San Diego Business Journal Corvas Waits for News From FDA on Status of Blood Clot Treatment

Carlsbad-based biotechnology firm Invitrogen Corp. posted higher than expected second-quarter earnings.

Invitrogen, which sells research kits to scientists worldwide, recently reported an income of $25.5 million, or 47 cents per share, excluding amortization and merger costs, for its second quarter ended June 30.

Wall Street analysts expected an operating income of 38 cents a share, with estimates ranging from 36 cents to 41 cents, according to Thomson Financial/First Call.

Last year, during the same period of time, Invitrogen reported $4.9 million, or 19 cents a share, in income, excluding amortization and merger costs.

James McCamant, editor of the Medical Technology Stock Letter in Berkeley, said toolbox companies like Invitrogen face tough competition.

"This is a very competitive business," McCamant said. "We see many rivals that do not meet their numbers."

He added mergers and acquisitions are good strategies to add value.

Last year, Invitrogen bought Life Technologies, a major chemical firm formerly based in Connecticut, for $1.9 billion in a cash and stock deal to widen its product portfolio and enter into untapped Asian markets.

Invitrogen posted a net loss for the quarter ended June 30, 2001 of $35.7 million, or 67 cents a share, which compares to a net income of $4.8 million, or 19 cents a share, for the same quarter last year.

Revenues for the second quarter of 2001 quintupled to $159 million from $28 million for the same quarter a year ago as a result of contributions from Life Technologies.

Amortization and merger costs totaled $71 million for the first three months of this year and $148 million for the six months ended June 30, Invitrogen reported July 26.

Invitrogen shares closed at $65.78 on July 30.

Drug Testing Delay: Corvas International Inc.'s chief scientific officer said the firm expects to hear from Food and Drug Administration officials this month on how to move ahead in testing a treatment to prevent blood clot formation after surgery.

Corvas shares plunged nearly 32 percent to $7.45 on Nasdaq on July 24 after the biotechnology firm announced it delayed the next stage of clinical testing on its experimental drug, rNAPc2.

George Vlasuk, chief scientific officer at Corvas, said the company recently met with FDA officials to "get clarification on points raised" and how to "go forward with the next series of trials."

Corvas recently published results of a Phase II trial, the second phase of three required by the FDA before a drug can be approved, in the July issue of Circulation, the official journal of the American Heart Association.

The study comprised 293 knee replacement patients who received rNAPc2 one hour after surgery to avoid blood clotting, a common threat after orthopedic surgery, Vlasuk said.

Vlasuk declined to comment on concerns raised by FDA officials.

He stressed, however, that "the discussions did not indicate Corvas can't move forward with a Phase III if they wanted."

But it is also possible Corvas may need to conduct another Phase II trial in order to satisfy FDA requirements.

McCamant, of the Medical Technology Stock Letter, said it is better to discuss "tough questions" and "confirm findings" at this stage vs. in Phase III.

"You want Phase III to confirm findings in Phase II, (such as) what you are treating, the amount of drug and effect," McCamant said.

McCamant remained cautiously optimistic about Corvas' future. He described the firm as having "interesting" technology, but wants to see more data to evaluate rNAPc2.

Vlasuk anticipates Corvas will present results of a second Phase II trial of 154 patients that received rNAPc2 for elective angioplasty at the American Society of Hematology meeting in December.

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