Investors show faith in Biopure
million (€2.5 million) public offering to boost its working
capital, despite its major drug for humans, Hemopure, an artificial
blood product, being licensed only in South Africa.
The announced public offering of 4,110,000 shares of its stock and options is the second for the company in the less than a month, demonstrating the confidence of investors in Biopure and the artificial blood market, which in the US alone is estimated to be worth $5 billion (€4.1 billion) a year.
On December 28, Biopure closed a $5.8 (€4.8 billion) million financing deal selling 10,120,000 shares.
In America, the Securities and Exchange Commission filed a civil complaint against Biopure in September accusing the Massachusetts-based corporation of a fraudulent scheme to "misrepresent and conceal from investors the truth" about its application to the FDA for Hemopure in 2002.
However, Biopure has a research agreement with the American Naval Medical Research Center, which has primary responsibility for designing, seeking FDA acceptance and conducting a proposed Phase 2/3 clinical trial of Hemopure in trauma patients with severe hemorrhagic shock in the out-of-hospital setting.
The biotechnology company also hopes to apply in mid 2006 for approval of Hemopure in Europe for the treatment of acute anemia in elective orthopedic surgery patients.
"We believe that Hemopure will be approved in the US but it's difficult to put a time frame on it," Douglas Sayles, Biopure's associate director of marketing communications, told In-Pharmatechonologist.com.
"We need to keep our operations going, so we needed the public offering for our working capital."
Herb Lanzet, a communication consultant for Biopure's investor relations, said to In-Pharmatechonologist.com: "2006 will be a bright year for Biopure where it will make progress correcting its overhangs."
"There will be Hemopure in the US market sometime in the future."
Hemopure consists of chemically stabilized bovine hemoglobin that can carry oxygen at low blood pressure and through constricted or partially blocked blood vessels to areas of the body that red blood cells cannot reach because to their larger size.
It is approved in South Africa for the treatment of adult surgical patients who are acutely anemic and for the purpose of eliminating, reducing or delaying the need for allogenic red blood cell transfusion in these patients.
But in many countries there are concerns about blood products derived from cows.
For example, a recent EU-funded survey by Nottingham University suggests that the British public would favour truly artificial blood over blood derived from cows, due to fears of variant CJD and objections from religious groups like Hindus.
Biopure's veterinary product Oxyglobin, the only oxygen therapeutic approved by the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs.