NEW YORK LONDON, Sept 17 (Reuters) - GlaxoSmithKline and Roche are both expected to win approval for new drugs in the all-important U.S. market in the coming days, providing a potential boost for their shares.
The two medicines -- Promacta and Actemra -- should expand Glaxo and Roche's businesses into new territories, although industry analysts say both are likely to start off as niche treatments.
Glaxo's Promacta is designed to treat a rare clotting disorder that can cause dangerous bleeding, while Roche's Actemra is the first in a new class of injectable medicines for rheumatoid arthritis.
In both cases, the U.S. Food and Drug Administration is due to give its approval decision by Sept. 19.
The two drugs have already received positive recommendations from FDA advisory panels, but investors are cautious about the final green light in view of the some surprising recent decisions by the U.S. watchdog not to approve new drugs.
Morgan Stanley analysts believe Promacta will be approved for the treatment of chronic idiopathic thrombocytopenic purpura (ITP) but its sales may be capped by restrictions on the label limiting its use to only a small minority of patients.
Promacta, a pill, will compete with Amgen's Nplate injection, which won U.S. marketing clearance last month. Both medicines help stimulate the production of blood platelets.
Citigroup analysts forecasts sales of Promacta reaching a modest 286 million pounds ($509.6 million) by 2012, equivalent to just 1 percent of group revenue.
Roche's Actemra, meanwhile, should provide a new therapeutic option for hard-to-treat patients who fail to respond adequately to the existing class of anti-TNF medicines.
As such, it will compete against Roche's own established medicine Rituxan, which is already given to anti-TNF drug non-responders.
Actemra, which Roche sees as a potential billion-dollar seller, is approved in Japan, where it is sold by Roche's partner Chugai Pharmaceutical.
Citi sees sales of the product reaching 714 million Swiss francs ($638 million) by 2012.
(Editing by Hans Peters) ($1=1.119 Swiss Franc) ($1=.5612 Pound) Keywords: GLAXO ROCHE/ Chuck Mikolajczak cm COPYRIGHT Copyright Thomson Financial News Limited 2007. All rights reserved. The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Financial News.
The two medicines -- Promacta and Actemra -- should expand Glaxo and Roche's businesses into new territories, although industry analysts say both are likely to start off as niche treatments.
Glaxo's Promacta is designed to treat a rare clotting disorder that can cause dangerous bleeding, while Roche's Actemra is the first in a new class of injectable medicines for rheumatoid arthritis.
In both cases, the U.S. Food and Drug Administration is due to give its approval decision by Sept. 19.
The two drugs have already received positive recommendations from FDA advisory panels, but investors are cautious about the final green light in view of the some surprising recent decisions by the U.S. watchdog not to approve new drugs.
Morgan Stanley analysts believe Promacta will be approved for the treatment of chronic idiopathic thrombocytopenic purpura (ITP) but its sales may be capped by restrictions on the label limiting its use to only a small minority of patients.
Promacta, a pill, will compete with Amgen's Nplate injection, which won U.S. marketing clearance last month. Both medicines help stimulate the production of blood platelets.
Citigroup analysts forecasts sales of Promacta reaching a modest 286 million pounds ($509.6 million) by 2012, equivalent to just 1 percent of group revenue.
Roche's Actemra, meanwhile, should provide a new therapeutic option for hard-to-treat patients who fail to respond adequately to the existing class of anti-TNF medicines.
As such, it will compete against Roche's own established medicine Rituxan, which is already given to anti-TNF drug non-responders.
Actemra, which Roche sees as a potential billion-dollar seller, is approved in Japan, where it is sold by Roche's partner Chugai Pharmaceutical.
Citi sees sales of the product reaching 714 million Swiss francs ($638 million) by 2012.
(Editing by Hans Peters) ($1=1.119 Swiss Franc) ($1=.5612 Pound) Keywords: GLAXO ROCHE/ Chuck Mikolajczak cm COPYRIGHT Copyright Thomson Financial News Limited 2007. All rights reserved. The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Financial News.