Hoffmann-La Roche Inc. received FDA clearance to sell Pegasys, a pegylated interferon for the treatment of hepatitis C, making it the second drug on the market for this disease developed using technology designed to improve circulation time in the body.
Roche, of Nutley, N.J., expects to launch a premixed solution of Pegasys (peginterferon alfa-2a) in two weeks for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Pegasys, administered once a week subcutaneously, will compete with Peg-Intron, a product sold by Schering-Plough Corp., of Kenilworth, N.J.
Pegasys is the PEGylated version of Roferon, a Roche product administered subcutaneously three times a week for the treatment of hepatitis C. The PEGylation technology was developed and licensed by Shearwater Corp., now a subsidiary of Inhale Therapeutics Inc., of San Carlos, Calif., and works to improve a drug's effectiveness by increasing the circulation time in the bloodstream, improving the drug's solubility and stability and reducing its immunogenicity.
"We've received approval for Pegasys as a monotherapy and we believe Pegasys is a very important advancement in the treatment of hepatitis C," Pamela Van Houten, director of public affairs for Roche, told BioWorld Today. "This is the most extensively studied hepatitis C treatment to date, not just in monotherapy, but in combination therapy as well. We've studied specific hard-to-treat patient populations including people who are co-infected with HIV and hepatitis B, as well as African-Americans, for a total of 25,000 patients to date studied.
The biologics license application was filed in May 2000 but the filing was delayed by manufacturing issues. (See BioWorld Today, May 23, 2000.)
"PEGylation is becoming the standard of care for improved performance and we see that by all the major players adopting it," Rob Chess, Inhale's chairman, told BioWorld Today. "Now you have Pegasys approved in the U.S., Peg-Intron approved, which we supplied the PEG for and Enzon Inc. [Bridgewater, N.J.] supplied the technology, and then you have Neulasta [Amgen Inc.] using the technology, and then another diagnostic product that's on the market that also uses the PEGylation technology."
And just last week, Inhale and InterMune Inc., of Brisbane, Calif., signed a deal to develop a PEGylated version of InterMune's chronic hepatitis C drug, Infergen. (See BioWorld Today, Oct. 9, 2002.)
Inhale inherited the Roche deal as part of its acquisition of Shearwater, said Chess, who would not disclose the royalty or milestone schedule except to acknowledge that Inhale will benefit financially from the Pegasys approval. (See BioWorld Today, May 23, 2002.)
Rich Silver, an analyst with Lehman Brothers Inc. in New York, said worldwide Pegasys sales are estimated to peak at $950 million annually.
Roche's Van Houten said Pegasys will cost about $291 a week, a price comparable to other marketed products. Clinical trials have shown that patients can determine at 12 weeks whether they are likely to attain a sustainable virological response using the product, she said. As a result, Roche will provide physician samples for 12 weeks of therapy for the first 15,000 patients who start Pegasys prior to Dec. 31. (The label calls for a recommended duration of 48 weeks of use.)
Pegasys was granted FDA approval based on three pivotal Phase III trials that demonstrated it is an effective treatment for patients with chronic hepatitis C, including cirrhotic patients with compensated liver disease, vs. treatment with Roferon-A (interferon alfa-2a).
According to the company, the sustained virological response rate in the Pegasys-treated patients was as high as 38 percent in the overall population vs. 19 percent in the interferon alfa-2a group. The sustained virological response in patients with cirrhosis treated with Pegasys was as high as 30 percent vs. 8 percent in the interferon alfa-2a group.
Roche also has been granted priority review status for use of Pegasys in combination with Copegus (Roche's ribavirin) and expects a decision late this year.
Pegasys has been approved for use in 50 countries, including all European Union countries.