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Exanta gains European approval

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http://uk.biz.yahoo.com/040505/241/esubr.html

AstraZeneca's Exanta gains European approval

Wednesday May 5, 03:54 PM

AstraZeneca (LSE: AZN.L - news - msgs) has successfully completed the mutual recognition procedure in Europe for Exanta for short-term use in the prevention of venous thromboembolic events in major elective orthopaedic surgery, the 'proof of concept' indication for this new anticoagulant. AstraZeneca has successfully completed the mutual recognition procedure in Europe for Exanta for short-term use in the prevention of venous thromboembolic events in major elective orthopaedic surgery, the 'proof of concept' indication for this new anticoagulant. France acted as the reference member state for the MRP, with approval in this first market achieved in December 2003. National Marketing Authorisations for an additional 14 countries will be issued in the coming months. UK and Ireland have been withdrawn from the MRP and regulatory discussions will be held to agree the appropriate route to secure approval of Exanta in orthopaedic surgery in these countries. Dr Hamish Cameron, vice president, head of Exanta, AstraZeneca, said, "As Exanta is the first new oral anticoagulant in nearly 60 years, completion of this first regulatory review in orthopaedic surgery is a historic milestone as we approach the introduction of this innovative new therapy." Completion of the MRP for this first indication for Exanta was based on the extensive clinical program and in particular the METHRO III study. The approved treatment regimen involves an early postoperative start of Exanta, with initial injectable dosing administered four to eight hours after the completion of surgery, followed by oral Exanta 24mg twice daily for up to 11 days. This approach reflects the changing trends in clinical practice across Europe with increasing use of spinal anaesthesia as well as enabling oral treatment, to be easily continued following discharge from hospital. More than half of patients undergoing major orthopaedic surgery can develop thromboembolic complications in the absence of preventative anticoagulant treatment, and while effective treatments are available, no treatment regimen to date has successfully balanced efficacy and bleeding risk with oral dosing. The worldwide market for anticoagulants is around $4 billion and growing at 13% annually, while the worldwide anti-thrombotic market is around $12 billion, growing at 15% annually. Exanta provides AstraZeneca with a welcome new source of significant income in the wake of falling sales of its ulcer pill Losec.

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http://www.astrazeneca.ch/index/ta-read.htm?id=16498

06.05.2004 zur?ck

Business and Financial Information

SUCCESSFUL OUTCOME OF THE MUTUAL RECOGNITION PROCEDURE FOR EXANTA? (XIMELAGATRAN) IN EUROPE

AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) in Europe for Exanta? (ximelagatran) for short-term use in the prevention of venous thromboembolic events in major elective orthopaedic surgery (hip or knee replacement) the ?proof of concept? indication for this new anticoagulant.

France acted as the Reference Member State for the MRP, with approval in this first market achieved in December 2003. National Marketing Authorisations for an additional 14 countries will be issued in the coming months. UK and Ireland have been withdrawn from the MRP and regulatory discussions will be held to agree the appropriate route to secure approval of Exanta in orthopaedic surgery in these countries.

Dr Hamish Cameron, Vice President, Head of Exanta, AstraZeneca, said, ?As Exanta is the first new oral anticoagulant in nearly 60 years, completion of this first regulatory review in orthopaedic surgery is a historic milestone as we approach the introduction of this innovative new therapy.?

Completion of the MRP for this first indication for Exanta was based on the extensive clinical programme and in particular the METHRO III study. The approved treatment regimen involves an early postoperative start of Exanta, with initial injectable dosing administered 4-8 hours after the completion of surgery, followed by oral Exanta 24mg twice daily for up to 11 days. This approach reflects the changing trends in clinical practice across Europe with increasing use of spinal anaesthesia as well as enabling oral treatment, to be easily continued following discharge from hospital.

More than half of patients undergoing major orthopaedic surgery can develop thromboembolic complications in the absence of preventative anticoagulant treatment, and while effective treatments are available, no treatment regimen to date has successfully balanced efficacy and bleeding risk with oral dosing.

Exanta is the first oral therapy in a new class of direct thrombin inhibitors to protect patients against thrombosis. Exanta is currently under regulatory review in the E.U. for key chronic-use indications including the prevention of stroke and other thromboembolic complications associated with atrial fibrillation and the treatment of venous thromboembolism (VTE).

In the US, FDA submissions were filed in December 2003 for stroke prevention in patients with atrial fibrillation and long-term secondary prevention of VTE, as well as for use of Exanta in prevention of VTE in major elective orthopaedic surgery (knee replacement).

The worldwide market for anticoagulants is around $4 billion and growing at 13 per cent annually, while the worldwide anti-thrombotic market is around $12 billion, growing at 15 per cent annually.

-Ends-

5 May, 2004

Media Enquiries:

Steve Brown, +44 207 304 5033 or Edel McCaffrey, +44 207 304 5034

Investor Enquiries:

Mina Blair-Robinson, +44 207 304 5084 or Jonathan Hunt, +44 207 304 5087

Notes

* Exanta is a trademark of the AstraZeneca group of companies.

* European MRP countries include: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, United Kingdom, Iceland and Norway

* METHRO: MElagatran for THRombin inhibition in Orthopaedic surgery study that compared injectable low molecular weight heparins initiated the evening before surgery, with preoperative (METHRO II) or post-operative (METHRO III) initiation of melagatran (active form) followed by oral ximelagatran in 4,688 patients undergoing total hip or knee replacement.

* AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

* For more information, visit: www.AstraZenecaPressOffice.com

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http://www.nam.fi/english/control/marketin...ion/mutual.html

MARKETING AUTHORISATION

Mutual Recognition Procedure

The mutual recognition procedure utilizes the marketing authorization granted for a medicinal product by another EU Member State, Norway, or Iceland. The Member State whose assessment is recognized as a basis for marketing authorization is called the Reference Member State (RMS), and the recognizing Member State is called the Concerned Member State (CMS). In the mutual recognition procedure, the time for handling applications is 90 days.

Applicants may select the Member State to be used as the Reference Member State and the states in which mutual recognition is sought. The principle behind the mutual recognition procedure is that the Concerned Member State should recognize the marketing authorization granted by the Reference Member State, unless use of the medicinal product concerned might present a risk to public health. If the issue of such risk is raised by the Concerned Member State, the applicant may cancel the application in that Member State, or the application may go through a conciliation procedure. In this procedure, processing of the application is transferred to the Scientific Committee of the European Agency for the Evaluation of Medicinal Products. This Committee issues a statement on the application, whereafter the EU Commission makes a decision binding on all parties. If the marketing authorization can be recognized, national marketing authorization can be granted for the product as soon as approved national translations of the product summary, package leaflet and sales package markings have been prepared. The majority of marketing authorizations are granted through the mutual recognition procedure.

The Mutual Recognition Facilitation Group (MRFG) meets once a month to discuss issues related to the mutual recognition procedure and applications, on the premises of the European Agency for the Evaluation of Medicinal Products (EMEA) in London.

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http://news.bbc.co.uk/1/hi/business/3917111.stm

New drugs fuelling AstraZeneca

AstraZeneca, the Anglo-Swedish drugs giant, has reported a sharp rise in sales fuelled by a strong take up of its new generation of drugs. Sales in the three months to June rose by 19% to $5.29bn (?2.87bn), with profits up 24% to $1.14bn (?619.7m). The company reported strong growth in products such as ulcer drug Nexium and anti-cholesterol product Crestor. Strong performances from new drugs were needed to offset the impact of patent expiries on older treatments. Chief executive Sir Tom McKillop said AstraZeneca was on course to hit full-year targets. "Although the world pharmaceutical market is becoming increasingly challenging, AstraZeneca is well placed with its new products to deliver good growth," Sir Tom said.

Sales of new cholesterol-lowering drug Crestor totalled $207m, above forecasts of $182m, giving Crestor a 6.8% share of the US market for drugs of its type. However, AstraZeneca said the drug had suffered from "recent unfounded challenges" to its safety profile. This followed an article in UK medical magazine The Lancet which said there was "an inferior evidence base supporting its safe use". Crestor is one of the drugs helping to make up for declining sales of older drugs such as ulcer pill Losec/Prilosec that have been replaced on the market by cheaper generic versions. AstraZeneca's next major new drug hope is an anticoagulant pill, Exanta, which is awaiting approval as a treatment to prevent strokes in patients with certain heart problems. Analysts reckon both Crestor and Exanta could each generate sales of more than $3bn a year for AstraZeneca.

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