LUVMyBirman
Well-known member
Study finds fewer strokes in patients taking Exanta
By Chris Michaud
NEW YORK, Dec 10 (Reuters) - Far fewer patients with heart rhythm problems suffered strokes after taking preventive doses of AstraZeneca Plc's (AZN.L) (AZN.ST) experimental anti-clotting pill Exanta than those who took the standard drug warfarin, the company said on Monday.
Interim results of the phase II trial were presented at the annual meeting of the American Society of Hematology in Orlando. The long-term trial involves 125 patients with non-valvular atrial fibrillation who got regular doses of Exanta and 42 patients who took warfarin, to prevent strokes.
Preliminary results found that patients taking Exanta (ximelagatran) suffered 0.9 strokes and 0.4 transient ischemic attacks, sometimes called ministrokes, per 100 treatment years -- the equivalent of one person taking the drug for a year. Patients in the ongoing trial were treated for between 21 months and 24 months, the company said.
That compared with 2.6 strokes and 2.6 ministrokes per 100 treatment years for those taking warfarin, a generically available anti-clotting drug sold by Bristol-Myers Squibb Co. (BMY.N) under the brand name Coumadin.
One of the most worrisome side effects from anti-clotting drugs is their tendency to cause excessive bleeding, which can be life-threatening. In the trial, Astra said incidence of major bleeding was 0.9 per 100 treatment years for Exanta versus 2.6 per 100 treatment years for warfarin.
"That's a small study, but I'm encouraged by the results," said analyst Catherine Arnold of Sanford C. Bernstein.
"Coumadin has so many issues, in terms of the drugs it interacts with and the extent to which it has to be monitored to be sure it's at the right level, that even if this is the equivalent to Coumadin, it will still be used extensively in our view in these populations," Arnold said.
"Of course the results will still have to be confirmed," she added. "It will need a larger-scale study."
AstraZeneca's chief executive officer said last week called Exanta, which if cleared would be the first new anticoagulant
pill in 50 years, a potential breakthrough drug that could generate annual sales of several billion dollars.
"It's a huge breakthrough potentially in the treatment of blood clots," said CEO Tom McKillop of Exanta, which is designed to work by inhibiting thrombin, an enzyme that is vital to blood clotting and one which he noted many companies had tried and failed to block.
Exanta is one of seven potential AstraZeneca "megabrands" each of which McKillop said he expects could generate over $1 billion in annual sales. The Anglo-Swedish drugmaker is looking to the new medicines to take up the slack once its $6 billion a year ulcer drug Prilosec loses its U.S. marketing exclusivity and faces competition from generic versions.
Prilosec is the subject of a patent dispute currently being contested in federal court by AstraZeneca and several smaller drug manufacturers.
Atrial fibrillation, in which two upper heart chambers quiver instead of beating effectively, is found in about 2 million Americans, according to the American Heart Association. Blood in the chambers can then clot, and the clot can then travel and become lodged in the brain, causing a stroke.
AstraZeneca (AZN.N) was trading down 15 cents at $45.05 late in the day.
By Chris Michaud
NEW YORK, Dec 10 (Reuters) - Far fewer patients with heart rhythm problems suffered strokes after taking preventive doses of AstraZeneca Plc's (AZN.L) (AZN.ST) experimental anti-clotting pill Exanta than those who took the standard drug warfarin, the company said on Monday.
Interim results of the phase II trial were presented at the annual meeting of the American Society of Hematology in Orlando. The long-term trial involves 125 patients with non-valvular atrial fibrillation who got regular doses of Exanta and 42 patients who took warfarin, to prevent strokes.
Preliminary results found that patients taking Exanta (ximelagatran) suffered 0.9 strokes and 0.4 transient ischemic attacks, sometimes called ministrokes, per 100 treatment years -- the equivalent of one person taking the drug for a year. Patients in the ongoing trial were treated for between 21 months and 24 months, the company said.
That compared with 2.6 strokes and 2.6 ministrokes per 100 treatment years for those taking warfarin, a generically available anti-clotting drug sold by Bristol-Myers Squibb Co. (BMY.N) under the brand name Coumadin.
One of the most worrisome side effects from anti-clotting drugs is their tendency to cause excessive bleeding, which can be life-threatening. In the trial, Astra said incidence of major bleeding was 0.9 per 100 treatment years for Exanta versus 2.6 per 100 treatment years for warfarin.
"That's a small study, but I'm encouraged by the results," said analyst Catherine Arnold of Sanford C. Bernstein.
"Coumadin has so many issues, in terms of the drugs it interacts with and the extent to which it has to be monitored to be sure it's at the right level, that even if this is the equivalent to Coumadin, it will still be used extensively in our view in these populations," Arnold said.
"Of course the results will still have to be confirmed," she added. "It will need a larger-scale study."
AstraZeneca's chief executive officer said last week called Exanta, which if cleared would be the first new anticoagulant
pill in 50 years, a potential breakthrough drug that could generate annual sales of several billion dollars.
"It's a huge breakthrough potentially in the treatment of blood clots," said CEO Tom McKillop of Exanta, which is designed to work by inhibiting thrombin, an enzyme that is vital to blood clotting and one which he noted many companies had tried and failed to block.
Exanta is one of seven potential AstraZeneca "megabrands" each of which McKillop said he expects could generate over $1 billion in annual sales. The Anglo-Swedish drugmaker is looking to the new medicines to take up the slack once its $6 billion a year ulcer drug Prilosec loses its U.S. marketing exclusivity and faces competition from generic versions.
Prilosec is the subject of a patent dispute currently being contested in federal court by AstraZeneca and several smaller drug manufacturers.
Atrial fibrillation, in which two upper heart chambers quiver instead of beating effectively, is found in about 2 million Americans, according to the American Heart Association. Blood in the chambers can then clot, and the clot can then travel and become lodged in the brain, causing a stroke.
AstraZeneca (AZN.N) was trading down 15 cents at $45.05 late in the day.
