Optimism infusion
Biopure says FDA signals Hemopure approval is near
By Jeffrey Krasner, Globe Staff, 8/2/2003
Shares of Biopure Corp. of Cambridge soared yesterday after the company said it received a letter from the US Food and Drug Administration that indicated it was one step closer to approval for its blood substitute, Hemopure. However, the company declined to make the letter available. Biopure said the FDA asked for ''clarification of clinical and preclinical data'' and made comments about prospective labeling for Hemopure. The company said the federal agency did not ask for any more clinical trials of the blood substitute -- a request that could add years to the company's 18-year quest to develop an approved product.
Shares gained $1.33, or 22 percent, to close at $7.30 on volume of 6.9 million shares, more than 10 times the average number traded in regular sessions this year. The shares briefly reached $9.03, a midsession 52-week high.
According to drug review rules, the FDA had been expected to give a final approval or other response to Biopure's application by the end of August. The request for additional information stops the clock while Biopure prepares a response. Company officials said they hope to provide the requested data within two months.
''We're encouraged that the FDA has finished its review and provided comprehensive feedback in advance of the formal action due date,'' said Thomas A. Moore, president and chief executive, in a statement. ''By maintaining 30 days on the review clock, the FDA is encouraging us to work with them to complete the approval process as quickly as possible.''
The FDA does not comment on pending applications. But investors clearly agreed with Biopure's assessment that the agency's request for additional information raised the probability of approval.
The company has initially sought approval to use the product to substitute for red blood cell transfusions in anemic patients undergoing orthopedic surgery.
Biopure does not call Hemopure a blood substitute, preferring to dub it an oxygen therapeutic. The product is derived from cow's blood. Hemoglobin, the chemical which binds with oxygen in the blood, is extracted from the cow blood, chemically stabilized, and suspended in a salt solution.
Like blood, the product absorbs oxygen in the lungs, then releases oxygen to the tissues as it circulates. In clinical trials, the product has shown an ability to transport oxygen, but its effectiveness quickly declines, disappearing over three days. Biopure already sells a version of Hemopure to veterinarians for treating anemia in dogs.
Biopure's efforts to commercialize Hemopure have stirred controversy. The company has come under fire from some investors who claimed the firm missed self-imposed deadlines for filing its application to the FDA. The company has also been unusually secretive about its clinical data. Though the phase III human trials -- those intended to show definitively that a drug is safe and effective in its intended patients -- were completed in 1998 and 2000, the company has released the results piecemeal. For instance, it once released the results from just one site out of many participating in the trial.
The company has also suffered ongoing delays in its efforts to build a $120 million plant in South Carolina that would provide enough capacity to supply commercial quantities of Hemopure. Biopure paid a fee to a development group and designed a plant. The local developers last year said they were on the verge of securing financing to build the plant, which Biopure will lease, and beginning construction. Biopure also said construction of the plant wasn't contingent on receiving final FDA approval.
But the developers, Sumter Realty Group, have neither secured financing nor begun construction yet, a Biopure spokesman said yesterday.
''We're frustrated with Sumter Realty Group,'' said Douglas Sayles, ''but right now we're focused on the FDA. Given we're this close to a potential approval, we wouldn't be surprised if the deal [to finance the plant] closed after a formal approval by the FDA.''
Sayles said that if the FDA gives approval to Hemopure, the company would have other alternatives for financing the plant.
Jeffrey Krasner can be reached at krasner@globe.com.
This story ran on page C1 of the Boston Globe on 8/2/2003.
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