iNova Partner Eisai Achieves New Paediatric Indication for Tambocor® in Japan

19 May 2010
 iNova Pharmaceuticals today announced its partner Eisai Co., Ltd. (“Eisai”) has received approval to market anti-arrhythmic Tambocor® (flecainide acetate) 50mg and 100mg tablets in Japan for the new indication of tachyarrhythmia (paroxysmal atrial fibrillation/flutter, paroxysmal supraventricular, ventricular) in children, toddlers and infants where other anti-arrhythmic drugs cannot be used or are ineffective.

The additional indication is the first paediatric approval for Tambocor® in the Asia-Pacific region and follows the United States where the therapy is already approved for the treatment of tachyarrhythmia in children.

Tambocor® is also the first drug in Japan indicated for the treatment of ventricular tachycardia in paediatric patients.

First approved and launched in Japan in 1991 to treat tachyarrhythmia (paroxysmal atrial fibrillation/flutter, ventricular) in adults, where other anti-arrhythmic drugs cannot be used or are ineffective, Tambocor® is a well established proven prescription anti-arrhythmic medicine in many countries.

Indeed, Tambocor® has a longstanding heritage in the Asia-Pacific region, spanning up to three decades in some countries, and the clinical usefulness of flecainide is well recognised in the medical literature.

The Japanese Ministry of Health, Labour and Welfare’s Council for Paediatric Pharmacotherapy determined there was a clinical need to make flecainide available for paediatric patients in Japan. Tambocor® tablets would be appropriate for patients who, due to age or body size, have difficulty using catheter treatments or who do not respond to currently marketed anti-arrhythmic drugs.

Arrhythmia symptoms in children can include heart palpitations, breathlessness and dizziness, among other symptoms, while infants may show poor feeding, rapid breathing, pallor, sweating, lethargy and irritability.

Arrhythmia is considered to be an area of unmet clinical need in paediatric medicine, and it is likely that most unexplained sudden deaths in children have a primary arrhythmic origin. Yet there are at present in Japan few anti-arrhythmic agents with limited indications approved for paediatric use.

With Tambocor® as a new treatment option in Japan for paediatric patients with tachyarrhythmia, Eisai plans to continue making further contributions to address their therapeutic needs.

iNova has established numerous partnership deals with healthcare companies over the last three years to make available in-house developed, licensed and acquired brands in an increasing number of countries in the Asia-Pacific, Australia, New Zealand and Southern Africa.

With a proven track record developing, registering and marketing leading consumer healthcare and prescription brands, iNova welcomes further partnering opportunities with companies looking to commercialise products to meet the needs of patients, consumers and provide value.

Media contact: Athena Kolivos 61 (0) 412 857 698
Visit iNova Pharmaceuticals at www.inovapharma.com



iNova Pharmaceuticals:

iNova Pharmaceuticals (Australia) Pty Limited is an Australian owned and operated pharmaceutical company, and corporate headquarters for iNova Pharmaceuticals (“iNova”) operations across Australia, Asia-Pacific and Southern Africa.

Exporting to over 20 countries, iNova has leading consumer healthcare and prescription product brands with a current portfolio of in-licensed and in-house developed drugs mainly in weight management, pain management, allergy, sexual health, dermatology, cardiology and respiratory health.

iNova has over 50 years heritage from Riker Laboratories and 3M Pharmaceuticals following the November 2006 purchase of 3M’s Asia-Pacific pharmaceutical business by Australian private equity firms Archer Capital and Ironbridge Capital. Many products originally from these companies contribute to iNova’s diverse product range, alongside new ones in-licensed or developed and manufactured at the Sydney iNova Technology Centre.

iNova’s broad in-house capabilities include high quality sales and marketing, in-licensing, developing/acquiring products, manufacturing, quality and regulatory processes. Consequently, iNova continues to introduce new products into a solid Australia/Asia-Pacific business and very strong South African business, with plans to enter China.

iNova works in partnership with external parties (e.g. sales/marketing partners, distributors) to make products available to patients and consumers in numerous countries, and is an attractive licensing partner for companies entering the Asia-Pacific and Africa regions.

Further information is available at www.inovapharma.com

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