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By Ben Hirschler, European Pharmaceuticals Correspondent
LONDON, July 5 (Reuters) - With treatments ranging from rat poison to extracts from pig intestines, today's options for dealing with thrombosis are hardly alluring.
But now a new generation of synthetic compounds are on the way which could offer a more predictable dosage and response.
New ways to treat blood coagulation will be under the spotlight at the July 6-12 annual meeting of the International Society on Thrombosis and Haemostatis in Paris -- and investors in three European drugmakers will be watching with interest.
Sanofi-Synthelabo of France and Anglo-Swedish group AstraZeneca Plc both have experimental medicines which could challenge Aventis SA's dominance of the $7-billion-a-year thrombosis market.
Analysts, however, believe the Franco-German group will keep its crown for a few years yet.
Much of the scientific debate at the meeting will rake over clinical studies already in the public domain but the meeting is highly topical with the U.S. Food and Drug Adminstration set to rule on Sanofi's new pentasaccharide drug Arixtra by mid-August.
Arixtra -- being developed with Dutch chemical group Akzo Nobel NV -- is the first in a new class of highly selective indirect inhibitors of Factor Xa, a key component in the biological chain that can cause blood clots.
BNP Paribas forecasts the drug will eventually achieve peak sales of more than $1.5 billion a year, shared between Sanofi and Akzo. But getting there may be a long haul.
HIP AND KNEE
Arixtra will initially be used to prevent blood clot formation during surgery. Sanofi wants approval in both hip and knee surgery but a cautious FDA may opt to limit its use, given relatively high instances of bleeding.
"The data would suggest, from our point of view, that the FDA will either issue an approvable letter and ask for more data in hips or just give it a limited indication in knee surgery," said David Beadle of UBS Warburg.
He thinks the immediate threat to Lovenox is therefore limited -- especially since hip and knee procedures together accounted for only 15 percent of Lovenox sales in 2000, a figure which is likely to fall to 13 percent this year.
With nine approved indications -- or therapeutic uses -- worldwide, Lovenox is currently the "gold standard" among low molecular weight heparins (LMWHs) which block the clotting process and are the mainstay of current thrombosis treatment.
Lovenox is Aventis' second largest product with sales growing 33 percent last year to one billion euros ($842 million), representing eight percent of prescription drug sales.
In the long term, Lovenox -- derived from porcine intestinal mucosa -- and other LMWHs will face competition from newer products, but analysts argue Aventis can offset the damage.
"Aventis have embarked on a very aggressive life-cycle management programme for Lovenox and they are adding indications," said Nigel Barnes of Merrill Lynch.
"So although we are likely to see the pentasaccharide eroding its share of the post-orthopaedic surgery indication, there will be a net improvement in Lovenox sales with new indications coming on-stream."
Sanofi is unlikely to launch its drug to treat arterial thrombosis before 2005, by which time Schroder Salomon Smith Barney expects Lovenox to be raking sales of 2.4 billion euros.
ORAL OPTION
AstraZenecaoffers a different proposition with Exanta, previously known as H376, a novel direct thrombin inhibitor which is given by mouth rather than injection.
Its first use is expected to be for venous thromboembolism, a relatively small market, with launches in arterial indications only expected in 2004, if trials are successful.
Exanta is one of four potential blockbusters which AstraZeneca hopes will revitalise sales following the demise of best-selling ulcer pill Losec, and analysts are looking for peak sales of $1.0-1.5 billion -- though concerns were raised recently about possible liver toxicity.
Its biggest potential, though, lies not in stopping clots after surgery but in preventing strokes in patients with atrial fibrillation -- characterised by fast heart rates in the upper chambers of the heart -- where it will not compete head-on with Lovenox.
The current standard treatment is with the drug warfarin -- originally developed as a rat poison. Warfarin, marketed by DuPont Co as Coumadin, is difficult to use since too much can cause serious bleeding and patients need costly monitoring.
07:48 07-05-01
Copyright 2001 Reuters Limited.
LONDON, July 5 (Reuters) - With treatments ranging from rat poison to extracts from pig intestines, today's options for dealing with thrombosis are hardly alluring.
But now a new generation of synthetic compounds are on the way which could offer a more predictable dosage and response.
New ways to treat blood coagulation will be under the spotlight at the July 6-12 annual meeting of the International Society on Thrombosis and Haemostatis in Paris -- and investors in three European drugmakers will be watching with interest.
Sanofi-Synthelabo of France and Anglo-Swedish group AstraZeneca Plc both have experimental medicines which could challenge Aventis SA's dominance of the $7-billion-a-year thrombosis market.
Analysts, however, believe the Franco-German group will keep its crown for a few years yet.
Much of the scientific debate at the meeting will rake over clinical studies already in the public domain but the meeting is highly topical with the U.S. Food and Drug Adminstration set to rule on Sanofi's new pentasaccharide drug Arixtra by mid-August.
Arixtra -- being developed with Dutch chemical group Akzo Nobel NV -- is the first in a new class of highly selective indirect inhibitors of Factor Xa, a key component in the biological chain that can cause blood clots.
BNP Paribas forecasts the drug will eventually achieve peak sales of more than $1.5 billion a year, shared between Sanofi and Akzo. But getting there may be a long haul.
HIP AND KNEE
Arixtra will initially be used to prevent blood clot formation during surgery. Sanofi wants approval in both hip and knee surgery but a cautious FDA may opt to limit its use, given relatively high instances of bleeding.
"The data would suggest, from our point of view, that the FDA will either issue an approvable letter and ask for more data in hips or just give it a limited indication in knee surgery," said David Beadle of UBS Warburg.
He thinks the immediate threat to Lovenox is therefore limited -- especially since hip and knee procedures together accounted for only 15 percent of Lovenox sales in 2000, a figure which is likely to fall to 13 percent this year.
With nine approved indications -- or therapeutic uses -- worldwide, Lovenox is currently the "gold standard" among low molecular weight heparins (LMWHs) which block the clotting process and are the mainstay of current thrombosis treatment.
Lovenox is Aventis' second largest product with sales growing 33 percent last year to one billion euros ($842 million), representing eight percent of prescription drug sales.
In the long term, Lovenox -- derived from porcine intestinal mucosa -- and other LMWHs will face competition from newer products, but analysts argue Aventis can offset the damage.
"Aventis have embarked on a very aggressive life-cycle management programme for Lovenox and they are adding indications," said Nigel Barnes of Merrill Lynch.
"So although we are likely to see the pentasaccharide eroding its share of the post-orthopaedic surgery indication, there will be a net improvement in Lovenox sales with new indications coming on-stream."
Sanofi is unlikely to launch its drug to treat arterial thrombosis before 2005, by which time Schroder Salomon Smith Barney expects Lovenox to be raking sales of 2.4 billion euros.
ORAL OPTION
AstraZenecaoffers a different proposition with Exanta, previously known as H376, a novel direct thrombin inhibitor which is given by mouth rather than injection.
Its first use is expected to be for venous thromboembolism, a relatively small market, with launches in arterial indications only expected in 2004, if trials are successful.
Exanta is one of four potential blockbusters which AstraZeneca hopes will revitalise sales following the demise of best-selling ulcer pill Losec, and analysts are looking for peak sales of $1.0-1.5 billion -- though concerns were raised recently about possible liver toxicity.
Its biggest potential, though, lies not in stopping clots after surgery but in preventing strokes in patients with atrial fibrillation -- characterised by fast heart rates in the upper chambers of the heart -- where it will not compete head-on with Lovenox.
The current standard treatment is with the drug warfarin -- originally developed as a rat poison. Warfarin, marketed by DuPont Co as Coumadin, is difficult to use since too much can cause serious bleeding and patients need costly monitoring.
07:48 07-05-01
Copyright 2001 Reuters Limited.
