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Pegasys Market Share
  Roche Hepatitis C Treatment Gains Half of Market Share From Schering-Plough
Kaiser Daily HIV/AIDS Reports, Dec 23, 2003
The hepatitis C drug Pegasys, which is manufactured by pharmaceutical company Roche, has gained half of the market share from Schering-Plough’s Peg-Intron hepatitis C treatment after being available for barely one year, the AP/Philadelphia Inquirer reports. Both drugs are "long-acting interferons" that are injected under the skin to boost the immune system to combat the hepatitis C virus and are taken in combination with ribavirin, an antiviral drug that increases the drugs' effectiveness. Schering-Plough's Peg-Intron had been on the market for nearly two years when Roche introduced Pegasys a year ago, according to the AP/Inquirer. To compete with Schering-Plough, Roche hired more sales representatives to reach out to the 15,000 U.S. doctors who specialize in HCV, gave 12-week samples of its drug to about 12,000 patients and offered wholesalers a 43% discount on its version of ribavirin, called Copegus. According to Liz Coyle of health information company IMS Health, Pegasys has captured 50% of the HCV market from Peg-Intron, with approximately 19,000 prescriptions dispensed for each drug. The number of people being treated for HCV is a "tiny fraction" of the four million Americans who have the virus, because most either do not know they are infected or cannot afford the $25,000 course of treatment, according to the AP/Inquirer. Schering-Plough spokesperson Bob Consalvo said that the company had erred in cutting its sales staff last year, but he said that the company plans to restore its sales force and offer discounts, according to the AP/Inquirer (Johnson, AP/Philadelphia Inquirer, 12/22).
New Drugs
New drugs are needed to treat HCV because current therapies from Roche and Schering-Plough -- which boost the immune system rather than attack the virus -- are ineffective for 60% of patients with the most common form of the virus, according to Investor's Business Daily. A "handful" of biotech companies are working to develop new HCV treatments, but the companies are still in the early stages of the process. Researchers are trying to develop drugs that attack the virus directly and have fewer side effects than current immune-boosting therapies, according to IBD.
--Rigel Pharmaceuticals plans to soon begin early studies of an HCV drug that the company hopes will "block the virus from growing inside the cell," according to Raul Rodriguez, Rigel's senior vice president of business development.
--Vertex Pharmaceuticals' drug Merimepodib targets an enzyme "critical" to HCV replication and cuts the energy level in cells infected with the virus, according to IBD. Phase II clinical studies of Merimepodib showed that 86% of patients taking the highest dose of the drug experienced undetectable viral loads, compared with 30% of patients who were taking a placebo. Late stage trials for the drug are scheduled for the second half of 2004, according to Vertex CEO Joshua Boger.
--Isis Pharmaceuticals' Isis 14803 drug, which is also taken in combination with ribavirin, is currently in Phase II trials. Earlier studies using the combination treatment showed that five of 17 patients experienced "at least" a 90% reduction in virus levels, according to IBD.
--Chiron is in the early stages of testing an experimental HCV vaccine that could both treat patients with the virus and prevent HCV infection.
"It may not be winner takes all," Boger said, adding, "It could be that the way the hepatitis virus is best tackled is by combining the best of several drugs that work by different mechanisms -- the way in which HIV is being treated" (Lau, Investor's Business Daily, 12/22).
Early push made new hepatitis C drug a big earner
By Linda A. Johnson
Associated Press/Philadelphia Inquirer
December 23, 2003
Eighteen months before Hoffmann-La Roche Inc. launched its advanced hepatitis C drug Pegasys, the drug company began reaching out to physicians who treat the tough-to-cure virus.
That strategy helped the Nutley, N.J., company grab half the market in barely a year from Schering-Plough Corp., of Kenilworth, N.J., which had nearly a two-year lead with its Peg-Intron. Both drugs are long-acting interferons that patients inject just under their skin to stimulate the immune system to better fight off the hepatitis virus, which silently destroys the liver over many years.
"We knew we were playing catch-up," said George Abercrombie, chief executive officer of Hoffmann-La Roche, the U.S. pharmaceutical subsidiary of Switzerland's Roche Group.
"This company was focused like a laser around the launch of Pegasys" in October 2002, Abercrombie said.
Besides hiring more sales representatives focused on the 15,000 U.S. doctors specializing in hepatitis treatment, the company gave 12-week supplies of Pegasys free to about 12,000 patients. It also offered wholesalers a 43 percent discount on Copegus, its brand of ribavirin, an antiviral pill taken with the interferon to boost its effectiveness.
Copegus and Schering-Plough's ribavirin, Rebetol, are swallowed once or twice daily, while Pegasys and Peg-Intron are injected weekly.
Liz Coyle of health information company IMS Health said last week that Pegasys sales grew quickly and, as of November, Pegasys had captured half of the market from Peg-Intron, with about 19,000 prescriptions dispensed for each. That's a tiny fraction, though, of the estimated four million Americans infected with hepatitis C - most of whom are not being treated because they do not know they are infected or cannot afford the roughly $25,000 for a course of treatment.
Still, Abercrombie said he expected Pegasys sales to peak at $1 billion.
"It's a big surprise to some extent that Schering, which literally owned the U.S. market, has now given up the market," said Hemant Shah, an independent pharmaceuticals analyst, of HKS & Co. in Warren, N.J. "Somebody dropped the ball, and now they're paying for it."
Spokesman Bob Consalvo conceded that Schering-Plough erred in cutting its sales force 10 percent last year. The company was struggling with a dramatic drop in sales for its longtime blockbuster allergy drug Claritin, now sold over the counter, and other major problems.
Now under a new CEO, turnaround whiz Fred Hassan, Schering-Plough is fighting to win back revenue for what is now the company's biggest franchise.
Consalvo said Schering-Plough was restoring its sales force to the original size and offering its own discounts. Early next year, it will launch a penlike injection device called Redipen that, with a click, mixes Peg-Intron with liquid stored separately inside - easier for patients than mixing the two in a vial and drawing it into a syringe.
Schering-Plough's drug comes in four doses according to patients' weight, which it argues increases effectiveness. Hoffmann-La Roche disputes that.
"They seem to be generally equal in efficacy... in combination with ribavirin," said Gary Simpson, medical director for infectious diseases at the New Mexico Department of Health.
Simpson said he was hoping that next-generation hepatitis C drugs, which are intended to target unique parts of the virus as HIV drugs do, would work even better with far fewer side effects. Both Schering-Plough and Hoffmann-La Roche are working on such drugs, but say they are years away.
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