AMT's muscular dystrophy drug obtains European orphan designation

Wed. October 14, 2009; Posted: 05:04 AM

Oct 14, 2009 (Datamonitor via COMTEX) -- AMLRF | Quote | Chart | News | PowerRating -- Amsterdam Molecular Therapeutics, a Netherlands-based company engaged in the field of human gene therapy, has reported that the European Medicines Agency has granted orphan drug designation to the company's gene therapy product AMT-080 for the treatment of Duchenne muscular dystrophy.

Orphan drug designation for Duchenne muscular dystrophy entitles Amsterdam Molecular Therapeutics (AMT) to 10-year market exclusivity in Europe following marketing approval for AMT-080 if this product candidate is the first new drug with a major medical benefit receiving marketing approval for the EU.

The designation also provides for special benefits, including research support, eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees during development or at the time of application for marketing approval, AMT said.

Jorn Aldag, CEO of AMT, said: "We are proud to have received this orphan drug designation for the treatment of Duchenne muscular dystrophy. This designation is an important next step in the development of a treatment for this progressive and devastating disease."

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