Investors left guessing on fate of new drugs in U.S.

WASHINGTON (Reuters) - Drugmakers and investors can no longer count on U.S. deadlines to see if a new medicine will enter the world's most lucrative pharmaceutical market.

U.S. regulators missed the once-predictable targets for at least eight new drugs this year. A handful won approval days or weeks later, but others remain pending with no apparent timetable.

"It's pretty difficult to know when the (Food and Drug Administration) is going to act. We've never seen anything like this," said Eric Schmidt, a biotech analyst with Cowen and Co.

With companies saying little while a drug is under review, "that period of uncertainty is just prolonged," he said.

The most notable drug left hanging is prasugrel, a new blood-thinner and potential blockbuster from Eli Lilly (LLY.N) and Daiichi Sankyo (4568.T). A decision was due September 26.

FDA officials partly blame a staff shortage for slowing reviews and say they expect the situation to improve once a wave of new hires is fully trained.

To drugmakers and industry analysts, the agency has grown unpredictable in general, and the missed dates add uncertainty about if and when a drug will reach the market.

Many executives complain the FDA has become too focused on drug side effects, making it tougher to win approval at any point in the process. That atmosphere also may contribute to longer reviews, analysts said.

A delay of even a few months beyond the usual six- or 10-month review time can cost companies millions of dollars.

"From the industry standpoint, it's a terrible situation. These companies are waiting to launch their product. Their patent life is ticking away," said Caris & Co pharmaceutical analyst David Moskowitz.

The decision dates are goals the FDA agreed to meet in exchange for collecting annual fees from drugmakers, not hard deadlines. The money helps fund extra staff to speed reviews and bring new medicines to patients quicker.

The agency met the targets like clockwork for years. FDA officials, however, warned of a growing workload and asked drugmakers to pay nearly $393 million in fiscal 2008, up $87 million from the previous year.

DELAYS VARY

Some drugs won approval this year after just a short delay, according to information compiled by Reuters from FDA documents and company statements. [ID:nN16326602]

Amgen's blood-disorder drug Nplate was cleared in August, about a month later than expected. And UCB SA's (UCB.BR) Crohn's disease drug Cimzia won approval in April, about three weeks after its deadline.

Others, in addition to prasugrel, remain in limbo, according to drugmakers. Telavancin, an antibiotic from Theravance Inc (THRX.O), was due for a ruling on July 21. The deadline for GlaxoSmithKline PLC's (GSK.L) bleeding disorder drug Promacta was September 19.

"There's some disappointment because this has really been the first year that we have seen significant deviation from performance goals," said Alan Goldhammer, a deputy vice president for the Pharmaceutical Research and Manufacturers of America, an industry group.

The FDA does not disclose the review dates prior to a product's approval, but companies often reveal them.

The agency misses the dates for various reasons, FDA spokesman Christopher DiFrancesco said. They include insufficient staff, competing priorities, or the need to complete manufacturing inspections.

Officials also are adjusting to new powers from Congress that require post-approval monitoring plans for some drugs.

More than one issue may apply to a drug, DiFrancesco said.

FDA officials take the review goals "very seriously, and work to meet them whenever we can," he said, adding he did not have a tally of how many approval dates were missed this year.

The agency agreed to meet 90 percent of the dates and other goals such as meetings with companies. The FDA met between 80 percent and 90 percent of the goals in fiscal 2007. The rates for fiscal 2008, which ended September 30, "will likely be somewhat lower" when they are calculated, DiFrancesco said.

The agency recently hired about 200 new drug-review staff. Once the FDA's drug division "is fully staffed and after the new employees are trained and become fully productive, we anticipate that we will make 100 percent" of the goals, DiFrancesco said.

For investors, the missed deadlines make it hard to gauge a drug's prospects. The fact that a date is missed is not necessarily a good or bad sign, JP Morgan analyst Ipsita Smolinski said.

"I don't think you can really read much into it. You're going to have to wait and see," she said.

(Reporting by Lisa Richwine; Editing by Tim Dobbyn)