Regulator ruling on artificial blood products causes companies to haemorrhage cash and cut staff
The synthetic blood business has taken a hit as regulators pan products and two major players are brought to the brink of collapse.
Artificial blood developers Biopure and Northfield Laboratories have both received unfavourable responses from the US Food and Drug Administration (FDA) in recent months, causing major problems for the US-based firms.
Northfield Laboratories is shutting down operations after the FDA rejected its biologic license application for PolyHeme - its only product - last month. The FDA concluded that the safety data from all controlled studies suggested that PolyHeme administration places patients ’at a higher risk of significant adverse events,’ and that Northfield’s pivotal study ’did not meet the pre-specified primary efficacy endpoint’.
National Institutes of Health senior scientist Charles Natanson and colleagues aired similar concerns in a meta-analysis of blood substitute studies published last year1. The research found that the products in question raised the risk of death by roughly 30 per cent and yielded a three-fold increase in risk of heart attacks.
Meanwhile, Northfield announced the layoff of nearly all its employees on 8 May. The company lost $6.3 million (?4.2 million) in the third quarter of the fiscal year, compared to losses of $4.8 million during the same quarter the previous year. Northfield says it is ’evaluating FDA’s response and is considering the options for the company going forward.’
Biopure is also facing significant obstacles. In December, the FDA advised the US Naval Medical Research Center (NMRC) that it couldn’t initiate two clinical trials of Biopure’s artificial blood product Hemopure under proposed protocols submitted to the FDA the previous month.
The FDA’s decision was based on concerns about subject safety, protocol design deficiencies, and related issues. Specifically, the agency noted the risk that Hemopure infusion exacerbates bleeding. For its part, Biopure says that the trial results the FDA cited as having adverse mortality rates did not involve Hemopure.
NMRC reportedly also takes issue with the FDA’s decision, and in March submitted a revised investigational new drug application for one of the studies in question, involving a trial of Hemopure for pre-hospital treatment of trauma patients.
Biopure is facing financial problems and needs a cash injection to remain afloat. The company, which only has two products, announced in January that it had had to layoff all but five employees. In June 2008, the firm’s headcount was 85.
’We are actively trying to raise money and hope the Navy is successful with FDA,’ Zafiris Zafirelis, Biopure’s president, tells Chemistry World. ’There is a definite need for such a product, but unfortunately we are going through very tough times.’
He notes that haemoglobin-based oxygen carriers have too often been viewed as substitutes for blood, which they are not. ’You cannot replace blood; if blood is available, none of these products are as good,’ Zafirelis says. But when blood is not available, he claims Hemopure offers an ’outstanding’ oxygen bridge until a blood transfusion can be performed.
Rebecca Trager, US correspondent for Research Europe
1 C. Natanson et al J. Am. Med. Assoc. 2008 DOI: 10.1001/jama.299.19.jrv80007