Tucked inside this morning’s earnings announcement is another disappointment: the forthcoming Pristiq antidepressant, which has been delayed due to ongoing compliance problems at Wyeth’s Puerto Rico manufacturing plant, won’t be approved for several months.

There’s more below, but let’s get the earnings out of the way: the drugmaker says first-quarter profit rose 12 percent, thanks to higher sales and higher interest income. Net income was $1.25 billion, or 92 cents, from $1.12 billion, or 82 cents.

Revenue increased 11 percent to $5.4 billion from $4.8 billion. Analysts surveyed by Thomson Financial forecast a quarterly profit of 87 cents and sales of $5.2 billion. As individual products go, Wyeth’s biggest seller, the Effexor depression pill, fell 6 percent to $891 million. Conversely, sales of the Prevnar vaccine jumped 43 percent to $617 million.

As for Pristiq, a study for vasomotor symptoms, or hot flushes, involving 50, 100 and 150 mg doses was submitted to the FDA, which told the company its extending the review period from April until July to look at the data. Wyeth claims the study found a ’substantial’ decrease in nausea and discontinuation side effects seen in earlier studies.

The depression indication is delayed until early 2008. Wyeth is reviewing study results of low-dose studies: data replicating efficacy at the 100 mg dose and demonstrating efficacy at the 50 mg dose in two separate studies. The company maintains low-dose studies showed fewer side effects due to discontinuation and improvement in rates of nausea and overall tolerability.

Wyeth is analyzing the data and plans to finish by late summer and include results in its complete response to the FDA approvable letter. The drugmaker expects the FDA will extend its review for the depression indication by six months from whenever the response is completed, including the low-dose data.

Meanwhile, the Viviant osteoporosis now won’t get an FDA decision until later this year. And earlier this month, Wyeth disclosed an unexpected delay until this summer of the Torisel cancer drug.

Says Barbara Ryan of Deutsche Bank: “The company’s late-stage pipeline has been a disappointment, in our view, with the Pristiq depression NDA PDUFA delayed to 1Q ‘08. Six new drugs have either been filed or will be by the end of ‘07, which in our estimation, do not have the combined commercial potential to replenish revenue streams that will be lost at the end of the decade.”

Updates will be provided.

Associated Press;
Wyeth earnings statement.[tags]Pristiq, Wyeth[/tags]