罗氏公司自信启动Pegasys研究；并计划夸耀疗效
NEW YORK (Reuters Health) - Roche executives expressed confidence on Thursday that the firm would be able to launch its highly anticipated hepatitis C treatment Pegasys (pegylated interferon alpha-2a) in the first half of 2002, following a meeting this fall with US regulators to resolve outstanding issues.
Despite the officials' optimism, questions linger as to how well Pegasys will be able to compete in the US market with Schering-Plough's PegIntron (pegylated interferon alpha-2b), which was approved by the US Food and Drug Administration in January.
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In an interview with Reuters Health, George Abercrombie, president and CEO of Roche's North American pharmaceutical operations, said that Pegasys' efficacy will be the most important factor, but pointed to a number of others that the company believes will help Pegasys overcome PegIntron's head start. Abercrombie was one of several top Roche officials who were in New York on Thursday to meet with the media.
"If you look at awareness, the awareness is very high for Pegasys," he said. "We have our clinicians throughout the country who've been studying the product in phase III studies, we've published data and we're sponsoring symposia where appropriate."
, 百拇医药
He also noted that Roche' strong background in diagnostics would be a positive when promoting Pegasys.
"We have a good history of partnering diagnostics [with therapeutics]," he said, offering FluStar--the company's online program for tracking and reporting influenza, which incorporates a Roche diagnostic and the flu drug Tamiflu (oseltamivir phosphate)--as one example.
Similarly, he said, Roche has plans for joining Pegasys with a number of different hepatitis C diagnostic products that the Swiss firm currently markets.
, 百拇医药
Abercrombie disregarded the impact recent cuts in Roche's US sales force might have on the promotion of Pegasys, noting that the company made the reductions with Pegasys in mind. "We looked at our total portfolio product by product, therapeutic area by therapeutic area, to say 'where do we need capacity over the next 3 to 5 years?'"
He declined to specify what percentage of the roughly 2,000 sales representatives Roche currently employes in the US would be dedicated to Pegasys, but said that it would be low in light of the relatively small number of US physicians that treat hepatitis C compared with other disease areas.
, 百拇医药
"We're sized right to be competitive," he said.
He reiterated that the biggest deciding factor in the Pegasys/PegIntron battle will be efficacy. "We think the better product will prevail, despite any lead in time [Schering-Plough] has, and the better product is Pegasys."
Some analysts, however, believe Roche will have a difficult time taking market share from Schering-Plough, due to the Kenilworth, New Jersey's significant head start in marketing its new hepatitis C therapy. Both companies have developed next-generation versions of the hepatitis C treatment interferon by joining the glycoprotein to a polyethylene glycol (Peg) molecule, thereby increasing the product's circulation time in the body while decreasing its immunogenicity.
, 百拇医药
On Wednesday, Roche reported relatively flat profits for the first half of 2001 and was cautious in its expectations for the full-year. Alex Isaac of Tilney Investment
Management in London, who owns the stock, told Reuters after the release of the first-half report, "...it's not one of my favourite pharma plays--the outlook statement is cautious and there is nothing to excite", 百拇医药
Despite the officials' optimism, questions linger as to how well Pegasys will be able to compete in the US market with Schering-Plough's PegIntron (pegylated interferon alpha-2b), which was approved by the US Food and Drug Administration in January.
, 百拇医药
In an interview with Reuters Health, George Abercrombie, president and CEO of Roche's North American pharmaceutical operations, said that Pegasys' efficacy will be the most important factor, but pointed to a number of others that the company believes will help Pegasys overcome PegIntron's head start. Abercrombie was one of several top Roche officials who were in New York on Thursday to meet with the media.
"If you look at awareness, the awareness is very high for Pegasys," he said. "We have our clinicians throughout the country who've been studying the product in phase III studies, we've published data and we're sponsoring symposia where appropriate."
, 百拇医药
He also noted that Roche' strong background in diagnostics would be a positive when promoting Pegasys.
"We have a good history of partnering diagnostics [with therapeutics]," he said, offering FluStar--the company's online program for tracking and reporting influenza, which incorporates a Roche diagnostic and the flu drug Tamiflu (oseltamivir phosphate)--as one example.
Similarly, he said, Roche has plans for joining Pegasys with a number of different hepatitis C diagnostic products that the Swiss firm currently markets.
, 百拇医药
Abercrombie disregarded the impact recent cuts in Roche's US sales force might have on the promotion of Pegasys, noting that the company made the reductions with Pegasys in mind. "We looked at our total portfolio product by product, therapeutic area by therapeutic area, to say 'where do we need capacity over the next 3 to 5 years?'"
He declined to specify what percentage of the roughly 2,000 sales representatives Roche currently employes in the US would be dedicated to Pegasys, but said that it would be low in light of the relatively small number of US physicians that treat hepatitis C compared with other disease areas.
, 百拇医药
"We're sized right to be competitive," he said.
He reiterated that the biggest deciding factor in the Pegasys/PegIntron battle will be efficacy. "We think the better product will prevail, despite any lead in time [Schering-Plough] has, and the better product is Pegasys."
Some analysts, however, believe Roche will have a difficult time taking market share from Schering-Plough, due to the Kenilworth, New Jersey's significant head start in marketing its new hepatitis C therapy. Both companies have developed next-generation versions of the hepatitis C treatment interferon by joining the glycoprotein to a polyethylene glycol (Peg) molecule, thereby increasing the product's circulation time in the body while decreasing its immunogenicity.
, 百拇医药
On Wednesday, Roche reported relatively flat profits for the first half of 2001 and was cautious in its expectations for the full-year. Alex Isaac of Tilney Investment
Management in London, who owns the stock, told Reuters after the release of the first-half report, "...it's not one of my favourite pharma plays--the outlook statement is cautious and there is nothing to excite", 百拇医药