AppId is over the quota
By Ransdell Pierson and Bill Berkrot
NEW YORK | Fri Oct 21, 2011 2:13pm EDT
NEW YORK (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 as much as 20 percent after the Abbott presentation and were down 12 percent in afternoon trade.
"The market was expecting Pharmasset to be the first all-oral combination regimen for hepatitis C," said Brian Skorney, an analyst for Brean Murray, Carret & Co.
He believes the Pharmasset sell-off was an overreaction, given how little data Abbott has provided.
"I'd be interested to see what the safety profile will be for the four drugs," he said of the Abbott combination. "Pharmasset's is two drugs."
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 interferon and ribavirin. 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 regimens is taken for less than 24 weeks.
Shares of Vertex, which has just the one drug on the market, fell almost 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.
Abbott shares were off 0.4 percent at $53.86.
(Reporting by Ransdell Pierson and Bill Berkrot, editing by Gerald E. McCormick)
TRENTON, N.J. (AP) — The first combination pill for the millions of people with the dangerous combination of diabetes and high cholesterol won U.S. approval Friday, offering convenience — and savings — to patients taking multiple pills.Juvisync, a probable blockbuster developed by Merck & Co. Inc., will be launched in a few weeks. It combines Merck's Type 2 diabetes pill Januvia with Zocor, a former Merck blockbuster in the widely used class of cholesterol drugs called statins.The combination pill will sell for the same price as Januvia alone, about $215 per month. Generic versions of Zocor cost roughly $30 a month.That should make Juvisync attractive for the millions of diabetics currently not taking a statin. Guidelines from the American Diabetes Association recommend that diabetics who have heart disease or are over age 40 take a statin pill daily."This provides a way to simplify their regimen and improve adherence," said Dr. Susan Spratt, an endocrinologist at Duke University Medical Center.Spratt said many diabetes patients are taking six or more pills a day, including different types of pills for diabetes, blood pressure and high cholesterol. It can be hard to consistently take them all at the right time, and even with health insurance, patients' out-of-pocket costs for their medications and diabetes testing supplies can be very high."Anything to reduce the cost is going to be helpful to patients," Spratt said, adding, "When you improve medication adherence, you actually lower health care costs because patients don't end up in the ER or the hospital."Merck shares rose 37 cents to $31.79 in late-afternoon trading, after rising nearly 3 percent.In Type 2 diabetes, the body either does not produce enough of the hormone insulin or does not use it efficiently, allowing excess sugar, or glucose, to accumulate in the blood. Over time, that damages blood vessels and crucial organs.Many of the more than 25 million U.S. diabetes patients also have high cholesterol, partly because both conditions often are linked to being overweight. The combination increases risk of heart disease, stroke, kidney disease and other chronic conditions. Diabetics also are at risk of blindness, amputations from wounds that do not heal and heart attacks.Despite those dangers, Merck scientists estimate that up to 4 million diabetes patients over 40 are not following the medication recommendation."Perhaps one third of the nation's eligible patients with type 2 diabetes are not being treated with a statin, so here's a convenient tool for doctors to target glucose as well as cholesterol levels," Dr. Sethu Reddy, Merck's director of clinical affairs for diabetes, said in a statement.Juvisync will be available in six different dosage strengths, to accommodate patients with varying levels of cholesterol and diabetes. Common side effects of the drug include stuffy nose and sore throat, headache, muscle and stomach pain.The approval revives Zocor, which had been Merck's top-selling medicine before it got generic competition in June 2006. It's now available in nearly a dozen generic forms as simvastatin.Januvia, Merck's third-best-selling drug, was approved in October 2006. It was the first diabetes drug in a new class called DPP-4 inhibitors that now includes Bristol-Myers Squibb Co.'s Onglyza and Tradjenta, made by Eli Lilly & Co. and Boehringer Ingelheim.The drugs work by making the body produce more insulin after meals, to reduce levels of glucose in the blood, and by limiting the amount of glucose made by the liver.Januvia brought in $1.5 billion in the first six months of this year and had sales of $2.4 billion last year. Merck already sells a pill that combines Januvia with a widely used generic diabetes pill, metformin. That combo pill, called Janumet, had sales of $626 million in the first half of this year.With Merck's top seller, asthma and allergy drug Singulair, getting generic competition next August, the Januvia franchise becomes even more important for the company, which is the world's third-biggest drugmaker by revenue.Merck, based in Whitehouse Station, N.J., is planning to seek approval of Juvisync in many other countries in the near future, according to spokeswoman Pam Eisele.___AP Business Writer Matt Perrone in Washington contributed to this story.Associated Press 
