By Lisa Seachrist
Cypress Bioscience Inc. received FDA approval to market the Prosorba column as a therapy for patients with moderate to severe rheumatoid arthritis (RA) who have failed common therapy.
The San Diego-based company and its German partner, Fresenius AG, of Bad Homburg, expect to launch the product April 5.
"The ability to treat patients without drugs is going to be very attractive to physicians, we think," said Carl Bobkoski, president and chief operating officer for Cypress. "This is fantastic for patients who are suffering from RA."
The Prosorba column has been on the market since 1987 as a device to treat idiopathic thrombocytopenia (ITP), an immune-mediated bleeding disorder. The device is a disposable filter that uses immobilized protein A to bind and remove circulating immune clusters of antibodies and antigens that are believed to be associated with autoimmune disorders such as RA.
The company was alerted by a physician in the early 1990s that the device appeared to have a favorable effect on patients with RA. Cypress then launched a clinical program in RA. The pivotal Phase III study ended in January 1998, more than a year early, due to favorable safety and efficacy data. The agency granted the product "special review" status in May 1998.
The standard course of treatment is 12 weekly outpatient apheresis sessions, each about 2 hours in length. The process is similar to kidney dialysis in which a patient's blood is removed, the cells are separated from the plasma, and the plasma is filtered through the column. The plasma is then recombined with the cells and returned to the patient.
The approval offers another option to the 250,000 rheumatoid arthritis patients in the United States who have moderate to severe rheumatoid arthritis, and either have failed disease-modifying anti-rheumatic drug (DMARD) therapy or can't tolerate those drugs.
Bobkoski said that currently the column sells for $1,100. Patients undergoing this therapy would need 12 columns. Bobkoski estimated that the cost of the entire procedure, including the columns and apheresis services, would total between $18,000 and $25,000 per treatment.
The profits from the sale of the columns could transform Cypress into a profitable company. Under the terms of the Fresenius deal, Fresenius has purchased $1.5 million in Cypress equity. In addition, Fresenius will pay licensing and milestone fees of up to $54 million based on sales. The agreement calls for a 50-50 profit split in countries outside the U.S. and profit sharing of 50-50 up to $25 million in sales. After that point, Cypress will receive 60 percent of the profits and Fresenius 40 percent. (See BioWorld Today, March 9,1999, p.1.)
"We anticipate that we will lose money this year," Bobkoski said. "We do anticipate breaking even next year and hope to have 10 percent to 20 percent of the patients using the column three to four years out."
Sales Projected To Exceed $25M In 2000
Jeffrey Davis, an analyst with the Bridge Technology Group in New York, estimated that sales will exceed the $25 million mark in 2000.
Cypress will manufacture the Prosorba column and has received a line of credit from Fresenius in order to support product launch and manufacturing scale-up. Fresenius will have the option to purchase the new manufacturing plant through the year 2000.
Fresenius, which operates dialysis centers, will serve as exclusive distributor of Prosorba and develop "Prosorba-friendly" instruments and disposables to make the therapy readily available at apheresis and dialysis centers.
Cypress will also conduct a Phase IV study to determine whether Prosorba is beneficial in combination with the commonly used DMARD, methotrexate.
"We think there will likely be a benefit from combining the two therapies," said Bobkoski. "It's just inherently logical. It's also likely the way that the column will be used."
Cypress' stock (NASDAQ:CYPB) closed at $3.938 a share Wednesday, up $0.313.