Acorda plans to submit 505(b)(2) NDA for diazepam nasal spray

Acorda Therapeutics says that it has completed its acquisition of Neuronex, including Neuronex’s diazepam nasal spray formulation, for $6.8 million. The company also announced that it plans to submit a 505(b)(2) NDA in 2013 for the diazepam nasal spray as a treatment for seizures in epilepsy patients.

In early 2012, Acorda paid $2 million to Neuronex as an option payment and subsequently paid the company $1.5 million per quarter for R&D activities. Additional payments of up to $18 million will be due as the company meets regulatory and manufacturing milestones, and royalties will be paid if the product is approved. Acorda will also pay up to $11 million in milestone payments and royalties to third parties who had licensing deals with Neuronex.

Acorda President and CEO Ron Cohen commented, “Diazepam nasal spray is an important addition to our pipeline and aligns with our core strategy to develop and commercialize products that offer unique benefits to people with neurological diseases. This product leverages our existing sales, marketing and medical organizations, which have proved highly successful in bringing novel neurological therapies to market.”

Read the Acorda press release.

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