* August 25, 2009, 2:47 PM ET
Company Cleared To Test Swine Flu Vaccine Fighting Off Liquidation
By Jacqueline Palank
As a new White House report raises the possibility that up to 50% of the U.S. population could contract swine flu this season, one drug maker has come a step closer to distributing a vaccine. That is, if the involuntary bankruptcy filing against it doesn?t get in the way.
Protein Sciences Corp., of Meriden, Conn., is a privately held vaccine maker that last week won federal approval to kick off clinical trials of its vaccine for the H1N1, or swine flu, virus, the Hartford Courant reported. That means Protein Sciences? PanBlok vaccine will be tested on humans as soon as the next few weeks. Such trials have already started in Australia, where winter - and flu season - are underway.
The Food and Drug Administration?s stamp of approval doesn?t mean it will be smooth sailing for Protein Sciences, however. The company was hit with an involuntary Chapter 7 bankruptcy filing last month by three creditors owed $11.7 million. The creditors - Emergent Manufacturing Operations Meriden LLC, PSI-BV and Impact Clinical Trials - said they sought Protein Sciences? liquidation because they?ve ?lost faith? in its managers. Protein Sciences is trying to fight off the creditors, accusing them of attempting to grab the company?s valuable vaccine technology on the cheap, but the bankruptcy court will have the final say after a trial that?s slated to begin Friday.
In the meantime, Protein Sciences is gearing up to launch the six-month clinical trials before the summer?s end, a target the company?s chief executive admitted to the Courant was ?optimistic.? If the company hits that mark and the trials are successful, the earliest that Protein Sciences could win federal approval to sell the vaccine is mid-2010.
The government could, however, decide to expedite the testing process, as it?s done for other pharmaceutical companies. According to ABC News, the U.S. Centers for Disease Control and Prevention expects that 45 million doses will be ready by Oct. 15 - the date White House experts believe that H1N1 infections will peak. The estimate is a substantial reduction from the 120 million doses that were originally expected to be ready by that time. Those experts further predict that in a worst-case scenario, the outbreak will cause between 60 million and 120 million Americans to take ill - and between 30,000 and 90,000 deaths.
http://blogs.wsj.com/bankruptcy/200...t-swine-flu-vaccine-fighting-off-liquidation/
Company Cleared To Test Swine Flu Vaccine Fighting Off Liquidation
By Jacqueline Palank
As a new White House report raises the possibility that up to 50% of the U.S. population could contract swine flu this season, one drug maker has come a step closer to distributing a vaccine. That is, if the involuntary bankruptcy filing against it doesn?t get in the way.
Protein Sciences Corp., of Meriden, Conn., is a privately held vaccine maker that last week won federal approval to kick off clinical trials of its vaccine for the H1N1, or swine flu, virus, the Hartford Courant reported. That means Protein Sciences? PanBlok vaccine will be tested on humans as soon as the next few weeks. Such trials have already started in Australia, where winter - and flu season - are underway.
The Food and Drug Administration?s stamp of approval doesn?t mean it will be smooth sailing for Protein Sciences, however. The company was hit with an involuntary Chapter 7 bankruptcy filing last month by three creditors owed $11.7 million. The creditors - Emergent Manufacturing Operations Meriden LLC, PSI-BV and Impact Clinical Trials - said they sought Protein Sciences? liquidation because they?ve ?lost faith? in its managers. Protein Sciences is trying to fight off the creditors, accusing them of attempting to grab the company?s valuable vaccine technology on the cheap, but the bankruptcy court will have the final say after a trial that?s slated to begin Friday.
In the meantime, Protein Sciences is gearing up to launch the six-month clinical trials before the summer?s end, a target the company?s chief executive admitted to the Courant was ?optimistic.? If the company hits that mark and the trials are successful, the earliest that Protein Sciences could win federal approval to sell the vaccine is mid-2010.
The government could, however, decide to expedite the testing process, as it?s done for other pharmaceutical companies. According to ABC News, the U.S. Centers for Disease Control and Prevention expects that 45 million doses will be ready by Oct. 15 - the date White House experts believe that H1N1 infections will peak. The estimate is a substantial reduction from the 120 million doses that were originally expected to be ready by that time. Those experts further predict that in a worst-case scenario, the outbreak will cause between 60 million and 120 million Americans to take ill - and between 30,000 and 90,000 deaths.
http://blogs.wsj.com/bankruptcy/200...t-swine-flu-vaccine-fighting-off-liquidation/