Acorda: Commentary

(from July/August 2008 NI)

Fampridine-SR for MS performed better than expected in the second Phase III, as they also hit a secondary strength endpoint. The NDA will be filed early in 2009, we expect approval by mid-2010. We have seen estimates of Fampridine-SR uptake that peak at $400 million annually. This seems on the low side to us: the symptomatic focus of Fampridine-SR will limit their pricing, but the subjective benefits for patients will guarantee significant demand. We suspect that the potential annual revenue from Fampridine-SR exceeds $500 million. This should allow a vigorous revival of their preclinical MS programs, whose regenerative/repair potential would counterpoint Fampridine-SR's symptom focus quite well.

(from January 2008 NI)

They raised $67.1 million in a secondary offering, and now have completed enrollment in the second Phase III for Fampridine-SR in MS. The second PhIII involves just one primary endpoint, one which Fampridine-SR should be able to make without problem. Data should actually come before we had projected (how often do we say that?), in 2Q:08. That is still the key milestone for Acorda. They will continue to build Zanaflex sales, and will eventually be able to turn more energy to their preclinical pipeline.

(rom July/August 2007 NI)

Following a most dynamic 2006, and having raised $67.1 million in a secondary offering, Acorda now can pay for, and must execute, the second Phase III for Fampridine-SR in MS. The second PhIII involves just one primary endpoint, one which Fampridine-SR should be able to make without problem, and thus this is a slightly easier task. Completion could come by 3Q:08.

added 10/6/06 (from October NI)

It almost felt like someone had set the 'Way-Back Machine' for those halcyon days of the 1990's, when clinical results could make investors a fortune in a day. In contrast to the 21st Century, where investors have been more likely to lose a fortune in a flash.

Acorda's Phase III success with Fampridine-SR in MS precipitated a veritable skyrocketing of their share price--by the next day it had gone as high as 11.90, up 441%(!) from its pre-news level. Fampridine-SR, which does not alter the disease process in MS, improved all reported functional outcomes: patients taking Fampridine-SR in addition to their other MS medications showed an average increase in walking speed of 25.2%, placebo patients increased 4.7%. 34.8% were 'responders', more than four times the rate of responders in the placebo group. These results were remarkably consistent with the PhII data. This gives Acorda hope, albeit not assurance, that the FDA might be willing to consider the Phase II and III trials as confirmatory and pivotal, permitting them to file the NDA with what they have. On the other hand, with rare but serious treatment-related side effects, particularly seizures, the FDA may yet hesitate. NI sees this as the kind of situation where patients and physicians should be allowed to weigh the risk-benefits, and that this data should be sufficient to make Fampridine-SR one of the available options.

Acorda has been remarkably persistent in the development of Fampridine-SR, a process which has gone on for close to a decade. It had eventually failed in spinal cord injury, but this MS success is a key developmental 'inflection point' for Acorda. The question remains open as to whether one-trial approval has been prematurely built into the share price. The FDA's stance, given the current regulatory climate, is a toss-up at best. If they require another trial, some of this euphoric runup will be deleted (beyond the rollback already extant). But there is little doubt that, with or without another trial, that Fampridine-SR will reach the market sooner or later, and that Acorda's fortunes have now taken an enduring upward turn.•