Boosted by 2011 net revenues of $210.5 million in the U.S., including fourth-quarter net revenues of $57.2 million, thanks to sales of Ampyra (dalfampridine) extended-release tablets, Acorda Therapeutics Inc. said Thursday it inked a deal to acquire privately held Neuronex Inc., which is developing a nasal spray formulation of diazepam for certain epilepsy patients.

In 2010, the FDA approved Ampyra, a potassium channel blocker, as the first therapy to improve walking in patients with multiple sclerosis (MS). The drug, launched last year, has FDA orphan drug status, giving it seven years of market exclusivity. (See BioWorld Today, Jan. 25, 2010.)

In laboratory studies, dalfampridine extended-release tablets were found to improve impulse conduction in nerve fibers in which the insulating layer, or myelin, was damaged.

The drug is marketed in the U.S. by Acorda and outside the U.S. as Fampyra (prolonged-release fampridine tablets) under a licensing agreement with Biogen Idec Inc., of Weston, Mass. That deal included $110 million up front and up to $400 million in milestones, plus tiered, double-digit royalties on ex-U.S. sales. (See BioWorld Today, July 2, 2009.)

Hawthorne, N.Y.-based Acorda reported 2011 GAAP net income of $30.6 million, or 76 cents per diluted earnings per share (EPS). For the quarter ending Dec. 31, 2011, the company's GAAP net income was $12.7 million, or 32 cents per diluted EPS.

Acorda was cash flow-positive in 2011 and closed the year with cash, equivalents and short-term investments of $295.9 million – an increase of $55.9 million over year-end 2010.

With wind in its sails from the first full year of Ampyra sales, Acorda made an up-front payment of $2 million to Neuronex, a development-stage biopharma based in Morrisville, N.C., and paid $500,000 of up to $1.2 million in research funding to prepare for a pre-new drug application (NDA) meeting on the nasal spray.

Neuronex was founded in 2010 by the former management team for Addrenex Pharmaceuticals Inc., which was sold in 2009 for $29 million to partner Sciele Pharma Inc., a unit of Osaka, Japan-based Shionogi & Co. Ltd. (See BioWorld Today, Nov. 17, 2009.)

Neuronex expects to file a 505(b)(2) NDA this year that will include pharmacokinetic data for the nasal spray and reference older investigations on efficacy and safety for Diastat AcuDial (diazepam rectal gel), a generic diazepam formulation marketed by Valeant Pharmaceuticals International, of Aliso Viejo, Calif. (See BioWorld Today, Aug. 29, 2008.)

"This acquisition fits within our strategy to bring in a near-term commercial opportunity in neurology, which leverages the company's experience in developing neurological products as well as leveraging our existing commercial infrastructure," Ron Cohen, Acorda's president and CEO, said during a conference call early Thursday morning.

Following the pre-NDA meeting, Acorda has the option to complete the Neuronex acquisition for an additional $6.8 million and assume responsibility for the nasal spray's development and regulatory programs. Cohen said those expenses would not exceed $8 million in 2012.

The deal, which closed Wednesday, includes potential payments to Neuronex and other undisclosed parties of $1 million for the completion and FDA acceptance of the NDA and up to $25 million following regulatory approvals in the U.S. and Europe. Acorda also will pay Neuronex milestone payments and royalties based on net sales of the compound.

"Our best guess is that, if approved, Neuronex could be a $25-$75M opportunity, which would likely be highly NPV-positive given the modest up-front cost and flexible back-end structure of the deal," ISI Group biotech and pharmaceuticals analyst Mark Schoenebaum wrote in a note following the company's conference call.

The Neuronex buy was made possible, in part, by growing sales of Ampyra. As of December 2011 , approximately 70 percent of individuals with MS prescribed Ampyra received a first refill, and about 40 percent received a sixth refill, according to the company.

Acorda hopes to increase that trajectory in 2012.

"We believe there is ample room to continue to grow Ampyra within its current indication, and we are supporting marketing initiatives to increase both consumer awareness and use in people with earlier stages of walking disability," Cohen said.

Although awareness of Ampyra among neurologists – particularly MS specialists – is nearly 100 percent, a poll commissioned by the company in mid-2011 suggested that consumer awareness was just 30 percent.

The company also is seeking to expand the drug's indications. In December, Acorda initiated a Phase II study of Ampyra in adults with cerebral palsy, with a proof-of-concept study in chronic stroke slated to begin in the second half of this year.

Acorda is weighting its 2012 R&D spending toward those studies. Cohen estimated the company would spend $50 million to $60 million in R&D next year, including Ampyra-related postmarketing studies, the proof-of-concept studies in cerebral palsy and stroke and sponsorship of investigator-initiated studies. Acorda also markets Zanaflex (tizanidine hydrochloride), a treatment for spasticity in MS and spinal cord injuries. In 2004, the company acquired the sales, marketing and distribution rights in the U.S. from Elan Corp. plc, of Dublin, Ireland. (See BioWorld Today, July 30, 2004.)

Acorda reported 2011 combined net revenue of $45.8 million for Zanaflex capsules and tablets and combined net revenue of $11 .8 million for the products in the fourth quarter. Earlier this month, Acorda authorized Watson Pharmaceuticals Inc., of Parsippany, N.J., to introduce generic Zanaflex capsules.

In addition, Acorda has a pipeline of therapies that have entered the clinic or will make such a move this year. Its glial growth factor 2 (GGF2) is in a Phase I study in heart failure that is expected to report top-line data in the second half of the year. That program was licensed in 2002 from CeNeS plc, of Cambridge, UK, which had gained GGF2 in its $44 million buyout of Cambridge, Mass.-based Cambridge Neuroscience Inc. (See BioWorld Today, May 7, 2004.)

Last year, Acorda licensed the worldwide development and commercialization rights to AC105, a proprietary magnesium formulation, from Medtronic Inc., of Minneapolis, in a $35 million deal that included $3 million up front, $32 million in regulatory and milestone payments, and single-digit royalties. The company plans to begin enrolling participants in a Phase II trial of AC105 in acute spinal cord injury in the second half of the year.

In 2000, Acorda inked a license agreement with the Mayo Clinic for exclusive worldwide rights to develop the remyelinating monoclonal antibody rHIgM22 and related antibodies in nervous system disorders. The company plans to submit an investigational new drug application for rHIgM22 in the first half of the year and to begin Phase I studies by the end of the year.

Cowen and Co. analyst Phil Nadeau said the year-end numbers offered no surprises, with pipeline developments key to the stock's upward mobility this year.

"We think Ampyra's proof-of-concept trials in new neurological conditions such as cerebral palsy, chronic stroke and transverse myelitis provide the best opportunities," he wrote in a research note.

Acorda's shares (NASDAQ:ACOR) gained 65 cents on Thursday, closing at $27.13.