CEO of Acorda Therapeutics Talks about Their Orphan Drug Products


Ron Cohen MD, President and CEO of Acorda Therapeutics Inc, spoke at the 31st Annual J.P. Morgan Healthcare Conference this week. According to Dr. Cohen, their lead drug, Ampyra (dalfampridine) had estimated sales in 2012 of approximately $266 million which is a 26% increase from 2011.

sales 2.jpgAmpyra for Multiple Sclerosis (MS)

In 2010, Ampyra was granted orphan drug approval to improve walking in patients with MS. Ampyra works by blocking potassium channels on the service of nerve fibers and thereby is believed to enhance the signal conduction in neurons that have lost or damaged myelin sheaths, such as the neurons damaged in MS.

ron cohen_0.jpgIn his presentation, Dr. Cohen noted that 73,000 patients have now taken Ampyra and that Acorda continues to increase patient access to the drug, especially in managed care where the drug renewed its tier 2 statuses with Aetna, Cigna, and United Healthcare. In 2013, Acorda plans to continue to establish Ampyra as the ‘standard of care to improve walking in MS’ through several measures including: 1) increased presence at consumer health fairs 2) ePrescribing pilot program to further streamline the reimbursement process, and 3) persistency programs through specialty pharmacies.


Ampyra for Other Indications

In addition to MS, Dr. Cohen said that Acorda is looking at hath safety and efficacy of Ampyra in both  post stroke deficits and cerebral palsy. Phase 1 studies for both indications have begun and results are expected in early 2013.

Diazepam Nasal Spray for Acute Repetitive Seizures (ARS)

In 2012, Acorda obtained diazepam nasal spray following the acquisition of Neuronex. It is estimated there are up to 175,000 patients with ARS and the only drug approved for ARS patients is diazepam rectal gel (Valeant’s Diastat).  At present Acorda’s diazepam nasal spray has an orphan designation for ARS and Dr. Cohen stated that they should file a NDA shortly and are hopeful that the nasal spray can be launched as early as 2014.

In a press release, Dr Cohen noted that in addition to ARS, diazepam nasal spray may also be effective for other neuromuscular conditions. Dr. Cohen said, “In December, we acquired rights to Diazepam Nasal Spray, which adds an important, potential near-term commercial asset to our pipeline. We are currently preparing a New Drug Application that we expect to submit to the FDA later this year. In addition, we expect to have three compounds in Phase 1 or Phase 2 clinical trials in the first half of 2013 that target significant unmet needs in the areas of heart failure, multiple sclerosis and spinal cord injury. We are also continuing to focus on potential in-licensing opportunities, primarily for approved or near-commercial medicines that can leverage our exceptional specialty commercial organization and other areas of company expertise.”

Printer Printing...