Japanese drugmaker Eisai said a site in the U.K. has won approval from the FDA to manufacture its new epilepsy drug, which the FDA approved nearly a year ago. Now it just needs the Drug Enforcement Agency (DEA) to quit sitting on it so it can get to market with Fycompa, a potential blockbuster.
"The FDA approval for the supply of our epilepsy drug perampanel is testament to the commitment we have made at our EMEA Knowledge Centre and the Hatfield manufacturing facility," Gary Hendler, CEO of Eisai EMEA said, according to Contract Pharma. "The U.K. is a competitive location for advanced manufacturing and packaging and I am delighted that we are now able to export products developed and manufactured here in the U.K. to the U.S."
The company said the site will make 6 different strengths of Fycompa tablets for the U.S. market. The FDA approved the drug in October 2012, but because it is classified a controlled substance with the potential for abuse, it also requires the DEA to take action. The agency assesses that risk and assigns each drug a classification accordingly. Fed up with waiting, Eisai last month asked a federal court to intervene, calling the delay "unreasonable and egregious."
It's the second time Eisai has had to wait on the DEA in recent months. Eisai is a partner with Arena Pharmaceuticals' ($ARNA) on the new diet drug Belviq. That drug was approved by the FDA in June 2012 but it was not scheduled by the DEA until this May.
The manufacturing site in the U.K. is also being readied for other new products, including its anticancer product, lenvatinib, now under development. The company in June said it was investing £8 million to expand its packaging there. The new facility will have 2,900 square meters of floor space and sit next to a packaging facility that is 7,800 square meters in size. The addition includes a 400-square-meter area for packaging highly potent compounds. The company said construction is set to begin this month and be ready for product launches in September 2014. Eisai said it expects to add up to 40 jobs at the new facility over the next 5 to 7 years.
- here's the Contract Pharma story
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