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GEN News Highlights : Apr 18, 2012
Acorda Eyes Additions to Neurodegenerative Disease Drug Pipeline
Two months after announcing plans to acquire Neuronex, the CEO of Acorda Therapeutics says his company hasn’t ruled out snapping up additional neuroscience drug developers that have reached commercial phase or are close to it.
“If we had opportunities that were going to be on the market soon or in the market now, that would be attractive. That was the impetus for the deal with Neuronex,” Acorda CEO Ron Cohen, M.D., told Xconomy in an interview before the company’s R&D day for analysts, held Tuesday in New York City.
On February 15, Acorda paid Neuronex $2 million up front and $500,000 of up to $1.2 million in research funding. The moeny will be used to prepare an NDA for a nasal spray formulation of the epilepsy treatment diazepam.
Cohen said that after a pre-NDA meeting with FDA, “we’ll make the determination of what we think the prospects are. If we like it, we’ll close the deal.” If Acorda closes the deal, it will pay Neuronex an additional $6.8 million, then assume oversight and financial responsibility for all future development and regulatory programs for diazepam nasal spray. Acorda has projected those expenses will not exceed $8 million in 2012.
That deal, Dr. Cohen said, attracted Acorda because diazepam was effective at stopping seizures, met an unmet need, and used a novel delivery method despite being an older drug. “That in itself constitutes an innovation that is beneficial to patients.”
If the Neuronex deal closes, the company’s former shareholders stand to gain up to an additional $18 million in payments tied to regulatory and manufacturing milestones for diazepam, plus up to $105 million tied to sales milestones for the nasal spray, as well as tiered royalty-style payments “ranging from the upper single digits to lower double digits, on worldwide net sales.” However, Neuronex must also pay the patent and IP holder SK Biopharmaceuticals up to $8 million tied to development milestones, including $1 million upon FDA acceptance for review of diazepam’s first NDA, up to $3 million linked to sales milestones, and a “tiered, mid-single digit” royalty on net sales.
“For us to bring in something now, it would have to be even more compelling than usual. We’re looking more in the commercial realm, where we can leverage our sales team in neurology,” Cohen said. That sales team, according to Acorda’s 10-K annual report for 2011, filed with the SEC, consists of “approximately 93 sales representatives in the field calling on a priority target list of approximately 7,000 physicians. The sales reps call primarily on neurologists and on other specialists and prescribers treating patients with multiple sclerosis (MS), as well as other conditions that involve spasticity.”
Acorda's sales force was formed initially to sell its first commercial product, the 10 mg dose of Ampyra extended-release tablets for improvement of walking in people with MS. Ampyra generated net revenue of $210.5 million last year, accounting for 82% of Acorda’s net revenue. According to the company, about 30% of all eligible MS patients have tried Ampyra between the 2010 launch and December 31, 2011, including roughly 19,000 new patients last year.
Acorda hopes to extend Ampyra’s success by expanding its indications. The company is now in a Phase II study of Ampyra in adults with cerebral palsy (CP), initiated in December. “There’s a tremendous unmet need in CP,” Dr. Cohen said. “People with CP have primarily the same issues as people with MS have: motor weakness, sensory weakness, spasticity, cognitive issues, walking issues, and so forth. Right now there’s nothing really that’s specifically indicated to improve neurological function in those people. Our hope is if it works, it will improve function to help them walk better and to use their arms and legs better."
Acorda has told investors it plans to begin a Phase II study of dalfampridine in chronic stroke patients during the second half of this year.
Last summer, Acorda moved to expand its drug pipeline by paying $3 million up front to Medtronic for worldwide rights to a Phase II-ready magnesium formulation, designated AC105, which will be evaluated as an acute treatment for patients with neurological trauma including spinal cord injury (SCI) and traumatic brain injury (TBI). In a statement at the time, Dr. Cohen hailed AC105 as “an important addition to our existing pipeline, saying it would complement preclinical programs in remyelination and spinal cord injury,” as well as GGF2, the clinical-stage lead drug candidate for Acorda’s neuregulins program, which has been in early Phase I trials for the treatment of heart failure.
Acorda plans to announce initial results for the GGF2 study during the second half of this year, during which it also hopes to begin a Phase I trial for the lead antibody in its remyelinating antibody program, rHIgM22, for MS. The company has said it plans to file an IND during the first half of 2012.
“If we are able to establish a proof of concept for treatment of heart failure through human clinical studies, we may decide to develop the product either by entering into a partnership, most likely with a cardiovascular-focused company, or by developing it on our own,” Acorda stated in its 2011 annual report. “We also are continuing with research on potential neurology indications for GGF2.”
For spinal cord injury, Acorda’s early-stage pipeline includes the enzyme chondroitinnase, which Dr. Cohen called his favorite program. “It has, in my view, the best chance to increase plasticity of the injured central nervous system—brain, spinal cord,” Dr. Cohen said. “We’ve shown restoration of walking and bladder function in animal models of spinal cord injury. The science is well understood. My dream is for us to get this into the clinic for spinal cord injury.”
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