Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the Company has completed the acquisition of Neuronex, Inc., a privately held company developing a nasal spray formulation of diazepam. Under the terms of the agreement, Acorda paid $6.8 million to Neuronex to complete the acquisition.
"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," said Ron Cohen, M.D., Acorda's President and CEO. "This product leverages our existing sales, marketing and medical organizations, which have proved highly successful in bringing novel neurological therapies to market."
Diazepam Nasal Spray is a proprietary formulation of diazepam that Acorda is developing as a treatment for the management of selected, refractory patients with epilepsy, on stable regimens of antiepileptic drugs (AEDs), who require intermittent use of diazepam to control bouts of acute repetitive seizures (ARS). Currently, the only approved outpatient treatment option for people who experience this type of seizure activity is DIASTAT® AcuDialTM (diazepam rectal gel), a rectally administered gel formulation of diazepam. The nasally administered formulation potentially offers patients and caregivers a more practical and socially acceptable treatment option.
"There are up to 175,000 people in the U.S. who suffer from acute repetitive seizures despite being on stable regimens of antiepileptic medications. These seizures can occur at any time and have a profound impact on a person's life," said Enrique Carrazana, M.D., Acorda's Chief Medical Officer. "As an epileptologist, I am very excited that we are developing a product which, if approved, will represent a major contribution to patient care."
In addition to the closing payment to Neuronex, Acorda will provide additional payments of up to $18 million based on achievement of certain regulatory and manufacturing-related milestones, and up to $105 million based on specified sales milestones. Tiered upper single-digit to lower double-digit royalty-like earnout payments on sales will be paid if the product is approved. In addition, Acorda will assume responsibility for regulatory and sales milestone payments of up to $11 million and single-digit royalties to third parties, based on existing Neuronex licensing agreements.
Acorda made an initial option payment of $2.0 million to Neuronex in the first quarter of 2012, and provided $1.5 million in ensuing quarters to support certain research and development activities conducted by Neuronex prior to completing the acquisition.
Acorda plans to submit a 505(b)(2)-type New Drug Application (NDA) for Diazepam Nasal Spray to the U.S. Food and Drug Administration (FDA) in 2013. A 505(b)(2) application allows for an NDA that relies on medical literature and FDA's finding of safety and effectiveness for a previously approved drug product.
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