Cypress Bioscience, Developer of Fibromyalgia Drug, Eagerly Awaits FDA Deadline

10/10/08Follow @xconomy

Cypress Bioscience is one of those biotech companies that has limped along for more than 20 years, losing loads of money. In the lovely language of chief operating officer Sabrina Johnson, it has gone through “several reincarnations.” The company now expects to find out by the end of this month whether its latest incarnation will enable it live a prosperous life here on Earth.

The San Diego-based company (NASDAQ: CYPB), and its partner, Forest Laboratories, expect to hear from the FDA by the end of this month on whether they have clearance to start selling milnacipran for fibromyalgia. I visited Johnson at Cypress headquarters last week during my tour of San Diego. Wall Street doesn’t seem to think too highly of what’s going on here, with Cypress trading down more than 60 percent from its one-year high.

Cypress started down this path in 2001, when it licensed rights to milnacipran, a drug approved outside the U.S. for depression. Johnson says they decided to test the drug for fibromyalgia because of the way it’s designed to block the re-uptake of serotonin and norepinephrine, two pain-and-mood signaling chemicals in the brain. Cypress was well aware of fibromyalgia’s reputation as a questionable diagnosis and some doctors doubt it is real. Yet advocacy groups insist that as many as 6 million Americans have the disease, with about 90 percent of them women, Johnson says. In theory, this looks like an opportunity to sell a whole lot of the drug.

Two pharma giants, Eli Lilly and Pfizer, evidently agree. Pfizer’s Lyrica, a drug for nerve pain, became the first treatment approved for fibromyalgia in June 2007. Lilly’s depression medicine, Cymbalta, was next, getting FDA approval last June.

“Lilly and Pfizer threw more money at it, so they beat us to the endgame,” Johnson says. “We were just 12 people, little Cypress.” (The company has 25 employees now.)

It took a fair bit of time for Johnson to explain the clinical trial data, but I still felt pretty skeptical about them.

Cypress set up its trials to measure milnacipran’s effect on three main problems associated with fibromyalgia. It had to decrease pain by at least 30 percent; patients need to say they feel much or very much improved overall on a questionnaire, and they need to show improvement in activities of daily living like tying shoes and being able to go to work.

About 20 percent of patients in Cypress’ key clinical trial reached that combined goal, compared with 12 percent to 15 percent on placebo, which was a statistically significant difference, Johnson says. By a different measure that doesn’t score the activities of daily living, the numbers look a little better, with 25 percent on the drug responding. That compares with 13 percent on placebo, she says.

Still, the studies show a high dropout rate of 35 to 40 percent. The most common side effects are nausea in about 20 percent of patients; an increased heart rate of 7-8 beats a minute, and an increase in blood pressure of 2-3 points on both the systolic and diastolic scores.

The competitors don’t have squeaky-clean side-effect profiles, either. Lyrica causes dizziness and sleepiness, blurred vision, and weight gain, according to the FDA. Cymbalta patients reported increased rates of nausea, constipation, and fatigue than those on placebo.

Cypress plans to build its own sales force of about 100 national sales reps who will try to make the case for milnacipran against those big guys. They will target specialists like rheumatologists, pain specialists and physical medicine and rehab docs who get these patients as referrals, Johnson says. That leaves the army of reps from its partner, Forest, to go after the masses of primary care physicians, she says.

One piece to the Cypress strategy that I found interesting is that they aim to build on their relationships with rheumatologists to do more than just pitch a new drug. Cypress plans to offer a test rheumatologists can use to measure how their patients metabolize methotrexate, a cheap drug for rheumatoid arthritis that doctors usually have to give first before they resort to more expensive biotech drugs like Amgen’s Enbrel or Abbott Laboratories’ Humira. “We want to be a resource for physicians,” Johnson says.

I’m not sure physicians will really warm up to a fibromyalgia drug that offers a benefit for something like 8 percent more patients than a placebo. If the FDA says that’s good enough, Cypress will be able to chart its new course. “We’re going to be a commercial organization,” Johnson says. “This is a model we think we can build a sustainable organization with.”

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