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Early 2013 sees drug filings, launches and approvals in Japan

Includes medicines from Bayer, Takeda, Astellas and Eisai

The start of the year was marked by several product filings, approvals and launches in Japan, with news from Bayer, Takeda, Nobelpharma/Eisai, Astellas/Sanwa and Otsuka.

Bayer filed for approval of its VEGF Trap-Eye (aflibercept) treatment for macular oedema following central retinal vein occlusion (CRVO). The product, originally developed by Regeneron, was approved in Europe as Eylea to treat neovascular wet age-related macular degeneration (AMD) last November and has been available in the US for AMD and CRVO since 2011. In Japan it will be marketed by Bayer Yakuhin.

Takeda launched Lotriga (omega-3-acid ethyl esters 90) for the treatment of hyperlipidemia last week under license from the product's originator Pronova BioPharma of Norway. The purified omega-3 fatty acid product is already available in 60 countries worldwide, including the US and EU member states. Lotriga will be the first prescription medicine in Japan that contains purified eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Takeda has predicted sales of the product in fiscal 2012 will total "several hundred million yen", equivalent to single digit millions in dollars.

Eisai and Nobelpharma have launched brain cancer drug Gliadel (carmustine), which becomes the only sustained-release formulation approved for intracranial implantation in Japan. The drug is approved to treat a form of brain cancer known as glioma and will be marketed by Eisai and co-promoted by both companies. Nobelpharma acquired manufacturing and marketing rights to Gliadel from Eisai in 2009, with the Japanese drugmaker retaining an option to assume full marketing rights. The product was first launched in the US in 1997, and Eisai divested US marketing rights to Arbor Pharmaceuticals last month.

Astellas and Sanwa Kagaku Kenkyusho launched a new granule formulation of its Argamate (calcium polystyrene sulfonate) product that is indicated to treat excess potassium levels in the body (hyperkalaemia), a condition generally caused by renal failure. The product works by exchanging potassium ions in the intestine with calcium ions. Argamate Granules are designed to be easier for patients to swallow, said the two companies, which set up a strategic alliance in the area of kidney diseases last year. SKK manufactures and supplies the product to Astellas, which markets it in Japan, while both firms share co-promotion rights.

Finally, Otsuka Pharmaceuticals has filed for approval of a new line extension in its veteran Meptin (procaterol hydrochloride hydrate) asthma range. The new product features an improved dry powder inhaler (DPI) which is smaller, does not require shaking prior to administration and more resistant to moisture and dust penetration.

15th January 2013

From: Sales

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