Sygnis sees blockbuster potential for stroke drug

Germany's Sygnis Pharma AG is hopeful its experimental stroke drug now in mid-stage testing will reach blockbuster sales, with greater commercial potential for helping patients recover from stroke, executives said on Monday.

Sygnis expects mid-stage data on the drug, AX200, by the middle of 2011 as a treatment for acute stroke, Chief Executive Officer Alfred Bach told Reuters in an interview.

Sygnis has talked to "a variety" of companies specializing in the central nervous system market "as potential partners but they would like to see data next year before considering partnerships," Bach said after a formal company presentation at the BIO CEO & Investor Conference in New York.

Bach said Sygnis' current cash can carry the company to the second half of next year - "in time to see top-line data."

"If the data knocks our socks off" the company could seek approval for AX200 as an acute stroke treatment around the middle of 2012, said Karoly Nikolich, chief executive of Sygnis subsidiary Amnestix.

But potential partners are particularly interested in use of the drug for post-stroke recovery, Bach said, "because that would involve three-to-four times higher potential sales than acute stroke."

Sygnis has defined acute treatment of stroke as happening nine to 12 hours after the incident, and recovery treatment as one to three days afterwards.

Sygnis is seeking to start a mid-stage study for recovery use this year with about 200 patients, and could seek approval in 2014.

"We know from rat studies it can be used three days after stroke," Nikolich said, noting that the current standard of treatment, TPA, has to be used within 4.5 hours.

TPA is used in fewer than 10% of stroke patients, said Nikolich, the former head of neuroscience at biotech giant Genentech, now part of Roche AG.

"If we can begin two to four days after stroke, by that time you could get everybody," Nikolich said, noting that rats substantially recovered use of their limbs with the drug.

Nikolich said the potential price tag would be USD 5,000 per treatment. With 400,000 patients a year, equivalent to half the market of recovery patients in the United States, he said, "then you'd be looking at multibillion-dollar sales."