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UPDATE 1-New Roche breast cancer drug wins backing in Europe and Japan

Fri, 20th Sep 2013 12:26

* Kadcyla approved in Japan, recommended for approval in EU

* EU agency also backs Algeta/Bayer prostate cancer drug

LONDON, Sept 20 (Reuters) - Roche's new breastcancer drug Kadcyla was approved in Japan on Friday andrecommended for approval in Europe, building on February's U.S.green light for the product.

Kadcyla is designed for patients with late-stage diseasewhose cancer cells contain increased amounts of a protein knownas HER2.

It works by attaching Herceptin to a drug called DM1,developed by ImmunoGen, which interferes with cancercell growth. ImmunoGen will receive a $5 million milestonepayment from Roche following the Japanese approval.

The European Medicines Agency (EMA) said on Friday itsexperts had also recommended a prostate cancer medicine, Xofigo,from Algeta and Bayer, which is alsoalready approved in the United States.

In addition, the EMA issued positive recommendations forJohnson & Johnson's diabetes drug Invokana, Gilead's HIV treatment Viteka, GlaxoSmithKline's lungdrug Relvar, AstraZeneca's flu vaccine Fluenz Tetra,Novo Nordisk's haemophilia drug NovoEight, Otsuka's schizophrenia drug Abilify Maintena and a prematureejaculation therapy from Plethora Solutions.

Recommendations for marketing approval by the EMA'sCommittee for Medicinal Products for Human Use (CHMP) arenormally endorsed by the European Commission within a couple ofmonths.

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Plethora Solutions Appoints New CFO, Non-Executive Director

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Plethora Says Fortacin Prescription Sales May Hit USD1 Billion A Year

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Plethora Solutions Continues Progress Towards Launch Of Fortacin

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Plethora Solutions' Treatment To Be Marketed As Fortacin In EU

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