The Jurong Island facility for the manufacture of enoxaparin sodium was opened in July 1999. Aventis commissioned the plant to meet the growing world demand for enoxaparin sodium, which had global sales in 2002 of €1.5 billion. Enoxaparin sodium was the first low-molecular-weight heparin to be introduced in the United States and Canada (approved in 1993). First approved in France in 1987, enoxaparin is now available in more than 96 countries, marketed as Lovenox (US) and Clexane (Europe).
ENOXAPARIN SODIUM IN USE
The drug is used to treat 108 million patients worldwide for deep vein thrombosis, unstable angina and non Q wave myocardial infarction. The European Society of Cardiology Congress in 2002 was presented with data, which indicated that anticoagulation therapy with enoxaparin is more effective than standard therapy using intravenous (IV) heparin and oral anticoagulants. Thus enoxaparin is becoming the accepted treatment for reducing the risk of embolism, major bleeding and death in patients undergoing cardioversion for atrial fibrillation.
PATENT CHALLENGES
Aventis announced in May 2003 that two companies were seeking to manufacture generic versions of enoxaparin sodium. The two companies, Teva Pharmaceuticals and Amphastar Pharmaceuticals, have filed Abbreviated New Drug Applications (ANDAs) with the US Food and Drug Administration.
The two companies claim the original patent is invalid or unenforceable. They further claim the generic versions of the drug they intend to produce would not infringe the original patent, which does not expire until 14 February 2012. Aventis has filed against the two companies. Aventis is entitled to automatic stays prohibiting the FDA from approving these ANDAs for 30 months or until the courts make a ruling.
SINGAPORE AS A CENTRE FOR BIOMEDICAL EXCELLENCE
Singapore is fast becoming a regional biomedical centre. With companies such as GlaxoSmithKline, Schering-Plough, Rhone Poulenc and Merck already well established. Singapore is encouraging a burgeoning biomedical and pharmaceutical industry. The government is backing the emergence of this sector by offering attractive tax incentives and manpower training initiatives. The Tuas Biomedical park has encouraged large pharmaceutical concerns such as Pfizer, Wyeth-Ayerst and Merck to build new facilities. The Singapore government is also building the Biopolis, a world class biomedical sciences research campus, which is to open in 2003.
Local industry experts forecast that the highly lucrative Singapore market for over the counter drugs is expected to grow by 11% to 15% a year. As patients begin to rely less on doctors for minor ailments, the market for these over-the-counter drugs continues to grow. Aventis employs over 350 people in Singapore with an additional 40 people recruited as a result of the investments in both the enoxaparin sodium and the dual purpose facilities.
ENOXAPARIN SODIUM PROJECT MAKE-UP
Aventis, formed by the merger of Rhone-Poulenc Rorer and Hoechst Marion Roussel, acquired the site for the Jurong island facility in October 1995 as a result of its acquisition of Fisons Plc, a British-based pharmaceutical company. Since 1993, the site has been used for the manufacture of nedocromil sodium. The three-storey facility, which cost $50 million and was opened in 1999, has more than doubled the company’s production of enoxaparin sodium. The present facility continues to make nedocromil sodium which is used in Tilade for the treatment of asthma. Aventis has also extended the facility on an adjacent four-acre plot at a cost of $15 million to manufacture increased supplies of sodium nedocromil and also sodium cromoglycate. Sodium cromoglycate is used in Intal for the treatment of ocular and nasal allergy conditions.
