Acorda Expands Pipeline With Neuronex And New Ampyra Indications

Acorda Therapeutics reports strong Ampyra results in the fourth quarter and highlights the other indications it’s pursuing for the drug, as well as the consumer marketing campaign the company is about to undertake. Acorda also announced its intention to acquire privately-held Neuronex Inc. for $2 million upfront plus $500,000 in R&D funding.

Now that awareness of the multiple sclerosis drug Ampyra (dalfampridine) is high among physicians, Acorda Therapeutics Inc. is concentrating on alerting consumers to the benefits of the drug. The company is undertaking a strong push to connect with patients via a direct-to-consumer advertising campaign, supporting what it says is the drug’s already strong performance.

Beyond multiple efforts on the Ampyra front, Acorda has been moving its pipeline along and announced along with its year-end financial results that it has intentions to acquire privately-held Neuronex Inc.

Ampyra Awareness And Indications

Ampya revenues for the year were $210.5 million, up from $133.1 million in 2010. The company expects total Ampyra revenues for 2012 to grow to $255 million to $275 million. Ron Cohen, Acorda president and CEO, told investors that 30% of all addressable multiple sclerosis patients in the U.S. have tried the drug since its launch, with about 70% of those patients going on to refill the prescription (Also see "Acorda Builds Ampyra Promotion On Years Of MS Outreach" - Pink Sheet, 1 Feb, 2010.).

“Now up until now in the launch, we have focused more effort on the physician and the prescribers, educating them on the label, then educating them on the full breadth of what the label implies, particularly the fact that even early stage patients who are just beginning to lose walking function have shown an ability to improve with Ampyra,” Cohen said at the BIO CEO & Investor Conference in New York on Feb. 14. “But this year, our major focus is going to be on the consumer.”

The company believes that only 30% of patients know what the drug is and how it can help improve their ability to walk, while more than 90% of neurologists and 100% of MS specialists have been educated about the drug. Acorda also said that it is beefing up its reimbursement program, which places specialists in the field that will help physicians navigate reimbursement issues (Also see "Acorda Increases Efforts Around Ampyra" - Pink Sheet, 1 Aug, 2011.).

Stepping up the consumer campaign may also be one way to counter what Acorda executives have previously said is a difficult managed care environment. Some 25% of Ampyra prescribers rate managed care approval as extremely difficult, while 74% of scripts require prior authorization with doctors providing pre-qualification walking tests, according to a BioTrends Inc. survey published by Baird Equity Research on Feb. 15.

Acorda also has been concerned that the Ampyra name is getting confused with other brands. The company plans a focused consumer campaign that includes both print and online advertising.

“So we’ve rebranded this as the walking pill. What we found is, this is how patients often refer to it spontaneously. They talk about my walking pill,” said Cohen. “So this is an organic way of getting patients to connect with the drug. And we’ll be launching campaigns later this year built around this concept.”

Beyond its push to make Ampyra more widely recognizable to patients, the company is studying it in a swath of other indications including its use for upper arm strength for MS. Acorda has initiated a Phase II trial of Ampyra in adults with cerebral palsy, and expects to make a no/no-go decision by year-end. A proof-of-concept study of Ampyra in chronic stroke patients is expected to begin in the second half of 2012.

Adding To The Pipeline

Along with year-end results, Acorda announced on Feb. 16 that it has paid $2 million upfront for an option to acquire the privately-held Neuronex. Acorda will also pay another $500,000 now of up to $1.2 million in R&D funding to prepare for the company’s pre-NDA meeting for its diazepam nasal spray for treatment of epilepsy to reduce seizures. Following the pre-NDA meeting, Acorda has the option to complete the acquisition by paying Neuronex an additional $6.8 million. If completed, Acorda will assume oversight and financial responsibility for all future development and regulatory programs for the diazepam nasal spray. Neuronex shareholders stand to receive another $1 million for the completion and acceptance of an NDA, and up to $25 million following regulatory approvals in the U.S. and EU. Neuronex shareholders will also receive milestone payments and royalties based on sales.

“Not surprisingly, the acquisition is consistent with Acorda’s strategy of targeting late stage neurology assets,” wrote JPMorgan analyst Geoff Meacham. “Although growth for Ampyra looks intact and the pipeline is expanding, we see limited opportunities for upside on the top and bottom lines at current levels and few significant value-driving events in 2012.”

It’s unclear what the market size might be for the nasal spray, but a rectally-delivered version currently has sales of $100 million annually.

While all of the company’s near-term pipeline opportunities rest with other indications in Ampyra (and now the Neuronex drug), earlier pipeline opportunities include a magnesium-based spinal cord injury drug acquired from Medtronic PLC and an early effort to treat heart failure. A Phase II trial of AC105 in spinal cord injury is expected to begin in the second half of 2012. About 12,000 people get spinal cord injuries every year. AC105 would be used during surgery within hours of trauma. Medtronic produced animal data that showed the drug reduced the amount of permanent damage done to the spinal cord.

A Phase I trial of GGF2, a protein that binds to erbB receptors, in heart failure is ongoing with data expected in before the end of the year. While the company brought the drug in for neurology purposes, animal studies showed positive results in heart failure and myocardial infarction, prompting Acorda to start studies there.