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Abbott Announces Positive Data from Mid-Stage Trial of Hepatitis C Therapy: 12 weeks duration with 2 Abbott oral HCV drugs protease inhibitor+NNRTI
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pharmpro.com
Oct 24 2011
Abbott on Friday announced interim data from mid-stage trials of its experimental hepatitis C drug combination that suggested patients could achieve a viral cure without use of interferon and that the duration of therapy could be about half as long as conventional therapies. Abbott's Richard Gonzales, who will take over as CEO of the company's new presecription drug business following its split, commented that the therapy could "dramatically change the treatment landscape" for the disease, adding that "we're on track to show patient cure rates in the 90 percent range."
In the trials, 44 previously untreated patients with hepatitis C were given ritonavir with Abbott's ABT-450 and one of two Abbott polymerase inhibitors, ABT-333 or ABT-072, and ribavirin for 12 weeks. All patients who remained in the studies achieved an early virologic response at 12 weeks, and of the 10 patients to date who were tested 24 weeks after completing the treatment course, nine had achieved a sustained virologic response, the company said. Abbott plans to present more detailed data on these and other trials of the drug regimen next year.
"While early, these results are unprecedented in that very high cure rates are being achieved ... with only 12 weeks of interferon-free therapy," Gonzalez commented. Abbott noted that the FDA has given fast track status to the regimen and indicated that it could reach the market by 2015. In addition, the drugmaker speculated that the treatment regimen could go on to capture $2 billion in annual sales.
Shares in Pharmasset, which is developing a similar therapy that includes two drugs versus Abbott's four components, dipped 15 percent on the news. Investors had expected that Pharmasset's treatment would not face competition from another therapy that doesn't use interferon, commented Leerink Swann analyst Howard Liang. "We are seeing there is another way of achieving a regimen without interferon that looks like it will be competitive," he said, adding that "it will eventually all boil down to who has the better data."
However, Brean Murray Carret & Co. analyst Brian Skorney noted that "the two-drug combination has a better chance of a very clean safety profile. I continue to believe Pharmasset's [therapy] will be better." Pharmasset will present new data on the therapy next month at the American Association for the Study of Liver Disease annual meeting.
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HCV News Today Abbott HCV Drugs: 12 weeks duration cure
from Jules: a number of companies are doing studies of 2 orals plus peg/rbv and you will see 90% cure rates from these studies. Abbott certainly has a good protease based on the data they have already presented and a good NNRTI they combined it with in this study. There are a number of companies developing 2 oral HCV drug combinations with peg/rbv and without peg/rbv, so what these data show you is you can expect 90%+ cure rates in the future and 12 weeks duration for at least some patients. Recently Vertex reported data from their study of their 2 orals telarevir+ their NNRTI VX222 + Peg/Rbv and they also saw similar cure rates after 12 weeks therapy. SO these data from Abbott confirm 12 weeks therapy will likely be adequate in the future for at least some patients. Just yesterday Vertex announced a new 12 week duration study for CC with telaprevir+Peg/Rbv.
(Reuters) - Abbott Laboratories Inc said on Friday that it could have a shorter duration combination therapy for hepatitis C on the market in 2015 with annual sales potential of about $2 billion.
Significantly, its combination therapy does not include tough to tolerate interferon, which causes flu-like symptoms that lead many patients with the serious liver disease to stop or delay treatment.
Abbott said that in very small mid-stage trials, a combination of two of its experimental medicines and two other drugs were showing the potential for cure rates as high as 90 percent with as little as 12 weeks of therapy. The shortest duration current patients can hope for is 24 weeks.
Abbott discussed its hepatitis C trials and other experimental medicines at a meeting with investors and analysts in New York just two days after announcing it would spin off its prescription drugs business into a separate company.
"While early, these results are unprecedented in that very high cure rates are being achieved ... with only 12 weeks of interferon-free therapy," said Richard Gonzalez, who will head the new company.
The data presented by Abbott were culled from a pair of trials with a total of just 44 patients. Far larger trials would be needed to confirm the efficacy and safety of the combination therapy.
JPMorgan analyst Michael Weinstein was taking a cautious stance on the potential for Abbott's approach to hepatitis C.
"It's still early and there are a lot of other companies working in this space," he said.
One such company, Pharmasset Inc, has seen its shares soar in recent months over promising data for its own experimental interferon-free hepatitis C regimen. But Pharmasset shares fell 14 percent after the Abbott presentation.
If the Abbott data were to hold up in much larger trials, its therapy could eclipse the new drugs from Vertex Pharmaceuticals Inc and Merck & Co that have been hailed as breakthroughs for achieving far higher cure rates with the potential for shorter treatment durations than the older standard regimen of pegylated interferon and ribavirin, which had to be taken for 48 weeks.
Both the Merck and Vertex drugs must be taken along with the two older medicines. Vertex, in its pivotal clinical trials, saw cure rates as high as 80 percent for its Incivek, while Merck's Vicrelis cured 66 percent of patients. Neither of the new medicines is taken for less than 24 weeks.
Shares of Vertex, which has just the one drug on the market, were off by 3 percent.
The two Phase II trials of previously untreated patients combined the antiviral drug ritonavir with Abbott's ABT-450 -- a protease inhibitor from the same class as the Vertex and Merck drugs -- one of two Abbott polymerase inhibitors, ABT-333 or ABT-072, and ribavirin.
All patients who remained in the studies achieved an early virologic response at 12 weeks, meaning the virus was undetectable in the blood, Abbott said, with no virus rebounds occurring during therapy.
Of the 10 patients so far who were tested 24 weeks after completing the 12 weeks of therapy, nine had achieved a sustained virologic response, or SVR, the company said.
"In other words, these patients were cured with a 12-week course of therapy without interferon," Gonzalez said.
The regimen has been well tolerated to date, the company said, without discussing side effect details.
Hepatitis C, which if untreated can lead to cirrhosis, liver cancer and the need for a transplant, infects an estimated 4 million Americans, and 180 million worldwide.
Abbott plans to present more detailed data on these and other trials next year. It said the U.S. Food and Drug Administration had given fast track status to the regimen.
With fast-track status a company can submit data from clinical trials on a rolling basis as it becomes available rather than waiting until pivotal Phase III studies are complete before submitting the results to the FDA.
In afternoon trading, Abbott shares were off 0.1 percent to $54.01.
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