Healthcare Industry News: Acute Coronary Syndrome
News Release - October 4, 2006
Arixtra(R) Receives Priority Review by the FDA in Acute Coronary Syndromes (ACS)BRISBANE, Australia, Oct. 4 (HSMN NewsFeed) -- Australian drug development company Alchemia Limited (ASX: ACL ) received further positive news for its Synthetic Heparin with the priority review for GlaxoSmithKline's (GSK) supplemental new drug application (sNDA) for Arixtra® in treating Acute Coronary Syndromes (ACS) by the US Food and Drug Administration. The application is the result of two of the largest ever clinical trials in ACS, OASIS-5 and 6, which demonstrated significant safety benefits over currently used therapies including Lovenox® and unfractionated heparins.
Alchemia Chief Executive Officer Dr Tracie Ramsdale said that the priority review process is an opportunity for Arixtra® to achieve a larger share of the heparin market sooner than anticipated. "Based on current FDA approval times, Arixtra® is now expected to be approved for all indications in quarter one of 2007," she said.
This marks a significant improvement on the original timetable for ACS of 2008. The median approval time for a standard review process is over 13 months (CDER 2005).
Dr Ramsdale said this highlights the significance for Alchemia's Synthetic Heparin, a generic version of Arixtra® as priority approvals are only sought for drugs that offer significant improvements compared with currently marketed products. The US Center for Drug Evaluation and Research (CDER) reported a total median approval time, including review, for priority drugs in 2005 of 6 months. As GSK lodged the sNDA for ACS on 31 July, it is expected that approval for ACS will be obtained in the first quarter of the 2007 calendar year.
Alchemia recently announced that it had agreed to terminate its Research & Development Collaboration Agreement with Abraxis Pharmaceutical Products (APP), resolving the uncertainty surrounding the collaboration. Alchemia expects to file an Abbreviated New Drug Application (ANDA) with the US FDA in the second quarter of 2007, to expedite the time to market, and is actively seeking a new North American marketing partner.
"With its safety and efficacy benefits over current heparin therapies, we expect our generic drug, Synthetic Heparin, to make significant in roads into the US$3.7 billion heparin drug market after launch," Dr Ramsdale said.
About Alchemia Limited - http://www.alchemia.com.au
Alchemia is a drug discovery company with a novel carbohydrate platform technology focused on the development of a generic Synthetic Heparin and on discovering a pipeline of oncology, eye disease, antibiotic and pain treatment therapeutics. Alchemia has leveraged its carbohydrate chemistry expertise to develop a more efficient, economical manufacturing process which Alchemia believes will ensure its generic Synthetic Heparin will be cost competitive with Arixtra® and other heparin-related drugs, providing Alchemia with a potentially significant market share of the $US3.7 billion worldwide heparin market. Alchemia's generic Synthetic Heparin is being developed in collaboration with manufacturing partner, The Dow Chemical Company.
In September 2005, results from the Arixtra® clinical trial, OASIS-5, found Arixtra® to be safer and as effective as the traditional drug (Lovenox®) in treating patients with Acute Coronary Syndromes (ACS). The study involved over 20,000 patients across 41 countries making it the world's largest study on ACS. The study found Arixtra® reduced major bleeding by almost half, compared to Lovenox®, and also reduced mortality rates.
In March 2006 the results of the large-scale Arixtra® trial (Organization to Assess Strategies for Ischaemic Syndrome) OASIS-6 demonstrated a significant risk reduction in death, or recurrent heart attack, in patients compared to standard therapy (unfractionated heparin or placebo). The study involved more than 12,000 patients and compared Arixtra® to standard therapy in ACS patients with STEMI (ST-segment elevation myocardial infarction).
Acute Coronary Syndromes (ACS) encompass a range of cardiac diseases including unstable angina, non ST-segment elevation myocardial infarction NSTEMI and STEMI. Over 2.4 million people in the US suffer form ACS each year.
Source: Alchemia Limited
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