other product specific pre-approval inspections (PAIs), he noted.

"So this is a complex inspection. It's a complex facility. There are several PAIs to deal with, and as a result, we can't predict when it will be completed, but it is most certainly going to be several more weeks," Martin said.

Wyeth had announced in January that the agency had begun the process of inspecting the site, which was the topic of a warning letter citing the facility for current Good Manufacturing Practices deficiencies last May (¹ Also see "Wyeth’s Pristiq Best-Case Launch Scenario Targets Menopause Market" - Pink Sheet, 30 January, 2007.).

Securing FDA's approval of the facility is critical for Wyeth, which has several drug approvals pending for products that would be manufactured at the site. Wyeth received an "approvable" letter for its serotonin-norepinephrine reuptake inhibitor Pristiq (desvenlafaxine) for major depressive disorder in January based on the outstanding issues at Guayama (² Also see "Wyeth’s Pristiq Deemed “Approvable” By FDA" - Pink Sheet, 23 January, 2007.).

The company also has applications pending at FDA for the osteoporosis agent Viviant (bazedoxifene), the extended cycle contraceptive Lybrel (levonorgrestrel/ethinyl estradiol), bifeprunox for schizophrenia and Torisel (temsirolimus) for renal cell carcinoma. Torisel, however, as an injectable product, will not be manufactured at the Guayama facility, and will be the subject of a separate pre-approval inspection, Wyeth noted.

"We know everyone's concern is that the issues in Puerto Rico will impact timing of new product launches," Martin said. "It's our impression that the FDA is aware of our action dates, and that they don't want to hold up products if our plants meet their [good manufacturing practice] requirements."

Pending a positive outcome of the evaluation, he assured analysts, "It's not going to hold up the ultimate launch of the products."

"Whether it finishes in the first week of March or the first week in April or the middle of April, it doesn't matter," he said.

Wyeth also reiterated previously projected earnings per share guidance for the year of $3.40 to $3.50 after rebalancing its business plan to consider several factors, including lower than projected revenue on Inderal LA (propranolol) after Par's generic version was approved in January.

- Jessica Merrill (j.merrill@elsevier.com)

Wyeth Guayama Inspection Will Take Longer Than Anticipated

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