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Pharmaceutical Executive


But now, at long last, Acorda has a shot at the big time. The results of a recently completed Phase III study confirmed fampridine-SR's ability to improve walking in multiple sclerosis (MS) patients. Because about half of all MS patients require assistance in walking within 15 years of diagnosis, this is a major unmet medical need. The drug works by enhancing the ability of nerves to conduct electrical signals, and some 42.9 percent of patients taking fampridine improved their walking speed, compared with 9.3 percent taking placebo.

The company is ripe for acquisition by an MS player looking to bolster its franchise, according to Eric Schmidt, a managing director and senior research analyst for Cowen and Company. It's an attractive acquisition that could offer some much-needed revenue. Drugs that mitigate the effects of MS all have blockbuster potential of more than $1 billion in annual sales, reports BioHealth Investor. (Acorda partners with Elan on an aspect of drug delivery.)

The company markets a $13 million drug, Zanaflex (tizanidine), to treat spasticity and, in addition to its lead candidate, has three other molecules of interest. Cohen says he expects two compounds to start human clinical trials by next year, while the third, although least far along, shows potential to grow new nerve connections back after spinal cord and brain injuries. "That's really what I dreamed about when I first started the company," says Cohen.

Acorda expects to file an NDA for fampridine-SR in the first quarter of 2009. Will it be the break Cohen has been looking for, or are the study results merely Acorda's 15 minutes of fame? Stay tuned to see if the stock will shine, or if it will be curtains for the company.

TRENDWATCH: Steven Burrill, CEO of Burrill & Company: "There are lots of specialized companies out there. And as Big Pharma tries to build out some of their franchises, these companies become the only places to go."

COUGAR BIOTECHNOLOGY

A bolt-on oncology pipeline




With a focused oncology pipeline, Cougar Biotechnology finds itself out in front with some promising molecules that could alter the cancer treatment paradigm. Skeptics caution against the hype that's surrounded its lead compound abiraterone (media have called it the next prostate cancer wonder drug), but for those willing to take a gamble could have a shot at the glory, even with additional therapies in the market.

Abiraterone is a small-molecule drug that inhibits the production of testosterone in all types of tissue—not just the testicles—through the androgen receptor, which moderates prostate cell growth. Small studies presented at ASCO and in the Journal of Clinical Oncology show that 48 percent of patients experienced at least a 50 percent decline in prostate specific antigen (PSA) levels, a marker of the disease, and 17 percent experienced PSA decreases of more than 90 percent.

The drug has recently entered Phase III testing—where trials are expected to enroll like "wildfire." If all goes well, the company could submit an NDA to FDA by 2011.

"The doctors have been very excited about the activity they have seen," says Liang, of Leerink Swann. "If you look at the data, it has been consistent. The large size of the market, first-in-class [status], clear unmet medical need—all the factors make the drug really striking."

Certainly, there is desperate need. The American Cancer Society estimates that in 2008 there will be about 186,320 new prostate cancer cases in the United States alone. Another 28,660 men with advanced prostate cancer, who don't respond to treatment, will die. It is these men, who have failed on Taxotere, that abiraterone could help.


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