Pfizer on track to meet drug submission goals

Pfizer reaffirmed its 2004 earnings guidance Tuesday and said that it is on target for meeting its goal of submitting 20 new applications for drug approvals in the five-year period ending in 2006, as reported in CNN Money and other news sources. The drugmaker said it will have completed 12 of the 20 filings by the end of this year.

Among the drugs that Pfizer is taking into clinical testing is a combination drug containing Lipitor and torcetrapib. The drugmaker has begun recruiting patients for 40 Phase III studies of the drug, with one trial seeking to find out if the combination therapy prevents death from cardiovascular disease, as reported in IWon.

While Pfizer reaffirmed that it expects earnings per share of $2.12 to $2.14 for the year, it warned that results over the next two years would be hurt by patent expirations of more than six of its top-selling medicines, as reported in CNN Money. Although too early to forecast 2005 results, the drugmaker did indicate that its results would likely feel a hit from generic competition to the antifungal treatment Diflucan, epilepsy drug Neurontin, antibiotic Zithromax and Accupril, an antihypertensive. These drugs, in particular, collectively rake in annual sales of over $5 billion.

In 2006, Pfizer may lose US market exclusivity for its antidepressant Zoloft, and it sees patent expiry for its allergy drug Zyrtec and hypertension treatment Norvasc in 2007, CNN Money reports. These three drugs had combined sales in 2003 of nearly $9 billion.

"We have long understood that we are facing significant patent expirations in the 2005 [to 2007] period that will impact $14 billion of current Pfizer revenue," CEO Hank McKinnell is quoted as saying in a press release, as reported in Morningstar.

In separate news, according to a report from IMS Health, Celebrex sales decreased in October to $260.2 million from September sales of $266 million, reports CBS MarketWatch. However, following Vioxx's withdrawal at the end of September, Celebrex garnered 63.5 percent of the market for COX-2 inhibitors in October, compared with 48.7 percent of the market in September, as reported in Forbes.

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