Updated from 10:58 a.m. EDT
dropped 9.9% Friday, the day after the company provided little extra news or clarification on the progress of its long-awaited artificial-blood product Hemopure.
The stock of the Cambridge, Mass.-based company fell 82 cents to $7.43.
The cause for the slumping stock appears to be based on investors' concerns that the Food and Drug Administration will take longer than expected to review Hemopure in what has already been a long review process. Company officials speaking to investors and analysts in a conference call Thursday after stock markets had closed offered no clear picture as to how long the FDA review would take.
These comments no doubt put a damper on Biopure's announcement Aug. 1 that sent the stock jumping 22.3% to a closing price of $7.30, after hitting a 52-week high of $9.03 during the day. That's when Biopure reported that it had received a letter from the FDA seeking additional information on Hemopure but not requesting additional, time-consuming clinical trials.
Biopure said at the time that the FDA's letter "focuses primarily on clarification" of certain data and on what Hemopure's label would say. A company spokesman said Biopure would expect to complete its response in 30 to 60 days.
Thursday, however, Biopure officials reported that they want to meet with the FDA in September -- a date hasn't been chosen -- to clarify some of the questions asked by the FDA and to determine if the agency will narrow the scope of some of its requests.
Based on what she heard at the conference call, analyst Sapna Srivastava said the FDA review process could now take four to five months instead of two months.
"We continue to believe Hempoure is approvable," she said in a research note issued Friday. She has an equal weight rating on the stock; she doesn't own shares. Her firm, ThinkEquity Partners, has an investment banking relationship with Biopure.
"We've developed many of our initial responses, and so far we feel will be prepared to answer FDA's questions," Thomas A. Moore, the company's president and chief executive, said in a prepared statement Thursday.
Speaking later to analysts and investors in a telephone conference, Moore wouldn't give a specific timetable on how long the data-gathering and question-answering would take. "We are cautiously optimistic on the approval track," he said.
When asked by one investor whether the company might need to raise more money before the FDA takes action on Hemopure, Moore said he didn't think the company would have to raise a "significant" amount of extra capital, adding, however, that he can't guarantee that prediction. Biopure completed a $17 million public offering last month.
Biopure filed its initial FDA request on July 31, 2002. The typical review period is 10 months, and just before the deadline the FDA imposed a three-month extension pushing the deadline to late August.
Later, the FDA sent Biopure what company officials and drug industry experts say was a unique letter asking for additional information and, in effect, stopping the clock on the FDA review while Biopure gathers the information. Once the company provides the data and answers the FDA's questions, the review clock -- which has 30 more days -- starts ticking again.
"We believe that the FDA is working closely with Biopure to help Hemopure get approved," Srivastava said in her report to clients. "We believe ... that the probability that Hemopure receives a favorable review remains high."
Hemopure belongs to a class of drugs called oxygen therapeutics. The drug would be administered intravenously to patients, improving the flow of oxygen to the body's tissues. The drug is derived from stabilized bovine hemoglobin. Hemoglobin is a protein carried by red blood cells that picks up oxygen in the lungs and carries it to tissues throughout the body.
The company sells one form of the product, called Oxyglobin, in the U.S. and three European countries for treating anemia in dogs. Anemia is caused by the lack of enough healthy red blood cells to carry oxygen.
Biopure is asking the FDA to approve Hemopure for acutely anemic patients undergoing orthopedic surgery and for the eliminating or reducing red blood cell transfusions in these patients. Hemopure has been approved for these uses in South Africa; no other Hemopure applications are pending.
Moore said that once Hemopure is approved for certain conditions, Biopure would discuss with the FDA what steps are needed to expand its approval to general surgery and/or other uses.
Biopure also said Thursday that its third-quarter loss declined to $11.31 million, or 28 cents a share, compared with $12.60 million, or 43 cents a share, for the same period last year.
Srivastava, the only analyst following the company according to Thomson First Call, had predicted a loss of 40 cents a share for the three months ended July 31. Revenue rose to $885,000 for the third quarter compared with $260,000 for the same period.